REVISED JUDICATURE ACT OF 1961
Act 236 of 1961
600.2946 Product liability action; admissible evidence.
Sec. 2946.
(1) It is admissible as evidence in a product liability action that the production of the product was in accordance with the generally recognized and prevailing nongovernmental standards in existence at the time the specific unit of the product was sold or delivered by the defendant to the initial purchaser or user.
(2) In a product liability action brought against a manufacturer or seller for harm allegedly caused by a production defect, the manufacturer or seller is not liable unless the plaintiff establishes that the product was not reasonably safe at the time the specific unit of the product left the control of the manufacturer or seller and that, according to generally accepted production practices at the time the specific unit of the product left the control of the manufacturer or seller, a practical and technically feasible alternative production practice was available that would have prevented the harm without significantly impairing the usefulness or desirability of the product to users and without creating equal or greater risk of harm to others. An alternative production practice is practical and feasible only if the technical, medical, or scientific knowledge relating to production of the product, at the time the specific unit of the product left the control of the manufacturer or seller, was developed, available, and capable of use in the production of the product and was economically feasible for use by the manufacturer. Technical, medical, or scientific knowledge is not economically feasible for use by the manufacturer if use of that knowledge in production of the product would significantly compromise the product's usefulness or desirability.
(3) With regard to the production of a product that is the subject of a product liability action, evidence of a philosophy, theory, knowledge, technique, or procedure that is learned, placed in use, or discontinued after the event resulting in the death of the person or injury to the person or property, which if learned, placed in use, or discontinued before the event would have made the event less likely to occur, is admissible only for the purpose of proving the feasibility of precautions, if controverted, or for impeachment.
(4) 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. Noncompliance with a standard relevant to the event causing the death or injury set forth in a federal or state statute or lack of approval by, or noncompliance with regulations or standards relevant to the event causing the death or injury promulgated by, a federal or state agency does not raise a presumption of negligence on the part of a manufacturer or seller. Evidence of compliance or noncompliance with a regulation or standard not relevant to the event causing the death or injury is not admissible.
History: Add. 1978, Act 495, Eff. Dec. 13, 1978 ;-- Am. 1995, Act 249, Eff. Mar. 28, 1996 ;-- Am. 2023, Act 285, Eff. Feb. 13, 2024
Notes of Decisions
Taylor v. Smithkline Beecham Corp., 658 N.W.2d 127 (Mich. 2003).
· cites it 48× “MCL 600.2946(5) provides: 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…”
Attorney Gen. v. Merck Sharp & Dohme Corp., 807 N.W.2d 343 (Mich. Ct. App. 2011).
· cites it 29× “In 1995, the Legislature amended MCL 600.2946 to provide immunity for products-liability claims against a manufacturer or seller of a drug that was approved for safety and efficacy by the FDA and labeled in compliance with FDA standards.”
Garcia v. Wyeth-Ayerst Labs., 265 F. Supp. 2d 825 (E.D. Mich. 2003).
· cites it 30× “Michigan has a drug products liability statute that immunizes drug manufacturers from liability for damages in suits contending that their drug was defective or unreasonably dangerous “if the drug was approved for safety and efficacy by the United States food and drug…”
Taylor v. Gate Pharm., 639 N.W.2d 45 (Mich. Ct. App. 2002).
· cites it 13× “At issue in these consolidated products liability appeals is the constitutionality of MCL 600.2946(5), which limits the liability of drug manufacturers and sellers.”
Vicki Marsh v. Genentech Inc., 693 F.3d 546 (6th Cir. 2012).
· cites it 7× “See Mich. Comp. Laws § 600.2946 (5). Marsh countered that Genentech was not entitled to immunity because it failed to submit updated safety information to the FDA after Raptiva had gone to market or otherwise comply with various FDA regulations regarding post-marketing…”
Downie v. Kent Prods., Inc, 362 N.W.2d 605 (Mich. 1985).
· cites it 10× “The second issue is whether evidence of warning labels, installed on defendants' presses manufactured after the date of sale of this press, but before the date of the plaintiff's injury, should have been excluded under MRE 407 or MCL 600.2946(3); MSA 27A.2946(3). The third issue…”
Zammit v. Shire US, Inc., 415 F. Supp. 2d 760 (E.D. Mich. 2006).
