Opinion ID: 173569
Heading Depth: 4
Heading Rank: 2

Heading: Merits of the Negligence Claim

Text: The nature of Buchanan's negligence claim is unclear. Her Amended Complaint states that Wyeth had a duty to manufacture, promote, and sell only safe drugs, and the duty to investigate and disclose material facts about risks associated with their drugs. Defendants breached their duty by ... putting Redux on the market in 1996, when Defendants knew the active ingredient in th[is] drug[], namely, dexfenfluramine, was unreasonably dangerous. Defendants further breached their duty by... failing to update the drug['s] labels, failing to adequately monitor the effects of the drug[], failing to make timely ... warning to the medical profession, failing to timely and accurately report to the FDA all adverse drug experience information obtained, and concealing and misrepresenting the results of studies to physicians and to the public. Longs I, 536 F.Supp. at 854 (reproducing Buchanan's Amended Complaint verbatim). The district court noted that at oral argument Buchanan characterized her negligence claim as attacking (1) Wyeth's alleged failure to investigate, prior to FDA approval, the early warning signs that led to the drug being taken off the market and (2) Wyeth's failure to take the drug off the market sooner. Id. at 855. We take this to mean that Buchanan's negligence claims may be divided into two general categories: (1) claims regarding Wyeth's acts and omissions, prior to the FDA's approval, in bringing the drug to market and (2) claims regarding Wyeth's acts and omissions subsequent to the FDA's approval of Redux. We will address the post-FDA-approval negligence claims first. As characterized by Buchanan and the district court, the post-approval negligence claims are either a general negligence claim or a design defect claim. Whatever the label, the claim focuses on Wyeth's actions after the drug went to market, primarily Wyeth's failure to take the drug off of the market sooner. Wyeth moved for summary judgment on the basis that Buchanan could not show that Wyeth's actions or omissions after FDA approval caused any of her injuries. Specifically, Wyeth contended that it had updated its warnings about the risks of Redux as information became available and that it removed Redux from the market as soon as it became aware of the extent of the risk, and it submitted a substantial amount of evidence in support of this position. But, just as she did with regard to Wyeth's request for summary judgment on the strict liability design defect claim, Buchanan did not highlight any evidence in the record that would contradict the evidence submitted by Wyeth. Instead, Buchanan again argued the law, insisting that the warnings were irrelevant because Wyeth should have known that the drug was so dangerous that no warning could make the drug acceptable. Critically, Buchanan did not point to any facts or evidence in the record that would reveal why Wyeth should have known any of this. The district court found that Buchanan failed to present evidence demonstrating proximate cause between Wyeth's alleged negligence after the FDA approved Redux and Buchanan's injury or death sufficient to survive a motion for summary judgment. We agree, for principally the same reasons as we agreed that summary judgment was proper on the strict liability design defect claim. When Buchanan failed to point to any actual evidence in a particularized manner, she failed to meet her burden under Rule 56. Accordingly, we affirm the entry of summary judgment for Wyeth on the post-FDA-approval negligence claims.