The DRI’s Drug and Medical Device Committee will present its annual seminar on May 10-11 at the New York Marriott Marquis. The presentations will include the latest mass tort trends, including litigation funding; the current status of the expanding opioid litigation; the internet of things and the increasing cyber security risk of new technology and medical devices; the importance of the power of persuasion in jury trials with a unique look at millennials; and current themes to expect during plaintiffs’ counsels’ closing arguments. These presentations will be made by in-house counsel, outside attorneys, law school academicians, experienced trial counsel and a jury consultant. For more information on the seminar, you may refer to the attached brochure and you may register here.
We have another guest post today, from Reed Smith‘s own Erica Yen. This one is about a recent, interesting decision concerning the interaction between the Health Insurance Portability and Accountability Act (“HIPAA”) and the common law – with a good result this time. As always, our guest bloggers are 100% responsible for their posts, and Erica deserves all the credit (and any blame) for what follows.
As noted in our post last month, the fact that HIPAA does not provide for a private right of action has not stopped some state courts from allowing negligence claims using HIPAA to define a standard of care. That post discussed the Connecticut Supreme Court’s questionable creation of a new tort of “unauthorized disclosure of confidential medical information” by a healthcare provider.
When the plaintiff in the recent case of Haywood v. Novartis Pharmaceuticals Corp., No. 2:15-CV-373, 2018 WL 437562 (N.D. Ill. Jan. 16, 2018), first filed her complaint in state court, she probably was hoping that the same expansive reasoning used in the Connecticut case would extend to the alleged disclosure by a pharmaceutical company of her private medical information to her employer. In federal court, however, her unusual negligence claims were not allowed to proceed, under HIPAA or otherwise.
In Haywood, the plaintiff had applied for a co-pay assistance program administered by the defendant to help offset the cost of purchasing that defendant’s prescription medications. Id. at *1. Despite an alleged written request that no information be sent to her workplace, the defendant allegedly faxed information that became available to the plaintiff’s co-workers. The information allegedly included her social security number, date of birth, income, Medicare number, disease, treatment, and medical providers. Id. The relevant (amended) complaint alleged negligence and negligent training and supervision in violating duties owed to her under (1) the defendant’s Privacy Notice and Privacy Statement, (2) Indiana state law, and (3) HIPAA. Id. She also claimed punitive damages based on supposed reckless indifference by disclosing the information against her written request not to do so. Id.
The end result? The court held that the defendant drug manufacturer did not owe the plaintiff any duty for the following reasons, and the plaintiff was not entitled to any punitive damages.
First, the court was not persuaded by the plaintiff’s argument that the defendant’s Privacy Notice and Privacy Statement, posted on its website, created a duty of privacy to her as a customer. Id. at *4. The privacy policies posted online concerned dissemination of information to business partners who were prohibited from using customers’ personal data for marketing purposes. Dissemination to plaintiff’s place of employment had nothing to do with third-party marketing. The defendant’s privacy policies did not set forth any obligations with respect to general non-disclosure, and the court found that the plaintiff’s unilateral request not to send information to her workplace could not, by itself, create a legal duty. Id.
Second, the section of the Indiana Code the plaintiff cited, Ind. C. §25-26-13-15(b), failed to create a duty either. While facially applicable to the defendant, as the specific statute applied to “any ‘person’ with patient information,” the court held that as a whole it regulated “Pharmacists, Pharmacies, and Drug Stores.” The defendant was not any of those, nor did the statute purport to regulate the manufacture of pharmaceuticals or the administration of co-payment assistance programs. That the defendant was a “provider of pharmaceuticals” was not enough to bring it within the purview of a statute addressed to other types of entities and conduct. Therefore, no statutory duty could be owed to the plaintiff. Id.
