The complaint, which also seeks a permanent injunction against the company’s owner and president Leonard Spada, was filed July 30 in the U.S. District Court for the Eastern District of New York. The Justice Department charges the defendant with violating federal food regulations by introducing food that was prepared, packed, or held under unsanitary conditions into the market and which may be contaminated.

FDA inspections in 2006, 2007, and 2009 found unsanitary conditions at NY Gourmet’s facility. Inspectors also documented the company’s failure to follow several federal regulations governing food products, including seafood. According to the FDA, the company promised to address and correct the violations each time, but a March 2010 inspection confirmed that the company failed to correct the problems.

Specifically, the complaint notes the presence of Listeria monocytogenes (L. mono) throughout the defendants’ facility and in a sample of its finished food products. The complaint also says that the strain of L. mono found in a sample of the defendants’ chickpea salad in 2010 was exactly the same as the strain found in the defendants’ facility during inspections last year, indicating that the bacteria had formed a lasting presence in the plant.

L. mono bacteria causes listeriosis, a disease that can be serious and even fatal for high-risk individuals such as unborn babies, newborns, the elderly, and those with weakened or impaired immune systems. The most serious forms of listeriosis can result in meningitis and septicemia. Pregnant women may contract flu-like symptoms from listeriosis, and complications from the disease can result in miscarriage or septicemia in the newborn.

“The continued presence of L. mono in a food processing facility is a particularly significant public health risk,” said Michael A. Chappell, acting associate commissioner for regulatory affairs. “In this case, the L. mono was not only found in the facility, but later turned up in a sample of the firm’s food. We will not allow food producers to put consumers at risk by repeatedly breaking promises to clean up their facilities.”

NY Gourmet Salads sells its products in New York and New Jersey, including supermarkets and airline caterers, possibly spreading germs and disease throughout the country’s most densely populated metropolitan areas and beyond.

SOURCE: Personal Injury Attorneys › FDA seeks to shut down Brooklyn food manufacturer for good

Since May 2010, The Centers for Disease Control and Prevention have identified a nationwide, four-fold increase in the number of Salmonella Enteritidis isolates reported by state and local public health laboratories and federal food regulatory laboratories. During late June and early July, CDC received reports of approximately 200 salmonella cases every week. Normally, CDC has received about 50 reports of Salmonella Enteritidis illness each week for the past five years. Many states have also reported the same pattern of increase since May.

The new food safety requirements apply to egg producers having 50,000 or more laying hens, which represents about 80 percent of production. Among other things, the new regulations require egg producers to adopt preventive measures and to use refrigeration during egg storage and transportation.

Salmonella associated with eggs poses a serious risk to public health. Infected individuals may suffer mild to severe gastrointestinal illness, short-term or chronic arthritis, and even death. The FDA and CDC expect that the new measures will reduce the number of Salmonella Enteritidis infections from eggs by nearly 60 percent.

Salmonella Enteritidis can be found inside eggs that appear normal. People typically become infected by eating contaminated eggs raw or undercooked. Eggs become contaminated on the farm, primarily by egg-laying hens that carry the infection.

“Preventing harm to consumers is our first priority,” said Margaret A. Hamburg, M.D., commissioner of food and drugs. “Today’s action will help prevent thousands of serious illnesses from Salmonella in eggs.”

The new rules requires smaller egg producers (those with fewer than 50,000 but at least 3,000 laying hens) whose shell eggs are not pasteurized or otherwise treated to comply with the regulations by July 9, 2012.

The rule does not apply to producers who sell eggs directly to consumers or have less than 3,000 hens.

SOURCE: Personal Injury Attorneys › FDA fights rapid rise in egg-related illness with new safety rules

According to a new report by the Transportation Department’s inspector general’s office, the allegations were first made by Mark Lund, an FAA inspector, who blew the whistle in 2005 and again in 2008, asserting that FAA managers routinely allowed Northwest to escape fines and other corrective action by voluntarily disclosing its safety violations.

According to the Dec. 2009 Investigator General’s report, because its problems and safety violations went uncorrected for so many years, “the status of Northwest’s compliance with more than 1,000 (safety orders) is unknown.” The report was released by the U.S. Office of Special Counsel, which handles federal whistleblower complaints.

Linda Goodrich, vice president of Professional Aviation Safety Specialists, the union that represents FAA inspectors, told the Associated Press that she is “appalled that an inspector has to go through this much of an extraordinary effort to raise serious safety concerns on behalf of the flying public.”

Lund has “taken a lot of abuse” since he went public with his allegations,” she told the AP. The special counsel’s office, which is required to report its findings to the president, said in a letter to the White House on Thursday that Lund’s allegations have largely been substantiated.

The letter also quoted Lund as saying that an inspector “has to typically fight through the FAA management chain” to perform his duties. He also said that the FAA’s “culture of placing the interests of the carrier over safety continues to pose a risk to the flying public.”

FAA spokeswoman Laura Brown said the agency “has taken corrective action on the issues identified in the whistleblower complaint and is continuing to monitor compliance.”

Northwest merged with Delta last year to become the world’s largest airline. All of the company’s planes now fly as Delta.

Delta spokesman Anthony Black told the AP that the company is “currently reviewing the documents and, as always, we will fully cooperate with the government agencies to ensure our core values of safety, quality and compliance are not compromised.”

SOURCE: Personal Injury Attorneys › FAA let Northwest Airlines ignore safety rules, government report finds

Quality

“The quality issues that the FDA has observed, many of which we had recently identified in our own quality reviews and communicated to the FDA, are unacceptable to us,” Johnson & Johnson admitted in a statement.

The FDA first expressed concern with the drug company’s manufacturing operations in February amid a flurry of complaints from consumers that the drugs contained foreign materials and black or dark specks. The plant was already scheduled for a routine inspection but based on the complaints the agency had received, the FDA acted more quickly and inspected the plant in April. By that time, the agency had received 46 consumer complaints over the past 11 months.

During the inspection, the FDA said there were no written procedures to ensure “the identity, strength, quality, and purity” of the drugs produced there. The agency also found that McNeill bought contaminated raw material from its vendors, which tested positive for a type of bacteria that the FDA has yet to identify. The agency cited McNeill for not following quality controls and for not maintaining adequate lab facilities for the testing and approval of drugs and their components. The FDA will continue its investigation and afterward will determine the best course of action to take against McNeil.

SOURCE: Personal Injury Attorneys › FDA finds children’s drug manufacturer lax in quality control

In January, Rep. Edward J. Markey, chairman of the House Energy and Commerce Subcommittee on Energy and the Environment, sent a letter to the FDA requesting information about the status of FDA’s ongoing review of triclosan in consumer products. Triclosan is an ingredient added to many consumer products to reduce or prevent bacterial contamination. It can also be found in products such as clothing, kitchenware, furniture and toys.

While it is not currently known to be hazardous to humans, several scientific studies have come out since the last time the FDA review the ingredient that show triclosan alters hormone regulation. Other studies suggest that triclosan contributes to making bacteria resistant to antibiotics.

In response to the chairman’s letter, the FDA explained that it is engaged in an ongoing scientific review of the product. The agency says that there is clear evidence that triclosan provides a benefit in some products but there is no evidence that it provides an extra benefit to health. The agency also says that it does not have evidence that triclosan in antibacterial soaps and body washes provides any benefit over washing with regular soap and water.

In light of the questions raised by the recent animal studies, the FDA is reviewing all the available data of triclosan in consumer products and will communicate its findings to the public in spring 2011.

Consumers can check the product’s ingredient list on the label to see if the product contains triclosan. For more information, read the FDA’s Consumer Update on triclosan.

SOURCE: Personal Injury Attorneys › FDA reviews safety of antibacterial products

Manufacturers claim using the candles can help rid the body of toxins as well as offer relief from sinus and ear infections, headaches and earaches, as well as improve hearing and brain function. Some report it being a cure for cancer. The FDA, however, says there is no scientific evidence to back up those claims and that instead, the agency has received reports of burns, perforated eardrums and blockage of the ear canal which required outpatient surgery from the use of ear candles.

Risk factors include fire; burns to the face, ear canal, eardrum and middle ear; injury to the ear from dripping wax; plugging of the ears by candle wax; bleeding; perforation of the eardrum; and delay in seeing needed medical care for an underlying condition.

The FDA is particularly concerned because some ear candle manufacturers are promoting the use of ear candles with children. Children of any age, including babies, are likely at increased risk for injuries and complications if they are exposed to ear candles as they can move during use and increase the likelihood of wax burns and ear candle wax plugging up the ear canal. The smaller ear canals may also make them more susceptible to injury than adults.

Ear candles are sold and promoted in a variety of retail markets including health food stores, flea markets, health spas and salons, as well as commercial Web sites. The agency , along with Health Canada, is taking action against manufacturers of ear candles, including import alerts, seizures, injunctions, and warning letters. Anyone who has been injured while using this or any other product is urged to report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.FDA.gov/MedWatch.

SOURCE: Personal Injury Attorneys › FDA warns consumers against using ear candles

Dr. Margaret Hamburg

“We’re trying to get the point across to industry that we want them to comply with the law because it affects public health,” Thomas Abrams, head of the FDA’s Drug Marketing, Advertising and Communications Division, (DDMAC), told Reuters. “If you don’t comply with the law, we are going to take action. We are not going to tolerate having consumers or health care professionals misled.”

DDMAC is charged with reviewing all drug promotions to consumers and health professionals, including television advertisements, Web sites and conference print materials, which companies are required to submit to the FDA for approval when they are made public. If DDMAC considers an advertisement to be overstating a drug’s benefits, the division issues a letter of enforcement. If at all possible, Abrams said, the agency tries to work with companies before they begin promotions to avoid sending out a misleading message.

Hamburg’s initiative on the matter, and a more streamlined process within DDMAC for reviewing product promotions has made the system run much more smoothly, Abrams said. The FDA announced it has already issued nine letters for the month of January.

SOURCE: Personal Injury Attorneys › FDA cracks down on misleading drug promotions

STERIS Corporation has modified its System 1 Processor, or SS1. The modified version has not been approved or cleared by the FDA, thus the agency has not determined whether it is safe or effective for its labeled claims, including claims that it sterilizes medical devices. Use of a device that is promoted to sterilize or disinfect a medical or surgical device, but does not do so properly, poses risks to patients and users, including transmitting pathogens to patients and health care staff, or exposing them to hazardous chemicals. Improper sterilization or disinfection may also adversely affect the quality and functionality of reprocessed instruments.

Some malfunctions of the SSI that had the potential to cause or contribute to serious injuries or infections to patients have been reported to the FDA. Infections that may have come from improperly sterilized or disinfected medical devices as a result of the SS1 may be difficult to attribute to the SS1 and may go unreported. The FDA has also received reports of injuries, mostly burns from exposure to the sterilant solution, to health care facility staff operating the device.

The FDA issued a warning letter to STERIS advising the company that its change to the SS1 caused it to be adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act, and that those changes could significantly affect the safety or effectiveness of the device.

STERIS says it will work with customers to transition them to legally marketed replacements for the SS1.

SOURCE: Personal Injury Attorneys › Surgical sterilizing, disinfecting system may pose risk to patients

Twenty-five percent of college drinkers prefer to party with alcoholic energy drinks because the caffeine enables them to keep going and drink more. After Anheuser-Busch and MillerCoors introduced the first caffeine-alcohol hybrids to the market two years ago, the attorneys general of 29 states successfully pressured them to remove the caffeine from the drinks. Sparks, made by MillerCoors, contained 6% alcohol, while the alcohol content of Anheuser-Busch’s Tilt varied from 6.6% to 8%, depending on flavor.

A multitude of smaller manufacturers began producing alcoholic energy drinks to fill the market void that was created when the beer giants agreed to eliminate caffeine from their alcoholic beverages.

According to research conducted by Dr. Mary Claire O’Brien of Wake Forest University’s School of Medicine, students who drank combinations of alcohol and caffeine risked injury and other alcohol-related consequences at a rate much higher than those who drank alcohol without caffeine. Alcoholic drinks containing caffeine effectively mask feelings of intoxication, making drinkers feel mistakenly sober or less intoxicated than they actually are.

The FDA says that although caffeine is an approved and legal substance, it is illegal to use it in ways that aren’t approved by the agency, such as combining it with alcohol.

SOURCE: Personal Injury Attorneys › FDA demands proof that alcoholic energy drinks are safe

More than 41 million doses of the 2009 H1N1 vaccine have been allocated to the United States for distribution, with more coming available daily. But a gap still remains between demand for the vaccine and the current available supply. The letter does not address if or when the demand will be met.

