January 2017

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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

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This post is from the non-Reed Smith side of the blog.

We use products with warranties every day. There are warranties on frying pans, on light bulbs, on computers. We once saw a warranty on a pair of nail clippers that cost $1.49 that allowed the owner to send them in for repair or replacement as long as you included $3.00 for return shipping. What a bustling warranty department that company must have had. Generally speaking, we don’t pay much attention to warranties unless they are on big ticket items. If something goes wrong with your car, you’re scrambling to see whether it’s covered by a warranty. If a light bulb that’s supposed to last five years burns out in three, you most likely just toss it out and screw in a new one. You probably forgot how long it’s been since you last changed it anyway (speaking for this blogger at least).

Medical devices such as implantable spinal neurostimulators (guess what today’s case is about) don’t come with warranties of the kind alluded to above. You’re not going to see a provision on the labeling that says should this device break or malfunction within 3 years of implant, just send it back for a new one. There are many reasons for this, the most obvious of which is the device is inside someone’s body. Returning the device it isn’t always an option, because revision surgeries aren’t always the best option. Moreover, most product warranties talk about normal wear and tear or under normal conditions. There is no such thing as “normal” or “typical” when you are talking about inside the human body. There are simply too many unknowns for medical device manufacturers to guarantee their products.

But that doesn’t stop plaintiffs from including express warranty claims in their complaints. Typically the allegations in express warranty claims in drug and device cases are general statements that the manufacturer’s labeling and advertising represented that the product would be safe, effective, fit, proper, etc. When pressed for the actual representations that constitute the express warranty or for proof of reliance on such statements – well, that’s when plaintiffs’ express warranty claims often fall away. That’s because they don’t exist. And, that’s usually the focus of our discussion on express warranty. Occasionally, however, plaintiffs come armed with a little more specificity.Continue Reading Express Warranty Claim Preempted

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Yesterday we commenced the dreary process of taking down the Christmas decorations. The German nutcrackers slid back into their cartons. Stockings marched from the mantle into plastic storage containers. We picked the ornaments off the tree, one by one, paying special attention to the souvenirs from this year’s trips (Newport mansions, the FBI tour, Comic-Con). After clearing out so many of these jolly gee-gaws, we spotted a present under the tree that had thus far gone unnoticed. This seems to happen every couple of years and never fails to make us feel simultaneously silly and grateful. Our carelessness somehow managed to extend the holiday.

The Utts v. Bristol-Myers Squibb Co., et al., 2016 WL 7429449 (S.D.N.Y. Dec. 23, 2016), is like a late-discovered Christmas present. Indeed, the court’s application of preemption in favor of a branded pharmaceutical is so strong, so compelling, and so useful, that it might have deserved spot on our 2016 top ten list.

The plaintiffs claimed that Eliquis, a drug used to reduce risks of stroke and embolism from a-fib, caused severe internal bleeding injuries. The complaint set forth the usual panoply of product liability actions under California law (the parties agreed that California law would apply) plus a claim under New York’s consumer protection law. The court was skeptical about that last bit, dismissed it, and afforded plaintiffs with leave to amend. The court was more than skeptical about the product liability claims, as we shall see momentarily. The court also did something very shrewd. It asked the parties to identify a motion to dismiss that might dispose of the case, and then held off initiation of discovery until resolution of that motion. Here, at last, is a court that has a proper sense of the burdens of discovery and the legal frailty of many plaintiff claims.Continue Reading SDNY Applies Preemption in Favor of Branded Drug

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This is a guest post from Michael Salimbene, an associate at Reed Smith.  It’s about learned intermediary causation, and the need for prescriber testimony.  Not infrequently, in mass torts with lots of solicited plaintiffs, the other side puts off doing anything, including preserving prescriber testimony, for as long as possible.  If the prescriber dies or disappears, plaintiffs don’t have any causation testimony, and since they bear the burden of proof, that’s a problem for them.  The guest post describes the latest example.  As always our guest poster deserves 100% of the credit (it’s not our work), and any blame, for what follows.

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This guest blogger lives just outside of Philadelphia. In this neck of the woods, the post-holiday, pre-Spring window is perhaps the most universally loathed time of year.  It’s filled with grey skies and frigid winds.  Partner in-office attendance, which tends to wane during the summer months and late December, hits its yearly high.  The all-important billable hour “clock” resets to 0.  Street corner sales of unlicensed Carson Wentz tee shirts have stalled, and playoff football will feature two of Philadelphia’s most hated rivals, the Giants and the Cowboys.  Your children, if anything like this guest blogger’s, will ignore the Frozen-themed electric car that “Santa” left (but took you 4 hours to assemble) in favor of a $6 pair of pink bunny slippers.  So for today’s post, in search of some good news, we travel to the Middle District of Georgia where the temperature hovers just above 60 degrees.  In a few short months, Northeasterners will also be enjoying warm skies and Georgia’s finest offering, The Masters.  Until then, we’ll have to make due with favorable warning-causation decisions like this one.

Today’s case comes to us from the Mentor Corp. Obtape Transobturator Sling Products Liability Litigation MDL in the Middle District of Georgia. In re Mentor Corp. ObTape Transobdurator Sling Prods. Liab. Litig., No. 4:13-cv-229, 2016 WL 4611572 (M.D. Ga. Sept. 2, 2016).  We’ve blogged about this MDL quite a bit (recently here, here, and here).  As were most plaintiffs in the ObTape litigation, this plaintiff’s prescribing surgeon treated her for a form of incontinence with the relevant device.  If you’ve watched daytime TV in the past 5 years, you’ll be familiar with the typical list of complaints that undergird vaginal mesh lawsuits:  mesh “erosion” or “extrusion” (movement of the mesh material into surrounding tissue); “dyspareunia” (painful intercourse); and the need to have additional surgery to correct mesh-related complications, to name a few.  Plaintiff never had her mesh removed, but alleged, among other things, that the product caused her to suffer from chronic pain.  So what makes this case different from the thousands of other mesh cases pending across the nation?  Plaintiff’s implanting physician died before he could testify in her case.Continue Reading Guest Post – Failure to Warn Claim Dead on Arrival Without Testimony from Prescribing Physician

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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