Perez v. Wyeth and Direct-to-Consumer Ads

The Learned Intermediary Doctrine

The term “learned intermediary” was first coined by the Eighth Circuit Court of Appeals in 1966. Sterling Drug Inc. v. Cornish, 370 F. 2d 82 (8th Cir. 1966). In Sterling Drug, the Eighth Circuit ruled that drug manufacturers have a duty to adequately warn physicians of risks associated with prescription drugs. The court held that because of the physician-patient relationship, doctors serve as “learned intermediaries” between prescription drug manufacturers and patient-consumers. Since Sterling Drug, prescription drug manufacturers have routinely asserted the learned intermediary doctrine as a defense to failure-to-warn claims.

Under most state's failure-to-warn statutes, a plaintiff has the burden of proving that defendant's alleged inadequate product warnings were a proximate cause of his or her injuries. In the prescription pharmaceutical context, the learned intermediary doctrine imposes a further duty on the plaintiff to demonstrate that adequate warnings would have altered the doctor's decision to prescribe the drug at issue. The threshold question in evaluating the adequacy of a drug warning, therefore, is whether or not it effectively communicates the medication's risk to a prescribing physician so that a sufficient risk/benefit analysis may occur before the drug is prescribed.

For example, in the seminal New Jersey case of Strumph v. Schering Corp., 133 N.J. 33 (1993), plaintiff Nancy Strumph alleged that she developed a neuroleptic malignant syndrome (NMS) as a result of her ingestion of Trilafon', a neuroleptic drug she was prescribed by her treating physician. Strumph v. Schering Corp., 256 N.J. Super. 309 (App. Div. 1992), rev'd 133 N.J. 33 (1993). Specifically, plaintiff's complaint asserted that her injury was proximately caused by the defendant pharmaceutical manufacturer's purported failure to adequately warn of the risk of NMS associated with Trilafon use. This premise, however, was directly contradicted by the testimony of the plaintiff's physicians, who emphatically stated that they had full knowledge of the risks associated with Trilafon and that nothing in the post-injury warnings provided by the defendant would have altered their decision to prescribe. Ultimately, the New Jersey Supreme Court affirmed the trial court's grant of summary judgment to the defendant, thereby bringing New Jersey into accord with the majority of jurisdictions that had considered the issue: “A defendant drug manufacturer may not be held liable for an alleged inadequate warning where the only evidence on the issue of causation is the prescribing physician's unequivocal testimony that her decision to prescribe the drug was not affected by the warning.” Id. at 328 (Skillman, J.A.D., dissenting).

Three overriding public policies have been regularly articulated by courts to justify adopting the learned intermediary doctrine. First, physicians are in the best position to warn patients about drug risks and make independent prescribing decisions. Physicians can better weigh the risks and benefits of prescription medications. The learned intermediary doctrine, therefore, appropriately requires drug manufacturers to adequately warn physicians. See, eg, Terhune v. A.H. Robins Co., 577 P.2d 975, 978-79 (Wash. 1978) (“[t]he patient is expected to and, it can be presumed, does place primary reliance upon [the physician's] judgment.”).

Second, drug manufacturers contend that they simply do not have the means to effectively communicate with patients. Even if a warning were to be given directly to patients, many courts have expressed concern that patients are unlikely to understand the technical language contained in such a warning. A patient's inability to fully understand the terminology, therefore, makes it virtually impossible for the manufacturer to adequately warn them. See, eg, Brooks v. Medtronic Inc., 750 F.2d 1227, 1232 (4th Cir. 1984) (positing that direct warnings to patients would be long and complicated and would likely not be in the patient's best interest).

Finally, imposing a duty on pharmaceutical manufacturers to warn patients directly, it is argued, would interfere with the physician-patient relationship. Pharmaceutical manufacturers cannot provide an adequate warning to the patient-consumer because manufacturers can only provide generic, standardized warnings that fail to account for a specific individual's medical needs. To that end, many observers have expressed concern that a manufacturer's warning might overshadow the doctor's more particularized advice. See eg, Curran: Package Inserts for Patients: Informed Consent in the 1980s. 305 N Engl J Med 1564 (1981) (contending that patients who read warning inserts may be dissuaded from taking needed medications ordered by their doctors out of fear of the potential risks involved).

