Justice GREEN delivered the Opinion of the Court.
Under 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. See, e.g., Gravis v. Parke-Davis & Co., 502 S.W.2d 863, 870 (Tex.Civ.App.-Corpus Christi 1973, writ ref'd n.r.e.). In this case, we consider the applicability of the learned intermediary doctrine to a patient's claims against a prescription drug manufacturer, whose product allegedly caused a serious injury. We hold that the doctrine generally applies within the context of a physician-patient relationship and allows a prescription drug manufacturer to fulfill its duty to warn end users of its product's potential risks by providing an adequate warning to the prescribing physician. We further hold that the court of appeals erred by
In March 2003, Patricia and Thomas Hamilton sued Centocor, Inc., a prescription drug manufacturer and subsidiary of Johnson & Johnson, claiming that Centocor provided "inadequate and inappropriate warnings and instruction for use" of its prescription drug Remicade, which made Remicade "defective and unreasonably dangerous," and seeking damages for injuries that Patricia allegedly incurred from using the drug.
In the course of her prescribed treatments, Patricia's treating physician, Michael Bullen, M.D., showed her an informational video that he received from Centocor. The Hamiltons alleged that Centocor's video over-emphasized the benefits of Remicade and intentionally omitted warnings about the potential side effect of lupus-like syndrome. They argued that the video bypassed the physician-patient relationship and required Centocor to warn Patricia directly of Remicade's potential risks and side effects, thereby making Centocor liable for Patricia's injuries. The jury found in favor of the Hamiltons, and the trial court entered judgment for approximately $4.6 million. The court of appeals reversed the award of future pain and mental anguish damages but affirmed the remainder of the trial court's judgment, adopted a DTC advertising exception to the learned intermediary doctrine, and held that the record contained sufficient expert evidence to prove that Centocor's actions caused Patricia's injuries.
Patricia Hamilton has a complicated medical history. For more than two decades, she has suffered from Crohn's disease, recurring joint pain, arthritis, and several other ailments. Crohn's disease is a chronic, lifelong inflammatory condition that can affect any part of the digestive system. There is no cure for the disease;
In September 2001, Patricia experienced a "flare" in her Crohn's disease and sought treatment from Ronald Hauptman, M.D., a gastroenterologist who was practicing in Corpus Christi. To confirm that Patricia's symptoms were caused by her Crohn's disease, Dr. Hauptman tracked Patricia's reported abdominal pains for several weeks and ordered a series of tests, including a CAT scan and an upper GI.
Dr. Hauptman testified that it was important to treat the Crohn's flare quickly to mitigate the risk that Patricia would lose more of her bowels. Based on Patricia's existing medical regimen and her reported allergic reactions to one type of anti-inflammatory medication used to treat Crohn's disease, Dr. Hauptman testified that Patricia's only two options to treat the Crohn's flare were through steroids or Remicade infusions. According to Dr. Hauptman, he consulted with Patricia about the available treatments and explained the risks and benefits of each approach. Based in part on Patricia's desire to avoid steroid treatments, which had previously caused severe adverse effects, Dr. Hauptman prescribed three treatments of Remicade, a relatively new drug that had been developed since Patricia's surgery in 1997, administered at six-week intervals of 400 milligrams each.
Remicade is a prescription drug, manufactured by Centocor, that is approved by the Food and Drug Administration (FDA) for the treatment of Crohn's disease and rheumatoid arthritis.
Barbara Matthews, M.D., an FDA administrator from 1994 to 2000, testified as an expert on the FDA approval process. Dr. Matthews was the clinical reviewer of Centocor's application for FDA approval of Remicade and testified about her knowledge of the drug and her review of the safety and clinical data supporting Centocor's
Additionally, once a drug has received FDA approval, the manufacturer must submit periodic safety update reports to the FDA. These post-approval reports contain cumulative summaries of the drug's safety information, including updated clinical studies and any other medical findings published about the drug. Depending on the number, nature, and severity of events reported for a given adverse reaction, the FDA may recommend that the manufacturer (1) continue to monitor the events, (2) change the warning label, or (3) conduct additional studies. Because the FDA requires continuing studies of the safety and efficacy of the prescription drug, it is common for the package insert to undergo revisions as new information becomes available.
At the time of Patricia's initial Remicade prescription in December 2001, Centocor provided Patricia's doctors with a package insert that warned Remicade's use could lead to certain adverse reactions. The package insert included the following warning information regarding lupus-like syndrome:
The package insert also included a table noting that serious adverse reactions — including systemic lupus erythematosus syndrome — occurred at frequencies of less than 2% "by body system in all patients treated with REMICADE."
According to Mary Olsen, M.D., an expert witness hired by Centocor but called by the Hamiltons, lupus-like syndrome, also called drug-induced lupus, has similar characteristics to the autoimmune disorder systemic lupus erythematosus (SLE), except that lupus-like syndrome is caused by a drug. All of the testifying experts generally agreed that symptoms of both lupus-like syndrome and SLE include joint pain and swelling, weight gain, fatigue, unusual weakness, leukopenia, lymphopenia, rash, oral ulcers, fever, and pericarditis. Patients with Crohn's disease or rheumatoid arthritis, another autoimmune disorder, could also present similar symptoms to lupus-like syndrome, making it sometimes difficult to diagnose SLE or drug-induced lupus.
Physicians can conduct lab tests to check for the presence of anti-nuclear antibodies (ANA), double-stranded DNA antibodies (anti-dsDNA), and antihistone antibodies, which are specific indicators that may help a physician diagnose the presence of an autoimmune condition. Although no antibody is definitive of lupus-like syndrome, positive tests for ANA or anti-dsDNA may indicate the patient has lupus-like syndrome. Physicians also use electrophoresis and immunoelectrophoresis as other immunology blood tests to help diagnose lupus. According to Atilla Ertan, M.D., an expert witness for Centocor, the anti-dsDNA test is the most important indicator for diagnosing drug-induced lupus. Additionally, Dr. Olsen testified that antihistone antibodies are classically seen in patients with drug-induced lupus and "as a rule, an antihistone antibody often is a flag [that indicates] a drug-induced problem." Because Remicade may produce ANA or anti-dsDNA in patients, however, Dr. Olsen explained that it is often difficult to diagnose lupus-like syndrome. A doctor must look to both the laboratory tests and the clinical presentation of symptoms. If a patient has drug-induced lupus rather than SLE, removing the patient from the drug should improve the patient's lupus-like symptoms.
