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This post comes from the Cozen O’Connor side of the blog.

We’ve been blogging about “removal before service” since we announced it to the world in 2007.  It’s a procedural tactic that enables defendants to remove cases to federal court despite the “forum defendant rule,” which ordinarily prohibits a defendant from removing to federal court a case that, while it meets the requirements of diversity jurisdiction under 21 U.S.C. § 1332(a), is also pending in the home state of the defendant. Here’s the rule as codified in 21 U.S.C. § 1441(b) (2):

A civil action otherwise removable solely on the basis of the jurisdiction under section 1332(a) of this title may not be removed if any of the parties in interest properly joined and served as defendants is a citizen of the State in which such action is brought.

(Emphasis added).

We emphasized the phrase “properly joined and served” because that’s the basis for “removal before service.” Defendants have had success, in certain courts before certain judges, arguing that this phrase should be interpreted according to its plain terms and that, therefore, a defendant who has not yet been served can remove a case on diversity jurisdiction grounds even if the case is in its home state court.

The court in Young v. Bristol-Myers Squibb Co., 2017 U.S. Dist. LEXIS 98736 (D. Del. June 27, 2017), is one of the courts that accepts this argument. Young was one of 33 cases in the Eliquis drug litigation that plaintiffs’ lawyers had filed in the Superior Court of Delaware. Each plaintiff and the two defendants, Bristol-Myers Squibb and Pfizer, were citizens of different states, suggesting that the cases were ripe for removal to federal court on the basis of diversity jurisdiction. But BMS and Pfizer are citizens of Delaware (as are so many corporations), implicating the forum defendant rule’s bar to removal of diversity cases.

But, as the Young court put it, all of this occurred “before Plaintiffs served (or, due to Superior Court procedures, could have served) their complaints on Defendants.” Id. at *2. The defendants had an opportunity. And they took it. They immediately removed the cases to the United States District Court for the District of Delaware where they had the good fortune of drawing a judge who had previously blessed “removal before service”—and did so again:

The undersigned judge has had several occasions to consider this issue. Having done so again, the Court sees no reason here to depart from its previously-adopted reasoning. See Munchel, 2012 U.S. Dist. LEXIS 128971, 2012 WL 4050072; Hutchins, 2009 U.S. Dist. LEXIS 4719, 2009 WL 192468. As in Munchel and Hutchins, the Court views the plain and unambiguous language of § 1441(b) as controlling. Section 1441(b)(2) provides that a case in which there is diversity jurisdiction “may not be removed if any of the parties in interest properly joined and served as defendants is a citizen of the State in which such action is brought.” Here, there is diversity jurisdiction, but because there was no service on any defendant before removal, none “of the parties in interest properly joined and served as defendants is a citizen” of “the State in which [this] action” was brought, i.e., Delaware. 28 U.S.C. § 1441(b)(2) (emphasis added).

Id. at *5 (emphasis in original). And so we have yet another decision approving “removal of service” under the plain terms of the statute.

In this instance, the Court suggested that it had an additional reason to rule the way it did. The plaintiffs had already engaged in forum-selection tactics of their own. The cases were originally filed in California state court, not Delaware. The defendants, who were not California citizens, promptly removed the cases to a federal court in California and started the process to transfer the cases to the Eliquis MDL, a place that plaintiffs most certainly did not want to be. So—and here it comes—the plaintiffs voluntarily dismissed all 33 cases. They then re-filed the cases, the very same day, in Delaware state court, a court from which they hoped the forum defendant rule would hamstring defendants from once again removing the cases to federal court. Id. at *1-2.

This history of forum shopping clearly influenced the Court’s decision on plaintiffs’ motion to remand:

Additionally, given the history of these cases — including that Plaintiffs voluntarily dismissed cases originally filed in California state court, seemingly (at least in part) to avoid transfer to the MDL — removal is not a nonsensical result. To the contrary, the totality of circumstances strongly supports exercising discretion to deny Plaintiffs’ motions to remand.

Id. at *4-5.

So the “removal before service” option lives on, at least in some courts. And Young offers precedent for an argument that “removal before service” may be even more appropriate when the history of the case suggests that the plaintiff had already engaged in some sort of procedural maneuvering before the case was even removed.

This post is from the Cozen side of the blog only.

The Third Circuit gets fraudulent joinder—as if the name of the doctrine isn’t enough to give it away. It refers to, quite simply, joining a defendant in a lawsuit for a purpose other than pursuing liability against that defendant. And so the Third Circuit, getting it, has established a standard for determining fraudulent joinder that considers more than simply whether the plaintiff’s complaint states a colorable basis for a claim against the defendant. It also considers whether the plaintiff has a good faith intent to actually pursue that claim. Earlier this month, we posted on a decision by a district court in the Third Circuit applying this standard to deny a plaintiffs’ remand motion.