Perez v. Wyeth

In Perez v. Wyeth Laboratories Inc., 161 N.J. 1 (1999), the New Jersey Supreme Court was charged with resolving the apparent conflict between the aforementioned principles underlying the learned intermediary doctrine and the serious public policy concerns created by the modern trend towards DTC pharmaceutical advertising. Perez was a case brought by multiple plaintiffs against Wyeth (formerly known as American Home Products Corporation) for injuries purportedly caused by the prescription contraceptive Norplant. Plaintiffs claimed that Wyeth advertised in popular magazines, but that these advertisements failed to mention any of the potential risks caused by Norplant. Perez, 161 N.J. at 6.

Wyeth moved for summary judgment, arguing that the learned intermediary doctrine applied. Id. at 7. The trial court dismissed plaintiffs' complaints, holding that the learned intermediary doctrine did apply. The court concluded that even where a prescription drug manufacturer markets a product directly to the public, and a patient is arguably influenced by that advertising campaign, the physician's duty to the patient is not alleviated.

Nonetheless, after granting the plaintiffs' petition for certification, the New Jersey Supreme Court concluded that the learned intermediary doctrine must evolve to more adequately reflect the modern prescription drug paradigm.

The court acknowledged a manufacturer's right to communicate with and advertise to the public, but stated that with that right comes the duty to warn of defects. As a result, the court carved out an exception to the learned intermediary doctrine and imposed on pharmaceutical manufacturers a duty to warn consumers of the risks associated with a particular prescription drug when marketing that drug via DTC advertising.

Notably, the court also reiterated that the New Jersey Product Liability Act (NJPLA) provides that where a drug manufacturer has FDA approval for its warning, there is a rebuttable presumption of adequacy. See N.J. Stat. Ann ' 2A:58C-4. While the court acknowledged that this presumption is not “absolute” or “conclusive,” it stated that a pharmaceutical manufacturer's compliance with FDA regulations provides “compelling evidence that [the] manufacturer satisfied its duty to warn.” Perez, 161 N.J. at 24. The court further intimated that “[f]or all practical purposes, absent deliberate concealment or non-disclosure of after-acquired knowledge of harmful effects, compliance with FDA standards should be virtually dispositive of such claims. Id. at 25. Absent an evidentiary proffer of expert testimony alleging this type of malfeasance, the court explained, the adequacy of FDA-approved warnings will not be deemed rebutted, and summary judgment for the manufacturer will be appropriate.

In dissent, Justice Pollock, joined by Justice Garibaldi, excoriated the majority for having, in his opinion, stepped outside the bounds of judicial authority by fashioning an exception to clearly stated legislative policy. “Contrary to the majority opinion, the point of this dissent is not that the court should await legislative action. Rather, the point is that the legislature has already acted. Believing that the court is bound by the [NJPLA], I respectfully dissent.” Id. at 33 (Pollock, J., dissenting). According to the dissenting justices, the New Jersey Legislature implicitly rejected the DTC advertising exception when it codified the learned intermediary doctrine. The dissent opined that the legislature was well aware of DTC advertising when NJPLA was enacted; the omission, therefore, must have been intentional. Justice Pollock explained that the legislative intent undergirding the NJPLA was to bring the New Jersey product liability law back to the mainstream. Several earlier New Jersey Supreme Court decisions were “plaintiff friendly” and New Jersey had become a “favorable forum for out-of-state injured parties.” Id. at 35. Justice Pollock concluded that the majority in Perez was acting without authority and, perhaps more egregiously, against the will of the legislature.

The dissent also posited that the case-specific facts presented in Perez were ill suited to exact the significant policy shift imposed by the majority. Id. at 39-40. In the case of Norplant, a physician or medical professional must insert the contraceptive and must also remove it; this procedure, therefore, is performed within the boundaries of the traditional physician-patient relationship. Id. at 40. Indeed, while the majority emphasized the role of DTC advertising and its influence on consumers, none of the Perez plaintiffs even saw any advertising about Norplant. Id. The majority had, the dissenting justices charged, essentially created “a phantom record to support the creation of its exception to the learned intermediary doctrine.” Id. at 39. Because the facts did not fit the exception they created, the majority had created law based upon a set of presumed facts, which is normally the province of the legislature, not the courts. See Id.

