We remember how, shortly after the atrocious decision in Johnson & Johnson v. Karl, 647 S.E.2d 899 (W. Va. 2007), rejecting altogether the learned intermediary rule, litigation tourists visiting West Virginia argued that Karl represented that state’s “public policy” and therefore the learned intermediary rule could not apply even to their out-of-state cases under the “public policy” exception to the ordinary rules for sorting out choice of law issues.  This was also back in the halcyon days (for the other side) of essentially unlimited plaintiff forum shopping pre-Bauman, so the specter existed that, if this argument succeeded, plaintiffs from all over the country, or even the world, would flock to West Virginia, and by the mere fact of their litigation tourism, thereby rid themselves of one of our side’s most significant arguments.

A couple of West Virginia federal courts were sufficiently pro-plaintiff to buy that “public policy” choice-of-law analysis.  Woodcock v. Mylan, Inc., 661 F. Supp.2d 602, 609 (S.D.W. Va. 2009) (“[b]ecause West Virginia has rejected the learned-intermediary doctrine on public-policy grounds and applying Alabama law to the marketing defect claim would violate that public policy, West Virginia law applies to that claim”); Vitatoe v. Mylan Pharmaceuticals, Inc., 696 F. Supp.2d 599, 610 (N.D.W. Va. 2010) (“it is impossible to apply the substantive law of Louisiana to [plaintiff’s] inadequate warning claim without violating West Virginia public policy”; following “Woodcock’s helpful public policy analysis”).  For doing this, we trolled Woodcock with eighth place on our 2009 bottom ten decisions list:

This decision invoked “forum public policy” to apply West Virginia’s rejection of the learned intermediary rule to a forum shopping plaintiff from Alabama – a staunch learned intermediary state.  That can’t be right.  Practically all major tort law doctrines are grounded in a court’s sense of “public policy.”  Thus the “forum public policy” exception (previously limited to legislatively set policy) becomes another constitutionally suspect means of applying forum law to cases with no significant ties to the state in question.  Any other forum shopper can presumably make the same argument. We’re sure we haven’t seen the last of this.  We blogged about Woodcock here.

Fortunately, the West Virginia legislature stepped in and did the right thing, making its own declaration of West Virginia public policy in 2011:

Choice of Law in Pharmaceutical Product Liability Actions.

It is public policy of this state that, in determining the law applicable to a product liability claim brought by a nonresident of this state against the manufacturer or distributor of a prescription drug for failure to warn, the duty to warn shall be governed solely by the product liability law of the place of injury (“lex loci delicti”).

W. Va. Code §55-8-16(a).  We cheered that development here.

Of course, the entire Karl learned intermediary brouhaha became moot (or so we thought) several years later when the legislature did themselves one better and directly overruled Karl on the merits.  See W. Va. Code 55-7-30 (restoring the learned intermediary rule).  Even more vigorously, we cheered on that development – after the fact, of course, since we made sure not to breathe a word about this before it was a done deal (we know the other side reads our blog, so there are some things we do keep quiet about).

Given this background, it is with no small degree of schadenfreude that we bring to you M.M. v. Pfizer, Inc., ___ S.E.2d ___, 2017 WL 5077106 (W. Va. Nov. 1, 2017).  M.M. involved the West Virginia sojourn of other litigation tourists, this time from Michigan.  Id. at *2.  Michigan, as anyone involved in the defense of prescription medical product liability litigation knows, has a statute that provides the strongest FDA compliance defense in the country (although Texas is close):

In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved . . . by the [FDA], and the drug and its labeling were in compliance with the [FDA’s] approval at the time the drug left the control of the manufacturer or seller. . . .

Mich. Comp. Laws Ann. §600.2946(5).  As we’ve mentioned before, that statute has produced a “diaspora” of Michigan plaintiffs all running away from the policy judgment made by the legislature of their chosen state of residence.  Those prior plaintiffs didn’t have much luck, and as it turns out, neither did this one.

This time, even if West Virginia courts might have been inclined to cut the Michigan plaintiffs a break, they ran headlong into the West Virginia choice-of-law statute mentioned above.  Even though it was passed to overturn half-baked Karl-based “public policy” determinations, the statute’s literal terms establish West Virginia choice of law “public policy” as to all prescription drug warning cases.  Thus, the M.M. plaintiff – despite having nothing to do with Karl – was entirely out of luck.  “Here, there is no dispute that the injuries alleged by [plaintiffs] all occurred in the State of Michigan.  Thus, [the] failure to warn claim is governed by Michigan law, which forecloses such a claim if the drug was approved by the FDA and the manufacturer complied with the FDA’s labeling requirements.”  2017 WL 5077106, at *3 (also discussing why fraud-on-the-FDA exception to statute doesn’t apply).  Thus, “Michigan law forecloses [plaintiffs’] failure to warn claim.” Id. Interestingly, the court added:

To recognize such a claim under West Virginia law where the same already is foreclosed in the same case by the law of another jurisdiction, however, would contradict the full faith and credit due our sister jurisdictions.

