[Drug and Device Law] S.D. Texas Upholds Texas Presumption of Non-liability for FDA-approved Drugs and Rejects Failure to Update Claim
Today’s post comes from the non-Dechert side of the DDL blog.
This week is the anniversary of the beginning of Facebook. The question of whether Zuckerberg et al. could successfully "monetize" that platform has apparently been answered. There are almost as many ads and push notifications as there are things that we actually care about, such as pictures and updates from friends and family. Even worse than the ads are the political rants, stalker high school classmates, and suggestions to join stupid games. After a nephew invited us to play Farmville for the fifth time, we unfriended him. It was an easy call, especially since most of his entries involved home-made backyard mixed martial arts films and his f-bomb quotient would have made the makers of Scarface and Midnight Run blush. Why isn't there a "Dislike" button we can click?
But today we will "Like" a pair of decisions out of the Southern District of Texas. The cases are Jackson v. Wyeth LLC, 2015 U.S. Dist. LEXIS 9286 (S.D. Tex. Jan. 27, 2015), and Garza v. Wyeth LLC, 2015 U.S. Dist. LEXIS 9292 (S.D. Tex. Jan. 27, 2015). The cases involve the same judge, the same defendants, and the same claim that ingestion of Reglan/metaclopramide caused tardive dyskinesia. They were issued on the same date. Both opinions are short, well-reasoned, and follow settled Fifth Circuit law.
In Jackson the plaintiff tried to get around the Texas law presumption that there is no liability for products and/or their packaging when they were approved by the FDA. That presumption gets rebutted only if the FDA has concluded/demonstrated that it was defrauded by the company. That didn't happen here, but the plaintiff insisted that she should be able to show on her own that the company had defrauded the FDA, even if the FDA had not made such a showing. The plaintiff's position was foreclosed by Buckman preemption and Fifth Circuit precedent, but that didn't prevent the plaintiff from making five arguments, all of which were rejected by the Jackson court:
1. Ignore the case law. Not surprisingly, the Jackson court said No Thanks.
2. Off-label promotion should call off Buckman preemption. That argument is flat-out wrong, but the Jackson court did not need to grapple with it, because the plaintiff's use of the medicine in Jackson was on label. Thus, the plaintiff’s argument was a non sequitur and non-starter.
3. Please wait until the plaintiff gets discovery from the company. That's also flat-out wrong, and shows what's wrong with our litigation system. It’s the argument that has been used to support weak-kneed or just plain awful opinions such as the Seventh Circuit’s execrable Bausch opinion. (Bausch! We just cannot let go of that one. Every time we think of it we become as depressed as if someone had just shown us that ghoulish Nationwide Insurance Super Bowl ad.) The Jackson court gave the let’s-wait-until-after-burdensome-discovery argument the back of its judicial hand, reasoning that discovery was not going to make the presumption go away, because the FDA simply had not found that it had been defrauded.
4. The limited ability to rebut the presumption violates the Texas Open Courts Act. That argument is always the last refuge of plaintiff lawyers. Under that theory, presumably summary judgment and Daubert motions also violate the Open Courts Act, since they can have the pesky effect of terminating a case before a jury ever gets to hear it. That is nonsense, of course. But the Jackson court was beyond clever in disposing of this argument, pointing out that if the Texas limited rebuttal provision is invalid, then it would be severed and all that would be left is the presumption of nonliability. Adios.
5. The presumption does not stop the design defect and deceptive practices claims from going forward. The Jackson court concluded that the underlying claim is what it is, that the names of the claims should not matter, and the presumption therefore applies with full force. Adios, again and again.
There was a different issue front and center in the Garza case. The claim against the generic manufacturer faced Mensing preemption. The plaintiff attempted to circumvent that preemption in the manner that is currently most popular and too often successful: arguing that the generic manufacturer failed to update its label as quickly as it should have done. But Fifth Circuit law is clear that a failure to update claim necessarily asserts that the generic manufacturer breached a federal labeling obligation. The standard is governed by federal requirements, not state law expectations. That means that preemption applies and that the claim must be dismissed.
The opinions in the Jackson and Garza cases are both short and sweet. They could easily fit in a snappy Facebook entry. They might even fit in a Tweet.
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Posted By Steve McConnell to Drug and Device Law at 2/02/2015 02:00:00 PM --
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