The Mensing Preemption and the Learned Intermediary Doctrine

Unlike most product liability actions in which a manufacturer owes a duty to warn end-users of product risks, in the prescription drug context, “the manufacturer's duty to warn extends only to the prescribing physician, who then assumes responsibility for advising the individual patient of risks associated with the drug or device.” Odom v. G.D. Searle & Co., 979 F.2d 1001, 1003 (4th Cir. 1992). In other words, “a drug manufacturer discharges its duty to consumers by reasonably informing prescribing physicians of the dangers of harm from a drug.” Stahl v. Novartis Pharmaceuticals Corp., 283 F.3d 254, 265'66 (5th Cir. 2002), cert. denied, 123 S.Ct. 111 (2002). “The rationale for the doctrine is that the treating physician is in a better position to warn the patient than the manufacturer, in that the decision to employ prescription medication involves professional assessment of medical risks in light of the physician's knowledge of a patient's particular need and susceptibilities.” Dietz, 598 F.3d at 815 (quotations omitted).

The vast majority of states recognize and apply the learned intermediary doctrine to prescription drug product liability actions. One court has noted the doctrine either applies or is recognized in 48 states, the District of Columbia, and Puerto Rico. See In re Norplant Contraceptive Prod. Liab. Litig., 215 F.Supp.2d 795, 806 (E.D.Tex. 2002). In fact, West Virginia is the only state that has completely rejected the Learned Intermediary Doctrine. See State ex rel. Johnson & Johnson Corp. v. Karl, 220 W.Va. 463, 647 S.E.2d 899, 906, 914 (2007).

In jurisdictions recognizing the Learned Intermediary Doctrine, the doctrine generally applies to all theories of product liability, including negligence, strict liability, and breach of warranty. See Hill v. Searle Laboratories, Inc., 884 F.2d 1064, 1070 (8th Cir. 1989). Further, the Learned Intermediary Doctrine forecloses a patient's failure-to-warn claim even if the warning did not include the specific risk complained of, so long as the doctor: 1) was aware of the information that allegedly should have been provided about the risk; or 2) would have taken the same action even if the manufacturer had included that information in its warnings. See, e.g., Odom, 979 F.2d at 1003 (“the manufacturer cannot be said to have caused the injury if the doctor already knew of the medical risk.”) (quotations omitted); Motus v. Pfizer Inc., 358 F.3d 659, 661 (9th Cir. 2004) (“a product defect claim based on insufficient warnings cannot survive summary judgment if stronger warnings would not have altered the conduct of the prescribing physician”).

Pliva, Inc. v. Mensing

The consolidated lawsuits in Mensing “involve[d] state tort-law claims based on certain drug manufacturers' alleged failure to provide adequate warning labels for generic metoclopramide (“MCP”).” Mensing, 131 S. Ct. at 2572. Faced with the question of “whether federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, these state-law claims,” the Supreme Court held unequivocally and broadly that they do. Id. Finding compliance with both state tort law and federal law governing generic drug labeling to be impossible, the Supreme Court held:

[S]tate law imposed on the [generic] Manufacturers a duty to attach a safer label to their generic metoclopramide. Federal law, however, demanded that generic drug labels be the same at all times as the corresponding brand-name labels. Thus, it was impossible for the [generic] Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same.

Id. at 2572

The majority opinion recognized the decision would be dispositive of essentially all product liability claims against generic manufacturers, beyond just failure-to-warn claims, holding that “because pharmacists, acting in full accord with state law, substituted generic [for the branded], federal law pre-empts these lawsuits.” Id. at 2581 (emphasis supplied). The four dissenting justices also lamented the fatal effect of the decision on a plaintiff's entire cause of action against generic manufacturers, stating “[i]f a consumer takes a generic drug, as occurs 75 percent of the time, she now has no right to sue.” Id. at 2592 (Sotomayor, J., dissenting, joined by Breyer, Ginsburg, & Kagan, JJ.) (emphasis supplied).

'Failure-to-Timely-Update Labeling' and 'Failure-to-Communicate Label Change'

Courts have, for the most part, rejected attempts by creative plaintiffs' attorneys to plead around the preemption recognized in Mensing. However, several courts have carved out exceptions to Mensing's preemption requirement for particular claims. Many plaintiffs have begun characterizing their claims not as pure failure-to-warn claims that are undoubtedly preempted under Mensing, but rather as claims alleging that the generic manufacturer failed to timely update its drug label to correspond with changes to the brand-name or reference-listed drug (“RLD”) counterpart. Failure-to-update claims attempt to differentiate from typical failure-to-warn claims by asserting that a generic manufacturer would not be violating the federal duty of sameness by updating its label to incorporate label changes added by the branded drug, and therefore plaintiffs reason that impossibility preemption would not apply to bar such a claim.