Id. (citations omitted).  “Full faith and credit”?   We confess we haven’t seen that much, indeed ever, before in prescription medical product liability litigation, but anything that keeps a plaintiff from relitigating something they’ve already lost finds favor here.

Unfortunately for these plaintiffs, they were also entirely unable to come up with any defect claim that wasn’t really a statutorily covered warning claim.  “[B]oth the strict liability and negligence claims allege that [defendant] improperly failed to include . . . warnings on its labeling, which, again, constitute allegations that [defendant] failed to warn.”  Id. at *4.  Even if West Virginia law could apply, the choice-of-law statute meant that West Virginia law kicked things back to Michigan, and was “foreclosed thereby.”  Id.  Both their strict liability and negligence claims, although making boilerplate allegations, were “merely a restatement of [plaintiffs’] failure to warn claim,” id. (strict liability), or “merely a reiteration of [plaintiffs’] failure to warn claim.”  Id. at *5 (negligence).  Any way one looked at the case, plaintiffs alleged only a failure to warn, and failure to warn claims had to be determined by Michigan law, where plaintiffs lost.

[B]ecause [plaintiffs’] failure to warn claim is governed by Michigan law, and the governing Michigan statutes provide that a manufacturer cannot be held liable where it has complied with the FDA reporting, disclosure, and labeling requirements, there exists no duty that could have been breached so as to establish a claim for negligence.

Id. at *5.

Now that BMS has pulled the welcome mat away from litigation tourists, we don’t expect much more of a Michigan diaspora, but even if there were, the West Virginia choice-of-law statute, enacted for an entirely different purpose, will preclude any of them from relying on more favorable West Virginia law.  See Id. at *3 n.2 (noting that §55-8-16(a) has since been expanded so that it applies to “all liability claims at issue,” not just warnings).

What follows is a guest post from long-time friend of the blog Thomas J. Hurney, Jr. of Jackson Kelly PLLC in Charleston, West Virginia.  Tom comes to us today with news of an interesting – and favorable – federal court remand denial in one of the recently filed opioid litigation in his state.  It raises interesting legal issues in the context of litigation where the possibility of local prejudice makes the right of removal to federal court extremely important.  As always with our guest posts, Tom is 100% responsible for what follows.  He thus deserves all the credit and any blame.

**********

With respect (a lot) to the Drug & Device folks, removal and remand cases are pretty hard to spice up.  While these cases may cry out for humor and whimsy, this guest post with an old-school case summary will have to do the trick.

A number of governmental entities – states, counties and cities – have sued drug manufacturers, distributors, pharmacists and doctors, alleging that because of their distribution, sales and prescription practices, communities have been “flooded” with opioids, resulting in “an acute epidemic of drug use and related social problems.”  Relying on tort and nuisance theories, these governmental plaintiffs seek damages to “compensate … for sums [they] expended and will be forced to expend responding to social problems caused by the opioid epidemic.”

In County Commission of McDowell County v. McKesson Corp., ___ F. Supp.3d ___, 2017 WL 2843614 (S.D.W. Va. July 3, 2017), the County Commission sued several pharmaceutical distributors, including named-defendant McKesson, and added a local physician.  The defendant distributors were all citizens and residents of states other than West Virginia.  The defendant physician was a West Virginia resident, transparently added to destroy diversity jurisdiction, so that plaintiff McDowell County could sue in (you guessed it) McDowell County Circuit Court.

The defendants removed the action, alleging the physician was fraudulent joined, and also fraudulently mis-joined, to defeat diversity.  The defendants argued that the physician was fraudulently joined because there was no possible cause of action against him, as the plaintiffs failed to serve him with a Notice of Claim and Certificate of Merit at least thirty days before filing suit, as required by the West Virginia Medical Professional Liability Act, W.Va. Code §55-7B-6.  Because this failure required dismissal of the complaint against the doctor, there was no possible existing claim, so he was therefore fraudulently joined.

Defendants also argued fraudulently mis-joinder, because “the claims against [the physician] arise out of different transactions, involve different evidence, and rest on different legal theories than the claims against the diverse defendants.”

The Plaintiff moved for remand.

Remand was denied with a scholarly opinion that literally started at the beginning. Citing Chief Justice Marshall’s decision in Strawbridge v. Custiss, 7 U.S. (3 Cranch) 267 (1806), this to-be-published opinion reviewed the history of diversity jurisdiction, noting that “[t]he rule of complete diversity appears nowhere in the statute.” Although diversity jurisdiction has existed since the First Judiciary Act of 1789, it has “always been the subject of some controversy,” with the stated reasons for diversity jurisdiction including local prejudice and perhaps a desire to protect creditors from state legislation favorable to debtors.  “In the early days of the republic, at least in Virginia [of which West Virginia was a part before 1863], prejudice was palpable.  The state courts there were notoriously hostile to foreign merchants.”  As an example, state juries were permitted to deny interest on a debt judgment for a creditor, effectively removing the profit from the transaction.  Id. at *1.

