Medical Device Lawsuit Watch - August 2008
This summary of key lawsuits affecting medical device companies is provided by the Health Care Law Group of Crowell & Moring LLP, in collaboration with the firm’s Torts, Antitrust, Commercial Litigation, and Intellectual Property Groups.
Cases in this issue:
The District Court for the Eastern District of Texas partially granted Boston Scientific’s motion for judgment as a matter of law, holding that the evidence did not support a finding of infringement on certain products, thus warranting a reduced damages award for Medtronic.
Medtronic had accused nine models of Boston Scientific catheters of infringing three of Medtronic's patents. A jury found that Boston Scientific's catheters infringed the three patents and awarded $250 million in damages.
In its order partially granting Boston Scientific's motion for judgment as a matter of law, the district court agreed that with respect to one of the three patents, Medtronic failed to provide evidence of infringement. Medtronic had tested only a sampling of the nine catheter models and applied the results from those samples to support its claim of infringement against the entire product group. Boston Scientific successfully argued that each size of catheter was a separately accused product and thus had to be separately evaluated in order to assess infringement. For those sizes that were not tested by Medtronic, the court found insufficient evidence to support a finding of infringement. Accordingly, the court ordered the parties to submit a proposed reduction to the damages award.
The United States District Court for the District of Nevada granted Johnson & Johnson’s Motion to Quash and Dismiss a claim on the grounds that the plaintiff failed to prove that Johnson & Johnson had sufficient contacts with Nevada despite the subsidiary’s conduct.
Roger Miller alleged that the Charité® artificial disc, manufactured by a Johnson & Johnson subsidiary, DePuy Spine, caused him severe back and leg pain making it difficult for him to walk. Although Miller included the parent company in his suit against DePuy Spine, the district court held that Miller did "not allege any facts to establish that Johnson & Johnson had any systematic ties to Nevada that would subject them to the [c]ourt's jurisdiction." According to the court, DePuy Spine operates independently of Johnson & Johnson and Johnson & Johnson was not involved in the research or production of the allegedly defective product.
A court has general jurisdiction over a non-resident defendant when the defendant's activities in the forum state are "continuous and systematic" and "approximate physical presence" there. The district court held that Johnson & Johnson had insufficient contacts with Nevada to grant general jurisdiction because the company was organized and located in New Jersey, and did not conduct business, own property or advertise locally in Nevada. The court also held that Miller did not prove any of the necessary factors to grant specific jurisdiction. Miller argued that the defendants marketed the artificial spinal disc all over the country. However, Johnson & Johnson submitted the affidavit of Douglas Chia, the company's Senior Counsel and Assistant Corporate Secretary who attested that Johnson & Johnson did not have systematic contacts with Nevada and "observed all corporate formalities with respect to [ ] separate governance" with Depuy Spine. Miller's inability to rebut these assertions led the court to grant Johnson & Johnson's motion.
The United States District Court for the Western District of Virginia dismissed the plaintiff’s common law claims related to design, manufacturing or labeling of a medical device, finding such claims were preempted, but permitted the plaintiff to re-plead her claims against the manufacturer for negligence of a corporate agent.
Lois Lorraine Adkins' lawsuit alleged breach of implied and express warranties, negligence through inadequate design and negligent warnings or instruction for injuries arising from the use of Cytyc's device, NovaSure®.
NovaSure is a device used to treat abnormal menstrual periods by emitting radio frequency energy, which vaporizes and causes coagulation in the endometrium. NovaSure is designed to be used on uterine walls more than four centimeters in size. According to the complaint, prior to performing the procedure, a Cytyc representative advised and directed a preliminary test, confirming that Adkins' uterine wall was 4.5 centimeters. After the procedure, Adkins discovered damage to her uterus and found out that her uterine wall was in fact two centimeters, which would have precluded use of the device.
The district court dismissed the breach of warranty and design claims, relying on the United States Supreme Court case Riegel v. Medtronic, and holding that common law claims against medical devices approved by the Food and Drug Administration are preempted. The district court, however, preserved Adkins' possible claim of negligence against the corporate representative that directed the preliminary test, reasoning that corporate representative interactions are traditional matters for the common law unrelated to the design, manufacturing or labeling of the device. In conclusion, the court found the complaint failed to adequately plead the negligence claim relating to Cytyc's agent, and dismissed the claim without prejudice, permitting Adkins to amend and refile her complaint.
The U.S. District Court for the Southern District of Texas concluded that a venture capital firm and its principals had sufficient contacts with the forum state and denied their motion to dismiss for lack of personal jurisdiction.
