Thursday, September 11, 2008

Holding The Line On The Duty To Warn

Having been in this business (defending pharmaceutical product liability) for a long time now, we’ve learned that what happens to prescribing doctors often comes back to haunt our clients. Nowhere is that better illustrated than with the thankfully discredited theory of regulatory informed consent, which since we’ve already discussed it, here, we won’t go into again in any depth.

You can stop cheering now.

That theory – that the docs had to tell their patients about off-label use – was ginned up for the sole purpose of inducing prescribers to turn around and point the finger at our clients for supposedly encouraging the off-label use in the first place.

We ended up learning more about the law of informed consent than we had ever hoped (or feared) was possible. But Herrmann won that issue when it first arose in the Ohio state court system, and Bexis got cited by the U.S. Supreme Court, so it sort of evened out.

From that experience, and others, we’ve learned to keep up, at least generally, on what’s happening in medical malpractice litigation. If some new theory comes along, and the plaintiffs start hammering the docs with it, sooner or later the plaintiffs (and maybe the docs) are going to turn around and try out their new favorite toy on us.

Just what we need.

And that’s exactly what happened last week in Gourdine v. Crews, ___ A.2d ___, 2008 WL 4068177 (Md. Sept. 4, 2008) (PDF copy here). Thankfully the Court of Appeals of Maryland (which we’ll call the “Supreme Court” from now on because it’s less confusing to everyone not steeped in Maryland terminology) was having none of the new, expansive theory that the plaintiffs were peddling. If plaintiffs had gotten their way, pharmaceutical companies would have been liable, not just to the people who use their drugs, but potentially to anybody.

Here’s what went down in Gourdine. Defendant pharma company made a drug (or possibly a biologic) used by diabetics to maintain steady blood sugar levels. The drug – allegedly accompanied by defective warnings – was used by a patient who wasn’t the plaintiff. While driving a car, the patient lost consciousness, allegedly from low blood sugar. There was an accident, and in that accident the plaintiff’s decedent (who, again for simplicity’s sake, we’ll call “plaintiff”), who was the driver of the other car, was killed. Who gets sued? Why the deep-pocket pharma company, of course.

Now, the lower courts – admittedly in response to defense arguments – had taken the easy way out. They relied on the learned intermediary rule to hold that, because the defendant drug company had no duty to warn the patient directly, there obviously could be no broader duty to warn the public at large. See Gourdine v. Crews, 935 A.2d 1146, 1150 (Md. App. 2007), affirming, 2006 WL 5277412 (Md. Cir. June 28, 2006).

The Supreme Court, which had only recently addressed the rule (Rite Aid Corp. v. Levy-Gray, 894 A.2d 563, 579 (Md. 2006) (“we adopted the ‘learned intermediary’ doctrine”)), found some problems with dismissing the case on this rationale. There was a factual problem. The learned intermediary rule only applies to prescription drugs. Both prescription and OTC (“over the counter,” meaning no prescription required) versions of this particular drug existed. And of course there was a factual dispute as to which version the patient had been using. See 2008 WL 4068177, at *1 nn. 5-6. There was also a legal hurdle – the plaintiff had conceded that there was no duty to warn the patient directly, and essentially didn’t care how the information would be transmitted to the product-using driver. See Id. at *1 n.2. Therefore, the dispositive question, as most of the Supreme Court saw it, wasn’t the learned intermediary rule at all, but rather the general scope of the duty to warn in product liability. Id. at *10. Cf. Id. at *19-21 (concurring opinion would affirm dismissal of the claims under the learned intermediary rule).

Oh goodie. We don’t see many pure no-duty-at-all cases in our line of work.

The plaintiff made two arguments: First, she claimed that, because it was “foreseeable” that a user of a diabetes drug could lose consciousness while driving if improperly warned about a risk of low blood sugar, she had a claim in negligence. Second, she argued that because she was injured by somebody else’s use of the product, she had a claim for “bystander” product liability.

The Supreme Court thankfully disagreed with both these arguments. We say “thankfully” because, if either of them were adopted, prescription drug makers would be exposed to a whole new wave of liability to various and sundry non-product users. Plaintiff was arguing for liability to “members of the motoring public,” 2008 WL 4068177, at *6, and in every subsequent case a duty would allegedly be owed to some similarly broad and amorphous group of non-users.

As to foreseeability, the court held: (1) that negligence and strict liability weren’t all that different and shared “duty” as an essential element, id. at *9-10; and (2) that the scope of duty in both negligence and strict liability actions was narrower than mere foreseeability. Id. at *11-12. That’s good because, with 20-20 hindsight, essentially anything can be described as “foreseeable.” Rather, “[d]uty requires a close or direct effect of the tortfeasor’s conduct on the injured party.” Id. at *12. Duty was constrained by “policy” considerations:


As a practical matter, legal responsibility must be limited to those causes which are so closely connected with the result and of such significance that the law is justified in imposing liability. Some boundary must be set to liability for the consequences of any act, upon the basis of some social idea of justice or policy.

Id. (citation and quotation marks omitted).

This is where the medical malpractice cases come in. All over the country, plaintiffs have for years been trying to tag doctors with professional duties to persons who aren’t their patients. They had tried that in Maryland and lost, in a case called Dehn v. Edgecombe, 865 A.2d 603 (Md. 2005). A doctor who performed a failed vasectomy wasn’t liable as a matter of law to the pregnant wife of the patient. Of course the claimed injury was “foreseeable,” but that wasn’t enough. “Policy” intervened. The court in Dehn refused to extend malpractice liability beyond the physician/patient relationship to essentially anybody with whom a plaintiff might have sex. 865 A.2d at 615.

