Pennsylvania Supreme Court rules drug companies can be found liable for negligently marketing dangerous prescription drugs

By: Chris Placitella @ Jan 27, 2014

Cohen Placitella & Roth PC senior shareholder’s commentary noted by court in ruling.

In what likely will be a highly considered and influential state court pharmaceutical precedent, the Supreme Court of Pennsylvania ruled in Lance v. Wyeth, 2014 Pa. Lexis 205 (PA Jan. 21, 2014) that pharmaceutical companies can be held liable in negligence for marketing or continuing to market prescription drugs that injure patients. In the court’s 4-2 majority opinion, authored by Justice Thomas G. Saylor, who is viewed as one the Pennsylvania high court’s most scholarly justices, it refused the request of drug manufacturer Wyeth and its ally the Products Liability Advisory Council, to limit potential liability claims against drug companies to just two: liability claims for negligent failure to warn or liability claims for manufacturing defects (such as having a contaminant or not meeting product formulation or specifications). Instead the court majority after a very extensive and through analysis of Wyeth’s and the industry oriented Council’s arguments and authorities held drug manufactures to a reasonable due care standard in marketing or withdrawing an unreasonably dangerous product once it knows or should know of product hazardous or dangers warranting not or ceasing to continue marketing the product. In the decision’s words:

“Under Pennsylvania law companies violate their duty of care if they introduce a drug into the marketplace, or continue a previous tender, with actual or constructive knowledge that the drug is too harmful to be used by anyone. There has been no supported presentation here which would persuade us to immunize companies from the responsibility to respond in damages for such a lack of due care resulting in personal injury or death.”

At issue in Lance was a wrongful death case involving Wyeth’s (formerly known as “American Home Products Company”) diet drug Redux (“dexfenfluramine). In 1997, Redux and a related Wyeth diet drug, Pondimin (“fenfluramine”), were voluntarily withdrawn from the market in1997 allegedly in response to several adverse reports of valvular heart disease associated with the two drugs. The Food & Drug Administration afterward prohibited anyone in the United States manufacture and distribute or compound and dispense these drugs. In a wrongful death suit brought in 2006 by the mother of a Redux primary pulmonary hypertension victim filed in the Philadelphia Court of Common Pleas’ “phen-fen” mass tort program , Mrs. Lance contended that Wyeth was liable for “negligently marketing” Redux. According to the complaint, plaintiff alleged that Wyeth owed a duty to her deceased daughter to not to introduce onto the market a drug that was unreasonably dangerous for any person to use, and that Redux was so unreasonably dangerous and defective in design that it should never have been on the market.” The trial court dismissed the count leading eventually to the appeal decided by the Pennsylvania Supreme Court.

The decision is an important and praiseworthy one for many reasons. It shows that State court jurists really do understand, appreciate and fairly take into account the modern realities in developing and marketing prescription drugs as well as the various functions, roles and rights of each and everyone of the actors and institutions involved in the creation, regulation, prescription and use of a prescription drug. Building upon this the decision continues in clear and reasoned fashion strongly recognizes and asserts the crucial roles and functions state common law suits, tort remedies, and civil juries serve in sorting out and addressing the aftermath and harm that negligently marketed dangerous drugs have on those injured by them. The court notably agreed with the contention urged on behalf of injured victims of defectively dangerous drugs that:

“FDA approval of a drug permits the manufacturer to market it, but it does not require it to do so. If the manufacturer concludes that its product is too unsafe to be used by anyone it can and must take it off the market.”

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Cohen Placitella & Roth’s legal scholarship played a part in court’s ruling. Among the case precedents, treatises and law review articles cited by Justice Saylor in his opinion for the Court was a law review article co-authored by CPR’s Christopher M. Placitella: Christopher Placitella & Justin Klein, The Civil Justice System Bridges the Great Divide in Consumer Protection, 43 DUQ. L. REV. 219,220-21 (2005) Placitella’s article discussed how the FDA appears to be falling under the influence of regulated industries and the political pressures of the executive administration in power.

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