When we first looked at the decision for today’s post, we thought about comparing it to fan fiction. If you aren’t familiar with the term it is fiction stories written about characters from an original work of fiction created by fans of the original work as opposed to its creator. Pretty straightforward in concept. But while fan fiction has become more mainstream in recent years (one of the most popular fan fiction websites has almost 600,000 entries under the Harry Potter category alone), it still has a fairly bad reputation as the dark side of geek fandom. And let’s face it, the bulk of the people writing fan fiction aren’t going to be the next J.K. Rowling. And, fan fiction is at its core a product of fandom. So, you have to be fairly well-versed in the original to even think about understanding its offspring. That said, fan fiction having found a home on the internet has led to the development of communities that rally around the original work and discuss and debate everything from literary theory to pop culture.

But upon further reflection, we think the court’s decision in Proffitt v. Bristol Myers Squibb Co., 2018 U.S. Dist. LEXIS 111895 (S.D.W.Va. Jul. 5, 2018), is more like a reimagining of an old classic. There are many lists of books based on other books. Some authors create sequels or prequels to old classics. Possibly delving into storylines that were only marginally touched in the original. Those might be classified as published fan fiction – and some of it quite good. Wicked, for instance, long before it was a hit Broadway musical, was a Wizard of Oz spinoff about the life of the Wicked Witch of the West written by Gregory Maguire. But there are books that are re-tellings of original masterpieces designed to give the reader a more modern or updated take. For example, if you’ve read A Thousand Acres by Jane Smiley and you haven’t read Shakespeare’s King Lear, you should. Shakespeare’s king has to divide his kingdom among his three daughters and only realizes too late which one is the worthiest. Smiley updated the story to a farm in Iowa and overall paints a kinder picture of the sisters but the parallel cannot be denied.   Or, what about Bridget Jones’ Diary and Pride and Prejudice. Bridget and Elizabeth Bennett certainly have plenty in common, but Helen Fielding really stayed close to Jane Austen’s classic when she wrote Mark Darcy who is unquestionably Fitzwilliam Darcy in the 20th century.

So what’s the upshot of all of this, other than perhaps to inspire a summer reading list? Sometimes a story is so good it’s worth telling again, just updated. That’s essentially what the court did in Proffitt. The slip opinion is 12 pages long and almost 5 full pages are block quotes. We don’t mean that to be a negative thing. The court found it needed to say little new because the important stuff was already written.

Plaintiff sued the manufacturer of an antipsychotic drug he took alleging it caused him to develop tardive dyskinesia (limb twitching, facial tics, jaw clenching, etc.). Id. at *1. Plaintiff brought claims for negligent and strict liability failure to warn and breach of implied warranty of merchantability based on a failure to provide a reasonable warning. Id. at *2. Defendant moved to dismiss the complaint on the ground that plaintiff’s claims were insufficiently pleaded. That’s chapter 1 – the background.

In Chapter 2 – the standard of review – the court recounts what has fondly become known on this blog as TwIqbal. Here, the court didn’t need to reinvent the wheel. The Fourth Circuit had already summed it up quite nicely in Nemet Chevrolet, LTD v. Consumeraffairs.com, Inc., 591 F.3d 250 (4th Cir. 2009). The complaint needs enough facts to state a claim that is plausible on its face. Proffitt, at *3-4.

Moving into Chapter 3 – the analysis – the court found two more significant texts on which to rely. Remember, all of plaintiff’s claims are based on alleged failure to warn about tardive dyskinesia. But the drug’s label always contained a warning about that very condition. While plaintiff failed to even allude to the warning in his complaint, the court quoted all 5 paragraphs about tardive dyskinesia. Id. at *6-8. Which led the court to observe that plaintiff’s complaint neither alleges how that warning was inadequate or what an appropriate warning would look like. Id. at *8.

