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New exposure for drug manufacturers

drugTheftLast month, the State Supreme Court in Pennsylvania ruled that drug companies may face exposure from product liability claims in PA for defectively designed drugs. The case Lance v. Wyeth involves the fatal use of a diet drug made by Pfizer subsidiary that was later taken off the market.

This ruling is significant in that it expands the ability of plaintiffs to pursue products liability claims against pharmaceutical companies. Previously, plaintiffs were only able to sustain a product liability claims against a prescription drug manufacturer by proving that

  1. the drug was manufactured improperly or
  2. the manufacturer was negligent in providing an improper warning.

The only viable products liability claims against pharmaceutical companies were manufacturing defects and inadequate warning. The Court’s decision means that now, this case appears to now allow the plaintiff to pursue a case involving negligent design and as well as negligent marketing. The case also addressed the distinction between strict liability design defect claim, which are not actionable against pharmaceutical manufacturers under PA law, and negligent design defect claims which are actionable against pharmaceutical manufacturers under PA law.

In the majority opinion, Justice Thomas G. Saylor held that the “learned intermediary doctrine” – which places the duty to warn about the drugs on the doctors, was not sufficient to limit a plaintiff’s access to recovery in a civil action. Justice Saylor indicated that there was a subtext of Wyeth’s position that the likelihood that a pharmaceutical company would actually tender an essentially worthless and dangerous drug into commerce is so minimal, and the burden or responding to meritless claims so great, that it is not sound to preserve an avenue for redress even for legitimate claims.” He believed that the court was being asked to not consider a traditional, fault based tort liability as an all-or-nothing proposition. Based on the arguments, the court was not able to see with reasonable clarity the results of that decision and therefore to say with reasonable certainty that the change would serve the best interest of society.

This ruling will possibly impact the laws of other jurisdictions as well. To date, not many other appellate courts have yet had the occasion to consider the availability of negligent design and negligent marketing against an available drug.

This decision may end up being somewhat theoretical in that Wyeth did not provide a factual record to support its defenses to the plaintiff’s negligence claim. Therefore, when the design defect theory is actually tested against all of the relevant facts, the theory may turn out to be far less expansive that it presently appears.

In light of the potential increased exposure to pharmaceutical companies and other parties who possibly may become involved as a result of the exposure, it is prudent to review your current products policies with your WGA team.


About the Author

Ann Mizner McKay is the General Counsel and Senior Vice President at WGA. She manages the legal affairs of the company and also manages the Claims Department.

617.646. 0238 | AMiznermckay@wgains.com | Connect with Ann on LinkedIn
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