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Williams v. Cyberonics

September 10, 2009

DIANE WILLIAMS, ET AL., PLAINTIFFS
v.
CYBERONICS, INC., DEFENDANT



The opinion of the court was delivered by: Anita B. Brody, J.

MEMORANDUM

This case involves a medical device that treats epilepsy and depression by electronically stimulating the vagus nerve in a patient's neck. Alleging that this device malfunctioned, Diane Williams, Keith Williams, and Audrey Knight (collectively, "Plaintiffs") have sued the manufacturer, Cyberonics, Inc. ("Cyberonics").

In the Third Amended Complaint, Plaintiffs assert the following claims: strict liability for a manufacturing defect (Count I), breach of warranty (Count II), fraudulent misrepresentation (Count III), and negligent misrepresentation (Count IV).

I. BACKGROUND

The VNS Therapy SystemTM ("VNS System") manufactured by Cyberonics consists of a small generator implanted in a patient's chest below the clavicle and a thin, flexible lead wire connecting the generator to the left vagus nerve, located in the neck. The generator sends periodic electrical stimuli through the lead to the vagus nerve, which in turn stimulates the brain. The VNS System is designed to deliver an electrical pulse every five minutes. The pulse itself lasts for 30 seconds. After the device is implanted, a physician programs the device to provide the appropriate level of stimulation. Patients undergoing VNS therapy wear a magnetic bracelet, which can be used to temporarily deactivate the generator.

The VNS System is a Class III medical device approved by the U.S. Food and Drug Administration ("FDA"). The FDA separates medical devices into three categories, based on the level of risk that they pose. Class III devices, which include replacement heart valves, implanted cerebella stimulators, and pacemaker pulse generators, receive the most oversight from the FDA. Riegel v. Medtronic, Inc., 128 S.Ct. 999, 1003 (2008). The Medical Device Amendments of 1976, 21 U.S.C. §§ 360c et seq. ("Medical Device Amendments"), require new Class III devices to undergo a rigorous process known as premarket approval. Premarket approval includes an in-depth review of scientific and clinical data. The FDA spends an average of 1,200 hours reviewing each application. Riegel, 128 S.Ct. at 1004. It is required to weigh "any probable benefit to health from the use of the device against any probable risk of injury or illness from such use." 21 U.S.C. § 360c(a)(2)(C). The FDA may approve devices that pose significant risks to the patient if they also offer large benefits. Riegel, 128 S.Ct. at 1004. After a device has been approved, the manufacturer is forbidden to change design specifications that affect safety or effectiveness without FDA permission. Id. at 1005 (citing 21 U.S.C. § 360e(d)(6)(A)(i)).

The VNS System was evaluated twice by the FDA through the premarket approval process. Based on its evaluations, the FDA approved the VNS System for treating epilepsy in 1997 and for treatment resistant depression in 2005. The claims at issue in this action relate to the use of the VNS System for treatment resistant depression.

Audrey Knight ("Knight"), a Florida citizen, underwent the VNS System surgical implantation in Orlando, Florida on March 23, 2006. Knight testified that VNS therapy did not help her symptoms and that she felt pain from the device. Eight months after the implantation, she felt the VNS System deliver a series of powerful electric shocks. These severe shocks continued until Knight was forced to tape a magnet over the device, effectively switching off the VNS System until it could be surgically explanted. Dr. Eric Trumble observed one of the severe shocks and Knight's "severe adverse reaction." Although he was unable to determine what caused the severe shock, he noted that "it was clearly not as a result of how the device had been surgically implanted." On March 15, 2007, Knight's VNS System was explanted. A Cyberonics product analysis of the VNS System after it was explanted revealed no evidence of any malfunction and determined that the device was functioning as designed.

Diane Williams ("Williams"), a Pennsylvania citizen, underwent the VNS System surgical implantation in York, Pennsylvania on November 21, 2005.*fn1 Four months after Williams underwent implantation, the device had no effect on her depression and Williams reported that she was no longer able to feel an electrical pulse from the VNS System. On April 28, 2006, Williams underwent an exploratory surgery to determine if there was a problem with the device. Dr. Joel Winer, a neurosurgeon who performed the surgery, told Williams that he did not see anything wrong with the device. During the procedure, Dr. Winer removed the generator, checked the battery, irrigated the site, and reinserted the generator. After the procedure, Williams was able to feel stimulation. However, in July 2006, Williams again reported that she no longer felt the electrical pulses. Her doctors adjusted the device output so that no stimulation was provided, and the device was explanted on July 16, 2008. Cyberonics conducted a product analysis after the device was explanted, which revealed no product related anomalies and established that the device was functioning as designed.

Williams' insurance company did not pay for the implantation or the second surgery. It did pay for the explantation. Williams testified that she did not personally manage the insurance claims, and that her husband, Keith Williams ("Mr. Williams"), took primary responsibility for dealing with Cyberonics and the insurance company on insurance related issues.

Mr. Williams testified that before the first surgery the insurance company told him it would not pay for the VNS System because it was experimental and investigational. He then spoke with a Cyberonics case manager, who said Cyberonics would help him get the VNS System approved through an appeal process to the Office of Personnel Management. The case manager told him "that they very rarely had any problem with [the Office of Personnel Management] denying approval" and that she was "pretty sure" it would be approved. The Williams decided to proceed with the implant of the VNS System. When asked why they decided to seek treatment with the VNS System implant even after the insurance company told him it would not pay, Mr. Williams responded that he felt it was necessary to save his wife's life. Mr. Williams testified that Cyberonics did not promise him that his insurance company would pay for the VNS System. He also testified that he understood that approval for payment was at the Office of Personnel Management's discretion.

II. SUMMARY JUDGMENT STANDARD

Summary judgment will be granted "if the pleadings, the discovery and disclosure materials on file, and any affidavits show that there is no genuine issue as to any material fact and that the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(c). There is a "genuine" issue of material fact if the evidence would permit a reasonable jury to find for the non-moving party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). The "mere existence of a scintilla of evidence" is insufficient. Id. at 252.

The moving party must make an initial showing that there is no genuine issue of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). The non-movant must then "make a showing sufficient to establish the existence of [every] element essential to that party's case, and on which that party will bear the burden of proof at trial." Id. at 322. The non-moving party must "do more than simply show that there is some metaphysical doubt as to the material facts." Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 (1986). In determining whether the non-moving party has established each element of its case, the court must draw all reasonable inferences in the non-moving party's favor. Id. at 587.

III. DISCUSSION

In their Third Amended Complaint, Plaintiffs assert claims of strict liability for a manufacturing defect (Count I), breach of warranty (Count II), fraudulent misrepresentation (Count ...


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