Tuesday, July 29, 2008

A Texas 82.007 Preemption Win

This falls into the category of "almost breaking news":

On Friday, Judge Todd Campbell, who's handling the Aredia/Zometa MDL, entered an order granting partial summary judgment based on Texas Civil Practice and Remedies Code Sec. 82.007 as to all failure-to-warn claims. In re Aredia and Zometa Prods. Liab. Litig., 2008 WL 2944910 (M.D. Tenn. July 25, 2008).

(We've plowed this ground at this blog before. Please click here for the legal background; the following description is a shorthand version meant for folks already generally familiar with the underlying legal issue.)

Eight Texas residents sued for personal injuries allegedly caused by Novartis' drugs. Seven filed their complaints in New York; one filed in Texas. The MDL Panel transferred all of the case to the Middle District of Tennessee for pretrial proceedings.

Under both New York and Texas choice of law rules, Texas law governed plaintiffs' claims.

Texas Civil Practice and Remedies Code Sec. 82.007(a) provides that drug manufacturers are not liable for failure to warn if the warnings that accompanied their product had been approved by the FDA.

Plaintiffs can rebut that presumption by, among other things, proving that the defendant misrepresented to the FDA material information that was causally related to the plaintiff's injury. Tex. Civ. Prac. & Rem Code Sec. 82.007(b).

Citing Buckman Co. v. Plaintiffs' Legal Comm., 121 S. Ct. 1012 (2001), Judge Campbell found that the fraud-on-the-FDA exception is preempted, leaving only the immunity from failure-to-warn liability intact. Rejecting the magistrate judge's contrary decision in Ackermann v. Wyeth, 471 F. Supp. 2d 739 (E.D. Tex. 2006), Judge Campbell granted partial summary judgment in favor of Novartis.

2 comments:

hg said...

I'm a little unclear why the summary judgement was "partial"?

If, as you have well explained, Buckman means that fraud-on-FDA rebuttal statutes are preempted, is there anything left that could be used to rebut the rebuttable presumption? (Understanding Kent result leaves the matter a bit uncertain on the SC level.)

Thanks for clarifying!

Beck/Herrmann said...

Plaintiffs typically plead multiple claims -- failure to warn, manufacturing defect, and design defect -- in their complaints. The Texas statute applies only to failure-to-warn claims. The court thus dismissed only the failure-to-warn claims, leaving the other claims to proceed -- hence, a "partial" summary judgment.