Third, the court dismissed the plaintiff’s attempt to allege a negligence per se theory that the defendant violated HIPAA standards. Id. at *7. Given that HIPAA does not provide for a private right of action and enforcement was intended to be solely under the authority of the Department of Health and Human Services, allowing state law claims that rely on HIPAA would allow plaintiffs to sidestep those enforcement mechanisms. Id. That sounds a lot like how the FDCA works.
Lastly, the court noted that there was no precedent in the jurisdiction to suggest that a pharmaceutical company has a general duty to safeguard an individual’s personal information from disclosure. Id. at *8. The court could have stopped there but went further to explain the reasons why it concluded a duty should not be imposed at common law, after examining (1) the relationship between the parties, (2) the reasonable foreseeability of harm, and (3) public policy concerns:
- The relationship between a potential customer and co-pay assistance company, as in the case here, was not similar to the relationship between a pharmacist and consumer “mainly because the direct contact, expertise, reliance, and counseling aspects of the relationship are wholly lacking.” Id.
- Given that much of an employee’s personal information was likely already available to his or her employer anyway and was unlikely to cause adverse consequences, the foreseeability of legally actionable harm was minimal. Id. at *8-9.
- Given the growing amount of sensitive personal information generally being made available to third parties in today’s digital society, even if a pharmaceutical company could theoretically bear the liability from inadvertent disclosures, “[a]ssigning significant moral blame to a pharmaceutical corporation in this situation is disproportionate to the actual acts performed (i.e., negligently disclosing information to an employer during a routine application process) . . . Imposing a duty to safeguard information from all possible disclosures upon any party or entity who happens to be in possession of the personal information of another would expand liability in a way that has the potential to stifle the collection of data and the routine processing of information.” Id. at *9. A Seventh Circuit decision analyzing the Indiana data disclosure statute had found no private right of action against a database owner for negligently disclosing information; rather the database owner only had to disclose the breach to customers and let the state attorney general handle enforcement. Id. (citing Pisciotta v. Old Nat. Bancorp, 499 F.3d 629, 636-637 (7th Cir. 2007)).
Based on this reasoning, and exercising appropriate restraint under the Erie doctrine, Haywood concluded that the plaintiff failed to state any viable claim for negligence, negligent training and supervision, or punitive damages. Notwithstanding the importance of protecting health information, and even assuming the defendant’s handling of the plaintiff’s information was done in error, the court acted reasonably in not opening the gates to the kind of expansive duty and liability the plaintiff sought. The unsatisfied plaintiff filed an appeal to the Seventh Circuit just a few weeks ago. See Case No. 18-1328 (filed February 24, 2018). It would be surprising if the Seventh Circuit did not agree with the district court’s analysis and conclusion.
Until very recently, the only state high court decisions (from VA and DE) on our ediscovery for defendants cheat sheet involved sanctions against plaintiffs for destroying social media evidence.
In Forman v. Henkin, ___ N.E.3d ___, 2018 WL 828101 (N.Y. Feb. 13, 2018), the New York Court of Appeals reaffirmed that discovery of plaintiff social media is available to defendants on the same basis as any other discovery, and put the kibosh on plaintiff-friendly discovery restrictions that had lower New York courts had developed to hamstring defendants seeking access to plaintiffs’ social media.
Forman was about as far from prescription medical product liability as one can get and still involve personal injury. The plaintiff fell off a horse, was badly injured, and sued the owner of the horse. Forman, 2018 WL 828101, at *1. Plaintiff, who claimed to have become “reclusive” following the accident, was a heavy social media user:
At her deposition, plaintiff stated that she previously had a Facebook account on which she posted “a lot” of photographs showing her pre-accident active lifestyle but that she deactivated the account about six months after the accident and could not recall whether any post-accident photographs were posted.
Id. She also claimed to “ha[ve] difficulty using a computer and composing coherent messages” after her accident. Id. Thus, the relevance of plaintiff’s social media activities was as plain as the nose on that horse’s face. After plaintiff testified to these facts, social media information confirming or refuting them, at minimum, bears on credibility, and goes to damages, as well – right?
