It’s hard to escape the suspicion that blue states are more pro-plaintiff and red states are more pro-defense, though that is not a hard and fast rule. There are parts of Alabama and Texas where it is hard for an out of state corporate defendant to get a fair shake. Delaware and West Virginia also do not fit neatly into the blue/plaintiff-red/defense model.

Still, when we read a case where a Massachusetts court tries to predict New York tort law, our fears toggle between whether the pro-plaintiff errors will be multiplied linearly or exponentially. Daley v. Mira, Inc., 2019 WL 499775 (D.Mass. Feb. 8, 2019), is pretty bad. Check that; it is really bad.

The plaintiff in Daley alleged that a surgical implant used in an eye operation in 1986 went bad in 2015 (that’s right – 29 years later) resulting in follow-up operations and near total vision loss in one eye. She sued the manufacturer and seller of the implant. She also sued a company that designed and patented the implant. The designer then licensed the product to the aforementioned manufacturer-seller, more than 29 years ago. This much is clear: the patent-holder had no dealings with the plaintiff. So how could it be a proper defendant?

To answer that question it is necessary to look at the plaintiff’s theories of recovery. After some initial skirmishing, it was determined that New York Law governed the tort claims. So goodbye to the claim under Chapter 93A of the Massachusetts General Law. Goodbye, also to the warranty claim, because of the statute of limitations. What was left against the patent-holder? Three other claims remained: negligent pre-market testing, strict product liability, and post-sale failure to warn. The patent-holder moved to dismiss these claims, contending that it would not be held liable under any of these theories under New York Law. That argument was premised largely on the defendant’s status as never having interacted with the plaintiff. You know – standard product liability stuff.

But hold up a moment. The claim of inadequate pre-market testing, based on an alleged failure to make sure the product could not fail after 29 years, is a bit of a reach. There is certainly no indication that the FDA required any of the testing for “long-term effects.” And whatever product testing is necessary is required by the FDA of the company that submitted the device. The court did not ask these questions, or many questions at all in waving this pre-market testing theory along. This ‘what, me worry’ approach may now be responsible for creating a very broad cause of action available to lots of future plaintiffs against lots of fairly remote defendants.

Whether any of these theories should apply to a non-manufacturer/seller is an issue of theoretical majesty. But the Massachusetts court seems to think it is fairly simple. Either the non-manufacturer/seller can be held liable for its own remote role, because New York Law recognizes “that a defendant can owe a duty of care to a third party – even without a contractual or other direct relationship between the defendant and the third party – and, thus, may be liable to the third party for injuries resulting from a breach of that duty,” or it can be dragged into court based on an allegation of concerted action. If that were so, we would see patent holders dragged into product liability litigation all the time – but we don’t.

The result in the Daley case is bad, and it follows ineluctably from the court’s deficient methodology. Here we have a Massachusetts federal court purporting to predict New York law. The opinion is quite short. That brevity is something we ordinarily welcome. But not one of the New York cases cited by the Massachusetts court is at all on point (they do not involve any kind of product, and one ultimately rejected the claimed duty). Absent is the usually rigorous duty analysis undertaken by New York courts. So what we have is something we have griped about many times before – a federal court expanding state law tort doctrine, and here it is doing damage to the law of a different state. (We are not completely discounting the possibility that what is really going on is that a Patriots or Red Sox fan is trying to wreak havoc on New Yorkers. Those two Super Bowl losses to the Giants must still sting. And, recent success notwithstanding, 100 years of losing to the Yankees really smarts.)

Even aside from lacking anything approximating a rigorous legal analysis, the Daley court seems oblivious to the real world implications of the decision. The extension of liability to the patent-holder is particularly dangerous in terms of the chilling effect it would have on the licensing of patents. Must a patent holder undertake extensive testing – including clinical trials – before it can license a patent? How can a patent holder, or anyone for that matter, test whether a medical device might fail after 29 years?