Since then, in fact just last week, this standard once again played a pivotal role in a determination by a court in the Third Circuit—this time the Zoloft MDL court—that a plaintiff had fraudulently joined a defendant to defeat diversity jurisdiction. In Re: Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., 2017 U.S. Dist. LEXIS 94953 (E.D. Pa. June 20, 2017). In that case, California plaintiffs sued Pfizer entities, none of which were California citizens, in a California state court. That complaint would ordinarily have been removable to federal court based on diversity jurisdiction, but plaintiffs also sued a California defendant, the (possible) distributor McKesson. In theory, McKesson’s presence as a defendant would defeat diversity jurisdiction. But the defendants nonetheless removed the case to California federal court, from whence it was swiftly transferred to the Zoloft MDL in the Eastern District of Pennsylvania.

Plaintiffs filed their remand motion in that court, which sits quite snugly inside the Third Circuit. In considering plaintiffs’ motion, the court began by laying out the Third Circuit standard:

In order to establish fraudulent joinder, a defendant must prove that there is no reasonable basis in fact or colorable ground supporting the claim against the joined defendant, or no real intention in good faith to prosecute the action against the defendants or seek a joint judgment.

2017 U.S. Dist. LEXIS 94953, at *5-6 (emphasis added) (citing Boyer v. Snap-On Tools Corp., 913 F.2d 108, 111 (3d Cir. 1990)). The court focused on the second half of the standard: plaintiffs’ real intentions for suing McKesson. Importantly, the court had the history of the Zoloft litigation to consider. A large mass tort, maybe even a not-so-large one, inevitably creates a litigation history that will highlight litigation maneuvers and counsel that have used them.

Here, the litigation history was determinative. The same plaintiffs’ counsel, along with other plaintiffs’ counsel, had sued McKesson in other Zoloft cases and then not seriously pursued discovery from McKesson, at times even dropping it as a defendant:

[T]he Court has been made aware of no instance in which any of the numerous Zoloft plaintiffs have propounded meaningful discovery on McKesson in either state or federal court, even though some cases have gone to trial. This failure to seek discovery includes other cases brought by Plaintiffs’ counsel. The lack of discovery requests directed towards McKesson casts doubt on Plaintiffs’ intent to pursue claims against McKesson.

Even more significantly, the plaintiffs in numerous Zoloft cases have dismissed claims against McKesson both before and after the Court granted summary judgment in favor of Pfizer and another Defendant and the plaintiffs appealed to the Third Circuit. One of these cases had been filed by Plaintiffs’ counsel in this case.

2017 U.S. Dist. LEXIS 94953, at *9.

The court saw a pattern. It rejected plaintiffs’ arguments that the Federal Rules of Civil Procedure establish no discovery standard upon which to determine whether a party was properly joined, holding that, regardless, the court may consider relevant information from the history of the litigation to determine plaintiffs’ intent in suing McKesson. Id. at *10.

The court then coupled the historical failures of plaintiffs and counsel to pursue McKesson after naming it as a defendant with the lack of specific, particularized allegations against McKesson in the complaint to determine that McKesson had been fraudulently joined. With that, the court held that it, in fact, did have diversity jurisdiction over the case:

Plaintiffs here have asserted non-specific claims against McKesson, Plaintiffs’ counsel has in separate Zoloft actions failed to propound discovery on McKesson, and, most notably, Plaintiffs’ counsel has outright dismissed McKesson as a defendant in other state and federal Zoloft cases. The Court thus concludes that Plaintiffs lack good faith intent to prosecute their claims against McKesson. The Court finds McKesson to be fraudulently joined in this action, and therefore does not take McKesson into account during its diversity jurisdiction analysis. Without McKesson, there is complete diversity between Plaintiffs and Defendants, and no dispute that the amount in controversy exceeds $75,000. The Court thus has jurisdiction over this case.

Id. at *10-11.

Obviously, this standard, along with the growing list of decisions applying it to reject remand motions, is a useful tool available to defense lawyers involved in mass torts, particularly in the Third Circuit. Allegations that are sufficient to state a colorable claim against a non-diverse defendant may not be enough to save a case from removal. The litigation history matters. Did plaintiffs actually pursue discovery against the non-diverse defendant? Did plaintiffs dismiss the non-diverse defendant late in the litigation? Did plaintiffs’ counsel ever depose the non-diverse defendant or subject it to the lengthy stream of depositions that they no doubt took of the employees and executives of the defendant that was the real target? Did plaintiffs pursue summary judgment against the non-diverse defendant when they pursued it against the real target? Has plaintiffs’ counsel used this tactic in other mass torts and a court called them out on it? And so on. We like the Third Circuit’s standard because it takes account of reality, and we expect to see more decisions adopting and applying it.

