We write this in the first minutes of the eclipse, about 75 minutes from whatever “totality” will be visible here in southeastern Pennsylvania. We have our certified safety glasses at the ready, we have instructed the midday dog-walker to keep the Drug and Device Law Little Shaggy Rescues indoors (lest they unwittingly look skyward), and we have a continuous loop of the Fifth Dimension’s “Age of Aquarius” going around in our head. (Parenthetically, we accidentally typed “Fifth Amendment” just then for the name of the band.) The song has nothing to do with the eclipse, but it talks about the moon. And about Jupiter aligning with Mars. Appropriately thematic, we thought.

And, while “love steering the stars” may be a little strong to describe recent activity in Risperdal litigation, we have been pleased by a recent spate of positive developments. Last week, Bexis reported on two favorable decisions out of federal courts, one a post-BMS personal jurisdiction denial and the second a refusal to consolidate dissimilar cases for trial. Today we round out the triumvirate with a nice summary judgment decision from Pennsylvania’s state court system.

In In re: Risperdal Litigation: P.D. v. Janssen Pharmaceuticals, Inc., 2017 Phila. Ct. Com. Pl. LEXIS 231 (July 26, 2017), the (male) plaintiff allegedly developed gynecomastia – excessive breast tissue – when he was prescribed Risperdal (beginning when he was eight years old). He sued, including claims for design defect, failure to warn, and fraud. The defendant won summary judgment. The published decision occurs in a peculiar posture that is a creature of the Pennsylvania Rules of Appellate Procedure. Under Pa. R.A.P. 1025, when a grant of summary judgment is appealed, the trial judge prepares a written opinion in support of affirmance, arguing that there were adequate grounds for the summary judgment decision.

Design Defect

First, the court addressed the plaintiff’s design defect claims sounding in both strict liability and negligence. Because there were unresolved choice-of-law issues, the court considered these claims under the laws of both North Carolina, where the plaintiff was prescribed Risperdal and developed gynecomastia, and Pennsylvania, the forum state. Both states prohibit strict liability design defect claims against pharmaceutical manufacturers. While Pennsylvania, since Lance v. Wyeth, permits claims for negligent design defect, “a drug manufacturer can shield itself from liability for the design of drugs by including appropriate warnings; however, when it becomes known that a drug should not be used in light of the relative risks, the manufacturer can only avoid liability by removing it from the market.” P.D., 2017 Phila. Ct. Com. Pl. LEXIS 231 at *8-9. Here, the plaintiff did not offer “any evidence that Risperdal was so dangerous no warning could mitigate the relative risk of gynecomastia.” To prevail on a negligent design defect claim under North Carolina law, the plaintiff was required to submit evidence of a safer alternative design, and he had not “even address[ed] this requirement . . . , let alone submit evidence of a safer alternative design for Risperdal.” Id., at *9. As such, the court held, the plaintiff’s negligent design defect claims also failed under either body of applicable law.

Failure to Warn

The court’s dismissal of the plaintiff’s warnings claims rested on a finding that the plaintiff had not met his burden, under either North Carolina law or Pennsylvania law, of proving “warnings causation;” in other words, he had not proven that any alleged inadequacy of the product’s warnings was causally related to the his injury. We love this doctrine, because a successful argument can turn on the opportunistic exploitation of a plaintiff’s lawyer’s failure to ask a single question when deposing the plaintiff’s prescribing physicians.

The plaintiff’s warnings expert opined that the 2006 Risperdal label, in effect when the drug was prescribed for the plaintiff, should have included: 1) a recommendation for physicians to monitor prolactin levels; and 2) an indication that there was a statistically significant association between Risperdal use and gynecomastia. Id. at *12. But, as the court explained, “[a]lthough the parties deposed Plaintiff’s prescribing physicians, neither party elicited any testimony from [the doctors] concerning whether [the expert’s] proposed warnings . . . would have affected their prescribing decision.” Id. And so, the court concluded, “In light of the dearth of testimony from his prescribing physicians that [the expert’s] proposed warnings would have changed their prescribing decision, Plaintiff failed to establish proximate causation.” Id. (citation omitted).

The plaintiff attempted to save his warnings claim by arguing that the defendant engaged in illegal off-label promotion. The court held that, because the plaintiff was in an indicated population and was prescribed the drug for an indicated use, any discussion of off-label promotion was irrelevant to the case.

Fraud

Finally, the plaintiff argued that the court erred in dismissing his fraud claim. Again the court considered this claim under both North Carolina law and Pennsylvania law. Federal courts have interpreted Pennsylvania law as ‘barring [fraud claims]against pharmaceutical manufacturers.” Id. at *18 (citations omitted). Pennsylvania appellate courts have not addressed this issue. North Carolina law permits such claims, but not “where the purported misrepresentation was made solely to a third party.” Id. (citations omitted). “Because . . . neither Plaintiff nor Plaintiff’s mother relied on any representation” from the defendant in deciding whether to use the drug, “Plaintiff’s fraud claim must fail under North Carolina law.” Id.

The parties agreed that, where a true conflict of law existed, North Carolina law would apply, as that state, where the Plaintiff ingested the drug and developed gynecomastia, had a greater interest in the application of its law than did Pennsylvania, the forum state. “Ultimately,” the court held,

[I]t is immaterial whether Pennsylvania law permits a fraud claim in pharmaceutical cases. Assuming, arguendo, that Pennsylvania permits [such a claim], then Pennsylvania law conflicts with North Carolina law and North Carolina law would apply. Conversely, if Pennsylvania law prohibits such a claim, then Pennsylvania law applies. In either scenario, Plaintiff’s fraud claims would be dismissed.

Id. at *19.

We love a good summary judgment decision.  P.D. is sound and well-supported, and we trust that it will be affirmed on appeal. We will keep you posted. In the meantime, the [very cool] eclipse has come and gone. In the words of the Fifth Dimension, “let the sun shine!”

 

As we discussed at the time, the MDL-wide innovator liability appeals in In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. 2014), resulted in rulings under more than 20 states’ laws that branded drug manufacturers could not be liable for injuries suffered by plaintiffs who never used their products, but only took competing generic drugs.  Twenty-something states in one opinion.  If that had ever happened before, we remain unaware of it.

Well, it recently happened again, albeit on a smaller scale. See In re Zofran (Ondansetron) Products Liability Litigation, ___ F. Supp.3d ___, 2017 WL 3448548 (D. Mass. Aug. 4, 2017).  The Zofran MDL is like Darvon in that it involves a relatively old drug, approved back in 1991, for prevention of nausea and vomiting in cancer patients undergoing difficult treatments such as chemotherapy. Id. at *1.  Since Bendectin was driven off the market by bogus birth defect litigation, drug companies have been loathe to pursue anything for treating morning sickness (we know of only one), which leaves off-label use.  Id. at *2.  Thus, Zofran and its generic equivalents are frequently used off-label by women (and their physicians) seeking some kind of relief from pregnancy-related morning sickness.

The Zofran litigation is a consequence of this off-label use – anything used during pregnancy becomes the target of birth defect lawsuits.  Plaintiffs make a rather extreme claim, that defendants should be liable for not researching the risks of off-label uses for which they never sought FDA labeling approval.  Id. at *3 (“The crux of all of the claims is that defendants failed to perform an adequate study of the safety of ingesting Zofran during pregnancy”).

