Consumer Fraud Actions: The Applicability of the Learned Intermediary Doctrine

The learned intermediary doctrine has long been commonly used as a critical defense in personal injury pharmaceutical and medical device failure-to-warn claims. Under the established doctrine, recognized in nearly all states, a pharmaceutical or medical device manufacturer's duty to warn is fulfilled once it has educated the prescribing or implanting physician of the known risks and side effects associated with the product. See In re Norplant Contraceptive Prods. Liab. Litig., 215 F. Supp. 2d 795, 808 (E.D. Tex. 2002); Restatement (Third) of Torts: Prod. Liab. '6 (1998). The learned intermediary doctrine is premised on the principle that the physician has a 'duty to inform himself of the qualities and characteristics of those products which he prescribes for or administers to or uses on his patients, and to exercise independent judgment, taking into account his knowledge of the patient as well as the product.' Ecke v. Parke, Davis & Co., 256 F.3d 1013, 1018 (10th Cir. 2001). The learned intermediary doctrine provides a powerful defense in defeating elements of failure-to-warn claims, such as duty and causation. There is no doubt the learned intermediary doctrine remains an effective tool in defeating pharmaceutical and medical device failure-to-warn claims.

In response to pharmaceutical and medical device companies' mounting litigation successes ' based in large part on the learned intermediary doctrine ' plaintiffs have begun seeking creative ways to circumvent the difficulties they traditionally face in product liability personal injury suits. One new vehicle that is quickly gaining popularity is non-personal injury consumer fraud actions. In contrast to traditional product liability claims, consumer fraud claims usually are based on state statutory consumer protection statutes. Although consumer protection statutes vary from state to state, in most states, a plaintiff must generally allege facts demonstrating that: 1) plaintiff is a consumer; 2) the defendant engaged in acts that were false, misleading, or deceptive; 3) the plaintiff relied on these false, misleading, or deceptive acts; and 4) these acts were a proximate cause of the plaintiff's injuries. See 58 Food Drug L.J. 269, 282 (2003).

Due to the relative novelty of these types of claims, there is much uncertainty surrounding if and how well-established defenses to traditional product liability claims will translate in non-personal injury consumer fraud actions. At the forefront of this uncertainty is the applicability of the learned intermediary doctrine in consumer fraud actions involving pharmaceuticals or medical devices. Of course, due to the varying applications of state consumer protection statutes, pharmaceutical and medical device manufacturers may find themselves in situations where the learned intermediary doctrine will be limited or inapplicable. For example, some state consumer protection statutes do not require a showing of causation or reliance. However, for the most part, the learned intermediary doctrine remains a viable defense. Although there is by no means an abundance of case law on the issue at this time, the general trend appears to weigh in favor of the learned intermediary doctrine in consumer fraud actions.

Deceptive Marketing

In the relatively sparse case law addressing the issue, the heart of the debate often centers on whether consumer fraud product liability actions are merely failure-to-warn claims parading in the costume of consumer statutory claims or whether these actions truly present a different animal. Naturally, plaintiffs argue that consumer fraud actions are based on state statutes enacted for the purpose of protecting consumers from economic harm caused by a defendant's deceptive acts. Thus, in contrast to failure-to-warn claims, the intent and focus of consumer statutes is on whether the defendant's marketing was deceptive or fraudulent, rather than on the sufficiency of the defendant's warning. See Wyeth-Ayerst Lab. Co. v. Medrano, 28 S.W.3d 87, 93-95 (Tex. Ct. App. 2000).