However, the fact that any vaccines are available at all is positive, says Hamburg. Her letter states that is the first time in history a vaccine has been available at the time that an influenza pandemic has struck. “We are not cutting any corners,” Hamburg said. “Just as for the seasonal influenza vaccine, no lot of the 2009 H1N1 vaccine can be used until it has been carefully evaluated and released as sterile and potent by both the manufacturer and the FDA.

The FDA and other agencies are also investigating any possible serious adverse events associated with the vaccine, and is urging consumers and health care providers to report any adverse effects believed to be linked to the vaccine to the Vaccine Adverse Event Reporting System at vaers.hhs.gov/index. More information is available at www.flu.gov.

“It is likely that most families in the United States will be touched by H1N1 influenza this year. Fortunately, many will experience mild illness. Others will endure unspeakable tragedy. The benefits of preventing serious consequences from infection with the 2009 H1N1 influenza virus far outweigh the risks associated with vaccination,” Hamburg said. “All Americans, and especially pregnant women and others at high risk of severe influenza infection, should seriously consider the recommendation for vaccination to help protect themselves and their loved ones.”

SOURCE: Personal Injury Attorneys › H1N1 vaccine coming at pivotal time

The particulate matter that may be in the recalled lots has been identified as stainless steel equipment used in the manufacturing process. Hospira is undertaking this recall in consideration of the potential for safety issues if the products are administered to patients. Since these particulate contaminants do not dissolve in blood they could potentially act as emboli and impede blood flow.

Particulates may also cause mechanical damage to the body and may escalate damage through the Systemic Inflammatory Response Syndrome (SIRS). Restriction in blood supply to tissues could lead to stroke, respiratory failure, kidney failure, liver failure, heart attack and/or death. Hospira has not received any reports of adverse events related to this issue.

In July, lots of propofol injectable emulsion made by Teva Pharmaceuticals were recalled after 41 reports of propofol-treated patients experienced post-operative fever, chills and other flu-like symptoms. Adverse health events such as fever, chills, or rigors are possible with exposure to products with high endotoxin levels. Serious adverse effects, such as disseminated intravascular coagulapathy, acute respiratory distress syndrome, shock and death are possible with exposure to products with high endotoxin levels.

Propofol is also one of the drugs found at pop star Michael Jackson’s house during an investigation into the singer’s sudden death. Propofol is a powerful anesthetic and not meant for home use.

Any adverse events that may be related to propofol or any other medication should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program online at www.fda.gov/MedWatch/report.htm.

SOURCE: Personal Injury Attorneys › FDA recalls contaminated lots of anesthetic propofol

Off-label marketing

After Bayer was admonished over its Yaz ads, attorneys general of 27 states joined the FDA in cracking down on misleading consumer advertising. In 2008, the FDA ordered Bayer to create new, corrective ads that clearly communicated the drug’s approved uses and risks. The new commercials cost Bayer about $20 million, just a minute fraction of the hundreds of millions Yaz earns Bayer each year.

$20 million, in big pharma terms, is a slap on the wrist – if even that. Bayer’s deceptive Yaz promotions earned the company many millions more. $600 million more, to be more precise. Unfortunately, Bayer’s dishonest and highly questionable marketing scheme paid off.

Johnson & Johnson execs are also playing dumb and forgetful now that former sales representatives are stepping forward with lawsuits alleging the company pressured them to push the drug Risperdal for unapproved uses. The FDA approved Risperdal for use in adults with schizophrenia, but Johnson & Johnson wanted its reps to persuade doctors to use it as a treatment for bipolar disorder in children.

36-year-old Lynn Powell filed a lawsuit against Johnson & Johnson in a New Jersey court, claiming that the company fired her from her sales position in 2004 when she complained she was being pressured to sell Risperdal as a treatment for children and others even though the FDA had approved it for use in schizophrenic adults only.

When Powell’s attorney asked Matthew Thompson, Powell’s supervisor at the time she was fired, if he was aware that making off-label claims was illegal, Thompson replied “I probably was.”

With powerful drug companies calling the shots in Washington and putting profits over people, it can’t hurt to explore the FDA-approved uses of the pharmaceutical medications you take. Always consult your doctor and pharmacist if you have any questions or concerns about the prescriptions you take.

SOURCE: Personal Injury Attorneys › Off-label marketing boosts drug company profits

Stiff Nights is manufactured by Impulsaria LLC of Grand Rapids, Michigan. It is sold in retail stores and on various websites in bottles containing 6, 12, or 30 red capsules. The product is also available in blister packs that contain one or two capsules.

According to the product’s website, Stiff Nights “works using natural ingredients to stimulate blood vessels, increase blood flow to the genitals, and special herbal extracts that help make the body feel sexually aroused and excited.”

Because it is made with herbs and other natural ingredients, the product is not regulated by the FDA. Consumers should avoid using natural supplements, including sexual enhancement remedies, that are unapproved by the FDA, as these substances can interact with other drugs, causing unwanted side effects, or may exacerbate certain medical conditions.

The FDA says that sexual enhancement products that claim to work as well as prescribed drugs “are likely to contain a contaminant.”

“Because this product is labeled as an ‘all natural dietary supplement,’ consumers may assume it is harmless and poses no health risk,” said Deborah M. Autor, director of FDA’s Center for Drug Evaluation and Research Office of Compliance. “In fact, this product is illegally marketed and can cause serious complications.”

“Use of such products exposes consumers to unpredictable risk and the potential for injury or even death,” the FDA said.

According to the FDA, over the last several years it has found many products marketed as “dietary supplements” for sexual enhancement that contain undeclared active ingredients of FDA-approved drugs, analogs of approved drugs and other compounds that do not qualify as “dietary ingredients.” The FDA has issued multiple alerts about these contaminated dietary supplements.

The FDA advises anybody who has experienced adverse events as a result of taking sexual enhancement products to see a health care professional. Side effects and negative reactions should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program, which can be accessed online at http://www.fda.gov/MedWatch/report.htm/. The information can also be reported by phone by calling the program at 1-800-332-1088.

The MedWatch web site also contains a section of postage-paid downloadable forms that may be filled out and returned to the FDA by mail to the address on the pre-adressed form or by fax (1-800-FDA-0178).

The FDA issued its warning about Stiff Nights after receiving reports of adverse events caused by the product.

SOURCE: Personal Injury Attorneys › FDA warns consumers about herbal enhancement pills

IV peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an IV drug is appropriate based on one or more of the following reasons:

1. The patient is not responding to either oral or inhaled antiviral therapy,
2. When drug delivery by a route other than intravenously, such as enteral (absorbed by the intestines) or inhaled, is not expected to be dependable or feasible,
3. In adults only, when the clinician judges IV therapy is appropriate due to other circumstances.

The FDA has reviewed the available scientific data on the medication and has concluded that the criteria for authorizing the emergency use of IV peramivir have been met. There are no FDA-approved intravenously administered antivirals for the treatment of influenza.

EUA authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products or their uses following a determination and declaration of emergency, provided certain criteria are met. The authorization will end when the declaration of emergency is terminated or the authorization is revoked by the agency.

Given the limited safety data on peramivir, mandatory reporting requirements are in place to help define the safety profile of this unapproved drug. Healthcare providers must report adverse events and all medication errors associated with peramivir to the FDA’s MedWatch program within seven days from the onset of the adverse event.

SOURCE: Personal Injury Attorneys › FDA issues authorization for investigational N1H1 drug

Although there is no way to completely avoid the bacteria that lead to food borne illnesses, there are some ways to reduce your risk of becoming sick. The Center for Science in the Public Interest (CSPI) has issued a list of 10 foods regulated by the Food and Drug Administration that are most commonly linked to outbreaks.

In issuing the list, the CSPI does not intend for consumers to avoid the foods most often contaminated altogether. Instead, it hopes that educating the public about the risks will help consumers dodge the bacteria rather than the foods themselves. Please note that the list does not include meat, which is regulated by the U.S. Department of Agriculture.

1. Leafy greens (363 outbreaks; 13,568 cases): lettuce, processed and bagged salad, and other greens account for nearly a quarter of all non-meat outbreaks, such as the 2006 spate of salmonella illnesses linked to fresh spinach. Generally, the more food is processed, the more opportunity it has to become contaminated by dirty water, equipment, and hands.
2. Eggs (352 outbreaks; 11,164 cases): Salmonella bacteria is sometimes passed from chicken to egg, and consumption of raw or undercooked eggs may cause illness. The bacteria is also sometimes transferred from the shell to other surfaces, such as the hands or food prep counter, causing cross contamination.
3. Tuna (268 outbreaks; 2,341 cases): fresh fish is highly perishable. When tuna starts to decay, it releases a poison called scombrotoxin, which causes headaches, cramps, diarrhea, eyesight loss, and other symptoms.
4. Oysters (132 outbreaks; 3,409 cases): Oysters feed by filtering the water they live in. If they live in dirty water, then the shellfish may become contaminated. They may also become contaminated by improper handling and storing. Nausea, vomiting, and diarrhea are the typical results of eating a bad oyster that is undercooked or raw.
5. Potatoes (108 outbreaks; 3,659 cases): Cross contamination is usually the way good potatoes go bad. While whole potatoes that are scrubbed and baked are normally safe, potatoes that are processed in the deli (potato salad for instance) sometimes come into contact with germs from other substances such as meat. Preparing potatoes on contaminated deli or restaurant counters also leads to food-borne illnesses.
6. Cheese (83 outbreaks; 2,761 cases): easily contaminated by salmonella and listeria. Soft cheese like feta, blue, and brie are typically to blame for food poisoning cases linked to cheese.
7. Ice cream (74 outbreaks; 2,594 cases): outbreaks in the past have been caused by transporting ice cream in a salmonella-infected truck and contaminated ingredients added after pasteurization. Illnesses from homemade ice cream usually are usually the result of using raw eggs.
8. Tomatoes (31 outbreaks; 3,292 cases): fresh tomatoes may appear clean, but they should always be washed thoroughly before using. Even fruits and vegetables that are peeled before eating should be washed, as the outer surface can contain a number of germs that can migrate to hands and other surfaces.
9. Sprouts (31 outbreaks; 2,022 cases): warm, moist growing conditions required for growing sprouts are also ideal fro growing bacteria. The FDA and CDC recommend that young children, the elderly, and people with weakened immune systems avoid eating raw sprouts.
10. Berries: (25 outbreaks; 3,397 cases): Berries imported from Central and South America have sickened people with Hepatitis A and Cyclospora, a germ that causes severe diarrhea, cramps, and dehydration.

The FDA found that the dosage dispenser in Tamiflu packages have dosage markings in 30, 45, and 60 milligrams (mg). American health care providers normally write prescriptions for liquid medicines , such as Tamiflu, in milliliters (mL) or teaspoons. The discrepancy between the American standard and the metric dosing dispenser has caused confusion and led some patients to erroneously ingest the wrong amount of medicine. The FDA has received reports that the doctor’s dosing instructions do not match with the dosing dispenser.

The demand for Tamiflu is extremely high worldwide because of the spread of H1N1 Swine Flu and other strains of influenza. Rather than recall the drug, the FDA has chosen to alert doctors, pharmacists and the general public about the Tamiflu dispensers. The agency advises doctors to write Tamiflu prescriptions in milligrams if the dispenser with the drug is marked in milligrams. Pharmacists should also compare the health care provider’s dosing instructions with the Tamiflu dispenser to ensure they match.

The Centers for Disease Control and Prevention (CDC) expects that the United States will experience “an early, prolonged and severe” influenza season in which both the H1N1 virus and seasonal flu are active. The CDC requests that pharmacists prioritize prescriptions for Tamiflu, with highest priority given to patients who are hospitalized with the flu virus or sick with flu symptoms and at increased risk of developing serious complications. People most at risk are pregnant women, young children, people age 65 or older, and people with chronic health problems.

SOURCE: Personal Injury Attorneys › Tamiflu dispensers cause dosage confusion and errors

According to Health magazine, consumers should keep these tips in mind while at the supermarket:

• Supermarkets should be clean and orderly. Avoid torn and broken packages and perishables stacked in the aisle. If cleanliness looks like it might be an issue, customers can ask to see the store’s grocery inspection results. Lower scores generally translate to higher risks.
• Buy nonperishable items first, then produce, dairy, frozen foods, meat and poultry, and prepared foods in that order to avoid foods thawing or becoming too warm. Separate items that are likely to contaminate, such as meat and poultry, away from produce and other items.
• Inspect the sell-by and use-by dates on product packaging. Quickly use or freeze any products if packaging dates indicate their time is nearly up. Look for fresher items toward the back of the shelves.
• Avoid produce with bruised or torn skin and suspect packages, which allow bacteria to easily enter and grow.
• Choose produce in its unprocessed form. Rebecca Spector, the Center for Food Safety’s West Coast director, told Health magazine that the majority of contaminated leafy green vegetables comes from packages, probably because the packaged produce goes through more processing steps and thus there is more opportunity for cross contamination. Wash and dry all produce thoroughly.
• Pay attention to how the items are stored. Meat and dairy products should be kept between 35-40 degrees. Produce should be displayed in open cases with misters. Items that are stacked too high or deep may be insulated and therefore too warm. Reach for the items toward the back of the case.