When generic drugs get involved, things get even worse. Plaintiffs using generic drugs are barred by preemption from suing those manufacturers (absent unusual situations like failure to update warnings with FDA-ordered changes), id. at *4, but they still want money, so they try to sue the branded manufacturers – innovator liability, in these cases for off-label uses.  Such claims seek to hold manufacturers liable for the risks of someone else’s product used in a manner for which that product was never labeled.

In Zofran, the court was having none of it.  It ordered all generic plaintiffs – 35 plaintiffs from 19 states − alleging innovator liability to justify those allegations.  Id.  Challenged to put up or shut up, most of the generic plaintiffs dropped out, leaving six plaintiffs suing under the laws of six states, those being Georgia, Indiana, Kentucky, Massachusetts, New York, and Oklahoma. Id.

Examining the laws of those six states, the court in Zofran, like the court in Darvocet, concluded that none of them would take the radical step of holding branded drug manufacturers liable for injuries caused by competing generic drugs.  Such liability ran contrary to “the long-settled principle that a manufacturer of a product cannot be held liable for injuries caused by another company’s product.”  Id. at *4.  Instead, plaintiffs alleged that:

As the holders of the New Drug Application (NDA) for Zofran and the patents for Zofran, [innovator] Defendants knew that any generic drug manufacturer would be required by law to use the same labeling as Zofran’s, and that any inadequacies in the labeling of generic ondansetron could be corrected by Defendants only.

Id. at *5.  Thus, the innovator defendants were being held liable not for what they chose to do, but rather for what was “required by law” – how Congress, in amending the FDCA, had chosen to structure the generic drug market.  While plaintiffs claimed this was not “novel,” id., to paraphrase Yogi Berra, “half the lies they tell about [the law] aren’t true.”

The overwhelming majority of courts—including all seven federal circuits to have addressed the issue—have held that the manufacturer of a brand-name drug may not be held liable for injuries caused by ingestion its generic equivalent, regardless of the theory of liability.

Id. at *6 (citations omitted).  The omitted citations, of just the federal appellate decisions, take up half a page of the opinion.  But don’t fret about that.  Our “Innovator Liability at 100” post, which discusses all these decisions, is closing in on 14,000 words.  The precedent rejecting innovator liability is truly “overwhelming.”

The “minority view,” on the other hand, consists of exactly four cases, one of which was “superseded by statute” “within a year” of being decided.  Id. at *8-9 & n. 6.  As for the relevant states in Zofran:

Georgia:  An intermediate state appellate court, the Sixth Circuit in Darvocet, and a federal district court, have all rejected innovator liability.  See PLIVA, Inc. v. Dement, 780 S.E.2d 735, 743 (Ga. App. 2015); Darvocet, 756 F.3d at 943; Swicegood v. Pliva, Inc., 543 F. Supp. 2d 1351, 1353-54 (N.D. Ga. 2008). Zofran, 2017 WL 3448548, at *8-9.  On the other side – zilch.  Actually, Georgia precedent rejecting innovator liability is more extensive than what was mentioned in Zofran.  See our “at 100” post for details.

Indiana:  The Sixth Circuit Darvocet case also rejected innovator liability under Indiana law.  756 F.3d at 845. Zofran, 2017 WL 3448548, at *10-11.  Again, there are several more Indiana law cases also rejecting innovator liability that aren’t mentioned in Zofran – but are in our post.

Kentucky:  Not only is Darvocet again on point, but the Sixth Circuit likewise rejected innovator liability in another Kentucky law case.  Darvocet, 756 F.3d at 945-46; Smith v. Wyeth, Inc., 657 F.3d. 420, 423-24 (6th Cir. 2011).  Zofran, 2017 WL 3448548, at *11.  As our post adds, a couple of Kentucky litigation tourists also got kicked out of court in Missouri on innovator liability grounds.

Massachusetts:  Two Massachusetts trial courts have rejected innovator liability. Rafferty v. Merck & Co., 2016 WL 3064255, at *4-5 (Mass. Super. May 23, 2016); Kelly v. Wyeth-Ayerst Laboratories Co., 2005 WL 4056740, at *2-5 (Mass. Super. May 6, 2005).  Zofran, 2017 WL 3448548, at *12-13.  We provide some more on-point Massachusetts precedent in our post, which never has to cite to a non-Westlaw slip opinion, because Bexis gets all the good ones added.

New York:  Darvocet, again, plus federal and state trial court decisions, all rejecting innovator liability under New York law.  Darvocet, 756 F.3d at 949; Goldych v. Eli Lilly & Co., 2006 WL 2038436, at *3-8 (N.D.N.Y. July 19, 2006); Weese v. Pfizer, Inc., 2013 WL 5691993, at *2 (N.Y. Sup. Oct. 8, 2013).  Zofran, 2017 WL 3448548, at *13-14.  Actually, there’s another recent federal district court decision that agrees, as our post discusses.

Oklahoma:  Not only Darvocet, but another federal appellate decision both reject innovator liability under Oklahoma law. Darvocet, 756 F.3d at 950-51; Schrock v. Wyeth, Inc., 727 F.3d 1273, 1281-84 (10th Cir. 2013).  Zofran, 2017 WL 3448548, at *14.  Our post adds another state trial court opinion applying Oklahoma law in a similar manner (a toughie, but we found it).

Thus, the Zofran decision concludes, as to the merits of innovator liability, that there aren’t any merits, and that contorting state law to impose liability for liability’s sake, without any basis in precedent or policy, isn’t a good idea:

In summary, none of the state supreme courts in any of the six relevant states have ruled on precisely the issues presented here.  Nonetheless, for each of the jurisdictions, there is case law suggesting, often strongly so, that dismissal is appropriate. . . .

It is true that dismissal would appear to leave consumers injured by generic drugs without any form of remedy.  But it is by no means obvious that the minority viewpoint is correct or fair, or even that it is the outcome that best protects consumers.  Just as it may be unfair to leave some injured consumers without a remedy, so too it may be unfair or unwise to require brand-name manufacturers to bear 100% of the liability, when they may have only 10%, or less, of the relevant market.

Id., 2017 WL 3448548, at *14 (citations omitted).

Finally, Zofran rejects what appears to be the new overall strategy of generic plaintiffs peddling innovator liability theories – try to shift the battle from federal to state courts.  Zofran refused to certify the issue to the high courts of the six states in question.  Id. at *15-17.  New York doesn’t even allow certification (an “oops” for plaintiffs).  Id. at *16.  “Clear and recent” appellate authority in every state but Massachusetts, leaves little doubt what the relevant law is.  Id.  As for Massachusetts (and indeed all the states), the question proposed to be certified “involve[d] alleged misrepresentations, none of which are identified by the plaintiff,” leaving the basis for those claims “unclear.”  Id. at *17.  Certification of such a “hypothetical” question would thus be “inadvisable”:

It is therefore entirely possible that the Court could wind up certifying a purely hypothetical question that has no actual relationship to the evidence.  It would be an enormous waste of judicial resources to certify a fact-bound question to the [state high court], only to find that the facts as ultimately proved are different. . . .  Any answer . . . to the proposed question might therefore prove to be entirely advisory.

Id. (footnote omitted).  Courts faced with innovator-liability-related certification requests in the future are likely to be facing similar situations, given how loosely our opponents throw around misrepresentation allegations.  Kudos to Zofran for not taking the easy way out, and declining to kick the decisional can down the road.