The Lonely Court

In the 6 years since Perez, not one other jurisdiction has elected to follow New Jersey's lead. Numerous plaintiffs have sought to invoke the Perez decision, but none have persuaded other courts to adopt its unique exception to the learned intermediary doctrine.

For example, the Supreme Court of Connecticut refused to adopt the DTC exception in Vitanza v. The Upjohn Co., 257 Conn. 365 (2001). In Vitanza, the plaintiff's husband died after taking a sample packet of the prescription drug Ansaid' that had been given to the plaintiff by her physician almost 2 years earlier. The samples were distributed in a box containing nine blister cards. Each blister card contained four tablets. The problem was that there was only one warning insert per box, and the blister cards themselves did not contain any warnings. The plaintiff sued the drug's manufacturer, alleging that her husband's death was caused by the defendant's failure to provide, on its sample packets, adequate warnings of possible adverse effects of Ansaid. Noting that all recognized exceptions to the learned intermediary doctrine “involve situations where there is a lack of communication between patients and their physicians,” the court found that there was “no reason to create an entirely new exception on the facts of this case because “the traditional doctor-patient relationship existed, there were no communication problems, and adequate warnings were provided to the prescribing physician.” Vitanza, 257 Conn. at 394.

Similarly, the Supreme Court of Kentucky chose not to rule on the validity of any learned intermediary exceptions. See Larkin v. Pfizer Inc., 153 S.W.3d 758 (Ky. 2004). In Larkin, the U.S. Court of Appeals for the Sixth Circuit certified a question of whether, under Kentucky law, the learned intermediary doctrine should apply to a case where a plaintiff alleged his injuries were caused by the purportedly inadequate warnings that accompanied two prescription pharmaceuticals. Answering the question in the affirmative, the court held that where a manufacturer of prescription drugs provides an adequate warning to the prescribing physician, the manufacturer is relieved of its duty to warn the patient regardless of whether or how the physician warns the patient. The Kentucky high court also stated in dicta, however, that “the posture of this case does not require us to decide which, if any, of the recognized exceptions to this rule should be adopted in Kentucky.” Id. at 770.

The U.S. District Court for the Northern District of Ohio refused to apply Perez in cases that were not bound by the New Jersey Supreme Court's precedent. In re: Meridia Products Liability Litigation, 328 F. Supp. 2d 791 (N.D. Ohio 2004). This MDL litigation involved Meridia', a prescription anti-obesity treatment. Plaintiffs alleged that Meridia caused numerous cardiovascular and cerebrovascular injuries, including “heart attack, stroke, tachycardia, heart palpitations, chest pain, high blood pressure, hypertension, and death.” In re: Meridia, 328 F. Supp. 2d at 795. In opposing defendants' motion for summary judgment, the plaintiffs argued that the learned intermediary doctrine should not apply based on the DTC exception created in Perez. Id. at 812. The court disagreed, stating that because it was sitting in diversity, it must apply the law of each state; or where a state's law is silent on a particular issue, its prediction of what that state's supreme court would hold. To that end, the court noted, 5 years had passed since the New Jersey Supreme Court decided Perez and in the interim no other state had followed New Jersey's lead. The court thus concluded that it could not apply Perez's holding to cases lacking a sufficient factual nexus to New Jersey even if it wanted to. For good measure, the court further criticized the plaintiffs' reliance on Perez because they had failed to offer any evidence that defendants violated FDA rules and regulations; thus, even under Perez, their claims could not withstand summary judgment. Id.

The U.S. District Court for the Eastern District of Texas made a very similar ruling in Norplant MDL litigation. See In re Norplant Contraceptive Products Liability Litigation, 215 F. Supp. 2d 795 (E.D. Tx. 2002). In deciding a summary judgment motion, the court had to determine whether the learned intermediary doctrine applied. The court reviewed case law from all 50 states and found that the majority of states (48) either applied or recognized the doctrine without significant exception. Id. at 809. For those jurisdictions, the court held that it would apply the learned intermediary doctrine, thus complying with the law in the overwhelming majority of states. Id. at 810. Still, as to those cases with a sufficient factual nexus to New Jersey, the court was forced to address the anomaly presented by Perez:

“Since Perez, no other court in any jurisdiction has directly addressed an advertising exception to the learned intermediary doctrine, making New Jersey the only jurisdiction to recognize this exception. Accordingly, New Jersey's advertising exception renders the learned intermediary doctrine wholly inapplicable to Norplant cases in this multidistrict litigation, but only to the extent that this court is required to follow the substantive law of New Jersey in deciding the instant motion. This means that New Jersey law is in direct conflict with the law of every other jurisdiction in the United States. Because the court must determine which jurisdiction's law to apply by looking at each individual case in this litigation, the court will examine pending cases that have a factual nexus to New Jersey and perform a choice of law analysis, if necessary.” Id. at 812 (emphasis added).

