Lawsuit Update Center
The Fosamax lawsuit suffered a long and slow death. The plaintiffs did not deserve this long and awful ride. But the litigation over a decade later appears to be (nearly) dead. This post was first written in 2013 and has been updated in 2023 and 2024.
September 2024 Foxamax Lawsuit Update
In a ruling that revives these lawsuits, the Third Circuit ruled that the FDA letter denying Merck’s proposed labeling changes for its osteoporosis drug, Fosamax, does not amount to a final agency action that preempts state law “failure to warn” claims. The decision centers on over 500 plaintiffs who allege that Merck failed to provide adequate warnings about the risk of atypical femoral fractures associated with the drug. The court concluded that the New Jersey federal judge wrongly prioritized FDA informal communications over the plaintiffs’ arguments against preemption.
The three-judge panel, citing the 2019 U.S. Supreme Court case Merck Sharp & Dohme v. Albrecht, emphasized that drug manufacturers have the primary responsibility to ensure their labels comply with both federal and state laws. Judge Kent A. Jordan, writing for the panel, noted, “With real respect for the thorough and thoughtful work the district court did in this complex case, we nonetheless conclude that it erred in its preemption analysis by giving too little weight to the required presumption against preemption.” The court found that the presumption, when applied, indicated that the plaintiffs’ state law claims were not preempted.
The ruling focuses on the FDA’s “complete response letter” (CRL), which had rejected Merck’s proposed warning about stress fractures. Plaintiffs argued that the CRL was not a final action with the force of law and left room for Merck to submit a revised warning label. In contrast, Merck maintained that the FDA would not have approved any differently worded warning due to insufficient evidence linking Fosamax to atypical femoral fractures.
The court highlighted that despite the competing pressures between federal and state law requirements, Merck still had the burden to show that federal law barred it from adding warnings to the label that would meet state law standards. In remanding the case for further proceedings, the court underscored that “there is no escaping the consequences of Albrecht,” which imposes a high bar for preemption claims.
This is a big win for these plaintiffs.
March 2024 Foxamax Lawsuit Update
Lawyers for patients involved in litigation against Merck regarding its osteoporosis drug Fosamax, which is alleged to increase the risk of painful bone fractures, argued before a Third Circuit panel on Tuesday that a letter from the FDA rejecting changes to the drug’s label does not constitute a final agency action triggering federal preemption of state law failure-to-warn claims.
The focus of the oral arguments in Philadelphia was on the FDA’s complete response letter (CRL), which turned down Merck’s proposed warning about stress fractures. Patients in the MDL, comprising 500 individuals, who claim that Merck failed to adequately warn about atypical femoral fractures, contended that the CRL did not represent a conclusive action supported by the force of law, leaving room for further discussion regarding the warning label.
The appeal arises from a ruling by now-retired U.S. District Judge Freda L. Wolfson, who determined that the claims were preempted because the FDA would not have approved a warning label with different wording, citing a prior statement from the agency about the lack of evidence linking Fosamax to atypical femoral fractures.
June 2023 Fosamax Lawsuit Update
The patients are appealing the dismissal of their multidistrict litigation, which was initially heard by a New Jersey judge. The multidistrict litigation involves claims from over 500 plaintiffs who allege suffering atypical femoral fractures between 1999 and 2010 after using Fosamax.
U.S. District Judge Freda Wolfson concluded that the claims were preempted because the FDA would not have approved a differently worded warning, given the agency’s belief in 2009 that there was insufficient evidence connecting Fosamax to atypical femoral fractures. The judge rejected the plaintiffs’ argument that the FDA’s response letter regarding Merck’s proposed warning should not be considered preemptive since it does not constitute a final agency action.
You know who disagrees with this? Former FDA officials, who told the Third Circuit that a ruling in favor of Merck, where patients’ claims regarding the failure to warn of fractures caused by the osteoporosis drug Fosamax would be preempted, could encourage drug companies to withhold safety data. In an amicus curiae brief filed on May 26, 2023, the ex-officials argued that a preemption ruling would incentivize drug companies to submit incomplete safety data for proposed warnings, ensuring the FDA’s rejection and providing a defense against product liability claims. The former officials contended that such a ruling would disrupt the delicate balance between FDA regulation and tort law liability and undermine drug companies’ responsibility to ensure accurate and up-to-date drug labels.
What Is Fosamax?
Fosamax is in a class of drugs known as bisphosphonates. The FDA has approved Fosamax for, among other things, the treatment and prevention of osteoporosis in postmenopausal women. Osteoporosis, as almost anyone reading this knows, is a ondition that causes bones to become fragile and more likely to break.
