In the annals of history, June 6 gets prime billing.  That’s understandable, because the successful Normandy landings on D-Day (June 6, 1944), probably saved Western Civilization.  (Or maybe that heroic endeavor simply preserved liberal democracy for another 75 years, now that we seem encircled by fanatics both home and abroad who view the Enlightenment with disdain.)  But June 7 is no slacker.  On June 7, 1776, Richard Henry Lee introduced the Lee Resolution, which later became the Declaration of Independence. 364 days before D-Day, the American Navy decisively won the Battle of Midway, which turned the tide of the Pacific War.  On June 7, 1892, Homer Ferguson refused to leave the whites-only part of a train.  He later lost his Supreme Court case, Plessy v. Ferguson.  That opinion upheld “separate but equal,” a nasty judicial stain that would not be scrubbed away until 1954.  (SCOTUS Lesson #1: Horrible Supreme Court precedents can be overturned, but it can take a terribly long time – almost as long as the interval between NBA Finals games.)  One year later, on June 7, 1893, an Indian barrister offered a very similar refusal in South Africa.  That refusal is usually counted as Gandhi’s first act of civil disobedience.  And on June 7, 1965, the Supreme Court issued its decision in Griswold v. Connecticut, holding that married couples have a constitutional right to contraception.  Maybe there are people in 2017 who regret that decision (see our overly political parenthetical above) but we’d be surprised to meet such people, just as we’d be surprised to meet people who regret Brown v. Board of Education.  Still, the High Court arrived at that sensible result via a fuzzy analysis (e.g., “penumbras” and “emanations”) that could justify just about anything.  (SCOTUS Lesson #2: Good results and good reasoning do not always operate in tandem.)

In the passage of time, whether viewed as a Hegelian movement of ideas or as merely One Damned Thing After Another, June 7 is a significant date.  Now here comes the inevitable strained segue: today’s case, In re Cook Medical, Inc. IVC Filters Marketing, Sales Practices and Product Litigation, 2017 U.S. Dist. LEXIS 82761 (S.D. Indiana May 31, 2017), is about the passage of time.  More specifically, it is about how statutes of repose apply in drug and device litigation.

We do not often get a chance to write about statutes of repose.  We get more opportunities to discuss statutes of limitations, though we infrequently seize those opportunities, because the issues are usually fact-specific and obvious.  By contrast, statutes of repose present interesting legal issues, and their force can be devastating to tardy claims.  In the In re Cook Medical case, the defendant made a motion on the pleadings to dismiss claims on the ground that they were precluded by statutes of repose.  The court wrestled with three different statutes of repose:  Georgia, Tennessee, and Texas.  The differences among those statutes resulted in different dispositions of the claims by the various IVC Filter plaintiffs’ claims.

Georgia

The Peach State bars claims for strict liability, negligence, or breach of warranty if the suit is not brought within ten years from the date of the first sale.  The Georgia plaintiffs’ claims in this case were filed more than ten years after the sale.  Buh-bye, right?  Not so fast.  Georgia’s statute of repose contains an exception if the defendant manufacturer engaged in conduct manifesting “willful, reckless, or wanton disregard for life or property.”  The plaintiffs argued that they had alleged such conduct.  How? it is not clear from the opinion.  Please excuse a slight rant.  It seems far too easy for drug and device plaintiffs to allege that any failure to warn equals reckless or wanton conduct.  Courts need to clamp down on this all-too-easy way to maintain settlement leverage or exploit jury anger.  Not adding a warning in the face of controversial or mixed studies should not be the stuff of punitive damages.  Maybe someday courts will wake up to this nonsensical hole in product liability law.  End of rant.  The In re Cook court was not such a court.  But it did limit the damage. It held that that the willful/reckless/wanton exception applied only to negligence claims, but not to strict liability and warranty claims.  Thus, the court dismissed the strict liability and warranty claims per the statute of repose.  The negligence claims remained.  So did the consumer fraud claim, which the court held was not subject to the statute of repose.

