Legislative Analysis
Phone: (517) 373-8080
REMOVE EXEMPTION OF FDA-APPROVED DRUGS
http://www.house.mi.gov/hfa
FROM PRODUCT LIABILITY
Analysis available at
Senate Bill 410 as reported from House committee http://www.legislature.mi.gov
Sponsor: Sen. Jeff Irwin
House Committee: Judiciary
Senate Committee: Civil Rights, Judiciary, and Public Safety
Complete to 11-8-23
SUMMARY:
Senate Bill 410 would amend the Revised Judicature Act to eliminate a provision that currently
makes the manufacturer or seller of a drug immune from product liability if all of the following
are met:
• The drug was approved by the federal Food and Drug Administration (FDA).
• The manufacturer or seller did not fraudulently obtain the approval by bribing someone
or withholding or misrepresenting information.
• The drug and its labeling complied with the approval.
• The approval was not withdrawn.
MCL 600.2946
FISCAL IMPACT:
Senate Bill 410 would have an indeterminate fiscal impact on local court systems. The impact
would depend on the degree to which court caseloads increased, as well the associated
administrative costs. Currently, it is not possible for a suit to be brought against a drug
manufacturer for injury caused by a drug if the drug is approved by the FDA. The state’s drug
immunity law has prevented residents and the attorney general from participating in national
class action suits and from filing complaints against pharmaceutical companies. Under the bill,
legal recourse would be an option. Plaintiffs would be able to pursue recovering damages if
faulty drugs lead to injuries or death. It is difficult to project the actual fiscal impact to courts
due to variables such as judicial discretion and the complexity of cases, but an increase in court
caseloads could be significant.
The bill also may result in revenue increases to the state and local governments from lawsuit
settlement proceeds, depending on any litigation that ensues from the bill’s removal of product
liability protections and associated court judgments.
By removing the product liability protections, the bill would provide the state and local
governments new legal approaches to pursue pharmaceutical and opioid-related lawsuits
against pharmaceutical manufacturers. Drug-related settlements can reach large sums due to
the size of the pharmaceutical market and the number of individuals affected by it. The use of
settlement proceeds would be dependent on individual case settlement agreements and the
efficacy of political enforcement of the agreements. Drug settlement agreements often require
proceeds to be spent on services to support individuals affected by defective or dangerous
drugs, prevention services, and litigation costs.
House Fiscal Agency Page 1 of 2
The bill may increase consumer protection litigation caseloads for the Department of the
Attorney General and local prosecutors, resulting in the potential need for additional attorneys,
support staff, and compensation costs. Annual state costs for an additional attorney FTE
position are approximately $200,000, and annual costs for a support staff position are
approximately $100,000.
POSITIONS:
Representatives of the following entities testified in support of the bill (10-25-23):
• Department of the Attorney General
• Michigan Association for Justice
The following entities indicated support for the bill (10-25-23):
• Michigan Health and Hospital Association
• Blue Cross Blue Shield Michigan
• State Bar of Michigan Negligence Law Section
• Families Against Narcotics
A representative of Shook, Hardy & Bacon testified in opposition to the bill. (10-25-23)
The following entities indicated opposition to the bill (10-25-23):
• Michigan Chamber of Commerce
• Pharmaceutical Research and Manufacturer Association
• Consumer Health Product Association
• Michigan Manufacturers Association
Legislative Analyst: Rick Yuille
Fiscal Analysts: Robin Risko
Michael Cnossen
■ This analysis was prepared by nonpartisan House Fiscal Agency staff for use by House members in their
deliberations and does not constitute an official statement of legislative intent.
House Fiscal Agency SB 410 as reported from House committee Page 2 of 2

Statutes affected:
Senate Introduced Bill: 600.2946
As Passed by the Senate: 600.2946
As Passed by the House: 600.2946
Public Act: 600.2946
Senate Enrolled Bill: 600.2946