Accordingly, the court held that the learned intermediary doctrine applied in all cases not governed by New Jersey substantive law.

Conclusion

Immediately following the Perez decision, many legal scholars and commentators questioned the continued viability of the learned intermediary doctrine in an age of the empowered pharmaceutical consumer. Six years later, however, Perez has proven to be the exception, not the rule. While DTC advertising has somewhat altered the calculus of the physician-patient relationship by allowing patients to play a more informed role in the prescribing process, one fundamental tenet of that physician-patient dynamic remains: prescription drugs cannot be dispensed without the physician's involvement. Furthermore, in the years since Perez, both the FDA and the pharmaceutical industry have recognized the need to regulate DTC marketing of prescription drugs. Cumulatively, their continued vigilance is more than sufficient to address that which the Perez court apparently feared most — the unfettered broadcast of falsehoods about potentially dangerous pharmaceuticals to an unsuspecting public.

Alternative Means of Addressing the Policy Concerns Underlying Perez

Notwithstanding the apparent demise of 'the Norman Rockwell image of the family doctor,' Perez, 131 N.J. at 18, Perez's essential holding was rooted in a desire to protect consumers from advertising that misrepresents the safety or efficacy of prescription pharmaceuticals. Id. at 32. (stating that New Jersey's codification of the learned intermediary doctrine was not intended to 'confer on pharmaceutical manufacturers a license to mislead or deceive consumers when those manufacturers elect to exercise their right to advertise their product directly to such consumers'). The court in Perez, of course, chose to effectuate that policy goal by imposing an additional common-law duty on pharmaceutical manufacturers to communicate highly technical scientific and medical information directly to an arguably unsophisticated class of patient consumers. Such a drastic step was hardly necessary.

PhRMA's new guidelines on DTC advertising will help to curb any potential abuses of such advertising. In addition, as the Perez court acknowledged, 'the FDA has established a comprehensive regulatory scheme for direct-to-consumer marketing of pharmaceutical products.' Perez, 131 N.J. at 31. Under the Federal Food, Drug, and Cosmetics Act, Congress has established numerous requirements for the advertisement of prescription drugs, including the requirement that advertisements include a true statement of the drug's 'established name,' the drug's ingredients, and a brief summary of the drug's efficacy, contraindications, and potential side effects. 21 U.S.C. ' 352(n) (2005); 21 C.F.R. ' 202.1 (2005). In addition, in August 1999 the FDA published industry-guidelines 'to assist sponsors who are interested in advertising their prescription human and animal drugs, including biological products for humans, directly to consumers through broadcast media, such as television, radio, or telephone communications systems.' U.S. Department of Health and Human Services, Food and Drug Administration, Guidance for Industry: Consumer-Directed Broadcast Advertisements, available at http://www.fda.gov/cder/guidance/1804fnl.htm (August 1999).

Six years ago, in Perez v. Wyeth Laboratories Inc. , 161 N.J. 1 (1999), the New Jersey Supreme Court enunciated a novel exception to the learned intermediary doctrine intended to address the rise of direct-to-consumer (DTC) marketing of prescription pharmaceuticals. The learned intermediary doctrine is a common law principle, codified in many states, that shields prescription pharmaceutical manufacturers from liability for failing to warn consumers of the potential side-effects associated with their products as long as they have adequately warned prescribing physicians. The Perez court, however, held that when pharmaceutical companies employ DTC advertising, there is an additional duty to warn consumers of potential risks.