Tennessee

Tennessee also has a ten year statute of repose, though apparently not the willful/reckless/wanton exception.  At least no such exception was raised in this case.  The Tennessee plaintiffs conceded that the strict liability claims were doomed, but they tried to keep their negligence and warranty claims alive.  Nice try, said the court, but Tennessee’s Product Liability Act defines “product liability action” to include all of the plaintiffs’ claims.  That did not quite end the debate. The plaintiffs pointed out that Tennessee extended the statute of repose to 25 years for asbestos and silicone gel implant claims.  Why should those claims get such special treatment?  Never you mind, said the court, which applied the rational basis test and concluded that the Tennessee legislature was allowed to make such distinctions.  Sure, IVC Filters might pose risks of latency, but the constitution does not compel legislators to treat all latent defects the same.  Put another way, “[i]t is no requirement of equal protection that all evils of the same genus be eradicated or none at all.”  In re Cook Medical, IVC Filters Prods. Litig., 2017 U.S. Dist. LEXIS 82761 at *14, quoting other cases.  The court dismissed all of the Tennessee claims.

Texas

“T for Texas, T for Tennessee.”  Those two states go together musically (see Guy Clark, Willie & Waylon, Lynyrd Skynyrd, etc.).  Here, they also go together legally, as the defendant prevailed on the statutes of repose from both states.  The Texas statute of repose is for 15 years.  (Of course it is bigger.  This is Texas.)  But there is an exception if the manufacturer/seller explicitly warrants that the product has a useful life longer than 15 years. The Texas plaintiff attempted to save her claims by filing an affidavit, wherein she said she was told that the device was permanent, and the Patient Guide, which stated that the IVC Filter was “safe and effective as either a permanent or temporary device.”  But this was a motion on the pleadings.  Outside materials are not allowed.  Looking just at the complaint, there was no allegation that the IVC filters were marketed as permanent devices.  That is very, very bad for the plaintiff:  “As this is a motion for judgment on the pleadings, the omission of her specific warranty allegations is fatal.”  Id. at *18.  You might think that is an extraordinarily severe result.  No matter. The court observed that even if the allegations of permanence were included in the complaint, the claims would still not fly, because the plaintiff nowhere alleged any specific person who warranted permanence, and nowhere alleged any reliance on such warranty of permanence. As for the Patient Guide, the plaintiff did not allege in either her complaint or her affidavit that “she read the Guide before her surgery, much less that she relied on the Guide rather than her own doctor’s recommendation.”  Id. at *20.  Accordingly, the exception to Texas’s statute of repose did not apply, the statute of repose did apply, the claims were timed-out, and they had to be dismissed.

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

A federal judge in Texas recently ruled that Texas law does not allow a claim for negligence per se based solely on alleged violations of the FDCA or FDA regulations. Monk v. Wyeth Pharmaceuticals, Inc., 2017 U.S. Dist. LEXIS 72477, *21-23 (W.D. Tex May 11, 2017). That seems pretty straightforward to us. Plaintiffs typically use negligence per se to try to privately enforce a provision of the FDCA, i.e., by using an alleged violation of a safety-related provision of the FDCA as the basis for their state law claim.  State law does not always allow this, but even when it does, such a claim should not withstand implied preemption under Buckman.  That is because Buckman and section 337(a) of the FDCA make it clear that litigants cannot privately enforce the FDCA, and a negligence per se claim based on a purported violation of the FDCA is an unveiled attempt to accomplish exactly that. Monk doesn’t say all of that explicitly, but it relies on cases that do. That’s good enough for us.

Plaintiff based her negligence per se claim on the defendants’ alleged failure to provide medication guides for distribution with amiodarone prescriptions.  The basis for the claim was the federal regulation requiring manufacturers of some prescription drugs to make medication guides available either by providing a sufficient number of guides to distributors and dispensers or by providing the means to produce guides in sufficient numbers. Id. at *3, *6 (citing 21 C.F.R. § 208.24(b)).

