Negligence

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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.

 

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. 

 

 

Back in 2013, inspired by a win of our own that we were actually allowed to blog about, we put up a post entitled “On Alternative Design.”  Taking the alternative design requirement for strict liability as a given, we concentrated in that post on the proposition that an “alternative” design must really constitute a different design for the same product, and not a disguised “stop selling” or “never start selling” claim where the only “alternative” is a different product or, worse, a completely different medical procedure not utilizing that sort of product at all.

Since then, we’ve written about alternative designs several other times, but never comprehensively.

Today, we’re doing something a little different. We’re examining whether an alternative design is also an element of a design-related claim sounding in negligence.  As the rest of this post demonstrates, the overwhelming weight of nationwide precedent established that negligent design claims require the plaintiff to establish the existence of a feasible alternative design the would have prevented the plaintiff’s injuries.

We touched upon the alternative design issue somewhat in our post excoriating the Pennsylvania Supreme Court’s bizarre opinion in Lance v. Wyeth, 85 A.3d 434 (Pa. 2014). Lance put the rabbit in the hat and held, for a product allegedly:  (1) “too dangerous to be used by anyone,” and (2) that had been removed from the market by the FDA, a negligent design case could be stated even though the plaintiff didn’t even attempt to prove an alternative design. Id. at 458-60.  What Lance adopted, of course, was a pure “stop selling” claim of the sort preempted under Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013).  “[W]e are convinced that a manufacturer or supplier has a duty to cease further distribution of a product . . . [that] is too dangerous to be used by anyone.” Lance, 85 A.3d at 460.

Generally, in Pennsylvania, negligent design cases have required proof of alternative designs, except in the limited Lance recalled product situation.  “The determination of whether a product was negligently designed turns on whether an alternative, feasible, safer design would have lessened or eliminated the injury plaintiff suffered.”  Berrier v. Simplicity Manufacturing, Inc., 563 F.3d 38, 64 (3d Cir. 2009) (emphasis original). See, e.g., Kosmack v. Jones, 807 A.2d 927, 931 (Pa. Commw. 2002) (“a plaintiff bears the burden of establishing that there is an alternative design” in negligent design defect cases); Smith v. Yamaha Motor Corp., 5 A.3d 314, 322-23 (Pa. Super. 2010) (requiring proof of alternative design for all-terrain vehicle).

Continue Reading On Alternative Design, Take Two − Negligence

Ponder the following:  A man attends an exercise class at a facility run by a local religious institution.  Assume that he belonged to this facility, wanted to attend an exercise class because his fitness was less than optimal, and was informed of the need to get medical advice before starting a new and potentially demanding exercise program.  He had a heart attack and collapsed right after leaving the class.  Assume that the heart attack was not a total surprise given his health, but that he had not had a heart attack before and had not informed the people running the class of any particular risk.  The class instructor rushed to the man’s aid while others called 911.  The instructor was certified in cardiopulmonary resuscitation (“CPR”) and did her best to help the man.  When paramedics arrived, they assumed care of the man, but he died despite their best efforts.

Based on these facts and assumptions, answer this question:

Who should the man’s estate sue over his death?

A) Nobody.  B) The class instructor.  C) The religious institution.  D) The entities that operate the 911/EMT system.

If you answered other than “A,” then you might need to examine your propensity to blame others.

Add in the following to the scenario presented above:  The class instructor tending to the man did not utilize an automated external defibrillator (“AED”) that she knew was present and was certified in using.  She brought the AED to the man’s side, but elected not to use it because, in her judgment, he was having a seizure and not a heart attack.

Based on these additional facts, answer these questions:

1.  Who should the man’s estate sue over his death?

A) Nobody.  B) The class instructor.  C) The religious institution.  D) The entities that operate the 911/EMT system.  E) The company that sold the AED and offered training to purchasers.

2.  If the man’s estate already sued the religious institution over his death, who should the defendant bring in via third-party complaint?

A)  Nobody.  B)  The class instructor.  C) The entities that operate the 911/EMT system.  D) The company that sold the AED and offered training to purchasers.

In Wallis v. Brainerd Baptist Church, No. E2015-01827-SC-R11-CV, 2016 Tenn. LEXIS 920 (Tenn. Dec. 22, 2016), the estate sued the church that ran the gym and then both turned their attention to the seller of the medical device that was not used.  It is often said that bad cases make bad law, but sometimes egregiously over-reaching cases can make good law.  Ultimately, Wallis fits into the latter category.  A contrary result, which would have allowed a negligence or contract claim against the seller of a device that was not used with the decedent, would have been bad, maybe bad enough to have been mentioned in our bottom ten post last week.

Continue Reading Decision Limiting Duties regarding Automated External Defibrillators Does Not Shock The Conscience