Another argument often asserted by plaintiffs advocating the inapplicability of the learned intermediary doctrine is that a pharmaceutical or medical device manufacturer actually creates a duty to warn patients directly by engaging in an allegedly deceptive marketing scheme through direct-to-consumer advertising. For example, in Heindel v. Pfizer Inc., the plaintiffs claimed that the defendant pharmaceutical manufacturer knew of certain risks posed by its products, but spent millions of dollars advertising those products directly to consumers. The plaintiffs alleged that the defendant engaged in a deceptive scheme when it advertised the subject products as safer than other comparable treatments, without disclosing any allegedly known risks. See Heindel v. Pfizer, Inc., 381 F. Supp. 2d 364, 384 (D. N.J. 2004). In arguing that the learned intermediary doctrine was inapplicable to their claims, the Heindel plaintiffs alleged their economic injury was caused by their reliance on the defendant's advertising, resulting in their purchase of the subject products. See Id.

Consumer Fraud

Defendants in such cases have often responded that the learned intermediary defense applies in all contexts involving prescription drugs or medical devices, regardless of how a plaintiff's claims are legally couched. Such consumer fraud claims are still the same failure-to-warn claims typically found in traditional product liability cases, but have simply been dressed up by plaintiffs in an attempt to circumvent the application of the learned intermediary doctrine. Defendants argue that despite plaintiffs' semantics, the gravamen of consumer fraud claims is that a defendant failed to adequately warn a plaintiff of an alleged danger associated with the subject product. See Beale v. Biomet, Inc., 492 F. Supp. 2d 1360, 1372 (S.D. Fla. 2007).

The vast majority of courts to have addressed this issue are in agreement with defendants and have held that the learned intermediary doctrine applies in the context of consumer fraud actions. As stated by the U.S. District Court for the Eastern District of Texas, 'whether the failure-to-warn is couched as an affirmative misrepresentation or a misrepresentation by concealment, the allegation collapses into a charge that the drug manufacturer failed to warn. If the doctrine could be avoided by casting what is essentially a failure-to-warn claim under a different cause of action such as violation of the [deceptive trade practices act] or a claim for misrepresentation, then the doctrine would be rendered meaningless.' In re Norplant, 955 F. Supp. 700, 709 (E.D. Tex. 1997) (applying Texas law). Other courts have also applied the learned intermediary doctrine in similar consumer fraud suits. See, e.g., Beale, 492 F. Supp. 2d at 1373 (holding same in the context of a medical device) (applying Florida law); Doe v. Solvay Pharm., Inc., 350 F. Supp. 2d 257, 274 (D. Me. 2004) (dismissing plaintiff's failure-to-warn claims, including claims under Maine's Deceptive Trade Practice Act, under the learned intermediary doctrine) (applying Maine law).

Similarly, some courts have held that a plaintiff's claim under a state's consumer protection statute is barred under the learned intermediary doctrine because such claims are in conflict with the learned intermediary doctrine. See Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514, 553 (E.D. Pa. 2006). Consumer fraud statutes generally prohibit deceptive acts by a manufacturer that mislead a consumer. Such statutes also generally require evidence that the defendant's deceptive acts were directed at those consumers. Thus, a plaintiff cannot establish his consumer fraud claims because under the learned intermediary doctrine, all necessary information is directed at the physician. Id.; Heindel, 381 F. Supp. 2d at 384 (holding there can be no cause of action based on an alleged warning omission because pharmaceutical manufacturers have no duty to disclose any information to a plaintiff) (applying Pennsylvania law); New Jersey Citizen Action v. Schering-Plough, 842 A.2d 174, 176-78 (N.J. Super. Ct. App. Div. 2003) ('The ultimate consumer is not in fact free to act on claims made in advertising,' and, therefore, the learned intermediary doctrine bars consumer claims despite direct-to-consumer advertising because of physician intervention in the decision-making process).

