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From Products Liability Law Daily, June 28, 2013

Bone loss drug failure-to-warn claims preempted because FDA would not have approved label change

By John W. Scanlan, J.D.

Failure to warn claims brought by a patient who suffered a fractured femur while taking an osteoporosis drug were preempted because the record showed that the Food and Drug Administration (FDA) would not have approved a stronger warning to the Precautions portion of the drug’s label, a U.S. District Court for the District of New Jersey ruled (In re Fosamax Products Liability Litigation (Glynn v. Merck Sharp & Dohme Corp.)), June 27, 2013, Pisano, J.).

Background. Bernadette Glynn was prescribed Fosamax (alendronate sodium), a bisphosphonate drug approved by the FDA for the prevention and treatment of osteoporosis, after she was diagnosed with “osteopenia – osteoporosis” in 2002. She took the drug until she fractured her right femur in April 2009. She brought, inter alia, claims for failure to warn, defective design, and negligence against Merck, Sharp, & Dohme Corp., the manufacturer of Fosamax. Merck moved for summary judgment, arguing that the claims were preempted because they were all ultimately based on a failure to warn and the FDA had rejected a label change proposed by Merck, which Merck asserted showed that the FDA would not have approved a stronger warning on the label’s Precautions section prior to Glynn’s injury. The court reserved judgment on this motion until after the trial. The jury found for Merck, determining that Glynn had not proved that she had experienced an atypical femur fracture (AFF). After the court took additional proposed fact findings on the preemption issue, Merck again moved for summary judgment.

Preemption. The failure to warn claim was preempted because there was clear evidence that the FDA would not have approved a change to the Precautions portion of the label prior to Glynn’s injury, rendering it impossible to comply with both federal and state requirements. Merck submitted a Prior Approval Supplement (PAS) to the FDA in September 2008, asking if it could add to the Precautions and Adverse Reactions portions of the label language about low-energy subtrochanteric femur fractures. In May 2009, the FDA approved the change to the Adverse Reactions portion of the label but not to the Precautions portion. The court found that this action constituted clear evidence that the changes would not have been approved to the Precautions portion of the label prior to Glynn’s injury. Furthermore, Dr. Lisa Rarick, an expert witness presented by Merck and who had worked for the FDA for 15 years, testified that when the FDA had rejected the proposed change, it did not ask for alternative precautionary language, further indicating that it would not accept a change to the Precautions portion. She also testified that the FDA had the authority to request Merck to make a label change to add this language but did not do so.

The court stated that Glynn did not present any evidence at trial against preemption. She offered no evidence for her contention that the requested PAS actually was rejected due to its use of the phrase “stress fracture” instead of “AFF,” with the court noting that the term AFF had not yet been coined until 2010 or 2011. Dr. Rarick testified that the proposed language was rejected by the FDA not because it would have confused doctors or because the stress fractures did not look as severe as AFFs, but because the FDA determined that the data did not support the precautionary language. There also was no evidence that Merck could have submitted a CBE supplement that would have allowed it to change the label without FDA prior approval because the FDA’s rejection of the PAS indicated that it subsequently would have rejected a CBE supplement containing the same language. In addition, Dr. Rarick testified that use of a CBE supplement for this purpose would have been inappropriate because the matter of low-energy subtrochanteric femur fractures was already under FDA review. Finally, Glynn did not prove her assertion that Merck had failed to provide all the information that it had on femur fractures to the FDA or warn it of a causal association between Fosamax and AFFs as soon as there was reasonable evidence.

The case numbers are 11-5304, 08-08.

Attorneys: Donald A. Ecklund (Carella, Byrne, Cecchi, Olstein, Brody, & Agnello, P.C.) for Bernadette Glynn. David J. Heubeck (Venable LLP) and Karen A. Confoy (Fox Rothschild LLP, PC) for Merck, Sharp, & Dohme Corp.

Companies: Merck, Sharp, & Dohme Corp.

MainStory: TopStory PreemptionNews WarningsNews DrugsNews NewJerseyNews

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