And here is where Proffitt really becomes a re-telling of Reed v. Pfizer, Inc., 839 F. Supp.2d 571, 575-77 (E.D.N.Y 2012). Because Reed had already done all the work. It explains exactly why given facts like Proffitt, a failure to warn claim can’t survive a TwIqbal challenge. The Reeds, like the Proffitts¸ failed to identify how the warning given by the defendant about the very risk at issue was inadequate. In both Reed and the more recent version, Proffitt, plaintiffs failed to allege any facts to suggest that the warnings in both cases were insufficient, erroneous, or contained misrepresentations. See generally Proffitt, at *8-12. Sometimes there is simply no improving on the original:

To cut to the chase, the fact (taken here as true) that [Reed/Proffitt] suffered from certain conditions that were also identified risks of ingesting [the drug] is tragic, but cannot alone make plausible a claim that defendants misrepresented or hid those risks in some way. Plaintiffs have alleged factual content sufficient only to make plausible that [Reed/Proffitt] ingested [the drug] and thereafter suffered serious harm. If such allegations were sufficient to state a failure to warn claim, then anyone experiencing harm after using a product where the harm is a warned-of risk could successfully plead a claim. Perversely, the pleaded fact that a warning was given would be the only pleaded fact supporting the claim that a lawfully adequate warning was not given. To allow such a naked claim to go forward would merely green light for plaintiffs an expedition designed to fish for an in terrorem increment of the settlement value, rather than a reasonably founded hope that the discovery process will reveal relevant evidence.

Id. at *11-12 (quoting Reed, other citations omitted).

Reed had also already done a good job of collecting many supporting cases but the Proffitt court updated the citations as well. Id. at *12-14.

And so the decision concludes by acknowledging the great work of the prior courts to have dealt with the issue and dismissing plaintiff’s claims as inadequately pleaded. Once again TwIqbal triumphs over a factually barren complaint.

This guest post is by Tom Hurney at Jackson Kelly, a genuine West Virginia lawyer who leaped at the opportunity to write about a recent favorable decision of his home state’s highest court and to give you a taste of what West Virginia is like.  We were happy to oblige.  So here’s a discussion of why plaintiffs really need expert witnesses in their West Virginia cases.  As always, our guest posters are 100% responsible for what they say – they deserve all the credit (and any blame) for their analysis.

[Sadly, on the day this Post was published, Mr. Bourdain passed away.  West Virginia was glad to host him.

**********

West Virginia is a great state. If you come to West Virginia, you, like Anthony Bourdain, will meet gracious and kind people, see nature’s beauty and have some great meals. In his “Parts Unknown” field notes on West Virginia, here, Bourdain said he was “intensely grateful for the kindness, hospitality, and patience the people of West Virginia showed to this ignorant rube from New York City who arrived with so many of the usual preconceptions, only to have them turned on their head.”  Bourdain tried squirrel, learning how to skin, gut and quarter, here, and had mortgage lifter tomatoes on salt-rising bread, salt trout, chow chow and vinegar pie, here.  We were glad to have him, although we would have included on his culinary tour some West Virginia hot dogs (with mustard and cole slaw and onions if you want them), beans and cornbread, pepperoni rolls and perhaps a few of our superior craft beers like Devil Anse IPA, Wild Trail Pale Ale, and Bridge Brew Ale.  We would have suggested pizza at Pies & Pints in Charleston, Morgantown or Fayetteville or DiCarlo’s in Wheeling or Lola’s in Charleston; sandwiches at the Secret Sandwich Society in Fayetteville; lunch or dinner at Stardust Café or Jim’s Drive In (great burgers) in Lewisburg; Italian at Oliverio’s in Morgantown or Bridgeport, Muriales in Fairmont, Fazio’s or Soho’s in Charleston; great steaks at the Char in Beckley or Boyd’s in Martinsburg or Chop House in Charleston; and Seafood at Tidewater Grill in Charleston, unless you just want a big fish sandwich, then go to the Fresh Seafood Co. at Capitol Market.  There are a bunch of other great places we don’t have room to mention.

We tell you all this because if you aren’t from here or haven’t visited (and many D&D Blog readers have) you might have the wrong impression of West Virginia. You should rethink that stereotype, like Anthony Bourdain, because in West Virginia it is now clear that plaintiffs need experts to prove warning cases in West Virginia.

On the heels of its 3-2 opinion rejecting “innovator liability” in McNair v. Johnson & Johnson, the Supreme Court of Appeals of West Virginia issued J.C. v. Pfizer, Inc., 2018 WL 2293297 (W. Va. May 15,
2018), where the plaintiffs appealed a summary judgment ruling from the West Virginia Mass Litigation Panel (, arguing that “the Panel’s decision was erroneously based on the absence of expert testimony to support their claims that Pfizer failed to adequately warn of the risks of a prescription medication.  The petitioners further assert that even if expert testimony were required, summary judgment was erroneous because Pfizer’s experts could supply the necessary testimony.”