In fact, several courts that have not yet addressed the applicability of the learned intermediary doctrine in the context of consumer protection statutes have indicated they will apply the learned intermediary doctrine to all claims involving a drug or device that cannot be obtained without a physician. See, e.g., Talley v. Danek Med., Inc., 179 F.3d 154, 163 (4th Cir. 1999) (holding that where drugs or medical devices that can be prescribed only by a physician are prescribed after having evaluated the patient, the manufacturer of the drug or device only owes a duty to provide the physician with adequate product instructions) (applying Virginia law); Huntman v. Danek Med., Inc., 1998 U.S. Dist. LEXIS 13431, *15-16 (S.D. Cal. July 27, 1998) (holding the learned intermediary doctrine applies to plaintiffs' claims for failure-to-warn, fraud, and breach of warranty because they all arise from the same set of allegations) (applying California law); Catlett v. Wyeth, Inc., 379 F. Supp. 2d 1374, 1381 (M.D. Ga. 2004) ('It is clear that Georgia courts would find the 'learned intermediary rule' encompasses any fraud, fraudulent concealment, misrepresentation, failure-to-warn or breach of warranty claims related to the sale and use of prescription drugs'). Like most courts that have addressed the applicability of the learned intermediary doctrine in consumer fraud actions, those courts that apply the learned intermediary doctrine broadly to failure-to-warn type claims (i.e., common law fraud, breach of warranty) will likely apply the doctrine in consumer fraud cases where the cause of action emanates from failure-to-warn allegations.

However, at least one court has indicated, in dicta, that the learned intermediary doctrine may not apply to unfair and deceptive trade practice actions. See Dellinger v. Pfizer Inc., 2006 U.S. Dist. LEXIS 96355, *19-20 (W.D. N.C. July 19, 2006). Although the Dellinger court ultimately declined to decide the issue, the court noted that the North Carolina statute codifying failure-to-warn causes of action indicates: 'no manufacturer or seller of a product shall be held liable in any product liability action for a claim based upon inadequate warning or instruction unless the claimant proves that the manufacturer or seller acted unreasonably in failing to provide such warning or instruction … ' Id. (citing N.C. Gen. '99B-5). The Dellinger court interpreted the words 'product liability action' as limiting the learned intermediary doctrine to traditional product liability failure-to-warn claims, and not deceptive trade practice actions. Id. Of course, in response to arguments like those presented by the Dellinger court, one could argue based on the rationale of those courts that have directly addressed the issue, that consumer protection actions alleging a deceptive or unfair act against pharmaceutical and medical device manufacturers are one and the same as a failure-to-warn product liability action.

Conclusion

The applicability of the learned intermediary doctrine in the context of consumer fraud actions is still uncertain, and consumer protection and fraud actions against pharmaceutical and medical device manufacturers remain on the rise. Those courts that have squarely addressed the applicability of the learned intermediary doctrine in the context of consumer protection statutes have overwhelmingly provided a familiar framework for defending against personal injury consumer fraud actions. Defense counsel should continue to analyze and develop their defenses around the learned intermediary doctrine.

It continues to remain critically important for defense counsel to understand the role of the prescribing physician to the case. At the outset of the case, defense counsel should assess the claims and determine how the learned intermediary doctrine could be used to defend each claim. For example, testimony by a prescribing physician can be used to defend fraud or misrepresentation claims to show that the prescribing physician did not detrimentally rely on the alleged misrepresentations.

In sum, the learned intermediary doctrine still should serve as a powerful tool in a pharmaceutical or medical device manufacturer's arsenal, even in cases asserting such claims. Pharmaceutical and medical device manufacturers should not shy away from asserting the learned intermediary defense, despite plaintiffs' novel packaging in these nascent pharmaceutical and medical device claims.

Lori G. Cohen is a shareholder with Greenberg Traurig, LLP. She focuses on litigation and trial work for the pharmaceutical and medical device industries, products liability, and medical malpractice. She has been recognized by The National Law Journal as one of 'The 50 Most Influential Women Lawyers in America' and 'Top 40 Under 40,' which highlights the most successful 40 litigators under the age of 40 in the country. Shirley Lee, an associate with Greenberg Traurig, focuses her practice on medical device and pharmaceutical products liability.