While it is often effective in treating this condition, it has also been linked to a number of serious side effects, including femur fractures.Femur fractures are one of the most serious side effects associated with Fosamax, and they can cause significant pain, disability, and even death. These fractures typically occur in the thigh bone, and they can be particularly difficult to treat because the femur is one of the strongest bones in the body. In many cases, individuals who suffer a femur fracture as a result of taking Fosamax will require surgery to repair the bone, and they may be unable to walk or engage in other physical activities for an extended period of time.
Numerous lawsuits were filed by individuals who have suffered femur fractures as a result of taking Fosamax, and these lawsuits have raised important questions about the safety of this drug.
In 2010, the FDA mandated that bisphosphonate manufacturers revise their labeling to include a warning that atypical femur fractures had been reported in some bisphosphonate users. The FDA took this action shortly after a task force of the American Society for Bone and Mineral Research (“ASBMR”) published a study of the issue of AFFs in bisphosphonate users. The ASBMR updated its analysis approximately three years later.
Lawsuits followed that alleged long-term use of Fosamax from 1999 to 2010 led to atypical femur fractures.
Fosamax Lawsuits
The first lawsuits related to Fosamax and femur fractures were filed in the late 2000s, and since then, hundreds of individuals have come forward with similar claims. These lawsuits alleged that the manufacturers of Fosamax failed to adequately warn patients and healthcare providers about the risk of femur fractures associated with the drug, and that the manufacturers should have known about this risk based on the available scientific evidence.
Fosamax Jury Verdict in 2013
It took a New Jersey federal jury an hour and twenty minutes to determine that Fosamax did not cause a Plaintiff’s femur fracture. In the first verdict in a Fosamax case where the Plaintiff claims that the osteoporosis drug weakened her thigh bone, the jury said that Plaintiff did not prove her case.
After having taken Fosamax for eight years, Plaintiff, now fifty-eight, fractured her right femur, requiring surgical repair. She sued, alleging that Fosamax caused her atypical femur fracture and that its manufacturer, Merck, failed to warn her doctor about the risk. Merck, pleased with the verdict, stated that the company provided appropriate and timely information about Fosamax to consumers.
Plaintiff’s suit had been transferred to the Fosamax femur fracture MDL, sometimes referred to as “Fosamax II” as an earlier Fosamax MDL was formed to deal with claims of osteonecrosis of the jaw (ONJ). Merck has said that there are about 3,300 Fosamax femur fracture cases, and about 1,230 ONJ cases.
In this case, Merck claimed that Plaintiff was at risk for a “fragility fracture” that Fosamax reduced, but could not eliminate. They further claimed that Plaintiff did not sustain an atypical femur fracture.
This case had been selected for the second bellwether trial in the MDL. The first trial ended in a mistrial after Plaintiff suffered a heart attack.
Federal Preemption Argument
Federal preemption arises when plaintiffs in state court lawsuits claim that the drug manufacturers failed to adequately warn them of the risks associated with the drug, and that they should have known about these risks based on the available scientific evidence.
In some cases, drug manufacturers have argued that these state law claims are preempted by federal law, because the Food and Drug Administration (FDA) has approved the labeling and marketing of the drug, and that state law claims are therefore barred. This argument is based on the idea that federal law preempts state law, and that the FDA’s approval of the labeling and marketing of the drug is conclusive and binding on the states.
2023 Update
On March 23, 2022, Fosamax fractures were dismissed in opinion issued by now retired Judge Freda Wolfson (who was also the baby powder litigation judge). The court’s decision in this case was based on an interpretation of the Food, Drug, and Cosmetic Act (FDCA), which governs the approval and regulation of prescription drugs in the United States.
Judge Wolfson granted summary judgment for the defendant, Merck Sharp & Dohme Corp., finding that the plaintiff’s claims were preempted by federal law. The court determined that the FDA’s labeling requirements for Fosamax made it impossible for Merck to comply with both federal and state law. The judge concluded that the plaintiff’s failure-to-warn claims conflicted with the FDA’s regulatory regime and were therefore preempted.
The ruling follows a previous decision in the same case in 2019, which had denied summary judgment for Merck and allowed the plaintiff’s claims to proceed. The latest ruling marks a significant victory for Merck, as it eliminates the need for a trial and effectively kills MDL if the appeal is denied. The Third Circuit is hearing the case now.
I get the court’s view that the FDCA provides for a comprehensive scheme of regulation for prescription drugs, and that this scheme preempts state law claims that are based on the same subject matter. I also understand the FDA’s approval of the labeling and marketing of Fosamax was conclusive and binding, and that the plaintiffs’ state law claims were, under the existing case law, preempted by federal law. No one can explain to me why this is fair or why efforts to legislate away these laws have failed so miserably.
