Contrary to [plaintiff’s] assertions, the affidavit of [an expert], attesting to what a “reasonable doctor” would have done had a different warning been supplied is insufficient evidence to create a material issue of fact and satisfy her burden on proximate causation. As [the law] makes clear, the evidence required to establish a reasonable likelihood is evidence that the learned intermediary. . ., and only [him], would provide to the effect that he . . . would have altered his behavior. Accordingly, an affidavit or testimony of [an expert] as to what a “reasonable doctor” would have done with appropriate knowledge is not admissible, is irrelevant and is contrary to the legal standard long established.
Friday, January 04, 2013
Asbestos Causation Tactics And Pharmaceutical Litigation
The recent magistrate’s decision in Fecho v. Eli Lilly & Co., 2012 WL 6681895 (Mag. D. Mass. Dec. 21, 2012) (“Fecho II”), isn’t good, but it could have been far worse. While the decision stretches prescription drug warning causation to the breaking point, at least it didn’t do what the plaintiffs sought, which was the wholesale importation of asbestos-style tactics of proving causation into drug litigation. Still, to escape summary judgment required unprecedented application of both the Federal Rules of Evidence and Pennsylvania law (although not the law ordinarily applied in product liability cases).
Gronniger, 2005 WL 3766685, at *5; accord Anderson, 2005 WL 1383174, at *5-6; Leffler, 2005 WL 2999712, at *5. Law across the country similarly rejects the substitition of "reasonable" physician" expert testimony for the missing testimony of the actual prescriber, as we previously discussed in some detail here. Paradoxically, Fecho II allowed lay testimony to accomplish what expert testimony has repeatedly prohibited from doing – the substitution of a hazy general standard of care for prescriber-specific causation evidence.
Here’s what went on. Fecho is a testament to old litigation not dying, but spreading to different injury allegations. Fecho involves DES. That’s right old-fashioned diethylstilbestrol – prohibited from use in pregnant women by the FDA since 1971. As everyone in our line of work knows, DES is linked to a rare type of cancer in young women exposed in utero – a cancer that developed around the time of puberty.
That development, of course, brought about a wave of litigation over events that happened – due to the delay in cancer development – between one and three decades earlier. Because DES was never patented, many DES plaintiffs could not determine who made the drug they were exposed to. That proof problem led pro-plaintiff courts in the 1980s to invent “market share liability,” which all in all was probably the radical and ill-conceived expansion of tort liability of our legal lifetimes. Fortunately, most states didn’t adopt it.
But time passes, and with the youngest of the so-called “DES daughters” now over 40, one would expect the statute of limitations finally to put this litigation to bed – NOT!
Rather than finding something else to sue over, plaintiffs (some of them, anyway) are now claiming that the same in utero exposure to DES causes breast cancer. Unlike the DES litigation of the 1980s and 1990s, the medical causation science for this new theory isn’t very good, being limited to a couple of studies that plaintiffs’ experts have to massage thoroughly in order to discover any statistically significant increase in any “cohort.” See Fecho v. Eli Lilly & Co., 2012 WL 194419, at *2 (Mag. D. Mass. Jan. 20, 2012) (expert found statistical significance in one “subset” of first study that “could be characterized as too thin” only after “control[ing] for” unspecified “confounding factors”); id. (second study had an even “smaller hazard ratio,” so the expert “discounted an excess risk calculation in preference for a proportionate hazards model”) (“Fecho I”). Not only that, but there’s no distinction between purported DES breast cancer and any other breast cancer. Id. (“temporal relationship between the exposure and the development of the disease . . . tracks the natural age at which breast cancer typically appears”). In short, DES breast cancer litigation not only has all the causation problems of earlier DES litigation, but junk medical causation science has replaced the prior “signature disease.”
But still some courts insist on bending the rules for these plaintiffs. Bad DES cases can still make bad law.
Which leads us back to Fecho II. The same magistrate judge who let plaintiffs slide on medical causation in Fecho I also let them slide on warning causation – that is, the requirement that the plaintiffs prove that a different warning would have changed the prescribing physician’s decision to prescribe the drug.
