Minnesota Court of Appeals Decides Wrongful Death Statute of Limitations and Federal Preemption Issues In Medical Device Product Defect Case

02/28/2013 / Melissa L. Hagstrum

Product manufacturers and plaintiffs’ attorneys watched closely as the Minnesota Court of Appeals issued its decision in the medical device product defect case Lamere vs. St. Jude Medical, Inc. (A12-0609) on February 19, 2013. This case required the Court to decide three primary issues. First, did the statute of limitations on the plaintiff’s wrongful death claim begin to run when the medical device was manufactured or implanted, which would make it possible for the wrongful death statute of limitations to expire before death and even before a product defect is discovered? Second, the case required the Court to decide an issue on which the federal circuit courts are split: does federal law preempt a plaintiff’s state-law claim that alleges generally that federal Good Management Practices may have been violated? Third, does state common-law strict liability impose general requirements that differ from federal device-specific requirements such that the plaintiff’s state common-law strict liability claims are barred by federal preemption?

The Facts
A mechanical heart valve manufactured by St. Jude was surgically implanted in Thomas Lamere in February 1988. Mr. Lamere died nearly twenty years later, in September 2007. Following Mr. Lamere’s death, a medical examiner performed an autopsy and concluded that his death likely resulted from “acute heart failure, secondary to a displacement of one of the mechanical heart valve leaflets.”
Mr. Lamere’s surviving spouse sued St. Jude, asserting claims for wrongful death, loss of consortium, strict liability (manufacturing defect), breach of express warranty, breach of implied warranty, negligence, misrepresentation, and fraud.
Statute of Limitations For A Minnesota Wrongful Death Action May Expire Prior To Death and Prior To Discovery Of A Product Defect
Minnesota’s statute of limitations provides that a wrongful death action “may be commenced within three years after the date of death provided that the action must be commenced within six years after the act or omission.” St. Jude argued that the “act or omission” was the date the mechanical heart valve was manufactured or implanted into Mr. Lamere. The Minnesota Court of Appeals agreed.  
The Minnesota Court of Appeals concluded that the plain meaning of Minnesota’s wrongful death statute of limitations is clear, even as it presents the possibility that the opportunity to bring a wrongful death action could expire before death. The Minnesota legislature expressed its intention to limit wrongful death actions to six years after the “act or omission,” even if that six years expires before death. Minnesota courts have expressly rejected that the statute of limitations for wrongful death claims does not begin to run until the time the decedent discovered the injury.
Ms. Lamere’s wrongful death claim was time-barred by the statute of limitations, which began to run when the mechanical heart value was manufactured or implanted into Mr. Lamere (in February 1988) and expired six years after that “act or omission” (in February 1994).
A Plaintiff Must Plead A Specific Violation Of A Federal Good Management Practice To Avoid Federal Preemption Of A State Common-Law Claim
Ms. Lamere argued that St. Jude violated two federal Good Manufacturing Practices when it manufactured a mechanical heart valve that contained “pores and crevasses creating an unacceptable risk that the device would develop cracks and ultimately break.” First, she asserted that St. Jude violated the Good Manufacturing Practice that requires: “Each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications.” Second, she alleged that St. Jude violated the Good Manufacturing Practice that requires: “Each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance.”
The federal circuit courts have split on whether a plaintiff may establish a state common-law claim by pleading a violation of a federal Good Manufacturing Practice. The Fifth, Sixth and Seventh Circuit Courts of Appeals have held that yes, a plaintiff may establish a state common-law claim by pleading a violation of a federal Good Manufacturing Practice. The Eighth Circuit Court of Appeals has held that no, a plaintiff may not establish a state common-law claim by pleading a violation of a federal Good Manufacturing Practice because the Good Manufacturing Practices are simply too generic. 
With the Lamere decision, the Minnesota Court of Appeals aligned with the Eighth Circuit Court of Appeals’ approach. The Minnesota Court of Appeals determined that Ms. Lamere’s claim that St. Jude violated two federal Good Manufacturing Practices was not pled with sufficient specificity. During the discovery process, Ms. Lamere had “ample opportunity” to discovery whether any Good Manufacturing Practices had been violated. In order to survive St. Jude’s motion for summary judgment following discovery, Ms. Lamere needed to do more than merely cite two Good Manufacturing Practices she alleged were violated. At a minimum, she needed to explain how the violations occurred or how those violations were causally related to the failure of the mechanical heart valve.
Federal Preemption Bars State Common-Law Strict-Liability Claims That Impose General Requirements On Medical Devices That Differ From Federal Device-Specific Requirements
The Medical Device Amendments of 1976 classifies medical devices in one of three categories: Class I devices pose the least risk to the public, Class II devices present a “more harmful” risk to the public, and Class III devices present a “potential unreasonable risk of illness or injury” to the public. St. Jude’s mechanical heart valve is a Class III device. The device underwent a rigorous premarket approval process before it was introduced into the market. For federally approved medical devices like St. Jude’s mechanical heart valve, federal law prohibits a state (or a political subdivision of a state) from establishing any requirements which are different from, or in addition to, any federal requirements that apply to the device. Federal law also prohibits a state (or a political subdivision of a state) from establishing any requirements which relate to the safety or effectiveness of the device.
The Minnesota Court of Appeals concluded that imposing the state’s strict liability rules on a medical device that underwent the premarket approval process would impose a general duty that would directly regulate the device itself, which would constitute a regulation that is different from the federal regulations that apply to the device. A state-law manufacturing-defect claim imposes a requirement that is different from, or in addition to, the existing federal requirements that apply to the device. Therefore, Ms. Lamere’s manufacturing-defect claim is barred by federal preemption.
Implications Of The Lamere Decision
Following the Lamere decision, product manufacturers and plaintiffs’ attorneys will closely monitor when Minnesota’s wrongful death statute of limitations began to run, knowing that the statute of limitations may expire prior to death and prior to discovery of a product defect. Plaintiffs asserting a Minnesota state law claim that federal medical device Good Management Practices have been violated must plead those allegations with specificity, which may require identifying how the violations occurred or how those violations were causally related to the medical device failure. Finally, medical device manufacturers may proceed knowing that plaintiffs may not bring Minnesota state-law strict-liability manufacturing-defect claims related to medical devices that underwent the premarket approval process.