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Dispatch
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« on: October 29, 2012, 09:07:27 AM »

http://finance.yahoo.com/news/cyberonics-discloses-unsealed-qui-tam-190102677.html

I've been out of the loop for so long now and was thrilled to read this article!  Has anyone else taken a looksee?

Cheers!  x
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VNS for TRD implant November, 2006.  Complete device removal including coils April, 2008.

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dennis100
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« Reply #1 on: October 29, 2012, 11:26:39 AM »

PRODUCT LIABILITY — PREEMPTION — MEDICAL DEVICES

32-7-6755 Banner v. Cyberonics, Inc., Dist. Ct. (Kugler, U.S.D.J.) (9 pp.) This matter arises out of an allegedly defective medical device, the Vagus Nerve Stimulation (VNS) Therapy System. Plaintiffs asserted five state law causes of action against Defendant Cyberonics, Inc.: 1) products liability malfunction; 2) breach of warranty; 3) fraudulent misrepresentation; 4) violation of the New Jersey Consumer Fraud Act; and 5) negligence and negligent misrepresentation. Defendant argues that Plaintiffs' product liability and breach of warranty claims are preempted by the Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetic Act (FDCA), and that the additional claims are otherwise deficient. Plaintiffs acknowledged that Counts Two through Five are dismissed. As to the products liability claim, in the wake of Riegel, once Defendants met their summary judgment burden by showing that the VNS Therapy System functioned properly, Plaintiffs had to do more than merely show that it did not work—they had to show a genuine issue of material fact exists as to whether the device's failure to work was the result of a deviation. Since no showing was made, Plaintiffs' product liability claim is preempted by the MDA. [Filed February 4, 2010]

http://www.law.com/jsp/nj/PubArticleNJ.jsp?id=1202442115531&Daily_Decision_Service_Alert_Vol_19_No_24_February_5_2010
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dennis100
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« Reply #2 on: October 29, 2012, 12:09:10 PM »

Banner v. Cyberonics

http://docs.justia.com/cases/federal/district-courts/new-jersey/njdce/1:2008cv00741/211309/31/
« Last Edit: October 29, 2012, 12:13:38 PM by dennis100 » Logged
dennis100
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« Reply #3 on: November 01, 2012, 06:27:36 PM »

Let's do it again.
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Bernard
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« Reply #4 on: November 01, 2012, 11:12:48 PM »

Looks like the suit was dismissed.
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