Well…. Not as the Appellate Division saw the issue (note: only plaintiff appealed, so the issues being considered are somewhat narrow). It limited disclosure only “to photographs posted on Facebook that plaintiff intended to introduce at trial” and “eliminate[ed] the authorization permitting defendant to obtain data relating to post-accident messages.” Forman, 2018 WL 828101, at *2. Why? The Appellate Division held that unless the defendant could find something in plaintiff’s public social media suggesting a specific basis for additional discovery, the defendant had no right to any discovery from the plaintiff’s private social media:
[T]he Appellate Division . . . employ[ed] a heightened threshold for production of social media records that depends on what the account holder has chosen to share on the public portion of the account. . . . Several courts applying this rule appear to have conditioned discovery of material on the “private” portion of a [social media] account on whether the party seeking disclosure demonstrated there was material in the “public” portion that tended to contradict the injured party’s allegations in some respect.
Id. at *4 (citations omitted).
The defendant argued that its right to discover relevant evidence under the control of an opposing party is not predicated on the legal equivalent of a snipe hunt. Id. Thankfully, the Court of Appeals “agree[d],” id., and threw out the Appellate Division’s made up impediment to ediscovery for defendants. First, discovery is discovery, no matter who seeks it:
Disclosure in civil actions is generally governed by CPLR 3101(a), which directs: “[t]here shall be full disclosure of all matter material and necessary to the prosecution or defense of an action, regardless of the burden of proof.” We have emphasized that the words material and necessary are to be interpreted liberally to require disclosure, upon request, of any facts bearing on the controversy.
Id. at *2 (citation and quotation marks omitted). New York recognizes only “three categories of protected materials” – “privileged matter,” “attorney work product,” and “trial preparation materials.” Id. A plaintiff’s (or defendant’s, for that matter) social media doesn’t fit in any of these categories.
Beyond the three categories, discovery may be limited if unduly “onerous.” Id. at *3. Discovery of photos actually posted by the plaintiff (with an exception for “nudity or romantic encounters” specified by the trial court) wasn’t “onerous” either, and plaintiff did not argue otherwise. Id.
The Court of Appeals in Forman flatly rejected the plaintiff’s supposed precondition to social media discovery, recognizing that it would let plaintiffs hide the ball:
[A] threshold rule requiring that party [seeking discovery] to “identify relevant information in [the social media] account” effectively permits disclosure only in limited circumstances, allowing the account holder to unilaterally obstruct disclosure merely by manipulating “privacy” settings or curating the materials on the public portion of the account. Under such an approach, disclosure turns on the extent to which some of the information sought is already accessible − and not, as it should, on whether it is “material and necessary to the prosecution or defense of an action.”
Forman, 2018 WL 828101, at *4 (citation, quotation marks and footnote omitted) (emphasis added). Hear, hear.
Rather, the principle circumscribing social media discovery is the same as for all discovery – relevance to the theories and defenses of the particular case. While blanket discovery of everything in every case, whether social media or otherwise, would be “onerous,” id., discovery tailored to the plaintiff’s claims and the defendant’s defenses is normal and proper:
[T]here is no need for a specialized or heightened factual predicate to avoid improper “fishing expeditions.” In the event that judicial intervention becomes necessary, courts should first consider the nature of the event giving rise to the litigation and the injuries claimed, as well as any other information specific to the case, to assess whether relevant material is likely to be found on the [social media] account.
Id. at *5. Plaintiffs would have a chance to assert “any specific ‘privacy’ or other concerns” about the social media discovery being sought. Id. In “a personal injury case . . . it is appropriate to consider the nature of the underlying incident and the injuries claimed.” “Temporal limitations may also be appropriate” so that social media “posted years before an accident” may not “be germane.” Id.
