PHILADELPHIA – New preliminary objections have been lodged in complex litigation related to claims over discontinued heartburn fighter and stomach acid suppressant drug Zantac, charging that the plaintiffs’ case is unsound, unsupported and jurisdictionally improper.
One of many programs in the Philadelphia County Court of Common Pleas’s Complex Litigation Center, Zantac’s is meant to handle injury claims surrounding that drug and connected to the reasons for its global recall nearly three years ago.
After Zantac (a.k.a. ranitidine) had already been on the market for nearly 40 years, it was learned in 2019 that the carcinogen N-nitrosodimethylamine (NDMA) was present in ranitidine products from several manufacturers, leading to speedy recalls and – per the Food and Drug Administration – the ultimate withdrawal of Zantac from the U.S. market and suspension from sales in Europe and Australia in April 2020.
“Zantac is the branded name for ranitidine, a ‘blockbuster’ drug sold to treat heartburn. For decades, Zantac and/or its generic equivalent ranitidine, were promoted by defendants as a safe and effective treatment for heartburn. Indeed, defendants had little incentive to investigate dangers in a pharmaceutical product that was producing over $1 billion in annual sales,” according to the consolidated long-form complaint in this matter.
“Instead, defendants turned a blind eye to the fact that ranitidine transforms, over time and under particular conditions, into high levels of N-Nitrosodimethylamine (NDMA), a well-known, cancer-causing compound. NDMA has no medicinal or beneficial purpose whatsoever: its only function is to cause cancer and its only use is to induce tumors in animals as part of laboratory experiments. The U.S. Food and Drug Administration’s allowable daily limit of NDMA is 96 nanograms. Yet, in a single dose of Zantac, researchers are discovering over 3 million nanograms of NDMA.”
Currently, nearly 400 Zantac cases reside in the Philadelphia County Court of Common Pleas’s Complex Litigation Center.
Defendants named in the case include GlaxoSmithKline, Pfizer, Boehringer Ingelheim, Sanofi-Aventis, Chattem, Inc. Patheon Manufacturing Services, Rite Aid and Giant Eagle, who all either manufactured or sold Zantac in the years it was on the market.
In three separate filings on both Jan. 3, and Jan. 9, the defendants lodged preliminary objections to the Zantac long-form complaint.
“Plaintiffs include Patheon with the ‘Manufacturer Defendants,’ and then alleged that all of the manufacturer defendants ‘designed, manufactured, marketed and sold prescription and/or OTC ranitidine-containing products to plaintiff[s] which were ingested by plaintiff[s].’ This is fatal to plaintiffs’ claims against Patheon because Patheon never designed, marketed, or sold prescription or OTC ranitidine-containing products,” the objections from defendant Patheon Manufacturing Services stated, in part.
“In their consolidated long-form complaint, plaintiffs assert that Patheon ‘packaged and manufactured the finished product.’ But nowhere in their 95-page, 354-paragraph complaint do plaintiffs allege or claim that Patheon ever designed, marketed, or sold any ranitidine-containing products. And nowhere in the complaint do plaintiffs allege or claim that Patheon’s manufacturing or packaging of the finished drug product was deficient in any way or caused or contributed to any damages to them. Nevertheless, plaintiffs ignored Patheon’s severally limited role and assert the same generic allegations against Patheon that they make against all of the manufacturer defendants.”
Objections from the other defendants cited other grounds for removal from the case.
“As plaintiffs have pled in the complaint, Pfizer, Boehringer Ingelheim and Sanofi-Aventis are not incorporated in Pennsylvania and do not maintain their principal places of business here. Because Pfizer, BI and Sanofi are not at home in Pennsylvania, the Court lacks general jurisdiction over them. The fact that some of the defendants allegedly are registered to do business in Pennsylvania does not change this analysis. The Supreme Court of Pennsylvania has held unequivocally that ‘compliance with Pennsylvania’s mandatory registration requirement does not constitute voluntary consent to general personal jurisdiction.’ The general jurisdiction analysis instead focuses on whether the corporate defendant is ‘at home in Pennsylvania,” per objections from counsel for defendants Pfizer, Boehringer Ingelheim and Sanofi-Aventis.