Here’s the crux of today’s case, In re Trader Joe’s Tuna Litig., 2017 WL 2408117, at *1 (C.D. Cal. Jun. 2, 2017):

Plaintiffs determined that the Trader Joe’s tuna cans were underfilled and underweight by commissioning testing with the U.S. National Oceanic and Atmospheric Administration (“NOAA”) on December 1, 2015. NOAA tested several varieties of Trader Joe’s tuna according to the FDA’s standards for canned tuna, pursuant to 21 C.F.R. § 161.190. This statute determines the standard fill of tuna within a container based on its pressed cake weight.

Even though there’s more, we cut this block quote short because we saw the word “cake.” It’s distracting. Cake has always distracted us. It’s a minor miracle that it didn’t cause us to simply insert a post-ending ellipsis and begin a blurry daydream about cake, like a daydreaming scene in a movie. The only thing that stopped us was that the block quote also said “tuna.” We like tuna just fine. But tuna cake? That’s not so enticing.

Unless—apparently—you’re a class action plaintiffs’ lawyer. Ever in search of financial damages and the type of factual and legal sameness that leads to class certification, pressed cakes of tuna had the plaintiffs’ lawyers daydreaming. They dreamed of financial damages for underweighted tuna cans and the necessary sameness created by an FDA regulation that set the standard for weighing them. And so they gathered putative class representatives and filed claims ranging from breach of implied warranty of merchantability, unjust enrichment and fraud to violations of New York General Business Law §§ 349, 350 and violations of the ever-present California Consumer Legal Remedies Act, Unfair Competition Law, and False Advertising Law. Id.

And, while many of these claims are not typical in product liability litigation, they certainly do implicate defenses that are. The claims are—explicitly—premised on alleged violations of FDA regulations. And that allowed defendants to bring a motion to dismiss asserting a number of very familiar defenses, including implied preemption, conflict preemption, and primary jurisdiction. Id. at *2. For instance, primary jurisdiction was in play because, according to defendants (id. at *1), the FDA was actively considering revising its weight regulation that relied on pressed cake. . . . . . .

. . . Yum, there it is again. Cake. We’re imagining it as chocolate cake—with chocolate icing. Better yet, chocolate ganache. That’s probably the same as chocolate icing, but it sounds so much tastier. And no “erries”—that means, no blueberries, strawberries, raspberries, or anything like them. They get in the way of the chocolate without being nearly as good. It’s fine to include vanilla, preferably as ice cream. But that’s it. No other additions. That is, unless we make it a chocolate soufflé—or bread pudding. Or how about a three-course meal of chocolate cake, soufflé and bread pudding . . . . .

Oh, sorry. Back to the law. . . . . .

It wasn’t primary jurisdiction that won dismissal. It was implied preemption under Buckman. A reminder on the standard:

The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by § 360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman). Perez v. Nidek Co., 711 F.3d 1109, 1120 (9th Cir. 2013) (quoting In re Medtronic, 623 F.3d 1200, 1204 (8th Cir. 2010) (emphasis in original)). Thus, “under principles of implied preemption … private litigants may not bring a state-law claim against a defendant when the state-law claim is in substance (even if not in form) a claim for violating the FDCA.” Loreto v. Procter & Gamble Co., 515 F. App’x 576, 579 (6th Cir. 2013)

Id. at *2.

And there simply was no way for the plaintiffs to get around the fact that they were absolutely suing “because” the underweighting of the tuna cases allegedly violated the FDA regulated testing standard. And so the court dismissed the claims:

In sum, Plaintiffs’ claims would not exist without the FDCA. Plaintiffs allege that Trader Joe’s misrepresented that its cans contained an adequate amount of tuna . . . . Plaintiffs also maintain that the reason the amount in the tuna cans was inadequate is because it failed to meet the pressed cake weight standard under 21 C.F.R. § 161.190. Consequently, the theory underlying Plaintiffs’ state-law claims depends entirely on an FDA regulation. Plaintiffs’ state law claims are in reality claimed violations of an FDA regulation, and therefore, the FDCA prohibits Plaintiffs from bringing them. On this basis, the Court GRANTS Defendants’ Motion to Dismiss.

Id. at *4.

Piece of cake.

This post is from the non-Reed Smith side of the blog.

The plaintiff thought she had a strong summary judgment opposition. She included the deposition testimony of her prescribing doctor, who suggested that Boston Scientific’s warnings for the pelvic mesh device were inadequate. And she included her own affidavit, in which she said that she wouldn’t have agreed to let her doctor implant that device in her if she’d known that it could cause the negative life changing conditions that she allegedly later suffered. Plaintiff thought her opposition was enough to save her failure to warn claim. It wasn’t. The MDL court granted partial summary judgment. It turned out that Plaintiff’s opposition papers contained a big gap—no evidence of proximate causation. Plaintiff offered no evidence that her doctor read Boston Scientific’s Directions for Use (“DFU”). And, if her prescribing doctor didn’t read the DFU, changing it to include the allegedly proper warning wouldn’t have changed anything, particularly her doctor’s decision to prescribe.

