A New York federal judge is allowing a lawsuit over the osteoporosis drug Fosamax to go forward, but with limitations. Judge John Keenan will allow plaintiff Linda Secrest to pursue her claim against Merck & Co., but she will not be able to claim punitive damages or to argue that Merck failed to warn her about potential risks in taking the drug. Secrest claims that a defect in Fosamax caused osteonecrosis of the jaw (“ONJ”), a condition in which the tissue in her jaw decayed. Secrest’s lawsuit is the fourth bellwether case against Merck over Fosamax, and the outcome will affect thousands of other Fosamax claims. Significantly, Judge Keenan stated in his decision that he found no evidence that any warning label would have caused Secrest’s prescribing physician to take her off the medication.
Fosamax, or its generic equivalent alendronate, treats and prevents osteoporosis, a condition in which the bones weaken and can easily break. It first came on the market in 1995. The drug works by inhibiting bone resorption, the process by which bones break down with age. Doctors often prescribe the drug for women who have gone through menopause.
The FDA began to collect reports of ONJ as far back as 2000, and other complaints such as broken legs began to come in as well. A 2008 finding from the FDA indicated a possible link between the drug and certain cases of esophageal cancer. A report from the American Dental Association followed soon after that suggested a connection between ONJ and medications in the same class as Fosamax. A 2010 press release from the FDA warned of a possible elevated risk of thigh bone fractures. These correlations led quickly to litigation.
Secrest’s lawsuit began in Florida, and in August 2006 it moved to the U.S. District Court for the Southern District of New York to be consolidated with other similar lawsuits. Secrest, along with dozens more plaintiffs around the country, filed suit against Merck, Novartis Pharmaceuticals, Procter & Gamble Pharmaceuticals, Aventis Pharmaceuticals, Sanofi-Aventis, Walgreen Co. and Mouhannad Budeir DDS. The lawsuit, styled In Re: Fosamax Products Liability Litigation, seeks tort damages for personal injury and products liability. Three bellwether cases preceded Secrest’s case. Merck one two of those cases at trial, and the third resulted in am $8 million jury verdict against Merck, which Judge Keenan reduced to $1.5 million.
Judge Keenan’s ruling means that Secrest’s lawsuit may proceed, possibly to the trial stage, and that a jury may consider the connection between Fosamax and ONJ. If Secrest prevails, thousands of other claims against Merck over Fosamax may see their own day in court. Secrest’s lawyers face a challenge, however, since Judge Keenan has eliminated her claim for failure to warn of the drug’s dangers. That claim would have required Secrest to prove by a preponderance of evidence (meaning it is more likely than not) that Merck knew about a risk inherent in Fosamax and failed to warn its customers. The evidence in that claim largely goes towards what Merck knew rather than towards the actual properties of the drug itself. Secrest and her lawyers must now pursue the product liability claim, which requires her to provide a preponderance of evidence of a defect in the drug’s design or production that caused her ONJ. Her damages are limited to “actual damages,” meaning her medical expenses, lost wages, and pain and suffering. These limitations imposed by Judge Keenan are specific to the facts of Secrest’s case. A future plaintiff may be able to recover further damages or pursue other claims for liaiblity.
The Maryland pharmacy error attorneys at Lebowitz & Mzhen can assist you if you have been injured by the drug Fosamax or any closely related drugs. Contact an experienced lawyer today to see if you are entitled to relief.
Judge narrows benchmark Fosamax case vs. Merck, Reuters, August 31, 2011
Will Side Effect Reports Scare Fosamax Patients?, ABC News, January 1, 2009
Related Web Resources:
Fosamax Medication Guide from Merck (PDF)
Fosamax information from Drugs.com
Fosamax Consumer Medication Information from the U.S. National Library of Medicine
Should Bisphosphonates be Continued Indefinitely? An Unusual Fracture in a Healthy Woman on Long-Term Alendronate, Geriatrics 61(1):31-33, 2006