Lawsuits arising out of severe side effects from Merck & Co.’s Fosamax drug go all the way back to around 2009. Merck has tried tirelessly to get the cases thrown out, arguing that the FDA’s rejection of its proposed warning label should preempt the lawsuits. The current multidistrict litigation (MDL) comes from Fosamax users claiming that the osteoporosis drug can cause femoral fractures. The number of cases has swelled to more than 1,000.
In 2008, Merck submitted data to the FDA suggesting Fosamax may be linked to certain bone fractures, but the FDA rejected its proposal to add a warning label to the drug. In October 2010, after conducting further research on the issue, the FDA ordered drug manufacturers to revise their labels to include a warning, which Merck eventually did in 2011. The patients attacking Merck are the ones that took Fosamax before the label change in 2011 that warned of atypical femoral fractures.
In 2013, U.S. District Judge Joel Pisano granted Merck summary judgment on the “failure to warn” issue, which terminated one plaintiff’s lawsuit against the company. Judge Pisano first heard the arguments for summary judgment then had the federal jury decide the verdict; the jury found that the plaintiff’s injury could not have been from Fosamax. The judge said that Merck could not be held liable for failing to warn consumers of the risks of long-term Fosamax use because the FDA didn’t approve the warning and would not have approved a stronger warning.
The case was successfully appealed to the Third U.S. Circuit Court of Appeals in Philadelphia. In March 2017, this court allowed the claims to proceed to trial, stating that a jury could probably find that the FDA had objected only Merck’s phrasingof the proposed warning label and might have approved “a properly worded warning” about Fosamax. The Third Circuit Court reversed the lower court’s ruling, saying that the drug-maker must prove to a jury that federal regulators blocked the warning.
Both parties have asked the U.S. Supreme Court to hear their side. Merck is asking for them to end the MDL over the alleged failure to warn patients of the atypical femoral fractures whereas over 500 patients are asking the Court to keep the MDL alive, claiming the 3rdCircuit properly determined the FDA would have welcomed a properly worded warning.
On June 28, 2018, the U.S. Supreme Court agreed to consider the Third Circuit decision that revived MDL over Merck’s alleged failure to warn patients about the risk of femoral fractures from its osteoporosis drug, Fosamax. The high court has not indicated why it decided to grant Merck for certiorari. At the Supreme Court’s request, the acting U.S. Solicitor General weighed in on the issue and urged the Court to take the company’s appeal, saying a judge should decide the issue, not a jury. With the main issue revolving around an action from a federal agency, the Solicitor General thinks the decision would be best handled by judges who are familiar with administrative law. He also said that the appeals panel wrongly focused on how the FDA would have responded to a differently worded proposed warning, rather than on the legal effect of the FDA’s decision. Further updates will be provided as the U.S. Supreme Court considers the case.
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If you or a loved one have experienced the side effects of a drug or medication and have suffered serious injuries as a result, the experienced attorneys at Hovde Dassow + Deets can help you get the compensation and justice that you deserve. Contact Hovde Dassow + Deets today at (317) 576-3241, initial, and confidential consultation to discuss your potential case.