You have to hand it to the Academy of Motion Pictures. By expanding the number of Best Picture nominees, it ended up selling lots more tickets. Like many people we know, we try to see all the Best Picture nominees so as to earn the right to grouse about the Academy’s inevitable injustices (e.g., Oliver!
Bexis is updating chapter 4 of his book, which includes a thorough discussion of negligence per se. Negligence per se in the context of the Food, Drug & Cosmetic Act (“FDCA”) has taken on increased salience, particularly in preemption cases where courts leave an “out” for parallel claims. Because there must be a pre-existing
It’s written somewhat strangely – weak at the beginning, strong at the end – but the Department of Justice’s amicus curiae brief , filed yesterday in Mutual Pharmaceutical Co. v. Bartlett, No. 12-142 (U.S. pending), eventually gets to the right place. That is, even the generally anti-preemption political leadership of this FDA and DoJ took the only institutionally logical position that they could take and told the Supreme Court that, yes, state tort claims asserting that an
FDA-approved product should have been removed from the market altogether were impliedly preempted.
Because we like good news (and still can use some after Stengel and Weeks), we flip right to the back of the DoJ’s Bartlett brief. The last substantive paragraph states:
Federal law would preempt a pure defective-drug-design claim that required a jury to second-guess FDA’s safety determination, without any further need to find the existence of new and scientifically significant evidence that rendered the product misbranded under federal law.
DoJ Bartlett br. at 34.
Let’s look at this. First of all, what’s this “pure” design defect business? As we said above, the DoJ brief starts out weakly, trying to turn Bartlett into something it wasn’t in order to avoid what it was. Instead of what really went on at trial (the trial court allowing plaintiffs’ counsel to ask the jury to flip a bird at the FDA), the DoJ first portrayed the verdict as based primarily on an “unreasonably dangerous even with warnings” theory under Restatement (Second) of Torts §402A, comment k (1965). DoJ br. at 14-18. The primary purpose of that argument was to reduce Bartlett to a “nothing to see here” misapplication of Mensing.Continue Reading Bartlett – DOJ Says Remove-From-The-Market Claims Preempted
This post is really the work of co-blogger Eric Alexander, but technical problems meant that Bexis had to post it.
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On this week of Martin Luther King Day and the Presidential Inauguration, we start this post with some regrets. We regret that we lack the eloquence to offer a sufficiently meaningful link between
Earlier this month we featured a guest post on a potentially game-changing forum non conviens decision by the Illinois Supreme Court, Fennell v. Illinois Central Railroad, ___ N.E.2d ___, 2012 WL 6725822 (Ill. Dec. 28, 2012). While Fennell was an asbestos case, our reading of the case suggested that it would be equally applicable
Here’s another “guest” post (at this point, only in the sense that we have to load it) from our semi-regular contributor, Melissa Wojtylak of Reed Smith. She gets all the credit for her work.
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The Fourth Circuit is the latest court to reject a claim that prescribing a drug for off label use gives rise to False Claims Act liability. As regular readers of the blog know, the False Claims Act imposes liability for knowingly presenting a false or fraudulent claim for payment to the government. See 31 U.S.C. § 3729 (a)(1)(A). And as regular readers also know, in recent years, enterprising relators (who can often also be described as “disgruntled former employees of the defendant”) have attempted to cash in under the FCA by bringing qui tam actions against pharmaceutical companies, claiming that the company purposely marketed its drugs for off-label uses. While various explanations and theories are advanced by these relators, the underlying premise of these actions is essentially the flawed proposition that the mere existence of off label use of a drug is, in and of itself, a bad thing. Which, or course, it isn’t. As we’ve discussed on the blog in the past, several courts have seen the flaw in this logic and sent relators packing.
In U.S. ex rel. Nathan v. Takeda Pharmaceuticals North America, Inc., 2013 U.S. App. LEXIS 765 (4th Cir. Jan. 11, 2013), the Fourth Circuit affirmed a district court’s dismissal of the relator-plaintiff’s third amended complaint on the grounds that it did not plausibly allege that any false claims had ever been presented to the government for payment, let alone that any conduct on the defendant’s part – in particular, an alleged scheme of promoting drugs for off-label uses − had caused those phantom claims to be presented. While the products liability lawyer in us in drawn to the latter part of that statement and really wanted to see the Fourth Circuit address it, the court didn’t, as it held that the relator couldn’t even get out of the gate on the first part – that is, the need to show that false claims for payment were in fact made to government programs such as Medicaid.
The court began its analysis by noting that the relator’s complaint was governed by Rule 9(b), which sets out the minimum standard for pleading an actionable (i.e., false) representation under the FCA. This relator, faced with a pesky absence of specifics about things such as the dates on which reimbursement claims were submitted to the government and who submitted them, argued that Rule 9(b)’s standard could be met if the complaint pled acts sufficient to show a scheme by the defendant to promote the drug for off label use. Id. at *11-14. Once that was done, relator argued, the court could plausibly find that false claims must have been presented as a result of this scheme. Id. Well, no, the court responded. Just because the existence of such a scheme could have led to presentation of false claims, it need not necessarily have done so, and therefore the relator was still required to plead some facts that showed that false claims actually were presented. Id. at *14. The court rejected cases cited by the relator in which other courts had relaxed the standard, while at the same time acknowledging that without such relaxation, some relators would face a tough road. In essence, the court held that the rules are the rules, for better or for worse, and the relator’s complaint would have to be judged by them.Continue Reading Off-Label Use and the False Claims Act – Another Win for Common Sense
This post is by the Reed Smith part of the blog only. The Decherts are too involved in this litigation to comment publicly.