Dr. Hauptman prescribed three infusions of Remicade over a six-week period from December 2001 to January 2002 and referred Patricia to Dr. Bullen for treatment. Dr. Bullen is an infectious disease specialist and, at that time, operated an infusion clinic in Corpus Christi where Patricia received the Remicade infusions. As the non-prescribing, treating physician, neither Dr. Bullen nor his staff discussed with Patricia the risks inherent in Remicade, but they informed her of the potential
Polly Swinney, a registered nurse at Bullen's infusion clinic, took Patricia's patient history, advised Patricia on the potential infusion-related side effects,
After Swinney connected Patricia's IV and started the first Remicade infusion, she showed Patricia an informational video about Remicade and the treatment process, which Centocor had provided to Dr. Bullen. Centocor had submitted the video to the FDA, but the FDA neither approved nor disapproved it.
Dr. Bullen, Dr. Matthews, and Swinney generally agreed that the main purpose of the video was to educate patients and make them more comfortable with the infusion process. The video, titled "Patient Guide to Remicade® (infliximab) IV Administration," was viewed by the jury during trial. It depicts the effects of Remicade on several people and includes statements from a doctor, identified as Alan Safdi, M.D., who explains the Remicade infusion process and warns about some of the drug's side effects. The video shows several patients receiving Remicade infusions, provides answers to common questions about the treatment process, and shows the patients continuing their daily routines after the treatment while the bottom of the screen states: "RESULTS MAY VARY." Although Dr. Safdi states that "there are very little side effects that people need to watch for" and adverse reactions are "extremely rare," he also instructs patients to contact their medical providers if they have any discomfort and states that there have been some reports of serious, life-threatening side effects.
In addition to Dr. Safdi's verbal warnings, the video provides several written warnings and disclaimers at the end of the production. It instructs patients to contact their healthcare provider if they have any questions and provides a Remicade website address for further information. The video warns of various risks associated with the infusion process, advises that "[p]hysicians should discuss with their patients all potential side effects that may occur during these infusions," and cautions that the "video should not be used as a substitute for talking with your doctor." For the treatment of fistulizing Crohn's
Swinney testified that the infusion clinic received the videotapes from Centocor in cellophane-wrapped boxes that usually contained the video, informational brochures about Remicade, and package inserts that provided more extensive details about the drug. She claimed that after showing Patricia the video, she placed it back in the box with the written materials on top and gave it to Patricia. At trial, Patricia denied receiving any written information about Remicade, but stated that she never looked in the box that Swinney gave her or reviewed any additional written information about Remicade. During one of Patricia's infusions, Swinney gave Patricia a second Centocor video to give to Patricia's sister, who had rheumatoid arthritis. The second video contained the same visual content but was enclosed in different packaging material. The box containing the second video had a plastic sleeve on the inside cover that contained the Remicade package insert and an informational brochure.
Patricia reported an excellent response to her Remicade treatments at Dr. Bullen's infusion clinic, and the treatments helped relieve the symptoms of her Crohn's disease. After her first two Remicade infusions, Dr. Hauptman performed a colonoscopy on Patricia, which revealed that Patricia no longer had abnormalities in her small intestine. Following her third Remicade infusion, Dr. Hauptman believed that Patricia's Crohn's disease was in remission. Dr. Hauptman then planned to continue monitoring Patricia's condition before determining whether Patricia needed a Remicade maintenance dose every eight weeks. Throughout her follow-up appointments with Dr. Hauptman, Patricia reported that she was having no problems with her bowels, leading Dr. Hauptman to conclude that the Remicade treatments were successful and that Patricia's Crohn's disease remained in remission. It is undisputed that, since taking Remicade, Patricia's Crohn's disease has been asymptomatic.
In the weeks following her initial treatments with Remicade, Patricia experienced severe arthritis-like pains in her joints. Patricia's family physician referred her to a local rheumatologist, Adriana Pop-Moody, M.D. During her initial visit with Dr. Pop-Moody, Patricia explained her recent treatments with Remicade and told Dr. Pop-Moody that it had dramatically improved her Crohn's condition and that her arthritis pains had markedly improved after her first three doses of Remicade. In April 2002, Dr. Pop-Moody prescribed treatments including additional Remicade infusions at regular intervals to treat Patricia's joint pains. Between April 2002 and September 2003, Patricia received fourteen additional Remicade infusions at the Corpus Christi Medical Center.
Because of Patricia's increasing joint pain and Dr. Pop-Moody's inability to determine the cause of Patricia's continuing ailments, Dr. Pop-Moody referred Patricia to rheumatologists at the University of Texas Health Science Center in Houston, where she saw Maureen D. Mayes, M.D., Noranna B. Warner, M.D., and Leslie Wilson, M.D. (collectively, the Houston Doctors). In response to Dr. Pop-Moody's request, the Houston Doctors examined Patricia's symptoms and Dr. Mayes and Dr. Wilson made the following assessment in September 2003:
The Houston Doctors stopped Patricia's Remicade treatments and, instead, prescribed steroids for her joint pains. At her October 2003 follow-up appointment, Patricia reported that she felt much better than she did at her previous visit. Dr. Warner sent Dr. Pop-Moody a status report, which documented Patricia's improvement and stated in pertinent part:
Within a few months of ceasing the Remicade infusions, Patricia's lupus-like symptoms subsided. Patricia's arthritic symptoms also improved dramatically after she ceased taking Remicade.
