Michigan
Michigan No Longer A Safe Haven For Pharmaceutical Companies?
By Elizabeth Chiarello, Julie Becker, Rachel Rein, Sidley Austin, LLP
Pharmaceutical companies may soon face more product liability litigation in Michigan after the state repealed its unique Drug Immunity Law. The Drug Immunity Law passed in 1995 provided an absolute defense for pharmaceutical companies in product liability suits stemming from the safety and efficacy of their drug products. Michigan reportedly had the only law in the nation that shielded drug manufacturers and sellers from such liability. This article addresses the impact of this change to Michigan’s law.
Michigan’s Drug Immunity Law Provided A Near Absolute Liability Defense
Section 600.2946 of the Michigan Compiled Laws governs products liability actions. Previously, § 600.2946 included a provision, subsection 5, that shielded the manufacturer or seller of a drug from products liability suits so long as the drug was approved by the FDA. Specifically, the statute said:
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.
M.C.L. §600.2946(5). Subsection 5 was known as the Drug Immunity Law and operated as a type of safe harbor provision for drug manufacturers and sellers.
The law contained three exceptions. A drug manufacturer and seller could still be liable notwithstanding subsection 5 if they (1) sold the drug after the FDA recalled it from the market or withdrew its approval; (2) bribed an FDA official to secure approval of the drug; or (3) committed fraud on the FDA by intentionally withholding or misrepresenting information in communications with the FDA. The first two exceptions to the Drug Immunity Law were exceedingly rare as a factual matter. The third exception was preempted by federal law: only the FDA itself — not a court — can determine a fraud has been committed on the agency during the regulatory-approval process.
As a result, lawsuits could not be brought by Michigan consumers under Michigan law for claims barred by subsection 5, and they were effectively barred from joining national litigation against pharmaceutical companies when Michigan law applied to their claims. Because of the slim chance that a plaintiff’s suit could fall into one of the three exceptions to the law, Michigan was among the states with the most stringent protections for drug manufacturers and sellers. But now the law has changed.
A New Act
Senate Bill 410 changed § 600.2946, effective February 13, 2024. Removing Michigan’s drug immunity provision, the law has left intact the rebuttable presumption that manufacturers and sellers of products are not liable if their product conformed to the applicable standards or regulations — for drug manufacturers and sellers, presumably FDA regulations — at the time of the product’s sale or delivery. Specifically, the law states:
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.
A rebuttable presumption means that a plaintiff can offer evidence to overcome the presumption and maintain his or her case. The previous exceptions to the drug immunity provision were repealed along with the immunity provision itself.
What largely remains to be seen is how case law will interpret the rebuttable presumption in the drug manufacturing and sales context, including what type of evidence and how much is necessary to successfully rebut a presumption that a drug conformed to FDA standards or regulations. This is because courts previously dismissed Michigan plaintiffs in drug products liability suits under the specific drug immunity provision, not the general products liability rebuttable presumption. The guidance that exists for courts applying Michigan law under the new act is from other areas of products liability law, including medical device manufacturing and sales. Because courts have applied the rebuttable presumption in other types of products liability suits, courts and the parties will likely look to those other areas of law to inform arguments about whether the presumption has been rebutted in pharmaceutical drug litigation.
The law appears to preserve traditional defenses to products liability claims such as misuse, assumption of risk, and lack of causation as it does not include language that bars or alters them. And because the bill is not retroactive, it does not technically impose new liability for past harms or revive claims previously dismissed under § 600.2946(5). Nevertheless, this is a noteworthy change to Michigan’s products liability law that companies operating in Michigan should consider.
Potential National Implications
The change in Michigan law may have broader significance beyond the state of Michigan. Michigan plaintiffs’ ability to join in products liability drug suits against pharmaceutical companies could lead to larger class sizes and potentially greater exposure. This also means that plaintiffs with sufficient ties to Michigan may be more likely to bring lawsuits, with the added costs that are attendant to additional litigation. And companies based in Michigan may be more likely to see lawsuits in their home state.
