Mention the Third Restatement of Torts and the learned intermediary rule in the same sentence, and our response would be to cite §6(d) of the product liability part of the Restatement. But the Third Restatement also confirms that this widely followed (perhaps the most widely followed) legal rule also applies to negligence causes of
Recently, Bexis attended the DRI drug and device committee spring conference. Among other things he heard a bang-up presentation on genomics and personalized (also known as “precision”) medicine from Paige Sensenbrenner. On that same day, co-blogger Steve Boranian alerted Bexis to a new defense argument in asbestos/mesothelioma cases that also utilizes genomics – certain mutations in a gene called “BAP1” – to identify persons at greater risk of idiopathic (that is, not related to asbestos) mesothelioma. Here’s a link to that article. A verifiable alternative cause could be a game-changer for asbestos litigation. The statement we quoted back in 2009, uttered by the first person ever to have his genome individually sequenced, that “individual genes are just not very informative,” appears in the process of being disproven by ongoing scientific events.
Both items, as informative as they were on scientific facts, were rather short on the law. That’s where we come in. We thought we’d take a look at what law exists concerning the intersection of pharmacogenomics, personalized medicine, and prescription medical product liability litigation. We’ve touched on these issues back in 2011, when we blogged about Mills v. Bristol-Myers Squibb Co., 2011 WL 4708850 (D. Ariz. Oct. 7, 2011), one of the first cases in which the plaintiff made allegations about pharmacogenomically-based risks. Back then we said:
The plaintiff is claiming that a drug is defective, not because of anything inherent in the drug itself, but solely because it is less effective (and therefore has a different risk-benefit profile) due to the plaintiff’s peculiar genetic makeup. Essentially, the allegations seek to impose a non-FDA-approved contraindication, using state law, based upon human genetic variability. With advances in computer technology making genetic testing exponentially cheaper and more detailed as times passes (see Moore’s law), more and more genetic variability in the efficacy of prescription drugs is bound to be discovered. Eventually – certainly within some of our lifetimes – we’ll be able to carry our entire individual genetic code around with us on a chip, should we so choose….
The complaint in Mills is a bare genetic susceptibility claim, frankly based on an allegation of “variant” genetic characteristics shared by only a minority of the population. In our view, unless and until – and only to the extent that – the FDA decides to assess drug approvals and contraindications on the basis of genetic subgrouping, this type of tort claim should not be recognized, because it is flatly contrary to the criteria by which the intended uses of drugs are currently determined. Claims such as in Mills, which are at loggerheads with FDA criteria for drug development, are precisely those with the most potential for making pharmaceutical manufacturers into “sitting ducks” for litigation, in this instance litigation based on extraneous genetic factors.
It may well be that the coming (and to some extent existing) revolution in genetically individualized medical therapy will require changes in how drugs are evaluated, labeled, etc., but this is a singularity-driven issue that needs to be addressed by the policy branches of our government, and not haphazardly in product liability litigation.
Perhaps you’ve seen the video of trees disappearing into a Louisiana bayou sinkhole. It is dramatic and it reminds us of the feeling that Louisiana litigation has occasionally served up to us over the years. Maybe it is the steamy climate (we mean the legal stuff, not the astonishing humidity), with plaintiff lawyers doing A-plus imitations of Foghorn Leghorn, that makes litigation in the Pelican state … unique. Right now we are thinking of an especially flamboyant Louisiana lawyer who is crazily combative (we were at a deposition where he threw punches), crazily successful, and, not to put too fine a point on it, crazily crazy. The fact that many of you out there are scratching your heads and wondering exactly which crazy Louisiana plaintiff lawyer we are talking about says something. But meanwhile, some really smart judges down there have been sneaking up on us with really smart decisions. Les bon temps rouler, indeed.
The case of Scianneaux v. St. Jude Medical, S.C., Inc., 2013 U.S. Dist. LEXIS 117081 (E.D. La. Aug. 19, 2013), is a gumbo bowl of tasty legal reasoning. In just a few pages, the judge clearly and elegantly disposes of a device case that might have provoked bloviation and evasion in some other courts. The court correctly applied the TwIqbal pleading standard to swat away the usual “parallel claim” effort to circumvent preemption. You arrive at the inevitable conclusion before getting to the bottom of your glass of sweet tea. Or, if you are of a certain bibulous nature, your Hurricane or sloe gin fizz.