And this is where things get confusing, because while the court dismissed plaintiff’s negligence per se claim based on violation of this regulation, the court reached the opposite conclusion regarding plaintiff’s negligent failure to warn claim based on exactly the same thing.  A state law failure-to-warn claim based on a violation of federal prescription drug regulations? Sounds like implied preemption to us, but the court concluded that this very federal-sounding claim was actually a parallel state law failure to warn claim. But wait. Isn’t plaintiff suing because the defendant allegedly violated the FDCA.  That’s Buckman implied preemption. As many courts have noted, plaintiffs seeking to avoid preemption have to weave their way through a “narrow gap” by alleging they are suing for conduct that violated the FDCA, but not because the conduct violated the FDCA. But the only allegation here is that defendants did not provide the medication guides as required by federal regulations.

The court’s reasoning is based entirely on dicta in the Fifth Circuit’s decision in Eckhardt v. Qualitest Pharmaceuticals, Inc., 751 F.3d 674, 679 (5th Cir. 2014) that “failing to provide FDA-approved warnings would be a violation of both state and federal law, this is a parallel claim that is not preempted.” Id. But the claim that defendants provided no warnings was not alleged in the complaint and so was not allowed by the court. There is no information in Eckhardt regarding the basis for plaintiff’s claim that defendant failed to provide any warnings and so it is unknown if it was “because” defendant’s violated a federal regulation.

In Monk, the court knew precisely the basis for plaintiff’s failure to warn claim – 21 C.F.R. § 208.24(b); the same basis as plaintiff’s negligence per se claim. That the result is different on both claims is really difficult to reconcile. So we won’t try. We’ll instead reiterate – no negligence per se based on FDCA in Texas.

 

We’re serious – we’re not planning to give a flip answer like “an extortion racket.”  No, it’s more like law school, where a first-year contracts professor began with the question “What is Chicken?”  (Hint – that’s discussed in Frigaliment Importing Co., Ltd. v. BNS International Sales Corp., 190 F. Supp. 116 (S.D.N.Y. 1960)).  The question of “what is product liability” is of interest to us primarily, but not exclusively, because of 21 U.S.C. §379r(e), which creates an exception for “product liability law” to what is otherwise a rather broad preemption provision governing over-the-counter (also called “monograph”) drugs.

We wrote a post in the early days of the blog – 2008 – about that particular provision, entitled “Preemption Without a Prescription,” where we discussed cases that, up to that time, had addressed the scope of §379r(e)’s saving clause.  That boundary of that clause, as we explained it then, was that “suits for purely economic loss – primarily, but not exclusively, brought under state consumer protection statutes – are not ‘product liability’ actions.”

That’s still true.

We’re not repeating the 2008 post, but we will update it.  Here is a list of cases not discussed in that post, which likewise hold that preemption defeats OTC drug litigation that does not involve personal injury claims:  Wiltz v. Chattem, Inc., 2015 WL 3862368, at *1-2 (C.D. Cal. May 8, 2015); Bowling v. Johnson & Johnson, 65 F. Supp.3d 371, 376-77 (S.D.N.Y. 2014); Gisvold v. Merck & Co., 62 F. Supp.3d 1198, 1202-03 (S.D. Cal. 2014); Crozier v. Johnson & Johnson Consumer Cos., 901 F. Supp.2d 494, 503-05 (D.N.J. 2012) (discussing scope of §379r(e)); Delarosa v. Boiron, Inc., 818 F. Supp.2d 1177, 1188 n.7 (C.D. Cal. 2011) (discussing scope of §379r(e)); Eckler v. Neutrogena Corp., 189 Cal. Rptr.3d 339, 357-61 (Cal. App. 2015) (discussing scope of §379r(e)).

Thanks to this recent blogpost, however, we’ve become aware of another way that the definition of “product liability” is important.  Down in Texas, they have a unique indemnification statute, Tex. Civ. Prac. & Rem. C. §82.002(a) that provides:

A manufacturer shall indemnify and hold harmless a seller against loss arising out of a products liability action, except for any loss caused by the seller’s negligence, intentional misconduct, or other act or omission. . . .

We’d vaguely heard of this statute before, in connection with a case, Hadley v. Wyeth Laboratories, Inc., 287 S.W.3d 847, 849 (Tex. App. 2009), which we liked because it held that prescribing physicians weren’t “sellers” of the drugs they prescribed, which means they can’t be sued for strict liability.

