New England Biz Law Update
The U.S. Supreme Court will weigh in on an issue that Congress, pharmaceutical companies and plaintiffs’ lawyers have been watching closely: Whether the approval of a medical device by the Food and Drug Administration precludes state tort claims arising from a patient’s injury or death.
The case, Riegel v. Medtronic, was recently argued before the court. It stems from an angioplasty procedure performed on the plaintiff, Charles Riegel. His surgeon used an Evergreen balloon catheter manufactured by Medtronic, Inc. that was designed to be inserted into an artery, moved to where a clog is found and inflated to reopen the artery. During Riegel’s procedure, the surgeon inflated the catheter balloon to a pressure of 10 atmospheres and it burst. Riegel survived, but was left permanently injured and disabled. (He died as his case wound its way through the courts. His wife was substituted as plaintiff.)
The catheter had been approved by the FDA under its “pre-market approval” standards, and the labeling – which warned doctors against inflating the balloon beyond eight atmospheres – were also approved by the FDA.
Riegel sued Medtronic for negligent design, testing and inspection. But Medtronic won a summary judgment by arguing that the federal Medical Device Amendment of the Food, Drug and Cosmetic Act preempted those claims. The 2nd Circuit affirmed.
FDA approval: no guarantee
Allison M. Zieve, a Washington, D.C. attorney with the non-profit consumer advocacy organization Public Citizen, argued on Riegel’s behalf during oral argument. Approval by the FDA, she said, is no guarantee that devices are not problematic or dangerous.
“After the company submits the application, the FDA evaluates it, based on information submitted, but it does no independent testing, no product development, no comparison with other products to see if this one is as good as or better than existing products, or even if it’s the best that it can be,” Zieve said. “Once on the market, a PMA device may prove to be unsafe, because very often problems and hazards come to light only after the device is in widespread use.”
But Zieve ran into trouble when Justice Antonin Scalia asked her if states were free to impose additional regulations on drugs and devices.
“If there is not a specific federal requirement that is the counterpart to a state requirement, there is no preemption,” Zieve said.
Scalia countered: “They can add additional requirements so long as these additional requirements do not prevent complying with the federal requirements? As long as there’s no conflict, the states can add additional requirements under the Medical Devices Act? That’s not my understanding of it.”
Chief Justice John G. Roberts, Jr., wondered if allowing state tort claims would ultimately put patients in danger.
“What’s going to happen for patients [if] the manufacturer looks at it and says: ‘Well, maybe there is a better device,’” Roberts said. “‘We don’t want to risk these tort suits, so we’re going to stop selling our old device that’s been approved, but now we have got to get FDA approval of the new device and that might take forever – or at least a year.’ And what happens to patients in that year? They’ve got no device.”
Zieve replied: “If the device is reasonably safe and effective, then the company is just not going to stop marketing it because of tort suits.”
Scalia said jurors may not be in the best position to set standards for medical device safety.
“It is not as though some expert agency of the state has conducted a very scientific inquiry and decided that there’s something safer than what the FDA approved,” he said. “What’s going on is simply one jury has decided that in its judgment, there was a safer device that should have been used. I find that extraordinary.”
Alternative standards
Theodore Olson, Washington, D.C. attorney and former U.S. Solicitor General, arguing on behalf of Medtronic said the FDA has created a drug approval system that balances the interests of making devices as safe as possible with ensuring that they are available for use to save lives.
Allowing state law tort claims would create problematic alternate standards, making compliance by device manufacturers impossible, he said.
“Preemption of potentially conflicting, confusing, and burdensome state law requirements is essential to this scheme,” Olson said.
Olsen said even risky devices should be available if they can be beneficial to some patients, and doctors should not be prevented from giving patients potentially life-saving options for fear of tort suits.
“There are some devices that are used in situations where a child might die,” Olson said. “There’s a 50 percent mortality rate even with using the device. So there’s got to be individual judgments with respect to variations of risk and safety and availability. Nothing is perfectly safe.”
Justice Samuel Alito asked what proof exists of the FDA’s diligence.
“If you look at the file of a [pre-market approval] proceeding after it is concluded, can you tell exactly which design features and which risks the FDA has considered?” Alito asked.
“No, I don’t think you can,” Olson answered. “[But] the FDA will have examined, and presumably done its job, with respect to every aspect of the design, manufacture, and labeling and marketing of the device.”
Justice Anthony Kennedy asked Deputy Solicitor General Edwin Kneedler, arguing for the United States in support of Medtronic, about what happens if an approved device is found to be unsafe.
“Suppose a label is approved in a very specific form under [pre-market approval], and then a year later, it turns out, unforeseen by anyone, that many good doctors are just reading it the wrong way and it’s dangerous? Can the manufacturer continue to sell new devices with the same label pending the annual report?” Kennedy asked.
Kneedler said yes. But “if there are incident reports a manufacturer is supposed to give [the information] to the FDA,” he said, and failure to do so makes it civilly and criminally liable.
The trial lawyers advocacy group American Association for Justice had successfully lobbied to include express anti-preemption language in an early version of the recently-passed bill boosting the FDA’s regulatory powers, but that language was removed last summer for fear it would cause lawmakers and President George W. Bush to reject the measure.
The bill – without the language on preemption – was signed into law in October, leaving the issue of preemption for the Supreme Court to decide.
A decision is expected later this term.
