On June 27, 2013, U.S. District Court Judge Joel A. Pisano granted Defendant Merck, Sharp & Dohme Corp.’s (“Merck”) Motion for Summary Judgment, finding allegations that Merck failed to warn consumers of the possible risk of atypical femur fractures (“AFFs”) from use of its bone drug, Fosamax, are preempted under federal law because the U. S. Food & Drug Administration (“FDA”) refused to strengthen the drug's label the year the consumer was injured. The Court heard oral arguments on the motion on March 8, 2013, but reserved decision until a trial record had been established in the case. A jury trial took place from April 8, 2013 to April 29, 2013. On April 29, 2013, the jury returned a verdict in favor of Merck, finding that Plaintiff Bernadette Glynn’s femur fracture could not have been caused by Fosamax. Judge Pisano found that the trial record contained clear evidence that the FDA would not have approved a stronger warning to the Precautions section of the Fosamax label.
On Sept 15, 2011, Plaintiffs Bernadette Glynn and Richard Glynn (“Plaintiffs”) brought a lawsuit against Merck, the manufacturer of Fosamax, which is an FDA-approved drug for the treatment and prevention of osteoporosis. Their lawsuit was part of a multi-district litigation (“MDL”) concerning Fosamax and involves allegations that Fosamax causes AFFs – severe fractures that occur in the absence of trauma. Bernadette Glynn claimed that she suffered a severe femur fracture in April 2009 after taking Fosamax for seven years to treat diminished bone density. Plaintiffs alleged that Merck failed to warn physicians about Fosamax and AFFs.
On January 15, 2013, Merck moved for summary judgment based on federal preemption, arguing that Plaintiffs’ claims, all of which ultimately concern a failure to warn, are preempted because the FDA rejected Defendant’s proposed labeling change and that the FDA’s rejection constitutes clear evidence that the FDA would not have approved a stronger warning to the Precautions section of the label. In June 2008, the FDA requested that Merck investigate possible links between the use of bisphosphonate drugs, such as Fosamax, and the occurrence of AFFs. After conducting research, Merck recommended that the FDA approve the addition of a warning on the Fosamax label indicating that there is a potential connection between bisphosphonate drugs and stress fractures. However, the FDA refused to update the label, citing a lack of evidence.
The Court found that the FDA did not approve a label change linking bisphosphonates to AFF until 2011, well after Plaintiff filed her lawsuit. According to Judge Pisano, evidence presented at trial showed that Merck was proactive in sharing information about the drug’s possible risks with the agency. Further, Judge Pisano rejected Plaintiffs’ argument that Merck could have circumvented the FDA and strengthened Fosamax’s label through a Changes Being Effected (“CBE”) supplement, stating that a CBE would still ultimately have been subjected to FDA approval.