We have a guest post today, from Luther Munford of Butler Snow.  He’s been doing some thinking about how something analogous to the “two schools of thought” medical malpractice doctrine should apply to medical product liability cases.  As always with out guest posts, our posters deserve 100% of the credit, and any blame, for their posts.

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When the law addresses medical judgment directly, it allows room for reasonable physician choice.  It is ironic then, that a product liability suit over design defect may not allow any such room.  In order to protect physician choice, courts need to resist the temptation to turn product liability disputes into a contest in which reasonable physician choice has no place.

In medical malpractice litigation, where the standard of care is directly in issue, there is room for diversity of opinion.  The jury focuses on the doctor’s choices.  And if, in the light of a diversity of medical opinion, the doctor’s conduct was reasonable, there is no liability.  Steven. E. Pegalis, 1 Am. Law Med. Malp. § 3:3 (2017) (“reasonably applicable alternative methods of diagnosis or treatment” allowed).  As it is phrased in Pennsylvania, if there are “two schools of thought,” the doctor is free to pick one over the other.  Jones v. Chidester, 610 A.2d 964, 969 (Pa. 1992) (“school of thought” means “a considerable number of recognized and respected professionals”).  See also Velazquez ex rel. Velazquez v. Portadin, 751 A.2d 102, 107-108 (N.J. 2000) (allowing practice with “substantial support as proper practice by the medical profession”) (quoting Schueler v. Strelinger, 204 A.2d 577, 585 (N.J. 1964)).

But in a product liability case over defective design, there may be no room for reasonable choice.  Design defect law may ask a jury whether there is any “safer alternative” to a defendant’s device, and, if the jury believes there is, the defendant’s device may be found defective and presumably unsuitable for sale to anyone.  In fact, this question can arise whether or not there is a specific “safer alternative design” requirement in state law because the plaintiff may simply offer such a design as evidence of unreasonable risk. In answering the question, the jury will be asked to choose which expert witness is “most credible” without any allowance for reasonable differences of opinion.

If the law is going to protect a doctor’s ability to exercise reasonable medical judgment in choosing among available devices and surgeries, the question is what needs to be done to keep the unsuitable instrument of design defect litigation – where the doctor may not even be a witness and there is no pre-suit screening panel — from taking away those choices.  Only if the doctor has a choice can the doctor have the ability to determine the best method of treating the patient.

There are at least five ways design defect law can be shaped to protect doctor choice.

First, there is the question of actual doctor choice.  Where the surgeon has chosen not to employ an alternative, perhaps because of the surgeon’s education, training and experience, the jury should not be allowed to find the manufacturer liable because a choice the surgeon rejected might be deemed by the jury to be  “safer.”  See Anderson v. PA Radocy & Sons, Inc., 865 F. Supp. 522, 531 (N.D. Ind. 1994) (manufacturer not liable for employer’s decision to purchase uninsulated fiberglass bucket rather than insulated one); James. A. Henderson & Aaron. D. Twerski, Optional Safety Devices: Delegating Product Design Responsibility to the Market, 45 Ariz. St. L.J. 1399, 1417 (2013) (delegation to learned intermediary defeats design liability).

Second, a court should apply established product liability law principles and exclude from any list of “safer alternatives” those alternatives that present different advantages and disadvantages that require doctor choice, such as a different treatment or different surgery.

This is consistent with the way product liability generally protects consumer choice.  It is generally accepted that, to be a “safer alternative design,” the design must be for the same product, not a different one.  A different product may be safer in one respect, but if it serves different distinct purposes, it cannot provide a basis for finding the less safe product defective.  Informed consumers remain free to choose, and manufacturers are allowed to innovate.  The issue comes up in a variety of product liability contexts.

For example, the Fourth Circuit held in an early negligence case that, given the “peculiar purposes of [the] design” of a Volkswagen bus to provide room for passengers and cargo by placing the driver in front of the engine, a plaintiff could not argue that the design was unsafe because it was not as crashworthy as that of a passenger sedan.  The court granted judgment as a matter of law for the defendant.  Dreisonstok v. Volkswagenwerk, A.G., 489 F.2d 1066, 1074 (4th Cir. 1974), followed in Restatement (Third) of Torts: Product Liability § 2, cmt. f, illus. 9 (1998).  Similarly, a safer bullet proof vest does not make a bullet proof vest with less coverage unreasonably dangerous when the vest allows a greater range of motion.  Linegar v. Armour of Am., Inc., 909 F.2d 1150, 1154 (8th Cir. 1990); see also Hosford v. BRK Brands, Inc., 223 So.3d 199, 208 (Ala. 2016) (smoke alarm not defective just because a more expensive dual-sensor alarm was sold).

This principle is particularly apt in the field of medical devices where different products offer different sets of benefits and complications and whose “safety” depends on professional judgment and, in the case of devices, surgical skill.  Like the learned intermediary doctrine, device defect law should recognize that the doctor relies not only on what the manufacturer has supplied, but also “other medical literature, and any other source available to him, and … the personal medical history of his patient.”  Lebowitz v. Ortho Pharmaceutical Corp, 307 A.2d 449, 457 (Pa. Super. 1973).  The Texas Court of Appeals so held in a hormone therapy case:

[A] plaintiff cannot prove that a safer alternative design exists by pointing to a substantially different product, even when the other product has the same general purpose as the allegedly defective product . . .  Thus, a safer alternative design must be one for the product at issue . . . [Plaintiff] does not explain how [the drug] could have been modified or improved . . .  In essence, [plaintiff] argues that the [drug] should have been a different product . . .  But, as the supreme court has explained, Texas law does not recognize this sort of categorical attack on a product.

Brockert v. Wyeth Pharm., Inc., 287 S.W.3d 760, 770-71 (Tex. App. 2009). See also In re Propulsid Prod. Liab. Litig., No. MDL 1355, 2003 WL 367739, at *3-4 (E.D. La. Feb. 18, 2003) (alternative or different methods of treatment insufficient to prove alternative design).

In medical device cases, courts have held that different devices which perform in different ways cannot be treated as safer alternatives. The principal authorities come from the pedicle screw cases where the courts refused to accept other fixation devices, such as those involving hooks and wires, as presenting safer alternative designs.  The Fifth Circuit explicitly gave doctor choice as a primary reason for its holding.  It said:

[Plaintiff] therefore argues that other products that do not use pedicle screws should be considered as alternative designs . . .  Underlying this argument is the assumption that all pedicle screws are defective and there can be no system using pedicle screws that would be an acceptable product.  The problem with this argument is that it really takes issue with the choice of treatment made by [plaintiff’s] physician, not with a specific fault of the pedicle screw sold by [defendant].

Theriot v. Danek Med., Inc., 168 F.3d 253, 255 (5th Cir. 1999).

Similarly, in other device cases it has been held that a treatment that uses no device at all cannot be considered as a safer alternative.  As the United States District Court for the District of Nevada explained:

Neither is the Court swayed by Plaintiff’s argument that the testimony of [the expert] to the effect that Plaintiff’s [surgery] could have been accomplished without use of [the product].  The fact that an alternative method of [surgery] was potentially available does not support Plaintiff’s design defect claim.  As argued by Defendants, non-mesh repair is not an alternative design and does not meet Plaintiff’s burden to support this particular claim.

Schmidt v. C.R. Bard, Inc., No. 2:11-CV-00978-PMP, 2013 WL 3802804, at *2 (D. Nev. July 22, 2013).