The Court of Appeals also rejected the plaintiff’s argument that social media discovery “necessarily constitutes an unjustified invasion of privacy.” No it doesn’t. A plaintiff who brings a lawsuit necessarily waives privacy with respect to evidence relevant to that action.
We assume . . . that some materials on a [social media] account may fairly be characterized as private. But even private materials may be subject to discovery if they are relevant. For example, medical records enjoy protection in many contexts under the physician-patient privilege. But when a party commences an action, affirmatively placing a mental or physical condition in issue, certain privacy interests relating to relevant medical records − including the physician-patient privilege − are waived. For purposes of disclosure, the threshold inquiry is not whether the materials sought are private but whether they are reasonably calculated to contain relevant information.
Forman, 2018 WL 828101, at *5 (citation omitted) (emphasis added). We note that one of the omitted citations is to Arons v. Jutkowitz, 880 N.E.2d 831 (N.Y. 2007), the decision confirming defendants’ right to informal interviews with treating physicians in New York, which we blogged about, here).
In short, plaintiffs who don’t want to produce their social media shouldn’t be plaintiffs. If you can’t stand the heat, get out of the courtroom.
Thus, it was “err[or]” to condition discovery of “private” social media on what a plaintiff might, or might not, have done on public social media. The Appellate Division had “effectively denied disclosure of any evidence potentially relevant to the defense.” Id. at *5 n.6. Rather, plaintiff’s testimony about her social media activities “more than met [any] threshold burden of showing that plaintiff’s Facebook account was reasonably likely to yield relevant evidence.” Id. at *5. Any photos of plaintiff’s activities “might be reflective of her post-accident activities and/or limitations.” Id. Further, “data revealing the timing and number of characters in posted messages would be relevant to plaintiffs’ claim that she suffered cognitive injuries that caused her to have difficulty writing and using the computer.” Id. at *6.
Forman thus confirms what we have always thought – anything a plaintiff puts on social media is fair game for discovery, to the same extent as any other information under the plaintiff’s custody and control. Decisions that seek to impose additional limitations on social media discovery, because social media is somehow different or more private, are wrongly decided.
What follows is a guest post from Mark Herrmann, the co-founder and former co-host of this blog. While he hasn’t litigated since going in house, he still writes on legal topics, including drug and medical device product liability. This post is also something of a shameless plug, since he’s announcing the latest edition of his treatise on the subject. But we’ll forgive that, because he’s Mark Herrmann and still funny as all get out to read. As always, guest posters (even if former bloggers) are totally responsible for their posts, entitled to all the credit (and any blame) for their posts.
I’m back from the dead again.
(The last guy to pull that off did it only once.)
I co-founded and co-hosted this blog from 2006 until the end of 2009, when I left private practice (and the defense of pharmaceutical product liability claims) to take a job as the head of litigation at Aon, the big insurance brokerage. I’ve reappeared in the drug and device space only once since then — in 2011, to write a book review that compared the first edition of my then-recently-published Drug and Device Product Liability Litigation Strategy to the umpteenth edition of Bexis’s Drug and Medical Device Product Liability Litigation Deskbook. (Yeah, yeah: Is it really fair to let the author of a book review his own work? Well, nobody ever accused Bexis and me of being fair. And besides, we figured we were doing a public service by letting the drug and device world know about the existence of the two books, even if the world slightly discounted my opinion of my own work.)
Anyway, the second edition of Drug and Device Product Liability Litigation Strategy has now been released (here at Oxford University Press, the publisher; here at Amazon). And if I’m foolish enough to update that book even though my life no longer touches the drug and device space, then I’m sure as heck going to “review” that second edition here.
(To say that I updated the book is a bit of an overstatement. I owe a debt of gratitude to my co-authors, Dave Alden of Jones Day, and Geoff Drake of King & Spalding, who manned the laboring oar. And Bexis probably owes some gratitude to Tony Vale of Pepper Hamilton, who’s his co-author.)
