A federal judge has thrown out several claims against the makers of Prevacid, a heartburn drug, but allowed several others, including one on a theory of manufacturing defect, that allege the product weakened a patient’s bones to the point of fracture, to survive.
Of the 14 claims filed earlier this year against Takeda Pharmaceuticals, which makes the drug, the company moved to dismiss 11 counts. Weighing issues on which courts in the district have split, U.S. District Judge Jan DuBois of the Eastern District of Pennsylvania came down largely on the side of the plaintiff, David S. Tatum.
DuBois relied heavily on the Pennsylvania Supreme Court’s 1996 opinion in Hahn v. Richter.
“Many courts have interpreted Hahn broadly to preclude all strict liability claims,” DuBois said in Tatum v. Takeda Pharmaceuticals.
“However, this court agrees with the decision in Doughtery, where the court concluded that strict liability claims for manufacturing defects are not prohibited,” he said, citing the July 2012 Eastern District of Pennsylvania court opinion in Doughtery v. C.R. Bard.
Tatum’s claims for strict liability based on manufacturing defect survived. On that count, DuBois held differently from some courts within the U.S. Court of Appeals for the Third Circuit to find that those claims are permitted under Pennsylvania law.
Considering Tatum’s strict liability claims, alleging design defects and failure to warn, DuBois held that they couldn’t be permitted under Pennsylvania law.
“Applying Comment k to Section 402A of the Restatement (Second) of Torts, the Pennsylvania Supreme Court ruled that ‘where the adequacy of warnings associated with prescription drugs is at issue, the failure of the manufacturer to exercise reasonable care to warn of dangers, i.e., the manufacturer’s negligence, is the only recognized basis of liability,’” DuBois quoted from the court’s opinion in Hahn. Comment k allows that a product that is unavoidably unsafe in its design, but properly prepared, can escape strict liability.
DuBois applied similar reasoning to Tatum’s breach of warranty claims.
“‘The theories of strict liability and breach of the implied warranty of merchantability are parallel theories of recovery, one in contract and the other in tort,’” DuBois said, quoting from Doughtery.
From the same opinion, he further quoted, “‘It would be inconsistent to exempt a manufacturer … from strict liability under Comment k and apply a negligence standard to determine liability for a design defect or a failure to warn, but allow a plaintiff to recover for the same alleged defect under a theory of breach of the implied warranty of merchantability.’”
Tatum’s claims for breach of implied warranty of fitness for a particular purpose and breach of implied warranty of merchantability, based on a manufacturing defect, are able to stand, DuBois held. If they were based on a design defect or a failure to warn, they wouldn’t, according to the opinion.
Regarding Tatum’s breach of express warranty claim, DuBois noted, again, that the courts have been split on whether the claim can be brought against prescription drug manufacturers under Pennsylvania law.
“This court concludes that such a claim is permitted,” DuBois held.
“‘While the reasoning of Comment k may prevent certain warranties or promises from being implied by law,’ that is not a ‘basis for declining to enforce a contractual promise expressly and voluntarily made by a manufacturer of prescription drugs or devices,’” DuBois said, quoting from Doughtery.
DuBois addressed several other claims in short order, including Tatum’s allegation of unjust enrichment, which the judge dismissed.
“This is not a case in which a claim for unjust enrichment is appropriate,” he said. “Specifically, there is no allegation that defendants refused to provide a service or goods after Tatum provided defendants with a benefit.”
However, DuBois did hold that Tatum had properly requested punitive damages as a remedy, so he denied Takeda’s motion to dismiss the request.
DuBois left standing seven claims and dismissed four.
Neither Claudine Homolash of Sheller P.C. in Philadelphia, who represented Tatum, nor Tiffany Alexander of Campbell Campbell Edwards & Conroy in Berwyn, Pa., who represented Takeda, could be reached for comment.
(Copies of the nine-page opinion in Tatum v. Takeda Pharmaceuticals, PICS No. 12-2014, are available from The Legal Intelligencer. Please call the Pennsylvania Instant Case Service at 800-276-PICS to order or for information.) •