Friday, June 08, 2012

News Flash: Texas Adopts Learned Intermediary Rule; Rejects DTC Exception

In his role as amicus curiae for the Product Liability Advisory Council ("PLAC") Bexis is now two for two since moving to Reed Smith - of course that also means that somebody else is doing the really heavy lifting, in this case Randy Roach of Roach & Newton and Gene Williams and Manuel Lopez of Shook Hardy.  Today the Texas Supreme Court, in a landmark (there goes Bexis breaking his arm patting himself on the back again) 55-page unanimous decision, the Texas Supreme Court held the following:
(1) the learned intermediary doctrine generally applies within the context of the physician-patient relationship, and a prescription drug manufacturer fulfills its duty to warn its product’s end users by providing an adequate warning to the prescribing physician; (2) the [lower court] erred by adopting a DTC advertising exception to the doctrine; (3) the learned intermediary doctrine is not a common-law affirmative defense, but a common-law rule and its applicability was not waived by [defendant]; (4) [a] non-prescribing, treating physician, owed no duty to warn [plaintiffs] of the risks associated with [the drug] beyond the risks directly attributable to the infusion process; (5) because all of [plaintiff's] claims are premised on [defendant's] alleged failure to warn, the learned intermediary doctrine applies to all of their claims; and (6) [plaintiffs] failed to introduce any evidence that the allegedly inadequate warning was the producing cause of [plaintiffs'] purported injuries.

Centocor, Inc. v. Hamilton, No. 10-0223, slip op. at 55 (Tex. June 8, 2012).

Texas was the largest state (by far) lacking state supreme court precedent adopting the learned intermediary rule in prescription medical products (although several lower courts had done so).  Plaintiffs made it a pitched battle, and Bexis pitched in on the defense side through PLAC.  We rated the decision that the Texas Supreme Court just reversed, Centocor, Inc. v. Hamilton, 310 S.W.3d 476 (Tex. App. 2010), as the #4 worst decision of 2010.

So its Texas-sized party time here on the Drug and Device Law Blog.

First, the Texas Supreme Court ringingly endorsed the learned intermediary rule in Centocor:
Our decision to apply the learned intermediary doctrine in the context of prescription drugs, prescribed through a physician-patient relationship, not only comports with our prior references to the doctrine and many years of Texas case law, but it places us alongside the vast majority of other jurisdictions that have considered the issue.  Our sister states have overwhelmingly adopted the learned intermediary doctrine in this context. . . .  The underlying rationale for the validity of the learned intermediary doctrine remains just as viable today as stated by Judge Wisdom in 1974 [citations, inclulding block quote from Reyes v. Wyeth Labs., 498 F.2d 1264, 1276 (5th Cir. 1974) omitted].  Because patients can obtain prescription drugs only through their prescribing physician or another authorized intermediary and because the “learned intermediary” is best suited to weigh the patient’s individual needs in conjunction with the risks and benefits of the prescription drug, we are in agreement with the overwhelming majority of other courts that have considered the learned intermediary doctrine and hold that, within the physician-patient relationship, the learned intermediary doctrine applies and generally limits the drug manufacturer’s duty to warn to the prescribing physician.
 
Slip op. at 29-30 (footnote omitted) (emphasis added).  The footnote that we've omitted was pulled together from the list compiled in Bexis' PLAC brief - because we recognize all of the citations (particularly the Nevada Allison case).  Texas becomes the sixth state in which Bexis has participated in high court briefing that has resulted in adoption/reaffirmance of the learned intermediary rule (Pennsylvania, Coyle; New Jersey, Niemiera; Ohio, White; Kentucky, Larkin (for PLAC); and Connecticut, Vitanza (for PLAC)).  See also Id. at 42 n. 27 (rejecting as "unpersuasive" an argument "that we should not adopt the learned intermediary doctrine because the fundamental basis for the doctrine has changed with the evolving dynamics of contemporary society and the developing system of healthcare in the United States").
 
Second, and as importantly, Hamilton reverses the lower court's adoption of a direct-to-consumer exception to the learned intermediary rule - leaving New Jersey as the only state to adopt that exception (although as Hamilton observes, West Virginia used DTC as an excuse for rejecting the rule altogether).  Slip op. at 33-34.  While the Court did not rule out a DTC exception in extreme cases, id. at 35, it found no need for such an exception generally:
On this record, the rationale for adopting a DTC advertising exception to the learned intermediary doctrine is simply non-existent.  Even so, we must believe that patients who seek prescription drugs based solely on DTC advertising will obtain them only when the prescribing physician has evaluated the potential risks and benefits for the particular patient.  To safeguard the public from harmful products and misleading advertising, both the federal government and Texas law regulate the design, marketing, and distribution of prescription drugs.  Drug manufacturers that fail to comply with FDA regulations can face criminal fines and imprisonment as well as civil penalties.  Although pharmaceutical companies have increased DTC advertising since courts first adopted the learned intermediary doctrine, the fundamental rationale for the doctrine remains the same:  prescriptions drugs require a doctor’s prescription and, therefore, doctors are best suited to communicate the risks and benefits of prescription medications for particular patients through their face-to-face interactions with those patients.