Let me start by saying, as I have said elsewhere, that this subject is important (even apart from the fact that I wrote the book). Pharmaceutical product liability cases, which, in federal court, disproportionately end up in MDLs, are a huge percentage of the federal docket: “Cases in multidistrict litigation proceedings constituted 36 percent of the federal case load in 2014, which is more than double the percentage they constituted in 2002. Not only that: ‘Removing 70,328 prisoner and social security cases from the total, cases that typically (though not always) require relatively little time of Article III judges, the 120,449 pending actions in MDLs represented 45.6% of the pending civil cases as of June 2014.’ Read that again: 45.6 percent of all pending federal civil cases. And virtually all of those cases are in pharmaceutical and health-care product liability MDLs.”
If we’re talking about a huge percentage of all pending federal cases, then we should take this subject very, very seriously — both as a matter of public policy and as a matter of business development.
Someone should write a book about it.
Wait! Someone did!
In fact, two guys did.
So how does the second edition of Herrmann compare to the umpteenth edition of Bexis?
The differences remain. Herrmann aims to be illustrative and practical. Thus, for example, Herrmann identifies the issue of innovator (versus generic) manufacturer liability, notes a key development or two (such as the Alabama legislature overturning what the Alabama Supreme Court had said about the issue), and moves on.
That would never satisfy Bexis. He notes the issue, cites most of the cases that discuss it, beats the issue to a bloody pulp, and then hammers the corpse.
If you’d like a book that identifies the major issues, cites a couple of leading cases, and moves on, go with Herrmann. It’ll do the trick.
But if you want a book that starts your research, finishes your research, and then tells you what your research should be next year, go with Bexis. He’s unstoppable.
(I bet the Herrmann book gets a couple more casual readers than the Bexis book, but the Bexis book pulls more law firm associates’ chestnuts out of the fire. It’s a matter of what you’re after.)
A couple of related things: Herrmann updates his book (very) periodically. The first edition came out in 2011; the second in 2018; the third will appear when he regains his energy. Bexis updates his book annually. That both explains why it can be more comprehensive — Bexis’s book is meant to stay up to date — and explains the price tags: Your firm shells out only a couple of hundred bucks for Herrmann’s 400-page opus; Bexis’s 1000-page ditty runs the firm 700 bucks. (Bexis updates a 1000-page book every year? No wonder he looks so tired.)
The fact that Herrmann’s book emphasizes the practical shows up in other ways. Herrmann’s book contains long chapters on picking juries and trying drug cases; Bexis’s book touches on those subjects, but devotes less time to them.
And the books also show the topics that Herrmann and Bexis always gravitated to: Herrmann was a student (of sorts) of the MDL Panel. It’s no surprise that his book spends a few extra pages talking about the Panel and some space analyzing issues that arise in MDL practice.
Bexis, on the other hand, is fascinated by everything. So no one is going to top, for example, his exegesis of negligence per se or punitive damages claims in the context of drug cases.
It’s also striking that the two books are quite different from each other. Herrmann could, after all, look to Bexis’s book to beef up his footnotes; Bexis could borrow some MDL analysis to include in his book. But we didn’t; we play fair.
Which book should you buy?
It depends what you’re after.
Or buy ’em both: That will make your library complete, and you’re spending other people’s money anyway.
I’m heading back to the crypt now. It’s way too sunny out here. Maybe I’ll see you again to celebrate the publication of the third edition of my book.
‘til then . . . .
Jurisdiction is hardly the spiciest of topics we discuss on this blog and yet it definitely qualifies for frequent-blogging status. That’s likely because as defendants, we don’t get first choice of jurisdiction. We get hauled into the court of plaintiff’s preference after which we are afforded some ability to change jurisdiction but that often requires putting up a fight – such as challenging fraudulent joinder or misjoinder. So, jurisdiction becomes a recurring theme. An undertaking at the start of each new case. Do I want to be in this court? If not, do I have a viable alternative?