Predictably, the plaintiff attempted to invoke the heeding presumption, arguing that (as with market share liability) the burden of proving causation should be shifted to the defendant. However, the prescription and everything else concerning plaintiff’s exposure to DES occurred in Pennsylvania. That didn’t stop the plaintiff, however. She claimed that Pennsylvania would recognize a heeding presumption, relying on asbestos cases. Fecho II, 2012 WL 6681895, at *12.
Fortunately for our side, abundant Pennsylvania precedent has rejected the heeding presumption in product liability litigation involving consumer goods such as prescription medical products. See Daniel v. Wyeth Pharmaceuticals, Inc., 15 A.3d 909, 923-24 (Pa. Super.) (“in failure to warn cases involving prescription medications . . . the plaintiff must establish that if defendant “had issued a proper warning to the learned intermediary, he would have altered his behavior and the injury would have been avoided”), appeal granted on other grounds, 32 A.3d 1260 (Pa. 2011); Simon v. Wyeth Pharmaceuticals, Inc., 989 A.2d 356, 368 (Pa. Super. 2009) (same; quoted in Daniel); Lineberger v. Wyeth, 894 A.2d 141, 145, 149-50 (Pa. Super. 2006) (rejecting heeding presumption in prescription drug case; presumption limited to products involuntarily encountered in the course of a plaintiff’s employment); Viguers v. Philip Morris USA, Inc., 837 A.2d 534, 537-538 (Pa. Super. 2004) (heeding presumption warranted only as to products that a plaintiff had no choice but to use), aff’d without opinion, 881 A.2d 1262 (Pa. 2005); Demmler v. SmithKline Beecham Corp., 671 A.2d 1151, 1155 (Pa. Super. 1996) (“proximate cause is not presumed” in prescription medical product cases). See also Gronniger v. American Home Products Corp., 2005 WL 3766685, at *5 (Pa. C.P. Philadelphia Co. Oct. 21, 2005); Leffler v. American Home Products Corp., 2005 WL 2999712, at *5 (Pa. C.P. Philadelphia Co. Oct. 20, 2005); Adams v. Wyeth, 74 Pa. D. & C.4th 500, 511-12 (Pa. C.P. Philadelphia Co. 2005); Berry v. Wyeth, 2005 WL 1431742, at *7 (Pa. C.P. Philadelphia Co. June 13, 2005); Anderson v. Wyeth, 2005 WL 1383174, at *6 (Pa. C.P. Philadelphia Co. June 7, 2005) – all holding that the heeding presumption is limited to strict liability and that Pennsylvania bars use of strict liability in prescription medical product litigation. Thus, Fecho II flatly rejected application of the heeding presumption to a Pennsylvania prescription medical product liability case:
Plaintiffs’ reasoning is misplaced because in prescription drug cases the manufacturer’s duty to warn goes to the learned intermediary, the physician, not to the patient. The physician has the choice of whether to prescribe a drug after weighing the data and warnings supplied by the manufacturer against his patient’s medical history and taking into account other relevant concerns. In asbestos failure to warn cases, there is no learned intermediary exercising his independent medical judgment. . . . [T]his case involves a negligent failure to warn claim under section 388 against the manufacturer of a prescription drug. . . . [P]roximate cause remains an essential element in failure to warn cases involving prescription medications. . . . [I]n the context of a negligence duty to warn claim, plaintiffs must further establish proximate causation by showing that had defendant issued a proper warning to the learned intermediary, he would have altered his behavior and the injury would have been avoided.
2012 WL 6681895, at *13-14 (citations and quotation marks omitted). So we like ther part of Fecho II that correctly applied Pennsylvania law and roundly rejected any heeding presumption in prescription medical product litigation.
The bad part is the opinion’s extremely lax view of causation evidence. It’s now 2013. That’s 40+ years after any pregnancy-related prescription of DES would have occurred. The prescriber in this case (a Dr. Bonacci in Hazleton, Pennsylvania) was dead, as many prescribers in litigation over forty-year-old events will be.
