pharmaceutical liability

A long-pending and widely anticipated opinion of first impression from the Pennsylvania Supreme Court last week is going to provide more causes of action for plaintiffs lawyers to pursue in the arena of brand-name drug litigation.

The Supreme Court---28 months after it heard oral argument--recognized causes of action for negligent marketing of brand-name drugs, negligent failure to remove prescription drugs from the market and negligence in the design of prescription drugs. Drugmakers now can face liability for “a lack of due care resulting in an untenably dangerous product being put into the marketplace,” the court said in a 4-2 decision. The decedent in Lance v. Wyeth, Catherine Lance, is alleged to have taken diet drug Redux, leading to her death from primary pulmonary hypertension.

Appellate counsel for the plaintiffs, Howard Bashman, said in an interview the case could provide more clarity on the debate over whether negligence principles can be imported into strict liability through the adoption of the Restatement (Third) of Law.

"The Supreme Court has rejected strict liability claims against drug manufacturers brought by people injured by ingesting dangerous medications,” Bashman said in an interview with me. “The court has … recognized as valid various sorts of negligence claims. The bright line seems to be strict liability no, negligence claims yes. It does bring clarity to that area. What Wyeth was arguing essentially was recognizing this type of design defect claim was absolute liability. What we said was” the claim sounds in negligence.

Robert C. Heim, appellate counsel for Wyeth (which is now wholly owned by Pfizer), said in an e-mail: “This is a very narrow ruling confined to facts not generally found in most pharmaceutical cases and, even then, there is a noticeable split in the court. The cause of action the majority espouses here has no applicability to the overwhelming number of cases where the FDA [federal Food and Drug Administration] has approved a drug and the medicine continues to be available to patients. Also, the ruling turns on large measure on the majority crediting plaintiffs’ allegations that Wyeth should have known that the drug was dangerous. This allegation has never been tested by any finder of fact. As the Court recognized, this is a case of first impression and the majority relies heavily on the Third Restatement which has yet to be adopted by the Pennsylvania Supreme Court.”

More Changes To Come in Products Law?

Lance is likely not to be the last change in Pennsylvania's products law. The court granted allocatur in the case of Tincher v. Omega Flex, Inc. on the question of: “Whether this Court should replace the strict liability analysis of Section 402A of the Second Restatement with the analysis of the Third Restatement.”

In a footnote, Justice Thomas G. Saylor, the majority opinion author, mentioned that there are “difficulties with some of the concepts and conventions which have been employed to buttress the theoretical divide between strict products liability and negligence theory.” The justices took up Tincher with the hopes of providing “needed reconciliation, clarification, or modification,” Saylor said.

There also is interesting dicta in the opinion that plaintiffs' lawyers could use to attack the learned intermediary doctrine in failure-to-warn cases. First, Saylor said the learned intermediary doctrine does not apply in cases in which plaintiffs are advancing theories like the one Lance is advancing.

A learned intermediary is beside the point if the product is so dangerous that “it should not have been ingested by anyone” because no warning would have ever been sufficient, the justice said.

But Saylor notes that “some of the underpinning of the [learned intermediary] principle have come into question in light of changed practices in the prescription drug industry. These include the emergence of direct-to-consumer advertising and the evolution of the health-care delivery system encompassing new forms of managed care.”

Plaintiffs lawyer Shanin Specter has said in interviews with me that the learned intermediary doctrine should be set aside in this era of direct marketing. The doctrine may have less value if prescribers are more like notaries putting the official seal on consumers' drug choices.

The defense-oriented Drug and Device Law Blog also notes another interesting ruling in Lance: that an alternative design may not have to be shown in design-defect cases involving prescription drugs.

Saylor Joins the Democrats

One of the most interesting things about the opinion is who authored it: Saylor. Saylor,“ordinarily the court’s most conservative member on product liability matters (and thus our favorite)” aligned “with justices with whom he frequently disagrees with on tort issues,” Drug and Device Law noted. Saylor was joined by Justice Max Baer, Seamus P. McCaffery and Debra Todd.

Saylor was unsparing to Wyeth at times in his opinion: “To the degree that Wyeth is uncomfortable with our jury-based civil-justice system, its complaint is with the Pennsylvania Constitution,” wrote Saylor, citing the state constitutional provision guaranteeing the right of trial by jury.

“We find that Wyeth is asking, in substance, that we should invoke policy justifications to scale back the existing duty of pharmaceutical companies to independently and vigilantly protect against unreasonable health risks which may be posed by products made for human consumption,” Saylor opined at another point.

Dissenting justice Justice J. Michael Eakin, joined by Chief Justice Ronald D. Castille, said the majority recognized a new cause of action for negligent design defect. “As I see it, Wyeth sought to preclude the creation of new claims, not extinguish ones already in existence,” Eakin wrote.

