Widely touted as ushering Texas into the fold of states adopting
the learned intermediary doctrine, in Hamilton v.
Centocor, the Texas Supreme Court did much more including
leaving the door open for future tort claims stating "future
claims may give rise to the need for Courts to recognize an
exception" to applying the learned intermediary doctrine. No.
10-0223, 2012 Tex. LEXIS 463 (Tex. June 8, 2012), available
here.
Centocor involved a prescription drug and claims that a
Direct-to-Consumer (DTC) video supported fraud and
misrepresentation claims. Plaintiff claimed that the drug,
Remicade, caused a serious drug-induced side effect called
lupus-like syndrome. Plaintiff alleged that the manufacturer's
video over-emphasized the benefits of the drug and intentionally
omitted warnings about the potential side effects. Plaintiff argued
that the video bypassed the physician-patient relationship and
required the manufacturer to warn Plaintiff directly of the
drug's potential risks and side effects, thereby making the
manufacturer liable for Plaintiff's injuries.
At trial, the Plaintiff and her doctors "gave conflicting
testimony about conversations concerning the risks and potential
adverse effects associated with Remicade." The treating
physicians testified that they fully informed Plaintiff about the
risks of developing lupus-like syndrome while Plaintiff stated that
she received no warning. The Supreme Court noted that all of the
physicians were aware of the risk of lupus-like syndrome when they
chose to prescribe and treat Plaintiff with Remicade.
Interestingly, Plaintiff continued receiving Remicade treatments
for approximately six months after filing
suit.
The Court of Appeals followed the Supreme Court of the State of
New Jersey recognizing a sweeping exception to the learned
intermediary doctrine for Direct-to-Consumer Advertisements and
affirmed the jury award of more than 15 million dollars. In
Perez v. Wyeth, the New Jersey Supreme Court noted that
"[c]onsumer-directed advertising of pharmaceuticals thus
belies each of the premises on which the learned intermediary
doctrine rests." 734 A.2d 1245, 1256 (N.J. 1999). As a result,
the Perez court held that the learned intermediary
doctrine no longer provided complete protection to pharmaceutical
manufacturers when that company chose to market directly to
consumers."
Unlike Perez, in Centocor Plaintiffs testified
that they first heard of Remicade through a textual banner
displayed on the CNN news channel, which stated that the FDA had
approved Remicade for the treatment of Crohn's disease. The
Texas Supreme Court recognized that "[t]his innocuous news
report is a far cry from the basis for the Perez
Court's adoption of a DTC advertising exception where the
pharmaceutical company 'ma[de] direct claims to consumers for
the efficacy of its product'" through prescription drug
advertisements. In Centocor, Plaintiffs' claims rested
on the video that was viewed after her doctor had prescribed the
drug and after the infusion process had begun. Furthermore, the
Court characterized the video as an "informational supplement
to the physician-patient relationship" and stated that
"the placement of informational brochures in a physician's
office cannot fairly be equated with a course of mass advertising
or be deemed direct-to-consumer advertising so as to remove the
predicates of the learned intermediary doctrine."
The Texas Supreme Court recognized that the learned intermediary
doctrine has been a part of Texas jurisprudence for many years and
articulated the doctrine as follows: "[u]nder the learned
intermediary doctrine, the manufacturer of a pharmaceutical product
satisfies its duty to warn the end user of its product's
potential risks by providing an adequate warning to a learned
intermediary, who then assumes the duty to pass on the necessary
warnings to the end user." The Supreme Court went on to
state:
The entire system of drug distribution in America is set up so as
to place the responsibility of distribution and use upon
professional people. The laws and regulations prevent prescription
type drugs from being purchased by individuals without the advice,
guidance and consent of licensed physicians and pharmacists. These
professionals are in the best position to evaluate the warnings put
out by the drug industry. Our holding in no way relieves the drug
company in their duty to warn or to provide a product free of
defects.
The Court further stated:
[W]hen a drug manufacturer properly warns a prescribing physician
of the dangerous propensities of its product, the manufacturer is
excused from warning each patient who receives the drug. The doctor
stands as a learned intermediary between the manufacturer and the
ultimate consumer. Generally, only the doctor could understand the
propensities and dangers involved in the use of a given drug. In
this situation, it is reasonable for the manufacturer to rely on
the intermediary to pass on its warnings. However, even in these
circumstances, when the warning to the intermediary is inadequate
or misleading, the manufacturer remains liable for injuries
sustained by the ultimate user.
While acknowledging that "the healthcare industry has
experienced substantial changes, especially surrounding the
marketing of prescription drugs," it reasoned that before a
patient receives a prescription medication, "it still went
through the learned intermediary to get to [the patient]." The
Court acknowledged that some courts have recognized circumstances
that may support an exception to applying the learned intermediary
doctrine in prescription drug cases but noted: "[b]ecause the
unique circumstances and specific types of prescription drugs at
issue in those cases are not before us, we need not determine
whether Texas law should recognize exceptions to the learned
intermediary doctrine in other contexts."
The Texas Supreme Court rejected the Court of Appeals'
reasoning that DTC advertising relegates physicians to a mere
dispensary role, but recognized that:
We agree that it is important to prohibit pharmaceutical
manufacturers from disseminating grossly misleading advertising,
and we note that Congress has enacted a comprehensive regulatory
scheme, implemented by the FDA, which is meant to control the
design, implementation, and marketing of prescription drugs,
including both criminal and civil penalties for manufacturers that
violate these regulations. We acknowledge that some situations may
require exceptions to the learned intermediary doctrine,
but without deciding whether Texas law should recognize a
DTC advertising exception when a prescription drug manufacturer
distributes intentionally misleading information directly to
patients or prospective patients, we hold that, based on
the facts of this case, no exception applies."
According to the Supreme Court, "[o]n this record, the
rationale for adopting a DTC advertising exception to the learned
intermediary doctrine is simply non-existent." But the Court
did leave the door open stating that, "future cases may give
rise to the need for the courts to recognize an exception to the
doctrine in other contexts..." The Court went on to recognize
that where "the warning to the intermediary was inadequate or
misleading, the manufacturer remains liable for injuries sustained
by the end user."
Thus, in the context of prescription medications, where
"inadequate or misleading" information concerning product
risk forms the basis for the prescribing physician prescribing the
product, a manufacturer may be liable and this information can come
from multiple sources, including DTC advertisements,
representations by sales representatives, on-line content and
social media. Indeed, in Centocor, the Court recognized
that when the drug company positively and specifically
misrepresents its product and when the treating
physician relies upon that representation, the drug company is
liable when the representation proves to be false and harm
results.
Nonetheless, even assuming that the Plaintiff presented sufficient
evidence to show that the manufacturer's warning to
Plaintiff's prescribing physicians was inadequate, the
Plaintiff still must prove that the inadequate warning was the
producing cause of Plaintiff's injuries. In this case it was
undisputed that all of Plaintiff's medical providers were aware
that Plaintiff could potentially develop serious side effects and
the Plaintiff presented no evidence that Plaintiff's
prescribing physicians would have acted differently had the
manufacturer provided a different warning.
In this era of electronic communications, this case underscores
the need for vigilance in compliance with the FDCA concerning
marketing materials. This case leaves the door wide open for future
litigation where direct communications to physicians and patients
form the basis for prescribing decisions, particularly where the
product is being used off-label.
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