New Jersey High Court: Some Warning, Warranty Claims About Stent Aren't Preempted

New Jersey High Court: Some Warning, Warranty Claims About Stent Aren't Preempted

TRENTON, N.J. - (Mealey's) The New Jersey Supreme Court on Aug. 9 ruled that some failure-to-warn claims and some breach of warranty claims involving the Cordis Cypher drug-coated coronary stent may survive federal preemption, a ruling that applies to 47 state court cases in which plaintiffs claim that they were injured or that family members died after being implanted with the now-withdrawn stent (Vonnie Cornett v. Johnson & Johnson, et al., No. A-88/89 September Term 2010 066671, N.J. Sup.; 2012 N.J. LEXIS 831). 

(Opinion available. Document #28-120823-001Z.) 

The ruling came in a master complaint for 48 cases.  While it dismissed the lead plaintiffs' claim for missing the statute of limitations, the court ruled on preemption issues affecting the remaining plaintiffs. 

In 2008, Vonnie Cornett sued Cordis Corp. and parent company Johnson & Johnson in the Middlesex County Superior Court, alleging that her husband, Billie Cornett, died in 2004 five months after being implanted with a Cypher stent.  The plaintiff alleged that a blood clot formed near the site of the stent and that Billie Cornett suffered a subacute stent thrombosis. 

Drug-Coated Stent Design 

The Cypher stent was coated with Sirolimus, a chemotherapy drug.  Called a drug-eluting stent, it was designed to release Sirolimus inside a coronary artery to inhibit or prevent the artery from narrowing by inhibiting cell growth. 

Vonnie Cornett alleged that the polymer used to bind the Sirolimus to the bare metal of the stent irritated the arterial wall.  She also alleged that Sirolimus prevents endothelial cells from growing over the stent and created a substantial risk of abrupt clot formation on the stent. 

In addition, Cornett alleged that the use of the Cypher stent in patients with coronary heart disease and diabetes, such as her husband, is off-label. 

In 2011, Cordis and Johnson & Johnson announced that they were exiting the stent business. 

Master Complaint For 48 Cases 

At the same time Cornett filed her complaint, 47 other complaints were filed in New Jersey state court by plaintiffs from 16 states.  Cornett's amended complaint was designated as the master complaint in the Cypher litigation. 

The Superior Court dismissed the master complaint in its entirety.  On appeal, the Superior Court Appellate Division affirmed that Cornett's complaint was time-barred but held that these plaintiff claims were not preempted:  manufacturing defect; failure to warn of approved and off-label uses that failed to satisfy federal disclosure requirements or federal limits on off-label promotion with the statutory safe harbor; and breach of express warranty based on voluntary statements about approve and off-label uses outside the safe harbor. 

Cornett and the defendants cross-appealed. 

Lead Plaintiff Time-Barred 

The Supreme Court first addressed whether Cornett's case was timely filed.  It concluded that Kentucky's one-year statute of limitations, rather than New Jersey's two-year statute, applies. 

Although Kentucky recognizes a discovery exception to its statute of limitations for latent injuries, the Supreme Court said "a reasonable person exercising reasonable diligence should have discovered by December 2006 that the drug-eluting stent implanted in December 2004 may have caused the May 18, 2005 thrombosis." 

Turning to preemption, the court found that that the great bulk of the plaintiffs' state statutory and common-law claims are preempted by federal law. 

Nonapproved Information Not Preempted 

However, the court said there is an exception to preemption of failure-to-warn claims "to the extent it involves wrongdoing apart from defendants' failure to comply with FDA [Food and Drug Administration] disclosure requirements and for off-label use of the stent to the extent defendants improperly promoted that device." 

The court said the plaintiffs allege that the defendants withheld information from the medical community and the public that was not part of the premarket approval process with the FDA.  It said that the failure-to-warn claim as stated by the plaintiffs overcomes the rebuttable presumption by the New Jersey Product Liability Act that FDA-approved warnings are adequate. 

The court added a caveat that its ruling is based on the plaintiffs' claims at an early stage of the litigation and said the defendants' have not filed an answer.  It said that the master complaint contains a "colorable claim" that avoids the case law bar against private enforcement of claims of fraud on the FDA. 

