Product Liability

February 22, 2010

Heart Attack and Heart Failure Side Effects of Avandia Diabetes Drug

Three years ago, Dr.Nissen, a cardiologist at the Cleveland Clinic, conducted a landmark study that suggested that the best-selling diabetes drug Avandia raised the risk of heart attacks. The study led to a Congressional inquiry, stringent safety warnings, a sharp drop in the drug’s sales of GlaxoSmithKline, Avandia’s maker.

The battle between Dr. Nissen and GlaxoSmithKline was waged from afar in news releases and published papers. But on May 10, 2007, 11 days before Dr. Nissen’s study was published in The New England Journal of Medicine, he and four company executives met face to face in a private meeting whose details have not been disclosed until now.

Read the full article here at the New York Times.

February 21, 2010

Glaxo to Remove Zinc From Denture Cream

by Dr. Shezad Malik

The maker of Poligrip denture cream will stop making formulas containing zinc amid lawsuits claiming years of excessive use caused neurological damage and blood problems in consumers, allegedly crippling some.

GlaxoSmithKline will stop making and marketing Super Poligrip Original, Ultra Fresh and Extra Care products in the U.S. The company plans to reformulate the creams without zinc.

Read the full story at the New York Times

February 21, 2010

GlaxoSmithKline Knew of Avandia’s Cardiac Risks, Senate Report Says

by Dr. Shezad Malik

Confidential studies by Food and Drug Administration officials recommend that GlaxoSmithKline’s Avandia, a diabetes medicine, get pulled from the market because it is linked to heart attacks.

The studies, released as part of a report on Avandia by staff of Senate Finance Committee members Chuck Grassley (R., Iowa) and Max Baucus (D., Mont.), also say any head-to-head trial where patients get Avandia and Takeda Pharmaceutical Co.’s diabetes medicine Actos would be “unethical and exploitative.” GlaxoSmithKline is currently sponsoring a study, called TIDE, where patients get either Avandia, Actos or other medicines.

Read the full Wall Street Journal Story here

February 20, 2010

FDA Report Avandia Diabetes Drug Harms Heart

by Dr. Shezad Malik

Hundreds of people taking Avandia, a diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market.

The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.

Read full New York Times dtory here.

February 18, 2010

Oregon Jury Finds for Plaintiff in First Pain Pump Verdict

by Dr. Shezad Malik

The jury ordered pain pump manufacturer I-Flow Corp. to pay $4.5 million to a man whose implanted pump caused the cartilage in his shoulder joint to wear almost completely away, a condition known as chondrolysis.

In the first verdict of its kind, an Oregon jury has found for the plaintiff in a case against the manufacturer of a pain pump, awarding $4.5 million to a man for permanent damage to his shoulder joint. The verdict, which included damages paid to his wife for loss of consortium, comes in what many considered a test case for the defense. (Beale v. I-Flow Corp., No. 080101554 (Or., Multnomah Co. Dist. Jan. 22, 2010).)
Read full story here Trial

February 18, 2010

U.S. to Probe Toyota Corolla Steering Reports

by Dr. Shezad Malik

Toyota Motor Corp. and U.S. regulators are looking into possible steering problems in the company’s popular Corolla compact, the latest quality issue to surface in the wake of two recalls that covered millions of vehicles and forced Toyota to halt U.S. sales of eight models.

The Corolla investigation could start as early as Thursday, said a U.S. Transportation Department official. The inquiry will cover about 500,000 model-year 2009 and 2010 Corollas, officials said.

The National Highway Traffic Safety Administration has received 163 complaints about the steering in Corollas from those model years, according to the safety agency’s Web site.

Read the full Wall Street Journal Article here.

February 17, 2010

U.S. Opens Probe into Toyota Recalls; Output Cut

by Dr. Shezad Malik

U.S. regulators on Tuesday opened an investigation into whether Toyota Motor Corp acted in a timely way to recall cars for acceleration problems, and the automaker moved to slow its U.S. production to avoid a costly ballooning of inventories.

The National Highway Traffic Safety Administration said it had requested production data, consumer complaints and other documents expected to shed light on how and when Toyota learned of problems affecting about 6 million vehicles it has recalled in the United States.

Read full Reuters story here.

February 16, 2010

Roche Ordered to Pay $25 M to Accutane User

by Dr. Shezad Malik

Roche Holding AG, the Swiss drugmaker, must pay $25.16 million in damages to a former user of its Accutane drug who blamed the acne medicine for his inflammatory bowel disease, a New Jersey jury ruled.

Andrew McCarrell, 38, won the verdict at a retrial in Atlantic City, New Jersey. An appeals court ordered the new trial after overturning a $2.62 million award he won in May 2007. McCarrell, a computer technician from Birmingham, Alabama, testified he got sick after taking the drug for acne in 1995. He needed five surgeries, including one to remove his colon.

Read the full story here at Bloomberg.

February 16, 2010

Roche Holding AG, the Swiss drugmaker, must pay $25.16 million in damages to a former user of its Accutane drug who blamed the acne medicine for his inflammatory bowel disease

by Dr. Shezad Malik

Roche Holding AG, the Swiss drugmaker, must pay $25.16 million in damages to a former user of its Accutane drug who blamed the acne medicine for his inflammatory bowel disease, a New Jersey jury ruled.

Andrew McCarrell, 38, won the verdict at a retrial in Atlantic City, New Jersey. An appeals court ordered the new trial after overturning a $2.62 million award he won in May 2007. McCarrell, a computer technician from Birmingham, Alabama, testified he got sick after taking the drug for acne in 1995. He needed five surgeries, including one to remove his colon.

Read the full Reuter story here.

February 16, 2010

Toyota Acceleration Complaints Cite 34 Deaths, U.S. Data Show

by Dr. Shezad Malik

Toyota Motor Corp. vehicles have been linked to 34 deaths by consumers filing complaints with the U.S. government over unexpected acceleration, according to the Transportation Department.

The total jumped by 13 fatalities since Jan. 27 as nine more filings were added to a database the department’s National Highway Traffic Safety Administration uses to track deaths, injuries and consumer complaints.

http://www.bloomberg.com/apps/news?pid=20601209&sid=aPso41xXZS60Read the full Bloomberg story here.