We’ve explained at length why Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), is an anachronism with respect to preemption, given the complete overhaul that Congress gave to §510(k). Still, strange things happen when preemption meets product liability, and there seems to be a conspiracy of silence among judges with respect to current FDA
Last weekend we returned to Utah, one of the most beautiful states in the USA. Over the years we had taken in the polite delights of Salt Lake City, the powderpuff snow of Park City, and the cinematic enthusiasms of the Sundance Festival. This time was different. It was an occasion to explore Zion National…
Strict liability is not the same as absolute liability. We learned that truth in law school, but too many plaintiff lawyers and judges seem to have unlearned it along the way. The key separator between strict liability and absolute liability is comment k to section 402A of the Restatement (Second) of Torts (1965), which observes …
One of the wonders of parenthood is its ability to deliver interludes so sublime in their exquisite simplicity that they provoke smiles long after they end. Such was an evening last week when we journeyed to New York to celebrate the birthday of the Drug and Device Law Rock Climber, now a waxing college senior…
A funny thing happened on the way to a defense verdict last year—after the jury decided that the defendant’s product was not defective, the MDL judge told the jurors that perhaps they did not “fully understand” and instructed them to try again. So the jury went back into the jury room, and having been duly…
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.
We have no personal anecdote to share, no movie to discuss, no holiday theme to weave in, and no (self-described) clever theme for our post. It is a beautiful fall day where we have a relative lull in our slate of depositions, briefs, and arguments, so we will get right to it. Last month, we had trouble making sense of a long Daubert and summary judgment order in a metal-on-metal hip implant bellwether case. This month, we think that the evidentiary rulings in the same case make more sense. Christiansen v. Wright Med. Tech. Inc., MDL No. 2329, 1:13-cv-297-WSD, 2015 U.S. Dist. LEXIS 6704750 (N.D. Ga. Nov. 2, 2015). Except for this: neither side filed timely motions in limine, they submitted a joint “Position Statement” on evidentiary issues, and the court issued rulings complete with limiting instructions. That was awfully generous of the court, as most judges will not rule on what evidence can come in absent a timely motion or objection. It may be too simplistic to say that plaintiff lawyers in drug and device product liability cases prefer the rules of evidence to be fast and loose, allowing them to spin a narrative that riles up the baser instincts in the jury, whereas defense counsel in such cases prefer that evidence be focused on the issues that the jury will be asked to decide. In any event, knowing what evidence will be coming in on what issues allows both sides to prepare their respective case so that the jury can hear something coherent. The Federal Rules of Evidence give trial judges a fair amount of latitude to maximize the chance that the jury will understand the evidence presented and how it fits with what they are asked to decide. The Christiansen rulings do a pretty good job of that.
In addition to what she could offer from her ten experts and apparently friendly implanting surgeon, plaintiff wanted to offer “fact” testimony from four other orthopedic surgeons who had not treated her and were not designated as experts. We can think of three basic plausible ways, but maybe objectionable depending on the facts, that these non-treating surgeons could be fact witnesses: 1) they could have something to say about their personal involvement in designing the product at issue; 2) they could have some interaction with the manufacturer before the plaintiff’s implant that allegedly provided notice of the risk of the injury that plaintiff claims (“metallosis” per the prior decision); or 3) they could have done some study on the risks and/or benefits of the product that they will talk about. No, plaintiff wanted them to talk about whether the product was defective under Utah’s consumer expectations test—with an orthopedic surgeon being the consumer for this prescription device—and what the manufacture told them about the device.
We have not posted for a while—that day job can really get in the way sometimes—so we agreed to tackle the ridiculously long decision in Christiansen v. Wright Med. Tech. Inc., MDL No. 2329, 1:13-cv-297-WSD, 2015 U.S. Dist. LEXIS 115601 (N.D. Ga. Aug. 31, 2015), as a bit of penance. This act may be appropriate given the recent Day of Atonement and, much like long Yom Kippur services during a fast, the decision drags on, repeats itself, has some highs and lows, and maybe induces some confusion and a touch of a headache. While we are not looking for a scapegoat, some of the reasoning for why the issues were presented how they were presented and why they were decided is lost on the reader, at least this reader. (Much like the original meaning of Azazel, to where/whom the original scapegoat was to be sent by Aaron. Or maybe not at all like that.) As a combination Daubert and summary judgment order on a bellwether case from an MDL for a product, a metal-on-metal hip implant, for which there is considerable litigation on similar products made by other manufacturers, there will likely to attempts to extend various parts of this decision to other cases. So, we will resort to the dreaded use of subheadings in discussing it.
Plaintiff had a left hip replacement in 1995 with a device that used a ceramic femoral ball, a polyethylene liner, and a metal acetabular shell. In 2006, plaintiff had her right hip replaced with the defendant’s product, which utilized a ball and cup each made of cobalt-chromium with no liner. In 2012, plaintiff started experiencing pain in her right hip and, within a week, had a revision surgery where the defendant’s product was explanted (and presumably something else was implanted). All three surgeries were done by Dr. Lynn Rasmussen, who happened to have been consulting with defendant on designing hip implants in between the second and third surgeries. In doing the third surgery, Dr. Rasmussen observed what he called “metallosis” (sometimes “metalosis” in the records and briefs), but did not send any explanted tissue or material for pathological evaluation. Plaintiff sued under a range of product liability theories based on the risk of “metallosis.” Thereafter, plaintiff named at least ten experts to weigh in on causation and defect in some form or other, most of whom relied to some degree on Dr. Rasmussen’s characterization of what he saw—and defendant filed a bunch of Daubert motions. Plaintiff filed a “motion for partial summary judgment” that preemption and the learned intermediary doctrine did not apply to her claims and, at the court’s request, the defendant filed a motion for summary judgment on all the claims that plaintiff did not drop. An affiliated defendant also filed for summary judgment on different grounds. There were some other motions we are ignoring, but everything was addressed in one big decision.
We’ve blogged before about the split among Utah courts about whether Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), preempts the fraud on the FDA exception to Utah’s statutory bar (Utah Code Ann. §78B-8-203) against punitive damages where the product complies with FDA standards.
The first case, Grange v. Mylan Laboratories, 2008 WL 4813311 (D. Utah Oct. 31, 2008), got it right. Buckman‘s rationale extends to any state-law assertion of fraud on the FDA that could bring about submission to the FDA of unnecessary and unwanted information due to fear of later tort liability.
Indeed, since punitive damages can (and often do) exceed compensatory damages in their amounts, allowing punitive damages based on fraud on the FDA is even more likely to bring about the prophylactic conduct that Buckman decried than the claim in Buckman itself – particularly since punitive damages are frankly intended to “deter” the conduct they punish – and thus create precisely what Buckman held was unacceptable.
The next case, Lake-Allen v. Johnson & Johnson, 2009 WL 2252189 (D. Utah July 27, 2009), botched the issue, for some reason asserting that Buckman involved express preemption. We criticized this patently wrong result here.