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Maryland District Court Finds Express Warranty and Negligent Misrepresentation Claims in Pacemaker Case Preempted Under 21 U.S.C. § 360k(a) and Riegel v. Medtronic

Byron Smith v. St. Jude Medical Cardiac Rhythm Management et al.
United States District Court for the District of Maryland, No. CCB-12-1746 (D. Md. Mar. 15, 2013)

by Jhanelle Graham, Law Clerk
Semmes, Bowen & Semmes (

In Byron Smith v. St. Jude Medical Cardiac Rhythm Management et al., Plaintiffs, Byron Smith and Carrie Youngbar, sued St. Jude Medical Cardiac Rhythm Management Division (“St. Jude”) and Lifewatch Services, Inc. (“Lifewatch”) for claims arising out of the death of their three (3) year-old daughter, India Smith. United States District Judge Catherine C. Blake granted St. Jude’s motion to dismiss and granted in part Lifewatch’s motion to dismiss. Judge Blake also stayed the proceedings pending the plaintiffs’ compliance with the Maryland Health Care Malpractice Claims Act (“MHCMCA”), MD. CODE ANN., CTS. & JUD. PROC. § 3-2A- 01, et seq.

India Smith was born on June 30, 2005, to Byron Smith and Carrie Youngbar. India was diagnosed with a serious heart condition in her first few months of life. On November 4, 2005, Mubadda Salim, M.D., a pediatric cardiologist, implanted India with a St. Jude Model 5380 Cardiac Pulse Generator (“the St. Jude pacemaker”). At follow-up appointments, Dr. Salim noted that, because of India’s particular condition, the ventricular threshold for pacing of her pacemaker was higher than the normal threshold, which decreased the expected battery life of the pacemaker from the anticipated “normal” battery life of four (4) years down to two (2) years. On May 3, 2007, India suffered cardiac symptoms, and Dr. Salim found a fractured ventricular lead in her pacemaker, which they replaced. Following the lead replacement, Dr. Salim noted that the ventricular capture rate of India’s pacemaker had decreased.

In late 2007, Dr. Salim explained to Plaintiffs that the pacemaker would signal when the battery had reached a level of depletion, thus indicating the need for replacement. Dr. Salim discussed with Plaintiffs the timing to replace the battery in India’s pacemaker, and asked the plaintiffs to increase the frequency of the telephone interrogations of the pacemaker to every six (6) weeks; however, Dr. Salim assured Plaintiffs that the pacemaker would continue to function as they evaluated when to schedule replacement of the battery. Dr. Salim ordered monthly telephone interrogation of India’s pacemaker by Lifewatch; pursuant to Dr. Salim’s order, Lifewatch was to call India’s home every thirty (30) days to interrogate her pacemaker over the phone to determine how it was functioning and how much battery life was remaining.

On May 11, 2009, Dr. Salim told Plaintiffs that the battery replacement likely would occur in September. Shortly after this appointment, Plaintiffs received an urgent message from Dr. Salim’s office. Dr. Salim explained that he had forwarded the latest interrogation results to the St. Jude company representative with whom he worked, and that representative led Dr. Salim to believe that the remaining battery life on the pacemaker was much shorter than he had initially anticipated. Dr. Salim requested to see India in early June to meet with the St. Jude representative and to schedule an elective battery replacement. On May 27, 2009, however, India died following a cardiac incident. As part of the protocol for managing recently deceased pacemaker patients, hospital staff removed India’s pacemaker and returned it to St. Jude for testing. Investigative reports by St. Jude and an autopsy performed on May 28, 2009 by the Office of the Chief Medical Examiner for the State of Maryland revealed that India’s pacemaker stopped working due to a dead battery.

Plaintiffs sued St. Jude and Lifewatch, alleging that each acted negligently, causing India’s death. Plaintiffs also asserted claims for breach of warranty against St. Jude. St. Jude filed a motion to dismiss, claiming that Plaintiffs’ claims were preempted under 21 U.S.C. § 360k(a) and Riegel v. Medtronic, 552 U.S. 312 (2008). Lifewatch also filed a motion to dismiss, arguing that Plaintiffs had not complied with the requirements of the Maryland Health Care Malpractice Claims Act.