The same policy rationale can be applied to preclude a drug manufacturer from being liable to anybody whom a user of its drug might injure due to some behavior linked to the effects of the drug. And that’s basically why the court in Gourdine refused to impose liability:

In the case sub judice [a fancy way of saying "this case"], there was no direct connection between [the defendant drug manufacturer’s] warnings, or the alleged lack thereof, and [plaintiff’s] injury. In fact, there was no contact between [the defendant] and [plaintiff] whatsoever. To impose the requested duty. . .would expand traditional tort concepts beyond manageable bounds, because such duty could apply to all individuals who could have been affected by [the patient] after her ingestion of the drugs. Essentially, [defendant] would owe a duty to the world, an indeterminate class of people, for which we have resisted the establishment of duties of care.


2008 WL 4068177, at *14 (citation and quotation marks omitted).

So from us here at Drug and Device Law, here’s a heart-felt thanks to our colleagues in the medical malpractice defense bar for being at the point of the spear on this issue. There’s more linking our respective clients than just the learned intermediary rule.

Getting back to Gourdine, the court next addressed the “bystander” issue, something we’re accustomed to thinking of as more of a strict liability than a negligence concept. The court didn’t, though. It concluded that bystander liability, as well, was a matter of “foreseeability” limited by policy. The court found a meaningful policy limitation in the fact that, in all prior bystander cases, the product itself had directly caused the injury. 2008 WL 4068177, at *14. With prescription drugs, however, the claimed “bystander” neither took the drug nor read any drug warnings. Id. at *14-15. All the plaintiff could come back with was more non-patient malpractice cases – from jurisdictions that used pure foreseeability to determine duty. Id. at *15. After Dehn, those cases were inapposite. Id.

So a second expression of thanks is due. The malpractice bar plowed this furrow first, too – even though they didn’t know it at the time.

Because the plaintiffs were asserting novel theories of liability, there were other interesting issues floating around in Gourdine. There was a preemption question, which the Supreme Court didn’t reach. See 2008 WL 4068177, at *1 n.4. But for that reason, you’ll find the trial court decision in Gourdine on our drug preemption scorecard.

Another really interesting issue the court did discuss was the attempted assertion of a negligence per se claim based on alleged violations of the Food, Drug and Cosmetic Act (“FDCA”). We’ve blogged before on the many reasons we believe that FDCA-based negligence per se claims are bogus, and we’re pleased (and relieved) to report that the Maryland Supreme Court agrees with us, at least on some points.

One of the limitations on negligence per se is the requirement that the supposedly violated statute establish a “specific” duty. That’s because there’s no good reason to set aside the ordinary negligence standard for something that’s just as vague as the common-law concept of “reasonable care.” A related limitation is that the statute in question, to qualify for negligence per se, must evince an intent to protect some particular class of persons – not the general public as a whole. 2008 WL 4068177, at *17.

In Gourdine, since the plaintiff was asserting a warning based claim, she relied upon the following FDCA provisions and FDA regulations: 21 U.S.C. §331(a)-(b) (prohibiting “adulteration” and “misbranding”); 21 U.S.C. §352(a) (imposing “false or misleading in any particular” standard for misbranding); 21 C.F.R. §201.56(b) (“labeling shall be informative and accurate” and not “false or misleading in any particular”); 21 C.F.R. §201.57(f)(2) (specifying contents of labeling); 21 C.F.R. §202.1(e)(5)(ii)-(iii) (extending “false or misleading” standard to advertising; adding “fair balance” requirement).

When we look at that list, we sit up and take notice. The adulteration/misbranding sections have been the most commonly invoked basis for FDCA-based negligence per se.

Not in Maryland. The court held that none of these sections could support negligence per se because they were too general to constitute obligations owed to any group other than the general public:


These statutes and regulations, however, are framed to protect the public in general, and, as we have heretofore stated, a statutory obligation which runs to everyone in general and no one in particular cannot impose a duty between two parties.

2008 WL 4068177, at *18 (citation and quotation marks omitted).

So we can move Maryland into our list of jurisdictions hostile to FDCA-based negligence per se. If we win preemption in Levine, this could be pretty important in dealing with any "parallel violation" claims that escape preemption.

Finally, the plaintiff asserted a fraud claim. The court blew out that cause of action as well. Gourdine imposed a tight limitation on fraud claims that required direct dealings between the plaintiff and the defendant:

Clearly, in order to sustain a cause of action based on fraud or deceit, the defendant must have made a false representation to the person defrauded. . . . In the case sub judice, [the defendant drug manufacturer] did not owe a duty to [plaintiff]; moreover, [plaintiff] was not a party to the alleged misrepresentations made by [defendant] to [the patient]. As a result, the Circuit Court did not err in entering summary judgment.


2008 WL 4068177, at *19 (footnote omitted) (emphasis original). The omitted footnote rejected an argument that Maryland law should follow Restatement (Second) of Torts §310-311 and allow indirect fraud.

While there’s a bit of “the bold face giveth and the fine print taketh away” quality to this part of Gourdine, our clients now have an argument that, in a real learned intermediary case where there are no direct-to-patient communications, fraud claims will not lie.

So Gourdine is one of those cases that we want to describe as a “big win” until we ask ourselves why?

It’s only “big” in the sense that our side prevented the adoption of an utterly unprecedented and wildly expansive theory of liability. While the decision puts a roadblock in the way of the other side’s never-ending quest to hold everybody liable to anybody for everything, after Gourdine our clients are essentially no better off than where they started – they’re just not a whole lot worse off. Our side has enough to worry about with liability to people who actually use its products. Opening up liability to the general public would amount to imposing national health insurance by contingent fee.

So while we’re grateful for the ruling in Gourdine – and, in particular, that the bottom line was unanimous – at the end of the day, we have to say that the opposite result simply would be too awful to contemplate.

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