Articles Posted in Product Liability

GlaxoSmithKline Plc’s scientists were alarmed by a rising number of birth defects among pregnant women taking the antidepressant Paxil in 1997, according to internal documents revealed in a trial in Philadelphia.

There was a 13.3 percent rate of incidence for congenital abnormalities as of November 1997, according to the documents presented by lawyers for the family of an injured child suing the company.

“Taken at face value this presents an alarming finding,” according to the internal report. That language was later deleted, the documents show. The information was never submitted to the U.S. Food and Drug Administration, former FDA doctor Suzanne Parisian told jurors Sept. 18.

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Forty years ago, on September 4, 1969, the Food and Drug Administration (FDA) declared the new birth control pill to be “safe” for use by women to regulate births.

Forty years later, the true safety of oral contraception is still in question.

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Judge Sandra Mazer Moss, Philadelphia Court of Common Pleas, consolidated all lawsuits filed in Philadelphia that involve Bayer’s popular birth control pills, commonly known as Yaz, and Yasmin. Philadelphia is likely to be the country’s center for state court litigation involving this widely used birth control pill.

The lawsuits allege that Yaz and Yasmin have risks beyond those of traditional birth control pills, because they contain DRSP (drospirenone), and that Bayer over-promoted the drug without disclosing risks. Bayer was warned by the FDA, in the fall of 2008, that Bayer’s television ads were misleading and were not disclosing these additional risks.

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– Pfizer Inc., the world’s biggest drugmaker, said a consultant to plaintiffs’ attorneys in lawsuits over its epilepsy drug Neurontin tried to tamper with a prospective witness.

Dr. David Egilman, a Brown University medical professor, “improperly contacted” the treating physician of a Massachusetts man whose family claims he killed himself after taking the drug, Pfizer said in a court filing. Pfizer asked the judge to punish Egilman for sending a sealed document to the doctor. Pfizer faces a trial in this case, brought by the family of Hartley Shearer, in March.

Egilman’s letter to Shearer’s doctor was “a transparent attempt to taint her perceptions of Pfizer shortly before her deposition,” Pfizer said. Egilman enclosed “a confidential internal e-mail between Pfizer employees,” along with other documents, in his letter to Dr. Lisa Catapano-Friedman, the company said.

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Officials of GlaxoSmithKline Plc, the U.K.’s largest drugmaker, said in 2001 that a birth defect in the fetus of a woman taking its Paxil antidepressant likely was linked to the drug, according to court testimony.

After analyzing a 2001 e-mail from a Paxil user who aborted her fetus because it had a heart defect, Glaxo officials noted in company files they were “almost certain” the drug was related to the problem, Jane Nieman, a former Glaxo drug-safety executive, told a Pennsylvania jury.

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GlaxoSmithKline Plc, the world’s second-biggest drugmaker, begins a trial in Philadelphia in what may be a test case for more than 600 lawsuits over claims its antidepressant drug Paxil causes birth defects.

Patients and their parents claim internal company documents produced for trial show Glaxo failed to warn about the risks of Paxil until forced to do so in 2005 by the U.S. Food and Drug Administration. In a trial set for Sept. 14, Michelle David blames the drug for causing life-threatening heart defects in her son Lyam Kilker, 3.

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Makers of injected promethazine, a sedative also used to treat nausea and vomiting, are being required to put the strongest warning possible on the product because it can cause tissue damage leading to amputation, the Food and Drug Administration said Wednesday.

The drug, previously sold by Wyeth Pharmaceuticals Inc. under the brand name Phenergan, was at the heart of a U.S. Supreme Court case this spring that ended in a ruling that consumers harmed by a medication approved by the FDA still have the right to sue the manufacturer.

Wyeth had appealed the case up to the Supreme Court after a Vermont woman named Diana Levine, who once played the guitar and piano professionally, sued because she had to have her right arm amputated after being injected with Phenergan. Levine’s lawsuit, which claimed she wasn’t sufficiently warned of the risks of using Phenergan, won her a $6.7 million jury award.

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GlaxoSmithKline Plc, the world’s second-biggest drugmaker, withheld birth-defect data tied to its antidepressant drug Paxil from physicians as the number of reports grew, a psychiatrist testified.

Doctors seeking information about birth defects linked to Paxil originally got the total numbers of side-effect reports about the issue from Glaxo, Dr. David Healy, a professor at Cardiff University in Wales, told a Pennsylvania jury today. He’s testifying on behalf of a family suing over a child born with heart defects allegedly caused by the drug.

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An executive of GlaxoSmithKline Plc, the world’s second-biggest drugmaker, talked about burying negative studies linking its antidepressant drug Paxil to birth defects, according to a company memo introduced at a trial.

“If neg, results can bury,” Glaxo executive Bonnie Rossello wrote in a 1997 memo on what the company would do if forced to conduct animal studies on the drug. The memo was read during opening statements in the trial of a lawsuit brought by the family of a child born with heart defects.

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