There aren’t many research-oriented pharmaceutical companies based in Alabama, and after last week’s execrable decision in Wyeth, Inc. v. Weeks, ___ So.3d___, 2013 WL 135753, slip op. (Ala. Jan. 11, 2013), that’s not likely to change any time soon. We don’t know why that started; Huntsville, at least, has a distinguished scientific background (and there’s a statue of a Vulcan in Birmingham – wait a minute, the ears don’t match Spock’s), but it’s certainly true now. Unfortunately it appears that, instead of (or perhaps in addition to, given the recent election results) the Ten Commandments, there’s another commandment that the Alabama Supreme Court is following: Thou Shalt (if you’re an Alabamian) Recover From An Out-Of-State Drug Company.
While the Alabama Supreme Court certainly has the power to abandon the notion of manufacturer liability for defects in its products (unlike a federal court sitting in diversity), having the power to do something doesn’t make it right. And if there’s one thing that’s not right, it’s having the liability of a defendant non-manufacturer turn on what its competitors did (or didn’t do). And if there’s another thing that’s not right, it’s imposing liability on a product manufacturer that didn’t make a cent (and probably was driven out of the market by) from the product that actually caused the injury in question.
Nor is it very likely that this novel theory of “fraud/misrepresentation” liability can be limited to prescription drugs, whatever its intended scope. There are lots of situations in which products bear similar warnings.
Sometimes, as with prescription drugs, such similarity is mandated by the government (cars, for example, or chemicals); sometimes similarity is simply a function of similar products having similar risks, and thus requiring similar warnings. One such example could be asbestos. There were lots of different asbestos products, and the same kinds of asbestos products do (or, at least, plaintiffs allege they do) have similar risks. We have to think that asbestos plaintiffs are going to have a field day with Weeks – more, perhaps, than even generic plaintiffs, since the learned intermediary rule still applies to prescription drug cases.
Anyway, we could go through each of these policy considerations at length, but we’re not going to. We already did that in connection with the original decision in Conte v. Wyeth, 168 Cal. App. 4th 89 (Cal. Ct. App. 2008). So we’ll rely on our discussions there:
First, this kind of liability is contrary to the fundamental legal tenet that manufacturers’ are supposed to be liable because they made money putting the injurious product on the market:
Well, [branded liability] is an end run around the heart of modern product liability, which was created . . . some fifty years ago. [Courts] recognized a core principle of social responsibility that justified what was then a new form of liability: The purpose of this [product] liability is to ensure that the costs of injuries resulting from defective products are borne by the manufacturers that put such products on the market. In other words, because manufacturers profit from the sale of their products, it is appropriate for them to answer for injuries caused by defects in those products. Time after time, . . . liability for injuries caused by allegedly defective products has been justified by reference to this paramount policy.
DDLaw, Closing The Arguments On Conte (1/22/2009) (citations and quotation marks omitted).Continue Reading Weeks Reasoning – No Sweet Home In Alabama For Research Pharma
We (well, Bexis) doesn’t know all that much about Arkansas. He’s only been there once – if driving through without stopping on I-55 to Memphis many years ago counts. Even his massive (excessive?) million-plus word Harry Potter fanfic had only one Arkansas reference in it (about James Potter once being the lead singer for a Hogwarts band called “Black Oak Azkaban”). Bexis did, however, vote for Bill Clinton twice (and would happily have done so in every election since – peace, prosperity, and budget surpluses look pretty good in retrospect).
But Razorback-related ignorance didn’t stop Bexis from purporting to state Arkansas law recently in our 50-state survey of hospital strict liability. That post stated:
Arkansas
The Arkansas Supreme Court avoided the issue in Adams v. Arthur, 969 S.W.2d 598, 614 (Ark. 1998) (“we do not decide whether a hospital . . . may be strictly liable as a supplier”). The holding in Adams – that the strict liability claims were barred by the statute of limitations applicable to malpractice claims – is suggestive that no separate cause of action for strict liability exists, but that’s not the ruling. There’s also mention of a holding rejecting hospital strict liability in Kirkendall v. Harbor Insurance Co., 698 F. Supp. 768, 770 (W.D. Ark. 1988), but it’s in a procedural history discussion. If somebody has access to the order in Kirkendall, please send it to us.
That turned out well (no, nobody sent the missing Kirkendall order, but that hardly matters anymore). Apparently, Bexis missed the crucial case, at least according to some recent opinions that we’ve learned about on this topic. See Wages v. Johnson Regional Medical Center, ___ F. Supp.2d ___, 2013 WL 120888 (W.D. Ark. Jan. 9, 2013); Shepherd v. Baptist Health, ___ F. Supp.2d ___, 2012 WL 6811076 (E.D. Ark. Nov. 30, 2012); Gunn v. St. Vincent Infirmary Medical Center, 2012 WL 6811786, *1 (E.D. Ark. Nov. 29, 2012).Continue Reading On Speaking Too Soon