Massachusetts and New York have always had a funny relationship. That is true in all sorts of areas, including historical and cultural. It is possible that Thoreau did not quite get Whitman’s poetry, or got only parts of it (certainly not the sexy bits). Such a misreading might have been unfortunate. But at least it didn’t actually hurt anybody. (Well, maybe it hurt Whitman’s feelings. Come to think of it, we could see a Massachusetts court making that actionable, too.)

We typically steer clear of discussing any opioid cases for client reasons. But today we have a case that did not involve our client in any way and that involves a discrete and important issue. Accordingly, we hereby render a bare-bones report.

The case, Floyd v. Feygin, et al., No. 507458/17 (Kings County, N.Y. Supreme Court Nov. 28, 2018) (available here: https://www.druganddevicelawblog.com/wp-content/uploads/sites/30/2018/12/Dabiri.pdf) is a civil case, but it pretty much was a follow-on to a criminal investigation involving, among others, the DEA, the Brooklyn District Attorney’s office, and the Department of Health and Human Services. That criminal investigation culminated in indictments of doctors, nurse practitioners, and even a member of the New York Assembly, all charged with running pill mills that issued medically unnecessary painkiller prescriptions and bilked funds from the Medicaid program.

The plaintiff filed a complaint that mostly tracked the criminal case, while also adding some entities that were not part of the criminal case, including the pharma company and a drug store. Here is the theory of the plaintiff’s negligence claim against the pharma company:

“Plaintiff alleges that Actavis had a duty to ensure that its Oxycodone product was not being prescribed, dispensed, and used in a fraudulent and harmful manner. Plaintiff further alleges that Actavis breached its duty by failing to take appropriate action to stop and prevent Oxycodone from being prescribed for fraudulent and illegal purposes, and by failing to maintain effective controls against having prescriptions for Oxycodone being written where such prescriptions were not for legitimate medical purposes. Plaintiff also claims that Actavis breached its duty by failing to design, implement, and operate a system to disclose suspicious orders of Oxycodone, and by failing to establish, implement, and follow an abuse and diversion detection program consisting of internal procedures designed to identify potential suspicious prescriptions of Oxycodone. Plaintiff claims that he suffered injuries by improperly receiving Oxycodone and becoming addicted to it.”

The plaintiff also alleged that the pharma company “keeps a close eye on how many pills a doctor or practice is prescribing” and that it is required to report any suspicious prescribing, pursuant to the Controlled Substances Act (both federal and the New York equivalent). And there’s the rub. Actavis filed a motion to dismiss, arguing that the plaintiff’s negligence cause of action was an attempt at private enforcement of the Controlled Substances Act. Neither the federal nor New York statute provide for private enforcement. The plaintiff was forced to concede that there was no private right of action, and then tried to escape preemption by arguing that the statutes “created a responsibility that Actavis failed to meet.” But the plaintiff encountered additional problems. First, the statutes imposed reporting requirements, but did not compel manufacturers to stop or restrict distribution. Second, the distributions of painkillers at issue were all made pursuant to purportedly valid prescriptions by licensed physicians. Third, the creation of pill mills by other defendants “was an intervening act which was of an extraordinary and criminal nature so as to break any causal nexus between any reporting requirement on the part of Actavis and plaintiff’s addiction to Oxycodone.”

Seeing that his negligence cause of action against the pharma company was going down the drain, the plaintiff argued that he needed more discovery. The court denied this request, reasoning that the pharma company simply had not breached any duty owed to the plaintiff. Discovery was not going to change that.

Multidistrict litigation is not special. By making this pithy observation, we do not mean to denigrate what has become the mother of all procedural mechanisms.  What we mean is that multidistrict litigation is, at its core, nothing more than a bunch of venue transfers, bringing multiple cases involving common issues before a single district judge for coordinated pretrial proceedings.  The MDL statute does not grant an MDL judge any extraordinary or special powers.  In fact, the statute purports to augment a district judge’s prerogative in only one way:  An MDL judge “may exercise the powers of a district judge in any district for the purpose of conducting pretrial depositions.”  28 U.S.C. § 1407(a).

