Lamere v. St. Jude Med., Inc., A12–0609.

• Decision Date: 19 February 2013
• Docket Number: No. A12–0609.,A12–0609.
• Citation: 827 N.W.2d 782
• Parties: Barbara A. LAMERE, Trustee for the heirs and next-of-kin of Sergeant Major Thomas C. Lamere, deceased, Appellant, v. ST. JUDE MEDICAL, INC., et al., Respondents.
• Court: Minnesota Court of Appeals

827 N.W.2d 782

Barbara A. LAMERE, Trustee for the heirs and next-of-kin of Sergeant Major Thomas C. Lamere, deceased, Appellant,

v.ST. JUDE MEDICAL, INC., et al., Respondents.

No. A12–0609.

Court of Appeals of Minnesota.

Feb. 19, 2013.

Syllabus by the Court

1. Pursuant to Minn.Stat. § 573.02 (2012), the statute of limitations on a wrongful-death claim arising out of an alleged product defect begins to run at the time the alleged wrongdoing occurred, not at the time the decedent discovered or could have discovered his injury.

2. To successfully plead a parallel claim to avoid federal preemption, a plaintiff must do more than merely cite to a federal Good Management Practice (GMP) that may have been violated.

3. State common-law strict-liability claims impose general requirements that are different from federal device-specific requirements and therefore are preempted by 21 U.S.C. § 360k(a) (2006).

Anthony J. Nemo, Andrew L. Davick, Rachel Simpson, Ashleigh Raso, Meshbesher and Spence, Ltd., Minneapolis, MN; and Scott L. Nelson, Public Citizen Litigation Group, Washington, D.C., for appellant.

Edward F. Fox, Carrie L. Hund, Bassford & Remele, P.A., Minneapolis, MN, for respondents.

Considered and decided by STAUBER, Presiding Judge; SCHELLHAS, Judge; and COLLINS, Judge.^*

OPINION

STAUBER, Judge.

On appeal from summary judgment, appellant argues that the district court erred by concluding that appellant's manufacturing-defect claim was preempted by the Medical Device Amendments (MDA) of 1976 to the federal Food, Drug and Cosmetic Act. By notice of related appeal, respondent argues that the district court erred by concluding that appellant's claim is not time-barred under Minnesota's wrongful-death statute of limitations. Because we conclude that a claim arises at the time the alleged wrong-doing occurred, we reverse the district court's order and hold that appellant's manufacturing-defect claim is time-barred, and affirm the district court's award of summary judgment. And because we conclude that the appeal is meritorious, we deny respondent's motion for sanctions pursuant to Minn.Stat. § 549.211 (2012).

FACTS

In February 1988, Thomas C. Lamere (Mr. Lamere), a California resident, underwent a successful surgical implantation of a mechanical heart valve to replace his mitral heart valve. The heart valve implanted in Mr. Lamere was a St. Jude Medical Mechanical Heart Valve, Model No. 33M–101, Serial Number 166155. In September 2007, Mr. Lamere died. An autopsy was performed, and the medical examiner concluded that Mr. Lamere's death was likely a result of “acute heart failure, secondary to a displacement of one of the mechanical heart valve leaflets.”

Appellant Barbara A. Lamere (Ms. Lamere), Mr. Lamere's wife and also a California resident, brought suit in Ramsey County District Court on July 9, 2010, against respondents St. Jude Medical, Inc., et al. (St. Jude). Ms. Lamere's complaint asserted numerous claims, including wrongful death, loss of consortium, strict liability (manufacturing defect), breach of express and implied warranty, negligence, misrepresentation, and fraud. St. Jude moved for summary judgment, arguing that Ms. Lamere's claims were barred by the applicable statutes of limitation, under either Minnesota or California law, and preempted by the Medical Device Amendments (MDA) of 1976 to the federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360k.

In opposition to the motion for summary judgment, Ms. Lamere provided the affidavit of Dr. Richard I. Fukumoto, M.D., who performed the autopsy on Mr. Lamere and concluded that the cause of death was likely related to the failure of the mechanical heart valve. Ms. Lamere also provided the affidavit of Dr. Constantine D. Armeniades, a professor emeritus at Rice University in the department of Chemical and Biomolecular Engineering. Dr. Armeniades stated that he examined Mr. Lamere's mechanical heart valve using an electron microscope and observed “pores near the fracture and crevasses on the fracture surface” indicating that “[t]hese defects led to the formation and propagation of cracks, which eventually caused the valve leaflet to fracture and separate.” In Dr. Armeniades's opinion, “the fracture of ... [Mr.] Lamere's valve was caused by a manufacturing defect which occurred due to the failure to properly finish and polish the valve leaflet, and failure to detect its flaws during the post-manufacture inspection.”