According to Health magazine, every year one in four Americans comes down with a food borne illness after eating contaminated food. That’s about 77 million people, many of whom are young children and the elderly, who can develop serious complications or possibly die if infected with bacteria such as salmonella and E. coli. The contaminated food is out there, but keeping these tips in mind can help keep you and your family safe and healthy.

SOURCE: Personal Injury Attorneys › Steering clear of potentially contaminated food

The recall, spurred by reports of a switch problem,  involves two ConMed Linvatec surgical service products. Self-activation in some circumstances cause injury, although ConMed has not received reports of injuries to patients. However, two reports of non-serious injuries to medical personnel were reported in 2006.

The recalled products include

• Power Pro, Power ProMax, and MPower 1 Handpieces, powered surgical handpieces in which a number of surgical tools (such as drills, blades, and small cutting devices) can be attached and are used during orthopedic surgical procedures.
• Universal Cables, MC5057, the cable connects Linvatec MicroChoice Small Bone, MicroChoice, Advantage and APEX Shaver System and Power Pro Electric I and II Large Bone System electric handpieces to the power source.

The handpieces were distributed from March 29, 2002 through June 24, 2009. The cables were distributed from January 24, 2001 through February 27, 2009. ConMed has instructed users to stop using the cable immediately if the handpiece self-activates or an intermittent operation occurs and to return the handpiece and cable to the company for evaluation.

Customers are encouraged to contact ConMed Linvatec with any questions or concerns at 1-800-535-8536 or email at CustServ1@linvatec.com.  Customers are also reminded that any adverse experiences with the use of these products, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

SOURCE: Personal Injury Attorneys › Surgical drills, blades, shavers self-activate spurring Class 1 recall

The analysis first came to light in early June through an early communication by the FDA, and early last month the FDA said it would require the drug makers to add a stronger warning to the black box warning currently on the products, which warns of an increased risk of malignancies but does not specifically mention leukemia. The new labeling will also add a warning of the occurrence of a new-onset psoriasis in patients treated with TNF blockers.

TNF blockers were approved in 1998 as a treatment for children with juvenile idiopathic arthritis (JIA), rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, inflammatory bowel disorder and Crohn’s disease. The updated black box warning applies to five drugs made by Abbott Laboratories, Johnson & Johnson, and a drug co-marketed by Amgen Inc. and Wyeth. TNF blockers are marketed as Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (Certolizumab Pegol) and Simponi (golimumab).

Between 2001 and 2008, the FDA received 48 reports of pediatric malignancy from patients. Thirty-two of the cases were from patients in the United States. Thirty-one cases of malignancy in children taking infliximab were reported; 15 cases of malignancy in children receiving etanercept were reported; and two cases of malignancy in children receiving adalimumab were reported.

Any adverse reactions to TNF blockers or any other medications should be reported to the FDA MedWatch Adverse Events Reporting program at www.fda.gov/medwatch/report.htm.

SOURCE: Personal Injury Attorneys › TNF blockers found to cause cancer in children

Pfizer has agreed to pay $1.3 billion in criminal penalties to the Justice Department for its illegal promotion of Bextra, a nonsteroidal anti-inflammatory drug used to treat arthritis and menstrual pain. Pfizer followed the recommendation of the Food and Drug Administration and withdrew Bextra from the market in 2005 after mounting evidence linked it with increased risk of cardiac arrest, stroke, and Stevens-Johnson Syndrome, a serious and often fatal skin disease.

Pfizer will pay an additional $1 billion in civil fines for fraudulent marketing of three other drugs, Geodon, Lyrica, and Zyvox.

The announcement was played up by the Obama Administration, which had Health and Human Services’ Kathleen Sebelius make the formal announcement today, presumably to offset criticism that not enough was being done to clean up Medicare and Medicaid fraud.

A New York Times report says that almost every drug maker stands accused of “giving kickbacks to doctors or shortchanging the Medicaid program on prices.”

“Prosecutors said that they have become so alarmed by the growing criminality in the industry that they have begun increasing fines into the billions of dollars and will soon start charging doctors individually as well,” the New York Times report said.

Pfizer has also agreed to pay $33 million amongst 42 states and the District of Columbia in claims involving the promotion of its drug Geodon, used in the treatment of schizophrenia.

SOURCE: Personal Injury Attorneys › Justice Dept. hits Pfizer with $2.3 billion in fines and civil penalties

A boxed warning is the sternest warning the FDA issues. Three drugs now have or updated updated information on their black box warning – Chantix (varenicline) 0.5 mg and 1 mg tablets, Wellbutrin (bupropion hydrochloride) tablets, sustained-release and extended release (XL) tablets, and Zyban (bupropion hydrochloride) sustained-release tablets. All three boxed warnings include risk for neuropsychiatric events including suicidality. All three drugs also have updated warnings and precautions. Chantix has updated its adverse reactions section as well.

New contradictions, warnings and adverse reactions have been added to the labeling of Ortho Evra (norelgestromin/ethinyl estradiol) birth control patch. The labeling emphasizes the risk of patients developing blood clots from elevated levels of estrogen. Those adverse events have resulted in serious injury or death in young women.

Other medications that had modifications to the BOXED WARNING, CONTRAINDICATIONS, ADVERSE EVENTS and WARNINGS sections in the FDA posting include Diabeta (glyburide), Lopid (gemfibrozil), Veramyst (fluticasone furoate), Actonel (risedronate sodium), Gardasil (Human Papillomavirus Quadrivalent Types 6, 11, 16, 18) Recombinant Vaccine, Letairis (ambrisentan), Myfortic (mycophenolic acid), Rilutek (riluzole), and Soliris (eculizumab).

SOURCE: Personal Injury Attorneys › FDA announces new warnings, adverse reactions on 38 drugs

Qualitest Pharmaceuticals, Inc., is recalling some lots of its Accusure Insulin Syringes because the syringes in the specified lots have been found to have needles that can detach fro the syringe. When the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after an injection.

The recall affects Accusure Insulin Syringes (1/2 cc – 31 G – short needle) with lot number 6JCB1 (Expiration 10.2010) – NDC 0603-7001-21. This lot was distributed between January 2007 and June 2007 to wholesalers and retail pharmacies throughout the U.S. and Puerto Rico. Qualitest is also recalling Accusure Insulin Syringes (1 cc-31 G – short needle) with lot number 7CPT1 (Expiration 03/2012) – NDC 0603-7002-21, which was distributed between May 2007 and June 2008 to wholesalers and pharmacies throughout the U.S. and Puerto Rico. The lot numbers for these syringes can be found on the white paper backing of each individual syringe.

Consumers who have any of the recalled syringes should stop using them and contact Qualitest at 1-800-444-4011 for product replacement instruction. Any adverse events associated with use of the syringes should be reported to the FDA’s MedWatch Adverse Event Reporting Program.

SOURCE: Personal Injury Attorneys › Insulin syringes recalled; may pose risk to patients

The new safety information will add the warning of the occurrence of leukemia and new-onset psoriasis in patients treated with TNF blockers to the current black box warning on TNF blockers. Those medications currently contain a warning for malignancies but does not specifically mention leukemia. The FDA also is requiring the manufacturers of TNF blockers to update the current Medication Guide to help patients understand the risks associated with TNF blocker therapy.

TNF blockers are a new class of arthritis drugs first approved by the FDA in 1998. The black box warning includes five drugs from Abbott Laboratories, Johnson & Johnson, and a drug co-marketed by Amgen Inc. and Wyeth. The drugs are prescribed to children with juvenile idiopathic arthritis (JIA), rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, inflammatory bowel disorder and Crohn’s disease.

The FDA urges both healthcare professionals and patients to report side effects from the use of TNF blockers to the FDA’s MedWatch Adverse Event Reporting program.

SOURCE: Personal Injury Attorneys › Arthritis drugs increase risk of cancer among children

Food safety has been a top priority for the U.S. government in modern times, but a slew of recent salmonella and E. Coli outbreaks threw open the curtains on a food safety system that has become dangerously inadequate and lax across the board, from regulation to inspection to enforcement.

John Dingell (D-MI), who sponsored the bill, said it would “fundamentally change the way in which we ensure the safety of our food supply.”

The bill would give the Food and Drug Administration, which regulates 80 percent of the nation’s food supply, more power to enforce food safety regulations. For instance, the FDA will be able to order recalls of contaminated food products. Currently, the agency only has the power to ask companies to recall contaminated products.

The bill would also increase the agency’s responsibilities by requiring it to inspect high-risk food processing plants every 6 to 12 months. Lower-risk plants would be inspected once every three years, while food storage warehouses would be inspected once every five years.

Under the current system, it was possible for some plants to run unlicensed and uninspected for years. For example, the peanut processing plant in Plainview Texas, which was part of the conglomerate that caused a massive salmonella outbreak last winter, didn’t have a license to operate and was never inspected by state or federal authorities. The outbreak was one of many in the last 3 years, drawing the ire of many legislators and compelling the Obama administration to vow a reform the federal food safety system.

Other provisions in the bill call for stricter and more thorough inspections of imported food, rules that will make the records of food processing companies more transparent to federal authorities, and a requirement that food companies establish safety plans aimed at slashing the incidences of contamination and food-borne illnesses.

In addition to more frequent and thorough inspections, the bill will require the FDA to develop a better way to quickly identifying the source of an outbreak. Such a plan would involve creating a tracking system for all food products, including ingredients.

The Consumer Federation of America praised the House on its passage of the bill, telling the New York Times that “the FDA has no specific authority right now, or responsibility, to prevent food-borne illness.”

“We hope the day will come when serious illness or death caused by contaminated food will be a thing of the past and we can feed our families without fear that the food carries a dreaded disease,” the federation said.

SOURCE: Personal Injury Attorneys › Historic food safety legislation passes House

The FDA has received adverse events reports for body building products that are labeled to contain steroids or steroid alternatives. These reports  involve men and include cases of serious liver injury, kidney failure and pulmonary embolism, commonly known as blockage of an artery in the lung.

Because of the serious nature of the adverse events reported following use of the body building products, the FDA is urging consumers to immediately stop using all body building products that claim to contain steroids or steroid-like substances. Health care professionals are advised to ask their patients about any over-the-counter body building and/or dietary supplement products they may be using.

Health care professionals and consumers are encouraged to report any adverse events related to use of the products to the FDA’s MedWatch Adverse Reporting program.

SOURCE: Personal Injury Attorneys › Body building products receive FDA warning; serious adverse reactions

POEA is a substance that is derived from animal fat. The U.S. Environmental Protection Agency considers POEA to be safe, both for the environment and for human health. The EPA even allows it to be added to ingredients that are USDA-certified organic. However, new studies show that POEA is actually deadlier to human cells than Roundup’s active ingredient, an herbicide called glyphosate.

Scientists call the finding “astonishing.” How can the government endorse the safety of both chemicals when they’re actually very destructive to human health?

The answer lies in the fact that POEA and glyphosate, both of which are FDA-approved for public use, are relatively safe by themselves. It’s when they’re combined that they become so dangerous.

The authors of the Roundup study said that their findings clearly confirm that the product’s inert ingredients are not inert at all. According to a report in the Environmental Health News, “the research team suspects that Roundup might cause pregnancy problems by interfering with hormone production, possibly leading to abnormal fetal development, low birth weights or miscarriages.”

POEA is a surfactant that is added to Roundup to help the glyphosate penetrate cell membranes more easily, thus intensifying the active ingredient’s toxicity. Similar studies conducted with other chemicals had similar results. In one Croatian study, researchers found an herbicide mixture containing the active ingredient atrazine damaged DNA structures, yet the atrazine by itself did not.

Monsanto stands by its claim that Roundup is completely safe when used as directed. The manufacturer contends that hundreds of studies spanning 35 years have demonstrated the safety of glyphosate.

“Roundup has one of the most extensive human health safety and environmental data packages of any pesticide that’s out there,” Monsanto spokesman John Combest was quoted as saying in the Environmental Health News. “It’s used in public parks, it’s used to protect schools. There’s been a great deal of study on Roundup, and we’re very proud of its performance,” he said.

The authors of the French University allege that even residual levels of Roundup and other “proprietary mixtures” can cause cell damage and even death. Many commercial crops are commonly treated with the herbicide. In the broader market, consumers use Roundup on their lawns and gardens.

