Happy New Year from all of us here at DDLaw! And happy old year, too. Was it a happy old year? In many ways it was, and it’s the purpose of this post, to list some of our top reasons why. So here are our choices for the best prescription medical product liability decisions of 2013. These are the decisions that put us in a most festive mood during this festive time of the year. And we are festive. This is the first time that our #1 best decision, has overturned last year’s #1 worst decision. It’s hard to beat that. The Supreme Court was good to us this year, but so were quite a few other courts.
So, the envelopes please – let’s get down to handing out this year’s DDL judicial Oscars. Here are our ten favorite judicial decisions (and some honorable mentions) involving drugs, medical devices, and vaccines in 2013.
1. Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013). Well, duh. The Supreme Court agreed with our assessment last year of the First Circuit’s decision. We posted that the “rationale . . . that nothing requires a manufacturer actually to sell a drug that the FDA has approved . . . like the lobbying argument rejected in Mensing . . . proves way too much.” The Supreme Court held that “[i]n every instance in which the Court has found impossibility pre-emption, the ‘direct conflict’ between federal- and state-law duties could easily have been avoided if the regulated actor had simply ceased acting.” 133 S. Ct. at 2477. Adding Bartlett to Mensing, means that warning claims are preempted, design claims are preempted, and plaintiffs can’t argue that a generic drug manufacturer should either go to the FDA to get its label changed or get out of the market. There’s not much left that generic plaintiffs can argue. About the only hope they have left is that the FDA might change the rules – which we think is a long shot − and even the FDA modifying its regulations wouldn’t apply to any prescription written before any new rule was effective. But there’s more. The implied preemption rationale that design claims demand the “impossible” because design changes require FDA preapproval isn’t limited to generic drugs. Nor is the Court’s rejection of the “stop selling” rationale. Preemption of these sorts of claims should extend to all prescription drug and medical device litigation. Indeed, tying impossibility preemption to the need for prior Agency action, should eventually have a variety of beneficial preemption consequences – on everything from off-label warnings, to comparative labeling. So Bartlett is our #1 decision of the year, and it wasn’t close. As you might expect, we blogged about Bartlett a lot, including here and here.
2. Strayhorn v. Wyeth Pharmaceuticals, ___ F.3d ___, 2013 WL 6224337 (6th Cir. Dec. 2, 2013). In cases involving generic drugs, our preferred outcome is the “one-two punch,” with generic manufacturers winning on preemption grounds coupled with a ruling that innovator manufacturers did not make the product that the plaintiff used, and therefore cannot be liable under any tort theory. Strayhorn is the best of a number of similar 2013 post-Bartlett decisions of this sort. For one thing, it considered and found “unpersuasive” the no-preemption non-rationale of the Reglan Trilogy (2013 #-4). For another, it held that “consumer expectations”-based design defect claims were also preempted because prescribers relied on warnings in forming expectations. On the innovator side, all informational claims, including oddball ones bases on alleged ghostwriting, “sponsored” CME, and seminars, fail in the absence of use of the defendant’s product. Also, Strayhorn relies on our favorite Erie principle – that federal courts are not to predict adventuresome expansions of state-law liability. We hailed Strayhorn here.
3. Perez v. Nidek Corp., 711 F.3d 1109 (9th Cir. 2013). Just when we thought that preemption in the Ninth Circuit had gone to hell in a handbasket in Stengel (2013 #-2), along comes Perez. First, the court held as a matter of law that off-label use was not “medical experimentation” under a California statute, but it was just getting warmed up. Distinguishing Stengel, Perez found all of the plaintiff’s claims concerning alleged off-label promotion of a PMA medical device preempted – in particular the demand for special labelling concerning off-label use. As we pointed out earlier this month, that’s squarely within the FDA’s bailiwick. We praised Perez here.