The U.S. District Court for the Southern District of Texas denied a motion to dismiss for lack of personal jurisdiction filed by a venture capital firm and its principals, the defendants. Calvin Timberlake had degenerative disc disease and while researching alternative treatment options, he read multiple reports of the successes of ProDisc®, an artificial intervertebral device originally developed by Spine Solutions, which later became Synthes Spine. Relying on these reports, he decided to have the ProDisc implanted. He suffered permanent injury resulting from the implant and sued the defendants. The defendants filed a motion to dismiss, arguing that the court did not have personal jurisdiction over them because the venture capital firm had its principal place of business in New York and the principals resided in New York. The court, however, denied the motion, finding that the defendants had sufficient contacts with Texas to satisfy the requirements for specific jurisdiction. In reaching this conclusion, the court relied on the defendants' concession that they had (1) occasionally traveled to Texas to target and solicit physicians to both conduct clinical trials for the ProDisc and to invest in Spine Solutions (the company the defendants had formed to obtain approval from the Food and Drug Administration ("FDA") and market ProDisc prior to FDA approval), (2) attended seminars in Texas and (3) met with investors on behalf of the venture capital firm. Further, the court noted that Timberlake's injuries arose out of the defendants' contacts with Texas because the testing and clinical trials of ProDisc took place in Texas. According to the court, these contacts were sufficient to establish the necessary minimum contacts to satisfy due process.
Although the defendants argued that they were not subject to jurisdiction because they sold Spine Solutions, the court rejected this argument, stating that Timberlake's claims included the defendants' alleged tortious conduct prior to their sale of ProDisc, which involved their deliberate creation of a fraudulent scheme by having physicians, who were also investors in Spine Solutions, conduct the clinical trials.
Pointing to the defendants' travel to Texas in connection with the clinical trials and the receipt of investment from Texas physicians and clinics, the court also concluded that the defendants failed to make a sufficient showing that litigating in Texas would be unfair and unreasonable.
Finally, the court held that the defendants were not protected from personal jurisdiction by the fiduciary shield doctrine because the doctrine does not protect officers engaged in tortious or fraudulent conduct directed at the forum state for which a defendant may be individually liable.
The District Court for the Northern District of Illinois dismissed a medical device product liability complaint, but granted the plaintiff leave to amend, acknowledging that the complaint contained some facts suggesting a properly pleaded action might not be preempted.
Genzyme Corporation, the maker of an adhesion barrier known as Seprafilm®, moved to dismiss Elmer Heisner's product liability claims on the basis that they were preempted by federal law. In ruling on the motion, the court noted that the U.S. Supreme Court, in Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), held that federal preemption provisions precluded state common-law tort suits against makers of devices approved through the pre-market approval process of the Food and Drug Administration ("FDA"). The court stated, however, the Riegel opinion specifically declined to address whether claims based on state requirements that are "parallel to" federal requirements are preempted.
The court explained that the parallel exception applied when resolution of a plaintiff's state law claims would impose requirements "substantially identical" to those imposed by the federal agency. For example, a state-law claim for failure to comply with federal requirements would not impose a requirement different from, or in addition to, a federal requirement and would be allowed to go forward. According to the court, Heisner's complaint referred only to a "defect" in the device, making it impossible to determine whether he attempted to plead a failure to comply with federal requirements. If the alleged defect was intrinsic to Seprafilm, the claim was preempted, but if not, the claim could proceed.
The court granted Heisner leave to amend his complaint to clarify the nature of the alleged defect. The court also granted leave to amend the complaint to state a claim that Genzyme failed to comply with the FDA's post-approval reporting requirements, thus implying another possible way to avoid preemption. The court commented that the complaint contained only a "vague suggestion" that Genzyme violated reporting requirements, but this was insufficient to put Genzyme on notice of such a claim.
A Kentucky state court held that federal law preempts claims by a patient allegedly injured by a surgical device because the device’s components had received pre-market approval from the Food and Drug Administration (“FDA”).
After undergoing a transurethral microwave therapy procedure, Thomas E. Mattingly developed a fistula. He sued several parties, among them Urologix, the manufacturer of the device, alleging various state product liability claims.
Urologix brought a summary judgment motion and argued that under the recent U.S. Supreme Court's ruling in Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), Mattingly's claims were preempted because the device was a Class III pre-market approval ("PMA") device approved by the FDA. In Riegel, the Supreme Court held that federal medical device law preempted common law claims against makers of devices approved through the FDA's PMA process.
Mattingly stipulated to the PMA process for the device, but argued that his claims would not be preempted if he could show that Urologix changed the device without the FDA's approval or failed to maintain post-approval requirements. He also argued that Riegel did not affect his negligence claims because they related to Urologix's training of doctors rather than the FDA's approval process.
The court disagreed and found that because the device had received approval from the FDA, "federal law proscribe[d] state law tort claims of product liability and any derivative claims of negligence from proceeding." Mattingly's negligent failure to train claim was also preempted as "in addition to" the FDA's requirements imposed upon the device. To address Mattingly's arguments that it would be premature for the court to extinguish his strict liability claims due to lack of evidence that Urologix changed the device, the court noted that Mattingly admitted he was unaware of any such changes.
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This material was prepared by Crowell & Moring LLP attorneys Bernadette Stafford, Chandra Westergaard, Jennifer Burdman, Jessica Hall, and Lauren Kim. It is made available on the Crowell & Moring website for information purposes only, and should not be relied upon to resolve specific legal questions. If you have questions or want additional information, please call your regular Crowell & Moring contact or you may contact the editor of Medical Device Lawsuit Watch.
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