The learned intermediary doctrine has long been commonly used as a critical defense in personal injury pharmaceutical and medical device failure-to-warn claims. Under the established doctrine, recognized in nearly all states, a pharmaceutical or medical device manufacturer's duty to warn is fulfilled once it has educated the prescribing or implanting physician of the known risks and side effects associated with the product. See In re Norplant Contraceptive Prods. Liab. Litig., 215 F. Supp. 2d 795, 808 (E.D. Tex. 2002); Restatement (Third) of Torts: Prod. Liab. '6 (1998). The learned intermediary doctrine is premised on the principle that the physician has a 'duty to inform himself of the qualities and characteristics of those products which he prescribes for or administers to or uses on his patients, and to exercise independent judgment, taking into account his knowledge of the patient as well as the product.' Ecke v. Parke, Davis & Co. , 256 F.3d 1013, 1018 (10th Cir. 2001). The learned intermediary doctrine provides a powerful defense in defeating elements of failure-to-warn claims, such as duty and causation. There is no doubt the learned intermediary doctrine remains an effective tool in defeating pharmaceutical and medical device failure-to-warn claims.

In response to pharmaceutical and medical device companies' mounting litigation successes ' based in large part on the learned intermediary doctrine ' plaintiffs have begun seeking creative ways to circumvent the difficulties they traditionally face in product liability personal injury suits. One new vehicle that is quickly gaining popularity is non-personal injury consumer fraud actions. In contrast to traditional product liability claims, consumer fraud claims usually are based on state statutory consumer protection statutes. Although consumer protection statutes vary from state to state, in most states, a plaintiff must generally allege facts demonstrating that: 1) plaintiff is a consumer; 2) the defendant engaged in acts that were false, misleading, or deceptive; 3) the plaintiff relied on these false, misleading, or deceptive acts; and 4) these acts were a proximate cause of the plaintiff's injuries. See 58 Food Drug L.J. 269, 282 (2003).

Due to the relative novelty of these types of claims, there is much uncertainty surrounding if and how well-established defenses to traditional product liability claims will translate in non-personal injury consumer fraud actions. At the forefront of this uncertainty is the applicability of the learned intermediary doctrine in consumer fraud actions involving pharmaceuticals or medical devices. Of course, due to the varying applications of state consumer protection statutes, pharmaceutical and medical device manufacturers may find themselves in situations where the learned intermediary doctrine will be limited or inapplicable. For example, some state consumer protection statutes do not require a showing of causation or reliance. However, for the most part, the learned intermediary doctrine remains a viable defense. Although there is by no means an abundance of case law on the issue at this time, the general trend appears to weigh in favor of the learned intermediary doctrine in consumer fraud actions.

Deceptive Marketing

In the relatively sparse case law addressing the issue, the heart of the debate often centers on whether consumer fraud product liability actions are merely failure-to-warn claims parading in the costume of consumer statutory claims or whether these actions truly present a different animal. Naturally, plaintiffs argue that consumer fraud actions are based on state statutes enacted for the purpose of protecting consumers from economic harm caused by a defendant's deceptive acts. Thus, in contrast to failure-to-warn claims, the intent and focus of consumer statutes is on whether the defendant's marketing was deceptive or fraudulent, rather than on the sufficiency of the defendant's warning. See Wyeth-Ayerst Lab. Co. v. Medrano , 28 S.W.3d 87, 93-95 (Tex. Ct. App. 2000).