Thus, the plaintiffs resorted to asbestos-style “proof” of causation involving long-ago events. Having no direct evidence of what Dr. Bonacci would or would not have done, they offered affidavits from another doctor who claimed to know Dr. Bonacci, and two of Dr. Bonacci’s former patients. Fecho II, 2012 WL 6681895, at *1. This other doctor was offered as providing “lay opinions” about what Dr. Bonacci’s warning practices were. Id. at *7. All this indirect testimony strikes us as eerily reminiscent of the type of circumstantial co-worker causation testimony that has run all too rampant in asbestos litigation.
The two patient witnesses fortunately got nowhere – so that part of Fecho II is good, too. All they could offer were their recollections of Dr. Bonacci’s prescribing practices for them. That wasn’t near enough to establish “habit” evidence under Fed. R. Evid. 406:
The testimony of two of Dr. Bonacci’s former patients . . . falls significantly short of the requisite number of instances and uniformity of response from which to establish Dr. Bonacci’s prescribing practices. [The patients] were Dr. Bonacci's patients for a lengthy period of time. Dr. Bonacci . . . had significantly more than two patients to whom he prescribed medication. The instances of prescribing medications to [two patients] are therefore not numerous enough to support a finding of habitual conduct.
2012 WL 6681895, at *6.
The other doctor claimed familiarity with the prescriber’s practices from “monthly staff meetings” at “two local hospitals” and from collaborating in the treatment of patients “referred” by Dr. Bonacci Id. at *2. But:
[The witness] did not treat patients in Dr. Bonacci’s office. He never attended any of the house calls Dr. Bonacci made and he never shared an office with Dr. Bonacci. [The witness], a general surgeon, did not practice medicine with Dr. Bonacci, a family practitioner. . . . [The witness] does not recall talking to Dr. Bonacci about DES. . . . [The witness] never witnessed Dr. Bonacci warn a patient about side effects of a medication let alone the side effects of DES. He never saw Dr. Bonacci inform a patient of risks or side effects contained in a manufacturer’s label for a drug. He therefore did not have first hand knowledge of Dr. Bonacci’s prescribing practices of heeding a manufacturer’s negative warnings and not prescribing a medication or informing a patient of side effects, if any, of a medication he was prescribing.
Id. at *2-3. That’s also pretty poor, we’d have to say – that might not even hack it in an asbestos case. But, in the absence of any specific knowledge, the witness went about transforming himself into a character witness, further testifying:
Dr. Bonacci’s character as being conservative, very compassionate and almost anal retentive as far as the care of his patients was concerned. And his patients always came first. And I am sure that if he read any warning on any drug, if he thought it was bad enough, he certainly would not dispense it, because that’s the type of individual he was.
Id. at *3. This other doctor claimed that “Dr. Bonacci’s ‘custom and habit’ was not to ‘prescribe any drug if it came with a warning similar to’ the warning attached to [the witness’] affidavit.” Id.
This character testimony, however, was inadmissible under Fed. R. Evid. 404(a). “Insofar as plaintiffs seek to rely on this evidence to establish Dr. Bonacci’s conduct on the particular occasions that he prescribed DES to plaintiffs’ mother, Rule 404(a) does not permit it. Fecho II, 2012 WL 6681895, at *5.
But the plaintiffs got away with essentially the same thing under Fed. R. Evid. 406. In an apparently unprecedented move (citing only “commentators”), Fecho II allowed “habit” evidence to be established by lay opinion testimony, and then construed the witnesses’ pathetically poor observations about the prescriber’s habits as, instead, being lay opinion testimony about the standard of medical practice (in following warnings) in the relevant area (Northeast Pennsylvania) at the relevant time (1950s):
For previously stated reasons, [the witness] lacks firsthand knowledge of Dr. Bonacci’s prescribing practices. Accordingly, there is an inadequate foundation under Rule 701(a) to consider [the] opinion that Dr. Bonacci would not have prescribed DES if it contained a warning similar to the one attached to [the witness’] affidavit.