The case proceeded to a multi-week jury trial. At trial, Patricia and her doctors gave conflicting testimony about their conversations concerning the risks and potential adverse effects associated with Remicade. Specifically, Dr. Hauptman and Dr. Pop-Moody testified that they fully informed Patricia about the risks of developing lupus-like syndrome while Patricia averred that she received no such warning from either doctor when they initially prescribed Remicade treatments. Although Patricia admitted that she was informed by her physicians of certain risks associated with Remicade, including the rare risk of cancer, she testified that her doctors made no mention of the risk of developing lupus-like syndrome. She further stated that the risk of lupus-like syndrome was something that she would have wanted to know, that it "would have impacted [her] decision," and that "[t]he question of lupus would have made [her] stop and ask more questions before [she] made a decision [to take Remicade]." Regardless of the conflicting testimony, it is undisputed that all of Patricia's doctors were aware of the risk of lupus-like syndrome when they chose to prescribe and treat Patricia with Remicade. And according to all of the doctors who testified on the subject, lupus-like syndrome can be difficult to diagnose.
At the charge conference, the Hamiltons abandoned their original failure-to-warn claim and proposed separate jury questions on claims against Centocor for (1) fraud, (2) negligent misbranding, (3) negligent marketing, (4) negligent undertaking, (5) misrepresentation to Patricia's prescribing physicians concerning the risk of lupus-like syndrome, and (6) misrepresentation to Patricia's prescribing physicians concerning the risk of hepatitis C and liver damage. Centocor raised several objections to the Hamiltons' proposed charge, including that it was error for the trial court to submit separately the claims for negligent misbranding, negligent marketing, negligent undertaking, misrepresentation regarding lupus-like syndrome, misrepresentation regarding hepatitis C and
Before the trial court submitted the charge to the jury, the court granted a directed verdict in favor of Dr. Bullen and his infusion clinic, finding that Dr. Bullen and his staff had no duty to warn Patricia of the risks associated with Remicade because Dr. Bullen was not the prescribing physician.
The jury found Centocor liable for fraud, misrepresentation to Patricia's doctors, negligent misbranding, negligent marketing to Patricia's doctors, and negligent undertaking. The jury awarded Patricia $1.2 million for past pain and mental anguish, $1 million for future pain and mental anguish, $1.1 million for past physical impairment, and $65,908 for past medical expenses. It also awarded Thomas $50,000 for loss of consortium and household services. The jury apportioned liability for the Hamiltons' damages, finding Centocor 85% liable, Dr. Pop-Moody 10% liable, and Dr. Hauptman 5% liable. The jury determined that the Hamiltons established fraud by clear and convincing evidence and awarded Patricia $15 million and Thomas $1 million in exemplary damages based on the fraud claim.
Before the trial court entered judgment on the jury's verdict, Dr. Hauptman and Dr. Pop-Moody settled with the Hamiltons, and the Hamiltons nonsuited those defendants.
Centocor timely appealed, arguing first that the learned intermediary doctrine precluded the Hamiltons' recovery because, as a matter of law, Centocor's warnings to Patricia's prescribing physicians were adequate and Centocor had no duty to warn Patricia directly.
The court of appeals first examined Centocor's duty under the learned intermediary doctrine, which generally limits a prescription drug manufacturer's duty to warn of its product's risks and potential side effects to prescribing physicians, who then serve as "learned intermediaries" and assume the duty to pass the warnings on to patients. See id. at 499-508. Relying on reasoning from the New Jersey Supreme Court's opinion in Perez v. Wyeth Laboratories, 161 N.J. 1, 734 A.2d 1245, 1246-47 (1999), the court of appeals adopted "an exception to the learned intermediary doctrine when a drug manufacturer directly advertises to its consumers in a fraudulent manner." 310 S.W.3d at 480-81. Guided by the Perez court's decision, the court of appeals held "that when a pharmaceutical company directly markets to a patient, it must do so without fraudulently misrepresenting the risks associated with its product." Id. at 508. The court therefore dismissed Centocor's arguments based on the learned intermediary doctrine and, in a footnote, stated: "[W]e hold today that Centocor cannot rely on its adequate warnings to Patricia's physicians when it directly misrepresented its product's dangerous propensities to Patricia." Id. at 508 & n. 18 (emphasis added).
The court of appeals next considered Centocor's argument that the Hamiltons failed to present legally and factually sufficient evidence of causation and held that the Hamiltons met their burden of proof on causation.
Centocor timely petitioned this Court for review, and raises four issues on appeal: (1) the court of appeals erred by creating an advertising exception to the learned intermediary doctrine, and the doctrine applies, thereby limiting Centocor's duty to warn to Patricia's prescribing physicians only and barring the Hamiltons' claims; (2) the Hamiltons failed to present any expert testimony that the warning in Centocor's informational video was inadequate, and the appellate court erred by considering Dr. Matthews's testimony about the FDA approval process and the FDA regulations as sufficient evidence to show that the video's allegedly inadequate warning made Remicade unreasonably dangerous; (3) the Hamiltons failed to show any evidence of causation because they presented no expert testimony of causation or epidemiological studies, but instead relied on the package insert and expert witnesses' unsupported references to clinical trials; and (4) the appellate court erred in affirming the Hamiltons' fraud claim because there was no evidence of any mens rea on the part of Centocor, which was isolated from the patient by the intermediary doctors, and that Patricia could not have relied on any alleged misrepresentation because she continued to take Remicade even after suing Centocor. In response to Centocor's first issue, the Hamiltons raise a conditional cross-issue, alleging that if we hold that the learned intermediary doctrine applies, we should reinstate the Hamiltons' claims against Dr. Bullen, the non-prescribing, treating physician, because Centocor deliberately used Dr. Bullen to provide direct marketing materials outside of the context of the prescribing physician's doctor-patient relationship. We granted both petitions. 54 Tex.Sup.Ct.J. 1578 (Aug. 26, 2011).