Today’s guest post is by long-time friend-of-the-blog, Dick Dean, of Tucker Ellis.  This post covers the preemption aspects of the recent (after remand from the Third Circuit) aviation decision in Sikkelee v. Avco.  If you’re interested in this issue, we heartily commend the actual decision (which, we warn you, is quite lengthy), since in addition to its many significant legal rulings, it is studded with pungent language, mostly calling out and rejecting plaintiff’s many off-the-wall arguments.  As always our guest poster deserves all the credit (and any blame) for the discussion that follows.

************

At times one can tell from the very first paragraph of an opinion that what follows will be an interesting read.  Such is the case with Sikkelee v. Avco Corp., Case. No. 4:07-CV-00886, 2017 WL 3317545(M.D. Pa. Aug. 3, 2017), a case involving the death of a pilot during a crash at take-off:

A weightless innocence so often attends our daydreams of flight. As the American aviator John Gillespie Magee, Jr., loftily described it, pilots “dance [ ] the skies on laughter-silvered wings,” soaring “high in the sunlit silence.”   Sadly, it would seem that Magee’s “high untrespassed sanctity of space” must belong to a universe far away from the dark origins and convoluted history of this case.

Id. at *1. From this ephemeral beginning, we are soon transported to the detailed world of federal aviation regulations and their interaction with design defect and implied preemption.

This case is indeed “convoluted.”  The crash occurred in 2005, and suit was filed in 2007, alleging different legal theories that distill to claims of a poorly designed carburetor.  There were two district court decisions (by two different district judges) dismissing plaintiff’s state law torts claims on grounds of field preemption before the case reached the Third Circuit in 2015.  Field preemption occurs where the subject matter of the law suit is so occupied by the federal government that there is no room for state activity.  It is rarely invoked and hardly ever found. [ed. note: we know of only one FDCA field preemption decision]  The factual underpinnings of field preemption in the aviation field was best summarized in a concurring opinion of Justice Jackson in a tax dispute, quoted by the Sikkelee Court in its recent decision:

As the late Honorable Robert H. Jackson, Associate Justice of the Supreme Court, once remarked, “Planes do not wander about in the sky like vagrant clouds.  They move only by federal permission, subject to federal inspection, in the hands of federally certified personnel and under an intricate system of federal commands.”  Northwest Airlines v. State of Minnesota, 322 U.S. 292, 303 (1944).  Justice Jackson’s observation sprang from “the national responsibility for regulating air commerce” and reinforced the notion that the “air is too precious as an open highway to permit it to be owned” by local interests.  Id.  “Local exactions and barriers to free transit in the air would neutralize its indifference to space and its conquest of time.”  Id.

Id. at *2.

Relying on the breadth of the Third Circuit’s decision in Abdullah v. American Airlines, 181 F.3d 363 (3d Cir. 1999) (holding that federal law preempts the field of aviation safety in the context of federal in-flight seat belt regulations versus state law negligence claims), the Sikkelee Court found preemption first at 731 F. Supp.2d 429 (M.D. Pa. 2010) and most recently at 45 F. Supp. 3d 431 (M.D. Pa. 2014).  The Third Circuit reversed the later decision, finding that state law design claims were not covered by the decision in Abdullah.  Sikkelee v. Precision Automotive Corp., 822 F.3d 680 (3d Cir. 2016).  But it is also observed that the claims might be barred by implied preemption—noting that the design changes advanced by plaintiff necessarily might have required FAA approval and thus would be barred under Pliva, Inc. v. Mensing, 564 U.S. 604 (2011) and Mutual Pharmaceutical Co. v. Bartlett, —U.S.—-, 133 S.Ct. 2466 (2013).  Indeed, it cited Mensing noting that where a party cannot “independently do under federal law what state law requires of it,” the state law claim is preempted.  822 F.3d at 703.  It remanded for consideration of that issue. (See DDLaw April 22, 2016 post discussing the Third Circuit’s suggestion that this claim might be conflict preempted).

On remand, the district court first examined the relevant FAA regulations noting “the FAA has littered the books with a maze of regulations not readily traversed by most laypersons.”  2017 WL 3317545 at *2.  It observed that the first step in production of a new aircraft or aircraft engine is a “type certificate” confirming that the aircraft or its component is properly designed and manufactured.  Id. at *3.  It is an “onerous process requiring numerous submissions that precisely detail the specifications.”  Id.  A type certificate holder may not independently change a type certificate’s design details without first obtaining FAA approval.  Id. at *5-*6 (citing 14 C.F.R. §21.31).  The district court observed that the relevant test was whether federal regulations prevented the defendant from unilaterally doing what state law required, citing the Mensing test of independent action.  The court found that the alternate design theory advocated by plaintiff would have required approval by the FAA and was therefore conflict preempted.  It specifically cited the key language from Mensing establishing that the mere fact that defendant could have asked the agency to change its rules does not defeat preemption.

“To decide these cases,” the PLIVA Court concluded, “it is enough to hold that when a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for preemption purposes.”  Id. at 623–24.  Justice Thomas then noted that in regulatory preemption cases such as these, “the possibility of possibility”—that is, the possibility that the agency will approve a requested change—does not defeat conflict preemption.  Id. at 624.

2017 WL 3317545 at *24. More colloquially, if you have to ask, it is preempted.

The Sikkelee Court also made two other points familiar to the readers of this blog.  First, it noted that impossibility conflict preemption may be found even in the absence of express preemption.  Id. at *22.  Second, it recognized that impossibility preemption requires no inquiry into congressional intent.  Id.  The only question is whether there is a conflict between state and federal law.

When Mensing was decided, the first argument of the plaintiffs’ bar (and one that is still run today) was that it was limited to generics.  That was clearly wrong based on the “any party” language of Mensing.  Cases like Yates v. Ortho-McNeil-Janssen Pharmaceutical, Inc., 808 F.3d 281 (6th Cir. 2015) and In re Celexa and Lexapro Marketing and Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015), and many others [ed. note: see our preemption cheat sheet for the citations] have expanded the Mensing test to brand drug manufacturers’ where regulatory approval was a predicate of the claim alleged.  Now the Mensing test has been appropriately applied to the federal aviation context.  With this decision, it can be said that Mensing applies generally—not just to generic drugs, or even just drugs at all.  In Mensing and Bartlett, “[c]onflict preemption did not turn on a drug maker’s status as a brand-name or generic manufacturer per se.”  Sikkelee, 2017 WL 3317545 at *31 n.26.  That is not a surprising conclusion, since this is how implied preemption is supposed to work, but it is nice to have this solid opinion building upon the Third Circuit’s observations actually finding implied preemption in the aviation context.  Going forward, one needs to read any complaint involving relevant federal regulations with an eye on preemption: if the relief sought could not be undertaken unilaterally by the defendant in light of federal law or regulations the claim is preempted.

[Ed. note: we’d like to add one final point – about proximate cause. Sikkelee also recognized something we’ve observed about design changes too “minor” to require FDA pre-approval:  that such changes can’t be causal in a product liability action. The same is true of “minor” design changes under the FAA:

If the alleged omission was a minor one, then by definition, it had no effect on the aircraft engine’s structural strength, reliability, operational characteristics, or airworthiness. . . .  [T]he underlying claims are nothing more than state law tort actions, which require proximate causation.  If the alleged breach of duty had no appreciable effect on the engine’s reliability, airworthiness, structure, or operation, then proximate cause cannot be met.

2017 WL 3317545 at *28 . Likewise, design changes too “minor” to affect a product’s safety and effectiveness (the corresponding FDA standard), could not possibly be causal in a product liability action.]

