In re Incretin-Based Therapies Products Liability Litigation

*1111 ORDER GRANTING DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT AND DENYING PLAINTIFFS’ CROSS-MOTION FOR SUMMARY JUDGMENT

I. INTRODUCTION

Through the ■ enactment of the Federal Food, Drug, 'and Cosmetics Act, *1112 21 U.S.C. § 301 et seq., Congress, delegated authority to the Food and Drug Administration (“FDA”) to regulate pharmaceutical manufacturers and their products. With subsequent amendments, Congress enlarged this authority, charging the FDA with the power to protect the public health, and to assure the safety, effectiveness, and reliability of drugs. In discharging its regulatory duties, the FDA oversees the introduction of new drugs into the market, regulates the" content of drug labeling, and ensures manufacturers comply with postmarketing requirements. Despite the FDA’s broad regulatory duties, a drug manufacturer remains primarily responsible for maintaining the adequacy of product 1 labeling. State tort law is therefore generally viewed as a complimentary form of drug regulation, providing additional protections and recourse for injured consumers. Yet, when state tort law imposes a duty impossible to meet in light of FDA regulations, federal law will preempt state…