In 1995, the Michigan Legislature enacted its Drug Immunity Law, which provided an absolute defense for pharmaceutical companies in product liability suits stemming from the safety and efficacy of their drug products, the only one of its kind in the nation.[1] The unique law, codified as Michigan Compiled Law § 600.2946(5), stated:
(5) In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved for safety and efficacy by the United States food and drug administration, and the drug and its labeling were in compliance with the United States food and drug administration’s approval at the time the drug left the control of the manufacturer or seller. … This subsection does not apply if the defendant at any time before the event that allegedly caused the injury does any of the following:
(a) Intentionally withholds from or misrepresents to the United States food and drug administration information concerning the drug that is required to be submitted under the federal food, drug, and cosmetic act …, and the drug would not have been approved, or the United States food and drug administration would have withdrawn approval for the drug if the information were accurately submitted.
(b) Makes an illegal payment to an official or employee of the United States food and drug administration for the purpose of securing or maintaining approval of the drug.
Simply put, the law provided immunity for pharmaceutical manufacturers from product liability suits if the drug was approved by the FDA unless the manufacturer defrauded the FDA or bribed FDA officials. The constitutionality of the law was challenged as impermissibly delegating lawmaking authority to the FDA and, in response, the Supreme Court of Michigan concluded that the “FDA does not decide who may bring a products liability action in Michigan; rather, the FDA, for its own reasons that are independent of Michigan tort law, simply makes a factual finding regarding the safety and efficacy of drugs.”[2] In upholding the law, the Court reasoned: a products liability action is an assertion that a pharmaceutical manufacturer has breached the duty of care in some way, and the Michigan Legislature decided that a pharmaceutical manufacturer fulfilled its duty of reasonable care if the drug product at issue satisfied the FDA’s requirements of safety and efficacy.
This statute makes sense considering the rigors and expenses associated with the FDA approval process. An article from Johns Hopkins’ Bloomberg School of Health estimated that the median cost of a clinical trial for FDA approval of a new drug was $19 million in 2018.[3] That figure pales in comparison to the then-estimated total cost of developing a new drug: $2 to $3 billion—with a “B.”[4] The time cost associated with the FDA approval process is substantial as well. The average amount of time it takes to get a new drug approved by the FDA is estimated to be 10 years.[5] Even if a company can endure the expense of billions of dollars and ten-years’ time, a pharmaceutical manufacturer’s odds of securing FDA approval are far from certain at the outset. “Only about ten percent of potential drugs make it through the rigorous process to become FDA approved.”[6]
With this context in mind, it is hard to imagine an industry that is asked to do more before a product can be publicly marketed and sold. Given this approval process, does it make sense to impose an even higher standard on pharmaceutical manufacturers by subjecting them to tort liability in state court? In the context of pharmaceuticals, a well-funded agency[7]—the FDA—exists solely to ensure the safety of the drugs we use and the food we eat. The first paragraph of the FDA’s mission statement reads: “The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.”[8] The FDA employs more than 18,000 people to help achieve this mission.[9]
This means the Michigan Legislature got it right, right? Alas, no. Michigan’s “Drug Immunity Law” was effectively repealed in February 2024.[10] The current version of that law now provides for only a rebuttable presumption and not absolute protection from claims:
In a product liability action brought against a manufacturer or seller for harm allegedly caused by a product, there is a rebuttable presumption that the manufacturer or seller is not liable if, at the time the specific unit of the product was sold or delivered to the initial purchaser or user, the aspect of the product that allegedly caused the harm was in compliance with standards relevant to the event causing the death or injury set forth in a federal or state statute or was approved by, or was in compliance with regulations or standards relevant to the event causing the death or injury promulgated by, a federal or state agency responsible for reviewing the safety of the product.
The “rebuttable” nature of the presumption by no means shields manufacturers from lawsuits and expense, given that plaintiffs can seek to overcome the presumption. And the new statute exposes pharmaceutical manufacturers to tort liability for claims related to the safety and/or efficacy of its FDA-approved drug product, even where the FDA found the drug safe and effective in the approval process.
What is the justification for imposing a higher standard of reasonableness than that imposed by the FDA? After all, the FDA employs more than 18,000 people and enjoys an operating budget in excess of $6 billion to ensure that all drugs marketed and sold to the public are safe and effective. If the FDA decides a drug is safe and effective, that should end the inquiry for drugs and devices that comply with the law, because that is the very reason for the FDA’s existence. To require more circumvents the FDA’s control of drug regulation and assessment of safety and effectiveness, and instead places such control in the hands of lay jurors.
The former law’s uniqueness does not necessarily support the conclusion that it was enacted without regard to reason and that its repeal was beneficial or justified. Michigan Compiled Law § 600.2946(5) reflected the policy rationale behind the preemption arguments that are routinely raised in product liability suits involving pharmaceutical products. With the Drug Immunity Law, the Michigan legislature took matters into its own hands and decided that the FDA’s stringent requirements were enough to adequately ensure that the drugs its citizens use are safe and effective. If pharmaceutical manufacturers are already subjected to a monstrous barrier to entry and are subjected to countless regulations, why impose an even higher standard? Unless a suitable answer can be provided to address that question, this article serves as a tribute to Michigan’s one-of-a-kind law, lest we forget. Memento Michigan Compiled Law § 600.2946(5), a return to the past may be a solution for future issues.
[1] Elizabeth Chiarello, Julie Becker, & Rachel Rein, Michigan No Longer A Safe Haven For Pharmaceutical Companies?, Life Science Leader(Apr. 17, 2024), https://www.lifescienceleader.com/doc/michigan-no-longer-a-safe-haven-for-pharmaceutical-companies-0001
[2] Taylor v. Smithkline Beecham Corp., 658 N.W.2d 127, 134 (Mich. 2003).
[3] Bloomberg School, Cost of Clinical Trials For New Drug FDA Approval Are Fraction of Total Tab, John Hopkins University (Sep. 24, 2018), https://publichealth.jhu.edu/2018/cost-of-clinical-trials-for-new-drug-FDA-approval-are-fraction-of-total-tab.
[4] Id.
[5] Kelin Wheaton, What Does it Take to Get a Medication Approved Through the FDA?, Nationwide Children’s: 700 Children’s – A Blog by Pediatric Experts (Feb. 6, 2025) https://www.nationwidechildrens.org/family-resources-education/700childrens/2018/03/what-does-it-take-to-get-a-drug-approved-through-the-fda.
[6] Id.
[7] The FY 2026 President’s Budget Summary, found on the FDA website, provides for a budget of $6.8 billion for the FDA in 2026. See FDA, The FY 2026 President’s Budget Summary 1 (2025), https://www.fda.gov/media/186731/download?attachment.
[8] FDA, What We Do, https://www.fda.gov/about-fda/what-we-do (last visited Oct. 31, 2025).
[9] FDA, About FDA, https://www.fda.gov/about-fda (last visited Oct. 31, 2025).
[10] Chiarello, supra note 1.
Finis
