Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

U.S. District Judge Berle M. Schiller has ruled that manufacturers of generic drugs are not protected from lawsuits even if the Food and Drug Administration (FDA) certifies them as the “bioequivalent” of their brand name predecessors. The lawsuit involved consumers who were previously taking the brand name antidepressant Wellbutrin.

The defendants allege after switching to a generic version of the drug, buproprion, made by Teva Pharmaceuticals and Impax Laboratories, they experienced side effects. The lawsuit contends Teva and Impax became aware of the side effects but failed to warn consumers. While the active ingredient in Wellbutin and buproprion is the same, the two have differing release rates, which the defendants say caused adverse events when they switched to bupropion.

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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.

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The anesthetic that may be linked to the death of pop star Michael Jackson has been recalled by the Food and Drug Association (FDA) due to the presence of elevated endotoxin levels that may be linked to severe adverse reactions in patients following use of the drug. Teva Pharmaceuticals announced it is recalling specific lots of propofol injectable emulsion, 10 mg/mL 100 mL vials after it was notified of 41 propofol-treated patients who 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. Affected lots of propofol injectable emulsion include numbers 31305429B and 31305430B.

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