Generally, a manufacturer is required to provide an adequate warning to
Centocor argues that the learned intermediary doctrine applies and therefore it had no duty to warn Patricia directly of the risks and potential side effects associated with Remicade. It asserts that it provided warnings of specific side effects and risks associated with Remicade to Patricia's doctors through the FDA-approved package insert, which Patricia did not challenge as inadequate. Centocor further argues that the appellate court erred by adopting a DTC advertising exception. Centocor claims that DTC advertising does not threaten the physician-patient relationship, but helps educate consumers about available medications — sometimes causing patients to seek treatment for ailments they otherwise would not have treated or sometimes even discovered. Additionally, Centocor points out that the FDA and other courts have recognized that over-warning can confuse the public and, ultimately, can harm treatment efforts by scaring patients from taking the necessary risks associated with some prescription drugs.
In response, the Hamiltons argue that Centocor cannot benefit from the learned intermediary doctrine because it provided an inadequate and misleading warning to the "learned intermediary" — Patricia's prescribing and treating physicians. The Hamiltons contend that Centocor misrepresented the risks and side effects associated with Remicade to Patricia and her doctors by conveying instances of lupus-like syndrome observed only in clinical studies instead of all reported cases, thereby preventing Centocor from relying on the defense of the learned intermediary doctrine. Alternatively, if the learned intermediary doctrine applies, the Hamiltons urge us to adopt the DTC advertising exception and affirm the court of appeals' judgment because when a drug manufacturer directly markets its product to patients, that manufacturer should have a duty, at minimum, to present non-misleading information about the drug and must be liable for its fraudulent or intentionally misleading marketing.
The learned intermediary doctrine has been part of Texas jurisprudence for many years. See, e.g., Gravis v. Parke-Davis & Co., 502 S.W.2d 863, 870 (Tex.Civ.App.-Corpus Christi 1973, writ ref'd n.r.e.). In
Id. Since the Thirteenth Court of Appeals' opinion in Gravis — the same court from which we consider the instant case — many Texas courts of appeals have applied the learned intermediary doctrine in prescription drug products-liability cases. See, e.g., Wyeth-Ayerst Labs. Co. v. Medrano, 28 S.W.3d 87, 91 (Tex.App.-Texarkana 2000, no pet.) ("In prescription drug cases, the courts have found that it is reasonable for the manufacturer to rely on the health care provider to pass on its warnings. This is reasonable because the learned intermediary understands the propensities and dangers involved in the use of a given drug, and as the prescriber, he stands between this drug and the ultimate consumer.").
We first discussed the doctrine in Alm v. Aluminum Co. of America, a case involving an aluminum bottle cap manufacturer's
Id. at 591. We then analogized Alm's position to that of a bulk supplier "who sells a product to another manufacturer or distributor who in turn packages and sells the product to the public." Id. at 592. Because the bulk-supplier rationale applied to Alcoa's duty to warn in that case, we explained:
Id. While Alcoa did not have a duty to warn Alm directly, it still had a duty to warn the bottler, and we concluded that the record contained some evidence to support the jury's finding that Alcoa's warning to the bottler was inadequate. Id. at 593-95.
Although Alm did not apply the learned intermediary doctrine within the context of a pharmaceutical manufacturer's duty to warn consumers of dangers associated with prescription drugs, we noted that other courts had done so:
Id. at 591-92 (citations omitted).
More recently, we addressed the learned intermediary doctrine's relevance in Humble Sand & Gravel, Inc. v. Gomez, 146 S.W.3d 170, 185-96 (Tex.2004). In that case, we considered whether a supplier of flint used for an abrasive blasting agent had a duty to warn its customers' employees of foreseeable dangers associated with
Id. at 190 (quoting Goodbar v. Whitehead Bros., 591 F.Supp. 552, 557 (W.D.Va.1984), aff'd sub nom. Beale v. Hardy, 769 F.2d 213 (4th Cir.1985)); see also Restatement (Third) of Torts: Products Liability § 2 cmt. i (1998); Restatement (Second) of Torts § 388 cmt. n (1965). We noted that each of these factors "must be weighed against each other, the measure being reasonableness in the circumstances." Humble Sand, 146 S.W.3d at 190. Because the record lacked "any evidence that, in general, warnings by flint suppliers could effectively reach their customers' employees actually engaged in abrasive blasting," we were unable to determine whether the suppliers had a duty to warn the customers' employees directly and, accordingly, remanded the case for a new trial. Id. at 173.
As in Alm, we again recognized in Humble Sand that other courts have applied the learned intermediary doctrine within the prescription drug context and explained: "The rationale for this `learned intermediary' rule is not that a direct warning from manufacturers to patients is infeasible, in the practical, physical sense of that word, but that it is better for the patient for the warning to come from his or her physician." Id. at 190-91; see also Restatement (Third) of Torts: Products Liability § 6 cmt. b ("The rationale supporting this `learned intermediary' rule is that only health-care professionals are in a position to understand the significance of the risks involved and to assess the relative advantages and disadvantages of a given form of prescription-based therapy. The duty then devolves on the health-care provider to supply to the patient such information as is deemed appropriate under the circumstances so that the patient can make an informed choice as to therapy.").
Until now, we have not considered a case that squarely presents the applicability of the learned intermediary doctrine within the context of prescription drug products-liability cases. For reasons stated in Humble Sand, Alm, and Gravis, we hold that a prescription drug manufacturer fulfills its duty to warn end users of its product's risks by providing adequate warnings to the intermediaries who prescribe the drug and, once fulfilled, it has no further duty to warn the end users directly. See Humble Sand, 146 S.W.3d at 190-91; Alm, 717 S.W.2d at 591-92; Gravis, 502 S.W.2d at 870. But as we have previously indicated, when the warning to the prescribing physician is inadequate or misleading, the prescription drug manufacturer remains liable for the injuries sustained by the patient. See Alm, 717 S.W.2d at 592.