While this rule would have its most direct application in states with a safer alternative design requirement, it would not be limited to those states.  It should apply wherever alternative design is used as a basis for declaring a device unreasonably dangerous.  In Driesenstock, the Fourth Circuit’s Volkswagen bus case, the issue was whether the alternative could be used to prove the defendant’s negligence.  And in Linegar, the Eighth Circuit’s bullet-proof vest case, the question was whether the vest was unreasonably dangerous.  In neither case was there a specific safer alternative design requirement.  See James Beck (“Bexis”), On Alternative Design, Take Two – Negligence, Drug and Device Law Blog (Feb. 27, 2017) (use of alternative design in negligence cases).

[Editorial note:  The Massachusetts Niedner decision (discussed here) is also an excellent example of this application]

Third, even where the products might be very similar, the jury should not be asked to choose between two products where either one is supported by a “school of thought” or “substantial medical opinion.”  From the “doctor’s choice” perspective, it is error for a court to intervene in the diagnosis and treatment of a patient in order to dictate the treatment of a patient when reasonable medical professionals could disagree.  For example, one court recognized the “same product” requirement but nevertheless said a jury could find that an alternative was safer if it did not alter “a fundamental and necessary characteristic of the product.”  Hines v. Wyeth, No. CIV. A. 2:04-0690, 2011 WL 1990496, at *8 (S.D.W. Va. May 23, 2011) (citing Torkie-Tork v. Wyeth, 739 F. Supp. 2d 895, 900 (E.D. Va. 2010)).  In that case the court said it was for the jury to decide whether natural progestin and synthetic progestin were different products. Id. at *9.  But if either choice would be within the doctor’s standard of care, that difference should not matter.

Fourth, the principle of reasonable doctor choice could also be used to interpret comment k to the Restatement (Second) of Torts §402A.  That comment rules out design defect liability for medical products if a proper warning is given and the device is “unavoidably unsafe.”  This has sometimes been incorrectly said to simply import a risk-utility test.  Mullins v. Ethicon, Inc., 117 F. Supp. 3d 810, 818-819 (S.D.W. Va. 2015).  But a better reading would be to say that a medical product is “unavoidably unsafe” and so qualifies for comment k protection if its use, within the professional standard of care, presents a risk of injury to the patient.  That would, for example, be true of nearly all implantable medical devices. See James Beck (Bexis), Unavoidably Unsafe PMA Medical Devices, Drug and Device Law Blog (Nov. 30, 2017).

Finally, the principle of doctor choice might be a basis for excluding from evidence actions of the federal Food and Drug Administration based on a comparison of one treatment to another if both treatments were considered to be within the doctors’ standard of care.  Congress has told the FDA that it is not to “limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient….”  21 U.S.C. § 396 (2009).  Nevertheless, the FDA does take regulatory actions based not on independent judgments about safety and effectiveness but rather upon comparisons among methods of treatment.  A negative comparison that failed to recognize reasonable doctor choice should be just as inadmissible as expert testimony that failed to apply the correct liability standard.  See, e.g., United States v. Wintermute, 443 F.3d 993, 1001 (8th Cir. 2006).

If the principle of doctor choice were applied in design defect law, it would be necessary to decide what theories of design defect liability would survive.  Certainly a device not considered to be within the standard of care would face liability if it were so egregiously dangerous as not to have any justifiable therapeutic use.  Or if scientific testing proved a way to design the same product so that it was both safer and equally effective, that might be considered in some jurisdictions.

And none of this would directly affect liability for failure to warn, because any rule that rests on doctor’s choice has to assume that doctors are aware of the complications that may arise out of use of the device.

We know that our blogposts are carried by legal aggregating services, such as Lexology and JDSupra.  Some of you may even be reading this post via one of these services.  In addition to writing for them, we actually read them, too.  Sometimes we find interesting things on them – like last week.

A bit of background, first.  Other than providing readers with:  (1) a post on how the municipal cost recovery rule is useful against municipal/county attempts to recover the cost of governmental services (actually, so can the economic loss and derivative injury rules, but we haven’t blogged about those − yet); and (2) some other posts on how the in pari delicto doctrine can be employed to defeat suits by individuals harmed by their own criminal activity, we haven’t had all that much to say about the “opioid epidemic.”  It’s a fast moving area, and to some extent it resembles the spate of litigation over firearms marketing (where Bexis became familiar with municipal cost recovery) a couple of decades ago.  In other ways it resembles something much more sinister – how the states ganged up to extort money from various cigarette companies after the companies had consistently prevailed in ordinary product liability litigation.

So while we feel we should have something to say about this “opioid epidemic” litigation threat to our clients, it’s difficult to decide what.  We were very interested to read – on JDSupra – a recent thought-provoking article entitled “De-Bunking the Opioid Litigation Epidemic.”  That blogpost is mostly about how overheated “opioid epidemic” rhetoric (and litigation) has outrun any basis in science.  Briefly, it makes the following points:

We compliment the Kelley Drye folks for this effort, and encourage our readers to read the whole article.

So what can we add?  We point out that, as to the last bullet point, injuries from illegal opioid use are precisely the sort of injuries that the in pari delicto doctrine was designed to preclude from being recovered in litigation.

Well, what about the states as plaintiffs?  In general we’re big fans of off-label use.  We never tire of pointing out that off-label use is 100% legal under the FDCA, and that the FDA cannot prevent physicians from prescribing FDA-approved drugs (which include opioids) for any therapeutically appropriate treatment, whether or not that indication appears on a drug’s FDA-approved labeling.  As the Supreme Court has held, “‘off-label’ usage . . . is an accepted and necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine.”  Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 350 (2001) (citing Beck & Azari, FDA, Off-Label Use, & Informed Consent: Debunking Myths and Misconceptions, 53 Food & Drug L.J. 71, 76-77 (1998)) – yes, that Beck, as in Bexis.

So who can restrict the rights of physicians to prescribe drugs for off-label uses?  That would be the states, in their traditional roles of regulators of medical practice.

It is elemental that a state has broad power to establish and enforce standards of conduct within its borders relative to the health of everyone there.  It is a vital part of a state’s police power.  The state’s discretion in that field extends naturally to the regulation of all professions concerned with health.

Barsky v. Bd. of Regents, 347 U.S. 442, 449 (1954).

We recognize that the States have a compelling interest in the practice of professions within their boundaries, and that as part of their power to protect the public health, safety, and other valid interests they have broad power to establish standards for licensing practitioners and regulating the practice of professions.

Goldfarb v. Virginia State Bar, 421 U.S. 773, 792 (1975).

“The State, in the performance of its duty to protect and preserve the public health, has the power, within constitutional limitations, to regulate the practice of medicine by those engaged therein.”  Comm’n on Medical Discipline v. Stillman, 435 A.2d 747, 755 (Md. 1981).  “[P]rofessional licensing and regulation is a traditional area of state power.”  Edinboro College Park Apartments v. Edinboro University Foundation, 850 F.3d 567, 577 n.9 (3d Cir. 2017).  “It is well established that a state can legitimately impose broad regulations on the practice of medicine through its police powers to protect the health, safety, and welfare of its citizens.”  People v. Rogers, 641 N.W.2d 595, 605 (Mich. App. 2001).  “States retain the police power to regulate professions, such as the practice of medicine.”  Betancur v. Florida, 296 F. Appx. 761, 763 (11th Cir. 2008).  The “the valid police power the legislature exercise[s] when it regulate[s] the practice of medicine” is widely recognized. State v. Pacific Health Center, Inc., 143 P.3d 618, 626 (Wash. App. 2006).

