Modern medicines and products are supposed to help us — not harm us. But when manufacturers cut corners, downplay risks, or conceal defects, injuries happen. In Michigan, as of February 2024, drug manufacturers no longer enjoy blanket immunity from product liability claims. This guide walks through what that means, how to pursue claims, and how your case may proceed.

What Is Product Liability?

Product liability is the legal doctrine that holds manufacturers, distributors, and sellers responsible when a defective or dangerous product injures someone. These cases may involve:

• Prescription or over-the-counter (OTC) drugs

• Medical devices or implants

• Household appliances, tools, machinery, or consumer products

A “defect” may take various forms:

1. Design defect: The product is inherently unsafe due to its design.

2. Manufacturing defect: The product deviated from its intended design (e.g. contamination, assembly errors).

3. Failure to warn / marketing defect: Insufficient instructions, inadequate warnings, or misleading labels about risks.

Michigan’s Legal Landscape: Immunity Repeal & What Has Changed

Historical Immunity Under Michigan’s Product Liability Act

From 1995 onward, Michigan’s Product Liability Act (MPLA) included a special immunity shield for manufacturers and sellers of FDA-approved drugs. Under the old version of MCL § 600.2946, so long as the drug was approved by the FDA, its labeling complied with that approval, and no fraudulent misrepresentation to the FDA occurred, manufacturers were largely protected from liability claims.

Because of that unique immunity, Michigan was the only state that effectively barred many drug injury claims even when damages existed.

Repeal of Drugmaker Immunity (SB 410)

In late 2023, the Michigan Legislature passed Senate Bill 410, and Governor Whitmer signed it into law on December 7, 2023. The law took effect February 13, 2024, at which point pharmaceutical manufacturers and sellers lost their blanket immunity in Michigan for defective drug claims.

Under the amended statute, the immunity provisions are deleted, meaning that FDA approval and compliance are no longer automatic shields. However, the law retains a rebuttable presumption that a product was not defective if it complied with FDA standards — a presumption that the plaintiff can try to overcome with evidence.

Issues of Retroactivity & Accrual

One key point: The new law is unlikely to apply retroactively to injuries that occurred before February 13, 2024. Michigan courts generally presume against retroactive application when a statute would impose new substantive duties or alter vested rights.

In practice, that means:

• If your injury occurred after February 13, 2024, you can bring a defective drug or device claim under the new regime.

• If your injury occurred before that date, claims will likely remain governed by the old immunity law — unless courts determine some limited retroactive effect is proper (which is unlikely under Michigan’s LaFontaine factors).

• Some claims filed after the effective date but tied to pre-2024 injuries may face legal challenges about which version of the law applies. Courts will consider legislative intent, whether rights have vested, and whether the statute is procedural or substantive.

Examples of Drug / Device & Consumer Products Claims

With immunity removed, Michigan plaintiffs can pursue claims in more categories, including:

• Prescription drugs causing adverse health events or organ damage

• Devices and implants (e.g. faulty hip replacements, cardiac devices)

• Medical devices failing prematurely

• OTC products (if defective design or warning)

• Consumer or industrial products (unaffiliated with drugs) with traditional product liability claims

Importantly, immunity repeal specifically affects pharmaceutical cases; product liability principles for non-drug products are largely unchanged.

Who Can Be Held Liable Now and What You Must Prove

After repeal, defendants in Michigan defective drug and device cases may include:

• Drug manufacturers

• Device makers

• Suppliers of components or raw materials

• Distributors, wholesalers

• Pharmacies or retailers (if tied to defect or misrepresentation)

To prevail, a plaintiff must generally show:

1. The product was defective (design, manufacturing, or warning)

2. The defect existed when it left the defendant’s control

3. The defect was a proximate cause of harm

4. The plaintiff used the product in a reasonably foreseeable way

5. The plaintiff has damages (medical costs, lost income, pain and suffering, etc.)

With the repeal, plaintiffs can now more effectively challenge prescribing drug manufacturers on design, warning, and marketing claims, even if the product was FDA-approved.

Defenses & Challenges in the Post-Immunity Landscape

While immunity is gone, defendants still retain certain tools:

• Rebuttable presumption from FDA compliance: Compliance with FDA standards (labeling, testing) will remain a presumption of non-defectiveness, but plaintiffs can present evidence (e.g. internal documents, adverse events, warnings omitted) to rebut it.

• Federal preemption: Some drug/device claims may still face preemption arguments — that state law claims conflict with federal regulatory decisions.

• Statute of limitations / accrual issues: Plaintiffs must bring claims within applicable time limits (see below).

• Comparative fault: Michigan allows apportionment of fault among parties, including the injured person.

• Causation disputes, expert testimony hurdles, Daubert challenges: As always, plaintiffs must establish complex medical and engineering causation.

What Compensation Is Available

When liability is established, damages may include:

• Past and future medical expenses

• Lost wages and reduced earning capacity

• Pain and suffering, emotional distress

• Loss of enjoyment of life

• In wrongful death or survivorship claims, damages to survivors under Michigan law

Unlike the immunity era, plaintiffs now have a clearer path to hold pharmaceutical companies accountable for injuries caused by their products.

Statute of Limitations in Michigan

Michigan’s statute of limitations for product liability claims is three years from the date of injury or death (MCL § 600.5805). The discovery rule may extend the deadline if the injury wasn’t immediately apparent, especially for latent drug injuries.

Because the immunity repeal is not expected to apply retroactively, plaintiffs whose injuries occurred before February 13, 2024 should pay careful attention to whether their claims were timely under the prior regime (if any exceptions applied).

How Our Firm Handles Defective Drug & Product Cases Now

With the immunity shield gone, pharmaceutical claims are now more viable in Michigan — but they remain technically and factually complex. Here is how we intend to approach them:

• Partnering with medical, pharmacology, engineering, and regulatory experts to analyze design and warning defects

• Investigating internal corporate documents, FDA submissions, adverse event data, research memos, and communications

• Developing strong causation models tying the defect to the client’s injury

• Navigating preemption and immunity defense arguments

• Strategizing about whether to litigate in Michigan state courts or coordinate with federal MDL proceedings

Because Michigan law now aligns more with national product liability standards, Michigan residents injured by drugs now have more opportunities for justice.

Talk to a Michigan Product Liability Lawyer

If you or a loved one was harmed by a defective drug, medical device, or product — especially after February 13, 2024 — now is a critical time to seek legal advice. The legal barrier that once blocked many valid claims is gone, but deadlines, evidence preservation, and litigation strategy remain essential.

Contact our firm today for a free, confidential consultation with a Michigan product liability attorney.