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
Reyes, 498 F.2d at 1276. Accord Bean, 965 S.W.2d at 662 (adopting Reyes' rationale for the doctrine). Cf. Diversicare Gen. Partner, Inc. v. Rubio, 185 S.W.3d 842, 850 (Tex.2005) ("The nature and intensity of care and treatment, including professional supervision, monitoring, assessment, quantities and types of medication, and other medical treatment are judgments made by professionals trained and experienced in treating and caring for patients and the patient populations in their health care facilities."). 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.
Having concluded that the learned intermediary doctrine generally applies in the prescription drug context, we next consider whether some exception to the doctrine is warranted here, so that, despite the doctrine, Centocor retained a duty to warn the patient directly. In the more than forty-five years since courts first adopted the learned intermediary doctrine in the prescription drug context, the healthcare industry has experienced substantial changes, especially surrounding the marketing of prescription drugs. See Vitanza, 778 A.2d at 846 (citing Sterling Drug, Inc. v. Cornish, 370 F.2d 82, 85 (8th Cir.1966), as the first case to adopt the doctrine). In light of these changes, some courts and commentators, including the Restatement, have recognized limited exceptions to the learned intermediary doctrine. See, e.g., Restatement (Third) of Torts: Products Liability § 6 (1998); see also, e.g., Timothy S. Hall, Reimagining the Learned Intermediary Rule for the New Pharmaceutical Marketplace, 35 SETON HALL L.REV. 193, 205-16 (2004) (discussing the recognized exceptions to the doctrine).
In the more than twelve years since Perez, many courts have declined to follow the New Jersey Supreme Court's sweeping departure from the learned intermediary doctrine. But cf. Murthy v. Abbott Labs., 847 F.Supp.2d 958 (S.D.Tex. 2012) (citing cases that rejected Perez, but relying on the appellate court's holding in Centocor to hold that Texas law recognizes a DTC advertising exception); see also Beale v. Biomet, Inc., 492 F.Supp.2d 1360, 1376 (S.D.Fla.2007) ("Since Perez was decided, no court — including any Florida court — has recognized the DTC exception to the learned intermediary doctrine, and several courts have expressly rejected the DTC exception."). Cf. Karl, 647 S.E.2d at 913 (decided after Beale and adopting Perez's reasoning but, instead of adopting a DTC exception to the doctrine, rejecting the learned intermediary doctrine entirely). Even the Fifth Circuit has expressed that it is "skeptical that a Texas court would adopt [an overpromotion] exception" to the learned intermediary doctrine, which is closely akin to the DTC advertising exception. Ebel v. Eli Lilly & Co., 321 Fed.Appx. 350, 355 n. 2 (5th Cir.2009); see also Beale, 492 F.Supp.2d at 1377-78 (discussing the overpromotion exception).
To date, West Virginia is the only state whose highest court has followed the New Jersey Supreme Court's holding in Perez. See Karl, 647 S.E.2d at 912-13.
At issue in this case is whether the court of appeals erred in adopting the DTC advertising exception to the learned intermediary doctrine. Not until the court of appeals' holding below had any Texas court adopted a DTC advertising exception to the learned intermediary doctrine. See Centocor, 310 S.W.3d at 508.
Here, the alleged harm was not caused by Centocor's direct advertising to Patricia. At trial, the Hamiltons admitted that the first time they heard of Remicade was when Patricia's husband, Thomas, saw a textual banner displayed on the bottom ticker of the CNN news channel, which stated that the FDA had approved Remicade for the treatment of Crohn's disease. This 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. Cf. Perez, 734 A.2d at 1247. Instead of DTC advertising prompting her to request Remicade from her doctors, Patricia's
Furthermore, the record indicates that this informational video is not the type of misleading DTC advertising that concerned the Perez court. According to Swinney, the nurse who remained present with Patricia during all of her Remicade treatments at Dr. Bullen's clinic, the videos were available to help patients feel more relaxed about the infusion process, by explaining some of the benefits and side effects of the treatment process. After viewing the video, Dr. Matthews testified that she considered the video to be an educational tool to help inform patients about the infusion process. And Patricia admitted that the first time she saw any literature about Remicade was when she received her first Remicade infusion at Dr. Bullen's clinic. Both Patricia and Swinney testified that Patricia was already receiving her first infusion when the video started. On this record, the rationale for adopting a DTC advertising exception to the learned intermediary doctrine is simply non-existent. See Norplant II, 165 F.3d at 379 (rejecting the plaintiffs' argument for an "`aggressive' marketing" exception because of "the absence of any evidence on the record that any of the five plaintiffs actually saw, let alone relied, on any marketing materials issued to them by [the manufacturer]"); Ebel v. Eli Lilly & Co., 536 F.Supp.2d 767, 782 (S.D.Tex.2008), aff'd, 321 Fed.Appx. 350 (5th Cir.2009) (rejecting the DTC advertising exception because there was no evidence that the plaintiff relied on the marketing website). But see Medrano, 28 S.W.3d at 93 n. 5 (rejecting the DTC exception on the facts of that case while noting that the court could "foresee a situation where a manufacturer's direct contact with the consumer could be received and relied on by that consumer outside the learned intermediary context").
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
Without deciding whether Texas law should recognize any of the other exceptions to the learned intermediary doctrine, we find no reason to adopt an exception where the physician-patient relationship existed, the pharmaceutical company provided a warning to the patient's prescribing doctors that included the side effect of which the patient complains, and the patient had already visited with her prescribing physician and decided to take the drug before she saw the informational video at issue. Accordingly, we hold that it was error for the court of appeals to create a DTC or fraudulent advertising exception to the learned intermediary doctrine based on the facts of this case.