The reference to “local prejudice” as a basis for diversity jurisdiction is telling, since McDowell Co. v. McKesson is precisely the type of litigation that, these days, highly likely to raise this concern, that being a local municipality suing in its home court seeking recovery of damages that would (among other things) be likely to reduce local jurors’ taxes.

Concerning the trend in federal courts against diversity jurisdiction, the opinion pointed out that “[i]n recent times, crowded federal dockets, a dearth of evidence showing the existence of state court prejudice, and continuing doubts about the utility of diversity jurisdiction have pushed federal courts in the direction of limiting it.”  Consciously bucking that trend, the decision defended the importance of diversity jurisdiction, stating

Nevertheless, Congress has created diversity jurisdiction and a litigant whose case comes within it has a right to be in federal court. As the Supreme Court has said:  “[T]he Federal courts may and should take such action as will defeat attempts to wrongfully deprive parties entitled to sue in the Federal courts of the protection of their rights in those tribunals.”  In re Lipitor (Atorvastatin Calcium) Mktg., Sales Practices and Prods. Liab. Litig., 2016 WL 7339811 at *3 fn.4 (D.S.C. Oct. 24, 2016) (quoting Alabama Great S. Ry. Co. v. Thompson, 200 U.S. 206, 218 (1906)).  Therefore, if diversity jurisdiction is to be assigned to oblivion, it is Congress, not the courts who should send it there.  Here, where the opioid epidemic is pervasive and egregious, there is at least a possibility of prejudice to the defendants at the hands of a jury drawn exclusively from the very county that is the plaintiff in this suit.  A federal jury casts a wider net and is drawn from a division composing several counties.  All may have an opioid problem, but not one that is specific to the plaintiff county.

Id. at *2.

Turning to the analysis of the defendants’ removal, the court provided a concise review of the fraudulent joinder and mis-joinder doctrines.  “Fraudulent joinder is applicable where a defendant seeking removal argues that other defendants were joined when there is no possible cause of action against those defendants or where the complaint pled fraudulent facts,” whereas “[f]raudulent misjoinder . . . is an assertion that claims against certain defendants, while provable, have no real connection to the claims against other defendants in the same action and were only included in order to defeat diversity jurisdiction and removal.”  Id. (citing Wyatt v. Charleston Area Med. Ctr., 651 F. Supp.2d 492, 496 (S.D.W. Va. 2009)).

Thus, “[i]n order to establish fraudulent joinder in a particular case, a removing defendant must show either (1) there is no possibility that the plaintiff can establish a cause of action against the removing defendant, or (2) that there has been outright fraud in plaintiff’s pleading of jurisdiction. Id. The claim against the doctor, therefore, requires remand “[i]f the plaintiff demonstrates a mere ‘glimmer of hope’ that its claim will succeed.  Id. at *3 (quoting Hartley v. CSX Transp., Inc., 187 F.3d 422, 424-26 (4th Cir. 1999)). However, “[t]his is the rare case that fits the ‘no possibility of recovery’ rubric.” Id.

The court agreed that the physician was fraudulently joined because McDowell County did not serve him with a notice of claim and screening certificate of merit at least 30 days before suing him as required by the Medical Professional Liability Act, W.Va. Code §55-7B-6 (MPLA).

West Virginia Code § 55-7B-6, imposes a series of procedural prerequisites for filing a medical malpractice claim.  The plaintiff, in such a case, is required, at least thirty days prior to filing suit, to service notice on the defendant of his intention to bring suit.  The notice must contain a ‘screening certificate of merit’ executed under oath by a qualified expert.’  If this requirement is not met, the case must be dismissed.

Id.  The MPLA plainly applied to the allegations of improper prescription by the doctor – “[i]t can hardly be questioned that writing prescriptions for controlled medication are acts done within the context of rendering health care services,” as defined in the MPLA.  Id.

Finding that state law requiring pre-suit requirements are jurisdictional (citing Flagg v. Stryker Corp., 819 F.3d 132, 137-38 (5th Cir. 2016) (en banc) [ed. note, we blogged about Flagg here], and Robinson v. Mon, 2014 WL 4161965, at *8 (S.D.W. Va. Aug. 19, 2014)), the court concluded “there is no possibility of recovery by the plaintiff against [the doctor] in this civil action as it presently stands” and the dismissed the county’s claim against him without prejudice.  Id.

That was not all.  Aiming to prevent a recurrence of this kind of jurisdictional subterfuge (remember the “local prejudice” point), the court further found that the local prescribing physician was fraudulently mis-joined because the claims against him for improperly prescribing some opioids were attenuated from the claim that the distributors “flooded” the market.