 

 

If not yet dead, the medical monitoring claim itself is hooked up to monitors and the prognosis is not good. It’s dying from a self-inflicted injury, which paradoxically is its lack of injury. Class action plaintiffs’ lawyers, the lawyers who have largely filed these claims, despise physical injuries. Physical injuries come with differences, and differences defeat class certification. On the other hand, they love financial damages, like those needed to implement a medical monitoring program. Financial damages come with sameness, and sameness increases the chances of class certification. This is the conundrum for medical-monitoring class action plaintiffs’ lawyers. They have struggled mightily to allege the financial damages that they so want while trying not to allege the physical injury that will kill their chances of certifying a class.

Cure v. Intuitive Surgical Inc., 2017 WL 3381848 (11th Cir. 2017), illustrates how this struggle is killing medical monitoring claims. In Cure, the plaintiffs claimed that, during heart surgery, instruments manufactured by the defendants shed small metallic particles that were later found in plaintiffs’ brains. Plaintiffs’ lawyers brought a medical monitoring claim, asking the court to set aside funds for monitoring plaintiffs, and those similarly situated, so that doctors could identify anything bad that might happen in the future.

But that’s where things go wrong. Plaintiffs could not allege that anything had actually gone bad. Not yet. So they hoped that the presence of small metal particles in their bodies would qualify. It doesn’t. The mere “presence of metal shavings in the plaintiffs’ brains does not, under Georgia law [applicable here], constitute a legally recognizable injury in itself.” Id. at *2. The metal particles had to have “caused or would eventually cause actual disease, pain, or impairment of some kind to support a finding that they suffered an injury.” Id. (quoting Boyd v. Orkin Exterminating Co., 381 S.E.2d 295 (Ga. Ct. App. 1989) (applying Georgia law), overruled on other grounds by Hanna v. McWilliams, 446 S.E.2d 741 (Ga. Ct. App. 1994)).

But the plaintiffs’ lawyers didn’t want to allege anything of the sort. Once they allege a disease, pain or impairment, they have entered the world of physical injury, which brings with it issues of causation, alternative causes, risk factors, predisposition and so many other things that wreck sameness and defeat class certification.

And so plaintiffs struggled mightily to avoid these class-killing problems by piecing together purported injuries that weren’t really injuries. They claimed that they “suffered and will continue to suffer physical, neurological, and mental effects.” Id. But those “vague, conclusory statements” weren’t nearly enough to satisfy the TwIqbal pleading standard. Id. They alleged that they would suffer future medical costs and lost wages. But, again, they were unable to tether these allegations to any explicit symptoms or conditions or how they would interfere with the plaintiffs’ work. Id.

In effect, plaintiffs’ claims had achieved sameness. They all had the same lack of injury. And, for that very reason, the district court dismissed plaintiffs’ medical monitoring claims, as had so many courts before it.  And, with its decision in Cure, the Eleventh Circuit upheld that dismissal. Id. at *3.

Risperdal, an antipsychotic drug prescribed to treat serious mental conditions – schizophrenia, manic depression, and autism – allegedly causes some male users to develop abnormal breast tissue growth. Particularly when compared to the consequences of the conditions Risperdal is indicated to treat, that seems like a relatively minor risk.  It isn’t fatal.  It isn’t a long-term disability.  It doesn’t prevent one from making a living.  Thus, Risperdal litigation is a prime example of low-value cases that only exist because of the mass-tort system that has saddled the country for so long.

Thus, it is hardly surprising that Risperdal cases are on the front lines of the battle to rein in our long national mass-tort nightmare.

Just last week we learned of these two decisions:

(1) Covington v. Janssen Pharmaceuticals, Inc., 2017 WL 3433611 (E.D. Mo. Aug. 10, 2017).  Covington was one of the ridiculously misjoined multi-plaintiff complaints that mashed together residents from all over the country.  Before Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017) (“BMS”), Missouri federal courts routinely remanded these atrocities to the St. Louis litigation cesspool because there was always at least one diversity-destroying non-Missouri plaintiff, as well as one jurisdiction establishing Missouri plaintiff in the bunch.  Covington, 2017 WL 3433611, at *2 (“Historically − and especially in this district − courts generally have addressed subject matter jurisdiction first”).

Not anymore.

Covington is typical of the multi-plaintiff complaint genre – 54 plaintiffs from 26 different states.  2017 WL 3433611, at *1.  “Only one plaintiff” alleged injury from use of the drug “in the state of Missouri.  Id.  As for the rest:

The Non-Missouri plaintiffs, or those who do not have any connection to the state of Missouri, do not allege that they were prescribed Risperdal or any of its variants in Missouri, ingested the same in Missouri, or were injured in Missouri.

Id.

With BMS, the personal jurisdiction issues involving litigation tourism of this sort were largely resolved.  With no fixed “jurisdiction hierarchy,” it was now logical to take up this “more straightforward issue first. ” Id. at *2.

However, these [contrary] cases were decided before [BMS] and State ex rel. Norfolk S. Ry. Co. v. Dolan, 512 S.W.3d 41 (Mo. 2017) (en banc) [our post on Dolan is here].  These decisions make the personal jurisdiction issue in this case much easier to decide. . . .  Further, analyzing the challenge to personal jurisdiction first avoids any issues relating to fraudulent joinder.  Personal jurisdiction is now the more straightforward inquiry and should be addressed first as it is in the interests of judicial economy and expeditiousness.

Id. (citations and quotation marks omitted).

The personal jurisdiction question was easy.  There could be no general jurisdiction.  “[N]o defendant is incorporated in Missouri nor has its principal place of business in Missouri.”  Id. at *4.  ‘Nuff said.  Nor was there specific personal jurisdiction for all but one of the plaintiffs – thus removing the planted plaintiffs from the defendants’ home states.

[B]esides the Missouri plaintiff, no other plaintiff allege that they, or a child or incapacitated person whom they represent as next friend, were prescribed or purchased Risperdal in this state, suffered an injury from Risperdal in this state, or received treatment for an injury from Risperdal in this state.

Id.  The “mere fact that other plaintiffs were prescribed, obtained, and ingested [the drug in Missouri] − and allegedly sustained the same injuries as did the nonresidents − does not allow the State to assert specific jurisdiction over the nonresidents’ claims.”  Id. at *4 (quoting BMS).  Thus 53 of the 54 plaintiffs were dismissed (without prejudice, and with the laws of their home states determining whether an unsuccessful litigation tourism jaunt tolled their statutes of limitations).  A single plaintiff’s low-value case thus remained in Missouri federal court.  Id. at *5.  It probably won’t last long, since the March 8, 2017 filing date was more than a dozen years after 2004, when that plaintiff admits discovering the supposed injury.  Id. at *6.

Plaintiffs mounted unsuccessful rearguard actions in Covington.  They sought a stay – claiming “prejudice” from the need to sort out a supposed jurisdictional morass that they, themselves, created.  That went nowhere.  Id. at *3 (“A motion to stay should not be abused by a party to dictate which motion is first addressed by the Court.”).  They also sought “jurisdictional discovery” – a fishing expedition to search for Risperdal/Missouri contacts.  Covington likewise saw that request for what it was:

Here, the plaintiffs do not plead any specific facts that support their contention that this Court has personal jurisdiction over all of the plaintiffs’ claims. Alleging that facts might be discovered during a jurisdictional discovery expedition will not allow plaintiffs to survive a 12(b)(2) motion to dismiss.