These general propositions apply to controlled substances, such as opioids. “[E]nforcement of the Controlled Substances Act to prevent illegal or illegitimate drug trafficking by registered medical professionals does not intrude upon the states’ ability to regulate the practice of medicine in accordance with their police powers.”  United States v. Brickhouse, 2016 WL 2654359, at *7 (Mag. E.D. Tenn. March 30, 2016), adopted, 2016 WL 2350137 (E.D. Tenn. May 4, 2016).  They also apply to off-label use.  “[R]egulation of the practice of medicine generally lies within the States’ police powers.”  United States v. Kaplan, 2014 WL 4402586, at *4 (D. Nev. Sept. 5, 2014) (off-label use case).

However, except for unusual forays such as informed consent relating to diet drugs (Utah), performance enhancing drugs in sports (Ohio, and probably others), and constitutionally questionable attempts to harass those seeking drug-induced abortions by prohibiting an off-label use that’s actually safer than the outmoded FDA-indicated use, see Cordray v. Planned Parenthood Cincinnati Region, 911 N.E.2d 871, 878 (Ohio 2009) (affirming such a provision), the states have generally not regulated medical practice and off-label uses.

In general, that’s a very good thing.

But if the states are now going to sue drug manufacturers, wholesalers, and others in the chain of sale over what are legal, FDA-approved drugs properly prescribed by state-licensed medical doctors, and properly filled by state-licensed pharmacists, then the states should be required to look in the mirror.  And if counties and other municipalities that are creatures of the states are going to sue over off-label uses that their sovereign states have not seen fit to prohibit, they may find themselves preempted from doing so – by state law.

States could ban precisely the off-label uses they are complaining about, but they haven’t.

Off-label use of prescription opioids (assuming the requirements set by FDA REMS and federal controlled substances regulations are complied with) is by and large perfectly legal under state law.  If the states believe that the risks of particular off-label uses outweigh the benefits, then they have the power to act to prohibit such uses outright.  Where the FDA has actually approved an indication, the result would be different – federal preemption would prevent such action.  But off-label use is state rather than federally regulated.  We thus believe that, for states to sue to recover, say, the costs off-label opioid prescriptions, without having exercised their own authority to prevent the underlying conduct, at minimum runs squarely into the defense of failure to mitigate damages.

So the question is, how much is that argument worth?  That depends on how much opioid use is off label.  We’ll take a look at that question.

It appears the argument might be worth quite a bit. A New England Journal of Medicine article from earlier this year asserts that “the risk-benefit profile of opioids used for chronic pain remains unknown” with “no studies lasting longer than 1 year that evaluated pain, function, or quality of life as a primary outcome.”  Assuming the statement is accurate, it suggests to us that long-term opioid use doesn’t have the level of scientific evidence behind it needed to obtain FDA approval, since “[g]enerally, the agency expects that the drug maker will submit results from two well-designed clinical trials” before approval can be granted.”  Another recent article states:

The FDA doesn’t have the statutory ability to limit the amount of pills or the duration of prescriptions.  However, the agency could deem prescriptions off-label if they’re too large.

Likewise, the FDA believes that “[m]ost analgesic use in pediatric patients is off-label.”  So that’s a second category of opioid prescription that could be off-label and thus regulated by states, rather than by the FDA.

Another place to look is for judicial admissions.  Most complaints (to hype plaintiffs’ damages) can be expected also to allege widespread off-label use, and thus conduct that the relevant state could have regulated, but hasn’t.  In the litigation context, it fits in with a possible narrative against state AG or parens patriae suits – that the plaintiff state, which has legal authority, has done nothing to curb off-label opioid prescriptions, while the FDA, which lacks this authority, has at least tried.

The DEA also appears to have stepped up scrutiny of at least some off-label opioid prescribing, according to this recent (11/9/17) alert from the Academy of Integrative Pain Management:

The Drug Enforcement Administration has recently taken criminal and administrative action against physicians who prescribe transmucosal immediate-release fentanyl (TIRF) off-label for the treatment of breakthrough pain.  Historically, prescribing medications off-label has been a decision left to the discretion of the prescriber based on the specific needs of the patient; therefore, physicians prescribing these products off-label for noncancer breakthrough pain should be aware of this increased scrutiny.

An editorial in the National Review addressed part of this equation, stating “opioids are harmful primarily when they are not used as directed, are cleared for sale by the federal government, and come with government-approved warning labels explaining the risks — all factors that will make judges skeptical of suits” by states.  But it’s even worse than that, since the states are suing, at least in significant part, over the consequences of their own governmental sloth.  Perhaps, having utterly failed to hold up their end, either legislatively or by regulation, a state should be estopped from trying to recover from drug companies for legal activities.

Thus, while we strongly support the right of physicians to prescribe off-label, and the right of everyone – including drug manufacturers – to provide truthful information about off-label uses, we recognize that off-label prescribing is ultimately subject to the police power of the states.  If a state has come to the conclusion that a particular off-label use is doing more harm than good, it has the legal authority (within constitutional parameters) to prohibit that use.  Unless and until a state does so, however, it should not engage in the hypocritical practice of suing over a legal medical practice that it could have stopped but has chosen not to.

Thus, to the extent that the “opioid epidemic” is an off-label use issue, in that respect it is a problem created largely by the failure of the states to utilize their existing police powers.

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).

As we mentioned several weeks ago, several of your Reed Smith bloggers are making plans to be in New York on December 5-6 to attend ACI’s annual Drug and Medical Device Litigation conference. We’re looking forward to great content and numerous networking opportunities – and maybe even the chance to catch up with some of our loyal readers.

Since we’d like to see you at ACI, we wanted to share two pieces of helpful news:

  • If you’ve been meaning to register for the event, this would be a great week to do so, as prices increase after Friday.
  • The good people at ACI asked the blog to be a media sponsor this year – and are offering a special registration discount for the conference for the blog’s readers. Make sure to use the code D10-999-DD18 when you register. You’ll save 10 percent.

If you want to register, you can do so here. We look forward to seeing you in New York!

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

Looking back on the blog, the last time we posted about the Pelvic Mesh MDL was this summer when we lauded a remand judge for not allowing plaintiffs to expand their expert reports to include opinions already excluded by the MDL judge. At that time we commented briefly on the uncertainty that accompanies remand. That decision was a positive post-remand development. Today’s decision is the flip side. Remand gone awry and unfortunately, affirmed by the Eleventh Circuit.

The decision is captioned Eghnayem v. Boston Scientific Corporation, 2017 U.S. App. LEXIS 20432 (11th Cir. Oct. 19, 2017) and is actually a consolidation of four plaintiffs’ cases. The cases all involve Florida residents and were consolidated and remanded from the MDL in the Southern District of West Virginia to the Southern District of Florida. Id. at *3. The remand court proceeded to try the 4 cases together over defendant’s objection. After almost identical multi-million dollar verdicts were entered for each plaintiff, defendant appealed.

The primary grounds on appeal were the improper consolidation of the cases for trial and the exclusion of evidence of FDA clearance. The Eleventh Circuit said both decisions by the district court were not an abuse of discretion. Interestingly while the court found limiting instructions were sufficient to overcome the prejudice of the multi-plaintiff trial, it also found that limiting instructions would not have cured the prejudice that would have resulted if the FDA clearance had been admitted into evidence. That’s a bit of plaintiffs getting to have their cake and eat it too.