These conflicting points of view should at least warrant a closer look and further research by the EPA and CDC. Even if the inert and active ingredients by themselves are safe, scientific evidence and real-life examples suggest their properties and abilities mutuate and intensify when combined.

SOURCE: Personal Injury Attorneys › Study suggests inert ingredients in Roundup are extremely hazardous

E-cigarettes generally contain cartridges filled with nicotine and other chemicals that are converted into a vapor that is inhaled by the user. The FDA’s analysis detected diethylene glycol in some samples and the carcinogens, including nitrosamines, in other samples. The e-cigarettes do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes.

The products are readily available online and at shopping malls and come in different flavors that may appeal to young people such as chocolate and mint.

Because the products have not been submitted to the FDA for evaluation and approval, the agency has no way of knowing the levels of nicotine or the amounts or kinds of other chemicals that the various brands of these products deliver to those who use it.

Health care professionals should report any adverse events or product quality problems associated with the use of e-cigarettes to the FDA’s Medwatch Adverse Event Reporting Program.

SOURCE: Personal Injury Attorneys › E-cigarettes found to contain carcinogens, toxic chemicals

Xolair is approved for use by adults and adolescents (12 years of age and older) with moderate to severe persistent asthma who test positive for reactivity to a perennial airborne allergen, and whose symptoms are inadequately controlled with inhaled corticosteroids.

The interim data, submitted by the manufacturer of Xolair, is titled Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS). The FDA is not recommending any changes to the prescribing information for Xolair and is not advising patients to stop taking Xolair at this time. Until the study’s data is completed and evaluated, patients and health care providers should be aware of the possible risks with taking the medication.

The safety communication is in keeping with the FDA’s commitment to inform the public about ongoing safety reviews of drugs. The FDA will communicate any new findings when its analysis of the interim safety data is complete. The EXCELS study is ongoing and results are not expected until 2012.

Patients are encouraged to report side effects from the use of Xolair to the FDA’s MedWatch Adverse Event Reporting Program.

SOURCE: Personal Injury Attorneys › FDA evaluating adverse events associated with Xolair asthma meds

The recalled products include brown gravy, brown gravy with mushrooms, brown gravy with onions, turkey gravy, pork gravy, country sausage gravy, country style gravy, Alfredo sauce mix, Cajun gumbo mix, and Hollandaise sauce mix manufactured by Sauer under the Sauer’s, Gold Medal, and Piggly Wiggly brand names.

According to the FDA, the recalled products include non-fat dry milk made by the Plainview Products Cooperative, which recently recalled its instant dry milk and other products because of salmonella contamination.

The recalled products are packaged in foil packets or plastic jars. Cartons of the mixes were shipped to retail stores in Alabama, Georgia, North Carolina, Mississippi, Ohio, Tennessee, Virginia, West Virginia, Kentucky, Florida, and Pennsylvania.

Salmonella bacteria cause serious and occasionally fatal illness in people with weakened immune systems, young children, and elderly people. Healthy people infected by Salmonella bacteria typically experience fever, nausea, vomiting, diarrhea, and abdominal pain. The bacteria may also enter the bloodstream and cause infected aneurysms and other arterial infections, endocarditis, and arthritis.

The FDA has not received any reports of Salmonella infection associated with this recall.

Consumers who have any of the recalled products may return them to the store of purchase for a full refund. They may also call the C.F. Sauer Company at 1-800-688-5676 between 8:00 am and 4:30 pm Eastern.

SOURCE: Personal Injury Attorneys › FDA announces recall of contaminated gravy and sauce mixes

The E. coli outbreak has sickened 70 people in 30 states since March 2009. Thirty of the reported illnesses led to hospitalization. While some of the E. coli infections have led to serious kidney damage, no deaths from renal failure or other complications have been reported.

The strain of E. coli found in the Nestle products lives in the lower intestines of cattle and other livestock and is typically spread after meat products have become contaminated with fecal matter. E. coli may also be found on unwashed produce, which was the case when contaminated spinach sickened dozens of people in the U.S. in 2006.

Because the contaminated cookie dough products don’t contain ingredients that harbor the bacteria and aren’t produced in shared facilities, investigators haven’t been able to determine how the E. coli found its way into the Nestle products.

Authorities are analyzing the ingredients, the factory’s premises and machinery, the workers and their health, and the plant’s proximity to cattle. The government is also considering whether the dough was contaminated intentionally.

The latest E. coli outbreak calls attention once again to the shortcomings of the U.S. food safety system and federal regulations. Congress has been working on new legislation that would hold food manufacturers to higher standards. At the same time, the FDA’s inspection system is being improved and its enforcement powers increased. The expected changes may come as early as this week.

SOURCE: Personal Injury Attorneys › Investigators still baffled over cookie dough contamination

According to the FDA, Nestle is cooperating fully with an ongoing epidemiological study being conducted by the CDC and several state health departments. Authorities say there have been 66 reports of E. coli food poisoning linked to the cookie dough products. The reported illnesses span 28 states.

Of the reported illnesses, 25 people have been hospitalized. Although there have been no reported deaths, 7 people have developed a severe complication called Hemolytic Uremic Syndrome (HUS), a form of kidney failure.

The FDA strongly advises consumers to throw out any prepackaged, refrigerated Nestle Toll House cookie dough products they may have in their home. The agency also advises against cooking the dough because the bacteria may easily be transferred to hands and other surfaces where it may cause infection.

Retail establishments, restaurants, and other food-service operations should also dispose of any of the cookie dough products immediately.

According to the FDA, the E. coli O157:H7 bacteria causes abdominal cramping, vomiting, and diarrhea. Healthy adults usually recover within a week. However, young children and elderly are at highest risk for developing HUS, which can lead to serious kidney damage and even death.

“We want to strongly advise consumers that raw cookie dough should not be eaten,” Nestle said in a statement.

Nestle said the recalled products included all varieties of Nestle Toll House refrigerated Cookie Bar Dough, Cookie Dough Tub, Cookie Dough Tube, Limited Edition Cookie Dough items, Seasonal Cookie Dough, and Ultimates Cookie Bar Dough.

Individuals who have recently eaten any of these products and have experienced food poisoning symptoms should contact their doctor or health care provider immediately.

SOURCE: Personal Injury Attorneys › Nestle cookie dough products recalled after E. coli outbreak

The study, which is funded by the FDA and the National Institute of Mental Health, compared the use of stimulant medications in 564 healthy children from across the United States who died suddenly, to the use of stimulant medications in 564 children who died as passengers in a motor vehicle accident. The study’s authors concluded that there may be an association between the use of stimulant medications and sudden death in healthy children.

The FDA cannot conclude at this time that data in the study affect the overall risk-benefit profile of stimulant medications used to treat ADHD in children. The study’s limitations include a significant lag time between dates when the deaths occurred and collection of the data; the difference in circumstances of death varied between family or caregiver; sudden, unexplained death in a child would be more likely to trigger a post-mortem inquiry into the cause of death than death due to blunt force trauma as a result of a motor vehicle collision; and there was a low frequency of stimulant use reported in both the study group and the control group.

The FDA advises that any child who develops cardiovascular symptoms such as chest pain, shortness of breath or fainting during stimulant medication treatment should immediately be seen by a doctor.

The FDA is continuing to review the strengths and limitations of this and other epidemiological studies that evaluate the risks of stimulant medications used ADHD in children. The FDA and the Agency for Healthcare Research and Quality are sponsoring a large epidemiological study that will provide further information about the potential for risks associated with stimulant medication use in children. That data is expected to be completed in late 2009.

SOURCE: Personal Injury Attorneys › FDA reviews possible link between ADHD meds, sudden cardiac death

Of heightened concern is that these products are promoted as antimicrobial agents for the treatment of open wounds and damaged skin and for protection against various infectious diseases.

The recall includes the following Clarcon products:
- Citrushield Lotion
- Dermasentials DermaBarrier
- Dermassentials by Clarcon Antimicrobial Hand Sanitizer
- Iron Fist Barrier Hand Treatment
- Skin Shield Restaurant
- Skin Shield Industrial
- Skin Shield Beauty Salon Lotion
- Total Skin Care Beauty
- Total Skin Care Work

The FDA warns consumers not to use any Clarcon products and to throw away any products currently in their possession. Health care professionals and consumers may report any serious adverse events or product quality problems with the use of any Clarcon products to the FDA’s MedWatch Adverse Event Reporting program here.

Source: FDA

SOURCE: Personal Injury Attorneys › FDA warns of contaminated skin sanitizers, protectants

Reports to the FDA’s Adverse Event Reporting System (AERS) suggest there is an increased risk of hepatotoxicity with PTU when compared to another medication used to treat hyperthyroidism, methimazole (MMI). Twenty-two adult and 10 pediatric cases of serious liver injury associated with PTU have been reported to AERS.

The FDA is asking healthcare professionals to carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease. Physicians also should closely monitor patients on PTU therapy for symptoms and signs of liver injury, especially during the first six months after initial therapy. PTU should not be used in pediatric patients unless the patient is allergic or intolerant to MMI and no other treatment options are available.

The FDA is continuing to monitor cases reported to AERS and working to make changes to the propylthiouracil prescribing information, particularly for use in pediatric patients. The American Thyroid Association also plans to update its treatment guidelines for Graves’ disease in the upcoming months to reflect the warnings.

Source: FDA

SOURCE: Personal Injury Attorneys › FDA issues serious risk warning with hyperthyroidism drug

Included in the recall are Respironics, Inc. SmartMonitor 2 Infant Apnea Monitor models 4002 and 4002 with serial numbers 3000033364 through 3000038740. The recalled monitors were manufactured from January 16, 2008 through November 13, 2008 and distributed from January 17, 2008 through December 31, 2008.

The devices are used for the continuous monitoring of respiration and heart rate of infants in the home or in the hospital. The monitor detects and sounds an alarm for periods of temporary interruption of breathing (central apnea) or low heart rates. The specified monitor models were recalled because of reports that the devices may fail to sound an alarm.

The recall follows an April 23, 2009 letter from Respironics, Inc. to its medical supply companies informing them of the potential problems. The letter specified that all units in inventory be returned and for the suppliers to retrieve and return all units already shipped to patients.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online at www.fda.gov/MedWatch/report.htm, by regular mail or by FAX at 1-800-FDA-0178. For a postage-paid FDA form for regular mail, visit www.fda.gov/MedWatch/getforms.htm.

SOURCE: Personal Injury Attorneys › FDA issues Class 1 recall on infant monitors

The paints are designed to be used on the face or body area using fingertips or brushes to make a desired design. The recall includes blue, purple, red, orange, black and green face paints. The FDA advises consumers to stop the use of these products and discard them or return them to the retailer.

Individuals with questions or who have experienced any adverse reaction from face paints should contact the FDA as well as state and local health authorities. To contact the FDA’s MedWatch Adverse Event Reporting system go online at http://www.fda.gov/medwatch/report.htm or call 800-FDA-1088.

Source: FDA

SOURCE: Personal Injury Attorneys › FDA issues recall of face paints due to adverse reactions

The labeling follows an FDA analysis of reports of suicidality (suicidal behavior or ideation) from controlled clinical trials of drugs used to treat the above mentioned conditions, which indicated a relative risk for suicidality was higher in patients with epilepsy compared to patients who were given the drugs in the class for psychiatric or other conditions.

The FDA is advising health care professionals to closely monitor all patients currently taking or starting any antiepileptic drug for noticeable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

The analyses included the brand name or generic versions of the following medications:

• Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
• Felbamate (marketed as Felbatol)
• Gabapentin (marketed as Neurontin)
• Lamotrigine (marketed as Lamictal)
• Levetiracetam (marketed as Keppra)
• Oxcarbazepine (marketed as Trileptal)
• Pregabalin (marketed as Lyrica)
• Tiagabine (marketed as Gabitril)
• Topiramate (marketed as Topamax)
• Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon),
• Zonisamide (marketed as Zonegran)

While the above mentioned drugs are the only ones included in the analysis, the FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly.

Source: FDA

SOURCE: Personal Injury Attorneys › FDA approves antiepileptic drug label update to include risk of suicidality

The recall notification applies to all ACCU-CHEK Sprint insulin pumps with serial numbers from SN02119552 through SN10006093. Disetronic says it has identified the root cause of the defect and is working to fix the problem. The company urges customers to continue to use their ACCU-CHEK Sprint insulin pumps but to monitor the functioning of the “up” and “down” buttons. Customers also are being asked to monitor their blood glucose as directed by their healthcare professional.

If the vibration or acoustic confirmation signal does not occur, the user should disconnect the pump and switch to a back up pump or an alternative method of insulin delivery. Immediately contact ACCU-CHEK Spirit hotline for a replacement pump or for any other questions regarding this potential defect. Customers should expect the replacement pump within 1-2 business days after contacting ACCU-CHEK Spirit hotline at 1-800-778-5095. This number is available 24 hours a day, 7 days a week.