Id. at *5.

Summing up, Covington observed:

Unfortunately for the plaintiffs, [BMS], under the facts of this case, made personal jurisdiction the more straightforward issue and therefore more proper to be analyzed first.  Further, [BMS] held that forums, like Missouri in this action, do not have specific personal jurisdiction over non-resident corporations when the plaintiffs do not allege any specific connection between the forum and the specific claims at issue.

Neither this Court nor the state court in which this action was removed can exercise personal jurisdiction − whether general or specific − over the defendants for the claims brought by the 53 non-Missouri plaintiffs.

Id. at *6.

That’s one.

(2) West v. Janssen Pharmaceuticals, Inc., 2017 U.S. Dist. Lexis 124276 (Mag. M.D. Ala. Aug. 4, 2017).  West is something of the obverse of Covington.  In Covington the plaintiffs joined together in an attempt to manufacture jurisdiction for a horde of weak cases, whereas in West, jurisdiction already existed, so the plaintiffs were trying to join their weak cases together to prejudice the defendant at trial.  Once again, the court wasn’t buying the consolidation.  West involved two plaintiffs, Harper and West, treated at one point by the same prescribing physician, both alleging the same injury from the same drug.  Id. at *2, 11.

But that was as far as the similarities went.

The two plaintiffs were of much different ages; one a minor, the other not. One involved off-label use; the other not.  One involved innovator liability (being filed during the few Weeks window when that theory was allowed in Alabama); the other not.  There were various other differences as well, such as duration of use, and when the drug was prescribed (affecting the relevant warnings), and the age at which the risk allegedly manifested.  Id. at *13-15.

The dissimilarities in the Plaintiffs’ claims have be-come more apparent as discovery and expert testimony have developed.  Harper began taking Risperdal as a five or six-year old and was always a minor while taking the medication.  In contrast, West did not begin taking the medication until he was almost eighteen years old and was physiologically an adult.  The significance of this difference is highlighted by the expert causation testimony. . . .  Further, the consequence of Risperdal not being approved for pediatric use takes on a much different meaning in the two cases.

Id. at *12-13.

These differences precluded a joint trial under Fed. R. Civ. P. 20.  “The critical differences between the claims asserted by Plaintiffs outweigh the similarities between the cases, and the court finds trying the cases together would thus be inefficient and confusing for both the Court and the jury.”  Id. at *14.  The presence of an innovator liability claim in one of the cases demonstrated their legal as well as factual disparity.  Id. at *15-16.  Further, “West and Harper were prescribed multiple prescriptions, written at different times by different physicians and in different doses at different physiological stages of their lives.”  Id. at *16.

Thus, two disparate plaintiffs could not claim injury “from the same series of transactions” as required by Rule 20. Id. at *17.  No consolidation synergies for these two weak cases.

*          *          *          *

Two Risperdal cases; two different jurisdictions; two attempts by plaintiffs to manipulate joinder to the disadvantage of defendants defeated.  We look forward to similar rulings in the future.

 

 

Not even three weeks ago, back on July 28,  we discussed the court’s rigorous application of Daubert in excluding expert medical causation opinions in Smith v. Terumo Cardiovascular Sys. Corp., a federal case in the district of Utah.  The plaintiff had undergone a heart valve replacement surgery.  As is typical, the surgery required use of a perfusion heart/lung bypass machine.  At some point, the machine stopped working for 10-11 minutes.  The patient died of a heart attack 11 months later.    The decedent’s heirs brought suit against various defendants, including the manufacturer of the heart/lung bypass machine.

 

In the opinion we discussed on July 28, the court excluded most of the opinions of a cardiologist tendered by plaintiffs as an expert on causation.  That expert was refreshingly candid in acknowledging that he could not say for sure that the heart attack was caused by any machine malfunction, though he thought the malfunction probably played some role.  Because the cardiology expert himself acknowledged an “analytical gap,” because he was plainly unqualified to render opinions on neurologic issues, and because he relied on diagnostic methods that were not generally accepted, the court limited the cardiologist expert’s testimony to an opinion that the decedent’s heart was injured during the valve replacement surgery.  Not nothing, but not much, either. 

 

Today, we discuss the same litigation with the same Daubert issue with a different expert but a similar result.  Smith v. Terumo Cardiovascular Sys. Corp., 2017 U.S. Dist. LEXIS 124866 (D. Utah August 7, 2017), involves a different plaintiff expert proffered to opine on medical causation.  This expert was a licensed perfusionist.  No one disputed that this expert could opine on the standard of care applicable to perfusionists and facilities where perfusion services are offered.  What was disputed was whether the expert could testify about a potential defect in the heart/lung bypass machine that may or may not have exhibited during the surgery in question.  The expert was going to testify that a defect in the machine’s air bubble detection system led to the inadvertent 10-11 minute shutdown during the surgery.  The expert primarily relied upon a recall of the heart/lung bypass machine that occurred almost two years after the decedent’s surgery.

 

The court begins its analysis in the right place with Federal Rule of Evidence 702.  Then we get a paragraph on how the law favors admissibility of expert testimony.  We wince whenever we read about such a presumption, anticipating judicial abdication of the gatekeeping function.  But that was not the case here.  Rather, the court carefully assessed the expert’s qualifications and found them wanting.  The expert knew all about perfusion and how to operate the heart/lung bypass machine, but that does mean he possessed the requisite expertise to analyze the design and technical functionality of the machine.  The defense deposed the expert, and did a nice job of bringing out the expert’s lack of expertise in mechanical engineering or design.  The existence of the product recall might have been suggestive, but to explain why the recall was issued, and why the reason for the recall also accounted for the device’s stoppage during the surgery, required precisely the sort of engineering or design expertise that was lacking.

 

Even aside from the threshold issue of qualifications, the court concluded that the expert’s opinions were unreliable.  The expert’s report disclosed reliance on depositions, reports, system logs, and medical records.  That sounds pretty good.  But the expert never explained how the facts he reviewed, including the device recall, added up to a defect in the device that prompted the stoppage during the surgery. The expert theorized that the perfusion system might have issued a false alarm, which then resulted in the stoppage, but nothing concrete supported that theory.  Indeed, the expert admitted in deposition that no one could explain exactly how the alleged malfunction occurred.   (More refreshing candor!) The court seized upon something that plaintiffs usually emphasize: the failure to test.  The plaintiff’s expert had never attempted to test his defect theory.  Testing, of course, is one of the key Daubert factors.  In this case, the expert’s failure to test his theory kept him in the realm of speculation, and kept his opinions away from the jury.

 

 

 

 

We are beginning to feel like the Drug and Device Law theatre critic. Or perhaps we should say “theatre cheerleader,” as we rarely wax critical (at least about the stuff we include in our blog posts).  Last week, we saw the wonderful new musical Come From Away.   It is a true story, and it begins in the tiny town of Gander, Newfoundland on September 11, 2001.  On that infamous day, Gander opened its doors, and its collective heart, to many thousands of U.S.A.-bound airline passengers whose planes were forced to land when U.S. airspace was closed in the wake of the 9-11 attacks.  Despite the tragedy in the background – and in the foreground for some characters unable to confirm whether relatives were victims of the attacks – the play is an exquisitely energetic and joyful celebration of the openness of the human heart and the resilience of the human spirit.  On the last note of the last song, the cheering audience rose in unison in a manner we have rarely seen.