Fraudulent joinder assumes that the claim against the nondiverse defendant is sufficiently related to the claims against the diverse defendant to have been properly joined in the same lawsuit.  Such is not the case with the related, but distinct, doctrine of fraudulent misjoinder.  Here, the inquiry is whether claims against the diverse and non-diverse defendants are sufficiently related to be properly joined in a single case.

Id.

Upon review of cases adopting misjoinder, the court found the Fourth Circuit has “not accepted nor rejected the doctrine” but noted several District Courts had done so (commending the reader to the list of cases in In re Lipitor (Atorvastatin Calcium) Mktg., Sales Practices and Prods. Liab. Litig., 2016 WL 7339811 at *3 fn.4 (D.S.C. Oct. 24, 2016)).  Id. at *4.  Since the propriety of joinder is a state law question, the court looked to Rule 20 of the West Virginia Rules of Civil Procedure, governing joinder, and cases on its federal counterpart.  “Under Federal Rule 20 and the corresponding West Virginia rule, the claims, to be properly joined, must (1) arise out of the same transaction or occurrence, and (2) present a question of law or fact common to all defendants.”  The court declined to apply a “heightened standard” similar to fraudulent joinder adopted in In re Lipitor (“[T]o establish fraudulent misjoinder, the removing party was required to show either outright fraud, or that there was no possibility that the plaintiff would be able to join the diverse and non-diverse claims”), instead finding “[t]he prevailing standard is whether there is a ‘reasonable possibility that a state court would find that [the plaintiffs’] claims against [one set of defendants] were properly joined with [the] claims against the other defendants.’” Id.

The court contrasted Wyatt v. Charleston Area Med. Ctr., a medical device case where the court found that product liability and malpractice claims arose “out of the same occurrence – the plaintiff’s surgery ‘and the after effects of that surgery,’” with Hughes v. Sears, Roebuck and Co., 2009 WL 2877424 (N.D.W. Va. Sept. 3, 2009), where the court found that the plaintiff, who fell off a treadmill, couldn’t combine product claims against the treadmill manufacturer with malpractice claims against the emergency room physician who misdiagnosed her injuries.  “[The emergency room doctor] had no control over the allegedly defective product.”  Id. at *5.

In the case before the court, there was no basis for a persuasive argument that the medical malpractice and products liability claims arose out of the same transaction or occurrence.  Moreover, “the evidence supporting these claims will be markedly different.”  Id.  McDowell County’s claims were more like Hughes than Wyatt, since:

 In this case, the connection, if any, between the actions of the corporate defendants, who allegedly flooded the market with opioids, and the doctor, who prescribed some of them, is far more attenuated than any connection between the manufacturers and seller of the treadmill in Hughes and the subsequent misdiagnosis by the treating physician.

Id.

Thus, the McDowell opinion concluded,

Since there is no possibility of recovery against [the doctor] in this case, he has been fraudulently joined. Additionally, the court finds no common questions of law or fact in plaintiff’s claims against the corporate defendants and the claims against [the doctor].  The cases against each are separate and distinct. Accordingly, [the doctor] has also been fraudulently misjoined. The Motion to Remand is therefore DENIED.  Since the court lacks jurisdiction over plaintiff’s claims against [the doctor] this action, insofar as it relates to [him], is dismissed without prejudice.

Id.

This remand ruling eliminates one possible jurisdictional ploy to defeat diversity. There are, however, others, and we will have to see what happens next.

We have two posts on innovator liability that we update on a consistent basis: our innovator liability scorecard, and our “Innovator Liability at 100” state-by-state collection of materials that we originally compiled when the one-hundredth judicial opinion on this topic was decided.  Well, not too long ago the Fourth Circuit, in McNair v. Johnson & Johnson, ___ F. Appx. ___, 2017 WL 2333843 (4th Cir. May 30, 2017), did what no court of appeals had done since the innovator liability first reared its ugly head in 1994 – it certified the question to the relevant state high court – in this case, the West Virginia Supreme Court of Appeals:

Whether West Virginia law permits a claim of failure to warn and negligent misrepresentation against a branded drug manufacturer when the drug ingested was produced by a generic manufacturer.