Here is the new syllabus point from the case, which as West Virginia lawyers (or our National Big Law friends who come down to visit frequently) know, is the binding precedent from the opinion:

The determination of whether expert testimony is necessary to sustain the burden of proof in complex cases involving matters of science, medicine, engineering, technology and the like is made on a case-by-case basis.  When the issues involved are beyond the common knowledge and experience of the average juror, expert testimony shall be required.

This isn’t a Daubert deal (or in West Virginia, a Wilt deal) – it doesn’t analyze the admissibility of expert testimony because there wasn’t any.  That’s right.  Basically, after losing their designated expert (detail on that below) Plaintiffs argued they could proceed without an expert in a case where they alleged “the children had suffered birth defects that were proximately caused by their mothers’ ingestion of the drug sertraline hydrochloride (brand-name ‘Zoloft’) while they were pregnant.”  Plaintiffs “alleged that Pfizer failed to adequately warn of the risks of birth defects from the use of Zoloft while pregnant and that adequate warnings would have prevented their injuries.  The petitioners do not dispute that the federal Food & Drug Administration (‘FDA’) has evaluated the safety of Zoloft for decades and that it remains approved as safe and effective.”  In furtherance of that claim, plaintiffs “designated Adam C. Urato, M.D., as their expert on the adequacy of the Zoloft label in 2003, specifically as it related to the use of Zoloft during pregnancy.”  They disclosed that “Dr. Urato would offer opinions concerning the label to a reasonable degree of medical and scientific certainty, as an expert in Maternal-Fetal Medicine and based on his education, training, experience, review of the relevant literature, and specialized knowledge[.].”  So far, so good, right?

We digress for a moment to point out that before you go off on West Virginia and the rejection of learned intermediary in State ex rel Johnson & Johnson v Karl, let’s take a moment and note the
action by the Legislature in 2016 to adopt the doctrine, as noted in footnote 9 of the opinion:

In 2016, the Legislature enacted West Virginia Code § 55-7-30, which provides, in part, that 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 medical devices.”  This Court had previously declined to adopt the doctrine. See Syl. Pt. 3, State ex rel. Johnson & Johnson Corp. v. Karl, 220 W.Va. 463, 647 S.E.2d 899 (2007) (“Under West Virginia products liability law, manufacturers of prescription drugs are subject to the same duty to warn consumers about the risks of their products as other manufacturers. We decline to adopt the learned intermediary exception to this general rule.”).  Because the case at bar was filed in 2012, the doctrine has no application here.

So, consistent with the separation of powers in the Mountain State, the Legislature stepped in to change a substantive opinion of the Court, which is how checks and balances are supposed to work.
Anywhoo, back to our discussion of J.C. v. Pfizer, which includes the Supreme Court’s careful recitation of the thorough analyses of the case by the Mass Litigation Panel.

Plaintiffs’ first expert, Dr. Urato was unable to appear for deposition “due to unspecified health reasons.”  With Urato a no-show, Pfizer moved to exclude him.  Plaintiffs’ opposition (which would come back to haunt them) “their labeling expert was a critical witness and their ‘key liability expert’ without whom they would be severely prejudiced.”  After noting the “great deal of work” he had done, plaintiffs “advised the Panel that should Dr. Urato’s medical situation prevent him from testifying, they would ‘seek to designate a new expert in his place, considering the importance of the liability topics on which he is designated to opine.’”  They argued at the hearing on the motion, ““Doctor Urato is a key liability expert of ours . . . We also want a trial to go forward with our key liability expert.  We shouldn’t be hamstrung and not have our key liability expert.”  Although the MLP ordered the deposition to proceed by a date certain, the plaintiffs “remained unable to produce him,” and instead moved for leave to designate a replacement again describing Dr. Urato as their “key” liability expert without whom the plaintiffs would be prejudiced.  The MLP directed plaintiffs to provide an affidavit under seal containing “a medical diagnosis for Dr. Urato and an affirmation that he was not medically able to sit for deposition.”  But, plaintiffs advised the Panel “we have had very limited contact with Dr. Urato and he has not supplied us with the affidavit from his treating doctor.”