While Eakin said he expressed no opinion on the wisdom of adopting negligent design defect as a cause of action, the issue was not before the Superior Court and the intermediate appellate court raised it on its own. Eakin also reasoned that the plaintiffs had not preserved their negligent design defect claim, only the negligent marketing claim.

Saylor rejected the notion that the majority was creating new claims because there was no “source of authority establishing an already existing, special rule immunizing pharmaceutical companies in the negligence arena.” Drug and Device Law argued that was just not so: the majority in Lance did not “cite a single decision by that or any other court allowing such a claim. Certainly, no prior decision has recognized a cause of action for 'lack of due case resulting in an untenably dangerous product being put into the market place.'”

A Job For Legislators?

Saylor argued that legislators, not the court, are best positioned to consider the drugmaker's policy arguments in favor of a “contraction of existing tort law.” One example of how legislators can balance the benefits of pharmaceutical products against the harms they can sometimes cause, Saylor said, is the no-fault compensation program Congress established for people who suffer side effects from some vaccines.

Bashman told me that Saylor's reasoning echoes an argument his co-counsel and he made in another case on punitive damages that the Supreme Court said it had improvidently granted: “The judiciary and the legislative bodies have different roles and responsibilities and, if certain types of claims are specifically to be ruled out of bounds, that should be a legislative-type of decision because the type of the record that you get through litigation is not aimed at that ordinarily, unless you truly have a test case. This was not brought as a test case where the record established whether negligent design-defect claims should be allowed or not."

The Superior Court panel had recognized negligent design defect as a viable cause of action, but rejected the claim of negligent marketing and negligence in failing to withdraw Redux from the market. Wyeth appealed the ruling that claims of negligent design defect are viable in Pennsylvania, while Lance appealed the rulings that claims of negligent marketing, testing and failure to withdraw drugs from the market are inviable in Pennsylvania.

Saylor also criticized the Superior Court panel of Cheryl Lynn Allen, Correale F. Stevens (who now is sitting as an interim Supreme court justice)and Susan Peikes Gantman. The panel “reconceptualized” the marketing claim as one sounding in strict liability, not negligence, Saylor wrote. In a footnote, Saylor expounded that, “given the material differences between strict liability and negligence theory … the panel's approach of analyzing appellee's main claim—which was expressly stated in negligence–as if it were grounds upon strict liability, is deeply flawed.”

Wyeth argued that Pennsylvania should only recognize negligence causes of action for manufacturing defects and inadequately warning of a drug's risks to prescribers. Saylor rejected Wyeth's exhortation to “adopt a potent, bright-line rule, applicable across the commonwealth, closely restricting claims against pharmaceutical companies.”

Yet all is not lost for drugmakers in Pennsylvania. Yes, the majority approved of the argument that a drugmaker could be liable for design defects if “a prescription drug carr[ies] risks which outweigh its benefits as to all possible classes of patients.” But I think plaintiffs will have a harder time prevailing on design-defect claims for drugs that have more demonstrable benefits. If defendants can show that some classes of patients benefit from their products, then Pennsylvania courts might have grounds to reject a design-defect theory under Saylor's reasoning.

It seems the design defect claim is going to be very context-specific. In fact, Saylor noted that judge-made law depends upon the facts of the case: “In seeking a bright-line, substantive rule of prohibition across a broad class of cases, Wyeth's advocacy is in tension with the nature of common-lawmaking. Initially, it is axiomatic that the holding of a judicial decision is to be read against its facts,” Saylor said.

Trip to U.S. Supreme Court?

Bashman said in my interview with him that he does not think that Wyeth has preserved its arguments that federal law pre-empts the case, and the U.S. Supreme Court would not care about Pennsylvania's decision to recognize certain types of pharmaceutical liability claims unless they are “somehow … contrary to federal law.”

Drug and Device Law argues design-defect claims are preempted by federal law because it would be impossible to both change the design of Redux or remove it from the market and comply with the FDA's requirement that drugmakers not change the formulations of drugs once they have been approved.

The U.S. Supreme Court rejected the First Circuit’s rationale in Mutual Pharmaceutical Co., Inc. v. Bartlett that the drugmaker “could escape the impossibility of complying with both its federal- and state-law duties by choosing to stop selling sulindac.” The majority said that the First Circuit's rationale “is incompatible with this Court’s pre-emption cases, which have presumed that an actor seeking to satisfy both federal- and state-law obligations is not required to cease acting altogether.”

In in Wyeth v. Levine, the U.S. Supreme Court said federal regulation was a floor, not a ceiling, for protecting consumers regarding the risks of brand-name drugs through failure-to-warn claims (generic drugs are another matter). It'll be interesting to see if impossibility preemption and Pennsylvania's decision to recognize design-defect and negligent marketing claims for brand-name drugs gets a ride to Washington, D.C.