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.

We are pleased to have left the bullpen and joined the starting rotation of contributors to this blog. We will strive for the relevance and style our colleagues’ posts consistently display.

We adopted a Drug and Device Rescue Cat this week.  Her housemates, two Drug and Device Rescue Dogs, are poodle mixes, so we haven’t dealt with the issue of shedding since we last had cats, years ago.   We have discovered a nifty tool that claims to dramatically reduce the hair deposited on furniture and clothing, reminding us of our fondness for anything that strips away the clutter of useless underbrush and leaves only what is neat and firmly rooted.   And that is the (admittedly tenuous) segue to today’s case, in which the United States District Court for the Northern District of West Virginia bushwhacks through plaintiff’s detritus to arrive at a solid holding and a (mostly) tidy opinion.

In Muzichuck v. Forest Laboratories, Inc., No. 1:07-CV-16, 2015 U.S. Dist. LEXIS 5440 (N.D.W.Va. Jan. 16, 2015), the Court considered defendant’s Motion for Summary Judgment in a Lexapro suicide case.   Plaintiff, who opted out of the global Lexapro settlement, alleged that defendants, Forest Laboratories, Inc. and Forest Pharmaceuticals, Inc. (“Forest”) failed to warn her decedent-husband and his prescribing physicians of the risk of suicide associated with the antidepressant Lexapro.

Continue Reading Opt-out Out of Court: Northern District of West Virginia Dispatches Lexapro Warnings Case

Perhaps no case in the 8+ year history of the blog (well, maybe Wyeth v. Levine, 555 U.S. 555 (2009)), invoked greater ire from us than the atrocity in State ex rel. Johnson & Johnson v. Karl, 647 S.E.2d 899 (W. Va. 2007), making West Virginia the only state in the nation (still) not to apply the learned intermediary rule.  We excoriated Karl, of course, but even more, the decision prompted two of our early research-heavy posts, “In Defense of the Learned Intermediary Rule” (going over the rule’s justifications) and “Headcount: Who’s Adopted the Learned Intermediary Rule?” (one of our first 50-state surveys).  Needless to say, Karl also led our inaugural list as the worst drug/device decision of 2007.

In the wake of Karl, we followed a federal court’s attempt to assert Karl as West Virginia “public policy” and refuse to apply the learned intermediary rule to non-West Virginia plaintiffs who brought suit in West Virginia courts.  See Woodcock v. Mylan, Inc., 661 F. Supp.2d 602 (S.D.W. Va. 2009).  The West Virginia legislature squelched that initiative by passing W. Va. Code, §55-8-16, which explicitly provided otherwise.

We also pointed out that the West Virginia Supreme Court seemed to be having second thoughts about this whole learned intermediary thing in White v. Wyeth, 705 S.E.2d 828 (W. Va. 2010), since it cited learned intermediary principles as one reason for precluding actions under the state’s consumer protection statute against manufacturers of prescription medical products.

The intervention by a physician in the decision-making process necessitated by his or her exercise of judgment whether or not to prescribe a particular medication protects consumers in ways respecting efficacy that are lacking in advertising campaigns for other products.

Id. at 141 (citation and quotation marks omitted).

Continue Reading A Learned Intermediary Comeback in West Virginia