The Michigan Senate recently passed a bill to repeal a long-standing state law immunizing pharmaceutical manufacturers and sellers from product liability suits where the pharmaceutical products were approved by the U.S. Food and Drug Administration ("FDA").
If Senate Bill 410 is signed into law, Michigan could soon become an active jurisdiction for product liability cases against pharmaceutical companies and health care providers who distribute their products.
Michigan's Product Liability Act currently provides an absolute defense to the makers and sellers of FDA-approved pharmaceuticals in product liability suits unless the FDA determines that fraud or bribery influenced the approval process. Senate Bill 410 eliminates this immunity provision, leaving pharmaceutical manufacturers and sellers protected only by a rebuttable presumption that a pharmaceutical product is not defective if it conforms to the FDA's standards and regulations while subject to the company's control. In such a case, a plaintiff will have to offer sufficient evidence to rebut that presumption. The bill, in its current form, preserves other traditional defenses to product liability claims, including comparative negligence, assumption of risk, and lack of causation.
If it becomes law, Senate Bill 410 will likely expose companies that make or sell pharmaceuticals to an increased risk of liability for manufacturing- and design-defect claims, failure-to-warn claims, and claims alleging breach of express or implied warranties. Importantly, the bill is not retroactive so it does not impose new liability for past harms or allow plaintiffs to relitigate claims previously dismissed under the immunity statute; it only impacts future claims for alleged injuries incurred after the bill takes effect. Note also that Michigan law limits recovery fornon-economicdamages to $537,900 in product liability cases, unless a product causes death or permanent loss of a vital bodily function, in which casenon-economicdamages cannot exceed $960,500. Senate Bill 410 retains these recovery limitations, which are subject to annual adjustment in connection with the consumer price index.
The House is expected to vote on Senate Bill 410 in the coming weeks. If Governor Whitmer signs it into law, the bill will take effect 90 days after the legislative session closes. Assuming the law is passed during the current legislative session, implementation is projected to occur in March 2024.
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