A very recent decision from the Fosamax litigation illustrates a causation principle that’s essential to keeping warning claims from spinning totally out of control. That principle is that there’s no claim for inadequate warnings except as to the risk that the plaintiff is suing over. Seems sort of basic, but every so often a case comes along that reminds us why this principle is important.

In Boles v. Merck & Co., 1:06-MD-1789-JFK, slip op. (S.D.N.Y. March 26, 2010), the court had earlier denied summary judgment on learned intermediary warning causation (i.e., that a different warning would have resulted in the prescriber not prescribing the drug) where plaintiff obtained an affidavit from the prescriber that he had not been warned of the relevant risk (osteonecrosis of the jaw, or “ONJ”), and that this may have affected his prescribing decision. See In re Fosamax Products Liability Litigation, 647 F. Supp. 2d 265, 282 (S.D.N.Y. 2009).

Anyway, now fast-forward to trial.  In a stark reminder not to trust the affidavits that plaintiffs’ counsel stick under the noses of prescribing physicians – the good doctor’s actual testimony diverged significantly from what was in that affidavit. Boles, slip op. at 10-11. The jury hung, and the court revisited the significance of the prescriber’s causation testimony in the context of a Rule 50 motion for judgment as a matter of law.

Here’s what happened.  The prescribing physician testified that while he wouldn’t prescribe Fosamax for the plaintiff, his reasons had nothing to do with ONJ, the only injury that the plaintiff was claiming. Rather, the prescriber had issues with the effectiveness of the drug for the use he had prescribed it:

At trial, [the prescriber] testified that he would not have prescribed Fosamax to Plaintiff had he known the complete truth regarding Fosamax’s efficacy. He explained that he believes Plaintiff, who had a T-score of -2.1 at the time he prescribed her Fosamax, received no benefit from the drug based on reports and studies that evidence that Fosamax has no fracture reduction efficacy in patients with T-scores better than -2.5. Based on the lack of perceived benefit, he would not have prescribed her Fosamax.

Slip op. at 10 (emphasis added). In other words, the prescriber didn’t think that the drug would benefit plaintiff as a treatment for osteoporosis. “[I]t wouldn’t have done any good. And it’s expensive.” Id. (quoting prescriber’s testimony).

Plaintiff, however, was not suing over broken bones. She didn’t have any. Assuming arguendo (that is, solely for the purposes of argument – we lawyers like to do that a lot) that the drug was no better than a glass of tap water as a treatment for osteoporosis (the reason it was prescribed), this plaintiff did not suffer any injury due to that condition.

The only injury she claimed was ONJ, and the prescribing physician did not testify that the risk of ONJ factored into his decision-making.

That turn of events left the plaintiff trying to contend that she could prove proximate causation based upon failure to warn of “the whole truth regarding [the drug]. . .both its risks and efficacy.” Slip op. at 11.  In other words, the plaintiff claimed in Boles that failure to warn about anything at all, regardless of whether it personally affected the plaintiff, could establish proximate cause in a failure to warn case.  We’re not making this up, the Boles opinion quotes plaintiff’s brief as asserting that she could establish causation based upon “any potential risk, be it a risk of harm [plaintiff] suffered or not.”  Id. at 12.

For very good reasons, the court in Boles tossed that particular warning argument out on its ear.

That a prescriber would not use a drug based on efficacy did not provide a causal link to injuries unrelated to that claimed ineffectiveness:

Plaintiff cannot save her claim by recasting it as one seeking relief for a failure to warn of both the risks and limitations of the efficacy of [the drug]. . . .  [P]laintiffs alleging a failure to warn. . .must establish that the inadequate warning was in regard to a risk or danger associated with the product. To allow Plaintiff to pursue a claim for the “failure to warn” of the efficacy of a drug would be an expansion of liability. . . .

. . .Plaintiff cannot establish proximate cause without evidence that Merck’s failure to warn of the specific risk that allegedly materialized to cause Plaintiff’s injury affected her treating physician’s course of treatment. The trial was completely devoid of such evidence and therefore Plaintiff’s failure to warn claims fail as a matter of law.