The parties dispute whether the learned intermediary doctrine is an affirmative defense, which would shift to Centocor the burden to plead, prove, and request jury findings on the learned intermediary doctrine at trial. We agree with Centocor that, within the prescription drug context, the learned intermediary doctrine is more akin to a common-law rule rather than an affirmative defense.
The Hamiltons rely heavily on the appellate court's holding in Coleman v. Cintas Sales Corp., 40 S.W.3d 544, 551-52 (Tex. App.-San Antonio 2001, pet. denied). Coleman involved a products-liability action brought by an employee against a uniform company when his uniform caught fire. Id. at 547. Cintas Sales Corporation did not argue the learned intermediary doctrine before the trial court but argued to the court of appeals that it had no duty to Coleman because Coleman's employer served as a learned intermediary. Id. at 549. The court of appeals stated that the "`learned intermediary' [doctrine is a] defense[] that must be pled and proved by the manufacturer in the trial court," and because Cintas failed to raise this issue to the trial court in its motion for summary judgment, the issue was not properly preserved for consideration on appeal. Id. at 551.
We find Coleman distinguishable from the instant case. Coleman did not involve a products-liability claim arising from a drug manufacturer's failure to warn about the risks associated with its prescription drug. See id. at 547. As previously discussed in Part III, for more than forty-five years, courts have applied the learned intermediary doctrine within products-liability claims against prescription drugs manufacturers. See, e.g., Gravis, 502 S.W.2d at 870; Cornish, 370 F.2d at 85. We have repeatedly referenced the doctrine's commonly recognized application in the prescription
In contrast to the non-prescription drug situation in Coleman, we find more persuasive the Sixth Court of Appeals' holding in Wyeth-Ayerst Laboratories Co. v. Medrano, 28 S.W.3d 87, 93-94 (Tex.App.-Texarkana 2000, no pet.), which directly addressed the issue in context of the plaintiff's failure-to-warn and Deceptive Trade Practices Act (DTPA) claims against the prescription drug manufacturer. In Medrano, the court held that the learned intermediary doctrine was not a common-law defense and that it, therefore, applied to all of the plaintiff's causes of action, including the DTPA claim. Id. at 94. The court reasoned:
Id. (citations omitted). The Medrano court's interpretation of the learned intermediary doctrine within the prescription drug context also comports with the Fifth Circuit's application of Texas law. See, e.g., Ackermann v. Wyeth Pharm., 526 F.3d 203, 207-08 (5th Cir.2008) ("The learned-intermediary doctrine is not an affirmative defense. Under Texas law, it delineates to whom a defendant — usually a prescription drug manufacturer — owes the duty to warn, but it is not used to show that the plaintiff has no valid case."); see also Norplant II, 165 F.3d at 378 (making an Erie guess that Texas law considers the learned intermediary doctrine to be a common-law doctrine rather than a common-law defense).
Here, it is undisputed that Patricia received Remicade through a physician-patient relationship. As discussed hereafter in Part VI, the underlying basis for the Hamiltons' claims stems from Centocor's alleged failure to warn Patricia of the risks and dangers associated with Remicade. Therefore, as in most failure-to-warn cases, the Hamiltons had to prove that
We now address the Hamiltons' conditional cross-issue. Because the learned intermediary doctrine applies and because we decline to adopt an exception to the doctrine in this context, the Hamiltons argue that we are implicitly expanding the doctrine and allowing drug manufacturers to bypass intermediary-prescribing physicians by sending informational videos and marketing materials to patients through non-prescribing, treating physicians and their clinics. By sending the Remicade patient video to Dr. Bullen, a non-prescribing physician, the Hamiltons claim that Centocor transferred its duty to warn to Dr. Bullen, who must warn Patricia of the risks associated with Remicade. In response, Dr. Bullen argues that the trial court correctly granted a directed verdict in his favor because, as a matter of law, he owed no duty to warn Patricia about medications that he did not prescribe. We agree with Dr. Bullen.
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. See Alm, 717 S.W.2d at 591. The Hamiltons offer no case law in support of their duty-shifting position and we, too, have found none. While informational materials provided by healthcare providers, pharmaceutical and medical-device manufacturers, or the government are meant to educate patients and make them better informed
Here, the decision to prescribe Remicade to treat Patricia's condition was made well before she visited Dr. Bullen's infusion center and well before she saw Centocor's informational video. After reviewing Patricia's complicated medical history, tracking her symptoms, and confirming the Crohn's disease flare, Dr. Hauptman was faced with two available treatments — steroids or Remicade — and he and Patricia made the decision to try Remicade. While Dr. Bullen owed a duty to inform Patricia of the relevant risks associated with the treatment process, including the infusion method of delivery, and to obtain her informed consent to the treatment, which he properly performed, he owed no further duty to explain all of the potential risks associated with Remicade nor was he required to second-guess the professional judgment of Dr. Hauptman. Cf. Morgan, 30 S.W.3d at 467 (holding that a pharmacist did not owe a legal duty to warn a patient of all the possible adverse effects of a prescription drug).
Having satisfied his responsibilities, Dr. Bullen owed no additional duty to warn Patricia merely because he provided informational materials to her that he received from Centocor. Here, Centocor provided the materials as a supplement to the physician-patient relationship, not meant to supplant that relationship. Moreover, none of the allegedly misleading information from Centocor could change the fact that Patricia could not receive Remicade except through a prescription. On the facts of this case, we decline to carve out an additional exception to the learned intermediary doctrine or create a "shared intermediary" duty to warn that would (1) encourage prescription drug manufacturers to withhold educational materials from patients, and (2) require other healthcare providers to second-guess the prescribing physician's decision and undermine the physician-patient relationship. Accordingly, we affirm the trial court's directed verdict in favor of Dr. Bullen, the infusion clinic, and its employees, and hold that, as a matter of law, Dr. Bullen owed no duty to warn Patricia of the potential side effect of lupus-like syndrome.
