Fosamax Warnings Lawsuit
This article discusses the proposed Fosamax Warnings language and the FDA’s rejection. We also discuss cases of osteonecrosis and femur fractures linked to the drug. We conclude that Fosamax should be required to carry a Warnings label, but the FDA’s rejection of the proposed language leaves a lot of questions unanswered. The FDA is not a party to the Fosamax Warnings lawsuit, but its decision will likely have a significant impact on the drug’s sales and profits.
Fosamax’s proposed warning language
Merck, the maker of Fosamax, sought preapproval from the FDA to change the drug’s labeling. The company proposed adding a warning for stress fractures to the drug’s label, but the agency rejected it because it was inconsistent with state law. Merck maintained that there was insufficient evidence to link the drug to stress fractures. The Trump administration, however, backed Merck’s claim and found that Merck did have incontrovertible proof of a link.
The court ruled that the plaintiffs’ claims against Fosamax were preempted. The decision was made last October and is 87 pages long. The decision is worth reading. It highlights the limitations of the current warning language and the burden of persuasion. It also rejects the impossibility of preemption and the Levine standard of proof. This makes it harder to prove a connection between Fosamax and the claims brought against it.
FDA’s rejection
A district court recently ruled that the FDA’s denial of a Fosamax Warnings lawsuit does not establish a preemptive claim against Merck. This preemptive claim requires that the manufacturer of a drug have a substantial burden of proof that its product caused injuries before the FDA’s warning was issued. However, the FDA’s denial of a preemptive claim does not mean the company has no duty to warn consumers of the risks associated with the drug.
This ruling does not directly challenge Wyeth’s decision, which was rendered in 2011. It does, however, address the question of when the “what-would-the-FDA-have-done” defense applies to drug litigation. It also discusses the standard of proof in cases where a defendant manufacturer’s actions were preempted by another agency’s rules. As a result, the ruling is narrow and unlikely to impact drug litigation much shortly.
Insufficient evidence of a causal link between Fosamax and femur fractures
The failure to warn claim filed by the plaintiffs alleges that the drug caused femur fractures and that the FDA failed to adequately warn patients. The failure-to-warn claim was based on the term “stress fracture” being used to describe a relatively minor fracture, contradicting the seriousness of atypical femur fractures. The District Court ruled that the claim was not sufficiently pled, and entered summary judgment in favor of Merck.
While FDA officials’ emails are not preemptive under Albrecht, they can be relevant in evaluating the FDA’s preemptive effect of formal action. In Fosamax, emails from the FDA showed how the agency viewed the scientific data about the drug. The FDA’s decision was based not on the use of the term “stress fracture,” but on how the drug affected patients’ understanding of this fracture type.
Cases of osteonecrosis caused by Fosamax
Some patients on Fosamax have reported femur fractures. These fractures usually occur in the long middle portion of the femur, the bone that lies below the hip joint. The bone is one of the strongest in the body, and the risk of breaking it is low. If you or a loved one is taking Fosamax, be aware of the warning signs.
One such case is a jury trial related to the effects of Fosamax. This drug is associated with over 900 cases of osteonecrosis. It is commonly prescribed to women to treat the bone loss associated with menopause. The drug is currently on the market, but some patients have reported a variety of problems. For example, the drug causes jawbone tissue to die, and patients may experience dental surgery or gum recession to trigger the condition. The jawbone can also look moth-eaten after dental work.
Patients taking Fosamax have been reporting osteonecrosis. Merck first became aware of the problems in late 2003 and put together a panel of doctors to evaluate the reports. The doctors determined that about 70 people developed dead jawbone tissue after taking the drug. While this number is unprecedented, it is not clear whether Fosamax is causing the condition. Merck’s lead attorney, Paul Strain, said there is no definitive proof of a connection between Fosamax and jawbone death.
This article discusses the proposed Fosamax Warnings language and the FDA’s rejection. We also discuss cases of osteonecrosis and femur fractures linked to the drug. We conclude that Fosamax should be required to carry a Warnings label, but the FDA’s rejection of the proposed language leaves a lot of questions unanswered. The FDA is not…