By Pamela C. Maloney, J.D.
The manufacturer of a cholesterol treatment drug and the pharmacies who sold the drug were protected from liability under Michigan’s products liability immunity act from claims for defective design, failure to warn, negligent misrepresentation, among others, the Michigan Court of Appeals ruled in an unpublished opinion. Despite the patients’ attempt to characterize their claims as negligence, the allegations involved the production and sale of the drug and, as such, fell squarely within the scope of the act. The court also found that neither of the two exceptions to immunity applied in this case (Trees v. Pfizer, Inc., December 20, 2018, per curiam).
Female patients who had been prescribed the drug Lipitor for lowering their cholesterol and for decreasing their risk of developing cardiovascular disease, brought negligence, negligent misrepresentation, negligent design, design defect products liability, failure to warn products liability, breach of express warranty products liability, breach of implied warranties products liability, fraud and misrepresentation, constructive fraud, and unjust enrichment claims against the drug’s manufacturer, Pfizer, Inc., and against Meijer, Inc. and CVS Caremark, the pharmacies that had sold the drug to the patients. According to the patients, they had sustained physical, economic, and emotional injuries, including being diagnosed with and treated for Type II diabetes, as a direct result of taking Lipitor. Finding that Michigan’s products liability immunity act applied to the patients’ claims, the trial court granted motions for summary disposition filed by Pfizer and the two pharmacies. The patients appealed.
Nature of claims. Under Michigan law, drug manufacturers and sellers are granted broad immunity from product liability lawsuits if the drug was approved by the federal Food and Drug Administration and if the drug and its labeling were in compliance with the FDA’s approval at the time it left the control of the manufacturer or seller (Mich. Comp. Ann. §600.2946(5)). Although the patients in this case had labelled their cause of action as one for negligence, the allegations that the manufacturer and pharmacies had breached their respective duties to properly test, manufacture, warn, label, and sell Lipitor fell within the definition of "production" as defined by the products liability immunity act. Thus, the claims sounded in product liability and were subject to the act, the court concluded.
Similarly, the claim labeled "negligent misrepresentation" contained allegations that also fell within the definition of a product liability action. The patients had alleged that the manufacturer and pharmacies, through their labeling and distribution of Lipitor, had provided false or misleading information to health care professionals and consumers regarding Lipitor. These allegations related to the manufacture, construction, design, formulation, development of standards, preparation, processing, assembly, inspection, testing, listing, certifying, warning, instructing, marketing, selling, advertising, packaging, and labeling of Lipitor and, therefore, they also constituted a product liability action, the court held.
Drug maker’s immunity. The patients argued that even if their claims fell within the scope of the products liability immunity act, the manufacturer was precluded from asserting immunity because it had not complied with the FDA approval process in that it failed to comply with regulations requiring: (1) post-marketing safety surveillance; (2) updating of drug’s label after such post-marketing surveillance; and (3) submission of safety update reports. However, these claims did not present any allegations as to the lack of FDA approval or noncompliance with the FDA’s approval as was required to defeat the act’s immunity provision. Unless the patients could show that the manufacturer had committed fraud on the FDA or that the bribery exception applied, the manufacturer was entitled to immunity because the drug had been approved by the FDA at the time the drug left the manufacturer’s control.
Furthermore, the patients had not alleged that the drug’s label failed to comply with FDA’s approval. They simply had alleged that the label was inadequate. In cases such as this in which the FDA had approved the label and the label followed that approval, the manufacturer was entitled to immunity under the act as a matter of law, the court ruled.
Pharmacies’ immunity. With respect to the pharmacies, the patients had alleged that they were not entitled to statutory immunity because they had provided warnings that were not the same as the FDA-approved warnings. However, the patients made this claim only with respect to Meijer. Therefore, the claims against CVS were summarily dismissed.
According to the court, the allegations against Meijer merely stated that the warnings it had provided were or might have been different from those approved by the FDA. The court reminded the patients that the act clearly provided that in a product liability action against a seller of a product, the seller was not liable if the drug had been approved by the FDA and the drug and its labeling were in compliance with the FDA’s approval at the time the drug left the control of the seller. Given that the patients had conceded that Lipitor had been approved by the FDA and that the court had already determined that the drug and its labelling complied with the FDA approval, the patients could only proceed against Meijer if they alleged that the pharmacy had committed fraud or bribed the FDA. Finding that these allegations were missing from the complaint, the court ruled that, as a matter of law, Meijer was entitled to immunity under the act.
The case is No. 338297.
Attorneys: Keith Altman (Law Office of Keith Altman) for Pamela L. Trees. Mark Steven Cheffo (Dechert LLP) for Pfizer, Inc., Pfizer International, LLC and Greenstone LLC.
Companies: Pfizer, Inc.; Pfizer International, LLC; Greenstone LLC
MainStory: TopStory DefensesLiabilityNews WarningsNews SCLIssuesNews DrugsNews MichiganNews
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