Boring title, but accurate. Here’s the latest.
First, Medtronic won another one the other day. Duggan v. Medtronic, Inc., ___ F. Supp.2d ___, 2012 WL 45503 (D. Mass. Jan. 10, 2012), involved an insulin delivery system. It had a number of components, including the pump, which physically moved the insulin from where it’s stored into the body. Plaintiffs alleged that the pump malfunctioned and caused undisclosed injuries.
The insulin system was a PMA device, so the defendants moved for summary judgment on grounds of preemption. Plaintiffs targeted the pump, rather than any other aspect of the system, because the pump had originally been §510k cleared (unpreempted under Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)) – by itself – in 2004. The insulin delivery system predated the pump, and was PMA approved. By PMA supplement in 2006, the FDA approved incorporation of the pump into the system. The plaintiff was prescribed that system. Duggan, 2012 WL 45503, at *3-4.
We’ve been around the preemption block a few times – we know what happens when the mainstay claim in prescription medical product liability litigation, that being inadequate warnings, gets preempted.
We first saw it in DTP vaccine litigation. We made a little headway with preemption and plaintiffs responded with “design’ claims based on non-FDA-approved formulations. It took the Vaccine Act to bury those.
We saw it again in Bone Screw litigation, pre-Lohr. Plaintiffs responded with fraud on the FDA claims. It took Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), to do those in.
We saw it yet again in prescription drug litigation, pre-Levine. Plaintiffs responded with all manner of things – design defect claims with no alternative design at all, failure to test, illegal promotion, you name it. Some of these we’re still fighting, but with the preemption threat to warning claims removed, most of these have receded into the background.
We saw – and see – it a fourth time in PMA medical devices, especially after Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). The plaintiff’s alternative has been disguised private FDCA enforcement actions presented as “parallel violation” claims.
And we expect to see it again now that PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), has knocked out warning claims in generic drug cases. So what’s the non-traditional (a/k/a weird) claim of choice there going to be? The jury’s still out on that, but judging from the Mensing reargument petition, which we discussed here, one oddball claim under serious consideration by the other side is the notion that a defendant can have a common-law obligation simply not to sell its product at all.
In other words, the flavor du jour in generic cases could be failure to recall, resurrected from what has to date been extensive and well-deserved judicial repudiation.
The plaintiffs in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) (not sure why it’s all-caps, but that’s the way the Supreme Court has it), have sought reargument. Here’s a copy of their petition.
Any Supreme Court rehearing petition is a long shot, but in this case, we’d have to say it’s worse…
Last week we reported on two recent decisions by the Pennsylvania Superior Court (an intermediate appellate court) in fen-phen litigation. Well, there was a third shoe out there, and yesterday it dropped. In Lance v. Wyeth, No. 2905 EDA 2008, slip op. (Pa. Super Aug. 2, 2010), affirmed – for the first time in a reported appellate decision in Pennsylvania – that the restrictions on strict liability recognized by the Pennsylvania Supreme Court in Hahn v. Richter, 673 A.2d 888 (Pa. 1996), precluded any claim for strict liability design defect in product liability litigation involving prescription drugs (and, we presume, medical devices as well.
Although Appellant labels her claim as “negligent and unreasonable marketing,” her proposed cause of action duplicates a design defect claim, seeking to impose strict liability on [defendant] because [its drug] was unreasonably dangerous. With our Supreme Court’s adoption of comment k, a design defect claim for strict liability is not cognizable under Pennsylvania law when it is asserted against a manufacturer of prescription drugs. For purposes of strict liability and §402A, a drug cannot be deemed unreasonably dangerous, even if it is defectively designed, so long as the drug is manufactured properly and contains adequate warnings.
Slip op. at 7-8 ¶15. We’ve made the argument, of course, that Hahn precluded strict liability of any sort (other that manufacturing defects, which are pretty rare), but now we’ve got an appellate court for the proposition.
