FDA Fosamax Warnings Lawsuit
- by Ayden
The FDA Fosamax Warnings lawsuit focuses on a failure to warn the public regarding atypical fractures. The lawsuit argues that Merck should have added this warning to the drug’s Adverse Reactions section before May 2009, if it had known about the risk of atypical fractures. Plaintiffs argue that Merck’s failure to warn proximately caused their injuries. However, the District Court ruled that the atypical fractures claim was insufficiently pled and entered summary judgment for Merck.
Merck’s failure to re-submit a revised CBE or PAS without stress-fracture language prevented the FDA from approving a change to the label
A recent case has highlighted the issue of the FDA allowing a manufacturer to make changes to the label on a drug without prior approval. In a nutshell, Merck has failed to resubmit a revised CBE or PAS without stress-fracture language, which prevented the agency from approving the change. Merck is a large pharmaceutical company with a large marketing budget. Therefore, any change to its label must be justified by a compelling medical need and a legitimate risk.
The District Court also found that the “Merck reference” contained a significant amount of irrelevant material. The relevant references included Taki and Wood, both of which discussed the insertion of human Ig genes into mice. Despite the conflicting information in these references, the District Court found Taki to be inequitable conduct.
Clear evidence that the FDA would not have approved a change to the label
The Supreme Court recently reversed a lower court’s ruling and remanded the case back to the district court, stating that the preemption requirement was not factual, but instead addressed whether the FDA would have rejected the proposed label change. The Supreme Court’s reasoning reflects a growing body of case law regarding preemption. Here are some of the major points from the case.
First, the Court noted that Merck was not relying on any “clear evidence” to support its preemption argument. Merck had argued that the FDA would not have approved a change to the Fosamax label before the fracture was discovered. The court agreed, concluding that Merck had failed to establish clear evidence that the FDA would not have approved a change to the Fosamax label before the fracture.
Merck’s appeal of the FDA ruling
Merck’s decision to appeal the FDA ruling on Fosamax warning language stems from its efforts to add a fracture warning to the drug’s label. The FDA rejected the addition of the warning because it based its conclusion on a general “stress fractures” language. The company argues that it was not seeking to warn patients about a specific injury and that the warnings are not required under state law. Merck’s appeal cites a broader interpretation of the CRL in other FDA communications. In other words, the CRL questioned the causality of the association between bisphosphonates and atypical femoral fractures.
The appeal cites a separate FDA decision. This case focuses on the FDA’s decision in the Fosamax case. Merck sought to change the warning on Fosamax because it was found to increase the risk of fractures, particularly those below the hip joint and in the thigh bone. Because of the risk, patients often must undergo surgery to treat the fracture. Merck has an available generic version of Fosamax, and sales of the drug reached $209 million in 2018.
Preemption of the lawsuits
The Supreme Court recently affirmed a lower court ruling in a case that relates to the preemption of FDA Fosamax Warnings. The ruling, however, is not entirely clear. The court’s opinion may be narrow and not have a major impact on drug litigation. Nonetheless, the decision could have important implications for the future of drug litigation. It will determine whether the preemption defense applies to Fosamax lawsuits.
A decision in a recent lawsuit in the United States District Court for the District of New Jersey has further complicated the issue of preemption. The court said that the FDA’s failure to warn about the risk of thighbone fractures on Fosamax is preempted by state law and that Merck has no obligation to issue a warning. Moreover, Merck’s response to the Glynn lawsuit argues that the FDA’s failure to warn about the risk of a fracture is sufficient to preempt the plaintiffs’ state-law claims.
Plaintiffs eligible for compensation
Many of the claims in the FDA Fosamax Warnings lawsuit center around patients who suffered femur fractures caused by the osteoporosis drug. The lawsuits allege that the drugs failed to adequately warn consumers about the risk of developing osteoporosis and other serious medical conditions. Many patients are considering filing a lawsuit to receive compensation for their injuries, but there are important legal considerations before pursuing the claim.
A recent ruling in a federal court decision could mean that the plaintiffs’ lawsuits against Merck and the FDA can move forward. Merck has appealed the ruling in a Fosamax lawsuit, arguing that the company was not responsible for failing to warn the public. Plaintiffs’ lawyers claim that Merck failed to warn consumers about the serious health risks associated with Fosamax and that the FDA rejected the initial warning wording and later approved a new warning. The company is attempting to have the lawsuits dismissed but has been unsuccessful in doing so.
The FDA Fosamax Warnings lawsuit focuses on a failure to warn the public regarding atypical fractures. The lawsuit argues that Merck should have added this warning to the drug’s Adverse Reactions section before May 2009, if it had known about the risk of atypical fractures. Plaintiffs argue that Merck’s failure to warn proximately caused their…
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