Guidance For Pharmaceutical Executives
Pharmaceutical companies can take action to protect their businesses from meritless claims, in light of the change in Michigan’s law. Companies can, for example:
- Consult with in-house counsel or others at the company with respect to ensuring that compliance with FDA requirements during the drug approval process can provide support later on during litigation, if appropriate;
- Communicate early and often with in-house counsel and their advisors about the best strategies for identifying, hiring, and managing counsel equipped to defend litigation in Michigan, as needed; and
- Stay abreast of the development of the law with respect to the rebuttable presumption to best position the company’s defense in any future Michigan litigation.
Although the law has changed, the extent to which that will lead to significant additional litigation remains to be seen. There is certainly an opportunity for litigation that was not previously available in Michigan. But it may be that the law operates exactly the same as before, because the presumption of compliance with FDA rules and regulations cannot be rebutted or the evidence needed to establish such a rebuttal is high. Companies based in or selling products through Michigan should take note because the law is likely to develop in new ways in the coming months and years.
About The Authors:
Elizabeth Chiarello is a partner in Sidley’s Products Liability practice and helps clients in the pharmaceutical industry manage their most complex cases, including preparing high-stakes matters for trial and serving as national coordinating and trial counsel in mass litigation.
Julie Becker is a senior managing associate at Sidley, focusing her practice on the defense of companies in products liability and class action matters in state and federal trial courts across the United States.
Rachel Rein is an associate at Sidley, focusing her practice on commercial litigation and disputes.
Michigan
Yaxel Lendeborg scores 29 points and No. 2 Michigan stays unbeaten with 101-83 win over Maryland
COLLEGE PARK, Md. (AP) — Yaxel Lendeborg had 29 points, a career-best nine assists and eight rebounds, and No. 2 Michigan rallied from a nine-point deficit Saturday night to defeat Maryland 101-83.
Aday Mara scored 18 points for the Wolverines (10-0, 2-0 Big Ten), who overcame a halftime deficit for the second time this season and the first since they beat TCU on Nov. 14.
Michigan scored 100 points for the fourth time in five games.
Diggy Coit made eight 3-pointers and scored 31 points for the Terrapins (6-5, 0-2), who lost center Pharrel Payne to a right leg injury late in the first half and forward Solomon Washington to ejection after he picked up his second technical foul early in the second half.
Coit scored nine of Maryland’s first 10 points and 22 before the break, helping to prevent Michigan from opening a lead larger than six in the first half.
The Terps lost Payne, their leading scorer at 18.7 points a game, with 4:36 remaining before halftime. Yet Maryland stretched its lead from one to 50-45 at the midpoint, then expanded it to 56-47 on Elijah Saunders’ 3.
Washington, who had a first-half technical for celebrating a 3 in front of the Michigan bench, was called for a delay-of-game technical just after Saunders’ basket. His departure left the Terps without their two most experienced and imposing interior players.
Lendeborg took advantage, scoring the next eight points. Mara’s dunk with 14 minutes left made it 64-63 and gave the Wolverines the lead for good.
Elliot Cadeau’s layup with 21.2 seconds remaining got the Wolverines to 100 points for the fifth time this season.
Up next
Michigan hosts La Salle on Dec. 21.
Maryland visits No. 24 Virginia on Dec. 20.
___
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GRAND RAPIDS, MI – After beginning a direct admittance program at one West Michigan high school in November, Aquinas College has now expanded the program to cover more classrooms.
The guaranteed admission program, first implemented for graduates of West Catholic High School with a 2.0 GPA or above, has now been expanded to Catholic Central High School in Grand Rapids and Muskegon Catholic Central High School.
The partnership will apply to students from all three schools entering college in the fall of 2026.
The direct admission program was described by Aquinas College leaders as offering high school students a “clear path to college success” while also continuing to develop partnerships.
Aquinas College, a private Catholic liberal arts institution located at 1700 Fulton St. E, was founded by the Dominican Sisters of Grand Rapids in 1886.
The college has enrolled 1,262 students during the 2025-26 academic year, and its new student numbers are up, with 419 new students on campus this fall, up from 311 in 2024-25.
The college’s overall enrollment total is just slightly under the approximately 1,300 students Aquinas recorded across its campus in 2023-24, according to a press release sent out in January 2025.
This year’s partnership announcements do not mark Aquinas’ first direct admittance deal.
The college also has a direct admit bachelor’s in nursing partnership with the University of Detroit Mercy, which allows students to take core curriculum courses at Aquinas and nursing classes from Detroit Mercy faculty.
