Product Liability

July 20, 2010

Paxil Birth Defect Dallas Attorney Update

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.

July 19, 2010

Doctors Say It’s Already Over For Diabetes Drug Avandia

by Dr. Shezad Malik

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.

July 18, 2010

Dallas Texas Update: Pain Pumps & Arthoscopic Shoulder Surgery Risks

by Dr. Shezad Malik

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.

July 18, 2010

GSK to Take Charge of $2.36B Related to Paxil, Avandia.

by Dr. Shezad Malik

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.

July 17, 2010

FDA: Avandia To Be Restricted

by Dr. Shezad Malik

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

July 12, 2010

NYTimes says patients should seek Avandia alternatives.

by Dr. Shezad Malik

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.

July 8, 2010

Avastin Causes Significant Kidney Damage in Some Patients.

by Dr. Shezad Malik

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.

July 7, 2010

Dallas CBS 11: North Texas Yaz Yasmin Lawsuits

by Dr. Shezad Malik

We were recently featured on Dallas CBS Channel 11 evening news.

Please click here to read the interview and watch the video link.

Our client suffered massive brain damage following the use of Yaz.

June 30, 2010

Update: 2 Studies Suggest Avandia Increases Risk of Heart Problems.

by Dr. Shezad Malik

ABC World News (6/28, story 7, 2:20, Sawyer) reported, “Two major studies have found the medicine called Avandia [rosiglitazone] could create a significant new risk of heart attack and other serious problems.”

The Washington Post (6/29, Stein) reports that one study, “involving more than 35,500 people, found that Avandia significantly raises the chances of a heart attack.” A separate study “of more than 227,500 Medicare patients — the largest such study to date — found that the drug boosts the risk for strokes, heart failure, and death.”

Los Angeles Times (6/29, Roan) reports that the first study “found Avandia raised the risk of heart attacks by 28% to 39% as compared with other diabetes medications. The study was published online in the Archives of Internal Medicine.”

Bloomberg News (6/29, Cortez) quotes Steven Nissen, MD, lead author of the study, as saying, “I think we’ve got more than enough evidence to say this drug should not be used.”

USA Today (6/29, Marcus) reports that in the second study, published in the Journal of the American Medical Association, “scientists from the Center for Drug Evaluation and Research at the Food and Drug Administration evaluated data from 227,571 Medicare beneficiaries taking either Avandia or Actos [pioglitazone hydrochloride].” The investigators found “no differences in the risk for heart attack between the two drugs, but the study found that compared with Actos, Avandia was associated with a 25% increased risk of heart failure, a 27% increased risk of stroke and a 14% increased risk of death.”

Lawmakers call for Avandia to be pulled from market. The Hill (6/28, Pecquet) “Healthwatch” blog reported that “Sen. Chuck Grassley (R-Iowa) and Rep. Rosa DeLauro (D-Conn.) on Monday called for the diabetes drug Avandia to be pulled from the market in the wake of two new medical studies.” In a joint statement, Sen. Grassley said, “The serious issues delineated in these two new, independent reports put additional onus on advisory committee members when they meet in July.”

Bloomberg News (6/29, Peterson, Cortez) reports that “Grassley and Senator Max Baucus, a Montana Democrat, in February released a report that said Glaxo knew Avandia may cause heart damage several years before” a “study documented the risk.”

June 29, 2010

Bad News Continues for Avandia Diabetes Drug

by Dr. Shezad Malik

The diabetes drug Avandia, once the world’s top-selling diabetes medication, took two more hits with one new study linking it to an increased risk of heart attacks and a separate study linking it to an increased risk of heart failure and stroke.

The research comes only weeks before an upcoming federal hearing to reconsider its fate. Shari Roan, LA Times 06/29/2010
The drug, known by its generic name, rosiglitazone, was approved in 1999 to help people with Type 2 diabetes control their blood sugar. At the time, it was considered a safer alternative than existing diabetes drugs used instead of insulin. Soon after approval, the drug was linked to an increased risk of heart failure and bone fractures; worries about the drug’s safety increased in 2007 when a meta-analysis — a pooling of previous studies — concluded that the drug increased the risk of heart attack.

Read Article: LA Times