We posit there is only one reason for consolidating trials of more than one plaintiff in a tort case not involving a common accident – to prejudice defendants. Plaintiffs argue consolidation saves time, but is there any proof to back that up? It certainly creates a host of appellate issues that clearly take more time. Plaintiffs in Eghnayem offered testimony from 25 witnesses at trial. Largely, testimony of individual plaintiffs and their individual physicians which have no relevance to the claims of the other plaintiffs. Id. at *7. Testimony that confuses juries with different plaintiff-specific facts and frankly invites juries to reach improper conclusions, such as all these people wouldn’t be suing unless something was wrong.

Defendant, of course, raised all these prejudicial concerns which the trial court and the appellate court believed could be swept away by “expressly instruct[ing the jury] to consider each plaintiff’s claims separately.” Id. at *12. How exactly a juror is supposed to do that is unknown and feels almost impossible. But the appellate court went even further and presumed that “even had the cases not been consolidated, the plaintiffs would likely have been able to submit evidence of other patients with similar injuries.” Id. at *15. Evidence of adverse events or clinical trial events may be admissible as to notice – but in a severely more limited way than when 4 distinct claims and injuries are litigated fully to the same jurors.

For example, one plaintiff had “graphic images” showing her removed mesh and the tissue that was removed along with it. The Eleventh Circuit concluded that sometimes graphic evidence is particularly helpful. Id. at *17-18. And it might well be – for that particular plaintiff. But to conclude that those images would have been admissible as to the other 3 plaintiffs borders on inconceivable.

What about evidence that post-dated some of the plaintiffs’ implantations. Where drug or device usage occurred at varying times, one of the many problems of consolidation is that defendants are deprived of the state of the art defense and exposed to improper admission of subsequent remedial measures. The result is a “perfect” plaintiff’s case being tried, with all plaintiffs able to rely on all evidence relevant to anybody, regardless of differences in time and place. The Eleventh Circuit agreed with defendant that post-implant evidence couldn’t go to notice in those cases, but it may be relevant for some other reason and therefore, limiting instructions over exclusion was the proper course. Id. at *19. But it is a course that wouldn’t be necessary if the cases were tried individually.

Finally, defendants argued that the similarity in the damage awards – almost identical – is evidence that the jury was confused; unable to distinguish between and among the plaintiffs. Given plaintiffs with “different medical histories, and different treating doctors; . . . prescribed the [mesh] at different times for different conditions; and claimed to suffer different injuries, after different lengths of exposure, resulting in different treatment courses,” id. at *6-7, the uniform result isn’t a mystery, it’s juror confusion leading to a formulaic verdict. The appellate court, however, found that “similar” injuries resulting in “similar” verdicts wasn’t unreasonable. Id. at *14. But that’s just buying into the flawed premise that these claims were similar enough to try together in the first place. With that as the starting place, it is no wonder the Eleventh Circuit found no abuse of discretion.

This case highlights several of the key reasons drug and device defendants fight against consolidated trials. If you want a more in depth discussion of the topic, including cites to rulings that agree with us, check out our post here.

There was one other significant issue on appeal. The district court excluded all evidence of the device’s 510k FDA clearance. This isn’t the first mesh case to reach this conclusion. See our post on the issue here discussing a post-remand case that made a better call by allowing the evidence albeit with a strong limiting instruction. While not perfect, that decision is certainly better than the Eleventh Circuit finding that 510k clearance “has no relevance to the state law claims.” Id. at *22. Or its decision that admitting the evidence would have been unnecessarily time-consuming and led to jury confusion on core issues. Id. at *23. We would disagree with those conclusions anyway but find them particular hard to swallow where the same court concluded that a multi-plaintiff trial wasn’t unduly prejudicial or confusing. We are in fact confused as to how a jury instruction regarding what the 510k process is and is not would not be curative, but a limiting instruction that the jury “may not even consider the fact that there’s more than one case being brought” alleviates the myriad of prejudices a multi-plaintiff trial visits upon defendants.

 

If you want to insult and annoy someone, consider suing them under the Racketeering Influenced and Corrupt Organizations Act, 18 U.S.C. section 1964.  That law is charmingly known as RICO, in an allusion to the big bad in the great 1931 gangster film Little Caesar, played by Edward G. Robinson at his most snarly.  It’s one thing to accuse someone of fraud, but to accuse them of racketeering is a bit over the top.  But there is, unfortunately, ample precedent out there supporting the abuse of RICO, extending it to ordinary business disputes.  Plaintiffs dazzled by the prospects of treble damages have not been terribly shy  about filing RICO claims against companies that do their best to dot all the i’s and cross all the t’s – those companies simply committed the offense of being “organizations” in a society where plaintiff lawyers know no bounds of judgment or taste.   Promiscuous use of RICO is often counterproductive because, while the plaintiff lawyers are usually trolling for a settlement, good luck settling with someone who is justifiably outraged that you called them a racketeer.

 

 RICO is yet another instance of the American system of jurisprudence taking a wild wrong turn, so it’s nice to see a court rein it in.  It’s especially nice to see that the judge who did the reining in was once one of our favorite law professors in a far away place (okay – Chicago isn’t that far away) long ago.   Last week the Seventh Circuit issued its opinion in Sidney Hillman Health Center v. Abbott Laboratories, 2017 WL 4544834 (7th Cir. Oct. 12, 2017), a Third Party Payor (TPP) action coming out of the Depakote MDL in N.D. Illinois.   The action by the TPPs was, as is typical, completely parasitic, opportunistically seizing upon the existence or conclusion of other litigation.  The TPPs filed their RICO action after a 2012 guilty plea and settlement of a False Claim Act lawsuit.  Judge Easterbrook wrote the Seventh Circuit’s opinion.  It is pithy and compelling and might very well make it onto our top ten list at the end of the year. 

 

Two welfare-benefit plans that paid for some of Depakote’s off-label uses filed this suit seeking treble damages under civil RICO.  The plaintiffs alleged that the off-label uses of Depakote were harmful and/or not effective. The alleged injuries were that the TPPs paid for (1) off-label uses that would not have been paid but for the company’s alleged misrepresentations, and (2) additional medical harm caused by the drug.  The TPPs asked the district court to certify a class comprising all third-party payors of drug expenses. The district judge dismissed the complaint on the ground that the plaintiffs could not show proximate causation.  The district judge reasoned that the allegedly improper marketing was directed, not at the plaintiffs, but at physicians, and concluded that tracing loss through the steps between promotion and payment would be too complex.  We wrote about the district court’s ruling here. The Seventh Circuit affirmed the dismissal of the case, and did so without footnotes or reservations.    

 

The headline is that Sidney Hillman rejected the type of attenuated causal chain typically asserted by TPPs:  “improper representations made to physicians do not support a RICO claim by Payors, several levels removed in the causal sequence.”  Sidney Hillman, 2017 WL 4544834 at *4.  As the Seventh Circuit recognized, under RICO, the initially injured parties are not payors, but rather the patients, who “suffer if they take [a drug] even though it is useless to them and may be harmful.”   Id. at *2.  Because TPPs are not initially injured parties, determining their alleged injuries would be difficult.  First, some off-label uses of Depakote may be beneficial, so how does any alleged injury arise from such uses?  Second, some doctors would have prescribed the drug regardless of any off-label promotion.  Third, other doctors may not have changed their prescribing practices at all, or they might have changed them but done so in response to information that the company did not influence.  How can the ‘injury” caused by the off-label promotions be calculated?