SOURCE: Personal Injury Attorneys › Possible insulin pump defect sparks FDA recall

Personal Care Products

Bingham Farms, MI-based Personal Care Products has recalled all lots of Personal Care non-acetone nail polish remover, condition enriched with gelatin 6 fl. Oz., UPC 4815592076 because its formulation does not meet proper specifications. To date, the company has received two complaints from consumers of burns to the fingers resulting from use of the product.

The product is sold nationwide in small discount retail stores. Retailers are being instructed to remove the product from sale and to return it to Personal Care Products. Individuals who purchased a bottle of Personal Care non-acetone nail polish remover, condition enriched with gelatin is urged to return it to the store of purchase for a refund. Consumers with questions may contact Personal Care Products at 1-248-258-1555, Monday through Friday from 9 a.m. until 5 p.m. EDT.

SOURCE: Personal Injury Attorneys › Nail polish remover recalled for risk of chemical burns

Patients reporting liver injuries consumed Hydroxycut in doses recommended on the product packaging. According to the FDA alert, common symptoms of liver damage are “jaundice (yellowing of the skin or whites of the eyes), brown urine, nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.”

Linda Katz, M.D., the interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition, urged all consumers to avoid using Hydroxycut products. “Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products,” she said.

Hydroxycut dietary supplements are marketed as weight loss agents, fat burners, energy enhancers, low-carbohydrate diet aids, and water loss aids under the Iovate and MuscleTech brand names.

The current Hydroxycut recall includes the following 14 products:

• Hydroxycut Regular Rapid Release Caplets
• Hydroxycut Caffeine-Free Rapid Release Caplets
• Hydroxycut Hardcore Liquid Caplets
• Hydroxycut Max Liquid Caplets
• Hydroxycut Regular Drink Packets
• Hydroxycut Caffeine-Free Drink Packets
• Hydroxycut Hardcore Drink Packets (Ignition Stix)
• Hydroxycut Max Drink Packets
• Hydroxycut Liquid Shots
• Hydroxycut Hardcore RTDs (Ready-to-Drink)
• Hydroxycut Max Aqua Shed
• Hydroxycut 24
• Hydroxycut Carb Control
• Hydroxycut Natural

Not affected by the recall are Hydroxycut Cleanse and Hoodia products.

The FDA has not yet identified which specific ingredients, dosages, or other factors caused the reported health problems.

Potential liver-related problems linked to Hydroxycut were first reported seven years ago, but a clear relationship between the product and cases of liver disease was not discernible until recently. Hydroxycut products once contained ephedra, but the substance was removed in 2004 following reports of illness. Reports of liver damage persisted, however, despite the removal of ephedra.

According to an AP report, “health officials said they have been unable to determine which Hydroxycut ingredients are potentially toxic, partially because the formulation of the products has changed several times.”

Some medical researchers have raised questions about the safety of hydroxycitric acid, the central ingredient in many Hydroxycut products. According to the AP, one medical journal claimed last month that the substance, which is also known as brindle berry and Malabar tamarind, could potentially cause liver damage.

For more information, visit http://www.fda.gov/medwatch/safety/2009/safety09.htm#Hydroxycut

SOURCE: Personal Injury Attorneys › FDA urges dieters to avoid Hydroxycut products

FDA has ordered manufacturers to develop and implement a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the product outweigh the risks. The REMS will include a plan to communicate information regarding the risk for distant spread of botulinum toxin effects after local injection as well as information to explain that botulinum toxin products cannot be interchanged. The strategy also will include a Medication Guide that explains risks to patients, their families, and caregivers.

Botulinum toxin products have been approved by FDA for one or more of the following uses: temporary improvement in the appearance of glabellar lines (frown lines between the eyebrows), treatment of strabismus (crossed eyes), blepharospasm (abnormal tics and twitches of the eyelids), cervical dystonia (involuntary sustained or repetitive contraction of the neck muscles), and primary axillary hyperhidrosis (severe underarm sweating). For these uses, botulinum toxin is injected into the skin or into muscle tissue.

In pediatric post-marketing adverse events reports, botulinum toxins were mostly used to treat muscle spasticity in patients with cerebral palsy, a use not approved by the FDA. Reported adverse events reported following such use included difficulty breathing, difficulty swallowing, muscular weakness, drooping eyelids, constipation, aspiration pneumonia, speech disorder, facial drooping, double vision or respiratory depression. Serious case reports described hospitalizations involving ventilatory support and reports of death.

The majority of adult post-marketing reports of distant spread of toxin events occurred following use of the product for treatment of spasticity, which is not an FDA-approved use, and cervical dystonia. Some cases resulted in hospitalization, including several cases that required placement of a gastric tube or mechanical ventilation. Several deaths have been reported though the FDA says it is not possible to attribute them to botulinum toxin because the patients also suffered from complications from pre-existing conditions. Some reports are from dermatologic use however no definitive serious adverse events of distant spread of toxin effects with dermatologic use of Botox at the labeled dose of 20 units (for glabellar lines) or 100 units (for severe primary axillary hyperhidrosis) have been identified.

Adverse events have been reported as early as several hours and as late as several weeks after treatment.

The FDA recommends that healthcare professionals who use botulinum toxin products understand that the dosage strength are different among the botulinum toxin products; be alert to and education patients and caregivers about potential adverse events due to distant spread; and to advise patients to seek medical attention if they develop any symptoms following treatment.

SOURCE: Personal Injury Attorneys › FDA issues boxed warning for Botox and botulinum toxin products

The undeclared substance, Sibutramine, is an FDA-approved drug used as an appetite suppressant for weight loss. However, the recalled ABC Beauty Supply products are not supposed to contain Sibutrame and thus, with their current formulations, are not approved by the FDA and are of unknown safety and effectiveness. The products pose a threat because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk with patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

The recalled products are
1. ProSlim Plus, 60 capsules, bottle in box
2. 3 DAYS fit, 60 capsules, bottle in box
3. EIGHT FACTOR DIET, 60 capsules, 3 pouches/box
4. 24hours Diet, 60 capsules
5. Slim 3in1 M-18 ROYAL DIET, 90 capsules, 3 pouches/box
6. 3X SLIMMING POWER, 60 capsules, bottle in box
7. Extrim Plus 24 Hours RE-BURN Formula, 60 capsules
8. Slim 3in1 EXTRA SLIM FORMULA, 90 capsules, 3 pouches/box
9. Slim 3in1 EXTRA SLIM WAIST FORMULA, 90 capsules, 3 pouches/box
10. SLIM EXPRESS 360º C
11. SLIM EXPRESS 4in1, 60 capsules, bottle in box
12. ROYAL SLIMMING FORMULA, 60 capsules, bottle/box
13. BODY CREATOR, 90 capsules, 3 pouches/box
14. Slim Waistline (labeling written in Chinese)
15. BODY SHAPING, 90 capsules, 3 pouches/box
16. PERFECT SLIM, 90 capsules, 3 pouches/box
17. Perfect Slim 100% Natural Herbal Essence
18. IMELDA Perfect Slim
19. Slim Waist Formula, 32 capsules, 2 pouches/box
20. Super Slimming, 60 capsules, bottle in box
21. 2 DAY DIET
22. Powerful Slim
23. BODY SHAPING
24. SUPER FAT BURNER, 60 capsules, bottle in box
25. SLIMMING FORMULA
26. SLIM FAST 2, 32 capsules, 2 pouches/box
27. SLIM FAST, 60 capsules, 3 pouches/box
28. Slim up, 120 capsules, bottle in box
29. 7 DAYS DIET, 60 capsules, 3 pouches/box
30. Perfect Slim Up, 60 capsules, bottle in box
31. JM Fat Reducer
32. SlimBurn
33. 21 Double SLIM
34. TRIM PLUS 2

No illnesses or injuries have been reported to the company to date in connection with any of the recalled products.

Consumers are advised not to consume any of the recalled products and should return any dietary supplements on hand to the place of purchase for a full refund or partial refund of the unused portion. Consumers with questions should contact Sandra Tan at 718-891-6888, Monday through Friday, 12:00 pm through 6 pm, EDT.

Source:
FDA

SOURCE: Personal Injury Attorneys › FDA recalls dietary supplements for undeclared substance

Obviously, large food manufacturers have a reputation to uphold, so it’s not surprising that many of them perform optional, randomized testing of their products. Kraft performed such tests on its Back to Nature trail mix, which is how it discovered that pistachios from Setton International Foods, a California-based pistachio manufacturer, were contaminated with salmonella bacteria.

Still, many companies avoid testing their products before market, while others that perform tests may ignore the results – all of which underscores the need for a more effective food safety inspection system and better regulations.

“We’re relying on companies to find the contaminated foods on their own, and since there’s no national standards for this, some companies don’t bother to test at all,” said Rep. Diana DeGette, D-Colo., in an Associated Press report. “What if these nuts had been distributed by a company that doesn’t test? We wouldn’t have found out until people got sick.”

Another critic of the country’s food regulation system, Rosa DeLauro, D-Conn, said that Americans should be safe to assume that the food they serve to their families is okay to eat. “Unfortunately – from peanuts to ground beef to peppers to imported seafood – and just yesterday, pistachios – we have seen one devastating case of widespread food borne illness after the next,” she said in a statement before Congress.

DeLauro, like a growing number of Americans, voices her concern about the duplicitous nature of government agencies such as the FDA and USDA.

“I have long been concerned about USDA’s dual mission of promoting the products it is supposed to regulate. I believe this inherent conflict of interest at the agency has contributed to some of the food safety problems we have encountered over the years,” she said.

DeLauro added that the Food Safety and Inspection Service (FSIS) must be modernized “in a way that emphasizes prevention not just reaction, and recognizes that as long as the threats from food borne pathogens are constantly evolving, so too must the food safety system.”

However, the idea of reforming the nation’s food inspection system — requiring mandatory testing by food companies in particular — is meeting resistance by some lobbyists who believe testing would hinder business interests.

Robert Brackett of the Grocery Manufacturers Association told the AP that “You don’t want to do testing just for the sake of doing testing. That tends to be this one-size-fits all situation where it may work really well for some products and not for others. What we really focus on is for companies to build the safety into their programs in the first place.”

SOURCE: Personal Injury Attorneys › Salmonella: the bacteria that changed Washington?

A Class 1 Recall is the most serious type of recall and involves situations in which there is a reasonable probability that use of the product will cause serious injury or death.

The ventricular catheters are part of a surgically implanted system (shunt) that redirects excess fluid from the brain to another part of the body. Shunts are used to treat hydrocephalus, which is an excess accumulation of cerebrospinal fluid in the brain.

The recall includes all versions and lot numbers from catalog numbers 27782, 27708 and 27802. The products were manufactured from October 2002 through December 2008 and distributed from April 29, 2004 through December 12, 2008.

In February, Medtronic sent a recall notice to its customers informing them that they should stop using the device and return all unused products to the company. Medtronic also required its customers to account for each used (implanted) device and to advise surgeons of the recall.

Consequences for a patient with failure of a ventricular catheter may include: nausea, vomiting, headache, lethargy, change in mental status, seizures, visual disturbance, and other more serious conditions. Patients with questions are encouraged to talk with their physician or contact Medtronic Neurosugery at 1-805-571-8400, Monday – Friday, 8 a.m. to 5 p.m. CDT. Physicians with medical questions related to this issue or Medtronic therapies should contact Medtronic at 1-800-328-0810, Monday – Friday, 8 a.m. to 5 p.m. CDT.

Sources:
Medtronic
FDA

SOURCE: Personal Injury Attorneys › Medtronic issues recall on snap shunt, ventricular catheter

The FDA announced that Setton International Foods, Inc., a division of Terra Bella Inc., would voluntarily recall approximately 2 million pounds of roasted pistachios that have been shipping since last fall. The investigation and recall come after two people contacted the FDA complaining of symptoms of salmonella poisoning after eating the nuts. Although the link has not yet been confirmed, the plant where the pistachios were processed temporarily shut down last week.

The FDA was first alerted to a potential problem when a representative of Kraft Foods informed the agency that its Back to Nature Trail Mix tested positive for salmonella contamination. The company identified Setton pistachios as the source of the contamination and issued a recall.

Dr. David Acheson, the FDA’s assistant commissioner for food safety, said that consumers should avoid eating but hold onto any pistachio products. “The number of products that are going to be recalled over the coming days will grow, simply because these pistachio nuts have then been repackaged into consumer-level containers,” he told the Associated Press.

According to the FDA advisory, “the contamination involves multiple strains of Salmonella. Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Thus far, several illnesses have been reported by consumers that may be associated with the pistachios.”

