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The U.S. Food and Drug Administration (FDA) issued a stern warning to patients who take Janssen Pharmaceutical’s Nizoral (generic name ketoconazole) oral tablets. In fact, the FDA issued a safety release advisiong that Nizoral should not be the initial treatment for any fungal infection. During 2012, approximately 5.2 million ketoconazole prescriptions were dispensed, of which 609,000 were for tablet formulation.
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A federal judge has opened a window for plaintiffs to make a claim for strict liability against prescription drugmakers on a manufacturing defect theory. Despite developing case law in the opposite direction, U.S. District Judge Malachy Mannion of the Middle District of Pennsylvania ruled that Ryan Bergstresser could bring a manufacturing-defect claim against Bristol-Myers Squibb over its antipsychotic drug, Abilify. Bergstresser alleges he suffered from dystonia, which is characterized by involuntary muscle contractions, after his psychiatrist increased his dosage of the drug.

A rare outbreak of fungal meningitis linked to steroid injections has sickened 119 and caused 11 deaths nationwide according to CNN. The FDA has linked the meningitis outbreak to a contaminated methylprednisolone acetate injection that is produced by the New England Compounding Center (NECC). This steroid injection, which is injected directly into the spine, is said to be contaminated with a potentially lethal fungus.
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Israeli newspaper Ha’aretz (7/2, Ben) reported that, “The highest-ever award in an Israeli class-action suit against a drug manufacturer – NIS 12.1 million – was recently made under a compromise agreement reached between a diabetes patient and GlaxoSmithKline, the maker of Avandia. The suit had been filed by a diabetic who claimed that GSK had concealed data from the public that showed the drug, which is used to treat people with type-2 diabetes, increased the risk of dying from a heart attack.”

In continuing coverage, the AP (7/6) reports from Boston, “A federal judge on Thursday approved an agreement by British drugmaker GlaxoSmithKline to pay $3 billion for criminal and civil violations involving 10 drugs, the largest health care fraud settlement in US history.” The AP adds, “The amount of money involved led US District Judge Rya Zobel to remark in court that she was having trouble keeping track of the numbers. GlaxoSmithKline pleaded guilty to promoting the popular antidepressants Paxil and Wellbutrin for unapproved uses.”
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Bloomberg News (6/22, Edney) reports that according to a report from the Food and Drug Administration, “almost 16,800 adverse events associated with metal-on-metal hip implants were reported in the US from 2000-2011.” Bloomberg notes that the FDA document found that reports of adverse events with the implants “almost quadrupled to 682 in 2008 from the year earlier, and rose again after a unit of Johnson & Johnson (JNJ) began recalling hip devices in 2010.”
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Osteoporosis is a disease that is characterized by reduced bone mass and brittle bones. It affects millions of women. To combat bone loss, women often turn to bisphosphonates. Around the age of 30, most women’s bones start to deteriorate faster than they can be rebuilt. The claim is that bisphosphonates combat the deterioration, giving bones a chance to repair themselves.
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The New York Times (6/12, O’Connor) “Well” blog reported, “A popular class of drugs used to treat type 2 diabetes may increase the risk of vision problems,” according to a study published online June 11 in the Archives of Internal Medicine. After following some 103,000 patients with type 2 diabetes for about 10 years, researchers found that thiazolidinediones “may increase the risk of macular edema, or swelling in the central part of the retina, which can result in blindness in one or both eyes.”
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Johnson & Johnson has announced that it will stop selling certain vaginal mesh products. In letters dated June 4, 2012, Johnson & Johnson advised judges overseeing transvaginal mesh litigations that Johnson & Johnson had informed the FDA that its Ethicon unit would no longer be selling certain vaginal mesh products. The stopping of sales is a result of numerous complaints of mesh erosion leading to serious pain and injuries. These injuries have resulted in hundreds of lawsuits being filed.
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The Judicial Panel on Multidistrict Litigation (JPML) has created a new MDL for Wright Medical “Conserve” hip implant cases in the United States District Court of Georgia for the Northern District. Plaintiffs’ counsel argued that more than 200 Wright patients have reported adverse events associated with the Wright Conserve system hip implants. Further, the defects alleged in the Wright Conserve hip are similar to those alleged in the DePuy ASR Device, which has a pending MDL in the Northern District of Ohio.
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