But §82.002(a) also means that, in Texas, the ability of an intermediate seller to recover indemnity (including counsel fees) requires that the underlying action to be one for “products liability.”  That’s where the blogpost comes in.  It discussed a recent case, vRide, Inc. v. Ford Motor Co., 2017 WL 462348 (Tex. App. Feb. 2, 2017), that also addressed the definition of “product liability.” vRide involved an indemnity claim brought by a lessor of a motor vehicle from the defendant, which manufactured the vehicle.  The underlying claim had not been for strict liability, but rather for misrepresentation – that the vehicle did not have the attributes that the original defendant (the lessor) claimed that it did.

The court in vRide held that a misrepresentation claim did not fall within the meaning of “product liability”:

The [plaintiffs’ complaint] did not allege that the [product] was unreasonably dangerous, was defective by manufacture or design, was rendered defective because it lacked certain safety features, or was otherwise defective. Instead, the petition alleged that [defendant] represented [that the product] had certain safety features when in actuality [they] did not have those safety features. . . .  In short, the [complaint] did not contain allegations that the damages arose out of personal injury, death, or property damage allegedly caused by a defective product.

2017 WL 462348, at *7. We can imagine situations in which this definition could come in useful in litigation involving OTC preemption, since it excludes from “product liability” even some actions involving (as did vRide) personal injury.

The most significant hypothetical involves a situation where the plaintiff’s injuries were caused by a generic OTC drug. In that situation, given the broad scope of preemption available in generic drug cases, one could expect plaintiffs to attempt to assert innovator liability against the branded drug manufacturer.  But innovator liability is based (like vRide) on the (we believe phony) proposition that “misrepresentation” is not “product liability” and thus can extend to non-manufacturers.  But if misrepresentation is not “product liability,” then the savings clause in §379r(e) would not apply, and innovator liability claims would be expressly preempted whether or not they involved personal injury. vRide would thus be precedent in favor of preemption.

That would be a good thing.  And so is cross-fertilization – where a definition in a completely unrelated statute can be utilized in support of preemption.

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

We found it strange that last month’s decision in Jenkins v. Boston Scientific Corp., 2016 WL 1448867 (S.D.W. Va. April 12, 2016), held – almost as a throw-away point – that Texas law wouldn’t apply Restatement (Second) of Torts §402A, comment k (1965) to medical devices as it does to prescription drugs. That’s a notable, indeed almost unprecedented, result.

Jenkins did recognize that Texas law has, for a long time, applied comment k across-the-board to bar design defect claims against all prescription drugs. Id. at *5, citing Carter v. Tap Pharmaceuticals, Inc., 2004 WL 2550593, at *5 (W.D. Tex. Nov. 2, 2004) (“Under Texas law, all FDA-approved prescription drugs are unavoidably unsafe as a matter of law.”). Carter is hardly the only Texas case for applying comment k generally to bar design defect claims. We collected that law in our 2011 Comment K,Some of the Way post: Centocor, Inc. v. Hamilton, 310 S.W.3d 476, 516 (Tex. App. 2010) (comment k “provide[s] a defense to a design defect claim”), rev’d on other grounds, 372 S.W.3d 140 (Tex. 2012); Schwarz v. Block Drug Co., 1999 WL 274409, at *1 (5th Cir. 1999) (“Under comment K of the Restatement of Torts (Second) § 402A, a drug manufacturer is responsible in damages only if it failed to warn of a defect of which it knew or should have known.”) (unpublished, in table at 180 F.3d 261); Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1273-74 (5th Cir. 1974) (applying unavoidably unsafe standard without individualized assessment); Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007) (“[p]rescription drugs are not susceptible to a design defect claim where, as here, the drug is “accompanied by proper directions and warning”); Hackett v. G.D. Searle & Co., 246 F. Supp.2d 591, 595 (W.D. Tex. 2002) (“[t]he Court thus holds that under Texas law and comment k of the Restatement, Defendants can only be held strictly liable if the drug was not properly prepared or marketed or accompanied by proper warnings”).

