Articles Posted in Wrongful Death

ACCUTANE STEVENS-JOHNSON SYNDROME: In February 2010, Health Canada reported that it had received reports of severe skin reactions, including sometimes fatal reaction known as Stevens-Johnson Syndrome from Accutane.

At least 66 reports of Accutane skin reactions were identified by Health Canada, including adults and children, with two of the cases resulting in death.

Stevens-Johnson syndrome (SJS) is a severe skin reaction that occurs as a side effect of several medications.

When the skin lesions affect more than 30% of the body, the condition is referred to as Toxic Epidermal Necrolysis (TEN).

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The number of Yaz, Yasmin and Ocella lawsuits that are part of a mass tort docket in New Jersey has increased significantly since the product liability cases were consolidated in February.

The number of Yaz lawsuits, Yasmin lawsuits and Ocella lawsuits centralized in Bergen County Superior Court has gone from 39 to about 400, according to court documents.

The New Jersey Yaz litigation was consolidated because of concerns about court filings, since New Jersey is the corporate headquarters in the United States for Bayer Healthcare Pharmaceuticals, Inc., which manufacturers the birth control pills.

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GlaxoSmithKline Plc has agreed to pay more than $1 billion to resolve more than 800 cases alleging its Paxil antidepressant caused birth defects in some users’ children, according to people familiar with the settlements.

The settlements, which provide an average payout of more than $1.2 million to families of affected children, leave more than 100 birth-defect cases pending, the people said. Officials of Glaxo, the U.K.’s biggest drugmaker, said July 15 they set aside $2.4 billion to resolve litigation over Paxil and its Avandia diabetes drug.

Read full Bloomberg story here.

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A settlement has been reached in a lawsuit filed against a pharmaceutical company by a Watertown woman who linked her prescribed use of Paxil to the death of her infant son, according to court files.

Jennifer Berg of Watertown sued SmithKline Beecham, doing business as GlaxoSmithKline, in October 2007. The complaint said Nathan Berg died in 2004 because of a heart disorder caused by her use of the antidepressant Paxil while she was pregnant. WAYNE ORTMAN, AP , The Washington Post 07/20/2010
Read Article: The Washington Post

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In treating diabetes, it might not matter much whether the Food and Drug Administration halts sales of the drug Avandia.

An FDA committee of outside experts met last week to provide advice on whether any regulatory action — from stronger warnings to removal — is needed. The FDA has the final say on the committee’s recommendations and could decide within weeks.

Doctors already have given their verdict. Avandia prescriptions have plummeted since a study in The New England Journal of Medicine in May 2007 raised concerns about whether the drug increased heart attack risk.

Rule the full story here.

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The New York Times (7/16, B2, Jolly, Harris) reports that UK pharmaceutical maker GlaxoSmithKline announced on July 15 that “it would take a second-quarter charge of $2.36 billion related to legal cases involving its drugs Avandia [rosiglitazone] and Paxil [paroxetine].”

This announcement comes one “day after an American medical advisory panel recommended that Avandia, a controversial diabetes drug, should either be withdrawn from the market or be severely restricted in its sales because it increases the risks of heart attacks.” According to GSK, “the charge announced Thursday, which will amount to about $2.1 billion after taxes, ‘includes provisioning for settled cases and an estimate for those cases which we have received and are still outstanding.'”

Read the full story here.

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An FDA panel has made a recommendation to the agency that the controversial diabetes drug Avandia should either be taken off the market or its sales should be severely restricted.

Avandia and its maker, GlaxoSmithKline, have recently come under fire for trial results that reveal that patients taking Avandia are at an increased risk for heart attacks.

A majority of the committee decided that if Glaxo wants to keep Avandia on the market, it must complete another clinical trial to prove it is safe.

FDA officials said they will consider the recommendations of the committee and make an official decision as soon as possible. Gardiner Harris, The New York Times 07/14/2010
Read Article: The New York Times

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