 

The plaintiffs’ lawyers  suggested that they could gin up a “regression analysis” to “determine the volume of off-label prescriptions that would have occurred in the absence” of the promotional activity.  We have seen this sort of thing before.  Maybe you have, too.  Yes, there are travelling econometricians who can regress their way to any conclusion you might want.  Luckily, the Seventh Circuit did not accept this suggestion, because the data such an analysis would require simply did not exist.  The wished-for regression analysis also “would not address the question whether patients suffered medical losses or out-of-pocket costs via co-pays, or whether physicians lost business by prescribing an ineffective or harmful drug, or what to do about patients whose off-label use of Depakote made them healthier.”  Id. at *3.  Moreover, it would not be proper to assume that TPPs would not have paid for anything, as they likely would have paid for some drug other than Depakote, which might have been more costly.  Importantly, the “absence of data leaves a serious problem in showing plausible causation, which is required even at the complaint stage.”  Id.  Thank you, TwIqbal

 

The Seventh Circuit acknowledged that five other courts of appeals have considered the extent to which TPPs can recover under RICO for wrongs committed while marketing pharmaceuticals.  The Second Circuit, in Sergeants Benevolent Ass’n Health & Welfare Fund v. Sanofi-Aventis, 806 F.3d 71 (2d Cir. 2015), held that the causal chain in TPP cases was too long to satisfy SCOTUS requirements.  (Sergeants Benevolent Ass’n made our 2015 Top Ten list.) The Ninth and Eleventh Circuits agreed with the Second, “and deem this so straightforward that they have issued nonprecedential decisions.”  Sidney Hillman, 2017 WL 4544834 at *3.  Those are the good decisions.  Spoiler alert: the Seventh Circuit agrees with them.  On the not-so-good-side of the ledger, the Seventh Circuit observed that In re Avandia Marketing, Sales Practices & Product Liability Litigation, 804 F.3d 633 (3d Cir. 2015), the Third Circuit “held that recovery under RICO is possible when misrepresentations are made directly to Payors, leading them to add certain drugs to their formularies, which means that they pay more per prescription than they would otherwise.”  (Honestly, despite this terrible result in Avandia, and despite the Fosamax legal-butchery that we’ve analyzed to a fare-thee-well, our hometown Circuit is usually wise and wonderful.)  Finally, in the Neurontin litigation the First Circuit kind-of-sort-of had been in the same place as the Third Circuit, while implying disagreement “with the other four circuits about the possibility of Payors’ recovery for misrepresentations made to physicians.”  Id. at *4.  It’s not clear exactly what the First Circuit held in Neurontin,  but don’t fret about it too much, because “to the extent there is a conflict the Second Circuit has this right.”  Id

 

And, almost needless to say, we think the Seventh Circuit has this right.   

And, with a Circuit split teed up for SCOTUS, we’re willing to bet that the efforts by Second, Ninth, Eleventh, and now Seventh Circuits to cabin RICO somewhat will prevail.   

Bexis gave a talk the other day at the Washington Legal Foundation on personal jurisdiction after last term’s United States Supreme Court decisions in Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017) (“BMS”), and BNSF Railway Co. v. Tyrrell, 137 S. Ct. 1549 (2017) (“BNSF”).  One of the highlighted areas of emerging jurisdictional issues was MDL practice – specifically the MDL practice of allowing plaintiffs anywhere in the country to “direct file” actions into the MDL after it has been established – thereby bypassing the provisions of the MDL statute, 28 U.S.C. §1407(a) that “transfers shall be made by the judicial panel on multidistrict litigation.”

We thought we’d examine that a bit today.

Essentially, we don’t think that there is any jurisdictional basis for direct filing – except the defendants’ waiver of any jurisdictional challenge.  Initially, the MDL statute itself does not confer such jurisdiction.  The statute nowhere mentions direct filing, and in only one instance is an MDL judge (also called the “transferee court”) clothed with extraordinary jurisdictional powers.  That has to do with depositions.  See 28 U.S.C. §1407(b) (MDL judge “may exercise the powers of a district judge in any district for the purpose of conducting pretrial depositions”).

Whether or not the legal maxim “expressio unius est exclusio alterius” (express mention of one item implies the exclusion of others of the same ilk) should apply here, we seriously doubt that Congress intended to hide any jurisdictional elephants in MDL statutory mouseholes.  Cf. Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26, 40-41 (1998) (refusing to imply MDL court jurisdiction to try transferred cases).  It “may or may not” be more efficient to allow direct filings, but the MDL statute does not so state, so “the proper venue for resolving that issue remains the floor of Congress.”  Id. at 40 (citations omitted).  We further note that the Judicial Panel on Multidistrict Litigation’s rule that has been interpreted as allowing direct filing, J.P.M.D.L.R 7.2(a), likewise does not mention jurisdiction – providing only that “[p]otential tag-along actions filed in the transferee district do not require Panel action.”

In BNSF (previously discussed here) the Supreme Court rejected an attempt to use a statute (the venue provision of the Federal Employees’ Liability Act) to create personal jurisdiction where it did not otherwise exist.  When Congress intends to expand jurisdiction (as opposed to venue) it “typical[ly]” does so by “authoriz[ing] service of process.”  137 S. Ct. at 1555 (list of examples omitted).  This statute did not expressly do so, and to the extent any prior precedent suggested otherwise, that precedent was obsolete:

[A]ll these cases . . . were decided before this Court’s transformative decision on personal jurisdiction in International Shoe Co. v. Washington, 326 U.S. 310 (1945).  See [Bauman], 134 S. Ct. [746], 761, n.18 (cautioning against reliance on cases “decided in the era dominated by” the “territorial thinking” of Pennoyer v. Neff, 95 U.S. 714 (1878)).

Id. at 1555-56 (citations modified).  We’ve already raised this cautionary note with respect to century-old precedent in jurisdiction by consent cases, but it applies more broadly.

Demise of their statutory arguments left the plaintiffs in BNSF with nothing but state law to rely on.  While the defendant “ha[d] over 2,000 miles of railroad track and more than 2,000 employees” in the state, that was insufficient to permit suit by non-resident plaintiffs under either general or specific jurisdictional principles:

[T]he business BNSF does in [the state] is sufficient to subject the railroad to specific personal jurisdiction in that State on claims related to the business it does in [the state].  But in-state business . . . does not suffice to permit the assertion of general jurisdiction over claims like [plaintiffs’] that are unrelated to any activity occurring in [the state].

Id. at 1559 (footnote omitted).

Turning to BMS, which was a mass tort worthy of a breaking news post, hundreds of plaintiffs filed in California to escape (among other things) an existing federal MDL.  Non-resident plaintiffs could not establish specific personal jurisdiction over a non-resident defendant, even though (like BNSF) resident plaintiffs could, and the non-residents might be able to sue a different defendant that was “at home” in that state.  “The primary focus of our personal jurisdiction inquiry is the defendant’s relationship to the forum State.”  137 S. Ct. at 1779.  Jurisdiction is “a consequence of the territorial limitations” on state power; therefore even a ‘convenient location for litigation’ may, as a consequence ‘of interstate federalism,’ be “divest[ed]. . . of its power to render a valid judgment.”  Id. at 1781 (quoting World-Wide Volkswagen Corp. v. Woodson, 444 U.S. 286, 294 (1980)).