Even though the MLP found plaintiffs, knew by June 9 the expert could not be deposed, did not provide an affidavit and did not timely determine Dr. Urato’s medical condition, whether he was able to testify in these cases, or request a replacement in a timely manner[,]” the MLP found good cause to name a new expert finding it “would be unfair to punish the litigants for their counsel’s lack of diligence.”  Plaintiffs named their new expert, David A. Kessler, M.D., purportedly “a nationally known expert and former Commissioner of the FDA.”  They then moved to limit Dr. Kessler’s deposition “to no more than three hours” arguing that Pfizer was already “well aware of his opinions,” because he issued a “116-page report detailing his opinions [gave a] deposition … in 2015 in a federal Zoloft multi-district litigation case….”  The Panel denied the motion to limit the length of the deposition and ordered plaintiffs to produce him.  “Two days before the deposition was to be taken, the petitioners filed a supplemental expert disclosure in which they withdrew Dr. Kessler.”

Pfizer moved for summary judgment “arguing that the petitioners could not meet their evidentiary burden on the alleged inadequacy of the 2003 Zoloft label.”  Plaintiffs responded that they could meet their evidentiary burden with Pfizer documents and, if expert testimony was necessary, they could get it from Pfizer’s witnesses.  The MLP granted summary judgment.

The MLP observed that whether the failure to adequately warn claim is based in strict liability or negligence, “the question is whether [Pfizer] acted reasonably under the circumstances.”  Relying on West Virginia precedent, the MLP noted the importance of having an expert witness in failure to warn cases, particularly when there are “complex technical, scientific, and medical issues beyond the common knowledge and experience of the average person.”  The MLP found that “[w]hether Pfizer behaved as a reasonably prudent manufacturer would when warning about the use of Zoloft during pregnancy involves complex issues of science and medicine”; that “this is not a case where the label is silent regarding the alleged risk” because the label during the relevant time carried the Category C pregnancy warning; that “the FDA has repeatedly approved Zoloft’s label”; that “numerous independent organizations have concluded that the evidence does not support a causal link between Zoloft and birth defects”; that the “inclusion of warnings that are not supported by the science can lead to unintended and adverse consequences for the patient”; and that the petitioners’ “prior statements regarding the importance of their labeling expert and the prejudice to their case without such an expert are inconsistent with any assertion that they do not need such an expert because the alleged inadequacy of the Zoloft label is “obvious.”

The MLP also found that the documents plaintiffs claimed proved their warning case – “animal studies, epidemiology, adverse event reports, Core Data Sheets, and FDA regulations” – were “not within the common knowledge and experience of the average juror…[and that] such evidence cannot substitute for expert testimony on the adequacy of the Zoloft label.  Further, “[n]either the interpretation of such studies nor the appropriate method for distilling such lengthy and complex information into a prescription drug label is within the ordinary knowledge and experience of the average juror.”  The MLP concluded “the adequacy of Zoloft’s label required expert testimony.  Because the petitioners had withdrawn their warning/label expert, the Panel concluded they could not meet the burden of proof on an essential element of their claim.”

After detailing plaintiffs’ argument – essentially, they didn’t need an expert because evaluation of the warning was an issue within its common knowledge of the jury – and Pfizer’s argument – you need an expert to prove a warning claim – the Supreme Court of Appeals of West Virginia stated it was plaintiffs’ burden to prove an inadequate warning or “to prove that Pfizer acted unreasonably regarding the pregnancy warning on its 2003 Zoloft label, i.e., the Category C warning mandated by the FDA, as well as the additional warning that patients should ‘notify their physician if they become pregnant or intend to become pregnant during therapy[,]’ and that the failure to adequately warn proximately caused their alleged injuries.”  Recognizing that the FDA approval of the label was evidence of reasonableness, the Court stated “our precedent reflects that expert testimony will be necessary to sustain an evidentiary burden when the matters involved are beyond the common knowledge and experience of the average juror.”

