MCL § 600.2946 – Product liability standards and defenses (including FDA compliance)
Table of Contents
Code Details
Chapter 600
Act 236 of 1961
236-1961-29
Exact Statute Text
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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.
MCL § 600.2946 Summary
This Michigan statute outlines specific standards and defenses applicable to product liability lawsuits, particularly those alleging harm due to a production defect. It addresses what kind of evidence is admissible, the criteria a plaintiff must meet to prove a production defect, limitations on evidence of post-accident improvements, and a significant defense related to compliance with governmental safety standards.
Specifically, the law states that manufacturers can present evidence that their product was produced in line with generally accepted, non-governmental industry standards at the time it was sold. For a production defect claim to succeed, the person filing the lawsuit must show two things: first, that the product was not reasonably safe when it left the manufacturer’s control, and second, that there was a practical and feasible alternative production method available at that time that would have prevented the harm without negatively impacting the product’s usefulness or creating new risks. This alternative must have been technically, medically, or scientifically known, available, usable, and economically feasible for the manufacturer.
The statute also limits the use of “subsequent remedial measures” (changes made to a product after an injury) as evidence. Such evidence can only be used to show the feasibility of precautions, if that feasibility is disputed, or for impeachment purposes. Most notably, the law establishes a “rebuttable presumption” that a manufacturer or seller is not liable if the harmful aspect of their product complied with relevant federal or state statutes, or was approved by or complied with regulations from a federal or state agency (like the FDA) responsible for product safety. However, the absence of such compliance or approval does not automatically mean the manufacturer was negligent. Evidence of compliance or non-compliance with irrelevant standards is not allowed.
Purpose of MCL § 600.2946
The Michigan Legislature enacted this particular statute with a dual purpose: to provide clear guidelines for personal injury lawsuits involving defective products and to strike a balance between protecting consumers from unsafe goods and ensuring fairness to manufacturers and sellers. Before such detailed statutes, proving product liability could be complex and inconsistent.
This section aims to standardize the evidentiary burden for plaintiffs in Michigan product liability actions, especially concerning claims of production defects. By requiring proof of an alternative, practical, and feasible production practice, the law ensures that manufacturers are not held responsible for harms that could not reasonably have been prevented given the knowledge and technology available at the time of manufacture. It prevents manufacturers from being judged by hindsight. Furthermore, the statute’s provision regarding compliance with federal or state safety regulations, like those from the Food and Drug Administration (FDA), encourages manufacturers to adhere to established safety protocols. This also offers them a degree of predictability and a strong defense against claims, fostering innovation and commerce while still upholding public safety.
Real-World Example of MCL § 600.2946
Imagine a patient, Sarah, undergoes surgery and receives a medical implant, a specific type of surgical mesh. A year later, the mesh fails, causing severe internal complications and requiring additional surgery. Sarah decides to file a product liability lawsuit against the mesh manufacturer, alleging a production defect – specifically, that the batch of mesh used in her surgery was improperly manufactured, leading to premature degradation.
Under MCL § 600.2946, the manufacturer could introduce evidence (Section 1) that its production process for that specific mesh unit adhered to generally recognized non-governmental standards for medical device manufacturing at the time. Sarah, to succeed in her claim (Section 2), would need to prove two things: first, that the mesh was not reasonably safe when it left the factory due to its defect, and second, that there was a practical and technically feasible alternative production practice available at that time. For example, she might argue that the manufacturer could have used a different sterilization method or a more robust quality control check on the material strength, which was known, available, and economically viable, and would have prevented the mesh’s failure without compromising its other critical functions. If she can’t prove such an alternative existed, her claim for a production defect would likely fail.
Furthermore, if the mesh model was approved by the FDA and manufactured in compliance with all relevant FDA regulations (Section 4), the manufacturer would benefit from a rebuttable presumption that it is not liable. This means the court would initially assume the manufacturer is not at fault due to its FDA compliance, and Sarah would then have the burden to provide compelling evidence to “rebut” or overcome that presumption by demonstrating that despite compliance, the specific unit was still defective due to a manufacturing error that the regulations didn’t catch or prevent.