Specific jurisdiction, as explained in BMS, requires “an affiliation between the forum and the underlying controversy, principally, an activity or an occurrence that takes place in the forum State.”  Id.  “[U]nconnected activities,” no matter how extensive, are irrelevant.  Id.  That “other,” in-state plaintiffs could bring suit was “an insufficient basis for jurisdiction,” as was the ability of the non-resident plaintiffs to sue other, in-state defendants.  Id. at 1781, 1783.  Jurisdictional requirements “must be met as to each defendant over whom a state court exercises jurisdiction.”  Id. at 1783 (citation and quotation marks omitted).  Where:

[t]he relevant plaintiffs are not [in-state] residents and do not claim to have suffered harm in that State[, and] all the conduct giving rise to the nonresidents’ claims occurred elsewhere[, i]t follows that the [state’s] courts cannot claim specific jurisdiction.

Id. at 1782 (citation omitted).  Mass tort plaintiffs have two choices after BMS:  they can all sue “in the States that have general jurisdiction” over a particular defendant, or “plaintiffs who are residents of a particular state . . . could probably sue together in their home States.”  Id. at 1873.

Returning to MDLs, as in BNSF, there is no “typical” jurisdictional provision anywhere in the MDL statute.  Unless a particular MDL happens to be located in a forum with “general jurisdiction” over a defendant, there is no constitutional basis for allowing plaintiffs anywhere in the country to file directly into the MDL and thereby bypass statutory procedures.  Further, since jurisdiction must exist “as to each defendant” individually, in MDLs with more than one major defendant (most MDLs), it is unlikely (albeit not impossible) for there to be any jurisdiction where all such defendants are “at home” so as to permit direct filing as a matter of constitutional Due Process.

Thus, the only jurisdictional basis for MDL direct filing is the acquiescence – and thus the waiver – of the defendant(s) being sued.  That is particularly dangerous in an MDL setting, as the recent decision in the Pinnacle Hip MDL litigation (discussed here) exemplifies.  See In re Depuy Orthopaedics, Inc., 870 F.3d 345 (5th Cir. 2017).  The defendants’ agreement to a direct filing order was – wrongly, a majority of the Court of Appeals held – interpreted as a waiver of jurisdictional objections.  Id. at 351-52.  As for the propriety of direct filing, there was no majority.  The lead opinion viewed direct filed cases as being “treated ‘as if they were transferred from a judicial district sitting in the state where the case originated.’”  Id. at 348 (quoting In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation, 2011 WL 1375011, at *6 (S.D. Ill. April 12, 2011)).  The first concurrence declined to reach the issue.  Id. at 356-57.  The second, concurring and dissenting, opinion would find direct filing invalid:

But for the possibility of a “global waiver” of personal jurisdiction, the [MDL court] had no claim to personal jurisdiction over the cases:  none of the plaintiffs’ surgeries occurred in [the state]; the plaintiffs aren’t [in-state] residents; and neither general nor specific jurisdiction exists over the [defendants] for purposes of these disputes.  For that reason, the district court relied solely on the “global waiver”. . . .  Petitioners are being forced to trial over their objections to personal jurisdiction.

By comparison, a scholarly opinion . . . in an MDL case resulted in dismissal of a nonresident defendant against which there was a “direct filed” case by a nonresident plaintiff.  In re Heartland Payment Systems, Inc. Customer Data Security Breach Litigation, 2011 WL 1232352 (S.D. Tex. March 31, 2011).  The court first noted that the defendant’s agreement to transfer for purposes of pretrial proceedings was not inconsistent with and did not waive its personal jurisdiction challenge.  2011 WL 1232352 at *5–6.  Finding no waiver, the court then decided that it lacked personal jurisdiction over the non-consenting defendant based on [its] lack of minimum or relevant contacts with the [state in question]. 2011 WL 1232352 at *6–10.

Depuy Orthopaedics, 870 F.3d at 357.

This is a good place to start, so we examined the decisions cited by both sides.  Looking at Yasmin/Yaz, we were disappointed.  That decision doesn’t even discuss the jurisdictional ramifications of MDL direct filing.  Rather, as the first sentence of the opinion makes clear, “[t]his matter is before the Court for the purpose of resolving choice of law considerations.”  2011 WL 1375011, at *1.  The direct filing order at issue specified that direct filing would have no effect on choice of law.  Id. at *4 n.2, so the reference in Yasmin/Yaz to how direct filings were “treated” occurred in the context of deciding what “no effect” on choice of law meant:

As to the foreign direct filed cases, the choice of law decision is not as clear.  Foreign direct filed cases are filed in this Court pursuant to a direct filing order . . . [that] expressly provides that the parties’ direct filing agreement will not impact the choice of law that otherwise would apply to the direct filed actions.

In general, direct filing orders are beneficial to both parties because they streamline the litigation and help to eliminate the judicial inefficiency. . . .  However, direct filing orders also present difficult choice of law issues. . . .  The Court concludes that the better approach is to treat foreign direct filed cases as if they were transferred from a judicial district sitting in the state where the case originated.  For purposes of this analysis, the Court considers the originating state to be the state where the plaintiff purchased and was prescribed the subject drug.

Id. at *5-6 (citations omitted).  There is not one mention of personal jurisdiction in the entire Yasmin/Yaz opinion.

Turning instead to Heartland Payment, that case did involve a dispute over personal jurisdiction in a directly filed action.  See 2011 WL 1232352, at *4 (observing that “direct filings may present jurisdictional, venue, or related issues”).  The defendant moved to dismiss a direct filed action under Fed. R. Civ. P. 12(b)(2) on the ground that the state in which the MDL was situated had no personal jurisdiction over it.  Id. at *5.  March, 2011 was, of course, three years before Bauman was decided and even several months before the Supreme Court’s “at home” test debuted in Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915 (2011).  But even under the more lax standards of that time, personal jurisdiction did not lie simply because an MDL against the defendant happened to exist in the state in question.

As in Depuy Orthopaedics, the MDL plaintiffs in Heartland Payment first attempted to use the defendant’s agreement to direct filing as a waiver of personal jurisdiction.  2011 WL 1232352, at *7.  Unlike Depuy Orthopaedics, the MDL court in Heartland Payment rejected that argument.  Id.  As for specific jurisdiction, neither the defendant’s use of an in-state processing center nor its agreements with national credit card networks sufficed.  “[M]erely contracting with a resident of the forum state is insufficient to subject the nonresident defendant to personal jurisdiction in that state.”  Id. at *8.  Plaintiff did not even try to argue that the fortuitous, after-the-fact creation of an MDL in the jurisdiction could be a “minimum contact” justifying jurisdiction.  Without a basis for jurisdiction, the directly filed case had to be either transferred or, if the parties could not agree, dismissed.  Id. at *12, 14.

On the basis of these two cases, we’d have to give the edge to the dissent on the jurisdictional issue, since Heartland Payment decided the question at issue – the jurisdictional impact of MDL direct filing – while Yasmin/Yaz did not.  But is there anything else out there, other than these two opinions, decided two weeks apart, in 2011?

