Judge rejects preemption in heart device case.

A federal judge in Minnesota has denied a motion for summary judgment by Medtronic, Inc., a heart-device maker based in Fidley, Minnesota, preserving the plaintiffs' state law claims alleging that the company may have violated FDA reporting requirements related to its implantable cardiac defibrillators (ICDs).

The lawsuits allege that Medtronic sold ICDs knowing that the devices had defective batteries that lost electrical charge within days rather than years.

Judge James Rosenbaum, rejecting Medtronic's argument that the claims were preempted, said he based his decision on the plaintiffs' ability to show that the defendant may have violated FDA reporting requirements.

"These claims merely impose parallel requirements, but impose no requirements different from, or in addition to, the federal requirements," Rosenbaum wrote. "Thus, state law claims which make a party liable for damages for failure to comply with federal law are not preempted." (In re Medtronic, Inc., ICD Litig., 2006WL 3420285 (D. Minn. Nov. 28, 2006).)

Hunter Shkolnik of New York City, one of several attorneys who represent the plaintiffs, said the ruling makes it clear that "you cannot hide such bad corporate behavior" behind preemption. Shkolnik, who spoke at a recent AAJ teleconference on the decision, is cochair of AAJ's Heart Devices Litigation Group.

Medtronic's products received FDA approval as Class III medical devices in 1998. Class III devices require premarketing approval (PMA), the highest level of FDA approval.

In early 2003, Medtronic became aware that the battery in its Marquis product line--the Chi 4420L battery--was faulty. The company began redesigning the battery and, in the meantime, received FDA approval for three additional ICD products (the Maximo, DRT-D, and Insync II Protect devices), each containing the defective Chi 4420L battery. In October 2003, Medtronic sought and received FDA approval for design changes to the battery.

"Even with this new approval in hand," Rosenbaum wrote, "Medtronic did not notify physicians or patients that its Marquis devices which contained the Chi 4420L battery posed a greater risk of battery depletion than [devices equipped with] its newly designed and approved battery. It also continued to ship and sell ICDs and DRT-Ds containing the Chi 4420L batteries."

In 2004, Medtronic began to receive field reports that the battery was depleting too quickly. In 2005, the company recalled the devices that had already been sold and disclosed the defect to the FDA. But, according to the lawsuits, Medtronic continued selling its stock of the faulty ICDs for over a year without notifying the agency or doctors who prescribed the devices that they were defective.

Medtronic argued that the federal Safe Medical Devices Act of 1990 preempted state law claims related to its products. "Medtronic thought that within one year, this litigation would be history because of preemption," Shkolnik said.

But Rosenbaum ruled that the plaintiffs had raised triable issues of fact as to whether Medtronic had actual knowledge of the defect and hid that evidence from the FDA.

"Medtronic vigorously denies these claims--and the court expresses no opinion as to which side's version is correct--but there is no question that there are unresolved fact issues here," he wrote. "For these reasons, and to the extent plaintiffs' claims are premised on violations of FDA requirements, their claims of failure to warn, negligence, strict liability, misrepresentation by omission, and negligence per se are not preempted."

Shkolnik, who argued the case, said that during oral arguments it was clear that Rosenbaum "was very, very disturbed at Medtronic's selling of devices with defective batteries, and its continuing to sell its stock of such batteries for over a year before notifying doctors. This caused the judge very serious concern, and that comes across in the decision."

In his ruling, Rosenbaum wrote, "It defies logic, and flies in the face of Congress's decision to impose a regime strictly regulating medical device manufacturers, to think Congress intended the result Medtronic advocates."

The judge also noted that "it is possible that Medtronic's own actions and inactions placed it entirely beyond the scope of FDA PMA approval protection.... The company's failure to exhibit absolute probity could be found to have knowingly deprived the FDA of information needed to confer its approval for the device to be implanted in humans. If proven, such a failure to fully comply with Congress's self-disclosure scheme may have deprived Medtronic of federal preemption protection altogether."

In a separate development in the heart device litigation, a judge in Ohio has set a firm trial date for five bellwether lawsuits against Guidant Corp., an Indianapolis-based manufacturer of pacemakers and defibrillators (now part of Boston Scientific of Natick, Massachusetts). The first trial is set to begin on July 17.