That wasn’t the end for plaintiff, though. She had other claims that survived and that she could take to trial. That trial, however, would happen before a different court.  After its summary judgment decision and completing other pretrial matters, the MDL court transferred the case back to the original transferor court for trial.

Plaintiff saw this as an opportunity. She moved the new court to reconsider the MDL court’s summary judgment decision. Her basis was that, in fact, her prescribing doctor had read the DFU. The plaintiff had simply failed to present that portion of his deposition testimony to the MDL court. On that basis, she asked the new trial court to change the MDL court’s decision and deny summary judgment against the failure to warn claim.

No luck. She lost her reconsideration motion.

So, with no failure to warn claim, Plaintiff went to trial.

She lost there too.

Undaunted and still fighting to revive her failure to warn claim, plaintiff appealed to the Fourth Circuit. She challenged both the MDL court’s original summary judgment decision and the trial court’s denial of her motion to reconsider that decision.

And she lost again.

All of this is described in the Fourth Circuit’s recent opinion. Carlton v. Boston Scientific Corp., 2017 WL 1854278 (4th Cir. May 9, 2017). The Fourth Circuit saw plaintiff’s problems as both substantive and procedural. Substantively, a failure to warn claim cannot survive without evidence that the doctor would have read the warning. Id. at *3. Procedurally, it’s not the court’s job to find the evidence that supports proximate causation. It’s the parties’ job to present that evidence to the court: “The responsibility to comb through the record in search of facts relevant to summary judgment falls on the parties—not the court. We therefore affirm the MDL court’s partial summary judgment award.” Id.

Her procedural failings were particularly problematic on her challenge to the trial’s court’s denial of reconsideration. This wasn’t new evidence on which she was relying. It was evidence that had indisputably been available at the time the MDL court decided the summary judgment motion:

At oral argument, Appellant’s counsel asserted that in light of this late revelation, the MDL court’s summary judgment award constituted clear error causing manifest injustice. Not so. We have consistently affirmed denials of motions to reconsider summary judgment rulings where the motion is merely a vessel for the very evidence that was initially lacking in opposition to summary judgment. Significantly, the entirety of Dr. Kennelly’s deposition testimony was available well before summary judgment briefing, and the additional portions of testimony Appellant provided to the district court for “reconsideration” thus did not amount to the type of evidence constituting grounds for a valid motion for reconsideration. We therefore affirm the district court’s denial of Appellant’s motion for reconsideration.

Id. at *4.

While not for lack of fighting on plaintiff’s part, we suspect that this one is now finally over.

This post comes from the Cozen O’Connor side of the blog.

Plaintiffs and defendants have now completed briefing before the Fifth Circuit on defendants’ appeal of the $498 million verdict in the second bellwether trial of the Pinnacle hip implant MDL. Obviously, there is a lot riding on this appeal. In March, we laid out for you the manner in which defendants’ opening brief addressed certain key issues. Below, we discuss the defendants’ responses, in their reply brief, to the arguments that plaintiffs make on those key issues in their opening brief:

Design Defect Verdict: While defendants have offered a number of reasons to overturn the verdict on design defect, the survival of that portion of the verdict could very well turn on whether plaintiffs can convince the Fifth Circuit that an allegedly safer alternative design for DePuy’s metal-on-metal hip implant, a necessary element of a design defect claim, can be an entirely different product—a metal-on-polyethylene hip implant—one that is already marketed by DePuy. In our experience, an entirely different product cannot serve as an alternative design. Here is a portion of defendants’ discussion of this failing in their reply brief:

To prevail on their design-defect claims, plaintiffs were required to prove that a safer alternative design existed for the Pinnacle Ultamet. Caterpillar, Inc. v. Shears, 911 S.W.2d 379, 384 (Tex. 1995). Yet plaintiffs do not argue that the Ultamet should have been shaped differently, secured differently, made of a different metal alloy, or altered in some other way. Instead, plaintiffs argue that the safer alternative design is the Pinnacle AltrX, an existing metal-on-polyethylene hip implant. The question here is whether that metal-on-polyethylene hip implant—which already exists and, indeed, is manufactured and sold by DePuy—is an “alternative design” for the Pinnacle Ultamet, or is instead an “entirely different product.” Brockert v. Wyeth Pharm., Inc., 287 S.W.3d 760, 770 (Tex. App.—Houston [14th Dist.] 2009).

Brockert provides the answer. In Brockert, the plaintiff argued that an “alternative design” for a drug combining estrogen with progestin was a drug containing only estrogen. Id. at 769. There, like here, that proposed alternative already existed and, again like here, was manufactured by the defendant. Id. The Fourteenth Court of Appeals held that plaintiff’s claim failed because she did not show how the defendant’s drug “could have been modified or improved”; she instead argued that the drug should be an entirely different product—i.e., the one defendants already made. Id. at 770-71. . . .

