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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…
As much as we liked those parts of In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, 888 F.3d 753 (5th Cir. 2018) (applying Texas law), that overturned a half-billion dollar verdict caused by a combination of attorney misconduct and judicial lassitude, we also recognized the problematic effects of certain other Fifth Circuit rulings in that decision. While the good parts of Pinnacle Hip were good enough to win that decision a spot in our 2018 top ten cases, that decision’s adverse aspects were bad enough that it also landed on our list of 2018’s worst ten decisions. Specifically we observed:
The most serious error the court made was refusing to apply established Texas law that comment k precludes strict liability across the board. Pinnacle Hip ignored – really ignored − a half dozen prior decisions (including one of its own) on this issue. Even if there wasn’t any precedent (which there was), expanding state-law liability where the state courts have not is not the job of a federal court sitting in diversity.
Continue Reading Comment K, Presumptions, and Medical Device Design Defects Under Texas Law
It has been a while since we’ve written about a case delivering a one-two punch against a plaintiff suing both brand and generic drug manufacturers for alleged injuries from ingesting generic drugs. Punch One is rejection of the claims against the brand manufacturers because they did not make or sell the products at issue in…
Delaware is having something of a moment in the sun. Although the state’s license plates have long announced it as “The First State,” that refers to being the first to ratify the U.S. Constitution. It is the second smallest in size and sixth smallest in population of the current fifty states. The casual peruser of…
Back during the Orthopedic Bone Screw mass tort litigation, one of major avenues of attack on the plaintiffs’ novel claims was to pursue every state-law avenue for rejecting the assertion of negligence per se predicated on supposed violations of the Food, Drug & Cosmetic Act (“FDCA”). That approach originally led us to 21 U.S.C. §337(a),…
Truly unique cases are, well, unique. Most cases involve variations or combinations of cases we have seen before. Sometimes you get different results between two decisions on basically the same case with a single fact different. In February, we posted on an Eastern District of Pennsylvania decision on a motion to dismiss in a case…
Some states seem stronger on FDA preemption than SCOTUS was in the Wyeth v. Levine decision. For example, Michigan, New Jersey, and Texas prevent or limit the ability of plaintiffs to sue over an FDA-approved drug, including attacks on the FDA-approved label. See, e.g., Texas Civ. Prac. & Rem. Code Ann. § 82.007. Sometimes…
This guest post is by Reed Smith associate Lora Spencer, who (as you might suspect) calls Texas her home. In her first rodeo on the blog, she discusses a recent MDL decision that she thinks is a few pickles short of a barrel, and hopes it’s not a harbinger of things to come. Not…
Sure, it was enjoyable to read In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Product Liability Litigation, ___ F.3d ___, 2018 WL 1954759 (5th Cir. April 25, 2018) (“Pinnacle Hip”), to see plaintiffs’ counsel hoisted on their own petard of improper and prejudicial evidence and arguments. But there’s more to Pinnacle Hip…
We’ve addressed many times Texas Civil Practice & Remedies Code §82.007, a tort reform statute that, essentially, creates a presumption in drugs cases that a drug’s warning is adequate if the FDA approved it. See §82.007(a)(1). The statute gives plaintiffs with five ways to rebut that presumption, one of which is to show that the defendant withheld information from, or misrepresented information to, the FDA. §82.007(b)(1). That means of rebuttal, however, was held to be preempted by the Fifth Circuit under Buckman because it requires a plaintiff to prove fraud on the FDA. Lofton v. McNeil Consumer & Specialty Pharma., 672 F.3d 372 (5th Cir. 2012).
We recently uncovered a case in which a plaintiff actually tried to expand the Fifth Circuit’s ruling as a way around §82.007’s presumption of warning adequacy. See T.R.M. v. GlaxoSmithKline LLC, 2015 U.S. Dist. LEXIS 183272, (S.D. Tex. Aug. 21, 2015). In particular, the plaintiff argued that, if Buckman preemption applies at all, it must invalidate all of §82.007, not just its fraud-on-the-FDA based rebuttal. In short, even though the statute created a presumption of adequacy and five ways to rebut it, the plaintiff asked the court to scrap the entire presumption regime because one means of rebuttal was preempted.
Uh, no.
Rules of statutory construction require courts to give effect to as much of a statute as possible while maintaining its original purpose, severing only as little as necessary. Preempting only the fraud-on-the-FDA rebuttal provision of §82.007 accomplishes that. Plaintiffs still have the potential options of four other means of rebuttal and, in fact, might even be able to use the fraud-on-the-FDA rebuttal if the FDA itself made such a finding.Continue Reading Texas Federal Court Rejects Attempt to Misapply Buckman to Invalidate Statutory Rebuttable Presumption of Warning Adequacy