Maryland Accident Law Blog

A jury in the United States has ordered drug manufacturer Roche to pay $12.9 million to three Accutane users who say they developed chronic bowel disorders from using the popular acne drug. The jury determined that the Swiss drug maker failed to properly warn of the side effects that can result from using Accutane.

The patients began using Accutane more than 10 years ago when they were teenagers to treat their acne. As a result of using the acne drug, two of the patients say they now require long-term drug rehabilitation and the third patient has to have his colon removed.

This is not the first drug litigation lawsuit filed against Roche that links Accutane to inflammatory bowel disease. This is the fourth IBD civil trial the Swiss Drug maker has lost.

Inflammatory Bowel Disease
There are two kinds of chronic diseases that can cause inflammation to the intestines and result in ulcers:

• Crohn’s Disease
• Ulcerative Colitis

While the drug’s warning label says Accutane is “associated with” chronic bowel problems, the drug maker maintains that there is no direct connection between chronic bowel ailments and Accutane. The drug litigation attorneys for the plaintiffs, however, say Roche has conducted internal studies that indicate Accutane can damage the intestinal tract and result in inflammatory bowel disease.

Hoffman-La Roche, Roche’s US subsidiary, plans to appeal the dangerous drug verdict. The company continues to maintain that there is no scientific evidence that proves using Accutane can cause IBD.

Accutane
Over 13 million people have used Accutane since 1982. Until the drug's patent expired six years ago, the acne medication was one of Roche’s top selling drugs. It is also a controversial drug.

Accutane was linked to birth defects in the 1980’s and 266 suicide cases in the US. It has also been associated with problems affecting the musculoskeletal, cardiovascular, and autoimmune systems, as well as the pancreas, liver, central nervous system, and kidneys. Some 500 lawsuits have been filed over the acne drug.

Roche Loses Fourth Accutane Trial, Ordered to Pay 3 IBD Victims, $12.9 Million, News Inferno, November 21, 2008

Pharma Roundup: Lawsuit for Roche, Teva Troubles for AstraZeneca, and More, BNET, November 19, 2008

Related Web Resources:

Roche Pharmaceuticals

Accutane, Drugs.com

Inflammatory Bowel Disease, FamilyDoctor.org

This week, the US Supreme Court heard arguments in a drug litigation lawsuit pitting a musician, whose arm was amputated after she was given an anti-nausea drug, and drug maker Wyeth. Diane Levine’s arm had to be removed after a physician’s assistant accidentally injected the anti-nausea drug Phenergan into her artery in April 2000. She was administered the drug at a clinic where she was treated for migraine headaches.

Levine sued the clinic, the supervising physician, and the physician’s assistant who injected the drug into her artery for medical malpractice and settled with all parties out of court. She sued Wyeth for its alleged failure to warn clinicians that they should use the safer IV drip, instead of the intravenous “push” method, to administer to Phenergan to her.

A civil jury awarded Levine $7.4 million million, and a judge reduced the amount to $6.7 million. The Vermont Supreme Court upheld the verdict.

Now, Wyeth wants the US Supreme Court to reverse the ruling. The drug maker says that it was in compliance with Food and Drug Administration standards and should therefore be protected from product liability lawsuits filed in state courts.

Wyeth, an independent record label owner, says her business was “crippled” by the loss of her arm. She also says that losing her arm destroyed her musical identity, her source of income, and her self-image.

Supreme Court Hears Arguments on Drug Labeling in Case of Woman Who Lost Forearm to Gangrene, Fox News, November 4, 2008

High Court Case Looms Large for Drugmakers, Washington Post, November 4, 2008

The Court Confronts a Grievous Injury, NY Times, November 7, 2008

Related Web Resources:

Wyeth Pharmaceuticals

Phenergan, Drugs.com

Food and Drug Administration

This week, a Food and Drug Administration panel will review the effect of the flu medicine Tamiflu on the brain. 55 children in the United States reportedly exhibited abnormal behavior and other brain effects after taking the medication. 22 of the cases included serious symptoms, such as delirium, convulsions, and delusions.

Globally, more than 1800 children who have taken Tamiflu showed similar effects worldwide. Five children in Japan died because of psychiatric or neurological problems. Seven adults died because of neuropsychiatric problems.

75% of the 48 million prescriptions for Tamiflu are administered in Japan. Last March, the Japanese government issued a warning that Tamiflu’s use be restricted in young people.

There is no concrete evidence to show that Tamiflu causes problems in the brain or abnormal behavior. Terry Hurley, a spokesperson for drugmaker Roche Laboratories, says flu patients who have not taken Tamiflu also showed these symptoms. However, if a child or adult was injured from taking Tamiflu, he or she may have grounds to file a dangerous drug claim or lawsuit against Roche Laboratories.

Tamiflu is Roche’s number nine best-selling drug and, according to the Tamiflu Web site, it is the “number one doctor-prescribed flu medicine.” The FDA has recommended Tamiflu for use in children and adults over age one. Tamiflu is used as a flu vaccine and to treat flu symptoms.

FDA safety reviewers are recommending that Tamiflu labels be updated to include information about possible neuropsychiatric side effects.

The FDA’s review of Tamiflu comes a little over one month after the makers of several infant cold medicines voluntarily recalled infant cold medicines Dimetapp, Robitussin, Pediacare, Triaminic, Little Colds, and Tylenol because of accidental overdose concerns.

Earlier this month in Chicago, a woman sued Walgreen Co. and McNeil for the wrongful death of her 4-month-old son who died after taking Infant Tylenol Cold Decongestant Plus Cough and Pediatric Drops-Cough Plus Cold, which are two over-the-counter medications.

FDA panel to review Tamiflu's effect on brain, USA Today, November 26, 2007

Lawsuit alleges Illinois infant died from cold medicine ingredient; mother suing 2 companies, International Herald Tribune/AP, November 14, 2007

Makers Pull Cold Medicines for Infants, CNN.com, October 11, 2007

Tamiflu

Related Web Resources:

FDA Questions the Safety Of Asthma Drugs for Kids, The Wall Street Journal, November 24,2007

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