2017 WL 2333843, at *1.

At least a dozen federal court of appeals decisions have rejected innovator liability under the laws of some two dozen states. Ironically, the first to do so was the Fourth Circuit itself, in Foster v. American Home Products Corp., 29 F.3d 165, 168, 171 (4th Cir. 1994), under Maryland law.  Plaintiffs did not begin resorting to the delaying tactic of requesting state court certification until relatively late in the game.  Courts of appeals were not accommodating, refusing to certify what they saw as an outlier issue in Johnson v. Teva Pharmaceuticals USA, Inc., 758 F.3d 605, 614-15 (5th Cir. 2014); Strayhorn v. Wyeth Pharmaceuticals, 737 F.3d 387, 406-07 (6th Cir. Dec. 2, 2013). See also In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 3610237, at *3 (E.D. Ky. Aug. 21, 2012), aff’d, 756 F.3d 917 (6th Cir. 2014); Mosley v. Wyeth, Inc., 719 F. Supp. 2d 1340, 1351 n.9 (S.D. Ala. 2010) (district courts refusing certification motions).  But plaintiffs got lucky (for a few months) in Wyeth, Inc. v. Weeks, 159 So. 3d 649, 653 (Ala. 2014), with a certified question, and with nothing left to lose they’ve been trying it ever since.

McNair is not only an outlier procedurally, but is troubling substantively.  First, the Fourth Circuit’s certification opinion seems more concerned with preemption rather than state law – addressing preemption before even bothering with state-law causation principles, and finishing that section with the observation, “while a state law failure-to-warn claim against a generic manufacturer is preempted, such claims are not preempted as to the warnings on a brand-name drug distributed by a brand-name manufacturer.”  2017 WL 2333843, at *3 (emphasis original).  Ordinarily, the existence of a recognized state law claim precedes any decision on whether that claim is preempted.  We always find it troubling when a federal court views principles of state law more through the lens of a preemption dodge than on their merits.

Although pointing out (as could hardly be denied) that even in the current preemption environment, “overwhelming” precedent rejects innovator liability, McNair, 2017 WL 2333843, at *4, the certification order makes it appear as if there is no prior West Virginia law on this subject.  That is simply not so.  As we state in our Innovator Liability at 100 post:

In In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. 2014), the Sixth Circuit concluded that West Virginia “has rejected claims attempting to impose liability on brand manufacturers where plaintiffs ingested only generic drugs.”  Id. at 953.  Darvocet relied upon Meade v. Parsley, 2009 WL 3806716 (S.D.W. Va. Nov. 13, 2009).

[Innovator defendants] are not responsible for the damage resulting from a product that they did not manufacture, distribute or sell. . . .  Product liability law in West Virginia allows for recovery when the plaintiff can prove that “a product was defective when it left the manufacturer and the defective product was the proximate cause of the plaintiff’s injuries.”  Because neither [innovator defendant] manufactured the product that injured plaintiffs, there is no proximate cause.

Id. at *2-3 (quoting Dunn v. Kanawha County Board of Education, 459 S.E.2d 151, 157 (W. Va. 1995)).

That the Fourth Circuit would decide to omit all of the most directly on-point West Virginia law-based precedent – including a published court of appeals decision − from its certification order is simply inexplicable.  Certainly, ignorance cannot be claimed, as both the Darvocet and Meade decisions were relied upon by the district court in McNair itself.  McNair v. Johnson & Johnson, 2015 WL 3935787, at *6 (S.D.W. Va. June 26, 2015).  We can only hope that the West Virginia high court (docket available here) will not be misled by these omissions.

 

We don’t write a lot on the various pelvic mesh MDLs in West Virginia because we are so heavily involved in two of them. But the MDL court entered an order last week on design defect and alternative design that we consider to be a real gem.  The case is Mullins v. Ethicon, Inc., No. 2:12-cv-02952, 2016 WL 7197441 (S.D. W. Va. Dec. 9, 2016), and we recommend it to all of you.  We say that not only because the district court held that West Virginia law requires that each plaintiff must prove a feasible alternative design—which is the correct result—but also because the order is particularly well reasoned.

Not every state requires proof of a feasible alternative design, but it is nevertheless a basic product liability concept. It is a particularly good fit when dealing with products that always bear risks—such as implanted medical devices.  The Restatement (Third) of Torts, Product Liability § 2 is as good a place as any to start, as it bakes alternative design right into the definition of a design defect:  “A product . . . (b) is defective in design when the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design by the seller or other distributor, or a predecessor in the commercial chain of distribution, and the omission of the alternative design renders the product not reasonably safe.”  (emphasis added).

Take the obvious example of a machine with sharp spinning parts. The same machine with a protective guard may be a safer alternative design.  Or it might not.  The point is that the plaintiff has to prove it.  Take also the example we discussed in Bexis’ aptly named post “On Alternative Design.”  That case involved hernia mesh, not pelvic mesh, and the plaintiffs’ claims failed because, among other reasons, they had failed to prove that a mesh of a different design would have been any safer.  Consider hormone-based contraceptives.  Cholesterol drugs.  We could go on and on.  All these products bear known and unavoidable risks, and those risks should not be labeled “defects” and result in potential liability unless the plaintiff can prove an alternate design would feasibly mitigate them.  And, no, it is not sufficient to say that the feasible alternative is to use a different product or not use any product at all.  As we observed in the aforementioned post, that would convert strict liability into absolute liability.  As we asked in yet another post on this topic, are motorcycles defective because full-sized automobiles are generally safer?  You get the point.