With respect to St. Jude’s contention that Plaintiffs’ claims were federally preempted under 21 U.S.C. § 360k(a) of the Medical Device Amendments (“MDA”) to the Food, Drug, & Cosmetic Act, which governs the Food & Drug Administration’s (“FDA”) regulation of medical devices, the Maryland district court held that Plaintiffs’ claims for negligent manufacturing and implied warranty were not supported by sufficient allegations to constitute a “parallel claim” and were therefore preempted. According to the court, Plaintiffs’ claims for negligent manufacturing and implied warranty appeared to lie squarely within the scope of claims found to be preempted in Riegel. Although Plaintiffs cited a narrow exception in Riegel for “parallel claims” allowing a State to provide “a damages remedy for claims premised on a violation of FDA regulations,” the district court found that the plaintiffs included no specific allegation of a violation of FDA regulations in the complaint, other than a conclusory allegation that India’s pacemaker did not meet “FDA standards for reserve battery capacity.” Because Plaintiffs alleged no deviation from the prescribed pre-market approval manufacturing process that would explain the alleged failure to meet the FDA standards, these claims were held to be preempted by the MDA.

With respect to Plaintiffs’ contention that St. Jude was also liable for breach of express warranty and negligent misrepresentation arising out of information allegedly provided by a St. Jude representative to Dr. Salim, the court determined that (1) no express warranty claim was viable because the representations in question happened almost four (4) years after implantation of the device and could not, therefore, have been part of the “basis of the bargain”; (2) St. Jude owed no duty to provide information or warnings directly to Plaintiffs, therefore Plaintiffs’ claim for negligent misrepresentation failed. To state a claim for negligent misrepresentation in Maryland, a plaintiff must allege a legal duty to provide the plaintiff with accurate information. See, e.g., Lloyd v. Gen. Motors Corp., 397 Md. 108, 136 (2007). The complaint, however, did not include any specific allegations regarding the content of what St. Jude may have communicated to Dr. Salim. Additionally, under Maryland law, a device manufacturer owes no duty to provide information or warnings about a device to patients or consumers. Lee v. Baxter Healthcare Corp., 721 F. Supp. 89, 94-95 (D. Md. 1989). Rather, the district court stated that the Fourth Circuit has recognized the specific need for the “learned intermediary” doctrine in the case of pacemakers, noting that “each pacemaker candidate presents different problems requiring individualized professional judgments.” Brooks v. Medtronic, Inc., 750 F.2d 1227, 1231 (4th Cir. 1984).

Finally, with respect to Plaintiffs’ claims of negligent medical care where St. Jude had a duty to provide ongoing follow-up medical care and treatment to India, the district court clarified that medical malpractice claims against healthcare providers are subject to the Maryland Health Care Malpractice Claims Act. Plaintiffs defined St. Jude not as a “healthcare provider,” but as a “health care medical products manufacturing, sales, service, and consulting institution.” Consequently, the court determined that Plaintiffs did not adequately allege facts to support any duty owed by St. Jude, a products manufacturer, to provide ongoing medical care.

Lifewatch sought dismissal of Plaintiffs’ claims for failure to comply with MHCMCA. The MHCMCA requires, in relevant part, that medical malpractice claims be presented to the Maryland Health Claims Alternative Dispute Resolution Office (“the HCADRO”) for mandatory arbitration before a court action may be filed. The Maryland district court concluded that a plain reading of the complaint indicated that Lifewatch was a health care provider and that its allegedly negligent employees included doctors and nurses. Taking the allegations in the complaint as written, the complaint included both medical negligence claims and claims for negligent failure to monitor battery life; therefore, the court determined that Plaintiffs’ claims against Lifewatch did not fall outside of the scope of the MHCMCA. Accordingly, the court held that the case should be stayed pending the outcome of medical negligence claims against Lifewatch in the HCADRO.