Plaintiffs attempt to distinguish Brockert and Caterpillar by noting that the proposed alternatives in those cases “impaired the product’s utility.” But that is no distinction at all: plaintiffs’ proposed alternative design here would impair the Ultamet’s utility by eliminating precisely the feature that makes it distinctive and an arguable improvement over pre-existing products. Plaintiffs do not deny that metal is more durable than plastic, making metal-on-metal implants a more “attractive option for the younger, high-demand patient who was wearing out their plastic previously.” Nor do they dispute that metal-on-metal implants eliminate plastic debris. Texas law requires plaintiffs to propose an alternative design that replicates those benefits, not just any two benefits they can conjure up. In short, plaintiffs were required to propose a safer alternative design for a metal-on-metal hip implant, but they instead pointed to a different product altogether, which is precisely what Texas courts have held that plaintiffs may not do.

(Defendants’ Reply Br. at 3-6.)

Failure to Warn (Marketing Defect) Verdict: In their opening brief, defendants argued that their Instructions for Use sufficiently warned about the risks that form the basis of plaintiffs’ claims, while plaintiffs’ opening brief argues that those warnings needed to be more specific. While we believe that defendants have the better of that argument, they appear to have even stronger arguments as to plaintiffs’ failures to offer expert testimony on causation or prescriber testimony on how a different warning would have changed their decisions to use the Pinnacle metal-on-metal hip implant. Here are key excerpts from defendants’ reply brief on these issues:

[Lack of Expert Opinion]

Regardless, plaintiffs can prevail under Texas law only if they established with expert testimony that the warnings were inadequate, and they did not do so here. Plaintiffs do not dispute this requirement, instead contending that Dr. Matthew Morrey’s testimony satisfied their burden. But Dr. Morrey was never tendered or admitted as a warnings expert at trial. Plaintiffs attempt to dance around that problem by stating that they designated Dr. Morrey as a warnings expert before trial, but the district court never evaluated his qualifications to be a warnings expert or admitted him as a warnings expert, and his testimony therefore cannot carry plaintiffs’ burden.

[Lack of Prescriber Testimony]

Greer: Greer’s surgeon, Dr. Goletz, did not testify at trial. . . .

Peterson: Peterson’s surgeon, Dr. Schoch, also did not testify at trial. . . .

Christopher: Plaintiffs do not dispute that Christopher’s surgeon, Dr. Kearns, “never read an [IFU] on the Pinnacle Ultamet” and did not know what the IFU said “regarding risks for the implantation of these devices.” . . .

Klusmann: Plaintiffs assert that Klusmann’s surgeon, Dr. Heinrich, testified that additional information “would have changed how he treated Klusmann.” But Heinrich did not say he would have used a different hip implant; he said only that he would have evaluated Klusmann’s post-implant symptoms differently. Dr. Heinrich never testified that he would have used anything other than the Ultamet, and in fact testified that he was aware of the risk of metal ions attacking tissue, but used the Ultamet anyway.

Aoki: The only testimony plaintiffs cite about Aoki is her statement that Dr. Heinrich told her the Ultamet could last “up to 20 years and perhaps life.” But that testimony does not prove that Dr. Heinrich would have used a different implant if DePuy provided different warnings, especially in light of his testimony that he was aware of the Ultamet’s risks. . . . .

(Defendants’ Reply Br. at 10-14.)

Verdict against J&J: Defendants’ reply brief surgically attacks plaintiffs’ arguments on why the trial court could maintain personal jurisdiction over DePuy’s parent company, J&J, as well as plaintiffs’ theories for ultimately holding J&J liable. Plaintiffs’ personal jurisdiction arguments appear to be different from those raised at trial (and therefore waived) and to rely on exhibits that, in some cases, were not even admitted at trial and acts that were not committed by J&J itself, but instead by its subsidiaries. Plaintiffs’ opening brief also struggles to support the viability of their substantive claims against J&J, including how plaintiffs can turn an affirmative defense for a non-manufacturing seller into a cause of action. Here is how defendants sum up these problems in the introduction to their reply brief:

Plaintiffs’ efforts to justify J&J’s presence in this case are no more persuasive. They abandon their previous personal-jurisdiction arguments for new ones, asking this Court to adopt a stream-of-commerce theory so expansive it would bring every parent company into any litigation involving a subsidiary. They try to buttress that argument with lengthy footnotes full of string-cites to evidence either not in the trial record or not what they claim, but super-sized footnotes are no substitute for minimum contacts, which are plainly lacking. And even if they could establish jurisdiction, plaintiffs have no viable claims against J&J. They do not point to a single Texas case holding a defendant liable in tort for a “nonmanufacturing seller” claim or an aiding-and-abetting claim, and they fail to show that J&J undertook a duty for their protection or that they relied on its performance.