But then the court goes and recognizes a negligent design claim for a prescription drug. That’s better than strict liability, given Pennsylvania’s weird evidentiary restrictions, but not by all that much. The court bases it on two things: (1) that Restatement of Torts §395 “contains no exemption or special protection for prescription drugs” and (2) the statement in Restatement of Torts §402A that strict liability “is not exclusive, and does not preclude liability based upon the alternative ground of negligence.” Slip op. at 10-11 ¶¶18-19.
This week the Superior Court of Pennsylvania (the intermediate appellate court) issued two new opinions on warning causation in the context of the learned intermediary rule. Cochran v. Wyeth, Inc., ___ A.2d ___, No. 2838 EDA 2008, slip op. (Pa. Super. July 27, 2010), and Owens v. Wyeth, No. 185 EDA 2009, slip op. (Pa. Super. July 26, 2010) (memorandum).
Both of these cases arise from the few remaining fen-phen cases in Philadelphia County, which involve primary pulmonary hypertension as the claimed injury. Obviously, Cochran is the more important of the two, because it will be published, and is precedential.
Cochran involved a peculiar warning claim. The plaintiff conceded that the warnings regarding primary pulmonary hypertension were adequate. Instead she claimed that the warnings about valvular heart disease (VHD) – a condition she admittedly never contracted – were inadequate, and that had the prescribing physician been warned of that risk (as opposed to PPH), he would not have prescribed the drug. Obviously, opening up the entire warning to inadequacy attacks, regardless of the injury actually suffered, would have been a major increase in the scope of liability. Fortunately the Superior Court didn’t buy the theory:
Here, [defendant] allegedly breached its duty in failing to disclose the risk of VHD, and Appellant’s injury was PPH. The risk of VHD did not develop into the actual injury of VHD. Although [the prescriber] testified in his deposition that he would not have prescribed [the drug] to Appellant had he known of the risk of VHD, this does not alter the fact that [defendant] failed to disclose the risk of VHD and Appellant suffered from PPH. In these circumstances, the relationship between the legal wrong (the failure to disclose the risk of VHD) and the injury (PPH) is not directly correlative and is too remote for proximate causation. Therefore, as a matter of law, there is no proximate, causal connection between [defendant’s] failure to disclose the risk of VHD and Appellant’s specific injury.
Cochran, slip op. at 14-15.
Last Friday we had a brief post about the new decision in Bartlett v. Mutual Pharmaceutical Co., 2010 WL 2765358 (D.N.H. July 12, 2010). That was a tickler; we promised you a more fulsome discussion of the opinion later.
Well, later is now, so here goes.
Briefly, the product involved in Bartlett is generic Sulindac, an anti-inflammatory NSAID. The plaintiff was prescribed Clinoral – the branded version of the drug – but in an increasingly common scenario, plaintiff’s pharmacist substituted generic Sulindac. 2010 WL 2765358, at *1. Plaintiff came down with Stevens-Johnson Syndrome (“SJS”), a nasty condition that among other things left her permanently blind.
Plaintiff sued, and we suppose in the course of discovery, discovered FDA-related issues with the generic manufacturer’s ongoing post-marketing research – like there wasn’t any. The following facts were taken as true for purposes of the defendant’s summary judgment motion:
More than a year before these events [that is, plaintiff’s prescription], an international medical journal published a study of the link between NSAIDs and [SJS]. The study revealed that . . . Sulindac had 89 reported cases of [SJS] . . . more than any other NSAID on the market and all but four drugs of any kind. [Defendant] was not aware of that study, however, because it had not been monitoring the medical literature for information about Sulindac’s safety risks. [It] believed that the manufacturer of Clinoril, the brand-name version of the drug, was responsible for such monitoring.
2010 WL 2765358, at *2.
At the time of the prescription, the defendant’s FDA-approved label didn’t mention SJS by name, instead describing it as “hypersensitivity” – albeit specifically mentioning “severe skin reactions” and “fatalities.” Id. Thus, the state of the labeling was something that, on the whole, tended to favor the plaintiff.
Once upon a time, quite a few years ago, one of us had the pleasure of a having a case before the (late?) Hon. John Dowling of the Dauphin County (Harrisburg, Pa.) Court of Common Pleas. We still remember winning the case on summary judgment – after finishing our argument, the first words out of…