Because the learned intermediary doctrine applies, we must determine whether the doctrine applies to all of the Hamiltons' claims. Centocor argues that regardless of the pleadings and the questions submitted in the jury charge, all of the Hamiltons' claims, including common-law fraud by omission, were premised on Centocor's alleged failure to warn about Remicade's potential side effects. Therefore, Centocor contends that the learned intermediary doctrine applies to all of the Hamiltons' claims and, accordingly, that it had no duty to warn Patricia directly about Remicade's potential side effects. In response, the Hamiltons contend that it was their prerogative as the plaintiffs to plead and try their case under any theory of liability they chose. They argue that consumers routinely sue for common-law fraud when manufacturers' misrepresentations about their products cause harm, despite this Court's adoption of the Restatement's position on strict products liability, and Texas courts have not imposed any additional burden on consumers to prove failure-to-warn elements from strict products-liability causes of action for common-law claims.
Several federal courts applying Texas law have considered whether a patient can plead around the learned intermediary doctrine by bringing other common-law and non-products-liability claims against a prescription drug manufacturer. See, e.g., Norplant I, 955 F.Supp. at 709. In Norplant I, the plaintiffs brought claims against a prescription drug manufacturer for "strict products liability, negligence, breach of implied warranty of merchantability, misrepresentation, and consumer fraud based upon the Texas [DTPA]" and alleged that the learned intermediary doctrine did not apply to "their claims for misrepresentation and violations of the DTPA arising out of a drug manufacturer's voluntary communications to consumers through physician-distributed materials." Id. at 709-10. Because the alleged misrepresentations and the allegedly false, misleading, and deceptive nature of the prescription drug manufacturer's materials were based on the manufacturer's failure to warn, the federal district court rejected the plaintiffs' argument:
Id. at 709; see Ebel, 536 F.Supp.2d at 773 (applying Texas law) ("Where the crux of the suit is based on a failure to adequately warn, the learned intermediary doctrine may apply to strict liability, negligence,
We find the Norplant I court's application of Texas law persuasive. Here, the Hamiltons initially pled a strict liability claim for failure to warn and retained that claim in their amended petition, but they decided not to carry it forward in their proposed jury charge. Furthermore, the Hamiltons' fraud-by-omission claim is premised solely on its allegation that Centocor knowingly omitted material facts about Remicade's potential to cause lupus-like syndrome. In sum, the crux of the Hamiltons' claims rests on Centocor's alleged failure to provide an adequate warning of the potential risks and side effects associated with Remicade. We hold that when a patient alleges a fraud-by-omission claim against a prescription drug manufacturer for alleged 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.
Although we conclude that the learned intermediary doctrine applies to all of the
Generally, "[t]he adequacy of a warning is a question of fact to be determined by the jury." Alm, 717 S.W.2d at 592; see Bituminous Cas. Corp. v. Black & Decker Mfg. Co., 518 S.W.2d 868, 873 (Tex.Civ.App.-Dallas 1974, writ ref'd n.r.e.). But when 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. See, e.g., Stewart, 780 S.W.2d at 912; Ethicon Endo-Surgery, Inc. v. Meyer, 249 S.W.3d 513, 516 (Tex. App.-Fort Worth 2007, no pet.); see also Ebel, 536 F.Supp.2d at 780 ("[W]here the physicians were unequivocal that new information about the risks would not have changed their decision to prescribe the medication, an inadequate warning was not the proximate cause of plaintiff's injury," and "where a physician testifies that he was aware of the risks of which plaintiff complains, it is then the plaintiff's burden to prove that a different warning would have changed the physician's decision to prescribe the medication." (citations omitted)); Ackermann, 526 F.3d at 209 ("We need not determine, however, whether the warning for risk level of suicide was misleading, because, as [the prescription drug manufacturer] contends, this appeal is resolved on the second prong of the analysis, namely, whether any defect in the [manufacturer's] warning was a substantial cause of [the plaintiff's injury]."). Cf. McNeil v. Wyeth, 462 F.3d 364, 373 (5th Cir.2006) ("Where the physician would have adequately informed a plaintiff of the risks of a disease, had the label been sufficient, but fails to do so on that account, and where the plaintiff would have rejected the drug if informed, the inadequate labeling could be a `producing' cause of the injury, because it effectively sabotages the function of the intermediary.").
Even assuming that the Hamiltons presented sufficient evidence to show that Centocor's warning to Patricia's prescribing physicians was inadequate, the Hamiltons still had to prove that the inadequate warning was the producing cause of Patricia's injuries.
To support their argument that Centocor's warning misrepresented the risks of contracting lupus-like syndrome, causing Patricia's doctors to prescribe the drug, the Hamiltons focused on the three cases of lupus-like syndrome reported on Centocor's 2001 package insert. The package insert stated: "In clinical studies, three patients developed clinical symptoms consistent with a lupus-like syndrome.... No cases of lupus-like reactions have been observed in up to three years of long-term follow-up." In an attempt to show that this warning was misleading, the Hamiltons introduced several documents indicating that Centocor was aware of more post-approval incidents of drug-induced lupus. Specifically, an internal Centocor e-mail referenced at least 174 reports of lupus-like syndrome associated with Remicade as of April 25, 2002.