(Defendants’ Reply Br. at 1.)

Highly Inflammatory, Irrelevant and Unduly Prejudicial Evidence: This is the BIG issue, the one that raised so many eyebrows as the trial moved on. In their opening brief, plaintiffs try to calm those reactions by underplaying their use of this evidence at trial and its importance to the verdict. But the defendants reply brief reacts effectively to this tactic, providing detail on plaintiffs’ repeated, not limited, used of this evidence, so much so that it formed a central component of their presentation to the jury. Here is how defendants address this issue in, once again, the introduction to their reply brief:

Plaintiffs’ defense of the inflammatory evidence they introduced at trial is to assert that each transgression was not that inflammatory. After all, they referenced Saddam Hussein in only “a handful of exchanges,” linked defendants to tobacco and asbestos companies while questioning only “one defense expert,” invoked the threat of cancer for only “three-and-a-half pages of testimony,” implied just “twice” that the Ultamet could lead to suicide, told the jury that plaintiffs considered jumping off a bridge for a mere “five lines of argument,” mentioned the thousands of other lawsuits in the MDL only “on five occasions,” and discussed transvaginal mesh lawsuits brought by “45,000 women” for only “12 lines of testimony.” The suggestion that the combined effect of all this profoundly prejudicial evidence was marginal does not pass the straight-face test; indeed, the best indication of the importance of this evidence is that fact that plaintiffs’ counsel repeated all of it in his closing statement to the jury. Inflaming the jury’s passions through irrelevant evidence was not just a happenstance but a core component of plaintiffs’ trial strategy, and the gargantuan verdict shows the success of that strategy.

(Defendants’ Reply Br. at 2.)

Next comes oral argument and then the Fifth Circuit’s decision. And that decision will, quite obviously, have a major impact on the future of an MDL that without appellate intervention appears destined to produce more and more massive verdicts.

Executions by lethal injection are in the news. Arkansas recently executed four inmates in just eight days. One of the drugs that it uses for its three-drug lethal injection protocol was set to move beyond its expiration date. And, apparently, Arkansas wanted to use them before that happened.  It seems that states are finding it more and more difficult to get the drugs that they need for lethal-injection executions.

In fact, Texas so badly needs to get access to one of those drugs that it is now suing the FDA to get it. The drug—thiopental sodium—is used to render inmates unconscious before the lethal drugs are administered. But Texas can’t get thiopental sodium anymore because the FDA, as of five years ago, bans its importation. It did so after a group of inmates successfully sued the FDA in federal court to stop it from allowing thiopental sodium into the country. The inmates claimed that thiopental sodium (i) was “misbranded” and (ii) an unapproved new drug. Interestingly, the FDA conceded both points. It argued that it could still allow thiopental sodium into the country, however, by exercising its enforcement discretion. The federal court disagreed. See Beaty v. FDA, 853 F. Supp. 2d 30 (D.D.C. 2012), aff’d in part, rev’d in part sub nom., Cook v. FDA, 733 F.2d 1 (D.C. Cir. 2013). The court held that the language of the Food, Drug and Cosmetic Act, in particular its repeated use of the word “shall,” gave the FDA no such discretion. We wrote about that decision here.

Since then, the FDA has banned the importation of thiopental sodium. And that’s where Texas comes in. Texas needs thiopental sodium for its lethal injection program. In 2015, Texas attempted to import thiopental sodium to be used in its lethal injection protocol, and the FDA detained it. On April 20, 2017, after a lengthy administrative process, the FDA reached (what Texas calls) a final decision, holding firm to its determination that it must follow the Beaty decision and ban the importation of thiopental sodium.

And so, just over a week ago, the Texas Department of Criminal Justice filed an amended complaint in federal court in Texas challenging the FDA’s determination. Texas, however, does not claim that the FDA does in fact have the enforcement discretion necessary to allow thiopental sodium into the country. Instead, it tries to shift the focus of the dispute, claiming that thiopental sodium is not misbranded and that its distribution does not require FDA approval.

In particular, Texas claims that thiopental sodium does not meet the FDCA’s definition of a “new drug” and therefore does not require FDA approval. Under the FDCA, a drug is a “new drug” requiring approval if it is not generally recognized by experts “as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.” 21 U.S.C § 321(p). Texas claims that the labeling of the thiopental sodium it imported makes no statements about its use at all and, therefore, it does not qualify as a new drug that requires approval. Texas also claims that its proposed use of thiopental sodium falls under a “law enforcement” exception (21 C.F.R. § 201.125) to the statutory requirement that a drug come with instructions for use and, therefore, the thiopental sodium was not “misbranded” for failure to come with such instructions.

Well, these are certainly interesting claims, ones that we are quite sure that the FDA will fight. In fact, the FDA’s administrative decision states that it doesn’t buy this arguments. The FDA believes that the statements made on the thiopental sodium packaging, as limited as they are, suggest its use for lethal injections and therefore constitute labeling requiring its approval as a new drug. It also believes that the “law enforcement” exception does not apply when the drug is to be administered to humans.