“The Court should sustain the objections to Counts I and II because it is well-settled in Pennsylvania that strict liability theories shall not apply in the context of ‘drugs, vaccines, and the like’ in light of the Supreme Court’s adoption of comment k of the Restatement (Second) of Torts in the strict liability context. The Supreme Court of Pennsylvania has repeatedly recognized this exception to its jurisprudence on strict liability, taking a ‘blanket approach to apply comment k to preclude strict-liability design-defect claims for all prescription drugs.”
The pharmaceutical companies’ counsel further argued the complaint “draws no distinction between prescription and over-the-counter Zantac, or which plaintiff took which formulation, alleging instead that the brand defendants are equally liable in strict liability – even though GSK is the only brand defendant that marketed prescription Zantac, and Pfizer, Boehringer Ingelheim and Sanofi-Aventis marketed only over-the-counter Zantac.”
Counsel for Rite Aid and Giant Eagle also called for the complaint’s dismissal.
“As courts in Pennsylvania and elsewhere have held, state-law design-defect and failure-to-warn claims – even if labeled as other causes of action – are pre-empted by federal law because non-NDA holders like the retailers cannot unilaterally make changes to the design or warnings of a drug. Moreover, plaintiffs’ claims regarding prescription Zantac/ranitidine are expressly preempted by the Drug Supply Chain Security Act, which governs the tracing and sourcing of pharmaceutical drugs, including Zantac/ranitidine, in the U.S. supply chain. Therefore, all of plaintiffs’ claims against the retailers should be dismissed as preempted by federal law,” their objections stated.
“Second, plaintiffs’ allegations fall short of Pennsylvania’s fact-pleading standard, where they impermissibly group all defendants together without differentiating what statements or conduct are being attributed to which defendant, including conduct regarding the manufacture of the products that could not be attributed to the retailers based on plaintiffs’ other allegations in the LFC. Third, apart from preemption, plaintiffs’ general negligence claim also fails because plaintiffs have not sufficiently pleaded any facts to demonstrate that the retailers had knowledge of an alleged, latent defect in Zantac/ranitidine.”
The retailers added that the plaintiffs’ fraud claim “lacks the requisite particularity under Pennsylvania Rule of Civil Procedure 1019(b) against the retailers, relying only on boilerplate allegations against all defendants” and similarly, the plaintiffs “are not entitled to punitive damages as to the retailers where they fail to assert any factual allegations of retailer-specific conduct” and that the plaintiffs’ “derivative claims for survival, wrongful death, and loss of consortium should be dismissed because plaintiffs’ underlying claims all fail.”
Counts against the defendants include negligence, strict products liability, negligent misrepresentation, breach of express warranties, breach of implied warranties, fraud, unjust enrichment, loss of consortium, survival and wrongful death.
Plaintiffs are seeking damages which include actual or compensatory damages in such amount to be determined at trial, exemplary and punitive damages, pre-judgment and post-judgment interest, costs, other litigation expenses and any other relief the Court may deem just and proper.
While the objections remain pending, a status conference in the Zantac litigation will be held remotely over Zoom on March 14, from 10 a.m. to 11 a.m.
The plaintiffs are represented by Conrad E. Adams of Matthews & Associates in Houston, Texas and Rosemary Pinto of Feldman & Pinto, in Philadelphia.
The defendants are represented by Tracey McDevitt Hagan of Reilly McDevitt & Henrich in Philadelphia, Sean P. Fahey, Christopher M. Brolley, Rebecca E. Younker and Halli D. Cohn of Troutman Pepper Hamilton Sanders in Philadelphia and Atlanta, Ga., Andrew T. Bayman, Robert B. Friedman and Julia R. Zousmer of King & Spalding in Atlanta, Ga. and Chicago, Ill., Stephen J. Finley of Gibbons, P.C. in Philadelphia, M. Elaine Horn and Emily Renshaw Pistilli of Williams & Connolly in Washington, D.C., Molly E. Flynn, Rebecca L. Trela and Robyn S. Maguire of Barnes & Thornburg in Philadelphia and Boston, Mass., Paige H. Sharpe of Arnold & Porter Kaye Scholer in Washington, D.C., Will W. Sachse and Caroline Power of Dechert, LLP in Philadelphia, and Christopher R. Carton and John D. Garrett of Bowman & Brooke, in New Brunswick, N.J. and Austin, Texas.
Philadelphia County Court of Common Pleas case 220601364
From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at nick.malfitano@therecordinc.com