We’ve heard more about the constitutional “emoluments clause,” Art 1 §9, clause 8, this year than during the entire rest of our legal careers. But while it’s illegal for anybody working for the U.S. government to accept anything of value from a “foreign state,” that doesn’t make it illegal, unethical, or even particularly
When this blogger hears “negligent undertaking,” my mind does not automatically turn to products liability – but rather to pre-teen children. Pre-teen children are at the age where they are asked (actually required) to “undertake” more and more duties and responsibilities. But often these duties are undertaken in a rather haphazard or lackadaisical way that…
We aren’t going to mince words today. We don’t like Christiansen v. Wright Medical Technology Inc., MDL 2329, 2016 U.S. Dist. LEXIS 46409 (N.D. Ga. Apr. 5, 2016). It is an opinion on post-trial motions in a case that went to trial in the Conserve Hip Implant Products Liability Litigation. It’s a beautiful spring day here in the Mid-Atlantic and we hope that’s true where you are. If it is, and if anything in this post makes you interested in the greater details and nuances of the decision, we recommend taking it outside, sitting under a tree, and enjoying some fresh air. You should at least have pleasant surroundings while you try to get through it. It’s long, and tedious, and frankly, muddled. So, we are going to try to focus in on the key parts – so that we might also try to get out and enjoy some of this fine weather.
Christiansen is a hip implant case. It went to trial on 5 theories of liability: strict liability design defect, negligent design defect, fraudulent misrepresentation, fraudulent concealment, and negligent misrepresentation. Id. at *2-3. Apparently the court had dismissed plaintiff’s failure to warn claim on summary judgment. Id. at *69 n.18. The jury ultimately returned a verdict finding the hip implant was defectively designed and caused plaintiff’s injuries and awarded $550,000 in compensatory damages. The jury also found in favor of the defendant on the fraudulent misrepresentation and concealment claims, but awarded another $450,000 to plaintiff on his negligent misrepresentation claim and $10 million in punitives. Id. at *18.
But that wasn’t the jury’s first verdict. It’s first verdict, delivered days earlier, answered the first question on the Verdict Form – do you find the hip implant was defectively designed – in the negative. Id. at *6. While that should have been the end of the inquiry, the jury didn’t understand the instruction to not go any further and they kept answering the verdict form. So, they went on to find that defendant had made negligent misrepresentations and awarded plaintiff $662,500 in compensatory damages and $2.5 million in punitives. Id. at *7.Continue Reading Georgia MDL Court Muddles Utah Law
Once upon a time there was a federal judge . . . . When we were little, we liked it when our mom spun free-form fairy tales for us. We would contribute the object of the “was” (“Once upon a time there was a . . . bullfrog”), and she would make up the rest as she went along. Which is fine for mommies, but less so for federal judges, as today’s (very short) case illustrates.
In Fay v. Depuy Orthopedics, Inc., et al, 2015 U.S. Dist. LEXIS 175344 (D.N.D. June 11, 2015), plaintiff’s hip was replaced with a metal-on-metal hip system. The system consisted of various components, two of which were at issue: the femoral head and the acetabular cup. Both components come in various sizes, but, for the system to work correctly, matched sizes of the two components must be implanted in the patient.
In Fay, it was undisputed that Plaintiff received mismatched components and had to undergo revision surgery. One of the defendants was a distributor that marketed and sold the system. Plaintiff’s surgeon testified that two specific sales reps employed by the distributor were always in the operating room when he implanted that particular hip system. According to the surgeon (who was not sued), the reps were responsible, based on a process called “templating” of the patient’s x-rays, for placing an appropriate range of sizes of the two components on a table in the operating room before the surgeon arrived. From the prepared template, the surgeon would determine what size acetabular cup would be implanted, and would ask for that size cup and the correspondingly-sized femoral head. The sales reps were allegedly responsible for selecting the components from the implant table, verifying for both that they had pulled the size the surgeon requested, and handing the packaged components to the circulating nurse, who unpacked them and placed them in the sterile field. In the absence of sales reps, the circulating nurse would be responsible for selecting the correct sizes of components.Continue Reading Sales Reps Denied Summary Judgment in Artificial Hip Case Despite Absence of Legal Duty to the Plaintiff
Way back when – before Restatement (Second) of Torts §402A (1965) crystallized the concept of strict liability – courts around the country were poking around, trying to come up with viable theories of what we would now call “product liability.” One method that gained some traction, prior to the advent of strict liability, was to strip contractual implied warranty of its historical requirement that the buyer and seller have been in “privity” (that is, that they dealt directly with each other). New York was one of the states that started down that road. In Goldberg v Kollsman Instrument Corp., 191 N.E.2d 81 (N.Y. 1963), the court held 4-3 that the manufacturer of a “thing of danger” (not otherwise defined, but in Goldberg, an airplane part that allegedly caused a crash) could be liable for breach of implied warranty without being in contractual privity with the plaintiff. Id. at 83 (“at least where an article is of such a character that when used for the purpose for which it is made it is likely to be a source of danger to several or many people if not properly designed and fashioned, the manufacturer as well as the vendor is liable, for breach of law-implied warranties, to the persons whose use is contemplated”). This was problematic, because until §2-318 was amended in 1975, New York’s UCC hadn’t done away with privity in all personal injury cases.
