NEW YORK - (Mealey's) The second bellwether plaintiff in the Fosamax multidistrict litigation failed to produce evidence that the osteoporosis drug caused her osteonecrosis of the jaw (ONJ), a panel of the Second Circuit U.S. Court of Appeals ruled Nov. 5 in affirming summary judgment (Bessie L. Flemings v. Merck & Co., Inc., No. 09-5242, 2nd Cir.).
The appeals court panel said that in order to prove a failure-to-warn claim under Mississippi law, which governs the case, plaintiff Bessie Flemings had to show that an adequate warning would have prevented a physician from prescribing the drug and that the injury would not have occurred if the drug had not been prescribed. The U.S. District Court for the Southern District of New York, where the Fosamax MDL is centralized, did not directly address the physician heeding requirement but instead found that there was insufficient causation evidence.
The Second Circuit panel agreed, noting that treating dentist Dr. David McDaniel testified in a deposition that he did not conclude what caused Flemings' ONJ at the time he treated her.
Flemings' family physician, Dr. Walter Rose, who also was identified as an expert, testified in a deposition that he could not say whether Fosamax caused or contributed to Flemings' ONJ.
"That testimony, standing alone and bolstered by nothing else, is simply insufficient as a matter of law to establish that Flemings' injury 'would not have occurred had the drug not been administered,'" the panel wrote, citing Fifth Circuit case law. The panel noted that Rose testified that Flemings' injury may not have been related to Fosamax and may have just been an abscess and also testified that Flemings' smoking habit since age 8 and her history of health and oral hygiene problems left her mouth "in pretty horrible shape" with just two teeth remaining.
"We therefore conclude, consistent with the district court's determinations, that Flemings failed to adduce sufficient evidence with respect to causation and, accordingly, that summary judgment on her product liability claim was appropriate," the panel said.
The panel said it considered Flemings' other arguments and rejected them as meritless.
[Editor's Note: Full coverage will be in the Nov. 18 issue of Mealey's Emerging Drugs & Devices. In the meantime, the opinion is available at www.mealeysonline.com or by calling the Customer Support Department at 1-800-833-9844. Document #28-101118-001Z. For all of your legal news needs, please visit www.lexisnexis.com/mealeys.]
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