On Nov. 14, Aquinas announced its direct admittance deal with West Catholic High School.
The school, located at 1801 Bristol Ave. NW, enrolled just over 500 students as of the 2024-25 school year, according to an online school profile.
West Catholic President and CEO Jill Wierzbicki said the initiative simplifies the college application process and offers students a straightforward path to higher education.
On Nov. 20, Aquinas then announced it had also partnered with Grand Rapids’ Catholic Central High School, 319 Sheldon Blvd SE, which enrolls 567 students and is the oldest co-educational diocesan Catholic high school in the nation.
Brian Matzke, vice president for enrollment management, said there’s “no doubt that Aquinas here has had more graduates from Catholic Central than any other school in our history.”
On Dec. 10, the college announced another partnership deal with Muskegon Catholic Central High School, 1145 W Laketon Ave., which enrolled just under 300 students in 2023-24, according to the National Center for Education Statistics.
Jerry McDowell, Muskegon Catholic Central president, said both the high school and Aquinas share a “deep commitment to developing the whole student — academically, spiritually, and individually.
“This direct-admit program provides our graduates with an exceptional opportunity to transition confidently into higher education while maintaining the Catholic values that guide their formation,” McDowell said.
Aquinas’ listed price for traditional undergraduate tuition is $41,192, according to senior director of strategic communications Dave DeJonge.
Students are eligible for annual merit scholarships between $15,000-$25,000, depending on their GPA and housing status. Additional scholarships may be available. This applies to all students who are admitted to Aquinas.
Matzke highlighted the direct admittance program’s easy transition from one West Michigan school to another, with those accepted to Aquinas able to live on campus or commute from home depending on what best fits their needs.
He also said a growing Grand Rapids job market, combined with support from the college’s career center, contributes to a 97% placement rate for graduates.
Michigan
Legal experts question University of Michigan’s role after charges against former HC Sherrone Moore
WASHTENAW COUNTY, Mich. – Former Michigan Wolverines head football coach Sherrone Moore appeared in court Friday on charges of stalking, home invasion, and breaking and entering, just days after being fired from his position.
The 39-year-old coach, who has no prior criminal history, was terminated by the university on Wednesday following an investigation that uncovered evidence of an inappropriate relationship with a staff member.
According to prosecutors, the charges stem from an incident that occurred after the victim, a University of Michigan staff member, ended her relationship with Moore on Monday (Dec. 8).
Following the breakup, Moore allegedly made numerous unwanted calls and texts to the victim.
The situation escalated on Wednesday, Dec. 12, 2025, when Moore allegedly forced his way into the victim’s Pittsfield Township apartment.
Prosecutors say he grabbed kitchen utensils and threatened to take his own life, allegedly telling the victim, “My blood is on your hands.”
“The totality of the behavior is highly threatening and highly intimidating. She was terrorized, your honor,” a prosecutor told the court during Friday’s arraignment.
Defense attorney Joseph Simon pushed back on prosecutors’ claims that Moore could be a threat to public safety.
“My client’s 39 years old, with zero prior criminal history, zero prior contact with the criminal justice system in any fashion,” Simon stated.
Attorney Todd Flood, who practices both criminal defense and civil litigation, said the fallout within the university could continue depending on when the organization was first alerted about the relationship and how university athletic officials first responded.
“What did they know, when did they know it, and what did they do about it when they found out? Those are going to be the three major questions,” Flood said.
“The university could possibly have some culpability there, that they didn’t put a stop to this,” noted Flood, adding that the victim may have grounds to pursue action against both the university and Moore.
Flood said the stalking charge against Moore likely stems from a documented pattern of harassment.
“When there is a position where he is harassing, either via text messages, harassing via telephone calls, social media content, or showing up at a place where he doesn’t belong,” Flood said. “Those stalking charges are ones where you can show that pattern of conduct.”
“He’s ultimately going to probably plead this case out, under some sort of either misdemeanor, or something that gives probation,” Flood said.
Moore posted his $25,000 bond Friday.
As part of his bond conditions, he must wear a GPS tether, undergo mental health treatment, and have no contact with the victim.
He is scheduled to appear in court in person on Jan. 22.
–> Jim Harbaugh talks Sherrone Moore’s firing, arrest after former Michigan football understudy posts bond
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