From our point of view, we know that a regulatory agency like the FDA is not going to accept a claim that limits it authority or jurisdiction without a fight—particularly when, as here, it addresses whether the FDA must approve a “new drug,” one of the most important roles that the FDA plays. Accordingly, this litigation will address important issues related to labeling and “new drugs,” and we will follow it.

We’ve addressed sunscreen class actions here from time to time. The FDA regulates sunscreen as an OTC drug, and so these class actions can generate decisions of interest in areas of preemption and primary jurisdiction. For instance, we told you about, Gisvold v. Merck & Co., 62 F. Supp. 3d 1198 (S.D. Cal. 2014), in which a court found preempted a putative class action plaintiff’s claim that the Coppertone SPORT SPF 100+ she bought at Walmart should have disclaimed that it was no more effective than sunscreen with an SPF of 50.  The court based its preemption determination on the plaintiff seeking labeling that was different from that required by the FDA.  In addition, the court invoked primary jurisdiction, deferring to the FDA on how to address SPF values greater than 50, as the FDA was already in the process of evaluating that issue.

But, as in medical device cases, preemption in sunscreen litigation can seem muddled. Just recently in another sunscreen class action, Dayan v. Swiss-American Prods., Inc. (E.D.N.Y. Mar. 30, 207), a federal court in New York rejected a preemption-based motion to dismiss a claim that the labeling of a sunscreen product as SPF 45 was misleading because the product actually performed at a lower SPF level.  As support for his claim, plaintiff pled data from tests conducted under the FDA’s SPF testing protocols. The court adopted a magistrate’s report and recommendation, which reasoned that the plaintiff’s “state law claims [sat] next to federal regulations and are not premised on Defendant’s alleged failure to comply with FDCA requirements.” Id. at *4. Sort of a parallel violation claim for sunscreen.

As the court conceded, though, its distinction between what is preempted and what is not is, at best, “tricky.” Id. at *10. There seems to be little to no air on which plaintiff’s claim can survive between express and implied preemption. If, as his case develops, plaintiff is left to argue that the defendant followed FDA-mandated protocols in testing the sunscreen and disclosing the results, his claim that the label should nonetheless be different would seem to trigger preemption because it would require something different from what the FDA requires. On the other hand, if plaintiff’s claim, as fleshed out through discovery, appears to be that the defendant failed to follow FDA protocols, it would start to read like an improper attempt to privately enforce FDA regulations.

In other words, sunscreen preemption seems every bit as messy as medical device preemption. Maybe, in this case, it can be cleared up at the summary judgment stage—that is, if this case gets passed class certification—where defendant may have another chance, based on a full record of what plaintiff is trying to do, to ask for judgment based on preemption.

Doctors warn patients and decide which warnings to give. Manufacturers warn doctors and, if a particular doctor already knows a particular risk, it doesn’t even matter—in a court room, that is—whether the manufacturer warned the doctor. That is the interplay between the learned intermediary doctrine and the proximate causation element of a failure to warn claim.

And, in Tomaselli v. Zimmer, Inc., 2017 WL 1011492 (S.D.N.Y. Mar. 15, 2017), they came together to hand summary judgment to the defendant manufacturer and distributor. The doctor in Tomaselli surgically implanted a hip repair device into one of his patients to repair the patient’s greater trochanter, part of the femur bone near the hip. Later, one of the device’s cables unwound while inside the patient so that it was laying alongside her femur, causing her some level of pain. The doctor discovered this but, ultimately, recommended to the patient that it not be removed. Thereafter, the patient and her husband sued the manufacturer, the distributor and other defendants.

But they ran into a problem, something that usually isn’t a problem unless you’re in a court room asserting a failure to warn claim. The doctor was very experienced. He had performed more than 5,000 hip surgeries over the course of a 30-year career. He knew things. And one of the things he knew was that cables in hip repair devices can fail:

Based on his experience. . . Dr. Nercessian testified that cable breakage is “a known risk of any wire, any cable,” and that cables tend to break “[b]y reaching and exceeding the maximum fatigue strength of the metal.” Asked whether a cable implanted to repair a greater trochanter fracture may break if the fracture fails to fully heal—a so-called “nonunion”—Dr. Nercessian replied, “Definitely.”

Id. at *1 (citations omitted).