The Court noted particularly that plaintiffs resisted Pfizer’s motion to disqualify their first expert, arguing that his testimony “was critical to their claim,” and explaining in detail why.  The Court expressed some amazement at the withdrawal of the second expert and stated “[n]otwithstanding the petitioners’ u-turn after they voluntarily withdrew their key liability expert, evaluating whether the language in the 2003 Zoloft label was adequate based upon the scientific and medical information that was available at that time, including the science related to the risks of untreated depression during pregnancy, is well beyond the ken and experience of the average juror.”  After a detailed discussion of West Virginia precedent on the need for expert testimony and the common knowledge exception, the Court concluded “[o]ur consideration of the complex issues in the case at bar concerning what should and should not be included in a drug label demonstrates that this is a case where expert testimony is necessary…,” and “[t]o find otherwise, following our consideration of the facts, claims, and circumstances of this case, would be to invite an unsound, unintelligent, and speculative verdict based upon matters beyond the cognition and experience of the average juror.”  (Here, we just have to interject Justice Neely’s separate opinion in Totten v. Adongay, 337 S.E.2d 2 (1985) (Neely, J., concurring), West Virginia’s seminal case on the “common knowledge” exception to the requirement of expert testimony:  “The reason that I have taken the time to concur in part and dissent in part in a case that appears to be of little moment is simply to point out that it is stupid to try any malpractice case, no matter how outrageous, without the help of an expert witness.”).

The Court further rejected plaintiffs’ argument that the warning case could be proven with Pfizer documents and testimony.  After a detailed review of the documents and Pfizer witness testimony, the Court concluded “[t]he foregoing deposition testimony shows that the petitioners cannot sustain their evidentiary burden with Pfizer’s witnesses…,” because “rather than supporting the petitioners’ claim, these witnesses each testified that the U.S. Zoloft label adequately conveyed the essential information in the Core Data Sheet, including the benefit/risk assessment to be conducted by the prescribing physician and the patient for use during pregnancy.”  Again, the Court recounted the plaintiffs fought to keep their expert even though they had “‘significant material evidence’ that would obviate the need for expert testimony….  As the petitioners previously represented, the advanced education, experience, and expertise of Dr. Urato, and later Dr. Kessler, were necessary for an intelligent consideration and analysis of this “significant material evidence” and the myriad of factors involved in the formulation of the Zoloft label.  The petitioners’ argument that they do not need their key liability expert but can sustain their failure to adequately warn claim with Pfizer witnesses is plainly untenable.”

Last, the Court rejected plaintiffs’ argument that requiring expert testimony would be “unfair”:  “Importantly, requiring a party to meet his or her evidentiary burden with expert testimony – where necessary – ensures that a jury’s verdict has a sound evidentiary basis and has been intelligently rendered.”

The Court therefore affirmed the MLP’s order granting summary judgment.

While the entire blogging team (RS, at least) was traveling home by planes, trains and automobiles from the DRI’s annual Drug and Medical Device conference, the West Virginia Supreme Court of Appeals – yes, the same court that rejected the learned intermediary rule little more than a decade ago – issued its blockbuster opinion today refusing to adopt innovator liability in McNair v. Johnson & Johnson, ___ S.E.2d ___, No. 17-0519, slip op. (W. Va. May 11, 2018).  Major congratulations to the winning team from Patterson Belknap, who not only emerged victorious, but sent McNair to us within minutes of its release – and were nice enough to let us know that they cited our Innovator Liability Scorecard in their briefing.  They, and their steadfast clients, just put a major finger in the dike to the benefit of us all.

As we’ve mentioned before, innovator liability in McNair found its way to West Virginia’s highest court via a certified question from a Fourth Circuit panel looking for a way around Foster v. American Home Products Corp., 29 F.3d 165 (4th Cir. 1994).  We infer that motive because the opinion certifying the question gave the false impression that no prior West Virginia law existed on this question.  McNair v. Johnson & Johnson, 694 F. Appx. 115, 120-21 (4th Cir. 2017).  It didn’t work. See McNair, slip op. at 7, 14-17 (citing and relying upon In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917, 944 (6th Cir. 2014) (applying West Virginia law), and Meade v. Parsley, 2009 WL 3806716 (S.D.W. Va. Nov. 13, 2009)).

McNair (with a couple of justices dissenting – no other opinions yet), reaffirmed the traditional limits – indeed the entire rationale − of product liability as making sure that manufacturers (and not others) are responsible for defects (and negligence) in products from which they profited.  Innovator liability ““would sever the connection between risk and reward” . . . that forms the basis of products liability law.”  Slip op. at 24 (quoting defendants’ brief).

[S]trict liability has only been applied to a manufacturer, seller, or distributor of the product in question.  In other words, a plaintiff cannot recover damages in a strict liability action against the defendant, in the absence of showing that the defendant either manufactured or sold the product that allegedly injured the plaintiff.

