Next week, under pressure from the Drug and Device Law Lifelong Best Friend, we are participating in a “murder mystery dinner theatre” in the “conservatory” of a local cemetery.   (We didn’t know cemeteries had “conservatories.”) It is a Halloween-themed event, with costumes encouraged, and we may or may not wear our eerily-lifelike Standard Poodle mask/hood.

At times, we have given a glimpse into the sausage making that goes into our production of posts on recent interesting cases and developments.  Part of the process involves standing searches for “published” (including by the electronic services) decisions from trial courts and appellate courts.  Sometimes, the trial court decisions are unpublished but interesting, and

Here’s the crux of today’s case, In re Trader Joe’s Tuna Litig., 2017 WL 2408117, at *1 (C.D. Cal. Jun. 2, 2017):

Plaintiffs determined that the Trader Joe’s tuna cans were underfilled and underweight by commissioning testing with the U.S. National Oceanic and Atmospheric Administration (“NOAA”) on December 1, 2015. NOAA tested several varieties

We talk a lot on this blog about Buckman preemption. That isn’t just out of pride regarding Bexis’s role in the bone screw litigation that led up to the Buckman decision. The principle in Buckman is important. What happened in Buckman? Here is a nice summary: “In Buckman, the plaintiffs brought state

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

There used to be a TV show called “That Was the Week That Was.”  It was a satirical look at the news of the prior week, but perhaps it’s most lasting accomplishment was to launch David Frost’s career.  Without an ounce of satire, however, we have to say that the business week of August 15 through 19, 2016 was a heck of a week for implied preemption utilizing Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  We’ve already blogged about the Ninth Circuit’s decision in DeBons v. Globus Medical, Inc., ___ F. Appx. ___, 2016 WL 4363171 (9th Cir. Aug. 16, 2016), which invoked Buckman preemption to affirm dismissal of a consumer protection class action that was seeking to recover based on allegations that a medical device wasn’t properly “approved” (but rather cleared under §510(k)) by the FDA.

But DeBons was only one part of that week’s Buckman hat trick.

On the same day, the Fifth Circuit got into the act, affirming a preemption-based dismissal of another medical device product liability suit in Estes v. Lanx, Inc., ___ F. Appx. ___, 2016 WL 4375644 (5th Cir. Aug. 16, 2016).  We’ve already blogged about favorable district court results in the Estes case three times.  The Fifth Circuit affirmed all of them.  Estes involved a spinal fixation system anchored with bone screws, some of which broke under the intense pressures of holding the human body upright.  The screws were explanted and replaced, but “neither the hospital nor [defendant]  retained” them. Id. at *1.

Plaintiff first screamed “spoliation” – he lost.  Id. (“we find no basis for disturbing the district court’s finding of no bad faith”).Continue Reading A Banner Week For Buckman Preemption

We are determined not to end 2015 on a bad note.  Thus, we turn, as we do with surprising frequency (and as we did last week), to a federal court decision out of Mississippi for a heaping helping of solid legal reasoning.  The case is Estes v. Lanx, Inc., 2015 U.S. Dist. LEXIS 171184 (N.D. Miss. Dec. 23, 2015), and the court got everything right.  The case involves the usual panoply of product liability claims against a spinal fixation system.  After a surgery on the plaintiff in 2011, two pedicle screws fractured.  A revision surgery was performed in 2012. The plaintiff then sued, claiming that the pedicle screws were negligently designed or manufactured, that the defendant breached warranties as to the pedicle screws, and that the defendant had failed to obtain FDA clearance for the
spinal fixation system.

Mississippi has a Products Liability Act (the MPLA) that supplants common law claims, such as negligence or negligent misrepresentation.  We wish every state enacted a product liability act.  In fact, we wish every state enacted the MPLA.  The MPLA requires a design defect claim to suggest a feasible alternative design.  The plaintiff offered no such alternative design, so that theory was dismissed.  The manufacturing defect and failure to warn claims also foundered, though there were wrinkles to those claims, and the court’s ruling on those wrinkles made the decision even better.Continue Reading N.D. Mississippi Invokes Buckman in Rejecting Plaintiff Efforts to Screw Up Product Liability Law

The very name “intellectual property law” suggests it’s not for us.  There are episodes of The Simpsons that seem too complicated for our pretty little heads.  Anything deemed “intellectual” scares us away.  We usually race right past the intellectual property section of Lexology, as those cases are seldom relevant to our practice.

Except sometimes they

On May 26, 2015, the Solicitor General’s office responded to the United States Supreme Court’s Oct. 14, 2014 invitation for the government’s views on the certiorari petition filed in Athena Cosmetics, Inc. v. Allergan, Inc., No. 13-1379.  The brief is on Westlaw at 2015 WL 2457643, and is also referenced (although not yet with

We’ve been watching for Armstrong v. Exceptional Child Center, Inc., ___ U.S. ___, 2015 WL 1419423 (U.S. Mar. 31, 2015), ever since we spotted an intriguing footnote mentioning the certiorari grant in Ouellette v. Mills, ___ F. Supp.3d ___, 2015 WL 751760 (D. Me. Feb. 23, 2015) (other aspects of Ouellette discussed here).  Ouellette noted:

The State also asserts that where the Plaintiffs have no private right of action under the FDCA, the Supremacy Clause does not create one.  This Court has already resolved that issue in favor of the Plaintiffs in light of Pharmaceutical Research and Manufacturers of America v. Concannon, 249 F.3d 66, 73-74 (1st Cir. 2001).   However, the Supreme Court has granted certiorari on a similar, potentially dispositive question.  See Armstrong v. Exceptional Child Ctr., Inc., 567 Fed. Appx. 496 (9th Cir. 2014), cert. granted, 83 U.S.L.W. 3077 (U.S. Oct. 2, 2014) (No. 14-15) (“Does the Supremacy Clause give Medicaid providers a private right of action to enforce § 1396a(a)(30)(A) against a state where Congress chose not to create enforceable rights under that statute?”). . . .

Id. at *3 n.5.

Any time courts mention private rights under the FDCA, we think back to Supreme Court’s implied preemption reasoning in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), specifically:

The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions: “[A]ll such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.” 21 U.S.C. § 337(a).

Id. at 349 n.4, and:

In the present case, by contrast, we have clear evidence that Congress intended that the MDA be enforced exclusively by the Federal Government. 21 U.S.C. § 337(a).

Id. at 352 (distinguishing Silkwood v. Kerr-McGee Corp., 464 U.S. 238 (1984)).Continue Reading Breaking News − Reinforcement For Buckman