Not very Earth-shattering stuff, but the point is that whatever exceptional gravitas you might attribute to an MDL comes not from an act of Congress.  It comes from the fact that one judge has all the parties and their attorneys in front of him or her with the power to preside over all their cases at the same time.  That includes deciding which cases will proceed, and which will wait, and how proceedings will be conducted for those chosen to go ahead, maybe a few at a time, or maybe in entire “waves.”

It also includes naming the plaintiffs’ Lead and Liaison Counsel, a function that is uniquely important for the plaintiffs’ side because there are usually many more plaintiffs’ lawyers involved and they are generally being paid based on the results. That requires a leadership structure with defined responsibilities and a common-benefit compensation structure to go along.

But where do Lead and Liaison Counsel’s responsibilities begin and where do they end? According to the Yaz MDL judge, who as far as we can tell is the first judge anywhere to address this particular issue, they begin and end with the court’s order creating those roles and defining those responsibilities.  That was the ruling in Casey v. Denton, No. 3:17-cv-00521, 2018 WL 4205153 (S.D. Ill. Sept. 4, 2018), where the district judge presiding over the Yaz hormonal contraceptive MDL held that the plaintiffs’ Lead and Liaison Counsel owed no general fiduciary duty to plaintiffs in the MDL, other than their own clients.  After the bulk of the cases in the MDL resolved, the MDL judge entered an order placing the unresolved cases on separate litigation tracks, with all the deadlines that you would expect:  Fact sheets, case-specific expert reports etc. Id. at **2-3.

Here is where is got ugly. Many of the non-settling plaintiffs blew the deadlines, resulting in motions to dismiss.  The plaintiffs blew the deadlines to oppose those motions, too.  Presented with violations of court orders and utter indifference from the plaintiffs (and their individual attorneys) toward their own cases, the MDL judge justifiably dismissed their cases. Id. No one appealed or sought reconsideration. Id.

So, what is a plaintiff to do, after rejecting settlement and opting to litigate, only then to blow off the resulting litigation deadlines? Of course, you sue your lawyer.  But not your own lawyer.  You sue the Lead and Liaison Counsel who created this whole mess, right?  That is exactly what these plaintiffs did, claiming that the Lead and Liaison Counsel “breached purported fiduciary duties by failing to address (or failing to delegate) the directives laid out” in the court’s orders. Id. at *2.  The plaintiffs analogized to duties owed by attorneys representing classes of plaintiffs, i.e., that Lead the Liaison Counsel’s duties arose from and were created by the court’s order creating those positions and “bestowing” certain duties. Id. at *3.

That proposition was a nonstarter for this judge. First, the court found no fiduciary duty:

It is well established that a “fiduciary” is a person, having a duty, created by his undertaking, to act primarily for another’s benefit in matters connected with such an undertaking. The Court finds the ending of that statement to be the pinnacle instruction on this entire dispute: One can only act in a fiduciary capacity, and thus have a fiduciary duty, to the extent his actions comport within the boundaries set by the agreement initially creating the relationship.

Id. at *4 (emphasis added).  In this case, the document creating the relationship was Case Management Order No. 2, which created the roles of Lead and Liaison Counsel and “very clearly set[ ] out what responsibilities the Lead and Liaison Counsel . . . owed to plaintiffs.”  Moreover, “it is clear from the text that Order No. 2 only imposed tasks geared towards facilitating general work product that could be used for the common good of all plaintiffs,” such as coordination of document depositories, preparing agendas, and conducting common discovery. Id. As the MDL judge concluded, “It was never the intention or spirit of Order No. 2 to supersede the authority or importance of each plaintiff’s individually-retained counsel when it came to specific matters unique to each case.” Id. at 5.