· cites it 18× “” Mich. Comp. Laws § 600.2946 (5). In support of its present motion, Defendant argues that Plaintiffs product liability claims in this action are defeated by the immunity granted under this Michigan statute, where Defendant secured the approval of the federal Food and Drug…”
Julia Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004).
· cites it 3× “The immunity is subject to two exceptions: (1) if the manufacturer intentionally withheld or misrepresented material information concerning the drug that it is required to be submitted under the Food and Drug Cosmetics Act and the drug would not have been approved, or the FDA…”
Wiley v. Henry Ford Cottage Hosp., 668 N.W.2d 402 (Mich. Ct. App. 2003).
· cites it 2× “1483, provides in relevant part: (1) In an action for damages alleging medical malpractice by or against a person or party, the total amount of damages for noneconomic loss recoverable by all plaintiffs, resulting from the negligence of all defendants, shall not exceed $280,000.”
Rowe v. Hoffman-La Roche, Inc., 917 A.2d 767 (N.J. 2007).
· cites it 2× “Mich. Comp. Laws § 600.2946 (5). [4] It seems clear that Michigan courts would apply Michigan law to this case, resulting in the type of "forum shopping" that attracts plaintiff to New Jersey.”
Rodney Palatka v. Savage Arms, Inc., 535 F. App'x 448 (6th Cir. 2013).
· cites it 3× “See Mich. Comp. Laws § 600.2946 (2). To prevail on a design defect claim in that state, a plaintiff must prove that “(1) the product was not reasonably safe when it left the control of the manufacturer; and (2) a ‘feasible alternative production prac *452 tice was available that…”
— Mich. Comp. Laws § 600.2946(2) — 12 cases
— Mich. Comp. Laws § 600.2946(3) — 2 cases
Downie v. Kent Prods., Inc, 362 N.W.2d 605 (Mich. 1985).
“The second issue is whether evidence of warning labels, installed on defendants' presses manufactured after the date of sale of this press, but before the date of the plaintiff's injury, should have been excluded under MRE 407 or MCL 600.2946(3); MSA 27A.2946(3). The third issue…”
— Mich. Comp. Laws § 600.2946(4) — 4 cases
— Mich. Comp. Laws § 600.2946(5) — 18 cases
Taylor v. Smithkline Beecham Corp., 658 N.W.2d 127 (Mich. 2003).
“MCL 600.2946(5) provides: 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…”
Attorney Gen. v. Merck Sharp & Dohme Corp., 807 N.W.2d 343 (Mich. Ct. App. 2011).
“In 1995, the Legislature amended MCL 600.2946 to provide immunity for products-liability claims against a manufacturer or seller of a drug that was approved for safety and efficacy by the FDA and labeled in compliance with FDA standards.”
Garcia v. Wyeth-Ayerst Labs., 265 F. Supp. 2d 825 (E.D. Mich. 2003).
“Michigan has a drug products liability statute that immunizes drug manufacturers from liability for damages in suits contending that their drug was defective or unreasonably dangerous “if the drug was approved for safety and efficacy by the United States food and drug…”
Taylor v. Gate Pharm., 639 N.W.2d 45 (Mich. Ct. App. 2002).
“At issue in these consolidated products liability appeals is the constitutionality of MCL 600.2946(5), which limits the liability of drug manufacturers and sellers.”
— Mich. Comp. Laws § 600.2946(5)(a) — 2 cases
Attorney Gen. v. Merck Sharp & Dohme Corp., 807 N.W.2d 343 (Mich. Ct. App. 2011).
“In 1995, the Legislature amended MCL 600.2946 to provide immunity for products-liability claims against a manufacturer or seller of a drug that was approved for safety and efficacy by the FDA and labeled in compliance with FDA standards.”
Garcia v. Wyeth-Ayerst Labs., 265 F. Supp. 2d 825 (E.D. Mich. 2003).
“Michigan has a drug products liability statute that immunizes drug manufacturers from liability for damages in suits contending that their drug was defective or unreasonably dangerous “if the drug was approved for safety and efficacy by the United States food and drug…”
— Mich. Comp. Laws § 600.2946(a) — 1 case
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