We took a look, but most of what we found were either MDL orders creating negotiated direct filing regimes, or cases, like Yasmin/Yaz, that dealt with the impact of direct filing on substantive choice of law issues.  See, e.g., In re Incretin Mimetics Products Liability Litigation, 2013 WL 12171761 (S.D. Cal. Nov. 13, 2013) (an example of the former); Wahl v. General Electric Co., 786 F.3d 491, 498-99 (6th Cir. 2015) (an example of the latter).  Other than that, it appears that the two 2011 precedents are pretty much all there is.  The issue was raised in In re New England Compounding Pharmacy, Inc. Products Liability Litigation, 2015 WL 178130 (D. Mass. Jan. 13, 2015), but mooted by plaintiffs refiling in their home jurisdiction and getting a JPMDL “tag along” order before it could be decided.  Id. at *1 n.3.  The court in In re Vioxx Products Liability Litigation, 478 F. Supp.2d 897, 904 n. 2 (E.D. La. 2007), noted the possibility that “the MDL forum” might not be able to “exercise personal jurisdiction over the defendant” in discussing direct-filed complaints, but that was an aside in another choice of law decision.  A direct-filed case was dismissed for lack of subject matter jurisdiction in In re Pradaxa (Dabigatran Etexilate Products Liability Litigation, 2014 WL 7145470, at *3 (S.D. Ill. Dec. 15, 2014), where the plaintiffs were from a foreign country – but personal jurisdiction was not discussed.  Thus, it appears that Depuy Orthopaedics and Heartland Payment are the only cases actually addressing personal jurisdiction in the context of direct-filed MDL actions.

In the context of an ordinary (non-MDL) transfer, the Supreme Court has sought to “ensure that the ‘accident’ of federal diversity jurisdiction does not enable a party to utilize a transfer to achieve a result in federal court which could not have been achieved in the courts of the State where the action was filed.”  Van Dusen v. Barrack, 376 U.S. 612, 638 (1964).  We think that this principle logically extends to personal jurisdiction – and to direct filed actions.

In MDLs that rest – as product liability litigation does – on state law and diversity of citizenship, there is no jurisdictional basis for direct filing of MDL actions other than the defendant’s waiver of their rights to assert lack of personal jurisdiction.  The Supreme Court’s recent jurisdictional decisions, culminating (so far; there will be more) with BMS and BNSF, have put the other side’s mass tort business model in significant jeopardy.  Thus, we see plaintiffs making extreme and exorbitant waiver arguments based on MDL direct filing agreements, not only in Depuy Orthopaedics, but also in the earlier Heartland Payment case, which also involved an aggressive waiver claim.  Our best advice is “don’t do it anymore.”  There is no statutory basis for personal jurisdiction in a direct filed MDL case, and Lexecon indicates that the Supreme Court won’t be inclined to create one.  Except for the rare MDL located in a place where every defendant is “at home,” there is no constitutional basis for direct filing creating personal jurisdiction either.

Weighing all these considerations, and given how the jurisdictional law is evolving, it is not a good idea for a defendant to waive any personal jurisdiction defense at this time.  Thus, we believe that there is no constitutional basis for personal jurisdiction in direct-filed MDL cases, and defendants should not do plaintiffs any favors by voluntarily agreeing to such procedures.

In our continuing quest to share worthwhile educational opportunities with our loyal readers, we have a double shameless plug this weekend.

First, some of your favorite Drug and Device Law bloggers will be presenting at Reed Smith’s Philadelphia Life Sciences CLE Day on Thursday, November 2 at Reed Smith’s Philadelphia office. This is a free, full-day CLE program designed for in-house counsel at life sciences companies.

Eric Alexander will be part of a panel discussing “Digital Health: Issues and Considerations with Patient Engagement, Connected Devices, and Integrated Data” and Bexis and Rachel Weil will be speaking on “Going Long: Addressing the Biggest Opportunities and Threats in Prescription Medical Product Liability Litigation.”

In between, some of our Reed Smith colleagues will discuss:

  • The False Claims Act post-Escobar
  • State AG trends/activities concerning the life sciences industry
  • The insurance implications of aggressive civil litigation by state and local governments against pharmaceutical companies and distributors
  • The jurisdiction and venue refresh provided by Bristol-Myers and TC Heartland
  • Trends and recent angles of attack in product liability jury trials
  • Lessons learned in international arbitration battles

The good people at Reed Smith are also providing a networking breakfast and lunch, with a reception immediately following the CLE day.

This is a free, full-day program presumptively approved for 7.2 CLE credits in New Jersey and 6 CLE credits in Pennsylvania (application for Delaware credit is pending; for lawyers licensed in New York, the day is eligible for 7 credits under New York’s Approved Jurisdiction Policy).

Interested? You can register here. (Please note that space is limited.)

Our second learning opportunity carries no such space restrictions. Bexis will be co-presenting a free (can’t beat free) Washington Legal Foundation webinar on “Personal Jurisdiction and Venue Disputes: Succeeding in a Changed Legal Environment” on October 11 at 1:00-2:00 pm EST, with Phil Goldberg of Shook, Hardy & Bacon.  Here’s a description of the topic (WLF wrote this, not me):

Previously relegated to law-school classroom debate, personal jurisdiction and venue are now front-of-mind issues for civil litigators.  Our speakers will address how lower courts, and the plaintiffs’ bar, have responded to the U.S. Supreme Court’s recent restrictions on forum shopping. They will also identify the open questions and possible loopholes in the new jurisprudence, and discuss strategic responses on how to obtain and keep a “home court” advantage.

RSVP: to glammi@wlf.org.  More information on the webinar, and instructions on how to register, are here.

With Bexis having originally conceived the preemption argument that became Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), we are always on the lookout for ways in which plaintiffs attempt to circumvent Buckman’s result and thus  to pursue private litigation over fraud on the FDA.

Plaintiffs love to claim fraud on the FDA. It’s their all-purpose response to any FDA action that they don’t like.  For over fifteen years, now, Buckman has severely cramped their style.

One group of plaintiffs thought they had found their way around Buckman – relators bring cases under a federal statute, the False Claims Act, 31 U.S.C. §3729 (“FCA”).  Since the FCA is a federal statute, the preemption rationale by which the FDCA, and specifically 21 U.S.C. §337(a), prohibiting private enforcement, bars conflicting state-law theories would not apply.  These plaintiffs thought they had reached the promised land.

Not so fast.

Actually, all they’d come up with were a few bits of legal trumpery. The Oxford Dictionary offers four definitions for trumpery:

  • “Attractive articles of little value or use.”
  • “Practices or beliefs that are superficially or visually appealing but have little real value or worth.”
  • “Showy but worthless.”
  • “Delusive or shallow.”

When the word fits, use it. All the definitions (the first two are nouns; the last two adjectives) fit here.

We saw the end coming, in this post, discussing United States ex rel. D’Agostino v. EV3, Inc., 153 F. Supp.3d 519 (D. Mass. 2015), and it has now drawn nigh.  First, D’Agostino was affirmed. D’Agostino v. ev3, Inc., 845 F.3d 1 (1st Cir. 2016).  We discussed that decision, with great glee, here.  Fraud on the FDA, unless the FDA actually found fraud, didn’t cut it under the FCA, because causation would be entirely speculative – plaintiffs would have to prove a counterfactual hypothesis, that the FDA would have done something other than what it in fact did:

If the representations did not actually cause the FDA to grant approval it otherwise would not have granted, [the government] would still have paid the claims.  In this respect, [relator’s] fraudulent inducement theory is like a kick shot in billiards where the cue ball “could have” but did not in fact bounce off the rail, much less hit the targeted ball.

Id. at 7.  Where the FDA didn’t act on an FCA plaintiff’s allegations, those claims are mere trumpery.  The materiality standard for FCA claims is tough – “[i]t is a ‘demanding’ standard.”  Id. (quoting Universal Health Services, Inc. v. United States, 136 S.Ct. 1989, 2003 (2016)).  If it’s not enough to impress the FDA directly under the FDCA, purported fraud on the FDA is certainly not enough to move the needle under the FCA.