4. Carrera v. Bayer Corporation, 727 F.3d 300 (3d Cir. 2013). Carrera is the best class action case of the year in the FDA-related products field, although it technically involves a dietary supplement rather than a prescription medical product. Carrera puts teeth in the aspect of manageability requiring that a class must have a membership that is ascertainable without that, too, becoming a long, drawn out, and individualized process. The defendant (like most drug and device manufacturers) didn’t sell directly to end users. The defendant had no lists of purchasers, and there was no evidence that consumers themselves kept any records that would make up for this glaring absence of proof. The Third Circuit reversed certification, requiring that there be “objective criteria” for ascertaining class membership. Otherwise, a defendant has no way of defending against a mass of unprovable claims, and class certification could amount to a due process violation. A defendant having the right to defend – what a novel concept in class actions. Anyway, Carrera ranks high on our list, despite being a supplement case, because it imposes significant restrictions on remote end-user consumer class actions, where arbitration clauses are less likely to be useful. We analyzed Carrera here.
5. United State ex rel. Ge v. Takeda Pharmaceutical Co. Ltd., ___ F.3d ___, 2013 WL 6399780, (1st Cir. Dec. 6, 2013), which affirmed 2012 #+20, demonstrates that there are some claims against drug companies that even the First Circuit can’t stomach. Specifically, the court rejected as woefully inadequate the plaintiff’s (relator’s) attempt to cobble together “false claims” out of allegations amounting to nothing more than accusations of fraud on the FDA (remember, the FCA is a federal statute, so there’s no preemption) by means of underreporting of adverse drug events. For once, the First Circuit enforced pleading rules regarding causation that, if applied consistently, should preclude such allegations from being pursued en masse. If this type of claim can’t survive even in the First Circuit, it doesn’t have much of a future – if it can’t make it there, it can’t make it anywhere. We discussed Ge here.
6. Morris v. PLIVA, Inc., 713 F.3d 774 (5th Cir. 2013). Shortly after the First Circuit’s frolic and detour in Bartlett, when we most needed appellate fortification of generic preemption, Morris provided it. Most critically, it gave the back of the judicial hand to that dangerous “just stop selling the product altogether” argument, when that treatment was most needed. But, not only did Morris reaffirm preemption and hold that there’s no state-law duty to adopt a label that the plaintiffs still allege is “inadequate,” it was also the first appellate decision to reject the notion that an FDA reference listed drug designation somehow made a difference. We applauded Morris here.
7. In re Fosamax Products Liability Litigation, ___ F. Supp.2d ___, 2013 WL 3270387 (D.N.J. June 27, 2013). After the debacle in Wyeth v. Levine (2009 #-1) favorable preemption decisions involving warnings for innovator drugs have become quite uncommon. Fosamax is a welcome exception. The kind of Levine-mandated “clear evidence” that the FDA wouldn’t have approved a label change was provided by the Agency’s rejection of a pre-approval supplement concerning the same claimed risk and under the same standard of scientific evidence also utilized in determining when a CBE submission is required. The FDA had been reviewing all the drugs in the same class and, unlike Levine, had more overall information than any particular manufacturer. We’ve heard that, under the recent Fosamax settlement, this case won’t be appealed, so we’re pleased to put this one in our pocket. We cheered Fosamax on here.