That is not to say that Lead and Liaison counsel own no duty to MDL plaintiffs.  The court analogized to a trustee, who owes a duty to pursue the “good of all.” Id. at *6.  As Judge Cardozo reminded us all in law school, “A trustee is held to something stricter than the morals of the market place. Not honesty alone, but the punctilio of an honor the most sensitive, is then the standard of behavior . . . .” Meinhard v. Salmon, 164 N.E. 545 (N.Y. 1928) (emphasis added).  Whatever the “punctilio of an honor” encompasses, it does not extend to representing an individual plaintiff when her or her own lawyer fails to do so.

Second, the court decided it would be a bad idea to create the fiduciary duty that the plaintiffs wanted.  After all, who would want to be Lead and/or Liaison Counsel if those roles came saddled with the duty to respond to every deadline and otherwise represent individuals with whom they have no engagement?  We have no qualm with the idea that the plaintiffs’ leadership in an MDL should earn their pay, and we know from our view from the other side of the aisle that they work very hard.  But even we have to admit that the plaintiffs in this case were asking too much.

The lesson here is that Lead and Liaison Counsel’s duties are defined by court order, and not so much by common law principles governing fiduciaries. So be careful in drafting and presenting those proposed orders for the judge’s signature.  They may be used against you.  A little gratuitous advice to plaintiffs’ attorneys, who are very unlikely to read our blog.

 


Way back in law school we learned that a plaintiff suing for negligence must satisfy four elements:  (1) duty, (2) breach, (3) causation, and (4) injury.  Every one of these elements can be a battleground.  Even what seems like the simplest inquiry – whether the plaintiff was injured – can be controversial.  We have seen cases where a plaintiff alleged increased chance, and consequent  fear, of injury.  Is that enough?  Psychological injuries present a host of difficulties.  Remember the “zone of injury” cases?  Some injury issues manage to be at once both straightforward and intractable.  One of the all-time great movies about litigation, The Fortune Cookie, centered around that great bugaboo of small-time litigation – soft tissue injury.  Not everyone who dons a neck-brace is really hurt. 

 

The element of breach can also be knotty.  Was the defendant insufficiently careful?  How much care is reasonable?  What is the standard of reasonableness?  Reasonable person?  Reasonable riveter?  Reasonable podiatrist?  When we sat on a jury in a med-mal case a couple of months ago, pretty much the only issue in play was whether the doctor had paid close enough attention to his patient’s hemoglobin levels.   Some jurors wanted to throw up their hands, exasperated at the impossibility of knowing what a doctor should do.  Theoretically, the breach element drops out in strict liability cases.  Fault should not matter.  But when the claim is strict liability failure to warn, negligence principles creep back into the case.  It can be hard for a defendant to win summary judgment on breach.  Courts are quick to throw that issue to the jury.  And then, like the jury we sat on, some poor fact-finders will want to throw the issue right back.

 

More often, it is the causation element that constitutes summary judgment bait.  In this blog, we have spilled a lot of web-ink on the causation issue, whether it be medical causation (did this drug or device hurt the plaintiff?) or warning causation (would a different warning in the label have steered the doctor away from this product?).  If the doctor did not even read the label, our clients win.  Some commentators say that there are five, not four, elements, because causation actually involves separate questions of but-for causation and proximate causation.  That latter item has given rise to quasi-philosophical musings.  Maybe something played a role in the causal chain, but is it so remote or obscure that putting the defendant on the hook for damages would be unfair?  Maybe Donny was a dolt to leave a lit candle on the dresser in his rental apartment, but should he be on the hook if a burglar broke in, knocked the candle onto the rug, and set the place ablaze?  Proximate causation, in the views of some, can boil down to whether it was reasonably foreseeable that the breach of the duty of care would cause this particular harm.  But evaluating foreseeability can almost seem like an epistemological exercise.  Whose perspective counts?  What are the sources of foreseeability?  We’ve always thought that foreseeability was a fuzzy criterion, because it can be altered by so many things – including court opinions.  Now that we know how clumsy burglars can be, thanks to F. Supp. or Law360 or the Philly Inquirer or Eyewitness News, shouldn’t we be extra-careful about leaving lit candles behind?  (Similarly, in Fourth Amendment jurisprudence, the notion of reasonable expectation of privacy seems mercurial.  Don’t SCOTUS pronouncements themselves shape such expectations?  Once we read how cops can identify marijuana grow-rooms via thermal imaging, doesn’t our expectation of privacy somehow diminish?  But we digress.)   

