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From Products Liability Law Daily, November 6, 2014

Patient’s express warranty claim against pacemaker manufacturer not preempted

By John W. Scanlan, J.D.

An express warranty claim brought by a pacemaker implant patient against the pacemaker’s manufacturer was not preempted by federal law, the U.S. District Court for the District of South Carolina ruled. However, the court found that his claims for negligence, strict liability, and breach of implied warranties were preempted, as was his attempt to base claims on the alleged violation of two federal regulations (Hesik v. Boston Scientific Corp., November 4, 2014, Childs, J.).

Background. In January 2009, Jeffrey Allen Hesik underwent surgery to have his existing cardiac defibrillator replaced with a COGNIS Cardiac Resynchronization Therapy Defibrillator Model N118, which was manufactured by Boston Scientific Corp. The defibrillator came with a five-year warranty from the date of implantation “if the pulse generator fails to function within normal tolerances due to defects in materials, workmanship, or design during the warranty period.” The defibrillator failed in late October of that year, causing Hesik a complete heart block and forcing immediate hospitalization; the next day, the implant was removed due to a “Product Performance Issue” and replaced. Boston Scientific examined Hesik’s defibrillator and subsequently issued a Physician Device Advisory Notice stating that the defibrillator could experience performance failure to due to a “[w]eakened bond between the header and the case.” Boston Scientific then credited the medical center that removed the defibrillator $25,056 pursuant to its warranty and sent Hesik a check for $2,500 to help address unreimbursed medical expenses from the replacement surgery.

Hesik brought claims for negligence, strict liability, breach of express warranty, and breach of implied warranties against Boston Scientific in South Carolina state court. Both parties filed cross-motions for summary judgment and responses in opposition.

Negligence/strict liability. The patient’s claims for negligence and strict liability were preempted by the Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetic Act because he was unable to establish that his state law claims paralleled requirements imposed by federal law. The court agreed with the patient that he would have a parallel claim to avoid preemption if his defibrillator did not conform to the standards set forth by the Food and Drug Administration (FDA) in its premarket approval (PMA). However, the patient failed to submit any evidence to support his claim that his device had lost its hermetic seal or to contradict Boston Scientific’s expert’s testimony that it had not. Further, documents submitted by the patient did not show any deviation from the PMA’s specifications.

Breach of implied warranties. The patient’s claims that Boston Scientific had breached the implied warranty of merchantability and the implied warranty of fitness for a particular purpose under South Carolina law were also preempted. The FDA had provided federal requirements for the design and manufacture of the defibrillator, as a Class III medical device, through the PMA process. Implied warranty claims are requirements upon a product that arise exclusively through the operation of state law. Because they would impose requirements that are different from, or in addition to, the requirements of federal law, they were expressly preempted by the MDA.

Express warranty. However, the court denied summary judgment to Boston Scientific on the patient’s express warranty claim because the claim was not preempted. The court observed that the claim would have been preempted if it had been based on statements made by Boston Scientific in a document required by the FDA. However, his claim was actually based only upon the manufacturer’s voluntary statements in its warranty, which was not subject to the PMA process or approved or mandated by the FDA. Therefore, there was no risk of interference with the federal regulatory scheme.

Violation of federal regulations. Finally, the court determined that the patient had not stated a parallel claim based on the violation of federal regulations. The patient had cited two federal regulations: one that stated that “[a]n implantable pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart,” and a second that provided that “[s]ection 521(a) does not preempt State or local requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices (e.g., requirements such as general electrical codes, and the Uniform Commercial Code (warranty of fitness)), or to unfair trade practices in which the requirements are not limited to devices.” The court found that these regulations did not refer specifically to the medical device at issue and did not provide any tangible or concrete standard. Imposing liability based on a violation of a flexible standard would itself be the imposition of a standard different from, or in addition to, those imposed by the MDA, the court reasoned. Therefore, these claims were also preempted.

The case number is 1:12-cv-00014-JMC.

Attorneys: John E. Parker (Peters Murdaugh Parker Eltzroth and Detrick) for Jeffrey Allen Hesik. Monteith Powell Todd (Sowell Gray Stepp and Laffitte) for Boston Scientific Corp.

Companies: Boston Scientific Corp.

MainStory: TopStory PreemptionNews DesignManufacturingNews MedicalDevicesNews SouthCarolinaNews

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