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 the 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.
Timothy O’Brien, the lead lawyer for Mrs. Boles, said that an updated number would be closer to 1,200 pending cases. His law firm represents about 400 Fosamax plaintiffs, he said.
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 Mrs. Boles had other health factors that could have caused her jaw problems.
Meanwhile, Mr. O’Brien, the lawyer for Mrs. 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. Mr. 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.
Fosamax had global sales of $1.55 billion last year, a decrease of almost 50 percent compared with 2007, according to a Merck financial statement.
On Wednesday afternoon, Judge Keenan asked the jury to decide several questions: Was Merck negligent in formulating Fosamax? Did the company fail to warn Mrs. Boles’s doctor of a known risk of the drug? Is Fosamax a defective product? And, if the jury answers yes to any of those questions, did that circumstance legally cause Mrs. Boles’s jawbone problems?
If the jury decides in favor of Mrs. Boles, it can award compensatory damages for her suffering. But Judge Keenan has ruled out punitive damages in this particular case because he said the evidence did not suggest malice on the part of Merck. Mrs. Boles developed a dental problem in 2002, he wrote, before scientific articles were published on the issue which would have alerted Merck to potential problems.
Plaintiffs may have a difficult time proving the drug has directly caused people’s jawbone injuries.
Jawbone death has long been a known side effect of radiation in patients being treated for oral cancer. But, about six years ago, a few oral surgeons began reporting jawbone death in patients who had not received radiation for oral cancer.
Instead, the patients had been prescribed bisphosphonates, a group of drugs that affect the way that bones renew themselves, said Dr. Salvatore Ruggiero, an oral surgeon in Lake Success, N.Y., who has not been involved in the court case. These include pills like Fosamax as well as Zometa, an intravenous bisphosphonate used to treat bone cancer.
Bisphosphonates work by inhibiting cells from breaking down old or damaged bone, a beneficial effect that inhibits bone loss. At the same time, the drugs can have a drawback. They can have a secondary effect of decreasing the formation of new bone tissue, Judge Keenan wrote in an opinion in July.
It is the drug’s potential for decreasing the formation of new bone tissue that may contribute to jawbone death, said Dr. Ruggiero, who was one of the first doctors to study and publish articles on the problem. Because of the trauma caused by chewing and teeth grinding, jawbone cells turnover more quickly than many other bones in the body, he said. Recognizing the high cell turnover, bisphosphonates may accumulate in the jawbone, and try to compensate by oversuppressing cell turnover, he said.
According to this theory, bisphosphonates might lead to jawbone death in patients who have dental surgery, like tooth extraction, from which the jaw needs to heal itself even more intensely, he said.
Dr. Ruggerio said he had a database of 70 patients who had developed dead jawbone tissue after taking oral bisphosphonates. “The number of cases that we are now seeing is unprecedented,” he said.
But there is no definitive scientific proof that Fosamax causes jawbone death, Paul Strain, the lead lawyer for Merck, told the jury on Wednesday morning. Although anecdotal case reports of the problem and animal studies have appeared in medical journals, nobody has conducted a rigorous clinical trial to look at whether there is a higher incidence of the problem in people taking the drug than in people who do not, he said.
In 2004, the Food and Drug Administration reviewed the safety of bisphosphonates and concluded that osteonecrosis of the jaw could be a risk for the class of drugs as a whole, not just those that are administered intravenously. The agency asked manufacturers to amend drug labels to acknowledge that there have been reports of jawbone death in patients taking the drugs.
If you or a family member has been personally injured because of the fault of someone else: by the use of dangerous and defective drugs, bad products, or toxic injury etc then please contact the Fort Worth Texas Defective Drugs Product Liability Attorney Dr. Shezad Malik. For a no obligation, free case analysis, please call 817-255-4001 or Contact Me Online.
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