The Court ruled against the company on preemption in Medtronic v Lohr, 518 US 470 (1996), a case where a pacemaker failed and resulted in the need for emergency surgery, and the plaintiff brought design, manufacturing and warning defect claims under state negligence and strict liability theories.
The Medical Device Amendments to the Federal Food, Drug and Cosmetic Act establish a federal statutory and regulatory scheme governing the sale of medical devices in the US.
After considering the case, the Supreme Court determined that the preemption clause did not preempt "all common law claims," because all such claims do not create "requirements" that would conflict with federal law under the MDA and because the MDA provides no private cause of action against manufacturers, and that preempting all common law claims would bar most, if not all, relief for persons injured by defective medical devices.Further, the Court determined that, if Congress had intended to preempt all state law remedies, it would have said so, and the Court noted the lack of legislative history going back to any such intent.
The Court stated that the state law damages remedy "merely provides another reason for manufacturers to comply with identical existing requirements," and did not amount to "additional" or "different" requirements than the federal law.
So basically, legal experts say, in order to convince the court that §360k preempts a state law claim, device makers must establish that the MDA procedure under which their device was marketed created an adequately specific or otherwise preemptive federal "requirement" and convince the court that the state law based cause of action creates a preemptible "requirement" that is "different from," or "in addition to," requirements imposed by the MDA procedure.
As one of the largest heart rhythm device makers in the U.S., Medtronic is currently facing scores of lawsuits in state courts with allegations that it failed to adequately inform doctors and the FDA when it learned of a potential battery shorting problem in January 2003.
The firm waited until February 11, 2005, to warn physicians about the defect in 8 models of defibrillators. By that time, approximately 87,000 patients had been implanted with devices powered by batteries that could go dead without notice which were manufactured between April 2001 and December 2003.
Doctors were provided with a list of affected patients, and Medtronic recommended that doctors contact the patients and manage the issue in a way they felt appropriate.
When the defibrillators were recalled in 2005, the company offered to provide free replacement devices but would only agree to pay $2,500 to patients for out-of-pocket expenses for the replacement surgery.
The same year, on June 22, 2005, Bloomberg reported that Medtronic's cardiac rhythm management business, which includes pacemakers and defibrillators, accounted for 46% of the company's $2.78 billion in sales in its latest quarter. The cost of a defibrillator is about $20,000, according to Bloomberg.
On February 18, 2006, the New York Times reported that, because Medtronic did not offer to pay the hospital and doctor bills for the replacement procedures, "publicly funded plans like Medicare and private insurers are typically paying them."
At the time of the article, the Times said, about 19,000 patients had undergone the replacement surgery since the recall.
Any patients who developed complications during the operations were left to fend for themselves. According to Bloomberg in February 2006, the cost of a defibrillator replacement and post-operative complications at a Des Moines hospital reached $100,000 for an unemployed 45-year-old father of six, who was uninsured and disabled when Medtronic sent a letter saying the defibrillator might need to be replaced.
Lawsuits have since been filed by private plaintiffs all over the country claiming personal injury and also by third-party payors seeking reimbursement of costs that resulted from with recall.
The lawsuits were consolidated in Multidistrict Litigation in the U.S. District Federal Court in Minneapolis before Judge James Rosenbaum, and in July 2006, Medtronic filed a motion for summary judgment arguing that the lawsuits should be dismissed, claiming FDA regulations for medical devices preempt the state laws on which the lawsuits are based and that the FDA had special authority over life-saving medical devices.
In the legal filings, Medtronic claimed the lawsuits are baseless, or preempted, because the defibrillator had passed the FDA approval process.
Documents revealed in litigation since the recall show that Medtronic knew of the problem that could cause the defibrillators to suddenly stop working long before the firm warned doctors who were implanting the devices. Company documents filed in a Federal court in San Jose, California, in the case of Randall v Medtronic, show the firm discovered the battery problem in January 2003.
In response to Medtronic's motion, the plaintiffs argued that the FDA's approval should have no bearing on the litigation because Medtronic provided the FDA with incomplete information when obtaining approval of the defibrillators, did not comply with the reporting obligations and failed to notify patients and the FDA of the defects in the devices.
On November 28, 2006, in what could be a major defeat for all device makers involved in similar litigation, the Minnesota Judge ruled against Medtronic and issued an order and opinion denying the motion and refused to accept the federal preemption argument.
In the opinion, the Judge stated that Medtronic "asks the Court to look past evidence, which if believed, tends to show it withheld critical information from the FDA while seeking the PMA Supplement approval for its newly designed battery."
"Plaintiffs have produced credible evidence," he wrote, "indicating that - after Medtronic discovered the design defect, and confirmed the discovery through patients' device failures, and after obtaining FDA approval for the modified battery - Medtronic continued to ship and sell devices containing the defective battery."
"In doing so," the court continued, "it failed to notify the FDA, physicians, or patients that the battery was defective."
The judge said Medtronic's own actions and inactions may have placed it entirely beyond the scope of FDA approval protection. "Congress has chosen, and FDA regulations impose," he wrote, "a scheme under which the manufacturer - not the government - determines a medical device to be safe and efficacious."
He said it is the duty of the manufacturer to develop, produce and offer products it knows to be safe. "The FDA," the judge wrote, "has only the most limited role in independently obtaining the information it needs; the duty to develop and fully disclose information concerning a medical device's safety falls upon the manufacturer."
In fact, the judge said, Medtronic's own actions and inactions may have placed it entirely beyond the scope of FDA approval protection. "Congress has chosen, and FDA regulations impose," he wrote, "a scheme under which the manufacturer - not the government - determines a medical device to be safe and efficacious."
The judge pointed out that a device maker's failure to disclose its own knowledge about the danger of an approved device has its own effect: "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," he stated.
"If proven," the court wrote, "such a failure to fully comply with Congress's self-disclosure scheme may have deprived Medtronic of federal preemption protection altogether."
He pointed out that the FDA recall did not occur until after Medtronic issued its February 2005 "Dear Doctor" letter, and said it defies logic and flies in the face of Congress's decision to impose a regime strictly regulating medical device makers, "to think Congress intended the result Medtronic advocates."
A favorable ruling on preemption in the Supreme Court might have allowed Medtronic to escape all liability, had the company not been so greedy in ripping off public health care programs and the Democrats had not taken control of Congress last fall.