But along came strict liability, and New York’s tentative steps down the road of privity-less implied warranty were largely forgotten. Nobody paid much attention to warranty in the Empire State until the Court of Appeals held that strict liability and implied warranty were “not identical” in Denny v. Ford Motor Co., 662 N.E.2d 730, 739 (N.Y. 1995), in that strict liability utilized a risk/utility approach whereas implied warranty focused on consumer expectations. Id. at 736. While this distinction “may have little or no effect in most cases,” it can in some. Id. at 738.Continue Reading The Citadel Revisited – New York’s “Thing of Danger” Privity Exception Is Obsolete (and Another New York Note)
The Judge in the ObTape device litigation has allowed another manufacturing defect claim to go to trial with no direct evidence that the device implanted in the plaintiff had a manufacturing defect. See In re Mentor Corp. ObTape Transobturator Sling Prods. Liability Litig., 2015 U.S. Dist. LEXIS 140263 (M.D. Ga. Oct. 15, 2015). In denying the manufacturer’s motion for summary judgment, the court relied solely on a review conducted by plaintiff’s experts of sample ObTape devices—that is, devices other than the one implanted in the plaintiff. The experts found that the pore sizes of those other samples were at times outside of the alleged manufacturing requirement of 40 to 100 microns. Relying solely on this, the court rejected the manufacturer’s argument that plaintiff had not shown a manufacturing defect in the device implanted in her. The court explained its reasoning, which from our point of view is less than convincing:
One way to prove a manufacturing defect is to test the specific subject product against manufacturing standards. For example, in BIC Pen Corp., the parties tested the cigarette lighter that caused the plaintiff’s injuries. 346 S.W.3d at 540-41. But Mentor [the manufacturer of ObTape] did not point the Court to any authority that such testing is the only way to establish a manufacturing defect under Texas law. Here, Mrs. Sanborn relies on the same evidence as the Phase I Georgia Plaintiffs, whose specific ObTape was not tested, either. Rather, their experts tested a number of ObTape samples and concluded that a substantial portion of each ObTape tested had pores smaller than 40 microns. In re Mentor, 711 F. Supp. at 1376. At this time, the Court remains satisfied that this evidence is sufficient to create a genuine fact dispute on Mrs. Sanborn’s manufacturing defect claim. Mentor’s summary judgment motion on the manufacturing defect claim is thus denied. The Court may reconsider this issue when ruling on any motion for judgment as a matter of law that may be presented at trial.
It wasn’t a complete win, but the summary judgment outcome in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), has to put a spring in the step of the defendants as they approach trial. What’s left doesn’t strike us as a very good warnings case. Rheinfrank involved claims that the antiepileptic drug Depakote caused the minor plaintiff’s birth defects. Make no mistake about it, Depakote has a known association with such injuries. First approved in 1983, it’s been a Pregnancy Category D drug since 1988, meaning, according to FDA regulations, that:
there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.
21 C.F.R. §201.57(c)(9)(i)(A)(4). Not only that, since 2003, this drug has carried a black box “teratogenicity” warning, as well as other quite explicit, and all-caps, language to the same effect. For details, see 2015 WL 4743056, at *2-3.
Plaintiff-mother had used Depakote for years, through four previous uneventful pregnancies. Id. at *1. On her fifth pregnancy, even though Depakote came with all these warnings, she continued to take it. Id. Her allegations did try to change the subject, however. In addition to claiming that the black box warning (more about that later) and all the other teratogenicity language were inadequate, she asserted that the defendants failed to warn altogether about “developmental delay.” Id. at *5.Continue Reading Preemption (and Other Things) Defanging Depakote Claims
This post is from the non-Reed Smith side of the blog.
In the latest decision from the Pelvic Mesh MDL, the court ordered a consolidated trial of no fewer than thirty-seven plaintiffs with nothing in common save claiming injury from the same product. See Mullins v. Ethicon, Inc., C.A. No. 2:12-cv-02952, slip op. (S.D.W. Va. Aug. 4, 2015). The consolidation is an attempt at a Rule 23(c)(4) single-issue class certification without the class action – since class actions are never certified anymore in personal injury prescription medical product litigation (as demonstrated here). To reach the same procedural result, Mullins limits consolidation to defect/breach of duty and “general causation”:
[T]he consolidated trial will only involve . . . issues concerning the design of the [defendant’s mesh] and whether that design was reasonably safe. Determining reasonable safeness necessarily involves consideration of the [product’s] capability to cause injury. As a result, causation will be relevant to the consolidated trial but only in the general sense. In other words, the pertinent issue will be whether the [product] can cause injury (general causation), not whether it did in fact cause injury to a particular plaintiff (specific causation).
Mullins, slip op. at 5 (citation omitted).Continue Reading Further Deconstruction of the Law in Pelvic Mesh
Yes, we’re well aware of the latest development in the Pelvic Mesh MDL. See Mullins v. Ethicon, Inc., C.A. No. 2:12-cv-02952, slip op. (S.D.W. Va. Aug. 4, 2015). However, due to Reed Smith’s Pelvic Mesh representations, we’re constrained in what we can say. We’ll just have to let prior, non-Mesh posts speak for us…
Since the inception of the blog we’ve taken interest in “flip side” lawsuits in which a plaintiff sues one of our manufacturer clients making allegations diametrically opposed to what we usually see in product liability litigation – that, far from being injurious or “defective” − our client’s product is so valuable that the plaintiff can’t do without it, and is suing because of some threat to his/her supply of that product.
The first time we commented on such suits, the plaintiffs were suing the government, claiming a constitutional right to try investigational drugs. We opposed that, knowing that, were such a right recognized, our clients would be the next targets of such constitutionally empowered plaintiffs, because our clients, not the government, had the drugs in question. The courts ultimately said “no,” see Abigail Alliance v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007), but the lawsuits followed anyway. Most of these cases involved desperately ill people grasping at investigational straws because there was no cure (or even reliable treatment) for their conditions (muscular dystrophy, multiple sclerosis, and similarly devastating and fatal conditions). We summed this kind of litigation up recently in reviewing the first comprehensive law review article on the subject.Continue Reading Still No Duty To Supply Drugs – In 22 States