A federal judge just ordered hundreds of cases involved in a multidistrict litigation (MDL) brought against Merck & Co. over alleged Fosamax jaw injuries be sent for trial in courts nationwide. Fosamax is Merck’s osteoporosis medication.
Drug and device manufacturers tend to seek settlements in mass tort cases such as these, when a large number of lawsuits are consolidated before one judge. The move, by U.S. District Judge John Keenan of Manhattan could end up costing Merck big. About 200 cases will be returned monthly to the courts were they were initially filed, with the oldest cases being heard first, according to Reuters.
Of the 5,075 cases pending nationally in federal and state courts, about one-fifth were before Judge Keenan, Reuters noted. The judge conducted a number of bellwether trials—early trials that allow both parties the opportunity to understand potential outcomes in MDLs. According to Reuters, having the lawsuits consolidated was beneficial for Merck.
The plaintiffs must advise Judge Keenan by October 11 to where they recommend the first batch of cases be settled.
The judge recently denied Merck’s request to force hundreds of alleged Fosamax victims to substantiate their injuries. Judge Keenan denied the request saying that the process would degrade into arguments over the merits of each individual case.
More than 1,000 plaintiffs claim Fosamax led to their suffering from osteonecrosis of the jaw (ONJ). Seven such cases reached trial as bellwethers; Merck won five. The remainder had been consolidated in an MDL before Judge Keenan for pretrial processing prior to being returned to plaintiffs’ home districts, Law360 recently explained.
Meanwhile, research found that risks for developing ONJ following dental extractions raises significantly in patients who are taking bisphosphonates. The risks increase dramatically when Fosamax is received intravenously, according to the study, which was published in the International Journal of Oral and Maxillofacial Surgery.
The U.S. Food & Drug Administration (FDA) ordered that ONJ warnings be included on Fosamax, and other bisphosphonate, labels in 2004. It is believed that osteonecrosis may develop when bisphosphonates, including Fosamax, prevent the body from repairing microscopic damage that occurs in the jawbone, such as what is seen during routine dental procedures.
Fosamax and other bisphosphonates have been associated with a number of other serious side effects. For example, in October 2010, the FDA asked that manufacturers of bisphosphonates used to treat osteoporosis, including Fosamax, include information to the “Warnings and Precautions” section of the drugs’ labels that describes the risk of atypical thigh fractures after research linked long-term use of these drugs to that particular side effect.
Recently, studies revealed that long-term use of oral bisphosphonates may increase risks for patients developing esophageal cancer.