Those questions predominately involve whether the federal courts have some basis for subject matter jurisdiction. Today’s case, while about jurisdiction, is about a type we rarely, if ever, have discussed here or have much experience with – the boundaries of tribal court jurisdiction. And while the case involves pharmacies and wholesalers, the court’s rationale for its decision would apply to other non-tribal entities sued on similar theories, such as drug and device manufacturers.
In McKesson Corp. v. Hembree, 2018 WL 340042 at *2 (N.D. Okla. Jan. 9, 2018), three pharmacies and three wholesalers who had been sued by the Cherokee Nation in the District Court for the Cherokee Nation filed for a petition for a preliminary injunction to halt the underlying action on the ground that the Cherokee Nation lacked jurisdiction. There are two components to the underlying lawsuit. First, the Cherokee Nation brought a parens patriae action on behalf of tribal members for violations of the Cherokee Nation Unfair and Deceptive Trade Practices Act (“CNUDPA”). Id. at *1-2. Second, the Cherokee Nation also asserted common law claims for nuisance, negligence, unjust enrichment, and civil conspiracy. Id. at *2. All of the claims are based on allegations that the pharmacies and wholesalers either knowingly or negligently distributed or dispensed prescription opioid drugs to the detriment of the tribe and its members. Id.
The defendants sought the injunction in federal court because the scope of a tribal court’s jurisdiction is a federal question. Id. at *3. The opinion contains a discussion of whether defendants were required to seek relief from the tribal court first and also examines whether defendants met the requirements for a preliminary injunction. We won’t address those aspects of the decision here, but wanted you to know they existed if you are interested. We focus on the substance of the ruling that the tribal court did not have jurisdiction.
Indian tribes in the United States have a recognized type of self-government but it is limited to “managing tribal land, protecting tribal self-government, and controlling internal relations.” Id. (citation omitted). The exercise of trial power is limited and tribal courts are not courts of general jurisdiction. One major limitation is that tribal jurisdiction does not extend to nonmembers of the tribe, with two narrow exceptions:
[a] tribe may regulate, through taxation, licensing, or other means, the activities of nonmembers who enter consensual relationships with the tribe or its members, through commercial dealings, contracts, leases, or other arrangements. [And]
[a] tribe may also retain inherent power to exercise civil authority over the conduct of non-Indians on fee lands within its reservation when that conduct threatens or has some direct effect on the political integrity, the economic security, or the health or welfare of the tribe.
Id. Essentially there is a “presumption against tribal civil jurisdiction over non-Indians.” Id. at *4. In this legal framework, the court analyzed whether the Cherokee Nation had jurisdiction over the two types of claims brought by plaintiff – CNUDPA and common law.
In its complaint, the Cherokee Nation alleged that the pharmacies and wholesalers violated the CNUDPA by violating the federal Controlled Substances Act (“CSA”). The CSA, however, like the FDCA, does not provide a private right of action. Id. at *5. So, we would say the claim is facially invalid regardless of jurisdiction. But that wasn’t the question the before the court and regardless of whether the claim was valid, the tribal court had no jurisdiction over a CSA claim, because there is no provision in the CSA that provides a tribal court jurisdiction over such a claim. Id. Remember, tribal courts are not courts of general jurisdiction. So, for example, the CSA differs from federal statutes the specifically allow tribal court jurisdiction over matters such as child custody disputes and mortgage foreclosure actions. Without such a provision, the court found that the tribe lacked jurisdiction over the CNUDPA claim because it was an unauthorized attempt to privately enforce the CSA. Id.