Immediately following the controversial ruling, one legal commentator hailed Perez as a “precedent-setting decision likely to have a huge ripple effect within and beyond the pharmaceutical industry.” Ritter N: Learned Intermediary Doctrine: Drug Makers Get a Warning of Their Own. 8 New Jersey Lawyer: The Weekly Newspaper, Aug. 16, 1999, at 1725. Indeed, to many scholars, Perez signaled the end of the age of “doctor knows best,” and thereby the end of the learned intermediary doctrine's relevance. See Perez, 161 N.J. at 4.

Reports of the learned intermediary doctrine's eventual demise, however, were greatly exaggerated. Since Perez, no other jurisdiction that recognizes the doctrine has adopted the DTC exception. Nor, as many predicted, has the learned intermediary doctrine been legislatively eviscerated to combat the continued rise of DTC advertising for prescription pharmaceuticals. Rather, the public policy concerns underlying Perez have proven to be more adequately and efficiently addressed by regulatory enactments of the Food and Drug Administration (FDA), as well as self-policing on the part of the pharmaceutical industry itself.

The Learned Intermediary Doctrine

The term “learned intermediary” was first coined by the Eighth Circuit Court of Appeals in 1966. Sterling Drug Inc. v. Cornish , 370 F. 2d 82 (8th Cir. 1966). In Sterling Drug, the Eighth Circuit ruled that drug manufacturers have a duty to adequately warn physicians of risks associated with prescription drugs. The court held that because of the physician-patient relationship, doctors serve as “learned intermediaries” between prescription drug manufacturers and patient-consumers. Since Sterling Drug, prescription drug manufacturers have routinely asserted the learned intermediary doctrine as a defense to failure-to-warn claims.

Under most state's failure-to-warn statutes, a plaintiff has the burden of proving that defendant's alleged inadequate product warnings were a proximate cause of his or her injuries. In the prescription pharmaceutical context, the learned intermediary doctrine imposes a further duty on the plaintiff to demonstrate that adequate warnings would have altered the doctor's decision to prescribe the drug at issue. The threshold question in evaluating the adequacy of a drug warning, therefore, is whether or not it effectively communicates the medication's risk to a prescribing physician so that a sufficient risk/benefit analysis may occur before the drug is prescribed.

For example, in the seminal New Jersey case of Strumph v. Schering Corp. , 133 N.J. 33 (1993), plaintiff Nancy Strumph alleged that she developed a neuroleptic malignant syndrome (NMS) as a result of her ingestion of Trilafon ' , a neuroleptic drug she was prescribed by her treating physician. Strumph v. Schering Corp. , 256 N.J. Super. 309 (App. Div. 1992), rev'd 133 N.J. 33 (1993). Specifically, plaintiff's complaint asserted that her injury was proximately caused by the defendant pharmaceutical manufacturer's purported failure to adequately warn of the risk of NMS associated with Trilafon use. This premise, however, was directly contradicted by the testimony of the plaintiff's physicians, who emphatically stated that they had full knowledge of the risks associated with Trilafon and that nothing in the post-injury warnings provided by the defendant would have altered their decision to prescribe. Ultimately, the New Jersey Supreme Court affirmed the trial court's grant of summary judgment to the defendant, thereby bringing New Jersey into accord with the majority of jurisdictions that had considered the issue: “A defendant drug manufacturer may not be held liable for an alleged inadequate warning where the only evidence on the issue of causation is the prescribing physician's unequivocal testimony that her decision to prescribe the drug was not affected by the warning.” Id. at 328 (Skillman, J.A.D., dissenting).

Three overriding public policies have been regularly articulated by courts to justify adopting the learned intermediary doctrine. First, physicians are in the best position to warn patients about drug risks and make independent prescribing decisions. Physicians can better weigh the risks and benefits of prescription medications. The learned intermediary doctrine, therefore, appropriately requires drug manufacturers to adequately warn physicians. See, eg, Terhune v. A.H. Robins Co., 577 P.2d 975, 978-79 (Wash. 1978) (“[t]he patient is expected to and, it can be presumed, does place primary reliance upon [the physician's] judgment.”).

Second, drug manufacturers contend that they simply do not have the means to effectively communicate with patients. Even if a warning were to be given directly to patients, many courts have expressed concern that patients are unlikely to understand the technical language contained in such a warning. A patient's inability to fully understand the terminology, therefore, makes it virtually impossible for the manufacturer to adequately warn them. See, eg, Brooks v. Medtronic Inc. , 750 F.2d 1227, 1232 (4th Cir. 1984) (positing that direct warnings to patients would be long and complicated and would likely not be in the patient's best interest).

