Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others. We specialize in Personal Injury trial litigation and focus our energy and efforts on those we represent.

Articles Posted in Product Liability

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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 2005, the Food and Drug Administration (FDA) warned doctors about a study showing that babies born to women who took Paxil during the first trimester of pregnancy had a higher rate of major birth defects. The study, which involved 3,500 pregnant women, showed that those on Paxil were twice as likely to have a child with defects than women on other antidepressants.

The FDA put out a statement warning that “[h]ealthcare professionals are advised to carefully weigh the potential risks and benefits of using [Paxil] in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients.”

At least 600 cases have been filed alleging that Paxil is responsible for congenital birth defects. GSK has also paid approximately $1 billion in settlements of Paxil-related cases not involving birth defects.

Read full story here.

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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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Patients undergoing arthroscopic shoulder surgery have received pain pumps to assist in their recovery. Now a new study suggests these pumps may deliver too much medicine, destroying cartilage and leading to a condition known as Postarthroscopic Glenohumeral Chondrolysis.

A study by The American Journal of Sports Medicine identified intra-articular pain pumps as the likely cause of Postarthroscopic Glenohumeral Chondrolysis (PAGCL).

PAGCL only occurs in patients who received a shoulder pain pump filled with bupivacaine and epinephrine during their surgery.

Numerous lawsuits are pending against the companies that manufacture, market or distribute the pain pumps, including Stryker, DJO Inc., I-Flow Inc., BREG Inc. and others.

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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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The New York Times (7/5) editorialized that the recent controversy over the diabetes drug Avandia — with “two major studies” saying it “raises the risk of cardiovascular ailments” and the third yet-to-be-published study that “seemed to exonerate” the drug — should probably lead patients to ask their doctors about alternatives.

The paper said that as expert advisers to the Food and Drug Administration work to deliver a more definitive judgment, it would throw its lot with the views of safety specialists, who focus solely on risks emerging after the drug is in use, rather than the opinions of those “who approved the drug as safe and effective in the first place.”

Read the full story here at the New York Times.

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The Los Angeles Times (7/1, Rick) reports that Avastin (bevacizumab) “can cause significant kidney damage in some patients,” according to a new study.

Researchers, “reporting in this month’s issue of the Journal of the American Society of Nephrology…wrote that patients on Avastin were at increased risk of severe protein loss from the kidneys, which can lead to permanent damage.” Altogether, “patients on Avastin were at a fourfold risk for protein loss and kidney damage, depending on dosage and the type of cancer.”

Kidney problems are the second serious condition linked to the cancer drug. Last year it was found that some patients on Avastin were at elevated risk of intestinal perforations.

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