Merck Wins Fosamax Side Effects Lawsuit; Plaintiff Plans to Appeal

New York, NYDespite the US Food and Drug Administration (FDA) advisory panel recommending stronger warnings about Fosamax side effects, a jury has found in favor of Merck in a Fosamax ONJ lawsuit. The lawsuit was the fourth bellwether case involving claims of Fosamax osteonecrosis of the jaw (ONJ) and other side effects.

The most recent lawsuit involved claims by Linda Secrest, a 66-year-old who alleged she developed serious jaw problems after using Fosamax from 1998 to 2005. According to The Wall Street Journal (10/03/11), Merck defended its conduct and the osteoporosis medication, arguing that Secrest had medical issues that resulted in the development of jawbone problems even without the use of Fosamax.

A jury agreed with Merck that Secrest's jaw problems were linked to a preexisting medical condition. This is the third of four bellwether cases found in favor of Merck. One bellwether case was found in favor of the plaintiff, with a jury awarding $8 million to a Florida woman. A judge, however, ruled the award was excessive and the award was reduced to $1.5 million. Merck is appealing that verdict.

A lawyer for the plaintiff said they plan to appeal the decision on the grounds that the judge improperly dismissed a failure to warn claim against Merck and also wrongly instructed the jury that a product should be presumed non-defective if it is approved by the FDA.

According to Business Week, approximately 1,650 lawsuits involving around 2,000 plaintiff groups are pending against Merck in state or federal court. Lawsuits were filed following a study published in the Journal of Dental Research (02/11) suggesting a link between the use of oral bisphosphonate medications—a class of drug that includes Fosamax—and osteonecrosis of the jaw.

Osteonecrosis of the jaw (ONJ) occurs when blood flow to the jawbone is reduced for weeks. The bone fails to heal properly following dental surgery or other trauma and dies.

Merck has said that it found no cases of ONJ in any Fosamax clinical trials.

In September 2011, the FDA convened an advisory panel to determine if changes were needed to the Fosamax label. Although the panel found that warnings should be changed to indicate how long patients can take the medication before developing side effects, it did not make specific wording recommendations. Furthermore, the panel did not find that patients should be advised to take a Fosamax holiday. In a report issued prior to the advisory panel's meeting, the FDA noted that studies have not found significant benefit to using Fosamax beyond five years.