Fecho II, 2012 WL 6681895, at *8. So even the doctor's "habit" testimony failed.
BUT – and it’s a big BUT….
Turning to the existence of the requisite knowledge under Rule 701(a) as a basis to consider [the witness’] opinion about standard medical practice in the Hazleton area, he practiced medicine as a surgeon in the area from 1956 to 1986. He is intimately familiar with the small community of doctors. . . . He therefore has the requisite knowledge within the meaning of Rule 701(a). The opinion is helpful to determine the proximate cause issue. . . . The opinion could therefore be admissible to show the practice of the small group of doctors in the local community allowing the jury to infer the practice of Dr. Bonacci.
Id. at *9.
Thus, in the end:
A lay witness, opines that the standard medical practice in Hazleton in and around the mid to late 1950s was for doctors to pass warnings from manufacturers of prescription drugs to their patients. Drawing reasonable inferences, Dr. Bonacci, a busy and therefore well known family physician in the area, adhered to this standard medical practice in Hazleton.
Id. at *14. We cannot lie – we hate this kind of big buts.
So asbestos-style indirect proof of causation ultimately defeats summary judgment, even though plaintiffs lost on the law and on about three-quarters of the factual/evidentiary issues in Fecho II. It took an unprecedented importation of lay opinion testimony into Rule 406 to bring about this result. Still, we think it’s wrong. We’re Pennsylvania practitioners, and we can’t think of any case in which a Pennsylvania court has allowed non-expert evidence to establish the medical standard of care. In the first place, a statute requires not only expert testimony as to the standard of care, but expert testimony from the “same subspecialty.” 40 Pa. Stat. §1303.512(c)(3). Granted, this statute is limited to medical malpractice actions, but the common law has likewise required expert – not lay – opinion testimony as to the medical standard of care in every case we know about.
Expert testimony is necessary to establish negligent practice in any profession. As plaintiff failed to offer any expert witness to establish the measure of professional skill . . ., she did not meet the burden of establishing, by the weight of the evidence, that defendant failed to treat her with reasonable and ordinary professional skill. The record discloses no testimony as to the standard of care required under the circumstances and such burden was therefore not met by plaintiff.
Powell v. Risser, 99 A.2d 454, 456-57 (Pa. 1953). And more recently…. “Because the negligence of a physician encompasses matters not within the ordinary knowledge and experience of laypersons a medical malpractice plaintiff must present expert testimony to establish the applicable standard of care.” Toogood v. Rogal, 824 A.2d 1140, 1146 (Pa. 2003). “To satisfy his burden of proving [physicians] negligent . . . [plaintiff] must introduce expert testimony to show that appellee physicians’ conduct varied from accepted medical practice.” Brannan v. Lankenau Hospital, 417 A.2d 196, 199 (Pa. 1980). We’ve limited our search to the Pennsylvania Supreme Court. Other cases, too numerous to name, make the same point under Pennsylvania law.
That's not all (although it should be quite sufficient). It's also been decided under Pennsylvania law that even expert testimony is ineffective in a learned intermediary case to establish what a "reasonable physician" - as opposed to the prescriber him or herself - would have done. You'll see a lot of the same case names:
In short, we think that Fecho II, in allowing lay – not expert – testimony to establish the medical standard of care, was wrongly decided. Fecho II uses Fed. R. Evid. 701 in a novel fashion to evade the longstanding requirement of Pennsylvania law that a professional standard of care (absent obviousness, which wasn’t an issue in the case) can only be established through the testimony of an expert witness. Nor may a general standard of care fill an evidentiary vaccum created by a prescriber's unavailability. Because, in a learned intermediary rule case, the actor is by definition a professional subject to a professional standard of care, asbestos-type methods of inferring causation through lay testimony have no place. We hope that these misapplications of both Pennsylvania law and the Federal Rules of Evidence is short-lived.