Medical Device Daily Washington Editor

The Supreme Court’s decision last week, in the case of Riegel v. Medtronic, to disallow the overturn of federal pre-emption of state liability law for medical devices (Medical Device Daily, Feb. 21) is the subject of impassioned commentary on both sides of the pre-emption debate, and it has stirred passions on Capitol Hill. Several Democrats have vowed to craft legislation that would gut pre-emption for PMA devices, but any such legislation may face long odds in an election year.

Sen. Ted Kennedy (D-Massachusetts) said in a statement that the Medical Device Amendments Act of 1976 was never intended to “give blanket immunity to manufacturers from liability for injuries caused by faulty devices... . Congress obviously needs to correct the court’s decision.” And he made the case that a failure to do so “will become a green light for shoddy practices by manufacturers.”

Manufacturers of medical devices might ask why anyone would believe that the state liability lawsuits would encourage shoddy manufacturing standards.

But the documented pressures on FDA’s staffing situation, and the publicity that device failures garner, provides the answer, even if not a complete answer. Device makers will also argue that the goal of high-tech, high-risk devices save lives that might have been lost otherwise.

True, but such arguments are unlikely to relieve the concerns of John Q. and Jane Q. Public.

Clearly, pre-emption will remain on the table. The question is whether it should have been put on the table, based on the Riegel case.

Widely known is that Charles Riegel underwent a balloon angioplasty in 1996. Less widely known is the name of the doctor who performed the procedure or why the Riegels opted not to sue him, instead of going after the product manufacturer, Medtronic (Minnesota).

According to multiple descriptions of the event, Eric Roccario, MD, the physician who inserted an Evergreen balloon catheter into Riegel, did so despite that the catheter’s label contraindicated use in patients whose vasculature was heavily calcified, as Riegel’s was. Roccario then compounded his error by inflating the catheter to 10 atmospheres, beyond the labeled limit of eight.

Lower courts have decided against stripping pre-emption, and they typically refer to the facts of the case as well as the notion of pre-emption. According to the decision going against the plaintiff in the U.S. Second Court of Appeals, “no genuine issue of material fact existed” to support the argument of a defective catheter. The justices stated: “We do not hold that all state tort claims as to PMA-approved devices are pre-empted,” but that claims that are based on a manufacturer’s departure from the standards set forth in the device’s approved PMA ... are not pre-empted.”

This latter passage probably set the table for the future of this suit as accurately as anything written before or since.

The Second Appeals decision also notes that the suit in the district court disallowed an overturn of pre-emption, but allowed the suit to proceed, based on a claim of negligent manufacturing and express warranty claims.

Medtronic successfully defended itself on these claims because no express warranty was made for the device and because the catheter encountered a calcium spicule, said to have precipitated the catheter’s deflation.

The apparent subscript in all of this is that these courts might have been more responsive to overturning pre-emption had they found any information finding Medtronic negligent. And jurists have been happy to find manufacturer negligence over the past 50 years.

In Riegel, the judicial system found no damning information despite numerous hearings and venues.

The problem for Charles Riegel, who passed away in 2004, and his wife Donna, probably is that they made a bogeyman out of the wrong party. On this strategic blunder, the judicial approach to overturn of pre-emption rose and ultimately fell.

In an interview with Medical Device Daily, Allison Zieve, the attorney representing the Riegels, acknowledged that the case was not particularly strong.

“I would like to have had [a case] with an egregious [product] design flaw,” she said, but that previous attempts to get pre-emption on the Supreme Courts docket had fallen flat.

Zieve, whose work on the case was part of the pro bono effort by Public Citizen Litigation Group (Washington), added that despite the perception that this was an uphill battle, “We had a client to represent” — and Public Citizen concluded that it was “our duty to keep trying to advocate on her behalf.”

She added that the facts of the case are “really atmospheric” in terms of the Supreme Court role, because pre-emption was at the heart of the suit.

As for whether the label should indemnify Medtronic, Zieve acknowledged that “the labeling claim [said] don’t go above eight atmospheres, but then you have the chart that shows the diameter” of the catheter for higher rates of inflation.

She said that in lower-court testimony, Roccario said he interpreted this additional data as indicating that the device was safe up to 13 atmospheres.

In the days succeeding the Supreme Court decision in Riegel, reports have surfaced that defendants in device liability cases will now press for dismissal of those lawsuits. However, many of those are based on products with established product problems.

Whether they should be legally lumped together with cases like the Riegel case is for legal scholars to debate, but the substantially different facts of those cases argues for a firewall.

Most Americans would probably say that manufacturers should not be immune to suits that are based on grounds of legitimate design and performance problems, but that suits against a device that performs as advertised should not be permitted. Whether Congress sees it the same way will go a long way to determine whether Riegel will put device makers at risk for devices that do what they are designed to do.