Finally, imposing a duty on pharmaceutical manufacturers to warn patients directly, it is argued, would interfere with the physician-patient relationship. Pharmaceutical manufacturers cannot provide an adequate warning to the patient-consumer because manufacturers can only provide generic, standardized warnings that fail to account for a specific individual's medical needs. To that end, many observers have expressed concern that a manufacturer's warning might overshadow the doctor's more particularized advice. See eg, Curran: Package Inserts for Patients: Informed Consent in the 1980s. 305 N Engl J Med 1564 (1981) (contending that patients who read warning inserts may be dissuaded from taking needed medications ordered by their doctors out of fear of the potential risks involved).

Perez v. Wyeth

In Perez v. Wyeth Laboratories Inc. , 161 N.J. 1 (1999), the New Jersey Supreme Court was charged with resolving the apparent conflict between the aforementioned principles underlying the learned intermediary doctrine and the serious public policy concerns created by the modern trend towards DTC pharmaceutical advertising. Perez was a case brought by multiple plaintiffs against Wyeth (formerly known as American Home Products Corporation) for injuries purportedly caused by the prescription contraceptive Norplant. Plaintiffs claimed that Wyeth advertised in popular magazines, but that these advertisements failed to mention any of the potential risks caused by Norplant. Perez, 161 N.J. at 6.

Wyeth moved for summary judgment, arguing that the learned intermediary doctrine applied. Id. at 7. The trial court dismissed plaintiffs' complaints, holding that the learned intermediary doctrine did apply. The court concluded that even where a prescription drug manufacturer markets a product directly to the public, and a patient is arguably influenced by that advertising campaign, the physician's duty to the patient is not alleviated.

Nonetheless, after granting the plaintiffs' petition for certification, the New Jersey Supreme Court concluded that the learned intermediary doctrine must evolve to more adequately reflect the modern prescription drug paradigm.

The court acknowledged a manufacturer's right to communicate with and advertise to the public, but stated that with that right comes the duty to warn of defects. As a result, the court carved out an exception to the learned intermediary doctrine and imposed on pharmaceutical manufacturers a duty to warn consumers of the risks associated with a particular prescription drug when marketing that drug via DTC advertising.

Notably, the court also reiterated that the New Jersey Product Liability Act (NJPLA) provides that where a drug manufacturer has FDA approval for its warning, there is a rebuttable presumption of adequacy. See N.J. Stat. Ann ' 2A:58C-4. While the court acknowledged that this presumption is not “absolute” or “conclusive,” it stated that a pharmaceutical manufacturer's compliance with FDA regulations provides “compelling evidence that [the] manufacturer satisfied its duty to warn.” Perez, 161 N.J. at 24. The court further intimated that “[f]or all practical purposes, absent deliberate concealment or non-disclosure of after-acquired knowledge of harmful effects, compliance with FDA standards should be virtually dispositive of such claims. Id. at 25. Absent an evidentiary proffer of expert testimony alleging this type of malfeasance, the court explained, the adequacy of FDA-approved warnings will not be deemed rebutted, and summary judgment for the manufacturer will be appropriate.

In dissent, Justice Pollock, joined by Justice Garibaldi, excoriated the majority for having, in his opinion, stepped outside the bounds of judicial authority by fashioning an exception to clearly stated legislative policy. “Contrary to the majority opinion, the point of this dissent is not that the court should await legislative action. Rather, the point is that the legislature has already acted. Believing that the court is bound by the [NJPLA], I respectfully dissent.” Id. at 33 (Pollock, J., dissenting). According to the dissenting justices, the New Jersey Legislature implicitly rejected the DTC advertising exception when it codified the learned intermediary doctrine. The dissent opined that the legislature was well aware of DTC advertising when NJPLA was enacted; the omission, therefore, must have been intentional. Justice Pollock explained that the legislative intent undergirding the NJPLA was to bring the New Jersey product liability law back to the mainstream. Several earlier New Jersey Supreme Court decisions were “plaintiff friendly” and New Jersey had become a “favorable forum for out-of-state injured parties.” Id. at 35. Justice Pollock concluded that the majority in Perez was acting without authority and, perhaps more egregiously, against the will of the legislature.