The 2 million pounds of possibly contaminated pistachios constitute a very small fraction of the 278 million pounds of pistachios harvested in California last year. California is the second largest grower of pistachios in the world, just behind Iran.

Officials believe that the contaminated nuts entered the consumer market in 31 states. A representative of Setton Pistachio said the recall applies only to a specific lot of both in the shell and shelled roasted pistachios.

Jeff Farrar of the California Department of Public Health said that it may take weeks to determine specifically which products the possibly contaminated nuts affects. Setton packaged the pistachios in 2,000-pound containers and shipped them to 36 wholesalers throughout the U.S.

“It will be safe to assume based on the volume that this will be an ingredient in a lot of different products, and that may possibly include things like ice cream and cake mixes,” Farrar told the AP. “The firm is already turning around trucks in transit to bring those back to the facility.”

The outbreak comes on the heels of one of the country’s largest salmonella outbreaks and product recalls in history. Last winter, the Peanut Corporation of America knowingly distributed contaminated peanut butter products to food manufacturers and institutions throughout the U.S., which led to an outbreak of salmonella poisoning in nearly every state.

The FDA has since come under fire for failing to adequately protect the public from such outbreaks. Agency leaders have been working to “drastically compress” the timeframe of salmonella detection from 2 weeks to 2 days, stressing the need for federal agencies to work with each other in a concerted effort to protect the public’s health.

SOURCE: Personal Injury Attorneys › FDA eyes pistachios as it receives reports of salmonella poisoning

A Class 1 Recall is the most serious type of recall and involves situations in which there is a reasonable probability that use of the product will cause serious injury or death.

AEDs are devices used to emergency or medical personnel or by others who have completed CPR AED training courses. It is intended to treat adults in a heart attack (cardiac arrest). The device analyzes an unconscious patient’s heart rhythm and automatically delivers an electric shock to the heart if needed to restore a normal heart rhythm.

The recall was issued because the devices may experience low defibrillation energy delivery, unexpected device shutdown, and/or inadequate filtering of electromagnetic noise. These issues could lead to a sudden stoppage of the device, may prevent defibrillation of a patient in cardiac arrest, which could lead to death.

The AEDs included in the recall were manufactured from October 3, 200 through January 25, 2007, a full listing of serial numbers, please refer to the company’s press release here.

Customers who have the recalled devices should contact Welch Allyn at 1-888-345-5356 between 8 a.m. and 5 p.m. Eastern Standard Time. Customers may also visit the company’s recall website at www.welchallyn.com/AED10Recall for more information or to learn if their unit is subject to this recall.

SOURCE: Personal Injury Attorneys › Defibrillator manufacturer issues class 1 recall notice

Scott S. Reuben, the hospital’s former chief of acute pain, conducted research on several painkillers that were published in various anesthesiology journals between 1996 and 2008. Those studies, which provided encouraging information about the combined use of painkillers like Celebrex and Lyrica for patients undergoing procedures such as knee and hip replacements, were highly regarded by other physicians.

During a routine review last May, the hospital found that some of Reuben’s research was not approved by an internal hospital review board and that some or all of the data published in the medical journals was fictitious. Data included favorable results of the use of Bextra, Celebrex and Lyrica, made by Pfizer Inc., and Vioxx, made by Merck & Co. Inc. Reuben’s research also touted the benefits of Wyeth’s antidepressant Effexor XR as a painkiller.

He also reportedly asked the U.S. Food and Drug Administration (FDA) not to restrict the use of many of the painkillers he studied, citing his own data on those drugs’ safety and effectiveness.

In 2004, the FDA issued a Public Health Advisory warning that painkillers classified as Cox-2 selective agents, such as Vioxx, Celebrex and Bextra, may be associated with an increased risk of serious cardiovascular events especially when used over a long period of time or in a very high risk setting, such as immediately after heart surgery. The agency said this week it wasn’t aware of the matter involving Reuben.

Baystate Medical Center has asked the medical journals to retract the 21 studies authored by Reuben. To date, the journal Anesthesia & Analgesia said it retracted 10 of Reuben’s studies and the journal Anesthesiology said it retracted three.

Reuben received five research grants from Pfizer over a five-year period and was a member of the drug company’s speaker’s bureau. He is currently on leave from the hospital.

Sources:
Wall Street Journal
Associated Press

SOURCE: Personal Injury Attorneys › Prominent doctor accused of faking studies involving Celebrex, Vioxx

Class 1 recalls are the most serious type of recall issued by the agency and involve situations where there is a reasonable probability that the use of the product will cause serious injury or death.

The recall, issued to health care professionals, includes certain models of the Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corp. issued the recall after it identified software and battery usage failures that result in a delay in or interruption of fusion that may cause serious injury and/or death.

Recalled models identified in the recall of the Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps include Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161and 2M9163. They were manufactured and distributed from February 1997 through December 2008.

The recall notice follows a January 23 correction letter sent from Baxter Healthcare Corp. to all its customers about failures that could lead to interruption of therapy, damaged battery messages, smoke and fire hazards and serious injury and/or death. It advised institutions to have contingency plans to verify that back-up pumps are available, and provided new steps for addressing an interruption of therapy with any failure code, instructions for addressing damaged battery messages, and instructions for proper device cleaning.

Heath care professionals and consumers may report adverse reactions or quality problems to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch/report.htm.

Source:
FDA MedWatch

SOURCE: Personal Injury Attorneys › FDA Class 1 recall of infusion pumps; danger of serious injury, death

NMS is a neurological disorder that presents with muscle rigidity, fever, autonomic instability and cognitive changes such as delirium and associated with elevated levels of the enzyme creatine phosphokinase. Once symptoms appear, the progression of the condition is rapid, reaching peak intensity in as little as three days. Symptoms can last anywhere from eight hours to 40 days. The symptoms of NMS sometimes are misinterpreted by doctors as symptoms of mental illness, which can delay treatment.

NMS is caused almost exclusively by the blocking of dopamine receptions with antipsychotic medications. The higher the dosage of the medicine, the more common the occurrence. It may also be caused by rapid and large doses of medication.

The labeling changes were issued by the Food and Drug Administration (FDA) in its January 2009 postings of 28 drug products with safety labeling changes on boxed warnings, contradictions, warnings, precautions, adverse reactions, patient package inserts and medication guides. The antipsychotic drugs that now carry the NMS warning include Celexa, Lexapro, Cymbalta, Effexor, Paxil, Pexeva, Pristiq, Prozac, Venlafaxine and Zoloft.

The FDA’s posting also includes a boxed warning on Cimzia, and adverse reactions, warnings and/or precautions for Avelox, Hycodan, Nicardipine Hydrochloride, Tygacil, Tyzeka.

For a full listing and the specific doses of antidepressants with revised “Contradictions and Warnings,” and other medications with labeling changes, check out the FDA’s MedWatch report.

SOURCE: Personal Injury Attorneys › FDA issues warning of serious adverse reaction to antidepressants

What they found at the plant defines corporate irresponsibility and underscores the shortcomings of government agencies on both federal and state levels in doing their job to serve and protect the public.

Some of the items on the FDA report include:

• A dead mouse stuck to a glue trap. “The mouse appeared to have died recently,” the report reads.
• “What appeared to be rodent excreta pellets too numerous to count were observed in the cabinet under the sink in the south most kitchen.”
• “In the cabinet north of the dishwasher … I counted approximately 27 rodent excreta pellets.”
• “Another dead mouse was found just outside the south most doorway of the kitchen. … This mouse also appeared to have recently died.”
• “What appeared to be a bird’s nest was observed in the wall/ceiling metal support beam at southwest corner of the mezzanine area.”
• Processing machines had buildup of “gooey” peanut paste.
• Numerous roof leaks.

Aside from hundreds of sick people and as many as 9 deaths, the irresponsibility that caused the salmonella outbreak had an enormous economic impact on individuals and companies alike. Thousands of products were pulled from the shelves, plants closed, employees became jobless, and two towns worried about their future. Even peanut butter manufacturers and other food companies that did no business with the Peanut Corp. saw a sharp decline in revenue as the public became fearful of all peanut products.

The peanut recall is one of the largest recalls in US history and the latest in a series of recalls that included contaminated lettuce, spinach, tomatoes, and peppers. The recalls have diminished public confidence in the effectiveness of the FDA and renewed calls in Congress to reform the agency.

Despite the peanut recall, the Centers for Disease Control and Prevention (CDC) reports that the outbreak continues as people continue to consume contaminated products.

Source: http://www.reuters.com/article/healthNews/idUSTRE5226LW20090304

SOURCE: Personal Injury Attorneys › FDA report reveals peanut plant’s carelessness in food safety

“It’s regrettable, but it’s inevitable with the events of last month,” Andrew S. Goldstein, the bankruptcy attorney who filed the petition, told the Associated Press.

Investigators have traced the national salmonella outbreak to peanuts produced by the Peanut Corp. in its Blakely, Georgia, factory. They estimate that the contaminated peanut butter has sickened 630 people and caused the deaths of 9.

According to the AP, the board “had considered a Chapter 11 bankruptcy, but decided on outright liquidation” instead. The recall has financially devastated the company.

The recall of Peanut Corp.’s peanuts led to further recalls of more than 2,000 other products that incorporated the possibly contaminated peanut butter from the Peanut Corp. Recalls of all the affected products amounted to one of the largest collective recalls in American history.

More than a dozen people affected by the contaminated peanut butter have filed civil lawsuits. Food safety attorneys remained optimistic that victims and their families would still be compensated despite the bankruptcy filing. The lawyers attached to the lawsuits will request they be allowed to proceed anyway.

The Peanut Corp. started in 1977 when the Parnell family turned a peanut roasting business into a $30 million peanut processing operation. The Parnells sold the company in 1995. In 2000, Steve Parnell began building another peanut processing company when he bought plants in Texas, Georgia, and Virginia.

The Blakely, Georgia, plant stopped operations when investigators from the Food and Drug Administration found that the Peanut Corp. sold and shipped peanut butter that tested positive for salmonella. The findings prompted an investigation of the Plainview, Texas, plant, where officials found similar problems.

Texas health officials on Friday ordered that all peanut products ever made at the Plainview facility be recalled after finding serious health risks in the plant. According to the AP report, “officials said they discovered rodents, feces and feathers in a crawl space above a production area. An air handling system sucked debris from the crawl space into an area where peanuts are processed.”

SOURCE: Personal Injury Attorneys › Peanut Corporation of America closes for good

Peanut Corporation of America

The Texas plant, operated as Plainview Peanut Company, LLC, produces peanut meal, granulated peanuts, and dry roasted peanuts. None of the possibly contaminated products appear to have reached consumers.

Investigators from the U.S. Food and Drug Administration have been conducting a criminal probe of the company. On Tuesday, Reuters reported that the FBI has joined the investigation in a support capacity, providing its resources in assistance to the FDA. Dee Rybiski, a spokeswoman for the FBI field offices in Richmond, Virginia, told Reuters that “there were simultaneous searches of the different locations,” including, she confirmed, Peanut Corp.’s headquarters in Lynchburg, Virginia.

In mid-February of 2007, the FDA announced a recall of certain batches of Peter Pan peanut butter because of reported salmonella poisoning. Other salmonella outbreaks have occurred since, sparking massive recalls of spinach, tomatoes, lettuce, and peppers and rattling consumer confidence in the safety of the nation’s food supply.

The salmonella outbreaks have re-energized efforts to reform the FDA, which the Government Accountability Office considers to be afflicted with inconsistent oversight, ineffective coordination, and inefficient in its use of resources. Consumer groups, certain members of Congress, and the Obama administration have all echoed calls to reform the FDA.

The latest salmonella outbreak is also proving to be a disaster for peanut processors whose products aren’t included in the recall but are affected by it, and for the peanut industry in general. Sales of safe peanut butter have been dropped 25% since the salmonella outbreak.

“These things kind of spook consumers,” said Bob Goldin of Technomic Inc, a Chicago-based food industry consulting firm, to Reuters.

The total damage caused by one company cutting corners and trying to save a few bucks may be impossible to quantify in the end.

SOURCE: Personal Injury Attorneys › Peanut Corp. halts its Texas operations as FBI joins investigation

These latest findings indicate that the Peanut Corporation was either grossly negligent or, more likely, that some of its decision makers were engaging in criminal business practices. Federal law prohibits producing and shipping food under conditions that could jeopardize the public’s health and safety, and it appears that the Peanut Corp. did both.

Michael Rogers, head of field investigations for the FDA, said that the agency uncovered the dubious activity during a closer review of documents provided by the Peanut Corp.

“We have not made a determination yet on liability,” attorney Amy Rotenberg, an attorney for the Peanut Corp., told the Associated Press. “We are neither denying or admitting liability at this point. We are still investigating.”

