Whiplash. I don’t know what else to call it when the US Supreme Court does a near 180° reversal on a decision from just a year ago on medical product liability. Consider the following…
On February 20th, 2008, the US Supreme Court ruled in favor of Medtronic in the case Riegel v. Medtronic. The case involved a cardiac catheter, which ruptured during surgery. Medtronic asserted (and the Court agreed) that, because the company had received premarket FDA approval for the device, the company was immune from suit in state courts. The prevailing argument was, in essence, that the rigor of the federal review and approval process trumped the individual’s right to seek judgment using the state courts.
Many supported the notion of keeping federally-regulated medical devices above the reach of state courts, but at the same time questioned whether the FDA was really capable of the safety rigor that the Court attributed to it.
Fast-forward one year to March 4th, 2009. On this day the US Supreme Court ruled in Levine v. Wyeth in favor of the plaintiff, a musician who lost her hand after an anti-nausea medication was injected arterially, contrary to the warnings on the drug packaging. Levine had prevailed in a state court, winning a judgment against Wyeth, a judgment which the pharmaceutical maker appealed all the way up the Supreme Court, and lost.
The warning for the medication, mandated and provided by the FDA for the package insert, was apparently not compelling enough for the Court. And despite its timeliness, the arguments in support of the Medtronic verdict do not appear to carry the same weight they did only 12 months ago as the Court cited the lack of FDA resources (compared to the 11,000 approved pharmaceuticals on the market) as a reason why the FDA should not be expected to police post-market medication safety.Is the Court acknowledging that the FDA has experienced a regulatory-capability meltdown in the past year akin to what we’ve seen in the financial markets?
I can imagine a scene in which there are two doors into the FDA, one labeled ‘drugs’ and one labeled ‘devices’. The applicants cued up in the ‘devices’ line are chatting and laughing with one another. They know that FDA approval is their ticket, a virtual ‘get out of product-liability free’ card. The applicants in the other line, however, are being browbeaten by attorneys and insurance adjusters. The applicants are sweating through their third shirt of the morning and the packaging designers are showing off the new microwave-sized box needed to include the encyclopedic disclaimers and cautions for each vial of product.
The Court has effectively bracketed the problem, but failed in both instances to provide a workable solution. Manufacturers, even those subject to the rigors of burdensome premarket approvals, should not be absolved of liability for their product. And manufacturers who play by the rules and include the FDA provided warnings in their packaging should not be held liable for a perceived insufficiency of the cautionary statements.
I don’t expect that the attorneys representing the medical manufacturers will be wearing neck-braces the next time they argue before the US Supreme Court, but I suspect that they’ll all be maneuvering carefully, seeking not to exacerbate the legal-whiplash with which they’re already afflicted.
Tobias Gilk is President and MRI Safety Director for Mednovus, Inc.