A woman, a resident of Florida, began taking Fosamax in 1998. Fosamax is a prescription drug manufactured by Merck that falls within a class of drugs known as bisphosphonates, which are commonly used to treat bone conditions such as osteoporosis.
The woman began to suffer dental injuries around 1999. In October 2003 Merck received a report explicitly stating that a Fosamax patient had developed osteonecrosis of the jaw (ONJ), a condition characterized by areas of dead jaw bone that become exposed to the oral cavity. In 2004 Merck received more reports of ONJ in Fosamax patients.
In 2004 the woman developed a serious and chronic infection in and around her jaw which was diagnosed as ONJ. The doctor who diagnosed her ONJ recommended she stop taking Fosamax in April 2005. In July 2005 Merck and the FDA agreed that Merck would include the following warning in the Fosamax label: “Osteonecrosis of the jaw ... has been reported in patients taking bisphosphonates.... Known risk factors for osteonecrosis include ... co-morbid disorders (e.g., pre-existing dental disease, anemia, ... infection).” That warning was first posted on Merck's website and distributed to physicians in August 2005. The woman’s ONJ allegedly healed by August 2005.
The woman sued Merck in federal court in Florida for product liability claims for failure to warn and design defect. The Judicial Panel on Multidistrict Litigation transferred the case to the Southern District of New York and consolidated it with all federal cases involving allegations that ingestion of Fosamax had caused ONJ. The case was then selected to proceed to trial as one of several bellwether cases.
On two occasions the defendant deposed the primary care physician who originally prescribed Fosamax for the plaintiff. First, the original prescriber was designated as a fact witness. At the first deposition the primary care physician admitted that he was not aware in 2004 and 2005, when the plaintiff developed ONJ, that she was continuing to take Fosamax. He did not recall speaking to her subsequent primary care physician, who took over her care around December 2003. He admitted that he was not aware that her subsequent primary care physician had continued to prescribe Fosamax for two years more than what he suggested. He also admitted that he did not know that she was on Fosamax from 2003 to 2005 because he had wanted her on a different drug.
Between the first and second depositions, the defendant filed a motion for summary judgment. In response, the plaintiff designated the original prescribing doctor as an expert witness.
At the second deposition, the original prescribing doctor testified that he knew the plaintiff was on Fosamax in 2004 and 2005 and that, had Merck warned him about the risk of ONJ, he would have recommended that she stop taking Fosamax. More specifically, he testified that, beginning in 2003, he was assisted by her subsequent primary care physician who was taking over his prescribing plan. He explained that he spoke with her subsequent primary care physician and advised him to continue his treatment before he knew any of the ill effects of Fosamax adding that he and the subsequent primary care physician “talked and that he agreed to assume her care and follow my care plan.” He further testified that he knew the plaintiff was on Fosamax based on her prescription fills.
The United States District Court for the Southern District of New York granted summary judgment to the drug manufacturer. After reviewing the original prescriber’s testimony from both depositions, the District Court held that there was no admissible evidence of a causal connection between Merck's failure to warn about ONJ in 2004 and 2005 and the plaintiff’s ONJ.
The United States Court of Appeals for the Second Circuit affirmed holding that the district court was entitled to disregard the original prescribing doctor’s new testimony relating to his knowledge based on the “sham issue of fact” doctrine. In the ordinary case where a district court is asked to consider the contradictory deposition testimony of a fact witness, or where the contradictions presented are not real, unequivocal, and inescapable, the general rule is that a district court may not discredit a witness's deposition testimony on a motion for summary judgment, because the assessment of a witness's credibility is a function reserved for the jury.
The “sham issue of fact” doctrine prohibits a party from defeating summary judgment simply by submitting an affidavit that contradicts the party's previous sworn testimony. Although this application is atypical, the doctrine may apply when a party attempts to use evidence from an expert witness’s deposition testimony to defeat summary judgment. The court held that the District Court did not err in determining that there was no genuine dispute of material fact raised by the later testimony because the physician's expert testimony contained contradictions that were unequivocal and inescapable, unexplained, arose after the motion for summary judgment was filed, and were central to the plaintiff's failure-to-warn claim.
The court found that the relevant contradictions between the first and second depositions were unequivocal, inescapable, and unexplained. In the first deposition, the doctor testified that he did not know if the plaintiff was on Fosamax from 2003 to 2005. In the second deposition, the doctor testified that he did know the plaintiff was on Fosamax in 2004 and 2005. The plaintiff offered no plausible explanation for this inconsistency. The court concluded that where, as here, the relevant contradiction is not only unequivocal but is left unexplained, a district court may determine that a plaintiff has manufactured a sham issue of fact.
Moreover, the inconsistencies arose after the defendant filed a motion for summary judgment. 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.
The court noted that the sham issue of fact doctrine applied only because the relevant contradictions in the doctor’s testimony were central to the plaintiff’s failure-to-warn claim. To prevail on a failure-to-warn claim under Florida law, a plaintiff must prove three elements: (1) the warnings accompanying an item were inadequate, (2) the inadequacy of the warnings caused the plaintiff's injury, and (3) the plaintiff suffered an injury from using the product. The manufacturer's duty to warn of the drug's dangerous side effects is directed to the physician rather than the patient. To prove causation on a claim alleging breach of the duty to warn of a drug's dangerous side effects, a plaintiff must show that a treating physician would have recommended that the patient cease taking the drug if a different, adequate warning had been provided. The court concluded that no reasonable juror could find that the original prescribing doctor would have recommended that the plaintiff cease taking Fosamax if he did not know she was taking it at the relevant time.
See: In re Fosamax Products Liability Litigation, 2013 WL 335967 (C.A.2 (N.Y.), January 30, 2013) (not designated for publication), affirming In re Fosamax Products Liability Litigation, 807 F.Supp.2d 168 (S.D.N.Y. Aug 30, 2011). For an additional opinion see In re Fosamax Products Liability Litigation, 2013 WL 335987 (2nd Cir.(N.Y.) Jan 30, 2013) (not selected for publication in the Federal Reporter).