The popular press and professional sources have well publicized the Supreme Court's June 25, 2007, decision to consider Riegel v. Medtronic (06-179). This case squarely presents the Supreme Court with the opportunity to settle the question of whether product liability claims involving devices approved by the FDA's premarket approval process are pre-empted by the FDA's regulatory system. A prior Supreme Court case (Medtronic v. Lohr) found no pre-emption for 510(k) devices (lower risk devices which can be marketed if they are "substantially equivalent" to earlier devices). Riegel poses the pre-emption question for devices that go through the complex and exhaustive PMA process and are approved by the FDA as being safe and effective. To date, subsequent to the Lohr decision, the majority of circuits have concluded that common law tort actions as to PMA-approved devices, in contrast to 510(k) devices, are pre-empted by federal law.

So what is important about this case for life science companies? What will change in the short term and what can happen in the long term? The bottom line is clear. If Medtronic wins, defendants will have a powerful defense in cases involving PMA devices.

Short-term impact:

First, resolution will not come quickly. Riegel will not be decided for many months. Oral argument will probably take place during the Supreme Court's fall term, with a decision likely during the first quarter of 2008.

Second, federal courts handling cases involving PMA devices and pre-emption cases will be inclined to move slowly until the Supreme Court decides this case. State court cases may also slow down.

Third, there will be a slew of amici briefs filed by advocates on all sides. Most of these briefs will reiterate arguments already made, including the inherent risk of different juries reaching different conclusions about the same device. Manufacturers have the opportunity to be heard through amici briefs, and trade or professional organizations for manufacturers should consider funding those efforts.

Fourth, pre-emption may continue to come under attack in Congress. Recently, House Democrats included in their draft FDA bills a far-reaching provision stating that federal food and drug law does not pre-empt state tort suits. The scope of that language has been limited, but debate will continue. Further efforts in Congress may be on hold until the Supreme Court rules in Riegel.

Finally, remember that Riegel involves a PMA device. The key prior Supreme Court case (Medtronic v. Lohr) found no pre-emption for 510(k) devices. Don't expect any changes in cases involving 510(k) devices.

Long-term impact:

A Defense Win:

First, if the Supreme Court upholds pre-emption, its decision will provide a strong defense to manufacturers in PMA cases, particularly in failure to warn cases. Some claims will survive, particularly manufacturing defect claims.

Second, plaintiffs will push hard in discovery to establish that the company failed to provide the FDA with required information. Plaintiffs likely will argue a variation of the fraud on the FDA position advanced (and rejected) in Buckman v. Plaintiffs' Steering Committee . Plaintiffs may also seek to prove that the company violated various FDA requirements. The plaintiffs will argue that a company cannot benefit from pre-emption by the statutory system it violated. Product liability cases, in turn, may become regulatory debates. Defense counsel and their clients will need regulatory expertise on the defense team.

Third, there will be some legislative push to repeal or limit pre-emption (specifically Section 360k(a) of the FDCA). Companies will need to be prepared to counter this inevitable push by the well-organized and well-financed plaintiffs' bar.

Finally, a defense win would strengthen the pre-emption defense in pharmaceutical cases. Even though the FDCA does not contain specific pre-emption language for pharmaceuticals as it does for devices, the preamble to the FDA's final rule on the "content and format of labeling for human drugs" (71 Fed. Reg. 3988, January 24, 2006 (comment 13)) included language evidencing that it is the FDA's intent to pre-empt state tort claims against FDA-approved labeling for pharmaceuticals. Indeed, the Supreme Court could consider a pharmaceutical pre-emption case late this term and directly address this question.

A Defense Loss:

First, if Medtronic loses, pre-emption will become a very narrow defense, available only in cases involving specific and irreconcilable conflict between the FDA requirement and the claimed defect. The classic example would be if the FDA required a 2" wire (not just permitted a 2" wire) and the plaintiff claimed that the product should have had a 1" wire. Otherwise, pre-emption will have little impact on PMA cases.

Second, courts likely will become more restrictive with pre-emption in pharmaceutical cases, tightening the application of pre-emption across the board.

Finally, there would be a low probability of any legislation that would establish pre-emption as a defense.