As in Come From Away, tragic facts are common in our line of work, but they can sometimes provide the framework for a silver lining. In the hands of a rigorous judge committed to correct application of the law despite the pull of sympathy, difficult facts can produce laudable precedent.   Such is not the case in today’s decision out of the Depakote litigation in the Southern District of Illinois.

In E.R.G. v. Abbott Laboratories, Inc., 2017 WL 3055520 (S.D. Ill. July 19, 2017), the plaintiff was a child who was conceived while his mother was taking Depakote and who was born with spina bifida and other birth defects.  At trial, the jury found for the plaintiff on his claim of negligent failure to warn and awarded fifteen million dollars in compensatory damages.  (The jury found that the evidence did not support an award of punitive damages.)  The defendant filed a post-verdict motion for judgment as a matter of law, arguing that: 1) the plaintiff did not produce evidence that the defendant failed to provide adequate warnings of the risk of spina bifida; 2) the plaintiff did not produce evidence that the defendant failed to provide adequate warnings of other birth defects; and 3) the plaintiff failed to prove warnings causation because no doctor testified that a stronger warning would have altered his prescribing decision.  In the alternative, the defendant moved for a new trial, citing evidentiary issues and improper comments during closing argument.

  1.  Motion for Judgment as a Matter of Law

                        Adequacy of Label Warnings

The defendant argued that the label warnings were adequate as a matter of law because the label contained a black-boxed warning of the (correct) 1-2% incidence of spina bifida when the drug was taken during pregnancy. This portion of the decision – like much of the rest – is confusing, but the judge seems to say that, notwithstanding the accurate spina bifida warning, it might have been the case that other portions of the label were inadequate and that the plaintiff’s mother might be saying that other proper warnings would have resulted in a decision to stop taking the drug when she was pregnant.  It’s not clear where the judge is getting any of this, because none of this hypothetical testimony is cited in the decision.  The judge also states that the plaintiff did not “concede” that the spina bifida warning was adequate.  Instead, according to the judge, the jury could adopt the plaintiff’s expert’s theory that the spina bifida labeling was not adequate because it did not state that the drug should be used by pregnant women “only as a last resort.”  In an opinion rife with wrong, we found this “last resort” argument to be the furthest from the mark.  We know of nothing in law or regulation that invites a judge to deem that only specific semantics would have rendered a warning adequate, when the label warned of the precise risk that befell the plaintiff and included an accurate statement of the incidence of that risk.

Finally, the judge held that the jury could reasonably infer that the label was “materially misleading” when it stated that all antiepileptic drugs carried a risk of birth defects, based on evidence that the defendant’s drug carried a higher risk of spina bifida than other drugs in the class. As such, the judge held, the jury could conclude that the defendant “watered down” the spina bifida risk when it lumped the drug in with others that carried a “much lower risk of spina bifida.” E.R.G., 2017 WL 3055520 at *3.  The judge concluded, “Ultimately, there was more than enough evidence presented in Plaintiff’s case in chief to support an argument that the label, including the spina bifida waning was inadequate.” Id. 

            Warnings Causation 

Because the plaintiff’s mother’s physicians testified that they were aware of Depakote’s teratogenic effects when they prescribed the drug, the defendant argued that the plaintiff had not established that any inadequacy of the drug’s warnings was a proximate cause of the plaintiff’s injuries. The plaintiff countered that the issue was not whether the defendant “failed to warn generally of ‘teratogenic effects’” but whether the defendant “provided full, accurate, and complete information about Depakote’s total teratogenic risks and instructions on the safe use of Depakote in women of childbearing age . . . .” Id. Forgive us, but we fail to see the distinction here.  One of the last two physicians to prescribe the drug before the plaintiff was conceived testified that he would have advised the plaintiff’s mother to stop taking the drug if he had been advised to use it as a “last resort” (the chosen language of the plaintiff’s expert and the judge), but he later testified that he would not have “taken away” the drug if the plaintiff’s mother had insisted on taking it.  The judge concluded, “. . . [A] reasonable jury could find that . . . a stronger warning would have caused [the last prescriber] (who was already on the fence about the efficacy of Depakote for [the plaintiff’s mother], to stop prescribing the drug.” Id. at *4.   We think this is a stretch, given the testimony.

The judge may have thought so, too, because she made a confusing attempt to justify her conclusion.   She postulated, “If the jury believed that [the doctor] would have discontinued [plaintiff’s mother’s] prescription in favor of a different [drug], then the jury could reasonably infer that she would still have been off of Depakote when she went to see [the other doctor] for her final visit” to the doctors’ clinic. Id. “Nothing in the testimony of [the second doctor] indicates that if [the plaintiff’s mother] had shown up for her appointment on [a different drug], he would have independently restarted the Depakote prescription.  [The second doctor] that, while he did make an independent assessment of [the plaintiff’s mother] at her last visit, he repeatedly asserted that he was ‘refilling’ her medication.” Id. (citation omitted).   Have trouble following that?  Can’t figure out what it has to do with warnings causation?  Neither can we.  Bottom line is that the prescribers knew that the drug could cause spina bifida and prescribed it anyway.  And, even if the imaginary “last resort” language had been included, the doctor would not have taken the drug away from the plaintiff’s mother if she wanted to keep taking it.  We fail to see how any of this adds up to warnings causation, except in the mind of a judge who didn’t want to grant the defendant’s motion.

  1.  Motion for New Trial 

Predictably, the judge also denied the defendant’s motion for a new trial. Some highlights of that decision:

Mother’s Testimony

In this case, unlike what we are used to seeing in the prescription drug context, the patient – the plaintiff’s mother – was apparently warned about birth defects while the plaintiff alleged that the prescribers weren’t. This led to an upside-down trial in which plaintiff didn’t call his mother in his case in chief while the prescribers testified live.   When the defendant learned that plaintiff’s mother was not being called, it filed a motion to compel her to sit for a de bene esse deposition.  The judge denied the motion, and this denial was one of the bases of the defendant’s motion for a new trial.  The judge held that her denial of the defendant’s motion was proper because the defendant had not adequately explained why the mother’s fact deposition (which was not videotaped) “did not accurately capture her testimony.” Id. (This in spite of the fact that, in our experience, plaintiffs routinely win motions like these.)

“Top 3” Opinion 

The defendant challenged the admission of one of the plaintiff’s expert’s opinions that Depakote was one of the “top three” teratogenic drugs in the PDR, arguing that the opinion was not the product of a reliable methodology. The court disagreed, holding, “While a different expert may come to a different conclusion or may even use a different methodology to determine what the three worst drugs are in terms of teratology, that is not the test for excluding an opinion under Daubert.” Id. at *6.

Improper Comments in Plaintiff’s Closing Argument 

The defendant argued that prejudicial comments in the plaintiff’s closing argument entitled it to a new trial.   These included the comment that the defendant was “guilty as hell” (the judge had to explain to the jury that this was not a criminal trial), as well as comments suggesting that compensatory damages should be based on the defendant’s alleged “bad behavior” (the judge halted this line of argument after the defendant objected that it was an argument for punitive damages, not compensatories) and that the jury, through its award “had a chance to make a decision about the kind of world [it] wanted to live in.” Id. at *7 (citation omitted).  The judge, predictably, held that none of the comments was “overly prejudicial.” Id.  

