Preemption Defense Doesn’t Hold For Medical Manufacturer On Appeal

Starting in 2010, hundreds of plaintiffs filed personal injury lawsuits against the drug manufacturer Merck, Sharp & Dohme, alleging that the osteoporosis drug Fosamax caused them to suffer serious thigh bone fractures.

Fosamax is meant to treat osteoporosis by correcting an imbalance in the bone remodeling process. However, plaintiffs claimed that the drug actually increased the risk of bone fractures by causing “microcracks.”

Each of the plaintiffs brought a state-law tort claim alleging that Merck failed to add an adequate warning of the risk to Fosamax’s FDA-approved drug label. Many also brought claims including defective design, negligence, and breach of warranty. Plaintiffs alleged that Merck was aware of the risk of the fractures but decided not to warn doctors and consumers.

In 2009, a Merck representative spoke with the Food and Drug Administration about adding language to the Adverse Reactions section of the Fosamax label. The FDA stated that it could agree to add language to the sections of the label but that Merck’s elevation of the issue would prolong the review. Later, the FDA contacted Merck and informed the company that it was not prepared to include warning language in the Warnings and Precautions section of the label and would only approve such a labeling in the Adverse Reactions section. More specifically, the FDA agreed that atypical and subtrochanteric fractures should be added to the Adverse Reactions and Post-Marketing Experience sections of the label, they rejected the language meant for the Precautions section because of the language identifying “stress fractures.” The FDA said that the stress fracture language was not warranted and was not adequately supported from the available reporting.

Plaintiffs’ suits were consolidated in multi-district litigation in the District of New Jersey. Ultimtely, the court granted Merck summary judgment, based on the Supreme Court’s holding in Wyeth v. Levine, that state-law failure-to-warn claims are preempted when there is “clear evidence” that the FDA would not have approved the warning that plaintiffs claim was necessary.

However, while Merck claimed that the FDA demonstrated that they did not think there was a link between Fosamax and atypical fractures and would have rejected any proposed warning, the plaintiffs had a different argument. Plaintiffs argued that the FDA was only objecting to Merck’s use of the term “stress fractures” in that it was imprecise. Plaintiffs argued that the FDA would have approved a warning that was more specific and discussed the risk of atypical femoral fractures while eliminating general references to stress fractures. In other words, had Merck dug deep to be more specific, a warning would have been approved by the FDA.

The higher court agreed with the plaintiffs and vacated and remanded the lower court’s ruling. The court agreed that preemption is an affirmative defense but it did not think Merck carried its burden to prove that it is entitled to that defense. In Wyeth, the “clear evidence” standard is demanding and requires a court sitting in summary judgment to anticipate the range of conclusions that a reasonable juror might reach and the certainty with which the juror would reach them.

Since plaintiffs produced sufficient evidence for a reasonable jury to conclude that the FDA would have approved a more specifically-worded warning about the risk of fractures the preemption defense failed.

Medical malpractice can have devastating effects that last a lifetime. If you have been injured by a physician’s neglect, attorneys Charles Gilman and Briggs Bedigian will work to get you the full compensation to which you are entitled. Call 800-529-6162 today or contact them online for a free case evaluation. They handle cases in Maryland, Pennsylvania, and Washington, D.C.