Slip op. at 12-14 (citations with long parentheticals omitted) (emphasis original).

If you’ve ever looked at the label of a prescription drug, you know that they almost always have multiple risks.  Quite often they have multiple benefits as well.  Just imagine what a prescription drug product liability trial would look like if courts trying warning claims declared open season on any aspect of drug labeling, no matter how far removed it was from the injuries that any particular plaintiff was claiming.  Plaintiffs who allege that they suffered from migraine headaches would be claiming they wouldn’t have taken a drug if their prescribers had been adequately warned about cancer.  If every risk or lack of benefit of a drug were suddenly rendered relevant to proximate cause, plaintiffs would jump at the opportunity to dump every conceivable problem a drug might have on juries.

Fortunately, the decision in Boles – while construing only the law of Florida – is in accord with the positions taken by both courts and commentators nationwide. It is axiomatic that “the injury suffered [by a plaintiff] must be within the class of injury that the warning requirement was meant to avoid.” Dan B. Dobbs, The Law of Torts, at 1018 (2001). The key consideration is one of proximate cause:

For example, the plaintiff, if properly warned that asbestos might cause cancer, might have ceased to work around asbestos. . . . But the failure to provide such warning would not result in liability if the plaintiff, not being warned, kept her job and lost a hand in a job-related machine accident. In that example, failure to warn would be a cause in fact. . .but it is not a proximate legal cause. It is not, in other words, within the risk that a warning was designed to avoid.

Id. (emphasis added).

For reasons we can’t explain, this issue tended to come up first in litigation against the government concerning vaccines.  In Mills v. United States, 764 F.2d 373 (5th Cir. 1985), the plaintiff suffered an anaphylactic reaction.  Because the vaccine’s warnings thoroughly addressed anaphylaxis, the plaintiff also argued that the warnings were inadequate with respect to other stuff – transverse myelitis and Guillain-Barre syndrome.  The court essentially held, “so what?”  The plaintiff didn’t have those injuries, so those aspects of the warnings were irrelevant.

The question of the adequacy of the warnings must be confined to consideration of whether the warnings were sufficient to inform the plaintiff of the risk of the particular condition or disease which allegedly caused his injury or death. . . .  [A] determination that warnings were inadequate with respect to some other condition does not bear on our conclusion that [plaintiff] was adequately informed of the risk of severe allergic reaction to the swine flu vaccine.

Id. at 379.

Similarly, in Novak v. United States, 865 F.2d 718 (6th Cir. 1989), the plaintiff ran into a scientific brick wall, since there was no research anywhere (and still isn’t) that a vaccine could cause dermatomyositis.  So the plaintiff claimed (and the district court allowed it) that the vaccine should have given better warnings regarding viral encephalitis – a condition the plaintiff did not have, and could not tie to what he did have:

There was, therefore, no reason for the defendant to make the references deemed important or vital by the district court, and there was no duty on the part of the defendant to warn about any of these conditions. Particularly, the district court erred in finding the warning inadequate, negligent, and insufficient because it did not specifically caution those who may have experienced “viral encephalitis.” It was not proven that Mr. Novak had actually suffered from viral encephalitis. . . .

Id. at 726.

In Eck v. Parke, Davis & Co., 256 F.3d 1013 (10th Cir. 2001), the plaintiff claimed that the prescriber “would have read and heeded a warning” not to prescribe two drugs, Dilantin and Isocet, at the same time.  Id. at 1020.  Only trouble was, the prescriber never did that – the second drug was prescribed later by somebody else.  Result:  no causation as a matter of law:

[I]t is undisputed that [plaintiff] did not ingest the Isocet concomitantly with Dilantin until April 1997, when his prescribing physician was [somebody else].  There was no concomitant use of the drugs when Isocet was originally prescribed. . . .  That [the first prescriber] might have heeded a warning. . .about possible adverse effects were he to prescribe Isocet to [plaintiff] in 1997 is of no significance given the facts before us.

Id.