8. Solomon v. Bristol-Myers Squibb Co., 916 F. Supp.2d 556 (D.N.J. 2013), along with Cooper v. Bristol-Myers Squibb Co., 2013 WL 85291 (D.N.J. Jan. 7, 2013), Begley v. Bristol-Myers Squibb Co., 2013 WL 144177 (D.N.J. Jan. 11, 2013), LaBarre v. Bristol-Myers Squibb Co., 2013 WL 144054 (D.N.J. Jan. 11, 2013), aff’d, ___ F. Appx. ___, 2013 WL 6053840 (3d Cir. Nov. 18, 2013), Carr-Davis v. Bristol-Myers Squibb Co., 2013 WL 322616 (D.N.J. Jan. 28, 2013), and Mattson v. Bristol-Myers Squibb Co., 2013 WL 1758647 (D.N.J. Apr. 24, 2013). This batch of similar summary judgment decisions all arose out of the Plavix MDL. They employ excellent reasoning, viewing each state’s law separately, refusing to allow novel claims (such as warning claims based on “lack of efficacy”), finding the label adequate as a matter of law, trashing bad experts, and properly applying warning causation issues under the learned intermediary rule – and the only appeal so far has produced an affirmance. But more broadly, they exemplify what we think even-handed MDL practice should be. Too often, MDL judges postpone case-specific, or state-specific legal issues until after cases are remanded (years later) to the courts from which they came. Allowing weak cases to persist, cases that would have been dismissed if litigated individually, puts an pro-plaintiff thumb on the scale in MDLs by preventing the ordinary winnowing process. Not in Plavix. This judge acts like a judge and decides cases, instead of behaving like a glorified settlement master. We blogged about these Plavix cases several times, here, here, and here, and here.
9. Caplinger v. Medtronic, Inc., 921 F. Supp.2d 1206 (W.D. Okla. 2013). We’ve pointed out that Medtronic’s Infuse litigation has generated a lot of favorable precedent about preemption and off-label use recently. You know how much we love preemption and off-label use. Caplinger was the first (and still arguably the best) of the lot, accepting propositions that PMA preemption applies to devices, not uses; that “off-label promotion” is not a proper parallel claim; that any claim dependent on the scope of the FDA’s label is really a disguised FDCA violation claim; and any claim premised on a PMA device’s safety and effectiveness is preempted. Full disclosure, Caplinger is an RS case. We, or should we say the non-RS part of “we,” blogged about Caplinger here.
10. Atwell v. Boston Scientific Corp., ___ F.3d ___, 2013 WL 6050762 (8th Cir. Nov. 18, 2013). Large-scale misjoined multi-plaintiff complaints are one of the banes of a mass tort defense lawyer’s existence. There are many reasons why plaintiffs do this (including cheating courts out of filing fees), but the chief one is to keep themselves out of federal court despite suing diverse defendants. After CAFA, most plaintiffs pursuing this strategy take care to keep the misjoinders under the 100-plaintiff CAFA limit for “mass actions.” However, plaintiffs want to have their cake and eat it too, so they try to “coordinate” these actions in state court. Atwell said “no dice” to the subterfuge and held that a request to coordinate cases involving the same product and defendant created a “mass action” when the plaintiffs wanted to imitate an MDL and have bellwether trials. Into federal court they went – and stayed. We lauded this result here.
Those are our top ten, but as in other years we also can’t ignore other favorable results that didn’t quite make our top ten. So, as they say in NOLA, laissez les bon temps rouler. To round out the festivities, here are our Honorable Mentions:
(11) Lamere v. St. Jude Medical, Inc., 827 N.W.2d 782 (Minn. App. 2013) – because a lot of medical device companies are based in Minnesota, it was particularly gratifying to see that state’s appellate court restrict “parallel claims,” particularly with respect to vague GMP regulations. See our post here;
(12) Guarino v. Wyeth, 719 F.3d 1245 (11th Cir. 2013) – another good “one-two punch” generic drug affirmance, just not as timely as Morris, being decided the day after Bartlett. See our post here;
(13) Kiobel v. Royal Dutch Petroleum Co., 133 S. Ct. 1659 (2013) – what’s a Supreme Court case doing down here? Well, it’s not a product liability case. Held: the Alien Tort Statute doesn’t create tort liability for acts taken overseas. That eliminates awful decisions like Abdullahi (2009 #-2 (after only Levine)), and that’s something. But it’s not something we see a lot, so it’s not more highly ranked. See our post, here;