Continue Reading A Gem on Alternative Design from a Pelvic Mesh MDL

Last week, the Drug and Device Law Lifelong BFF asked us if we were interested in a quick trip to New York to use tickets for an early morning taping of “Live with Kelly.” Sure, we said – sounds like fun.  And so, after nearly two hours in line and significant drama over whether we were in front of or behind the “make it into the studio” line we were told would be drawn, we  were seated.   And we had a great time.  Kelly is as adorable and effervescent as she appears on television.  Her guest co-host interjected continuous comments from the “intelligent and engaged host” playbook.  And the guests were bona fide celebrities whom it was fun to observe at a distance of a scant ten feet.   But what was most impressive about the whole exercise was the opportunity to see what goes into the daily illusion that the hosts and the guests are responsible for the “workings” of an interview show.  Because, in fact, the stage was swarming with people who kept the machine operating, and the familiar faces were a tiny nucleus at the center of it all.  There were stylists and producers and directors and cameramen everywhere – so much so that they often blocked our view and we resorted to watching on monitors or on the screens mounted on the huge cameras.  And we realized that there would be no final product without every piece of this puzzle.

In today’s case, the absence of a requisite puzzle piece – a qualified specific causation expert – doomed the plaintiff’s case. In In re Zoloft Litigation, 2016 WL 5958372 (W. Va. Cir. Ct. Oct. 5, 2016), the court considered the defendants’ motion to exclude the plaintiff’s (general and specific) causation expert, who was a research scientist and not a medical doctor..  The expert had designated the expert to render the opinions that the defendants’ product could cause “deleterious effects both in developmental autonomy, neuroautonomy, and neurological function including the development of autism and other neurodevelopmental disorders,” 2016 WL 5958372 at *1 (emphasis in original), and that the plaintiff’s mother’s ingestion of the product while she was pregnant caused a seizure disorder and “cognitive and neurobehavioral disorder” in the plaintiff. Id.

The expert was deposed, on successive days, in four pending cases including this one. After the first day of his deposition, when he testified on behalf of two other plaintiffs, he met with plaintiffs’ counsel for several hours and drafted an updated disclosure in this case, omitting all references to autism and deleting the opinion that the defendants’ product caused the plaintiff’s seizures.   Instead, the new disclosure stated that the expert would testify that the plaintiff’s mother’s use of the product during pregnancy was a cause of the plaintiff’s developmental delays. Id. at *2.   Asked to explain why he revised his disclosure, the expert testified that, after “going back over the [plaintiff’s] records in preparation for” his deposition, he “felt it was prudent to focus on the developmental delay” and to delete the opinions that the defendants’ product caused autism and epilepsy. Id. Why?  Because the plaintiff had not been clinically diagnosed with autism, and because there was not a “good differential diagnosis” concluding that the plaintiff’s seizures “occurred at the right time to be related to his mother’s use” of the defendants’ product.” Id.

Continue Reading Expert Who Admitted That He Was Unqualified and That His Opinions Lacked Methodology Not Allowed to Testify in Zoloft Litigation.

The West Virginia legislature has passed, and the governor signed today, S.B. 15, adopting the learned intermediary rule.  Here is a link to the legislative history of the bill. Here is the text of the bill:

[Passed February 17, 2016;  in effect 90 days from passage.]

AN ACT to amend the Code of West Virginia, 1931, as amended, by adding thereto a new section, designated §55-7-30, relating generally to manufacturers and sellers of prescription drugs and medical devices and liability of those entities for alleged inadequate warning or instruction; and adopting the learned intermediary doctrine as defense to civil action based upon inadequate warnings or instructions.

Be it enacted by the Legislature of West Virginia:

That the Code of West Virginia, 1931, as amended, be amended by adding thereto a new section, designated §55-7-30, to read as follows:

ARTICLE 7. ACTIONS FOR INJURIES.

§55-7-30. Adequate pharmaceutical warnings; limiting civil liability for manufacturers or sellers who provide warning to a learned intermediary.

(a) A manufacturer or seller of a prescription drug or device may not be held liable in a product liability action for a claim based upon inadequate warning or instruction unless the claimant proves, among other elements, that:

(1) The manufacturer or seller of a prescription drug or medical device acted unreasonably in failing to provide reasonable instructions or warnings regarding foreseeable risks of harm to prescribing or other health care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings; and

(2) Failure to provide reasonable instructions or warnings was a proximate cause of harm.

(b) It is the intention of the Legislature in enacting this section to adopt and allow the development of a learned intermediary doctrine as a defense in cases based upon claims of inadequate warning or instruction for prescription drugs or devices.

NOTE: The purpose of this bill is to adopt and codify the learned intermediary doctrine as a defense to a civil action against a manufacturer or seller of a prescription drug based upon inadequate warnings or instructions.

