Drug Safety Expert

Plaintiff Cannot Join Class Action in Hormone Replacement Medication Case

Elina Shindelman, JD — Wed, 30 Nov 2011 15:11:02 +0000

An Arkansas federal court ruled that a plaintiff’s suit involving the hormone replacement medications Premarin and Provera was barred by the applicable statute of limitations. The plaintiff attempted to bring her case as part of a class action brought by women who used hormone replacement medication after November 17, 1995. The plaintiff, however, stopped taking the hormone replacement medications after she was diagnosed with breast cancer in 1993.

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Judgment for Manufacturers in Digitek Case

Elina Shindelman, JD — Wed, 30 Nov 2011 15:01:40 +0000

A West Virginia federal court granted judgment to the defendant-manufacturer Actavis in a case involving the heart medication Digitek. The case was brought by the families of two individuals who had allegedly died after taking defective Digitek pills. Actavis had recalled Digitek in 2008 after discovering that some pills contained a higher dosage of the active ingredient than approved, but the court held that the plaintiffs failed to show that their relatives possessed the defective tablets.

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Public Citizen Urges FDA to Place a Black Box Warning on Tygacil

Elina Shindelman, JD — Wed, 30 Nov 2011 14:52:57 +0000

Consumer group Public Citizen has urged FDA to put a black box warning on the antibiotic Tygacil due to a higher mortality rate associated with the medication than with similar antibiotics. FDA approved Tygacil in 2005 for the treatment of skin and intra-abdominal infections. Tygacil was approved in 2009 for the treatment of pneumonia. Tygacil is manufactured by Pfizer, Inc. FDA mandated that the warning label be updated to specify the increased mortality risk, but Public Citizen considers this inadequate.

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FDA Study Finds No Link between ADHD Medications and Heart Conditions

Elina Shindelman, JD — Wed, 30 Nov 2011 14:46:06 +0000

A recent FDA study did not establish a link between the use of attention-deficit/hyperactivity disorder (ADHD) medications and heart problems in children and young adults. The studies were conducted in order to analyze the risks of heart attack, stroke, or cardiac death associated with ADHD medications. Among the medications studied were stimulants, atomoxetine, and pemoline.

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Court Holds Woman Adequately Stated Claim against Novartis

Elina Shindelman, JD — Wed, 30 Nov 2011 14:42:43 +0000

A federal court in Florida held that a plaintiff who sued Novartis Pharmaceuticals Corp. after allegedly developing heart problems while taking Novartis’s medication Zelnorm stated a strict liability manufacturing defect claim against the manufacturer. Zelnorm is used to treat irritable bowel syndrome (IBS) and has since been taken off the market. However, the court found the plaintiff’s fraud claim lacking.

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Alabama Supreme Court to Decide Generic/Brand Name Liability Issue

Elina Shindelman, JD — Wed, 30 Nov 2011 14:39:34 +0000

The Alabama Supreme Court said that it would decide whether patients who ingested generic drugs would be permitted to bring suits against the manufacturers of corresponding name-brand medications. In March 2011, the Middle District of Alabama federal court allowed plaintiffs to sue brand-name manufacturers Wyeth LLC, Pfizer Inc. and Schwarz Pharma on a failure-to-warn theory even though the harmed plaintiff had ingested a generic version of Reglan, the drug at issue. The Middle District of Alabama then granted a motion by the defense to certify the question of the manufacturers’ liability to the Alabama Supreme Court.

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Summary Judgment for Novartis in Aredia/Zometa Case

Elina Shindelman, JD — Wed, 30 Nov 2011 14:35:33 +0000

The Northern District of Georgia granted summary judgment to manufacturer Novartis in a case involving Novartis’s medications Aredia and Zometa. The suit was brought by a patient who alleged that Novartis failed to warn that Aredia and Zometa could cause osteonecrosis of the jaw. The court held that the plaintiff failed to prove that her osteonecrosis was caused by the medications at hand.

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FDA Revokes Avastin’s Approval for Treatment of Breast Cancer

Elina Shindelman, JD — Tue, 29 Nov 2011 14:47:41 +0000

FDA Commissioner Margaret A. Hamburg revoked FDA’s prior approval of Avastin (bevacizumab) for the treatment of breast cancer, stating that it has not been proven to be safe and effective for this particular use. Avastin is currently approved for the treatment of colon, lung, kidney, and brain cancer.

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Plaintiffs Sue Pfizer over Zoloft

Elina Shindelman, JD — Mon, 28 Nov 2011 15:41:28 +0000

Four plaintiffs sued Pfizer, Inc. on a failure to warn theory, alleging that the manufacturer should have known that its antidepressant Zoloft exposed pregnant women who ingested the drug to the risk of harm to their babies. Two of the women alleged that taking Zoloft while pregnant resulted in the death of their newborns, and the other two alleged that their children suffered serious injuries.

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Verdict for Eli Lilly in Zyprexa Case

Elina Shindelman, JD — Tue, 22 Nov 2011 15:06:11 +0000

A jury in California issued a verdict for Eli Lilly and Co. in a case involving the company’s antipsychotic medication Zyprexa. The plaintiffs in the case, the parents of a man who died of a diabetes-related condition while taking Zyprexa, alleged that Eli Lilly failed to warn physicians of the risks of diabetes associated with Zyprexa. The jury found that the prescribing doctor should have known of these risks.

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