Even assuming that Centocor's knowledge of at least 174 post-approval reports of lupus-like syndrome and its failure to include that information in the package insert and the informational video made the warning to Patricia's prescribing physicians inadequate or misleading, the undisputed evidence indicates that, even with those cases, the risk of experiencing drug-induced lupus was still "rare." Experts from both sides testified that "rare" is commonly understood in the medical industry to mean less than 1% or 2% of all cases. The uncontroverted testimony of Dr. Matthews indicated that the 174 reported cases were out of nearly 500,000 patients who had received Remicade post-FDA approval — a mere 0.03% of all cases and well below the 1% definition of "rare." Cf. McNeil, 462 F.3d at 368 n. 4 ("We do not mean to suggest that de minimis differences in risk would send the adequacy question to the jury...."). Furthermore, Dr. Matthews testified that based on her review of all the post-approval data, at the time of trial, she believed the chance of developing lupus-like syndrome was still rare. Therefore, even if the patients in the 174 post-approval cases actually developed lupus-like syndrome because of Remicade
Moreover, the Hamiltons failed to show that the warning's alleged inadequacies regarding lupus-like syndrome would have changed Patricia's prescribing physicians' decision to prescribe Remicade in light of her complicated medical history and serious ailments. Dr. Hauptman testified that, based on his review of the academic literature, the Remicade package insert, and information he received from Centocor and through other experts at national meetings, he considered lupus-like syndrome to be a very rare side effect of the drug. Dr. Hauptman stated that he would want to know if Centocor was aware of more cases of patients contracting lupus-like syndrome and he believed reasonable patients would want to know if the risk had become "common or serious." The fact that Dr. Hauptman would consider all clinical trials and post-approval evidence does not prove that he would not have prescribed Remicade — one of only two available treatments for Patricia's Crohn's disease — if additional reports would not have changed the relative risk of the side effect. Even if the additional reports mentioned in the Centocor e-mail constituted valid and reliable evidence of an elevated risk of developing lupus-like syndrome beyond that of a "rare" Remicade side effect, the fact that Dr. Hauptman would have considered such information, if included in the package insert, does not prove that the presence of such information would have changed his decision to prescribe Remicade to Patricia — a critical element of the Hamiltons' claims.
Dr. Pop-Moody also testified that she was aware Remicade could cause lupus-like syndrome, but considered the cases very rare or "[l]ow on the differential." When questioned about the three cases of lupus-like syndrome mentioned on the Remicade package insert, Dr. Pop-Moody testified that those were the only cases she was aware of at that time. Instead of proving that greater risk of lupus-like syndrome would have changed Dr. Pop-Moody's decision to prescribe Remicade, the Hamiltons elicited no evidence to that effect. Like Dr. Hauptman, Dr. Pop-Moody admitted that she would have considered all available and pertinent information when making her decision to prescribe Remicade to Patricia. Yet again, the assertion that a doctor would consider all available information about a prescription drug's risks and benefits before prescribing it does not prove that the alleged omission, which would not have changed the relative risk of contracting a potential side effect, was a producing cause of the patient's injuries.
Not only did the Hamiltons fail to prove that Dr. Pop-Moody would have changed her prescription had Centocor provided information suggesting a higher risk of lupus-like syndrome, but the record indicates the opposite. Although post-approval studies after the Hamiltons filed suit in 2003 showed more reports of lupus-like syndrome and an increase in the number of patients in the pre-approval clinical studies that developed lupus-like syndrome, at the date of trial in 2006, Dr. Pop-Moody stated that she continued to prescribe "a lot of Remicade" and that she believed it to be an effective drug for many of her patients. Dr. Pop-Moody specifically warned Patricia that she might have SLE or lupus-like syndrome in April
Because Patricia's prescribing physicians were aware of the potential risk of contracting lupus-like syndrome but chose to prescribe it in spite of those risks, and because the Hamiltons failed to present any evidence that including additional post-approval reports in the warning would have caused Patricia's physicians to change their prescription, the Hamiltons failed to meet their burden of proof. See Stewart, 780 S.W.2d at 912; see also Ackermann, 526 F.3d at 208 ("If, however, `the physician was aware of the possible risks involved in the use of the product but decided to use it anyway, the adequacy of the warning is not a producing cause of the injury' and the plaintiff's recovery must be denied." (quoting Porterfield v. Ethicon, Inc., 183 F.3d 464, 468 (5th Cir.1999))). Accordingly, because there is no causation evidence to support the Hamiltons' claims, all of which are premised on Centocor's alleged failure to warn, the Hamiltons' claims must fail.
All of the Hamiltons' claims are premised on their theory that Centocor failed to adequately warn Patricia and her prescribing physicians of the risk that she could develop lupus-like syndrome from Remicade. Because the Hamiltons failed to meet their burden of proof on the causation element of their claims, as a matter of law, their claims fail. In sum, we hold that: (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 court of appeals 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 Centocor; (4) Dr. Bullen, as the non-prescribing, treating physician, owed no duty to warn Patricia of the risks associated with Remicade beyond the risks directly attributable to the infusion process; (5) because all of the Hamiltons' claims are premised on Centocor's alleged failure to warn, the learned intermediary doctrine applies to all of their claims; and (6) the Hamiltons failed to introduce any evidence that the allegedly inadequate warning was the producing cause of Patricia's purported injuries. Accordingly, we reverse the portions of the court of appeals' judgment that are inconsistent with this opinion and render judgment that the Hamiltons take nothing.
Id. at 509 (citing Werner v. Colwell, 909 S.W.2d 866, 870 n. 1 (Tex.1995)); see also TEX.R.APP. P. 43.3; Horrocks v. Tex. Dep't of Transp., 852 S.W.2d 498, 499 (Tex.1993). Centocor did, however, properly raise and preserve its causation argument regarding its contention that the Hamiltons failed to present any evidence that a different warning would have prevented Patricia's doctors from prescribing the medication or prevented Patricia from taking Remicade.
Additionally, we note that scores of other intermediate state courts and federal courts applying state law have also recognized the validity of the learned intermediary doctrine within the context of prescription drugs, the physician-patient relationship, and the drug manufacturer's duty to warn. See, e.g., In re Norplant Contraceptive Prods. Liab. Litig. (Norplant III), 215 F.Supp.2d 795, 806-09 (E.D.Tex.2002) (listing cases and noting that the learned intermediary doctrine either applied or was recognized without relevant exception in forty-eight states); Diane Schmauder Kane, Annotation, Construction and Application of Learned-Intermediary Doctrine, 57 A.L.R.5th 1 (1998) (listing cases).