Continue Reading Breaking News – West Virginia Statute Adopts Learned Intermediary Rule

This is a quick-hit post as we head into the Independence Day holiday weekend.  The Southern District of West Virginia’s order this week in McNair v. Johnson & Johnson, No. 2:14-17463, 2015 WL 3935787 (S.D. W. Va. June 26, 2015), dismissed claims against the seller of an innovator drug for precisely the right reason: The defendant neither made nor sold the generic drug that the plaintiff ingested.  That is to say, there is no Conte-style “innovator liability” in West Virginia.

It seems obvious, doesn’t it?  It has been seven years since the California Court of Appeal issued its wrongly reasoned and wrongly decided opinion in Conte v. Wyeth, where the court held that a plaintiff who used a generic drug could sue the manufacturer of the listed version.  As we like to say, the court took the “product” out of product liability and held a company potentially liable for injuries allegedly caused by a product that it did not make and did not sell.  The late Roger Traynor and his colleagues on the California Supreme Court, who presaged strict product liability way back in 1944 in Escola v. Coca-Cola Bottling Co., must have rolled in their graves.

The Conte opinion has predictably become an outlier, and courts have rejected the opinion and its reasoning many times over, often expressly. (Check out our Innovator Liability Scorecard here and our survey of innovator liability here.)  As we reported here, the Alabama legislature abolished innovator liability just a few months ago, and we believe the California Supreme Court overruled Conte in Crane v. O’Neill, 53 Cal. 4th 335 (2011), where it held that a manufacturer has no duty to warn of hazards in another manufacturer’s product due to “foreseeability.”

Continue Reading No Innovator Liability: National Drug Code Saves the Day

Two days ago, we posted on a West Virginia Supreme Court decision that told non-resident plaintiffs the closing time refrain “you don’t have to go home, but you can’t stay here.”  OK, we took some liberties there, but the non-resident plaintiffs who had gone shopping in a non conveniens forum could not stay even after poking around for two years.  We commented that the same result seemed dictated by last year’s Bauman decision on personal jurisdiction, which has been the subject of a few other posts, like this, this, and this.  Last week, another Wild and Wonderful court took the Bauman route to send 141 plaintiffs packing, although they will probably be back.

Starting in Texas state court with the sort of CAFA-defying, misjoindering gamesmanship that we often see in serial product liability and mass tort litigation, two cases presenting virtually identical motions to dismiss were eventually heard by the pelvic mesh MDL court in Huston v. Johnson & Johnson, No. 2:15-cv-01519, 2015 WL 1565648 (S.D.W. Va. Apr. 8, 2015), and Kraft v. Johnson & Johnson, No. 2:15-cv-01517, 2015 WL 1546814 (S.D.W. Va. Apr. 8, 2015).  Separated only to help the effort to stay out of federal court, one case had ninety-four plaintiffs with only three allegedly from Texas (or connected to Texas by their medical care), and the other had fifty-two plaintiffs with only two allegedly from Texas (or connected to Texas by their medical care).  Of course, each case had the obligatory one plaintiff from the defendant manufacturer’s home state.  The plaintiffs were linked together in that they were suing over the same or similar products and injuries, although with nothing suggesting it was appropriate for these plaintiffs to be together.  On the same schedule, with the fairly predictable procedural steps, these cases made their way to the MDL court to address the basic—and appropriately first addressed—issue of whether all these non-Texans could drag a non-Texas company into Texas state court without offending due process requirements of general personal jurisdiction.

If they could, then trials through the MDL court sitting by designation or after remand back from the MDL would be in the United States District Court for the Northern District for Texas.  If they could not, then each forum shopping plaintiff faced the choice of 1) not re-filing, 2) re-filing in her home jurisdiction (where there would be probably specific personal jurisdiction over the defendant), or 3) coming up with some other way to avoid removal.  The second option eventually gets the plaintiff back to the MDL court, but in a single plaintiff case and with any eventual trial in the federal district court whose boundaries cover where she lives.  The “but” part of the preceding sentence makes a difference to defendants, but there is also the larger issue of striking a blow against forum shopping in its various forms.  A manufacturer of drugs or medical devices (principal among potential defendants, at least here) is entitled to expect to face individual product liability lawsuits in its home state’s (state) courts or in the federal court in plaintiff’s home state (as of the relevant events) after a successful removal. Setting aside MDLs or state coordinated proceedings, other options typically mean some jurisdictional games have been played.

Continue Reading More Plaintiffs Go Home (Eventually And Based on Bauman)

Last weekend, we saw the surprisingly effective “Danny Collins,” a new movie starring Al Pacino as an aging rock star wondering how the focus of his life would have changed if he’d known contemporaneously about an admiring letter from John Lennon that was not given to him until decades later.