Id. at 10 (citation, footnote, and quotation marks omitted).  There’s very good reason for this limitation:

[T]his Court, as well as other courts, adopted products liability to place responsibility for the harm caused by a product on the party who profits from its manufacture and sale.  Because the brand manufacturer did not place the generic product on the market, it cannot spread the cost of compensating generic consumers by including the cost of insurance or judgments as part of the product’s price tag.

Id. at 24 (citations and quotation marks omitted).  Particularly in the case of prescription drugs,

If brand manufacturers become liable for injuries allegedly caused by generic drugs, significant litigation costs would be added to the price of new drugs to the disadvantage of consumers.  Further, the increase in litigation against brand manufacturers could stifle the development of new drugs, which would have negative health consequences for society.

Id. at 25 (citation omitted).  This logic applied to all theories by which a product manufacturer could be held liable.  Negligent misrepresentation likewise failed, for the reasons stated in Darvocet, supra, and Huck v. Wyeth, Inc., 850 N.W.2d 353 (Iowa 2014).  McNair, slip op. at 15-18.  As to general negligence, “all federal circuit courts that have considered the question have held, under the laws of different states, that a brand manufacturer does not owe a duty to a consumer who uses a generic drug.”  Id. at 18-19 (string citation omitted; see our scorecard for these cases).  “Any recognition of an outlier theory of liability permitting a generic drug consumer to bring an action against the brand manufacturer for an injury allegedly arising from the use of the generic drug would be plainly at odds with this public policy.”  Id. at 24.

McNair, further rejected plaintiffs’ attempt to distinguish between a defective product and a defective label:

[W]here necessary safety information is missing from a label, that makes the drug defective, not the label. . . .  [I]n Cardinal v. Elsevier Inc., No. MICV201104442, 2014 WL 10937406, at *3 (Mass. Super. Aug. 11, 2014), the court explained that “the label . . . is not the product, but a way in which a plaintiff can claim that the product is defective.” (citations omitted).  We agree with this reasoning, which is consistent with our own products liability law.  Here, the allegedly injury-causing product is the generic drug ingested by the consumer, not the warning label.

Slip op. at 13-14 (other citations and quotation marks omitted) (note: Bexis tracked down the Cardinal decision and sent it to Westlaw).

Ironically, the court’s prior learned intermediary-related outlier also figured into McNair’s most excellent result.  As we mentioned at the time, the West Virginia legislature reinstated the learned intermediary rule by statute. See W. Va. Code §55-7-30.  That statute just happened to be phrased in terms of a drug’s “manufacturer or seller”:

(a) A manufacturer or seller of a prescription drug or medical device may not be held liable in a product liability action for a claim based upon inadequate warning or instruction unless . . . [t]he manufacturer or seller . . . acted unreasonably in failing to provide reasonable instructions or warnings . . . to prescribing or other health care providers. . . .

Id. §55-7-30(a)(1) (quoted at McNair, slip op. at 23).  “[T]his statute incorporates this Court’s long-standing restriction of products liability to the manufacturer and seller of the allegedly injury-causing product.” Id. at 24.  Once again, the past excesses of West Virginia plaintiffs have come back to haunt them.

Nor was the McNair court influenced by plaintiffs’ argument that the common law should be distorted in order to allow plaintiffs to evade federal preemption as recognized in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).  Preemption is no reason to jettison traditional product liability principles:

Just as the Supreme Court refused to distort the Supremacy Clause in Mensing to prevent the undesirable result of providing immunity to generic manufacturers in failure to warn cases, we decline to distort our products liability law to hold a brand manufacturer liable for injuries allegedly caused by a generic drug that the brand manufacturer neither manufactured nor sold.  Like the Supreme Court, we find that the proper remedy for consumers harmed by generic drugs rests with Congress or the FDA.

McNair, slip op. at 27.  “[A] brand manufacturer does not choose for its warning label to accompany the drugs marketed by its competitors.  Instead, federal law mandates such a result. Id. at 25.

Thus, the Supreme Court of Appeals’ syllabus (the binding precedent under West Virginia practice) reads:

There is no cause of action in West Virginia for failure to warn and negligent misrepresentation against a brand-name drug manufacturer when the drug ingested was produced by a generic drug manufacturer.

Slip op. at syllabus, point 4.

What a way to come home from DRI Drug and Medical Device.

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.

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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