D’Agostino was good, but a more recent case, United States ex rel. Nargol v. DePuy Orthopaedics, Inc., 865 F.3d 29 (1st Cir. 2017), is even better.  The allegations in Nargol were practically indistinguishable from what the Bone Screw plaintiffs alleged two decades ago in Buckman itself.  The plaintiff, a pair of doctors who “claim to be experts in hip-replacement techniques and devices,” id. at 31, claimed that the manufacturer of a such a device “made a series of false statements to the FDA . . ., but for which the FDA would not have approved the [product] or would have withdrawn that approval.”  Id. at 32.  Sounds like a broken record to us:

Plaintiffs say petitioner made fraudulent representations to the Food and Drug Administration (FDA or Administration) in the course of obtaining approval to market the [product]. . . .  Had the representations not been made, the FDA would not have approved the devices, and plaintiffs would not have been injured.

Buckman, 531 U.S. at 343.  This plaintiff-side trumpery also reminds us of an advertising “slogan” from the Onion.  The only difference between Nargol and Buckman were the purported damages – while Buckman invoked fraud on the FDA to allege that every use of the device in question was automatically a tort, Nargol pushed the same theme to claim that every such use (on Medicare and certain other patients) was automatically a false claim.

Talk about allegations “of little use or value.”

Focusing on the claims, “whether direct or indirect, that rest on the allegation that [defendant] misrepresented the safety and effectiveness of the product’s design in order to secure or maintain FDA approval,” the panel “appl[ied and extend[ed]” D’Agostino to affirm dismissal.  Id. at 31, 34.  Unlike D’Agostino, which had involved a PMA medical device, Nargol involved a device that had been cleared for marketing as “substantially equivalent” under so-called “§510(k) clearance.” Id. at 34.  That difference didn’t matter, since the claims in both cases sought to attack the integrity of the process by which the FDA allowed the products in question to be marketed.

The claim in this case is not quite on all fours with the claim we confronted in D’Agostino because the FDA does not independently assess the safety and effectiveness of a [510(k)] medical device. . . .

Nevertheless, the process constitutes the government’s method of determining whether a device is safe and effective as claimed.  That determination is what makes the product marketable, and Relators offer no suggestion that government reimbursement rules require government health insurance programs to rely less on section 510(k) approval than they do other forms of FDA approval.

Id. (emphasis added) (citations to Lohr and Buckman omitted).  We would be remiss if we failed to note that, in this respect Nargol is congruent with what the FDA itself said earlier this year – that, yes, the 510(k) process does involve determinations of device safety and effectiveness.  Lohr is anachronistic on this point, and will eventually be reconsidered.

But we digress.  Back to fraud on the FDA, where Buckman, by comparison, isn’t out-of-date at all.

The FDA, as Buckman observed, wields plenty of tools to protect itself from being defrauded and to punish anyone so bold as to try.  531 U.S. at 349 (listing administrative powers).  Its lack of exercise of such powers in Nargol demonstrates the trumpery nature of the plaintiffs’ claims:

The FDA, in turn, possesses a full array of tools for “detecting, deterring, and punishing false statements made during . . . approval processes.”  Its decision not to employ these tools in the wake of Relators’ allegations so as to withdraw or even suspend its approval of the . . . device leaves Relators with a break in the causal chain between the alleged misstatements and the payment of any false claim.

865 F.3d at 34 (emphasis added) (Buckman citation omitted).  For this reason, the FDA’s decision not to act “also renders a claim of materiality implausible.”  Id.

Even in an ordinary situation not involving a misrepresentation of regulatory compliance made directly to the agency paying a claim, when “the Government pays a particular claim in full despite its actual knowledge that certain requirements were violated, that is very strong evidence that those requirements are not material.”

Id. at 34-35 (quoting UHS, 136 S. Ct. at 2003).  Such evidence is not just “strong,” but “compelling” when “an agency armed with robust investigatory powers to protect public health and safety is told what Relators have to say, yet sees no reason to change its position.”  Id. at 35.

Thus, without an FDA finding that it was defrauded, fraud on the FDA allegations by FCA relators are both too speculative to plead causation plausibly and not material.  That’s not quite preemption but is satisfyingly close.  Fraud on the FDA allegations, without support from the FDA itself, amount to trumpery:

[T]here is no allegation that the FDA withdrew or even suspended product approval upon learning of the alleged misrepresentations.  To the contrary, the complaint alleges that Relators told the FDA about every aspect of the design of the . . . device that they felt was substandard, yet the FDA allowed the device to remain on the market. . . .  Such evidence does show that the FDA was paying attention.  But the lack of any further action also shows that the FDA viewed the information, including that furnished by Relators, differently than Relators do.

Id. at 35 (emphasis added).  Right.  The FDA considered these allegations to be fake news.

Plaintiffs had a fallback position – that even after the device was approved, its mere use could constitute a “false claim.”  To wit:  “In theory, a product may be sufficiently ‘safe’ and ‘effective’ to secure FDA approval for a given use, yet its use might nonetheless not be sufficiently ‘reasonable and necessary’ for patient care to warrant Medicare reimbursement.”  Id.  More trumpery, held Nargol.  The “complaint was devoid of particularized allegations,” the differences being claimed were within the “maximum failure rate provided under industry guidelines,” and ultimately “simply runs Relators back into” their fraud on the FDA claims.  Id. at 36.  Thus, no causation and no materiality:

We see no reason, though, why such a likely and customary repetition of the statements made to the FDA renders it more plausible that a materially false statement caused the payment of a claim that would not have been made otherwise.  The government, having heard what Relators had to say, was still paying claims . . . but because the government through the FDA affirmatively deemed the product safe and effective.

Id..  Yes, a 510(k) clearance means “the FDA affirmatively deemed the product safe and effective.”

Ultimately D’Agostino prevailed.  Plaintiffs “offer[ed] no rebuttal at all to D’Agostino’s observation that six jurors should not be able to overrule the FDA.”  Id.  Their arguments “offer[ed] no solution to the problems of proving that the FDA would have made a different approval decision in a situation where a fully informed FDA has not itself even hinted at doing anything.”  Id.

Between them, D’Agostino and Nargol should slam the door on plaintiffs’ attempt to assert fraud on the FDA under the guise of FCA claim (unless the FDA itself has reached the same conclusion).  See In re Plavix Marketing, Sales Practice & Products Liability Litigation (No. II), 2017 WL 2780744, at *21-23 (D.N.J. June 27, 2017) (rejecting similar FCA fraud on the FDA allegations against prescription drug).  Moreover, the emphasis in these cases on the speculative nature of attempting proof of what the FDA might have done if presented with a different set of facts also casts doubt on the Third Circuit’s terrible Fosamax decision, which, as we have pointed out, would saddle juries with the task of doing just that.

Your bloggers always do our best to alert our loyal readers to interesting, informative events. For those of you on the right side of the v and in the Greater Philadelphia area, the Drug & Device Defense Forum definitely makes the list.

This is a defense-only program for litigators and in-house counsel, and it counts the blog’s own Michelle Hart Yeary as one of its co-chairs, so you know it’s a quality program. Several of your bloggers have spoken at the event in the past, and Bexis will be doing so this year as part of a panel on “Emerging Issues in Drug and Device Litigation & Regulation.”

For more information, or to register, you can visit the event website.