(14) Calisi v Abbott Laboratories, 2013 WL 5441355 (D. Mass. Sept. 27, 2013) – when you’re in mass tort litigation, getting your label declared adequate as a matter of law is a big deal. That and more took place in Calisi. See our post here;
(15) In re Fosamax Products Liability Litigation, 707 F.3d 189 (2d Cir. 2013) – it’s not very often that an appellate court comes right out and calls the testimony of a plaintiff’s expert (a treater turned plaintiff’s expert) an outright “sham,” but that’s what happened in this case. See our post here;
(16) Goldin v. Smith & Nephew, Inc., 2013 WL 1759575 (S.D.N.Y. April 24, 2013) – there were a number of good TwIqbal decisions in 2014, particularly in New York federal courts. Goldin led the way. See our post here;
(17) Payne v. Novartis Pharmaceuticals Corp., 2013 WL 4779571 (E.D. Tenn. Sept. 6, 2013) − probably the strongest application of warning/causation we’ve seen all year. See our post here;
(18) Jenkins v Medtronic, ___ F. Supp.2d ___, 2013 WL 6172234 (W.D. Tenn. Nov. 21, 2013) – a while ago we surmised that PMA medical device cases raising primarily “parallel claims” might be removable under a Grable federal question basis; in Jenkins that finally happened;
(19) In re Pelvic Mesh/Gynecare Litigation, No. ATL-L-6341-10, slip op. (N.J. Super. Law Div. Dec. 3, 2013) – we’ve been critical of the lack of a level playing field in New Jersey with respect to informal interviews with treating physicians for quite some time. But things in New Jersey changed last year (2012 #+5). Now even Judge Higbee is requiring plaintiffs and defendants to play by the same rules. See our post, here;
(20) In re Fosamax Products Liability Litigation, ___ F. Supp.2d ___, 2013 WL 4306434 (S.D.N.Y. Aug. 15, 2013) – a “bullseye” in our estimation. The court bluntly recognizes the pickle generic plaintiffs are in after Bartlett. Preemption bars demands for changes to both design and warnings, and also removes removal from the market claims. What’s left? Nothing, according to this decision. See our post here.
Looking back, all of our top ten from 2012 remain intact, with only POM Wonderful (2012 #+8) still at risk – a certiorari petition is pending, but the Solicitor General recently opined that the Supreme Court should not take the case. All of our honorable mentions from last year have survived as well with the Ge case (as mentioned) being affirmed. As for our bottom ten, as we mentioned above, Bartlett (2012 #-1) was reversed.
Looking ahead, Weeks (2013 #-5) has been argued on rehearing, and we await a decision. In the Supreme Court, we’re looking forward to decisions whether: (1) the reliance requirement in fraud claims can be finessed by a “fraud on the market” presumption, in Halliburton Co. v. Erica P. John Fund, Inc., No. 13-317; and (2) CAFA (in accordance, we believe, with how the Founders intended diversity jurisdiction to work) puts state AG actions against out-of-state corporate defendants into federal court, in Mississippi v. AU Optronics Corp., No. 12-1036. We are also following an Attorney General’s action before the Arkansas Supreme Court (State ex rel. McDaniel v. Janssen, No. 13-102) that hasn’t generated any opinions yet, but did produce a $1.2 billion verdict. From this year’s lists, Stengel (2013 #-2) has a certiorari petition pending and the Solicitor General’s office has been asked for its view. Caplinger (2013 #+9, above) is on appeal to the Tenth Circuit. At least some of the Reglan Trilogy (2013 #-4) and Malander (2013 #-6) will be appealed to their respective state high courts. From last year, the Caldwell false claims act case (2012 #-2) remains pending before the Louisiana Supreme Court. The perpetually pending Lance case (2010 #-6) remains undecided by the Pennsylvania Supreme Court, some three years after oral argument.
Next year, we’ll also start to see the fall-out from the FDA’s proposal to change the rules to eliminate generic drug preemption, although we doubt that process will run its course in 2014.
So next stop, 2014. We wish an equally Happy New Year to all our readers on the right side of the “v.”.