However, after recognizing Texas law with respect to comment k and prescription drugs, Jenkins declined to apply comment k in the same fashion to medical devices:

I reject [defendant’s] contention that Texas’s absolute bar for FDA-approved prescription drugs, applies here, given that the products are neither FDA-approved nor prescription drugs. See Lofton v. McNeil Consumer & Specialty Pharm., 682 F. Supp.2d 662, 679 (N.D. Tex. 2010) (refusing to “take a leap not taken by Texas courts” in applying comment k categorically outside the prescription drug context).

2016 WL 1448867, at *5 (citation omitted).

That’s it. The entire extent of the discussion of Texas law on this point is one sentence and one citation. Absent is any discussion of why the policy reasons that have led Texas courts to apply comment k in every prescription medical product case over the last forty years don’t apply to prescription medical devices.

But what about Lofton?

Continue Reading Don’t Mess With Texas

Sometimes it takes us a while to catch on to things. This is more than a little embarrassing for a Jersey guy to admit, but while many of our high school classmates were devout Springsteen fans after his first two albums, Greetings from Asbury Park and The Wild, The Innocent, and The E Street Shuffle, we would not commit until after the release of Born to Run, by which time Bruuuuuuuce had become a national phenomenon. For years we saw shaved kale salad on menus and passed it by, thinking that we probably did not like kale and definitely did not like shaving, so why bother? Now it is our go-to appetizer for when we want to feel vaguely virtuous. We were late adopters of on-line banking, Apple Pay, and Twitter. Our garage will surely be the last in the neighborhood with a hybrid powered car, a self-driving car, or a flying car. On the way back from visiting the Drug And Device Law Son in Moscow, the British Airways entertainment offerings included season 2 of Catastrophe, an Anglo-American miracle of fun and filthy television comedy. Now we are queuing up season one on Amazon Prime. We are complete-ists, even backwards, if nothing else. Better late than never, right?

Today we are taking a look at an old case (two and a half-years old, but turning up in our topic searches just now). The case is called Meredith v. Nuvasive, Inc., 2013 U.S. 190130 (W.D. Texas Dec. 9, 2013). The plaintiff in Meredith alleged injuries from malfunction of a neuromonitoring device during spinal surgery. Her claims were for manufacturing defect, breach of implied warranties, negligence, gross negligence, and res ipsa loquitur. There is nothing especially unusual in any of that. But here is the man-bites-dog aspect of the case: the product liability plaintiff moved for summary judgment against two relatively unusual defenses, the manufacturer defendant as a “health care provider” under the Texas malpractice statute, and lack of any sale of a medical device precluding warranty claims.

For those of you in need of an executive summary, know this: The plaintiff in Meredith went one for two. (1) The court held that a device manufacturer was not a health care provider under the relevant medical malpractice statute. (2) Because the device was simply used in the hospital, and not sold to the plaintiff or anyone else, the defendant had a real shot at picking off the warranty claims.

Continue Reading Texas Federal Court Says Device Manufacturer is not a Health Care Provider, but also not a Seller

We’ve read a fascinating new case out of Texas, Verticor, Ltd. v. Wood, ___ S.W.3d ___, 2015 WL 7166024, No. 03-14-00277-CV, slip op. (Tex. App. Nov. 13, 2015), posing the question whether a medical device company can be a “health care provider” within the meaning of that state’s pretty restrictive laws regarding medical malpractice.  While rejecting the manufacturer’s appeal on the record before it, the court in Verticor didn’t flatly say “no.”  Instead, it held:

As the issue is framed here, [[manufacturer’s] license authorizes it “to provide” (at least in the sense of manufacturing and selling) the [device] − and nothing more.  Consequently, [manufacturer] can be “licensed . . . by the State of Texas to provide health care” only if the [device] is, in itself, “health care” as the [statute] defines that term. . . .  Under it, “health care” is distinguished by either of two nouns − “act” or “treatment” − that is “performed or furnished,” or should have been, “for, to, or on behalf of a patient during the patient’s medical care, treatment, or confinement.”  The first alternative, an “act,” denotes some sort of deed or activity.  As an inanimate object, [the device], in itself, could not be an “act,” although it might be utilized in acts that qualify as “health care,” such as surgery.  Similarly, the other alternative, “treatment” also denotes some form of activity that is performed or furnished for or to a patient. Consequently, the [device] would not, in itself, be a “treatment,” although it might be utilized in a “treatment.”

