NEW YORK - (Mealey's) A defense verdict for Merck, Sharp & Dohme in the fourth federal Fosamax jaw injury trial was upheld Jan. 30 by the Second Circuit U.S. Court of Appeals, which found that the trial court didn't err in excluding a plaintiff expert or in its trial rulings (In Re: Fosamax Products Liability Litigation, Linda Secrest v. Merck, Shark & Dohme Corp., No. 11-4358, 2nd Cir.).
Linda Secrest was prescribed Fosamax from 1998 to 2005 to prevent fractures and osteoporosis. In 2004, she was diagnosed with osteonecrosis of the jaw (ONJ).
In 2006, Secrest sued Merck in the U.S. District Court for the Middle District of Florida, alleging that Fosamax caused her ONJ. The case was transferred into the Fosamax jaw MDL in the Southern District of New York.
4th Bellwether Trial
The case was selected as the fourth MDL bellwether trial. Judge John F. Keenan granted summary judgment on Secrest's claim of failure to warn, and the case went to trial on a design defect claim.
In 2011, a jury found in favor of Merck.
Secrest appealed, arguing that the trial court erred in granting summary judgment on her failure-to-warn claim, in not properly instructing the jury on Florida products liability law that governed the case, in limiting evidence from her two treating physicians and in admitting evidence about a $350,000 settlement with Secrest's dentist from the ONJ injury.
Florida Law Instruction
The Second Circuit said the District Court properly charged the jury with respect to the defective design standard under Florida law: the overall risks and benefits for the public as a whole. In addition, it said the court didn't err in employing an objective standard to consider the risks and benefits of Fosamax to the public as a whole, as opposed to a particular user or sub-category of users.
The trial court also didn't err by instructing the jury on Florida's government rules defense, the panel said. The defense creates a rebuttable presumption against defect if a manufacturer complied with laws and regulations designed to prevent the harm claims.
Judge Keenan found that Merck was entitled to the rebuttable presumption after it got plaintiff regulatory expert Dr. Suzanne Parisian to concede that the Food and Drug Administration approved Fosamax and its label.
The panel also said the trial court did not err when it gave the jury a version of Florida's concurrent causation instruction with respect to "shoddy dental work" and a concurrent medical condition, Sjogren's syndrome. The panel said the jury decided that Merck was not liable for apportionment of damages, so any error about that was harmless.
Experts Properly Excluded
Secrest also said the trial court erred by excluding the expert opinions of Drs. Lawrence Epstein and Philip Marciano. The panel said the trial court properly excluded Epstein's testimony because it was based on insufficient facts.
Some of Epstein's assertions were irrelevant, the panel said, and his opinion about the competency of the FDA was properly excluded because he was unqualified to testify about the FDA's work.
Marciano's ONJ causation opinion was properly excluded, the panel said, because it was offered in his capacity as a treating physician, the panel said. It agreed with the trial court that Marciano's opinion was largely based on that of another expert's opinion.
Evidence about Secrest's settlement with her dentist was admissible, the panel said, because Secrest brought it up in her opening statement and thus waived any objections to Merck expounding on the settlement.
In its second opinion, the panel said the trial court did not err in granting summary judgment on Secrest's failure-to-warn claim. The panel said the testimony of Secrest's warnings expert "contained contradictions that were unequivocal and inescapable, unexplained, arise after the motion for summary judgment was filed, and were central to Secrest's failure-to-warn claim."
Secrest had identified one of her treating physicians, Epstein, as a fact witness. After Merck moved for summary judgment on the warnings claim, Secrest identified Epstein as an expert.
The panel said that in his 2008 deposition, Epstein testified that he was not aware in 2004 and 2005 that Secrest was still taking Fosamax, but in his 2011 deposition, he said he was aware of her use of the drug.
'Sham Issue Of Fact'
The panel said that in view of Epstein's contradictory deposition testimony, his 2011 testimony was based on the "sham issue of fact" doctrine that prohibits a party from defeating summary judgment simply by submitting a contradictory affidavit.
"In particular, the doctrine applies to stop Secrest from manufacturing a factual dispute by submitting testimony from an expert whom she tendered, where the relevant contradictions between the first and second depositions are unequivocal and inescapable, unexplained, arose after the motion for summary judgment was filed, and are central to the claim at issue," the panel wrote.
Secrest, the panel said, did not offer any plausible explanation for Epstein's inconsistencies. If she had, the panel said it might conclude that the District Court erred in excluding Epstein's expert testimony.
In addition, the panel said, "The timing of the testimony recanting the prior sworn testimony clearly increased the likelihood that it was intended solely to defeat the motion for summary judgment."
Doctor Didn't Know About Drug
Finally, the panel said no reasonable juror could find that Epstein would have recommended that Secrest stop taking Fosamax if Epstein did not know she was taking it at the relevant time.
The panel comprised Circuit Judges Robert A. Katzmann and Raymond J. Lohier Jr. and U.S. Judge Jed S. Rakoff of the Southern District of New York, sitting by designation.
Secrest is represented by Timothy M. O'Brien of Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor in Pensacola, Fla. Merck is represented by Andrew Goldman of Goldman, Ismail, Tomaselli, Brennan & Baum in Chicago, Theodore V.H. Mayer and William J. Beausoleil of Hughes, Hubbard & Reed in New York and Paul F. Strain of Venable in Baltimore.
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