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Cornett v. Johnson & Johnson , 211 N.J. 32 (2012)

Cornett v. Johnson & Johnson , 211 N.J. 32 (2012)

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Published by George Conk
New Jersey Supreme Court opinion holding product liability action preempted in part, and allowed in part to extent founded on promotion by defendants of off-label uses of the Cypher coronary stent.
New Jersey Supreme Court opinion holding product liability action preempted in part, and allowed in part to extent founded on promotion by defendants of off-label uses of the Cypher coronary stent.

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Categories:Types, Business/Law
Published by: George Conk on Dec 18, 2013
Copyright:Attribution Non-commercial


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CautionAs of: December 18, 2013 2:30 AM EST
SupremeCourt of New JerseyJanuary 30, 2012, Argued; August 9, 2012, DecidedA-88-10, A-89-10 September Term 2010, 066671
Prior History: [***1]
 On certification to theSuperior Court, Appellate Division, whose opin-ion is reported at
 414 N.J. Super. 365, 998 A.2d 543 (2010)
.Cornett v. Johnson & Johnson, 414 N.J. Super.365, 998 A.2d 543, 2010 N.J. Super. LEXIS142 (App.Div., 2010)
Case Summary
Procedural Posture
Plaintiff widow appealed the judgment of theSuperior Court, Appellate Division (New Jer-sey), which dismissed her complaint. against de-fendants, two medical device manufacturers.Plaintiff asserted claims for manufacturing de-fect and failure to warn involving a medicaldevice used by her husband. Plaintiff assertedvarious state common law and statutory claims,including violations of the Product LiabilityAct,
 N.J.S.A. § 2A:58C-1 et seq.
Plaintiff’s husband lived in Kentucky and suf-fered from coronary artery disease. He receivedan implant of a stent manufactured by defen-dants, with the parent company being a New Jer-sey corporation. Plaintiff’s husband also haddiabetes. He suffered thrombosis in the areawhere the stent was placed and died. The Courtagreed that the one-year Kentucky statute of limitations governed the case and that Ken-tucky applied a discovery rule to product liabil-ity actions involving latent injuries and ill-
nesses, but plaintiff did not timely file hercomplaint. Further, the great bulk of the statestatutory and common law claims were pre-empted by federal law. However, the Courtfound that exceptions were plaintiff’s failure towarn claim for approved use to the extent it in-volved wrongdoing apart from defendants’ fail-ure to comply with United States Food andDrug Administration disclosure requirementsand for off-label use of the stent to the extent de-fendants improperly promoted that device,and the breach of express warranty claim for vol-untary statements to third parties that deviatedfrom the approved label and packaging informa-tion material.
As modified, the Court affirmed the judgmentof the Appellate Division.
(This syllabus is not part of the opinion of theCourt. It has been prepared by the Office of the Clerk for the convenience of the reader. Ithas been neither reviewed nor approved by theSupremeCourt. Please note that, in the inter-est of brevity, portions of any opinion may nothave been summarized.)
 Cornett v. Johnson & Johnson andCordis Corp
. (A-88/89-10) (066671)Argued January 30, 2012 -- Decided August9, 2012CUFF, P.J.A.D. (temporarily assigned), writ-ing for a unanimous
 Court.In this appeal, the Court considers whetherplaintiff filed her complaint within the statuteof limitations, whether the law of Kentucky orNew Jersey applies, and whether the variousstate statutory and common law claims in thiscase are preempted by federal law governing ap-proval of the Cypher® stent, a Class III medi-cal device that was subject to the rigorous pre-market approve (PMA) process of the Food &Drug Administration (FDA).Billie Cornett resided in Kentucky and sufferedfrom coronary artery disease. On December16, 2004, Billie received an implant of a Cy-pher® stent, manufactured
 by CordisCorp., a wholly-owned subsidiary of John-son & Johnson, a New Jersey corporation withits principal place of business in New Jersey.Billie also had diabetes. Use of the Cypher®stent on a patient with coronary heart dis-ease and diabetes is considered
 butnot necessarily medically contraindicated. On
211 N.J. 362, *362; 48 A.3d 1041, **1041; 2012 N.J. LEXIS 831, ***1Page 2 of 30
May 18, 2005, five months after surgery, Billiesuffered a subacute stent thrombosis in thearea where the Cypher® stent was placed. Hedied on May 31, 2005, as a result of the throm-bosis. Billie lived and worked in Kentucky.He received all medical care in Kentucky.On September 15, 2008, Vonnie Cornett, the ex-ecutor of the estate of Billie Cornett, and oth-ers from sixteen states and New Jersey filedforty-eight complaints against defendantsJohnson & Johnson and Cordis for injuries al-legedly resulting from use of the Cypher® stent.In response to a motion to dismiss that ar-gued all causes of action pled by plaintiffs werepreempted by the Medical Device Amend-ments of 1976 (MDA) to the Food, Drug andCosmetic Act (FDCA), plaintiffs requested per-mission to file an amended complaint and didso bearing the Cornett caption. All complaintshave been consolidated and the
 Cor-nett complaint was designated the Master Com-plaint. Defendants moved to dismiss theamended Master Complaint. The motion judgedismissed the amended Master Complaint inits entirety.The motion judge held the Cornett complainttime-barred and all claims preempted by fed-eral law. On appeal, theAppellate Division af-firmed the dismissal of the Cornett complaintas time-barred. Cornett v. Johnson & Johnson,414 N.J. Super. 365, 382-83, 998 A.2d 543(App. Div. 2010). The panel concluded a con-flict of laws existed and the law of Kentuckygoverned, and held the complaint barred byKentucky’s one-year statute of limitations. Thepanel held the following claims were not pre-empted by federal law: manufacturing defect;failure to warn of approved and off-labeluses to the extent plaintiffs alleged failure to sat-isfy federal disclosure requirements or federallimitations on off-label promotion within thestatutory safe harbor; and breach of expresswarranty to the extent plaintiffs based their claimon voluntary statements relating to approveduses or off-label uses outside the safe harbor.The panel held the remaining claims, other thanthe breach of implied warranty, preempted byfederal law. In addition,
 the panel heldthe Product Liability Act (PLA),
.2A:58C-1 to -11, subsumed the breach of im-plied warranty claim; therefore, the motion judge properly dismissed this claim.The SupremeCourt granted the parties’ cross-petitions for certification to consider whether the
211 N.J. 362, *362; 48 A.3d 1041, **1041; 2012 N.J. LEXIS 831, ***2Page 3 of 30

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