Actos Linked to Bladder Cancer

Actos is a drug that has been used to treat Type-2 diabetes.  Studies now indicate that Actos can cause serious injuries, including heart attack, heart failure, and an increased risk of bladder cancer. 

As a result of a study linking Actos to bladder cancer, France withdrew Actos from the market in June 2011.  Likewise, Germany, has advised doctors against prescribing the drug due to the increased risk of bladder cancer resulting from its use.

The Food and Drug Administration (FDA) has updated the warning label of Actos, announcing a link between the drug and increased risk of bladder cancer.

Many lawsuits have now been filed across the country regarding Actos.  The Judicial Panel on Multidistrict Litigation (JPMDL) will hold a hearing in early December to determine if all Actos lawsuits should be consolidated in one federal court for discovery and pre-trial proceedings.  A decision is expected in early 2012.

Texas Supreme Court Re-Affirms Havner and Clarifies Causation Threshold Requirements to Prove Causation

On Friday, August 26, 2011, in Merck & Co., Inc. v. Garza, the Texas Supreme Court ruled that Merck & Co. does not have to pay a $32 million jury award to the family of a man who used Vioxx and subsequently died of a heart attack.  In doing so, the Texas Supreme Court reaffirmed its decision in Merrell Dow Pharmaceuticals, Inc. v. Havner which set forth standards that must be met in determining whether epidemiological evidence is sufficiently reliable to prove causation.

Leonel Garza had a long history of heart disease, and took Vioxx, as prescribed by his doctor, for pain relief for the 25 days leading up to his death.  After his death, his family sued Merck & Co., alleging Vioxx was defective and was marketed with inadequate warnings.  At trail, Merck challenged the scientific reliability of evidence that Vioxx caused Garza’s death.  The trial court overruled Merck’s objections, and the jury returned a verdict awarding $7 million in actual damages and $25 million in punitive damages. The jury verdict was reduced to $7.75 million because of a state cap on punitive damages.
 

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Meridia Recalled by Abbott Laboratories

Today, the U.S. Food and Drug Administration announced that Abbott Laboratories recalled its obesity drug Meridia (sibutramine) off the market.  The recall occurred because clinical trial studies showed there was an increased risk of heart attacks and strokes in people who used the drug. 

According to Dr. John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, "Meridia's continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke. Physicians are advised to stop prescribing Meridia to their patients and patients should stop taking this medication."

Dr. Gerald Dal Pan, director of the Office of Surveillance and Epidemiology at the FDA'S Center for Drug Evaluation and Research, said that "[i]n all its investigation of the drug, the FDA could find not one person whose benefit from the drug outweighed its risk."

According to the FDA, approximately 8 million people worldwide take Meridia , including 100,000 Americans.

F.D.A. Internal Reports Recommend Avandia Be Withdrawn From Market

There is a fierce debate going on within the Food and Drug Administration regarding the drug Avandia.  According to the New York Times, recent internal reports from the Food and Drug Administration recommend that Avandia (a drug used to treat Type 2 diabetes) be removed from the market.  The reports indicate that people who use Avandia needlessly suffer heart attacks and heart failure each month and 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.   Avandia was linked to 304 deaths during the third quarter of 2009.  It is expected that an advisory committee within the FDA will debate the drug further this spring and summer and will then make a final decision regarding the drug and whether or not it should be sold.

Avandia is manufactured by GlaxoSmithKline and was once one of the best-selling drugs in the world.  In 2006 alone, sales were $3.2 billion.

Eleventh Circuit Affirms Dismissal of Accutane Lawsuit

On June 10, the Eleventh Circuit Court of Appeals affirmed a district court's granting of summary judgment in favor of Hoffman-La Roche, Inc., the manufacturer of the drug Accutane.  The case involved the tragic death of the son of U.S. Rep. Bart Stupak (D-Mich), who was 17 years old when he took his own life.  Laurie Stupak sued Hoffman-La Roche, Inc. alleging the manufacturer was negligent in failing to warn that Accutane (an acne drug) could cause suicide without any premonitory (warning) symptoms.

The package of Accutane that B.J. Stupak was taking did not warn of a risk of suicide without any warning symptoms.  The court ruled, however, that because Hoffman-La Roche, Inc. did not know at the time that patients using Accutane could experience a desire to kill themselves without any warning signs, the drug manufacturer could not be held liable.