The Plaintiff in Stahl v. Novartis Pharmaceuticals Corp., 2000 WL 33915848 (E.D. La. Nov. 29, 2000), aff’d, 283 F.3d. 254 (5th Cir. 2002), was frustrated by the fact that their prescriber knew all about Lamasil’s alleged risks of liver pathology and skin reactions.  Id. at *4.  Thus, plaintiff alleged all sorts of more serious injuries that he didn’t have.  Sorry, Charlie:

[T]his Court is unpersuaded by Stahl’s complaints that the warnings did not warn of death, liver failure, and the need for transplant. Stahl has not suffered any of those injuries and is, therefore, precluded from imposing a duty to warn regarding those injuries not suffered. . . .  [A] claimant cannot seek to impose a duty to warn on a manufacturer of damage not sustained.

Id. (citation and quotation marks omitted).

Nor was Fosamax the first MDL in which plaintiffs had taken this extreme position.  In the Norplant litigation, the plaintiffs sought to introduce evidence of product risks they didn’t claim for themselves, forcing defendants to file a motion “that the adequacy of warnings concerning injuries not alleged are not relevant and therefore not admissible.” In re Norplant Contraceptive Products Liability Litigation, 1997 WL 81094, at *1 (E.D. Tex. Feb. 21, 1997). Following Mills, the court granted the motion:

[I]n keeping with Mills, the court finds that whether the Norplant physician warnings were not adequate with respect to an injury not alleged is not relevant to whether physicians were adequately warned of Plaintiffs’ alleged injuries.  Additionally, even if relevant, the court finds that any probative value is substantially outweighed by the danger of unfair prejudice, confusion of the issues, and misleading the jury.

1997 WL 81094, at *1.

Essentially the same thing happened in breast implant litigation.  In Greiner v. Medical Engineering Corp., 99 F. Supp.2d 759 (W.D. La. 2000), aff’d, 243 F.3d 200 (5th Cir. 2001), the plaintiff alleged injury from encapsulation but the inconvenient fact was that the warnings were adequate on that score – so she also alleged inadequate warning of “rupture.”  She fared no better because her implants never ruptured.

This Court notes that Plaintiffs specifically cite “rupture” of the implant as an injury sustained by Mary Grenier.  A claimant cannot seek to impose a duty to warn on a manufacturer of damage not sustained.

Id. at 766.

Similarly, in the Rezulin MDL, a bunch of plaintiffs claimed “dizziness” and other minor injuries that were all “identified as a potential side effect” in the drug’s labeling.  In re Rezulin Products Liability Litigation, 2004 WL 1802960 (S.D.N.Y. Aug. 13, 2004), vacated on other grounds, 2004 WL 2009445 (S.D.N.Y. Sept. 8, 2004) (converting partial summary judgment to full summary judgment as to one plaintiff).  Seeking to avoid dismissal, these plaintiffs alleged inadequate warning of liver toxicity – which none of them had.  The court found that claim “quite beside the point.”  Id. at *2.  Warning claims were limited to risks that plaintiffs actually had:

[T]hese plaintiffs do not claim to have suffered any liver injury.  Their physicians were warned of the risks of the conditions of which they do complain.  The fact that there may have been a breach of the duty to warn of liver toxicity for which patients suffering from liver dysfunction may recover  does not avail these plaintiffs.

Id. at *3.

It’s not just federal courts, either. State courts impose much the same limitations. Like practically everything else, this issue also came up in the Bone Screw litigation.  Throwing in the kitchen sink, the plaintiffs’ expert in King v. Danek Medical, Inc., 37 S.W.3d 429 (Tenn. App. 2000), alleged that bone screws could cause osteoporosis, and the defendants didn’t warn about that.  However, as neither of the plaintiffs claimed to have osteoporosis, the court ruled fuggedaboudit:

[Plaintiffs’ expert] did not attempt to testify that either [plaintiff] developed osteoporosis as the result of their implants. In fact, as to the products of these defendants, [the expert] stated:

Q. And you’re not here to render an opinion that any of the systems manufactured by [defendants] have caused osteoporosis. Is that correct?

