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PHILADELPHIA — (Mealey’s) Pennsylvania law allows drug companies to be sued if they fail to stop marketing drugs known to be unreasonably harmful, and the manufacturers are not immune from being sued for damages for lack of due care, the Pennsylvania Supreme Court ruled Jan. 22 in an eight-year-old diet drug lung injury case (Patsy Lance, et al. v. Wyeth, et al., Nos. 17 EAP 2011 and 18 EAP 2011, Pa. Sup.; 2014 Pa. LEXIS 205 [enhanced opinion available to lexis.com subscribers]).
In 1997, Catherine Lance took Redux-brand dexfenfluramine for weight loss. In 2004, Lance was diagnosed with primary pulmonary hypertension (PPH) and died within a month. In 2006, Lance’s mother, Patsy Lance, sued Redux manufacturer Wyeth (formerly American Home Products Corp., now Pfizer Inc.) in the Philadelphia County Common Pleas Court.
Lance sued Wyeth for negligence for the unreasonable marketing of a dangerous drug and for unreasonable failure to remove Redux from the market before January 1997. The plaintiff alleges that by mid-1997, there were reports of an association between Redux and valvular heart disease, but Wyeth did not withdraw Redux until September 1997.
Summary Judgment Granted
Wyeth moved for summary judgment, which the trial court granted. The court said that because Redux was approved as reasonably safe by the U.S. Food and Drug Administration, a plaintiff cannot sue for injuries unless they can prove that the drug was impure or the label inadequate.
Lance appealed, and in 2010, a Pennsylvania Superior Court panel found that Lance should have been permitted to proceed with a claim of negligent design defect only. The panel agreed with Wyeth that the only basis supporting a strict liability claim is manufacturing defect or failure to warn.
The Superior Court panel rejected Lance’s allegation that Wyeth negligent failed to withdraw Redux from the market, deferring to federal authority. It agreed, however, that Lance had a valid negligent design defect claim
Lance and Wyeth cross-appealed to the Pennsylvania Supreme Court, challenging the Superior Court’s holding that under Pennsylvania law, drug companies are not immune from the claims of negligent drug design and that claims of negligent marketing, testing and failure to withdraw are unviable.
Duty Of Care For Harmful Drugs
In a 4-2 vote with one justice not participating, the majority held, “Under Pennsylvania law, pharmaceutical 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,” the majority continued. “Indeed, Congress and the [Pennsylvania] Legislature are in the best position to make these sorts of weighty and consequence-laden policymaking judgments impacting a traditional, state-law, civil, remedial scheme.
“Neither body has conferred such immunity, however, albeit Congress has taken measured action relative to certain vaccines and prescription medical devices,” the majority said. The majority was referring to the National Childhood Vaccine Injury Act of 1986, which created a manufacturer-funded, federally administered compensation program for people injured by vaccines.
The majority also referred to the Medical Device Amendments of 1976 to the Food, Drug and Cosmetic Act, which federally preempts state law tort claims involving certain FDA-approved medical devices.
Benefits Of Patent Protection
The majority rejected Wyeth’s argument that tort liability impinges on the development of new drugs, citing the enormous cost of developing them. The majority said Wyeth did not discuss the advantage of the federal patent system, which grants exclusivity for up to 20 years.
The majority also said it is “convinced that a manufacturer or supplier has a duty to cease further distribution of a product at such point as it may know, or may reasonably be charged with knowledge that the commodity is too dangerous to be used by anyone.”
The majority rejected Wyeth’s argument that adulterated drugs can be subject to criminal prosecution. The majority said that does not support immunity from civil liability or lack of due care.
The majority opinion was written by Justice Thomas G. Saylor. The other majority members were Justices Max Baer, Debra McCloskey Todd and Seamus P. McCaffery
Justice J. Michael Eakin dissented, joined by Chief Justice Ron D. Castille. Justice Eakin said the Superior Court panel erred in addressing an issue that was not preserved or developed by the parties.
“Given the significant public policy implications of allowing ‘negligent design defect’ claims to be brought in the prescription drug cases, this Court should wait for a full, developed record on a properly preserved claim, in order that we may consider advocacy on both sides expressing the various incentives and disincentives created by changing this area of products liability law,” Justice Eagan wrote.
In a response, the majority said negligent design defect claims “have long been recognized against product manufacturers generally in this Commonwealth.”
Diet Drug Litigation
Redux was a new variation of Pondimin (fenfluramine), which was also made by Wyeth. In 1992, fenfluramine was combined with another weight loss drug, phentermine, to create fen-phen, which became popular with doctors and patients.
By 1997, doctors noticed that young patients taking fen-phen were developing heart valve damage. Some users also developed PPH.
Thousands of personal injury lawsuits were filed in federal and state courts. In Pennsylvania, the cases were centralized in the mass tort docket in the Philadelphia County Common Pleas Court, where Lance filed her case.
Wyeth eventually agreed to a national class settlement of heart valve injury claims. PPH cases were defined by the agreement, but plaintiffs were left to litigate those separately.
Justice Convicted In Interim
Former Justice Joan Orie Melvin took part in arguments but did not participate in the decision. After arguments were heard in September 2011, Justice Melvin was removed from the court after being charged with theft of government services.
Justice Melvin was subsequently found guilty and sentenced to house arrest.
The majority opinion indicated that the opinion was reassigned to Justice Saylor but did not indicate which justice was previously assigned.
Lance is represented by Howard J. Bashman of the Law Offices of Howard J. Bashman in Willow Grove, Pa., Tobias L. Millrood of Pogust, Braslow & Millrood in Conshohocken, Pa., and Michael L. Love of Williams, Love, O’Leary & Powers in Portland, Ore.
Wyeth is represented by Fredrich Wilhelm W. Sachse, Robert C. Heim and Judy L. Leone of Dechert and Raymond M. Williams of DLA Piper, both in Philadelphia.
Amicus curiae Product Liability Advisory Council is represented by Stephen B. Devereaux, Geoffrey M. Drake and Chilton D. Varner of King & Spalding in Atlanta.
Amici American Association for Justice and the Pennsylvania Association for Justice are represented by Clifford A. Rieders of Rieders, Travis, Humphrey, Harris, Walters & Waffenschmidt of Williamsport, Pa.
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