On January 28, the Peanut Corp. issued a statement on its website denying accusations that it shopped around for more favorable test results. “PCA uses only two highly reputable labs for product testing and they are widely used by the industry and employ good laboratory practices. PCA categorically denies any allegations that the Company sought favorable results from any lab in order to ship its products.”

The FDA and USDA also knew that the Peanut Corp. was operating a dirty plant, yet its representatives failed to take action. In the past, inspectors found dead insects near peanuts, holes in the plant large enough to admit mice and rats, and dirty duct tape holding broken equipment together. They also discovered that the company used insecticide foggers in the plant but didn’t wash the exposed areas and equipment. The FDA gave Peanut Corp. the liberty to fix the problems on its own because the food products it tested at the time showed no signs of chemical or organic contamination.

As it happens all too commonly in government, a crisis is usually needed before substantial improvements are made. In this instance, 8 people died from salmonella poisoning linked to the Peanut Corp.’s contaminated peanut butter. Another 575 people were sickened.

Some members of Congress are calling for both criminal investigations by the Justice Department and an overhaul of the FDA and USDA. The USDA was one of Peanut Corp.’s two biggest buyers before it suspended all business with the company.

Sen. Patrick Leahy of Vermont said that food producers need to be held responsible for deadly outbreaks of disease such as this latest salmonella outbreak with jail time, not fines alone. Traditionally, the federal government has not been aggressive in penalizing companies that knowingly violate food safety laws.

Since news of the massive peanut butter recall surfaced, many customers have shunned peanut butter altogether, including brands that have been deemed safe. Sales of all peanut butter brands are down 25 percent, according to a report by the New York Times. Some industry officials worry that Peanut Corp’s recklessness could be catastrophic to the peanut industry.

SOURCE: Personal Injury Attorneys › Case worsens against Peanut Corp. tied to salmonella outbreak

The notice is the result of a retrospective study in patients with severe sepsis and baseline bleeding precaution that showed an increased risk of serious bleeding events and death in patients with those risk factors who received drotrecogin alfa, which is marketed as Xigris.

The increased risks are described in the drug’s prescribing information under Contraindications and the Warnings and Precautions of the medication’s package insert, and says that bleeding is the most common serious adverse reaction experienced by patients who received Xigris. The Contraindications section also states that Xigris should not be used in clinical situations where the patient has active internal bleeding, recent hemorrhagic stroke, recent intracranial or intraspinal surgery or severe head trauma, trauma with an increased risk of life-threatening bleeding, presence of an epidural catheter, or intracranial neoplasm or mass lesion or evidence of cerebral herniation.

The warnings and contraindications are consistent with the information in the current product label. Those who prescribe the medications should refer to the label warnings, precautions and contraindications and weigh the patient’s risks against benefits before prescribing Xigris.

FDA and Xigris are continuing to evaluate the incidence of serious bleeding events and mortality in patients who receive Xigris and will give its conclusions and any recommendations once the review is complete. Healthcare professionals and patients should report any side effects of Xigris to the FDA’s MedWatch Adverse Event Reporting Program.

SOURCE: Personal Injury Attorneys › FDA issues notice to health care providers about sepsis drug

Just how the Texas plant could have operated under the radar for four years raises questions about the effectiveness of government in keeping the nation’s food clean and safe to eat. The Food and Drug Administration relies on the state of Texas, as it does with many other states, to administer federal food safety regulations. The FDA maintains that it does not have enough inspectors to check 65,520 food production facilities nationwide. The agency examined less than 6,000 plants in fiscal 2008, according to a report in The Washington Post.

After investigators traced the salmonella outbreak to Peanut Corporation’s Georgia facility, Texas sent Patrick Moore, an inspector with the Texas Department of State Health Services, to the Plainview, Texas, plant. Texas law requires that food manufacturers renew their licenses every two years and be routinely inspected. The Plainview plant operated since its opening in March 2005 without doing either.

“I was not aware this plant was in operation and did not know (what) type of products processed,” Moore wrote in an inspection report, according to the Associated Press.

The problems with the Texas plant do not necessarily represent any wrongdoings by the parent company, but they do expose a state and federal regulatory system that is extremely inept. The plant is registered with the Texas Comptroller of Public Accounts as Plainview Peanut Co., LLC. It was also properly registered with the FDA as a food processing plant. However, neither the state nor the federal government bothered to check on the plant.

In an AP report, Margaret Glavin, former associate commissioner for the FDA’s regulator affairs, said that no regularly updated database exists to assist food inspectors. “The database is terrible,” she said.

Representative Rosa DeLauro, D-Conn., oversees the FDA’s funding and acknowledges the agency’s serious shortcomings. She has been working on legislation that would take the “F” out of the FDA by creating a separate national food safety agency. “I think this is one more example of the real breakdown in the process of regulating food safety and making sure public safety is ensured,” DeLauro told the AP.

Since the salmonella outbreak, the Plainview, Texas facility has been inspected by both state and FDA officials. No salmonella has been detected there.

SOURCE: Personal Injury Attorneys › Peanut Corp’s Texas plant ran unlicensed, uninspected since 2005

The particular strain of salmonella that sickened the boy is the same strain as the salmonella tied to Peanut Corporation’s manufacturing facility in Blakely, Georgia. Investigators from the U.S. Food and Drug Administration identified the strain as Salmonella Typhimurium. The salmonella found in the peanut butter products was one of four different strains detected in the factory.

The salmonella outbreak has sparked one of the largest and most complicated food safety recalls in U.S. history. Contaminated peanut products from the Peanut Corporation were used as ingredients in hundreds of other products such as crackers, cookies, candy, cake, and ice cream. The tainted peanut butter was also distributed to long-term care facilities, cafeterias, and other institutions. The Centers for Disease Control (CDC) blames the contamination for more than 500 reported illnesses and 8 deaths across the country and Canada.

The attorney representing the Meuniers filed the lawsuit in U.S. District Court in the Middle District of Georgia.

The peanut plant at the root of the salmonella problems has a record of unsanitary conditions, according to government inspection records. The storage cooler is reported to have mold growing on the ceiling and walls and the plant has had a major roach infestation. Salmonella was found in the plant’s production line late last September, yet no measures were taken to clean the infected area.

Peanut Corp. had its peanut products re-tested at different labs when original test results came back positive for salmonella. Once negative test results were obtained, the company shipped the products out. Because of these actions, some members of Congress believe those responsible should face criminal charges.

Gabrielle Meunier expressed her alarm over the news about the salmonella outbreak. “I am absolutely so dismayed, so saddened that this could happen,” she told the Burlington Free Press.

In reference to the system that state and local governments have in place to enforce food safety, Meunier said “I know the process doesn’t work.”

“Nobody is going to tell us the truth until it becomes one big court matter,” she told the Burlington Free Press.

Four illnesses linked to the salmonella outbreak were in Vermont.

SOURCE: Personal Injury Attorneys › Vermont couple sues Peanut Corp. over son’s salmonella poisoning

The shipment was refused by the importer in Canada in April 2008. The importer requested that it be destroyed. Tests of the refused shipment later showed that the chopped peanuts contained metal fragments. The shipment was not destroyed until November 17, more than 7 months after it was rejected, because the Peanut Corporation tried to clean it up.

“The shipment was rejected from Canada and imported back to the U.S. and PCA,” Domenic Veneziano, director of import operations and policy for the FDA’s office of Regulatory Affairs, told the Chicago Tribune.

“They tried to recondition the shipment … and clean it up, and it could not be done. … The FDA went out and witnessed that shipment … and ensured that it was destroyed,” the Tribune reported.

Although the FDA maintains it took the right measures in preventing distribution of the contaminated shipment, the federal government says that the agency did not inspect the processing plant in Blakely, where the shipment originated.

Some members of Congress accuse Peanut Corporation of America of shopping around for negative test results on batches of peanut products that already tested positive for salmonella bacteria.

Peanut products contaminated with salmonella have caused 529 cases of food poisoning in nearly every state and Canada, according to the Centers for Disease Control and Prevention (CDC).

All of Peanut Corporation’s roasted peanuts, granulated peanuts, peanut meal, peanut butter, and peanut paste have been recalled by the FDA. The peanut products have been used in more than 400 other products nationwide, in addition to institutions such as long-term care facilities, cafeterias, and even the U.S. Army.

SOURCE: Personal Injury Attorneys › Probe of salmonella outbreak uncovers earlier peanut problems

Last week we reported how Peanut Corp. found some of their peanut butter to be tainted with salmonella but sold and shipped the products anyway. After the products tested positive for salmonella in internal tests, the company had the products retested by external labs, who reported negative readings.

The re-tests outraged some members of congress, who accused Peanut Corp. of shopping around for negative readings. Others say retesting was inappropriate because the nature of peanut butter makes it possible for salmonella to be present in pockets rather than spread throughout, so that samples taken from a contaminated batch could easily come out negative.

“The situation at the plant is alarming,” said Rep. Waxman. “It shows major gaps in our food safety system. I am extremely troubled by reports that the plant tested positive for salmonella numerous times but nothing was done to ensure that the product did not go on the market.”

Rep. Waxman, who serves as Chairman of the Energy and Commerce Committee, said that the hearings should focus on Peanut Corp.’s Blakely, Georgia, facility, which is where the tainted peanut butter originated. According to the FDA, more than 500 people are reported to have been sickened and at least 8 people have died because of the salmonella outbreak.

The president of Peanut Corporation of America, Stewart Parnell, will be among those called to testify at the hearings. Representatives from two labs used by the Peanut Corp. for testing will also be present. Dr. Frank Torti, Acting Commissioner of the FDA, and Thomas Irvin, Commissioner of the Georgia Department of Agriculture will testify as well.

Rep. Stupak, who chairs the Subcommittee on Oversight and Investigations, believes the FDA may also be at fault for the outbreak. “There are still far too many questions surrounding FDA’s role in allowing the Peanut Corporation of America to distribute contaminated products,” Rep. Stupak said. “We have already requested a number of documents from the company and I hope this hearing will help bring to light not only what went wrong but also what FDA and industry can do to prevent future outbreaks.”

The first hearing will be held on Wednesday, February 11 at 10:00 a.m. ET.

SOURCE: Personal Injury Attorneys › Congress announces first hearing on peanut butter recall

Company records examined by the Food and Drug Administration indicate that the Peanut Corporation had the contaminated products retested by external labs after in-house lab tests found salmonella bacteria.

The most recent re-test of contaminated peanut butter was ordered in September. Health officials began detecting signs of a salmonella outbreak in October.

According to the AP, “Michael Rogers, a senior FDA investigator, said it’s possible for salmonella to hide in small pockets of a large batch of peanut butter. That means the same batch can yield both positive and negative results,” he said. “The products should have been discarded after they first tested positive.”

The Peanut Corporation issued a statement saying that it “categorically denies any allegations that the company sought favorable results from any lab in order to ship its products.”

“We have been devastated by this, and we have been working around the clock with the FDA to ensure any potentially unsafe products are removed from the market immediately,” Stewart Parnell, the company’s president, said.

Congresswoman Rosa DeLauro, D-Conn., who oversees the FDA’s funding, issued a statement in which she is clearly outraged by the Peanut Corp.’s actions.

“The actions by the Peanut Corporation of America can only be described as reprehensible and criminal. Not only did this company knowingly sell tainted products, it shopped for a laboratory that would provide the acceptable results they were seeking. This behavior represents the worst of our current food safety regulatory system,” she said.

“I will be contacting the Department of Justice to request an investigation into the behavior by the Peanut Corporation of America to determine whether their actions warrant criminal prosecution,” DeLauro said.

“We must pursue a zero-tolerance policy when dealing with businesses that intentionally sell tainted products.”

Georgia’s top agricultural official, Tommy Irvin, echoed DeLauro’s call for a Justice Department investigation.

“They tried to hide it so they could sell it,” Irvin said. “Now they’ve caused a mammoth problem that could destroy their company — and it could destroy the peanut industry.”

SOURCE: Personal Injury Attorneys › Peanut Corp. may face criminal charges over salmonella outbreak

According to records kept by the Centers for Disease Control and Prevention (CDC), more than 500 people in 43 states and Canada have become sick after eating products containing the Peanut Corporation of America’s contaminated peanut butter. The FDA blames the salmonella outbreak on eight deaths so far.

Approximately 400 products from several manufacturers have been pulled from store shelves as part of the massive peanut butter recall. Most of the contaminated peanut butter and peanut butter paste made by PCA is used as an ingredient in other products such as cookies, crackers, candy, and ice cream. It is also distributed to a number of institutions and cafeterias.

Federal investigators tested the PCA facility in Blakely, Georgia, where the contamination occurred. They found four different strains of salmonella. However, only one strain — Salmonella Typhimurium — has been found in the company’s food samples.