In support of its motion for summary judgment, St. Jude presented the affidavit of Michael F. Coyle, its regulatory-affairs manager. Included as an attachment to the affidavit was the “Traveler,” a document that recorded each federally required step in the device's manufacturing process. According to Coyle, the Traveler “reflects that the Model 33M–101 Standard Bi-leaflet Mechanical Heart Valve, serial number 166155 completed all manufacturing processes, inspections, and quality control processes satisfactorily with no discrepancies noted, meaning that ... [it] complied with all FDA requirements at the time it was shipped out of St. Jude's custody and control.”

The district court issued its order on February 7, 2011, denying St. Jude's motion for summary judgment on statute-of-limitations grounds. The district court concluded that Minnesota's wrongful-death statute does not bar Ms. Lamere's claim because the event that caused the limitations period to run was Mr. Lamere's injury and death, not the implantation or manufacture of the device as claimed by St. Jude. In its choice-of-law analysis, the district court concluded that Minnesota's three-year statute of limitations applied and not California's two-year statute of limitations because statutes of limitation are procedural, not substantive, and the procedural law of the forum state applies.

However, the district court granted St. Jude's motion for summary judgment on preemption grounds on all of Ms. Lamere's claims except her claim that the device was damaged in the manufacturing process. The district court concluded that the affidavit of Dr. Armeniades created a genuine issue of material fact as to whether the mechanical valve was manufactured in accordance with the applicable federal rules and that such a claim is not preempted by federal law because it parallels the federal requirements and does not add a new or different requirement.

Following several months of discovery, St. Jude again moved for summary judgment, arguing that Ms. Lamere failed to present any evidence that St. Jude violated any federal rules with respect to its manufacture of the device implanted in Mr. Lamere, and therefore her claim was preempted because Ms. Lamere failed to present evidence of a parallel claim. The district court granted St. Jude's motion for summary judgment, concluding that Ms. Lamere failed to cite any federal requirement that St. Jude failed to follow, and that Ms. Lamere's common-law claim based in either negligence or strict liability is preempted by federal law.

This appeal followed. Ms. Lamere contested the district court's grant of summary judgment on federal-preemption grounds. St. Jude also appealed, contesting the district court's denial of summary judgment on the statute-of-limitations issue, and moved for sanctions pursuant to Minn.Stat. § 549.211.

ISSUES

I. Did the district court err by denying summary judgment on the statute-of-limitations issue, concluding that Ms. Lamere's wrongful-death claim is not time-barred by Minn.Stat. § 573.02?

II. Did the district court err by granting summary judgment in favor of St. Jude, concluding that Ms. Lamere's manufacturing-defect claim is preempted by federal law?

III. Is St. Jude entitled to attorney fees under Minn.Stat. § 549.211?

ANALYSIS

A motion for summary judgment shall be granted if “the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that either party is entitled to judgment as a matter of law.” Minn. R. Civ. P. 56.03. On an appeal from summary judgment, an appellate court “review [s] the record to determine whether there is any genuine issue of material fact and whether the district court erred in its application of the law.” Dahlin v. Kroening, 796 N.W.2d 503, 504–05 (Minn.2011). Both questions are reviewed de novo. Riverview Muir Doran, LLC v. JADT Dev. Grp., LLC, 790 N.W.2d 167, 170 (Minn.2010). The evidence is reviewed in the light most favorable to the party against whom judgment was granted. Fabio v. Bellomo, 504 N.W.2d 758, 761 (Minn.1993). No genuine issue of material fact exists “when the nonmoving party presents evidence which merely creates a metaphysical doubt as to a factual issue and which is not sufficiently probative with respect to an essential element of the nonmoving party's case to permit reasonable persons to draw different conclusions.” DLH, Inc. v. Russ, 566 N.W.2d 60, 71 (Minn.1997).

I.

St. Jude argues that, under either Minnesota or California law, Ms. Lamere's manufacturing-defect claim is time-barred because her claim arose when the mechanical heart valve was manufactured prior to 1988. In the alternative, St. Jude argues that the district court should have applied California's shorter limitations period in this case, because the case lacks sufficient ties to Minnesota for Minnesota law to be applied.

Minnesota's statute of limitations provides that an action for wrongful death “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.” Minn.Stat. § 573.02, subd. 1. Appellate courts review the interpretation and construction of a statute of limitations or repose de novo. State Farm Fire & Cas. v. Aquila Inc., 718 N.W.2d 879, 883 (Minn.2006). “If the meaning of a statute is unambiguous, [appellate courts] interpret the statute's text according to its plain language. If a statute is...