If discovery reveals that the plaintiffs' claims are nothing more than private fraud actions, the court said the defendants may move for summary judgment "and the trial court should not hesitate to grant such relief." 

Deviating, Voluntary Statements Actionable 

In addition, the Supreme Court said there is also an exception to preemption of breach of warranty claims "for voluntary statements to third parties that deviate from the approved label and packaging information material."  It said that such an express warranty claim does not impose additional requirements or obligations on the defendants. 

Again, the court said that if discovery shows that the warranty claims are based on statements derived from the FDA-approved label or packaging, "a motion for summary judgment would be appropriate." 

The opinion was written by Judge Mary Catherine Cuff of New Jersey Superior Court Appellate Division, temporarily assigned to the Supreme Court.  The other court members were Judges Dorothea O'C. Wefing, Ariel A. Rodríguez and Jose L. Fuentes, all of the Appellate Division and all temporarily assigned to the Supreme Court, and Supreme Court Justice Jaynee LaVecchia. 

Supreme Court Chief Justice Stuart Rabner and Justices Barry T. Albin, Helen E. Hoens and Anne M. Patterson did not participate in the case. 


Cornett is represented by Bruce D. Greenberg and Mayling C. Blanco of Lite DePalma Greenberg in Newark, N.J., and Peter E. Seidman and Alastair Findeis of Milberg in New York. 

The defendants are represented by Peter C. Harvey of Patterson, Belknap, Webb & Tyler in New York. 

Ellen Relkin of Weitz & Luxenberg in New York represents amicus curiae Kentucky Justice Association. 

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  • 08-13-2012

Chronic cerebrospinal venous insufficiency (CCSVI), or the pathological restriction of venous vessel discharge from the CNS has been proposed by Zamboni, et al, as having a correlative relationship to Multiple Sclerosis. From a clinical perspective, it has been demonstrated that the narrowed jugular veins in an MS patient, once widened, do affect the presenting symptoms of MS and the overall health of the patient. It has also been noted that these same veins once treated, restenose after a time in the majority of cases. Why the veins restenose is speculative. One insight, developed through practical observation, suggests that there are gaps in the therapy protocol as it is currently practiced. In general, CCSVI therapy has focused on directly treating the venous system and the stenosed veins. Several other factors that would naturally affect vein recovery have received much less consideration. As to treatment for CCSVI, it should be noted that no meaningful aftercare protocol based on evidence has been considered by the main proponents of the ‘liberation’ therapy (neck venoplasty). In fact, in all of the clinics or hospitals examined for this study, patients weren’t required to stay in the clinical setting any longer than a few hours post-procedure in most cases. Even though it has been observed to be therapeutically useful by some of the main early practitioners of the ‘liberation’ therapy, follow-up, supportive care for recovering patients post-operatively has not seriously been considered to be part of the treatment protocol. To date, follow-up care has primarily centered on when vein re-imaging should be done post-venoplasty. The fact is, by that time, most patients have restenosed (or partially restenosed) and the follow-up Doppler testing is simply detecting restenosis and retrograde flow in veins that are very much deteriorated due to scarring left by the initial procedure. This article discusses a variable approach as to a combination of safe and effective interventional therapies that have been observed to result in enduring venous drainage of the CNS to offset the destructive effects of inflammation and neurodegeneration, and to regenerate disease damaged tissue. As stated, it has been observed that a number of presenting symptoms of MS almost completely vanish as soon as the jugulars are widened and the flows equalize in most MS patients. Where a small number of MS patients have received no immediate benefit from the ‘liberation’ procedure, flows in subject samples have been shown not to have equalized post-procedure in these patients and therefore even a very small retrograde blood flow back to the CNS can offset the therapeutic benefits. Furthermore once the obstructed veins are further examined for hemodynamic obstruction and widened at the point of occlusion in those patients to allow full drainage, the presenting symptoms of MS retreat. This noted observation along with the large number of MS patients who have CCSVI establish a clear association of vein disease with MS, although it is clearly not the disease ‘trigger’.For more information please visit