As to the common law claims, because they were being brought against non-tribe members, the court looked to see if they fit one of the two exceptions to the rule prohibiting such jurisdiction. The first exception is based on consensual relations which the Cherokee Nation said the pharmacies and wholesalers entered in with the tribe and its members by distributing products within the tribe’s jurisdictional area. But the exception is not so broad as to allow jurisdiction for any dealings with non-members:
Because nonmembers have no say in the laws and regulations that govern tribal territory[,] … those laws and regulations may be fairly imposed on nonmembers only if the nonmember has consented, either expressly or by his actions. Even then, the regulation must stem from the tribe’s inherent sovereign authority to set conditions on entry, preserve tribal self-government, or control internal relations.
Id. at *6 (citation omitted). The opinion details the extent, or lack thereof, of the relationship between the defendants and the Cherokee Nation, concluding that “at most, any relationships between Plaintiffs and the Cherokee Nation or its members are simply routine business or consumer transactions.” Id. (“the mere act of doing business with a tribe or its members even on tribal land, does not subject a nonmember to broad tribal civil authority”). Given that drug and device manufacturers are even more removed from direct dealings with individuals and health care plans, they would have an even more attenuated relationship that should not fit within this exception.
This first exception typically applies to a tribe’s right to tax or regulate business activities of nonmembers on tribal lands, not to claims of negligence or unjust enrichment. The pharmacies and wholesalers did not have contractual relationships with the Cherokee Nation relating to opioids and their conduct was not specifically directed at the Cherokee Nation or its members. Finally, there is no nexus between the allegations of the complaint and the Cherokee Nation’s sovereign authority over conditions on entry, self-government, or control of internal relations. Id. at *7.
The second exception has to do with conduct that threatens or directly impacts “the right of reservation Indians to make their own laws and be ruled by them.” Id. The Cherokee Nation offered declarations attesting to the harm done to tribe members from the opioid epidemic arguing that the conduct alleged in the complaint rises to a “mass tort.” Id. The court was sympathetic, as we all are, to the damage being done by opioid abuse. “However, a generalized threat of injury to the tribe or to its members for tortious conduct is not enough to confer tribal jurisdiction.” Id. at *8. The threat which invokes the exception is a threat to “tribal sovereignty.” Therefore, even if the conduct occurred on tribal lands, it does not constitute a threat to the tribe as a whole and the second exception does not apply.
With no applicable exception, the court granted the preliminary injunction to prevent the case against the pharmacies and wholesalers from moving forward. This is a completely legal analysis, with broad applicability in any alleged “mass tort.” Therefore, another significant jurisdictional victory for defendants.
If you found yourself wanting more information on these cases and their impact – perhaps with a side of CLE credit – we’re pleased to announce that four of your bloggers (Bexis, Steve McConnell, Eric Alexander, and Steven Boranian) will be presenting a free 90-minute webinar on “The Good, the Bad and the Ugly: The Best and Worst Drug/Medical Device Decisions of 2017” on January 17 at 12 p.m. EST.
The webinar is presumptively approved for 1.5 general CLE credit in California, Illinois, New Jersey, Pennsylvania, Texas and West Virginia. (For lawyers licensed in New York, it’s eligible for 1.5 credit under New York’s Approved Jurisdiction Policy.)
The program is free and open to anyone interested in tuning in, but you do have to sign up, which you can do here.
We posted our 2017 “Worst 10 decisions” list a day too soon, because the California Supreme Court issued its anticipated decision in TH v. Novartis, No. S233898, slip op. (Cal. Dec. 22, 2017) today, and if it is not the worst drug and device decision of 2017, it is awfully close. With an emphasis on awful.
This case presents two issues of duty: (1) Does an innovator prescription drug manufacturer owe a duty to patients who used a competitor’s generic product; and (2) does that manufacturer also owe a duty to patients who used a competitor’s product years after the innovator sold the NDA and stopped selling the drug altogether? The California Supreme Court decided “yes” on both counts, and in doing so it has broken away from decades of precedent placing responsibility for defective products on the companies that made and sold the products.