Another argument often asserted by plaintiffs advocating the inapplicability of the learned intermediary doctrine is that a pharmaceutical or medical device manufacturer actually creates a duty to warn patients directly by engaging in an allegedly deceptive marketing scheme through direct-to-consumer advertising. For example, in Heindel v. Pfizer Inc. , the plaintiffs claimed that the defendant pharmaceutical manufacturer knew of certain risks posed by its products, but spent millions of dollars advertising those products directly to consumers. The plaintiffs alleged that the defendant engaged in a deceptive scheme when it advertised the subject products as safer than other comparable treatments, without disclosing any allegedly known risks. See Heindel v. Pfizer, Inc. , 381 F. Supp. 2d 364, 384 (D. N.J. 2004). In arguing that the learned intermediary doctrine was inapplicable to their claims, the Heindel plaintiffs alleged their economic injury was caused by their reliance on the defendant's advertising, resulting in their purchase of the subject products. See Id.

Consumer Fraud

Defendants in such cases have often responded that the learned intermediary defense applies in all contexts involving prescription drugs or medical devices, regardless of how a plaintiff's claims are legally couched. Such consumer fraud claims are still the same failure-to-warn claims typically found in traditional product liability cases, but have simply been dressed up by plaintiffs in an attempt to circumvent the application of the learned intermediary doctrine. Defendants argue that despite plaintiffs' semantics, the gravamen of consumer fraud claims is that a defendant failed to adequately warn a plaintiff of an alleged danger associated with the subject product. See Beale v. Biomet, Inc. , 492 F. Supp. 2d 1360, 1372 (S.D. Fla. 2007).

The vast majority of courts to have addressed this issue are in agreement with defendants and have held that the learned intermediary doctrine applies in the context of consumer fraud actions. As stated by the U.S. District Court for the Eastern District of Texas, 'whether the failure-to-warn is couched as an affirmative misrepresentation or a misrepresentation by concealment, the allegation collapses into a charge that the drug manufacturer failed to warn. If the doctrine could be avoided by casting what is essentially a failure-to-warn claim under a different cause of action such as violation of the [deceptive trade practices act] or a claim for misrepresentation, then the doctrine would be rendered meaningless.' In re Norplant, 955 F. Supp. 700, 709 (E.D. Tex. 1997) (applying Texas law). Other courts have also applied the learned intermediary doctrine in similar consumer fraud suits. See, e.g., Beale, 492 F. Supp. 2d at 1373 (holding same in the context of a medical device) (applying Florida law); Doe v. Solvay Pharm., Inc. , 350 F. Supp. 2d 257, 274 (D. Me. 2004) (dismissing plaintiff's failure-to-warn claims, including claims under Maine's Deceptive Trade Practice Act, under the learned intermediary doctrine) (applying Maine law).

Similarly, some courts have held that a plaintiff's claim under a state's consumer protection statute is barred under the learned intermediary doctrine because such claims are in conflict with the learned intermediary doctrine. See Colacicco v. Apotex, Inc. , 432 F. Supp. 2d 514, 553 (E.D. Pa. 2006). Consumer fraud statutes generally prohibit deceptive acts by a manufacturer that mislead a consumer. Such statutes also generally require evidence that the defendant's deceptive acts were directed at those consumers. Thus, a plaintiff cannot establish his consumer fraud claims because under the learned intermediary doctrine, all necessary information is directed at the physician. Id.; Heindel, 381 F. Supp. 2d at 384 (holding there can be no cause of action based on an alleged warning omission because pharmaceutical manufacturers have no duty to disclose any information to a plaintiff) (applying Pennsylvania law); New Jersey Citizen Action v. Schering-Plough , 842 A.2d 174, 176-78 (N.J. Super. Ct. App. Div. 2003) ('The ultimate consumer is not in fact free to act on claims made in advertising,' and, therefore, the learned intermediary doctrine bars consumer claims despite direct-to-consumer advertising because of physician intervention in the decision-making process).