And so the verdict was allowed to stand. While we reiterate that we were not always able to follow the judge’s reasoning, our takeaway was that she started with her desired result and worked backwards.   As for us, our next foray onto the Great White Way occurs next week, when we accede to a request from the Drug and Device Law Rock Climber that we accompany her to the production of 1984 currently playing at the Hudson Theatre.  This production is notable for the proliferation of audience members fainting and vomiting during the torture scene, so we suspect that cheerfulness may not permeate our description.  And we will have to find a case that makes us queasy so we can easily tie it in.  Based on today’s decision, we suspect this will not be too difficult.  We’ll keep you posted.

The beast part may be a bit of an exaggeration, but it serves the purpose of depicting what at least on the surface are two very opposite things. But if you delve more deeply, you find a lot of similarities. So many similarities that the two things shouldn’t really be opposites at all. That’s what happens in the fairy tale. The beast is really a prince. But life’s not a fairy tale. And neither is pharmaceutical litigation. And if it were, it wouldn’t be a Disney version, it would be one of those original Grimm Brothers’ stories – the dark and twisty ones. And that’s what we have today. Two cases that come to opposite conclusions but based on the same allegations about the same failure to warn about the same drug. We should be talking about a beauty and a prince. Instead we have a beauty and a beast . . . or at least maybe a frog.

Within two days of each other, two decisions were handed down in cases involving the generic prescription drug amiodarone manufactured by the same company – Hernandez v. Sandoz Inc.,  2017 U.S. Dist. LEXIS 120938 (N.D. Ill. Aug 1, 2017) and Tutwiler v. Sandoz Inc., 2017 WL 3315381 (N.D. Ala. Aug. 3, 2017). Both were second bites of the apple. In Hernandez, defendants moved for reconsideration of the court’s prior ruling rejecting preemption and allowing a failure to warn claim premised on defendants’ failure to provide medication guides per federal regulations. We blogged about that earlier decision here. In Tutwiler, the court had previously dismissed that same claim but plaintiff included it in her amended complaint. Defendants moved to dismiss again. Both courts stuck to their prior decisions.

Our prior post on Hernandez explains how we think the court got preemption wrong – notably by applying the Seventh Circuit’s awful PMA, medical device express preemption decision in Bausch v. Stryker to a pharmaceutical drug case and finding a parallel violation claim. On reconsideration, defendants argued that the court misapplied Bausch. In response, the court cited other district courts within the Seventh Circuit to also have applied Bausch to pharmaceutical cases, including another amiodarone case that we blogged about here. Hernandez, at *5-7. The old adage two wrongs don’t make a right comes to mind.

Unable to make the court see that this is really an implied preemption case – plaintiff was seeking to enforce an FDCA requirement regarding distribution of medication guides – defendants were left to argue that the claim isn’t really parallel to a state law duty to warn. There is no Illinois state law duty to warn pharmacists so they can in turn warn consumers. In fact, in prescription drug cases, the manufacturer’s duty is to warn the prescribing physician – not the consumer. Id. at *9n.4. From the court’s description of plaintiff’s allegations, plaintiff alleges both traditional failure to warn the prescriber and failure to warn the consumer by failing to provide medication guides. Id. at *9. The court then seems to conflate all those allegations into one plausible failure to warn claim. See id. (“The court remains convinced that plaintiff has sufficiently alleged each of the elements necessary to establish a failure to warn claim under Illinois law despite focusing much of his complaint on his allegations that defendant’s actions violated the FDCA.”). By alleging both failure to comply with the FDCA and failure to warn the prescriber plaintiff got to dodge both preemption and learned intermediary. But those are two separate claims and they should both fail.

And that’s how you turn the beast/frog into a prince. You apply both preemption and learned intermediary like in Tutwiler. First, in this case the court already dismissed plaintiff’s traditional failure to warn claim – the failure to warn plaintiff’s prescriber – under Mensing. These are after all generic prescription drugs and the Supreme Court has said they don’t survive conflict preemption. Which is presumably why plaintiffs in these cases are focused on the medication guide allegation. In Tutwiler, plaintiffs argued that failure to provide the medication violated the “duty of sameness” on which Mensing rests making Mensing inapplicable. Id. at *2. As we noted above, failure to warn based on failing to adhere to an FDCA requirement should also be impliedly preempted under Buckman or the prohibition of private causes of action to enforce the FDCA.

But the Tutwiler court said it didn’t need to consider preemption because the claim is barred by the learned intermediary doctrine. In Alabama, like in Illinois, in a prescription drug the case the duty to warn runs to the physician. Id.

[I]t does not follow . . . that if the manufacturer inadequately warns the physician, it owes an independent duty to warn the patient directly. This is the reason why this Court previously stated that “it appears unlikely that Plaintiff can state a failure-to-warn claim based on Defendant’s failure to provide a Medication Guide to her pharmacy that avoids the application of both the learned-intermediary doctrine and Mensing.”

Id. And there’s the beauty.

There is one thing that both Hernandez and Tutwiler agree on – plaintiffs’ off-label promotion claims are fraud claims that must be pleaded to the heightened standard required by Federal Rule of Civil Procedure 9(b). Both plaintiffs tried to argue that these were negligent marketing claims. Hernandez, at *3; Tutwiler, at *2. But both courts were unpersuaded by those labels given the context of the allegations. Hernandez, at *4 (“Plaintiff’s complaint is a sprawling and, at times, confusing collection of largely unnecessary allegations that, for the most part, seem to attempt to assert a fraudulent misrepresentation claim as it relates to off-label promotion.”; Tutwiler, at *2 (Plaintiff “claims that Defendant engaged in a ‘concerted and systemic effort to persuade physicians’ . . . that the drug was safe and efficacious for off-label uses). Plaintiff Hernandez is getting another chance to re-plead his fraud claims with specificity. Since this was Plaintiff Tutwiler’s second attempt, and her complaint still failed “to identify a single statement in any promotional material to support [Plaintiff’s] contention that Defendant unlawfully promoted amiodarone for [an off-label use],” her claim is dismissed.

They say beauty is fleeting – and so too is a beautiful case. The beast/frog on the other hand lives to see another day.

 

We have offered our view that cases seeking to impose liability based on well-known risks found with an entire class of prescription medications tend to be weak.  We think design defect claims usually are clearly preempted in this context and warnings claims will often be preempted too, even with Levine’s high “clear evidence” hurdle.  Cases about thrombotic risks with hormonal contraceptives have featured prominently in such posts, like this opus, precisely because design is not the issue and FDA has long been intimately involved with labeling of these products.

Another obvious fertile ground for preemption has been with gastrointestinal bleeding with anticoagulants, something of the therapeutic flip side to the risk of thrombosis.  First, it is a well-known issue.  Our quick PubMed searches easily got us to articles about this from the 1950s.  Second, this risk has been described in drug labels for a long time.  We easily found this as the first warning in prescription labels as early as 1998, although we suspect they had been around for a few decades by that point.  Third, this risk has been seen with every anticoagulant since there have been anticoagulants.  We have no doubt that any anticoagulant drug coming to market gets a thorough review of its bleeding risk and its labeling about that risk by FDA.  This surely includes attention to any differences in the labeling of the different anticoagulants and whether any post-approval studies or adverse events merit changes.  These facts should make it hard to articulate, let alone prove, a design defect claim that gets by Bartlett or a warning claim that gets by Levine, unless Buckman gets ignored.

