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The owner of two construction crane and rigging companies and a mechanic have been indicted on manslaughter charges after a 200-foot construction crane crashed onto a New York City apartment, killing 2 men and seriously injuring a third.
Exjade (deferasirox), a treatment for chronic iron overload due to blood transfusions for adults and children age 2 years and older, now has an Food and Drug Administration (FDA) black box warning alerting health care professionals and consumers of a risk of serious complications that may lead to death. A black box warning is the strongest form of warning issued by the FDA and is placed on drugs that have potentially harmful or deadly side effects. As a result of the FDA warning, new language was added to the drug’s Contraindications, Warnings and Precautions, and Drug Interactions sections of its packaging. The labeling states that the product may cause renal impairment, including failure; hepatic impairment, including failure; and gastrointestinal hemorrhage. The warning affects Exjade Tablets for Oral Suspension.
Tekturna (aliskiren) tablets, a prescription medication used to treat high blood pressure, has updated its safety label to include a new black box warning about the risk of injury and death to developing fetuses when taken by women who are pregnant or become pregnant, according to the Food and Drug Administration (FDA).
Collier Ursprung was a year and a half old when his parents walked into his bedroom and found the toddler standing in his crib with the cord of a window blind wrapped three times around his neck. “As he pulled it kept getting tighter,” his father, Robert, told ABC News. “We just averted a disaster that could have changed our lives forever.”
The Food and Drug Administration (FDA) has notified health care professionals of serious adverse events including liver failure and death linked to a topical NSAID prescribed for the treatment of osteoarthritis. Postmarketing reports indicate that cases of drug-induced hepatotoxicity have been reported in the first month but can occur at any time during treatment with Voltaren Gel (diclofenac sodium topical gel) 1 %. Postmarketing surveillance has reported cases of severe hepatic reactions including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.
The Food and Drug Administration (FDA) postmarket reviews have identified serious adverse reactions that have resulted in death of newborns associated with the use of ceftriaxone and calcium salt in the body. Ceftriaxone is often used in infants between 4 and 8 weeks of age who have a high fever and are admitted to the hospital.
To help educate parents about toy safety, Consumer Product Safety CommissionChairman Inez Tenenbaum held a town-hall style meeting in New York City. Discussions centered on new federal safety rules that raise the standards for toys and help protect children from unnecessary harm.
A device used to block off the aorta, monitor aortic pressure, and deliver solution to stop the heart during cardiopulmonary bypass procedures has been recalled by the Food and Drug Administration (FDA) because the device’s balloon catheters may spontaneously rupture during surgery and may result in serious health consequences or death to patients.
A brand of the anesthetic propofol is being recalled by the Food and Drug Administration (FDA) because the injectable emulsion may contain particulate matter that could potentially impede blood flow and lead to serious health issues such as stroke, respiratory failure, kidney failure, liver failure, heart attack and/or stroke. The recall includes 85 lots of Hospira, Inc. brand Liposyn™ II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, Liposyn III 30% and 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80. The affected lots were distributed between July 2009 and October 2009.
The Food and Drug Administration (FDA) is investigating certain types of medical devices made by Hospira Inc. and Abbott Nutrition after 122 reports of sparking, charring and fires from the power cords used with the devices. The announcement follows a recall announcement and FDA warning last August on some medical devices made by Hospira Inc. because of faulty electrical cords that could lead to serious injury or death.
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