A. That’s correct.

The theoretical possibility that some [products] of other manufacturers can cause various bone problems, without proof that it occurred to these plaintiffs because of the products of these defendants, cannot defeat summary judgment.

Id. at 446-47.

The New York Court of Appeals grappled with this same question in Martin v. Hacker, 628 N.E.2d 1308 (N.Y. 1993), where the plaintiff argued that the drug should have been contraindicated due to suicide risk for patients with a history of depression.  The problem was, this particular plaintiff has no history of depression. As a result, that part of the plaintiff’s went out the window:

Since it is undisputed that [plaintiff] had no history of mental depression, we are not concerned with the adequacy of the Contraindications section of the insert (see, McFadden, supra, 86 A.D.2d at 762, 448 N.Y.S.2d 79).

628 N.E.2d at 1313. The McFadden cite in Martin is critical to understanding what went on.  McFadden v. Haritatos, 448 N.Y.S.2d 79 (N.Y.A.D. 1982), held, in a factually identical case:  “Since there was no showing that when plaintiff began taking [the same drug] he suffered from mental depression or had a history of that condition, the “CONTRAINDICATIONS” and “WARNINGS” sections are not applicable to plaintiff.”  Id. at 81.

Similarly, in Peterson v. Parke Davis & Co., 705 P.2d 1001 (Colo. App. 1985), the court refused to require a jury instruction that a defendant had a duty to warn about every drug risk under the sun:

[T]he request for an instruction that [defendant] had a duty to warn of all known dangers was properly denied. In a failure to warn case, the plaintiff has the burden of proving that the manufacturer gave inadequate warning of the danger which caused the injury.

Id. at 1004.

Here in Pennsylvania the issue has come up in a couple of mass torts.  In a breast implant case, the plaintiffs claimed that they could recover for inadequately conveyed warnings, even thought the allegedly undisclosed risk never happened to them.  The court found that the potential import of such liability was too broad to be permitted:

If I accept plaintiffs’ argument, the law will be permitting recovery for a risk that the plaintiff assumed because the plaintiff might have made a different decision as a result of knowing of other risks for which the plaintiff did not experience any harm.

In re Silicone Breast Implant Litigation, 64 D. & C. 4th 21, 25-26 (C.P. Allegheny Co. 2003).  To allow liability based upon undisclosed risks that never happened to a plaintiff “would have a reach that extends far beyond the purposes for the [duty to warn] doctrine.”  Id. at 26.

And in fen-phen litigation, plaintiffs alleging primary pulmonary hypertension (“PPH”) have been precluded from arguing that better warnings about valvular heart disease (“VHD”) would have made a difference – and vice versa – in cases where their physicians testify that they would not have been deterred by better warnings about the injuries those plaintiffs actually had:

Warning claims based upon risks that plaintiffs did not suffer have been routinely precluded by the judges of this Court in the Fen-Phen litigation, as Judge Tereshko recently pointed out:

Plaintiffs have failed, however, to present any Pennsylvania case law suggesting they should be able to proceed under this theory of liability.  This Court has previously held that the only warnings properly at issue in a failure to warn case are those relating to the condition to which the plaintiff alleges to have suffered.  See Order dated Nov. 6, 2001, Tereshko, J., P.C.C.P., May Term 1999, No. 0001 (Granting Defendant Servier’s Global Motion to preclude any evidence related to PPH where plaintiffs only damages were the result of VHD).  Just as evidence regarding PPH is irrelevant to a plaintiff who suffers from VHD, so too is evidence of Defendant’s failure to warn of VHD irrelevant to Owen’s alleged injuries related to PPH.

Owens v. Wyeth, 2009 WL 3244890 (C.P. Phila. Co. Aug. 17, 2009).

The lesson to be learned from Boles and all these other cases is quite simple.  Product liability trials are not supposed to be three-ringed circuses.  One-ringed circuses, maybe, but not open-ended inquiries into every “bad thing” that could possibly be said about a drug.  The law is clear that only warnings relevant to a risk that the plaintiff actually suffered factor into whether the plaintiff has proven adequacy or causation in a failure to warn case.  Don’t let them get away with anything more.