Verticor, slip op. at 10 (footnotes omitted).  All this manufacturer submitted was that it was licensed to manufacture medical
devices.  That wasn’t enough.  Texas medical malpractice tort reform was separate from that state’s product liability tort reform.  Id. at 11-12.  Further, the “common usage” (how such statutes are construed) of the term “health care” denoted something different from manufacturing:

In common usage, one associates “health care” with medical intervention, assistance, or other acts − e.g., one’s family doctor performing an annual physical or a nurse administering a flu shot − as opposed to the mere making or selling of a product used in providing such services.  Focusing as it does on acts and treatment provided to patients, the [statute’s] definition of “health care” does not clearly depart from this basic notion.

Id. at 13.

Continue Reading Medical Device Manufacturers as “Health Care Providers”

The Judge in the ObTape device litigation has allowed another manufacturing defect claim to go to trial with no direct evidence that the device implanted in the plaintiff had a manufacturing defect.  See In re Mentor Corp. ObTape Transobturator Sling Prods. Liability Litig., 2015 U.S. Dist. LEXIS 140263 (M.D. Ga. Oct. 15, 2015).  In denying the manufacturer’s motion for summary judgment, the court relied solely on a review conducted by plaintiff’s experts of sample ObTape devices—that is, devices other than the one implanted in the plaintiff.  The experts found that the pore sizes of those other samples were at times outside of the alleged manufacturing requirement of 40 to 100 microns.  Relying solely on this, the court rejected the manufacturer’s argument that plaintiff had not shown a manufacturing defect in the device implanted in her.  The court explained its reasoning, which from our point of view is less than convincing:

One way to prove a manufacturing defect is to test the specific subject product against manufacturing standards.  For example, in BIC Pen Corp., the parties tested the cigarette lighter that caused the plaintiff’s injuries.  346 S.W.3d at 540-41.  But Mentor [the manufacturer of ObTape] did not point the Court to any authority that such testing is the only way to establish a manufacturing defect under Texas law.  Here, Mrs. Sanborn relies on the same evidence as the Phase I Georgia Plaintiffs, whose specific ObTape was not tested, either.  Rather, their experts tested a number of ObTape samples and concluded that a substantial portion of each ObTape tested had pores smaller than 40 microns.  In re Mentor, 711 F. Supp. at 1376.  At this time, the Court remains satisfied that this evidence is sufficient to create a genuine fact dispute on Mrs. Sanborn’s manufacturing defect claim.  Mentor’s summary judgment motion on the manufacturing defect claim is thus denied.  The Court may reconsider this issue when ruling on any motion for judgment as a matter of law that may be presented at trial.

Id. at *8-9.

Continue Reading MDL Judge Allows Manufacturing Defect Claim to Go to Trial with No Direct Evidence of a Defect in the Device Actually Implanted in Plaintiff

We have posted many times about cases where a manufacturer of a regulated product is sued over alleged violations of a state consumer protection or deceptive trade practices act because of something allegedly amiss in the product’s name, labeling, advertising, or sales practices.  We know that drug and device manufacturers like the ones we represent can spend resources dealing with state attorneys general over the threat that such suits will be brought.  We cannot recall seeing, let alone posting on, a case where the manufacturer sued the state attorney general because its threat of suit—relayed to major retailers, who stopped selling the product—allegedly hurt its business and constitutional rights.  There would seem to be lots of reasons why an action like this might not be taken by a company that wants to keep doing business in the particular state for other products it manufacturers.  But if you are a one product, dietary supplement company and your presumably large market in Texas disappeared after letters went out based on a determination by the Texas AG’s office, not by a court, then you might be the one to bring suit preemptively.  That is what happened in NiGen Biotech, L.L.C., v. Paxton, No. 14-10923, 2015 U.S. App. LEXIS 17223 (5th Cir. Sept. 30, 2015).