So this doctor knew the risk. That meant that, for purposes of the plaintiffs’ failure to warn claim, it didn’t matter whether the manufacturer had warned the doctor. He already knew. Moreover, this doctor chose, for whatever reason, not to warn this patient about that risk. That didn’t matter either. The doctor’s knowledge of that risk, whether he chose to convey it to his patient or not, cut off proximate causation. Here is the court laying out these principles under New York law:

Under the “informed intermediary” doctrine, a manufacturer “discharges its duty by providing the physician with sufficient information concerning the risks of the device.” Moreover, “where the treating physician is independently aware of potential adverse events, that knowledge is an intervening event relieving the manufacturer of any liability to a patient under the failure to warn theory.” “A physician’s existing awareness of a potential risk or side effect thus severs the causal chain between an allegedly inadequate warning and a plaintiff’s injury.”

Id. at *3 (citations omitted). And, finding no proximate causation, the court granted summary judgment to the manufacturer and distributor on plaintiffs’ failure to warn claim.

A couple of months ago, we reported on the magistrate’s report and recommendation in this case to grant summary judgment against all plaintiff’s claims, which included her failure to warn, design defect and warranty claims. At that time, we seriously doubted that plaintiff would object to the report and recommendation. It was so well-reasoned. You can read our discussion of that report, which was much more detailed, here. As it turns out, plaintiff did object, but only to the failure to warn recommendation. And, as it also turns out, we were right. The report and recommendation was well reasoned. With this decision, the district judge adopted the magistrate’s “thorough and well-reasoned Report in its entirety.”  Id. at *4.  And, now, we can be virtually certain that this is the last we will hear of this case.

 

This post comes from the Cozen O’Connor side of the blog.

We’ve been following the Pinnacle MDL closely through the last two bellwether trials, starting with the news coming out of the second bellwether trial of particularly curious and prejudicial evidence being presented to the jury. Given that evidence, we expected a plaintiffs’ victory, an expectation that was borne out with a whopping $498 million verdict. It raised an immediate question: “What will the Fifth Circuit do?”

Well, we’re on our way to finding out. The defense recently filed their opening appellate brief. While it features the controversial evidentiary rulings, much more is in play. If you would like to take a look for yourself, here is the brief.  Below are some of the key issues, along with a quick description of the defense’s arguments:

Design Defect Claim against DePuy (Brief at 20-29): Claim that all metal-on-metal hip implants are defective is not viable under Texas law because a wholly different product cannot serve as a safer design; design claim is preempted because the FDA approved metal-on-metal hip implants; and design claim fails under Restatement (Second) of Torts 402A comment k (adopted in Texas), which recognizes that products like implantable devices are unavoidably unsafe and therefore not defective if properly made and warned about.

Continue Reading Briefing Underway in Appeal of Half-Billion-Dollar Verdict in Pinnacle MDL

Court Finds Fraudulent Joinder by Relying on a Sales Rep’s Affidavit and Common Sense

Buckles v. Coombs, 2016 U.S. Dist. Ct. LEXIS 180784 (S.D. Fla. Jan. 4 2017), is a decision that illustrates how a defendant’s proper introduction of facts via an affidavit and a court’s introduction of common sense into its decision process can come together to result in the denial of a plaintiff’s motion to remand an action to state court.

In Buckles, the plaintiff alleged that she was injured due to an allegedly defective cutting device used in her knee replacement. In her state-court complaint, she sued not only the diverse manufacturer, Howmedica, but its non-diverse sales rep. The defendants, having seen that move before, claimed fraudulent joinder of the sales rep and removed the action to federal court based on diversity jurisdiction.

Plaintiff moved to remand the action back to state court. Plaintiff argued that the sales rep was, in fact, a proper defendant because he had been negligent in promoting, marketing, testing and warning about the device—and so on. She supported these arguments with nothing more than the allegations in her complaint, which were fairly broad and conclusory. That was her mistake.

The court made clear that the proper standard under which a court should determine whether a non-diverse defendant has been fraudulently joined is like that applied to summary judgment motions, not the standard for motions to dismiss: “A district court’s process for resolving a claim of fraudulent joinder is similar to that used for ruling on a motion for summary judgment.” Id. at * 5 (citing Crowe v. Coleman, 113 F.3d 1536, 1538 (11th Cir. 1997). And the defendants were relying on more than the general allegations in the complaint. They offered facts from the sales rep himself in an affidavit in which he specifically refuted the general allegations of the complaint:

As set forth in [the sales rep’s] affidavit, however: (1) he was present during [plaintiff’s] surgery “only to facilitate bringing the implants to the operating room and for no other purpose” (2) he did not call on [plaintiff’s] surgeon at any time prior to her surgery on August 21, 2012, or anytime thereafter (3) he did not “promote, advertise, represent, recommend or sell” the Cutting Guide used during [plaintiff’s] surgery; (4) he had no involvement in the preoperative imaging for [plaintiff’s] Cutting Guide and had no other involvement in the planning of her surgery; and (5) he has no medical training, but rather, relies on the materials and information provided to him by Howmedica in carrying out his job duties.

Id. at *8.

Continue Reading Court Finds Fraudulent Joinder by Relying on a Sales Rep’s Affidavit and Common Sense