In fact, several courts that have not yet addressed the applicability of the learned intermediary doctrine in the context of consumer protection statutes have indicated they will apply the learned intermediary doctrine to all claims involving a drug or device that cannot be obtained without a physician. See , e.g. , Talley v. Danek Med., Inc. , 179 F.3d 154, 163 (4th Cir. 1999) (holding that where drugs or medical devices that can be prescribed only by a physician are prescribed after having evaluated the patient, the manufacturer of the drug or device only owes a duty to provide the physician with adequate product instructions) (applying Virginia law); Huntman v. Danek Med., Inc., 1998 U.S. Dist. LEXIS 13431, *15-16 (S.D. Cal. July 27, 1998) (holding the learned intermediary doctrine applies to plaintiffs' claims for failure-to-warn, fraud, and breach of warranty because they all arise from the same set of allegations) (applying California law); Catlett v. Wyeth, Inc. , 379 F. Supp. 2d 1374, 1381 (M.D. Ga. 2004) ('It is clear that Georgia courts would find the 'learned intermediary rule' encompasses any fraud, fraudulent concealment, misrepresentation, failure-to-warn or breach of warranty claims related to the sale and use of prescription drugs'). Like most courts that have addressed the applicability of the learned intermediary doctrine in consumer fraud actions, those courts that apply the learned intermediary doctrine broadly to failure-to-warn type claims (i.e., common law fraud, breach of warranty) will likely apply the doctrine in consumer fraud cases where the cause of action emanates from failure-to-warn allegations.

However, at least one court has indicated, in dicta, that the learned intermediary doctrine may not apply to unfair and deceptive trade practice actions. See Dellinger v. Pfizer Inc. , 2006 U.S. Dist. LEXIS 96355, *19-20 (W.D. N.C. July 19, 2006). Although the Dellinger court ultimately declined to decide the issue, the court noted that the North Carolina statute codifying failure-to-warn causes of action indicates: 'no manufacturer or seller of a product shall be held liable in any product liability action for a claim based upon inadequate warning or instruction unless the claimant proves that the manufacturer or seller acted unreasonably in failing to provide such warning or instruction … ' Id. (citing N.C. Gen. '99B-5). The Dellinger court interpreted the words 'product liability action' as limiting the learned intermediary doctrine to traditional product liability failure-to-warn claims, and not deceptive trade practice actions. Id. Of course, in response to arguments like those presented by the Dellinger court, one could argue based on the rationale of those courts that have directly addressed the issue, that consumer protection actions alleging a deceptive or unfair act against pharmaceutical and medical device manufacturers are one and the same as a failure-to-warn product liability action.

Conclusion

The applicability of the learned intermediary doctrine in the context of consumer fraud actions is still uncertain, and consumer protection and fraud actions against pharmaceutical and medical device manufacturers remain on the rise. Those courts that have squarely addressed the applicability of the learned intermediary doctrine in the context of consumer protection statutes have overwhelmingly provided a familiar framework for defending against personal injury consumer fraud actions. Defense counsel should continue to analyze and develop their defenses around the learned intermediary doctrine.

It continues to remain critically important for defense counsel to understand the role of the prescribing physician to the case. At the outset of the case, defense counsel should assess the claims and determine how the learned intermediary doctrine could be used to defend each claim. For example, testimony by a prescribing physician can be used to defend fraud or misrepresentation claims to show that the prescribing physician did not detrimentally rely on the alleged misrepresentations.

In sum, the learned intermediary doctrine still should serve as a powerful tool in a pharmaceutical or medical device manufacturer's arsenal, even in cases asserting such claims. Pharmaceutical and medical device manufacturers should not shy away from asserting the learned intermediary defense, despite plaintiffs' novel packaging in these nascent pharmaceutical and medical device claims.

Lori G. Cohen is a shareholder with Greenberg Traurig, LLP. She focuses on litigation and trial work for the pharmaceutical and medical device industries, products liability, and medical malpractice. She has been recognized by The National Law Journal as one of 'The 50 Most Influential Women Lawyers in America' and 'Top 40 Under 40,' which highlights the most successful 40 litigators under the age of 40 in the country. Shirley Lee, an associate with Greenberg Traurig, focuses her practice on medical device and pharmaceutical products liability.