The dissent also posited that the case-specific facts presented in Perez were ill suited to exact the significant policy shift imposed by the majority. Id. at 39-40. In the case of Norplant, a physician or medical professional must insert the contraceptive and must also remove it; this procedure, therefore, is performed within the boundaries of the traditional physician-patient relationship. Id. at 40. Indeed, while the majority emphasized the role of DTC advertising and its influence on consumers, none of the Perez plaintiffs even saw any advertising about Norplant. Id. The majority had, the dissenting justices charged, essentially created “a phantom record to support the creation of its exception to the learned intermediary doctrine.” Id. at 39. Because the facts did not fit the exception they created, the majority had created law based upon a set of presumed facts, which is normally the province of the legislature, not the courts. See Id.

The Lonely Court

In the 6 years since Perez, not one other jurisdiction has elected to follow New Jersey's lead. Numerous plaintiffs have sought to invoke the Perez decision, but none have persuaded other courts to adopt its unique exception to the learned intermediary doctrine.

For example, the Supreme Court of Connecticut refused to adopt the DTC exception in Vitanza v. The Upjohn Co. , 257 Conn. 365 (2001). In Vitanza, the plaintiff's husband died after taking a sample packet of the prescription drug Ansaid' that had been given to the plaintiff by her physician almost 2 years earlier. The samples were distributed in a box containing nine blister cards. Each blister card contained four tablets. The problem was that there was only one warning insert per box, and the blister cards themselves did not contain any warnings. The plaintiff sued the drug's manufacturer, alleging that her husband's death was caused by the defendant's failure to provide, on its sample packets, adequate warnings of possible adverse effects of Ansaid. Noting that all recognized exceptions to the learned intermediary doctrine “involve situations where there is a lack of communication between patients and their physicians,” the court found that there was “no reason to create an entirely new exception on the facts of this case because “the traditional doctor-patient relationship existed, there were no communication problems, and adequate warnings were provided to the prescribing physician.” Vitanza, 257 Conn. at 394.

Similarly, the Supreme Court of Kentucky chose not to rule on the validity of any learned intermediary exceptions. See Larkin v. Pfizer Inc. , 153 S.W.3d 758 (Ky. 2004). In Larkin, the U.S. Court of Appeals for the Sixth Circuit certified a question of whether, under Kentucky law, the learned intermediary doctrine should apply to a case where a plaintiff alleged his injuries were caused by the purportedly inadequate warnings that accompanied two prescription pharmaceuticals. Answering the question in the affirmative, the court held that where a manufacturer of prescription drugs provides an adequate warning to the prescribing physician, the manufacturer is relieved of its duty to warn the patient regardless of whether or how the physician warns the patient. The Kentucky high court also stated in dicta, however, that “the posture of this case does not require us to decide which, if any, of the recognized exceptions to this rule should be adopted in Kentucky.” Id. at 770.

The U.S. District Court for the Northern District of Ohio refused to apply Perez in cases that were not bound by the New Jersey Supreme Court's precedent. In re: Meridia Products Liability Litigation, 328 F. Supp. 2d 791 (N.D. Ohio 2004). This MDL litigation involved Meridia', a prescription anti-obesity treatment. Plaintiffs alleged that Meridia caused numerous cardiovascular and cerebrovascular injuries, including “heart attack, stroke, tachycardia, heart palpitations, chest pain, high blood pressure, hypertension, and death.” In re: Meridia, 328 F. Supp. 2d at 795. In opposing defendants' motion for summary judgment, the plaintiffs argued that the learned intermediary doctrine should not apply based on the DTC exception created in Perez. Id. at 812. The court disagreed, stating that because it was sitting in diversity, it must apply the law of each state; or where a state's law is silent on a particular issue, its prediction of what that state's supreme court would hold. To that end, the court noted, 5 years had passed since the New Jersey Supreme Court decided Perez and in the interim no other state had followed New Jersey's lead. The court thus concluded that it could not apply Perez's holding to cases lacking a sufficient factual nexus to New Jersey even if it wanted to. For good measure, the court further criticized the plaintiffs' reliance on Perez because they had failed to offer any evidence that defendants violated FDA rules and regulations; thus, even under Perez, their claims could not withstand summary judgment. Id.