The unusual posture of the case—in comparison to those we usually handle or read—means that it delves into constitutional issues that we knew better back when we clerked and the docket was sprinkled with cases against state actors.  The ones brought by prisoners are remembered more for their unique fact patterns and brand of advocacy than for the constitutional principles they implicated.  NiGen, likewise, holds our interest not because its treatment of sovereign immunity, federal question jurisdiction, and standing has direct implications for the sort of cases that normally fill our posts.  Rather, it shows that a manufacturer can go on the offensive against a state AG who probably thought it could do just about whatever it wanted prior to bringing its own suit.  It is not that we think the manufacturer Nigen is right on the underlying issue of whether the product’s label was deceptive, which touches on some complex constitutional issues, especially since Amarin has come down since this case started.

Continue Reading Going on Offense against State Deceptive Trade Practices AG Actions

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)

Today’s case, blogger fanatics, is a good illustration of grinding out a victory.  It’s the story of a defendant calmly and effectively pressing its legal and factual arguments, winning a partial victory before trial, continuing to press its position on the law and facts at trial until it won a directed verdict, and then successfully having it all upheld on appeal.  See Lewis v. Johnson & Johnson, 2015 U.S. App. LEXIS 3150 (4th Cir. Mar. 2, 2015).

The first part of the victory came via summary judgment.  The plaintiff claimed that defendant failed to warn of risks connected with tension-free vaginal tape (TVT) used in a surgery intended to address plaintiff’s incontinence.  Id. at *1-2.  Given how these cases often go, plaintiff likely pointed to multiple marketing materials and labeling documents as evidence of the defendant’s alleged failure to warn.  But, come the end of discovery, defendant had whittled those documents down to only two: a patient brochure and the instructions for use that came with the device. Id. at *5-6.  The defendant then eliminated those two documents at the doctor’s deposition.  The doctor testified that she had never read the patient brochure.  There went the patient brochure.  Id. at *5.  And, while the doctor read TVT’s instructions for use, it was years earlier.  She admitted that she did not rely on those instructions when she decided to use the TVT in plaintiff’s surgery.  She relied on her education, experience and evaluation of the patient’s presentation.  Id. at *6.  There went the instructions for use.  Plaintiff was left with no evidence of proximate causation: “When a physician relies on her own experience and examination of a patient in deciding to prescribe a device, and not on the device’s warning, the warning is not the cause of the patient’s injury.”  Id.

Plaintiff was still able to take a design defect claim to trial.  In pretrial motions, however, the defendant was able to exclude one of plaintiff’s causation experts, Dr. Klinge, a hernia surgeon.  Id. at 7-8.  Dr. Klinge had never performed incontinence surgeries and was not a pathologist.  Yet he purported to be able to opine that pathology slides taken from plaintiff established that the TVT caused plaintiff’s post-surgery pain and discomfort.  Id. at *8-9.  Defendant was able to undermine all of this at Dr. Klinge’s deposition, exposing his questionable qualifications.  Defendant moved to exclude his causation opinion, and the court granted the motion:

Dr. Klinge was a specialist in hernia surgery, not pathology or stress urinary incontinence.  He did not receive training or board-certification in pathology.  Dr. Klinge had never treated Lewis, performed surgery to treat SUI, or collected and studied mesh explants from SUI patients.  The district court was clearly within its discretion in concluding that Dr. Klinge’s opinions regarding Lewis’s pain and mesh explant were beyond his area of expertise, and so did not abuse its discretion in excluding those portions of Dr. Klinge’s testimony.

Id. at *9 (upholding district court’s decision to exclude Dr. Klinge’s causation testimony).

Plaintiff still called Dr. Klinge as a witness at trial.  And, as you’d expect, plaintiff’s attorneys still tried to elicit causation testimony.  But the defendant stuck to its guns, continually objecting to any testimony on causation. The court sustained those objections.

Without that testimony, and without causation testimony from any other experts, plaintiff’s case was hobbled.  After plaintiff rested, the defendant moved for a directed verdict and got it.  Plaintiff appealed, and defendant won that too.

This isn’t a situation in which the defendant hit on a Hail-Mary Pass and ended the litigation. It happened, instead, the way these cases are more often won—by slowly advancing the ball down the field until it crosses the goal line.  The defendant focused on the weaknesses in plaintiff’s warnings and causation evidence, stuck to it from discovery through trial and appeal, and then it won.  That’s how it’s done.