Because the federal government does not require companies to disclose the results of tests conducted internally, heath regulators were not aware of the contamination. Still, the company likely broke federal law, according to Stephen Sundlof, director of the FDA’s Center for Food Safety and Applied Nutrition.

“Foods are supposed to be produced under conditions that do not render them damaging to health,” he told The Washington Post. Whether the criminal charges could be pressed against the company is not yet clear.

No one knows at this time exactly how the salmonella bacteria migrated from its source to the food, but investigations are still underway. The Blakely plant has suspended operations until more is known about the contamination.

According to health regulators from the state of Georgia, inspection reports indicate the Blakely plant has a long history of unsanitary conditions. Despite any violations, however, no records indicate the company was ever subject to state or federal fines.

The FDA has never inspected the plant itself but relied on the Georgia Department of Agriculture for routine inspections. The FDA claims that it simply does not have enough inspectors to send to all of the nation’s food production plants. Likewise, Oscar Garrison, Georgia’s assistant agriculture commissioner for consumer protection, said that the state doesn’t have enough resources to test all of the state’s food-processing plants and food stores.

Nevertheless, Georgia officials were inspecting the plant last October when the contaminated products were being made. Unfortunately, neither the factory nor the food were tested for salmonella.

Michael Rogers, director of field investigations for the FDA, told The Washington Post that “all inspections are a snapshot in time; they only reveal what is happening at the firm at that particular time.” Assuming the statement is accurate, why didn’t Georgia inspectors leave the PCA plant last October with a snapshot of salmonella contamination?

“The average plant is inspected once every 10 years. This one was getting inspected a couple of times a year by Georgia, but neither they nor the FDA were taking enough enforcement action,” Jean Halloran, the director of food safety for Consumers Union, told The Washington Post.

SOURCE: Personal Injury Attorneys › Company knowingly sold contaminated peanut butter many times

The FDA notified PCA on Monday that samples of peanut butter originating from the company’s facility in Blakely, Georgia, tested positive for the salmonella bacteria. The peanut butter was distributed under the King Nut brand name and sold wholesale to food manufacturers and institutions such as long-term care facilities and cafeterias.

PCA sells its peanut butter in containers ranging from 5 to 1,700 pounds. Its peanut butter paste is sold in bulk containers ranging from 35 pounds to tanker loads.

Jarred peanut butter is safe to eat, the FDA says, but consumers should avoid consuming foods containing peanut butter and peanut butter paste. PCA does not sell its peanut butter directly to consumers in jar form. The FDA is maintaining a continually updated  list of all products affected by the recall.

Stores throughout the U.S. and around the world continue to pull products containing peanut butter off the shelves. While not all products containing peanut butter may be affected, the FDA suggests that it is best to avoid buying and eating them altogether as a precautionary measure until more is known. Affected products were sold between between Aug. 21, 2008, and Jan. 19, 2009.

At this time, tests have confirmed the presence of the salmonella bacteria found in a package of Austin Quality Foods Toasty Crackers with Peanut Butter manufactured by Kellogg of Battle Creek, Michigan. The FDA does not yet know which other specific products contain the contaminated peanut butter.

Products known to be safe, according to their manufacturers, include those from ConAgra, the maker of Peter Pan brand peanut butter, J.M. Smucker, Russell Stover Candies, Inc., and ABC Bakers-Interbake Foods, the maker of Girl Scout cookies. None of the four companies buy peanut butter from PCA.

SOURCE: Personal Injury Attorneys › contaminated peanut butter sparks massive recall

And change is apparently what the FDA needs the most. On Thursday, the Government Accountability Office (GAO) said that from 2003 to 2007, the FDA cleared 228 medical devices for the market without a complete evaluation of their safety and effectiveness. Some of the devices were intended for sensitive and risky uses, such as pacemakers and heart valves, and a few have since been recalled because of malfunction or other problems.

“It all adds up to less-than-rigorous rigorous device review, and it’s placing tens of thousands of Americans at risk,” said Peter Lurie, deputy director of Public Citizen’s health research group, in a report by the Associated Press.

The GAO report (link to PDF of report) did not evaluate the number of people, if any, who were harmed by the hastily approved devices. Instead it focused on the approval process for medical devices, calling into question why FDA scientists are routinely pressured to approve of medical machinery against their professional judgment.

A factor that may be contributing to the FDA’s problem is the quickening pace of technology development. Manufacturers of high-tech medical devices have made giant strides in the past decade, and so the number of devices trying to enter the market has grown. The number of upgraded products up for review has also increased. As technology began to outpace the FDA’s approval process, which was established as a three-tier system in 1976, the Federal government pressured the FDA to speed things up.

With drug companies and medical device manufacturers seeking refuge in legal preemption, the current FDA approval system can be a formula for disaster for the American public. Last year, the U.S. Supreme Court ruled that federal (FDA) approval of medical devices could displace many laws on the state level. In other words, someone who has been harmed by an FDA-approved medical device may have little legal recourse in state courts.

SOURCE: Personal Injury Attorneys › FDA approval of medical devices was rushed and incomplete

I spent a couple hours last week replacing most of the incandescent bulbs in my vacation home with CFLs. I had seen a report about them on the news well over a year ago and have been gradually replacing the bulbs at home with CFLs as they burn out. Last night, in fact, I replaced the eight bulbs in the dining room chandelier with CFL bulbs only to discover that they do not work on a dimmer switch. Had I read the small print on the box, I would have avoided that mistake.

But there are more important things missing from the small print on the boxes of CFL bulbs that I bought. This morning, a friend coincidentally emailed me an announcement by the Energy Working Group, which listed steps to take when a CFL bulb breaks. I had no idea.

For the most part, you have to treat the incident like a biohazard event by donning a makeshift safe suit, clearing and cleaning the area, and isolating the broken bulb in a sealed glass container. A broken CFL bulb releases fine particles of mercury, a potent neurotoxin, which is a dangerous substance even in minute quantities.

The particular box of CFL bulbs I bought does not say how much mercury the bulbs contain and what to do in the event that one breaks. The only warning on the box and the bulbs themselves concerns electric shock. So it seems that just as the FDA worries that adequate warnings might scare people away from some pharmaceutical drugs, the EPA worries warnings and safety information on the packaging of CFL bulbs might be bad for business, too.

The bulbs that I bought do carry the Environmental Protection Agency’s Energy Star logo, which means by law they must contain no more than 5 mg mercury, which is the government’s Energy Star standard. But even that standard is considered too high in the European Union and, surprisingly, by the bulb manufacturers themselves. These days, CFL bulbs have an average mercury content of about 3.5 mg. In the E.U., mercury content is capped at 4 mg.

To be fair, I went back to the store and looked at other brands. Some packages say “lamp contains mercury” and “Manage in Accord with Disposal Laws,” but other than that, the toxic nature of these bulbs when broken is invisible.

For more information about CFL bulbs, go to http://www.ewg.org/node/27220

SOURCE: Personal Injury Attorneys › Energy efficient bulbs should be handled with extreme caution

The Food and Drug Administration has issued a recall of teddy bears sold at Walgreens stores. The 9-inch high Christmas toy bears are sold as “Dressy Teddy Bears” and come with 4-ounce chocolate bars that are believed to contain melamine.

Walgreens has instructed all of its stores to stop selling the teddy bears. Customers who have already purchased one of the bears, which have been sold in Walgreens since late September of this year, should return them to the store immediately for a full refund.

The UPS number on the bears is 047475864485. The merchandise tag on the bears is 291332.

Although Walgreens has not received any reports of illnesses related to the teddy bears, the FDA tested the product and found that some samples of the chocolate were contaminated with melamine.

Melamine is a colorless and tasteless substance that gives food the appearance of being protein-rich when illegally added. It is commonly used in a number of industrial applications but is not approved for human or animal consumption in the United States. To date, all of the food contaminated with melamine has been manufactured in China or Taiwan or has an ingredient (usually milk based) that originated in China or Taiwan.

The Chinese government has found that certain Chinese companies were adding melamine to food products as a means of cutting costs and giving them false nutritional value. Contaminated products from China have been blamed for countless pet injuries and deaths in the U.S. in the past. More recently, more than 52,000 children in China have fallen ill because of melamine consumption, leading to more than 12,000 hospitalizations and numerous deaths.

For a list of other products that have tested positive for melamine contamination, go here for a list.

SOURCE: Personal Injury Attorneys › FDA recalls melamine-tainted chocolate

Diabetes patients who use the recalled syringes may inadvertently receive an overdose of up to 2.5 times the intended dose. Possible complications could include hypoglycemia and other serious side effects and death.

The warning is especially urgent for parents or others caring for children with diabetes.

The product consists of sterile, single-use, disposable, hypodermic needles attached to a syringe barrel and plunger rod. The recall applies only to sets of needles with the lot number 813900 and label “ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin.”

The needles are distributed by Can-Am Care Corp and sold only at Wal-Mart and Sam’s Clubs with the ReliOn brand name.

Wal-Mart requests that customers who purchased needles with the 813900 lot number return them to the Wal-Mart or Sam’s pharmacy where they were purchased for a replacement.

Additionally, consumers and healthcare professionals who have or suspect they have the mislabeled syringes may contact ReliOn (also known as Covidien) at 866-780-5436 or go to www.reion/recall for more information and assistance.

The error occurred during the packaging process when syringes for U-40 insulin were mixed with U-100 insulin syringes and then packaged individually and boxed in units of 100 as “U-100 insulin.”

The recalled lot affects 4,710 boxes / 471,000 individual syringes. Wal-Mart has sent more than 16,500 letters to customers notifying them of the recall.

One adverse event resulting from use of these needles has been reported to the manufacturer.

SOURCE: Personal Injury Attorneys › Recalled insulin syringes may be mislabeled

Journal editor Dr. Jeffrey M. Drazen says the litigation process and the court system is a “key defense mechanism” to insure drug safety and to obtain justice if drug manufacturers have not made the risks involved with its product clear.

The doctors say the FDA is incapable of being the sole guardian of drug safety and that without the information supplied by liability litigation, “the American public would be deprived of a vital deterrent against pharmaceutical company misconduct.”

The opinion was submitted to the Supreme Court as a friend-of-the-court brief in the matter of Wyeth v. Levine, a case expected to be heard later this year. According to the AP story, the case involves Diana Levine, a guitarist who lost her right arm below the elbow after an injection of Phenergan. She sued the drug’s manufacturer, Wyeth, alleging the company had not adequately warned consumers of the risks associated with its product. The case was tried in Vermont, and the court agreed, awarding Levine $7 million.

Wyeth is appealing the case, saying the FDA had approved the drug, and that the state court could not overrule the FDA’s judgment.

However, the editors of the New England Journal of Medicine sided with 47 state attorneys general and two former FDA commissioners in supporting Levine’s position, the AP report states.

SOURCE: Personal Injury Attorneys › Doctors support drug litigation

A report on WAVY TV-10 in Virgina Beach said the hospital initially denied using the recalled product on the patient, Judith Coyne. But Coyne and her son, who uncovered the mesh patch recall alert while researching possible reasons for his mother’s pain, found that the ID number on the hospital’s records for the mesh patch used during Judith’s surgery matched the product code and lot number for the recalled product.

The day after the initial television report, the hospital admitted it had made a mistake, and that doctors did, in fact, use the recalled product in Ms. Coyne’s procedure.

Judith Coyne is fearful about what happens next, as surgery to remove the damaged mesh patch could be life-threatening.

SOURCE: Personal Injury Attorneys › Recalled product inserted in patient

According to the report, Pfizer’s smoking-cessation drug Chantix came in for a bit more trouble as a research group cited reports of physical side effects associated with the drug. The FAA, which reviewed the report, barred pilots and air traffic controllers from taking the drug, the WSJ reports.

The Institute for Safe Medication Practices examined adverse-event reports turned into the FDA in the fourth quarter of last year, and found 988 serious health problems reported in association with Chantix use, including seizures and heart trouble.

Pfizer told the WSJ the Institute’s findings are consistent with the drug’s label, which lists many of the events cited in the Institute’s report as “infrequent” or “rare,” and aren’t unusual given that more than five million Americans have taken the medicine.

Up to this point, Chantix has been under scrutiny primarily for potential psychiatric trouble, with reports of agitation and suicidal thinking in some patients. But the drug has remained popular, with sales of $277 million in the first quarter of this year, making it a bright spot for the company.

But Chantix sales growth has slowed lately due to the psychiatric concerns, and the Institute’s report prompted Sanford Bernstein analyst Timothy Anderson to cut his 2012 forecast for the drug’s sales to $700 million from $1.6 billion.

SOURCE: Personal Injury Attorneys › FAA Bans Chantix