The focus of today’s post might have changed if, instead of celebrating a correct appellate decision, we were blogging about the underlying order.  Those of us who practice in the mass tort arena are all too familiar with the forum-shopping propensities of plaintiffs’ lawyers and the inevitably-resulting dockets filled with plaintiffs who bear no relation to the states in which their cases are pending.  In State of West Virginia ex rel. J.C. v. Mazzone, 2015 W.Va. LEXIS 259 (W. Va.  Apr. 10, 2015), the West Virginia Supreme Court entertained a Motion for Writ of Prohibition seeking to prevent West Virginia’s Mass Litigation Panel from enforcing its October 2014 order dismissing petitioners –  20 Zoloft plaintiffs from numerous other states – on forum non conveniens grounds.  (The named plaintiffs were infants who had allegedly sustained birth defects; hence, the Court referred to them by their initials). Had we blogged about the Panel’s order, we would have pointed out that the Panel did not need to consider the convenience of the forum.  Under SCOTUS’s April 2014 decision in Daimler AG v. Bauman, 134 S. Ct. 746 (2014), which we discussed here,  the fact that Pfizer was registered to do business in West Virginia did not confer general jurisdiction over it on West Virginia’s courts.  But forum non was the route the Panel chose and was the subject of the Court’s consideration.

The Court explained that “disputes over venue, such as a dismissal for forum non conveniens,” are exceptions to the “general proposition that prohibition does not lie to review discretionary rulings. . . .”  J.C., 2015 W.Va. LEXIS 259 at *14.  In considering a Motion for Writ of Prohibition, a court is to consider five factors, but “the third, the existence of clear error as a matter of law, should be given substantial weight.  Id. at *13.

Continue Reading Plaintiffs Go Home: West Virginia Supreme Court Affirms Forum Non Dismissals of Non-Resident Zoloft Plaintiffs

Back in November, we exulted over the pelvic mesh MDL judge’s resurrection of West Virginia’s learned intermediary doctrine.   In Tyree v. Boston Scientific Corp., ___ F. Supp.3d ___, 2014 WL 5431993 (S.D.W. Va. Oct. 23, 2014), as we reported, the Court held that the learned intermediary doctrine governed a medical device manufacturer’s duty to warn when the manufacturer had never engaged in direct-to-consumer advertising. We are pleased to report that such displays of common sense are no longer confined to the mesh litigation.

In O’Bryan v. Synthes, Inc., 2015 U.S. Dist. LEXIS 32361 (S.D.W.Va. Mar. 17, 2015), the plaintiff alleged that Synthes was liable for failure to warn her that the metallic fixation plate implanted to repair her fractured fibula could fail if subjected to full weight-bearing before the bone had healed.  Synthes moved for summary judgment on the plaintiff’s warnings claims.  As the Court discussed, the plate’s package insert contained detailed warnings to exactly this effect in both the “Warnings” and “Precautions” sections.  Nevertheless, plaintiff argued that her doctor did not provide her with the package insert, and that she would not have undergone her implant surgery if she had known the device could fracture in less than four weeks.  O’Bryan, 2015 U.S. Dist. LEXIS 32361 at *12.

The Court gave Plaintiff’s argument the back of its hand.  Citing Tyree, the Court held, “Because Defendant Synthes is a ‘manufacturer of medical devices,’ the learned intermediary doctrine applies to the Plaintiff’s failure to warn claims.”  Id. at *17 (citation to Tyree omitted).   The Court emphasized that Tyree limited the application of State ex rel. Johnson & Johnson v. Karl, 647 S.E.2d 899 (2007), the West Virginia Supreme Court’s decision rejecting the learned intermediary doctrine, to cases involving “prescription drug manufacturers and manufacturers engaged in direct-to-consumer (“DTC”) advertising.”  Id (more on this later).  Granting summary judgment for Synthes on plaintiff’s warnings claims, the Court held, “This Court finds the analysis and reasoning in Tyree particularly persuasive in this case involving implantation of a plate or medical device with no evidence of direct to consumer advertising.  The learned intermediary doctrine requires Synthes to warn only the plaintiff’s treating physician about the Synthes plate.”   Id. (internal punctuation and citation
omitted).   Synthes, of course, had done just that.  And plaintiff’s warnings claim was dispatched to an appropriate learned intermediary graveyard.

We remain troubled by a window the Tyree opinion left open.  The O’Bryan court’s proclamation that the learned intermediary doctrine applied because Synthes was “a manufacturer of medical devices” buys into Tyree’s insistence that there is a distinction, for learned intermediary purposes, between prescription drugs and prescription medical devices, rendering device manufacturers more deserving of the doctrine’s constraints.  There is no such distinction (99.9% of all cases treat them identically), and, ever optimistic, we await such a proclamation in a West Virginia prescription drug case.  In the meantime, O’Bryan is another positive link in the jurisprudential chain.