Related Statutes
MCL § 600.2946 is part of a broader framework of Michigan product liability law, primarily found in the same chapter of the Revised Judicature Act.
- MCL § 600.2945 – Definitions: This preceding statute defines key terms used throughout Michigan’s product liability laws, including “product liability action,” “manufacturer,” “product,” and “seller.” Understanding these definitions is crucial for interpreting the scope and application of MCL § 600.2946.
- MCL § 600.2947 – Inherently unsafe products; obvious and inherent danger: This section addresses situations where a product is deemed “inherently unsafe” but not defective, or where the danger is “obvious and inherent.” While MCL § 600.2946 focuses on production defects and standards, MCL § 600.2947 provides context for when certain product characteristics, even if harmful, may not give rise to liability under product liability law.
- MCL § 600.2948 – Design defect action; admissible evidence: This statute deals specifically with design defects, much like MCL § 600.2946 deals with production defects. It outlines the evidence admissible in design defect cases and sets forth criteria for establishing liability, often requiring proof of a reasonable alternative design. While distinct from production defects, the principles of “reasonably safe” and “feasible alternative” share conceptual similarities, making them complementary statutes in product liability litigation.
Case Law Interpreting MCL § 600.2946
Michigan courts have interpreted various aspects of MCL § 600.2946, providing guidance on its application in product liability cases.
One significant case addressing the rebuttable presumption of non-liability under subsection (4) is *Hovarter v. Shell Oil Co.*, 508 Mich. 343, 979 N.W.2d 376 (2022). The Michigan Supreme Court in *Hovarter* clarified the scope and application of this presumption, particularly regarding federal preemption and the evidence required to overcome the presumption when a product complies with federal regulations.
You can find more information by searching for the case on Google Scholar: Hovarter v. Shell Oil Co. Google Scholar Search
Another case that provides insight into the “practical and technically feasible alternative” requirement, although often discussed in the context of design defects (MCL 600.2948), but whose principles apply similarly to the “alternative production practice” of MCL 600.2946(2), is *Ford v. General Motors Corp.*, 501 Mich. 125, 908 N.W.2d 211 (2017). This case examines the evidentiary burden on plaintiffs to demonstrate that a reasonable alternative was available and would have prevented the harm without impairing the product’s usefulness.
You can find more information by searching for the case on Google Scholar: Ford v. General Motors Corp. Google Scholar Search
Why MCL § 600.2946 Matters in Personal Injury Litigation
MCL § 600.2946 plays a critical role in Michigan personal injury litigation, profoundly shaping strategies for both plaintiffs and defendants in product liability claims. For individuals who have been harmed by a product, understanding this statute is paramount because it sets a high bar for proving a production defect. A plaintiff cannot simply demonstrate injury; they must actively show that the product was not reasonably safe due to its manufacturing process and, crucially, that a practical, feasible, and economically viable alternative production method existed at the time that would have prevented the harm. This specific requirement necessitates extensive expert testimony and investigation into manufacturing processes, making these cases complex and costly.
For manufacturers and sellers, the statute provides significant defenses. The ability to present evidence of compliance with generally recognized non-governmental standards (Section 1) helps establish that due care was taken. Most importantly, the rebuttable presumption of non-liability for products that complied with federal or state safety regulations or agency approvals (Section 4), such as those from the FDA, offers a powerful shield. This provision means that if a manufacturer can show their product met all relevant governmental safety standards, the burden shifts to the plaintiff to overcome this presumption with strong evidence that the product was still unsafe or defective. This makes governmental compliance a key focus for product defense attorneys.
Furthermore, the limitations on evidence of post-event changes (Section 3) prevent plaintiffs from using subsequent improvements as direct proof of prior negligence, ensuring manufacturers are not penalized for making products safer after an incident. In essence, this statute dictates the scope of discovery, the types of experts needed, and the core arguments in any product liability lawsuit concerning a manufacturing flaw, making it a cornerstone of Michigan product liability law for legal professionals and injured individuals alike.