 

If proximate cause turns, at least in part, on foreseeability, so does the first negligence element, duty.   Today’s case, Martinez v. Walgreen Co., 2018 WL 3241228 (S.D. Texas July 3, 2018),  is about the scope of duty.  Maybe the Martinez case will end up being one for the law books.  Even though the defendant in Martinez is not a drug or device company, we feel duty-bound to report on it.  The defendant was a pharmacy, and the claim was the pharmacy dispensed the wrong prescription to its customer.  The medication incorrectly given to the customer allegedly caused the customer to experience hypoglycemia, which adversely affected his ability to drive (blurry vision, dizziness, etc.), which resulted in a series of auto wrecks that killed the occupants of other vehicles.  Those other drivers/passengers happened to be in the wrong place at the wrong time.  The estates of those victims sued the pharmacy for dispensing the wrong drug.  Even assuming that the pharmacy was negligent and that such negligence caused the terrible injuries, and assuming that the pharmacy owed a duty to its own customer to get the prescription right, did the pharmacy owe a duty of care to the people in the cars struck by its customer?    

 

The federal court, applying Texas law, said No, and granted summary judgment to the pharmacy.  In Texas, pharmacists are considered health-care providers and owe their customers a duty of care.  That much is clear.  But Texas courts have not recognized a general common-law duty for health-care providers towards third parties for injuries that may be the result of the provider’s negligence to the patient.  So far, so bad for the plaintiff.  Nevertheless, Texas has recognized a duty for medical professionals towards third parties in very limited circumstances when the breach of a duty to the patient gives rise to a reasonably foreseeable harm to an identifiable person or class of persons as a consequence of that breach.  For example, if a medical facility housing a criminally insane patient – one who presented a clear danger to the public – failed to control that patient and permitted him to shoot someone, the facility could be liable for breach of the facility’s duty to control the patient.  Is that a good analogy to what happened in Martinez?  Perhaps the best case that plaintiffs cited was one in which a Texas court held that a doctor who failed to warn a patient who had a known history of drug abuse not to drive while under the influence of Quaaludes and the patient then drove and injured third party motorists.  Pretty close, right? 

 

But Texas courts over the years have considerably reined in the duty to third parties.  Thus, physicians have no duty to warn epileptic patients not to drive and mental health professionals have no duty to warn third parties about specific threats (the law might be different elsewhere).  Texas courts have also ruled that pharmacists have no duty to warn about the potential side-effects of medication.  Against this not entirely consistent or clear legal backdrop, the Martinez court asked the following question:  “Under Texas law does a pharmacist owe a duty to unconnected third parties for the negligent prescription of medication?”  The court answered that question in the negative because “In order for a third-party duty to arise, the breach of the health-care provider’s duty to the patient must create a reasonably foreseeable consequence to an identifiable party or class.  Here, Plaintiffs are not identifiable third parties.”  The defendant pharmacy had no duty to control its customer’s behavior or to warn him about side effects.  To find a duty to the plaintiffs, the court would have to find that “a pharmacist has a general duty to the public for negligent provision of medication.  The Texas Supreme Court has never held that such a duty exists, and thus, this Court, Erie-bound cannot so find now.”  Well, that sort of respect for Erie is eerily refreshing, isn’t it?

 

The plaintiffs still did not give up.  They argued that the pharmacy’s dispensation of the wrong medicine violated a statute and that, therefore, this was a case of negligence per se.  The negligence per se doctrine simply means that a defendant’s violation of a statute removes the need for a jury to assess whether the defendant was careless.  The statute itself sets the bar for due care.  But what that means is that negligence per se answers the breach question –  “negligence per se does not impose a duty.”  It is the absence of duty in the Martinez case that puts the plaintiff out of court.   It is the absence of duty in the Martinez case that puts that case in our blog.