Public Citizen often appears in opposition to conflict preemption in drug cases. That’s their right. One of our number, Bexis, does the same thing on the defense side for PLAC. But Public Citizen goes farther, and actually assumes representation of plaintiffs on appeal. That’s why Public Citizen was arguing the plaintiff’s side of Riegel v. Medtronic the other day. At the argument, Public Citizen made some interesting concessions that are very relevant to drug cases involving situations where the FDA has actually examined a particular question and said “don’t add that warning” or “don’t tell doctors to do that.” Then a plaintiff comes along and sues the manufacturer for not adding that same warning or instruction. Anti-depressants (SSRIs) and suicide is the prime example.

So what did Public Citizen tell the Supreme Court when the rubber hit the road? That there would, in fact, be preemption in the “FDA said no” situation – that’s what. Here are the quotes:

First pitch:

JUSTICE GINSBURG: Take a concrete situation where the FDA is asked: We’d like to make this improvement. And the FDA says no, we don’t think that enhances safety. And then there’s a tort suit based on the failure to make that improvement. Wouldn’t the FDA rejection of permission to make that improvement -wouldn’t that at least be preemptive?

MS. ZIEVE [counsel for Public Citizen/plaintiff]: If the — if 360k(a) ever preempts tort claims, I think that would be a situation, but if — only the tort claim is — is specific in that way, that you — that the company failed in its duty of care because it didn’t design the device in the specific way that the FDA had rejected.

Riegel Oral Argument Tr. at 13 (emphasis added).

Strike one.

Second pitch:

JUSTICE GINSBURG: I thought your response was it wouldn’t go to the jury if the FDA had said no, you cannot make this, and the plaintiff’s point is you must make it in order to make this device safe.

I thought your answer to me was that the FDA regulation — the FDA’s action in refusing to allow the change to be made would be preemptive and you wouldn’t give it to a jury to second-guess that determination by the FDA.

MS. ZIEVE: Yes. That’s right.

Tr. at 14 (emphasis added).

Strike two.

Third pitch:

 

JUSTICE GINSBURG: I was asking you, if it was — as a matter of Federal law, if the FDA says –rejects.

MS. ZIEVE: Yes.

JUSTICE GINSBURG: — a proposed change, can a State court say, well, we think the FDA was wrong in rejecting that, so we’re going to let it go to the jury. I thought the question I was posing to you is, isn’t Federal law preemptive in that situation, when the FDA says you can’t do it and the personal injury lawyer wants it to convince the jury that they had to do it?

MS. ZIEVE: Yes.

Tr. at 14-15 (emphasis added).

Strike three. As to SSRI cases where that FDA said “no” to suicide warnings and the plaintiff wants a common-law jury to say “yes” – Public Citizen says “YER OUT!” – at least when put on the spot in the Supreme Court.

See also Tr. at 15 (agreeing that there would also be preemption in the converse situation where “FDA says you must include X in this device or we won’t give you the pre-market approval. . . and then there’s a lawsuit that wants to charge that putting X in made the device dangerous”).

Not only that, but this same concession of preemption also concedes – as our intrepid correspondent observed: (1) that FDA actions short of device-specific regulations can create preemptive “requirements” and (2) that state tort suits, as such, are capable of imposing preemptive “requirements” under the express preemption clause in the MDA.

Where does that leave us? Well, we think it places a responsibility on the lawyers representing manufacturers (that’s us) in any “FDA already said so” case (whether its a drug or device, and whether the FDA said “do it” or “don’t do it”) in which Public Citizen appears to remind courts of what PC just told the Supreme Court in Levin.

We, for two, do not intend to shirk that responsibility.