We say “should,” but, in all fairness, it certainly depends on where the case is and who is deciding it.  Even in the nascent era of drug and device product liability litigation where cases should pretty much be in federal court unless they are in state court in the defendant’s true home state, the court can be all but determinative of the decisions on litigation-altering issues.  The selection of court can, in turn, depend on the selection of the MDL’s home in litigations where the lawyer advertising drums up enough cases to get the JPML’s attention.  We were going to contrast cases decided by different MDL courts overseeing product liability litigation over the bleeding risk of relatively new prescription anticoagulants.  Instead, we will be discussing one decision addressing allegations we think are pretty typical of what is getting offered up elsewhere and our dear readers can draw their own conclusions.

Fortner v. Bristol-Myers Squibb Co., No. 17cv1562 (DLC), MDL No. 2754, 2017 U.S. Dist. LEXIS 117030 (S.D.N.Y. July 26, 2017), comes out of the Eliquis MDL.  Based on the JPML’s statistics, when decided, there were 23 pending cases out of a total of 69 ever-filed cases in this relatively young MDL.  The drug was approved in 2012 with extensive warnings about the risk of bleeding.  Plaintiffs in the MDL offered various allegations about how the drug was defectively designed because it had a clotting risk, was not accompanied by a drug-specific clotting test, was not accompanied by an “antidote,” and was to be taken twice a day.  These same criticisms were offered as warnings claims, but there were no allegations that the manufacturer had received post-approval safety information triggering some alleged duty to try to change any aspect of the label through the CBE process.  The manufacturers challenged whether these allegations stated any state law claim that was not preempted and, before there was even an MDL established, dismissed a number of cases without prejudice in Utts I, which we discussed here.  After the MDL was established, the plaintiffs got another shot with amended complaints and still came up short in Utts II, this time with prejudice.  The court, in an exercise of magnanimity, invited the remaining plaintiffs to see if they could come up with complaints that stated a non-preempted claim.  That is how we get to Fortner, who alleged a variety of claims under Tennessee law based on the same allegations about the drug, manufacturers, and FDA that most of the remaining plaintiffs apparently offered.

As is often the case with pleading around statutes of limitation—complaints with dates for everything but when plaintiff’s alleged injury occurred—it looks like the fourth attempt at a complaint was modified to be vague, repeating allegations “in less detail and without identifying or appending the specific studies from which these allegations are drawn.” Id. at *7.  The Fortner court saw through this “pleading tactic” of “masking the basis for her claim”:  The complaint’s “claims do not become more plausible simply because the plaintiff has omitted from the FAC the sources upon which her conclusory factual allegations are based.” Id. at **7-8.  Well stated and clearly correct, but many courts let uncertainty work to the plaintiff’s advantage in this posture, despite TwIqbal’s requirement of factual allegations that plausibly state a claim.

The critical aspect of Fortner’s approach is that the court required the plaintiff to plead a warning claim based on “sufficient factual content to support a plausible inference that there exists newly acquired information such that the defendants could unilaterally have changed the Eliquis label to include additional warnings.” Id. at *8.  This, in turn, flowed from the court’s prior decisions holding that “post-approval failure to warn claims are preempted unless the plaintiff can plausibly allege that there existed ‘newly acquired information’ such that, pursuant to the Changes Being Effected (‘CBE’) regulation, the defendants could independently have updated the Eliquis label to include such warnings.” Id. at *5.  There is no such thing as a pre-approval warning claim—absent an allegation that the launch label resulted from fraud-on-the-FDA that side-stepped Buckman—so this is a pretty good statement of what a non-preempted prescription drug warnings claim should allege.

By contrast, under the court’s prior analysis, there is no such thing as a non-preempted post-approval design defect claim because “FDA regulations prohibit a change of the type implicated by the claim.” Id. Here, the first urged defect was twice daily dosing—which is a design issue if the plaintiff alleges the product should have been designed to deliver the effective dose by taking it once a day, for instance, and something that clearly cannot be changed without a new NDA.  The other urged defects are things we see as more labeling than design issues—lack of a drug-specific clotting test or an “antidote” to the drug that could be recommended or sold with the drug.  Even if such a test or antidote existed, it could not be sold with the drug based on anything the manufacturer could have done independent of FDA action.  In reaffirming its prior decision on the preemption of pre-approval design defect claims, the Fortner court noted that Yates was the only appellate court to address the issue and no binding authority disagrees with its analysis.

Based on a trio of preemption rulings at the pleading stage, it looks like the Eliquis MDL will be short lived.  That is not always the case with MDL proceedings based on dubious claims, where the burden of one-sided discovery and the weight of the docket tend to dictate the result more than anything approaching the merits.  In terms of issues that seem as obvious to us as preemption of pre-market prescription drug design defect—we note that “duh” and “no duh” mean the same thing, like “regardless” and “irregardless” or “flammable” and “inflammable”—it will help to have more appellate courts follow Yates.

 

Posts on personal jurisdiction, or the lack of it, have been all over this blog ever since the Supreme Court decided Bristol-Myers Squibb Co. v. Superior Court. Something similar happened three years ago after the Supreme Court decided Daimler AG v. Bauman. Together, these two decisions establish that federal courts are not empowered to find a reason to assert personal jurisdiction simply because the defendant is a large company doing business nationally. General jurisdiction requires the state in which the federal court sits to be the defendant’s “home,” meaning that it was incorporated there or has its principle place of business there. Specific jurisdiction requires that the very transaction from which the plaintiff’s claims arose involve the state in which the federal court sits. Otherwise, the court should dismiss the case. These decisions hold the promise of virtually eliminating litigation tourism.

But the plaintiffs in the Pinnacle Hip Implant MDL are trying to resurrect it, if only in their own litigation. The MDL is pending in federal court in Dallas. And yet the MDL court recently held, seemingly, that it can exert personal jurisdiction against the defendants and conduct trials in every case before it, even those that have no connection to Texas.

As many of us know, MDL courts have jurisdiction over the many cases that are transferred to them, but only for pretrial purposes. The transfer does not create personal jurisdiction for trial. Cases over which the MDL court does not have such personal jurisdiction must be transferred for trial back to the originating district court—or an appropriate district court that can exert personal jurisdiction. 28 U.S.C. 1407(a).

So, how is the MDL court doing this? Well, the lack of personal jurisdiction defense is waivable. And that’s where the MDL court is hanging its robe. It ruled in its June 28, 2017 decision that the defendants waived their defense of lack of personal jurisdiction—and not just for cases already tried, but (seemingly) for every Pinnacle hip implant case that has been filed and will be filed and that makes its way to the MDL. The defendants made this perpetual waiver, according to the MDL court, during proceedings before the special master, who at the time was working to arrange the first and second bellwether trials.

The defendants vehemently disagree. They say that their waiver, given the setting and the very language that they used, was limited only to personal jurisdiction as to the cases involved in the first and second bellwether trials, not all cases and forever. They believe this so strongly that they have filed a petition for a writ of mandamus to the Court of Appeals for the Fifth Circuit, asking that court to order that the MDL Judge cannot exercise personal jurisdiction in any of the eight cases with New York plaintiffs that the MDL court scheduled for the next bellwether trial, which starts in September.

It’s a petition for a writ of mandamus, so from the start defendants’ chances of victory are slim. But, last year, even in losing a petition for a writ of mandamus on another issue, the defendants got one of the Circuit Court judges (in a concurring opinion) to say that the MDL judge got it wrong. We’ll see what happens here. Plaintiffs must respond by the 14th. And the Fifth Circuit will almost certainly rule before September 5, when this next multi-plaintiff bellwether trial is set to begin.

The Pinnacle hip implant litigation is never without intrigue.