The U.S. District Court for the Eastern District of Texas made a very similar ruling in Norplant MDL litigation. See In re Norplant Contraceptive Products Liability Litigation, 215 F. Supp. 2d 795 (E.D. Tx. 2002). In deciding a summary judgment motion, the court had to determine whether the learned intermediary doctrine applied. The court reviewed case law from all 50 states and found that the majority of states (48) either applied or recognized the doctrine without significant exception. Id. at 809. For those jurisdictions, the court held that it would apply the learned intermediary doctrine, thus complying with the law in the overwhelming majority of states. Id. at 810. Still, as to those cases with a sufficient factual nexus to New Jersey, the court was forced to address the anomaly presented by Perez:

“Since Perez, no other court in any jurisdiction has directly addressed an advertising exception to the learned intermediary doctrine, making New Jersey the only jurisdiction to recognize this exception. Accordingly, New Jersey's advertising exception renders the learned intermediary doctrine wholly inapplicable to Norplant cases in this multidistrict litigation, but only to the extent that this court is required to follow the substantive law of New Jersey in deciding the instant motion. This means that New Jersey law is in direct conflict with the law of every other jurisdiction in the United States. Because the court must determine which jurisdiction's law to apply by looking at each individual case in this litigation, the court will examine pending cases that have a factual nexus to New Jersey and perform a choice of law analysis, if necessary.” Id. at 812 (emphasis added).

Accordingly, the court held that the learned intermediary doctrine applied in all cases not governed by New Jersey substantive law.

Conclusion

Immediately following the Perez decision, many legal scholars and commentators questioned the continued viability of the learned intermediary doctrine in an age of the empowered pharmaceutical consumer. Six years later, however, Perez has proven to be the exception, not the rule. While DTC advertising has somewhat altered the calculus of the physician-patient relationship by allowing patients to play a more informed role in the prescribing process, one fundamental tenet of that physician-patient dynamic remains: prescription drugs cannot be dispensed without the physician's involvement. Furthermore, in the years since Perez, both the FDA and the pharmaceutical industry have recognized the need to regulate DTC marketing of prescription drugs. Cumulatively, their continued vigilance is more than sufficient to address that which the Perez court apparently feared most — the unfettered broadcast of falsehoods about potentially dangerous pharmaceuticals to an unsuspecting public.

Alternative Means of Addressing the Policy Concerns Underlying Perez

Notwithstanding the apparent demise of 'the Norman Rockwell image of the family doctor,' Perez, 131 N.J. at 18, Perez's essential holding was rooted in a desire to protect consumers from advertising that misrepresents the safety or efficacy of prescription pharmaceuticals. Id. at 32. (stating that New Jersey's codification of the learned intermediary doctrine was not intended to 'confer on pharmaceutical manufacturers a license to mislead or deceive consumers when those manufacturers elect to exercise their right to advertise their product directly to such consumers'). The court in Perez, of course, chose to effectuate that policy goal by imposing an additional common-law duty on pharmaceutical manufacturers to communicate highly technical scientific and medical information directly to an arguably unsophisticated class of patient consumers. Such a drastic step was hardly necessary.

PhRMA's new guidelines on DTC advertising will help to curb any potential abuses of such advertising. In addition, as the Perez court acknowledged, 'the FDA has established a comprehensive regulatory scheme for direct-to-consumer marketing of pharmaceutical products.' Perez, 131 N.J. at 31. Under the Federal Food, Drug, and Cosmetics Act, Congress has established numerous requirements for the advertisement of prescription drugs, including the requirement that advertisements include a true statement of the drug's 'established name,' the drug's ingredients, and a brief summary of the drug's efficacy, contraindications, and potential side effects. 21 U.S.C. ' 352(n) (2005); 21 C.F.R. ' 202.1 (2005). In addition, in August 1999 the FDA published industry-guidelines 'to assist sponsors who are interested in advertising their prescription human and animal drugs, including biological products for humans, directly to consumers through broadcast media, such as television, radio, or telephone communications systems.' U.S. Department of Health and Human Services, Food and Drug Administration, Guidance for Industry: Consumer-Directed Broadcast Advertisements, available at http://www.fda.gov/cder/guidance/1804fnl.htm (August 1999).