Monday, March 09, 2009

Should Congress Distinguish Between Drugs And Devices?

Here's the deal:

Riegel v. Medtronic tells us that there is preemption for medical devices approved through the premarket approval process.

Wyeth v. Levine tells us that there is often not preemption for prescription drugs.

Is there a reasoned basis for distinguishing between drugs and devices?

Of course: The Medical Device Amendments of 1976 contain an express preemption clause (21 U.S.C. Sec. 360); the Food, Drug and Cosmetic Act does not have a similar provision for drugs.

But that's a legal reason for making a distinction, not a policy reason.

And Congress is now thinking about eliminating the legal reason.

The Medical Device Safety Act of 2009, introduced last week, proposes to undo Riegel and to eliminate the preemption defense for PMA-approved devices. The new logic, announced in the wake of Levine, is that drugs and devices should be regulated similarly. In the words of Representative Frank Pallone: "Yesterday the Supreme Court rightfully upheld a patient's right to legal recourse after sustaining an injury from a pharmaceutical product. . . . Today, we introduce legislation that gives patients that same right when injured by a medical device."

Congress will now predictably start debating why devices have historically been regulated differently than drugs (with respect to preemption) and whether it makes sense to maintain the difference.

The historical answer is easy. In 1962, when Congress amended the Food, Drug and Cosmetic Act to require manufacturers to prove that new drugs were "effective" (as opposed to simply "safe"), the states were not doing much to regulate drugs. Because there was so little state law, Congress had no reason to focus on whether the federal regulatory scheme should displace that non-existent state law.

By 1976, when Congress passed the Medical Device Amendments, times had changed. "Most notably, the Dalkon Shield intrauterine device, introduced in 1970, was linked to serious infections and several deaths, not to mention a large number of pregnancies. . . . Several States adopted regulatory measures, including California, which in 1970 enacted a law requiring premarket approval of medical devices." Riegel v. Medtronic, 128 S. Ct. 999 (2008). In that environment, Congress naturally focused on the possibility of state regulation interfering with the federal regulatory scheme, and Congress chose affirmatively to preempt state law.

This historical record suggests (albeit gently, we concede) that preemption may be a good idea: When Congress focused on the issue, Congress expressly preempted conflicting state laws.

As Congress debates the Medical Device Safety Act, however, it should also consider possible policy reasons for maintaining broad preemption for medical devices even though there's now only narrow preemption for drugs.

(Please don't get us wrong here: In case you missed our last two years of blog posts, we believe that both drugs and devices should get the benefit of broad preemption. But Levine says we're wrong, and we don't wear the robes. We're now saying that, even with the loss in Levine, there may still be policy reasons to treat devices differently than drugs and to maintain preemption for devices.)

One of us thought about this issue a dozen years ago, as Lohr v. Medtronic was heading to the Supreme Court. (Actually, both of us were thinking about this issue back then, but only one of us published the thought in the following words.) Here are a couple of possible policy reasons for maintaining the preemption defense for PMA-approved devices, even if drugs generally won't have the defense:

[I]n light of the differences between drugs and medical devices, it was
neither ironic nor anomalous for Congress to distinguish between them in
establishing the preemptive scope of federal regulation. The
pharmaceutical industry is dominated by large manufacturers investing in products (drugs) that will likely be on the market for 30 to 50 years after they are
approved. [Citation omitted.] When it passed the Medical Device
Amendments, Congress understood that 'devices [are] subject to rapid
obsolence.' [Citation omitted.] And the Senate 'specific[ally]
noted' its consideration of 'the impact of this legislation on the small
manufacturer of medical devices,' in light of 'the importance of the small
innovative manufacturer in the invention and development of new medical devices
and the inability of these firms, because of limited financial resources, to
sustain the high level of administrative costs demanded of a highly regulated
industry.' [Citation omitted.] In this circumstance, it was
reasonable for Congress to decide that device manufacturers required more
protection from the costs of litigation than did pharmaceutical
manufacturers. [Citation omitted.]

Mark Herrmann and Geoffry J. Ritts, "Preemption and Medical Devices: A Response to Adler and Mann," 51 Food & Drug L.J. 1, 6 n.21 (1996).

After Lohr came down, we thought those words had been relegated to the dustbin of legal history. Now, with the debate over the Medical Device Safety Act, we can open the bin, blow off the dust, and renew that old debate.

The more things change . . . .

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