Thursday, May 14, 2009

A Device Preemption Quickie -- Heisner v. Genzyme

In Heisner v. Genzyme, No. 08-C-593, 2009 U.S. Dist. LEXIS 37322 (N.D. Ill. Apr. 30, 2009), Heisner allegedly died as a result of an allergic reaction to Seprafilm, an anti-adhesive surgical barrier implanted in her body during a surgery. Seprafilm is a Class III medical device approved by the FDA through the premarket approval process.

Heisner's surviving spouse and estate filed the usual product liability claims against Genzyme, which manufactured Seprafilm. The trial court granted Genzyme's motion to dismiss on the ground of federal preemption.

Two items merit quick note: First, plaintiff asserted that his claims were "parallel" to, rather than "different from or in addition to" the federal requirements applicable to Seprafilm, because Genzyme had allegedly failed to report to the FDA (1) the death of plaintiff's decedent, and (2) a clinical trial protocol and related warnings finalized after Heisner's death. The trial court didn't have to address the "parallel requirements" issue, because events that took place after Heisner's death could not possibly have proximately caused Heisner's injury. Id. at *5.

Second, plaintiff's express warranty claims were based on statements made by Genzyme in (1) the package inserts for Seprafilm, and (2) the PMA protocol for certain Seprafilm clinical trials -- both of which had been approved by the FDA. Because the alleged warranties were based on statements that had been approved by the FDA, the court found those allegations of breach of warranty to be preempted. Id. at *8.

We'll include this one in the ever-expanding (New) Medical Device Preemption Scorecard.


Anonymous said...

Herrmann and Beck,
I'm just wondering, why wouldn't the fact that Genzyme didn't report Mrs. Heisner's death to the FDA be a violation of their PMA? During the House Committee on Energy and Commerce's Health subcommittee hearing the other day, it was contended several times that, if a medical device manufacturer violates their PMA, they are no longer preempted. I'm interested to hear your thoughts on this.

Anonymous said...

Herrmann and Beck,
I know that you've been busy today with your other posts, but I'm still wondering, how does a violation of a medical device's PMA affect its preemption status. At the House subcommittee hearing that was held this week, it was stated very explicitly by some members of the House that, if a medical device company doesn't report to the FDA as is required by the PMA, it will not enjoy preemption status. In your opinion, is this or is this not accurate? I respect your opinions and am interested to know your thoughts on this

Beck/Herrmann said...

To the Anonymi:

Assuming arguendo (that's how lawyers say "for the sake of argument") that there was a post-marketing violation of an FDA regulation not to report the death in question, that has nothing to do with the prior approval of the PMA.

The law is quite clear that the PMA-approved status of the drug at the time is what governs. The FDCA does not automatically, let alone retroactively, revoke PMAs for post-marketing violations - even in a recall situation (there are cases on this; check the post-Riegel scorecard for recalled drugs; maybe we'll do a separate post on it some day).

So it's not a "PMA" violation.

That's not to say non-reporting is legal. It could well be a violation of the FDA's post-marketing regulations governing reporting - but there's no private right of action under the FDCA, so a plaintiff would have to come up with a "parallel" state claim.

Unfortunately that "parallel" state claim would be - in substantive effect, although any smart plaintiff would change the namen - fraud on the FDA. That, however, is independently preempted under Buckman.

Congress could change the law on this (except the part about fraud on the FDA, which is implied preemption), but as the law now stands - that's how we think it works.

Hope that answers the question.