Slip op. at 37-38 (various citations omitted) (emphasis added).
 
Third, the learned intermediary rule is a legal doctrine, not an affirmative defense.  Plaintiffs can't use application of the rule to avoid having to prove their cases:
While the learned intermediary doctrine shifts the manufacturer’s duty to warn the end user to the intermediary, it does not shift the plaintiff’s basic burden of proof.  Doing so would create an anomalous situation where, once the defendant prescription-drug manufacturer invokes the learned intermediary doctrine, the plaintiff would be relieved of proving a key burden in any product warning case—that the product warning was inadequate.

Slip op. at 41.

Fourth, the learned intermediary rule flows through prescribing - but not non-prescribing physicians.  Just because a non-prescriber used a manufacturer's patient education materials, the non-prescriber did not become obligated to provide full warnings to the patient:
Despite the intricate web of modern healthcare providers and treatments, the bedrock of our healthcare system is the physician-patient relationship, and the ultimate decision for any treatment rests with the prescribing physician and the patient.  As a matter of both necessity and practicality, the duty to warn the patient of the potential risks and possible alternatives to any prescribed course of action rests with the prescribing physician.

Slip op. at 43 (emphasis added).  To impose such a duty on a non-prescriber would only "undermine" the physician/patient relationship by requiring second-guessing by non-prescribers, and "thwart the efforts of prescription drug manufacturers to provide valuable educational information about available treatments."  Id. at 43.

While #4 wasn't an issue that PLAC briefed, we note that it's been raised recently in organophosphate-related litigation. 

Fifth, the learned intermediary rule can't be avoided through claims of fraud.  Rather it applies to any claim that is based upon the information that flows through a learned intermediary to the end user of the product:
Texas appellate courts have applied the learned intermediary doctrine to a variety of causes of action predicated on the alleged inadequacy of a prescription drug manufacturer’s product warning.   We find the [this] application of Texas law persuasive. . . .   [W]hen a patient alleges . . . omissions about a prescription drug’s potential side effects, (1) the patient cannot plead around the basic requirements of a failure-to-warn claim, and (2) the learned intermediary doctrine applies.  Therefore, the learned intermediary doctrine applies to all of [plaintiffs’] claims.

Slip op. at 46-47 (footnote omitted).

Sixth, and finally (in another non-PLAC issue), the court applied what we call "learned intermediary causation" to hold, as a matter of law, that plaintiffs could not prove that any inadequacy in the defendants' warnings caused them injury.
[W]hen the prescribing physician is aware of the product’s risks and decides to use it anyway, any inadequacy of the product’s warning, as a matter of law, is not the producing cause of the patient’s injuries. . . .  It is undisputed that all of [plaintiffs'] medical providers were aware [of the risk at issue] as a side effect of [the drug].  [Plaintiffs] presented no evidence that [the] prescribing physicians or [plaintiffs] would have acted differently had [defendant] provided a different warning that included [the information plaintiffs advocated].

Slip op. at 49-50 (lots of citations omitted).  Thus a multi-million dollar verdict became a judgment n.o.v.:
Because [plaintiffs'] prescribing physicians were aware of the potential risk . . . but chose to prescribe [the drug] in spite of those risks, and because the [plaintiffs] failed to present any evidence that including additional [information] in the warning would have caused [the prescribing] physicians to change their prescription, [plaintiffs] failed to meet their burden of proof.
 
Slip op. at 54.
 
Thus a really bad Texas intermediate appellate decision has been replaced by a really good Texas Supreme Court opinion.  As an extra added benefit another really bad (we described it previously as "ugly") decision purporting to apply Texas law should also fall as a result of that decision's undue haste in following the now reversed intermediate decision in Hamilton v. CentocorSee Murthy v. Abbott Laboratories, ___ F. Supp. 2d ___, 2012 WL 734149 (S.D. Tex. Mar. 6, 2012) (cited twice, and not favorably, by the Texas Supreme Court, slip op. at 33, 35 n.22).  Since Murthy made #8 on our bottom ten decisions last year, we won't be sad to see it go.

3 comments:

Max Kennerly said...

Imagine that, an injured plaintiff losing in front of the Texas Supreme Court. It only happens every single time.

Chip said...

Max is right. Such scoreboarding from Bexis, when the only "news" would have been if the decision had gone the other way. (That said, your amicus brief was quite good, Bexis, and so well-suited to your audience too. Now, if only you could get a state court somewhere, anywhere, to buy the snake oil you're selling re Mensing . . . .)

This is from an email I wrote to several non-Texas colleagues on 6/23/10, or about 7 months before Bexis filed his amicus:

We have practiced extensively before th[e] [Texas Supreme] Court, and one of us served as a Staff Attorney there for several years. We expect that this decision [the court of appeals' decision in Centocor] will be reversed by the Texas Supreme Court.

Bexis said...

Working on it. Have the Mensing/Conte issue teed up in the Alabama Supreme Court. I think we've blogged about that.