We will have more to say on this opinion, but our first read reveals that the Supreme Court fundamentally misframed the issue as whether the Court should create an “exception” to the duty to warn that all branded drug manufacturers owe. That is exactly backwards, and the Court framed “duty” in absurdly broad fashion (everyone owing a duty to everyone else not to be negligent in giving warnings) in order to posit an “exception” rather than what is really happening, that being a huge expansion of liability. The law in every jurisdiction, including California, is that one manufacturer generally does not owe duties to those who use other manufacturers’ products.
So how did the California Supreme Court justify its departure from this general rule? Let’s take innovator liability first. The Court held unanimously that an innovator drug manufacturer can be liable for its competitors’ generic products, with a particular fixation on a listed manufacturer’s exclusive right to “unilaterally” update a label. For one thing, the Court considerably overstates a listed manufacturer’s ability to “unilaterally” change a label under the CBE regulations, which require “newly acquired information” among other things. On the case-specific facts – off-label use – the opinion is simply wrong. Only the FDA, and not a company “unilaterally,” can require a warning about an off-label use – it’s right there in the regulations.
The main problem, however, is the Court’s overreliance on foreseeability to define a new tort duty. Although the Court discusses other factors, its core rationale is that a listed manufacturer can foresee that a generic manufacturer will use substantially the same label. Fine, but why does the law not require more than that to deviate from decades of product liability law? And why are other factors not as relevant? The Court, for example, quantifies the burden on brand-name manufacturers’ as “zero,” which is astonishing as it is potentially shifting 100% of liability onto 10% (if that) of the prescription drug market. The Court also assumes that insurance against this new liability would be readily available. If any reader knows of such a policy actually existing, please tell us. When expanding duties so fundamentally, we are not sure how the Court can purport to draw these conclusions.
The opinion on predecessor liability—or as we would call it, “perpetual liability”—deviates from prevailing law by equal measure, if not more. By a vote of 4 to 3 (with the margin provided by an “assigned” judge filling an open seat), the Court held that an innovator owes duties to users of a competitor’s product, even after the innovator has sold the NDA and stopped selling the drug. Again, the focus is on foreseeability, because a listed drug manufacturer purportedly can foresee that another manufacturer will make a generic product using a similar label in the future. Is such a manufacturer supposed to “foresee” off-label promotion (alleged in the complaint but not mentioned in the opinion) as well? We will definitely have more to say on this, but to start, what exactly can the innovator foresee and for how long? Who will sell the product? For how long, to whom, and for what purposes? What scientific developments will come down the pike, and what will the new owner of the product do with the label, into which the innovator now has no input? The result goes far beyond any other version of innovator liability ever adopted, in particular leaving in the dust the time limited, learned intermediary rule-respecting version adopted in the briefly extant Weeks v. Wyeth decision in Alabama.
We also take issue with the majority framing the issue as whether selling a product line “automatically terminates” liability for its negligence. The defense never proposed such a thing—a product manufacturer will continue to owe duties to users of its own products, even after it has left the market. We again think the Court has it backward: The issue is not whether liability “terminates”; the issue is whether the law should create a new form of liability in the first place.
We cannot help but think that the Court was motivated to create a remedy for plaintiffs who otherwise may not have one. Footnote 2 suggests that the decision is, at least in part, intended to lobby the FDA (and federal authorities generally) to trade generic preemption for elimination of this radical new innovator liability theory. In this regard, the opinion treats innovators like insurers of competing products, potentially forever, and seeks to hold them hostage in a larger, more political game. More to come.
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.
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:
- The annual addiction rate for opioids used according to prescription is between 1 and 2%.
- The vast majority of opioid overdoses stem from polypharmacy (use of more than one drug).
- A few bad actors among the medical community are disproportionately responsible for opioid prescriptions.
- Alleged medical mistakes involving opioids factor into almost a quarter of drug-related medical malpractice suits.
- Opioid abuse is strongly associated with mood disorders, depression, and mental illness.
- To determine who is likely to abuse opioids, start with people who have already illegally used drugs.
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).