Posted on Fri, Sep. 04, 2009
Fosamax case first of many against Merck
By Natasha Singer New York Times News Service Drug executives, product liability lawyers and Wall Street analysts are closely watching a jury trial in New York over medical problems associated with Fosamax, a drug from Merck that has been taken by millions of women to offset bone loss associated with menopause. It is the first of about 900 state and federal cases pending against Merck in which plaintiffs claim that taking Fosamax caused them to develop a rare problem called osteonecrosis of the jaw. Dental surgery is one of the triggers for the condition that can break down jawbone tissue, causing the gums to fall away and expose bone that looks moth-eaten, oral surgeons said. In the first case against Merck, which began last month in a United States District Court in Manhattan, Shirley Boles, a 71-year-old retired deputy sheriff from Fort Walton Beach, Fla., alleges that taking Fosamax from 1997 to 2006 caused her jawbone tissue to die. The problem developed after she had tooth extraction in 2002, leaving her with ongoing medical problems that include infections that drain through open wounds in her chin. United States District Judge John F. Keenan is presiding over this case and several hundred other lawsuits from many districts, consolidated in New York to establish common issues in the litigation. A jury of three men and five women began deliberating the case on Wednesday afternoon. Compared with other drug product liability cases that have involved many thousands of plaintiffs, the Fosamax litigation is relatively small. But because Merck is trying to complete a $41 billion merger with Schering-Plough, industry analysts are closely watching this first trial to gauge Merck's potential financial liability. Merck spent $7 million in the second quarter of this year on legal expenses in the case and has set aside $42 million to defend itself in about 900 federal and state Fosamax cases brought by about 1,280 plaintiff groups, according to a company regulatory filing at the end of June. Meanwhile, other drug companies and plaintiffs' lawyers expecting to try similar cases involving related bone drugs have been closely monitoring the case to see which arguments resonate with the jury.
Merck's main defense is that there is no definitive medical evidence proving that Fosamax causes jawbone death and that Boles had other health factors that could have caused her jaw problems. Meanwhile, Timothy O'Brien, lead lawyer for Boles, has been using the case to put Fosamax itself on trial, contending that Merck as a corporation put patients at risk by overpromoting Fosamax and by not warning doctors who prescribe the drug about the potential for jawbone disintegration. The trial began Aug. 12. O'Brien has presented internal Merck e-mail messages, company documents and case reports from medical journals to bolster his case that Merck knew about jaw problems associated with Fosamax and did not study the problem or warn doctors about it in a timely fashion. Merck contends that the company became aware of the problem only in late 2003 after the first case report associating bisphosphonates with jaw injuries appeared in a medical journal. According to evidence in the case, the company subsequently assembled a panel of doctors to review reports it had received and determine which cases were likely to be osteonecrosis of the jaw. The Food and Drug Administration approved Fosamax in 1995 to treat the bone loss of osteoporosis associated with menopause. In 1997, the agency approved the drug to prevent osteoporosis itself. Until the recent introduction of branded and generic competitors for the osteoporosis drug market, Fosamax was one of the most popular drugs in the United States. Doctors in the United States wrote about 2.6 million prescriptions for the drug last year, which was down from more than 15 million prescriptions in 2007, according to annual reports from Drug Topics, an industry magazine.
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