While a handful of state and federal courts have recognized failure-to-update and failure-to-communicate claims as exceptions to Mensing preemption, a growing number of courts have found failure-to-timely-update claims still fall within Mensing's broad preemption holding. See, e.g., In re Darvocet, Darvon and Propoxyphene Prod. Liab. Litig. (“In re Propoxphene“), No. 2:11-md-2226-DCR, 2012 WL 718618, at *4 (E.D. Ky. March 5, 2012) (noting plaintiffs' failure-to-update claim was not only insufficiently pled, but also was likely preempted); Bell v. Pliva, Inc., No. 5:10-cv-00101-BSM, 2012 WL 640742 (E.D. Ark. Feb. 16, 2012) (finding even if the manufacturer did fail to incorporate a label change, any claim challenging this failure was still preempted); Gross v. Pfizer, Inc., No. 10-cv-00110-AW, 2011 WL 5865267, at *4 (D. Md. Nov. 22, 2011) (the weight of authority suggests claims for a generic manufacturer's failure-to-timely-update are unavailing). In rejecting failure-to-update claims, these courts have often noted the Mensing Court. The Eighth Circuit on remand in Mensing, and the Sixth Circuit in Smith were presented with similar failure-to-timely update arguments, but nonetheless found the claims preempted. See, e.g., In re Propoxypyhene, 2012 WL 718618 at *4, n.8.

However, a handful of state and federal courts have recognized an exception to Mensing preemption for failure-to-timely-update claims. See, e.g., Fisher v. Pelstring, No. 4:09-cv-00252-TLW, 2011 WL 4552464, at *10 (D.S.C. Sept. 30, 2011) (recognizing failure to update and failure -to -communicate claims); Couick, 2012 WL 77670, at *3-5 (recognizing failure-to-update claim); Lyman v. Pfizer, No. 2:09-cv-262, 2012 WL 368675, at *5 (D. Vt. Feb. 3, 2012) (same). These courts have generally focused on the fact that once a branded drug or RLD changes its labeling, generic companies are no longer barred from unilaterally changing their own labeling to correspond with the RLD's changes. See Couick, 2012 WL 79670, at *5. Thus, these courts have held, because federal law requiring generic labeling to be identical to brand labeling, it no longer conflicts with state law claims challenging the sufficiency of the generic drug's labeling, and thus such claims are not barred by impossibility preemption. In the same vein, “failure-to-communicate” claims generally assert that a generic drug manufacturer could have communicated or disseminated changes to its warnings to health care professionals, provided such communications were consistent with and were not additional to the labeling itself. See, e.g, Moretti v. Pliva, No. 2:08-cv-00396-JCM, 2012 WL 628502, at *5 (D. Nev. Feb. 27, 2012) (addressing claim alleging defendant's “'failure-to-communicate' warnings about metoclopramide by 'tools' other than labeling”). One of the most common avenues that plaintiffs assert drug manufacturers could have utilized are “Dear Doctor” or “Dear Health Care Professional” letters. These types of letters are a common means by which drug manufacturers sometimes disseminate information about their drug products to health care professionals.

Numerous courts have held that claims alleging that a generic defendant failed to communicate warnings to health care professionals are preempted by Mensing. See, e.g., Guarino v. Wyeth LLC, No. 8:10'cv'2885, 2011 WL 5358709, at *3 (M.D.Fla. Nov. 7, 2011) (Mensing rejected failure-to-communicate claim based on “Dear Doctor” letters); Grinage v. Mylan Pharm., Inc., No. CCB-11-1436, 2011 WL 6951962, at *3-4 (D. Md. Dec. 31, 2011) (rejecting argument that generic drug manufacturer could have more effectively communicated warnings to healthcare professionals through “Dear Doctor” letters, training programs, or notifications); Kellogg v. Wyeth, No. 2:07-cv-82, 2012 WL 368658, *4-5 (D.Vt. Feb. 3, 2012) (plaintiff's claim alleging that defendants could have provided warning through dissemination of nonpromotional information was preempted). As one federal court has recognized, “[a]ny claim based on the errors in the label ' or omissions in labeling or communications with health providers ' is pre-empted by the FDA regulations for the same reason that failure-to-warn claims are pre-empted.” Coney, 2012 WL 170143 at *7 (emphasis added).

These courts have often relied heavily on the Mensing Court's discussion of Dear Doctor letters. In Mensing, the Court recognized that, because Dear Doctor letters constituted labeling under FDA regulations, a “Dear Doctor letter that contained substantial new warning information would not be consistent with the drug's approved labeling.” Mensing, 131 S.Ct. at 2576. The Supreme Court further reasoned that “if generic drug manufacturers, but not the brand-name manufacturer, sent such letters, that would inaccurately imply a therapeutic difference between the brand and generic drugs.” Id.

Despite Mensing's clear directive on Dear Doctor letters, a handful of state and federal courts have also recognized a failure-to-communicate exception to preemption. See, e.g., Fisher, 2011 WL 4552464, at *10 (recognizing failure-to -update and failure -to -communicate claims); Brasley-Thrash v. Teva Pharmaceuticals USA, Inc., No. 10-100031-KD-N, 2011 WL 4025734, *3 (S.D. Ala. Sept. 12, 2011) (recognizing failure-to-communicate claim); Sacks v. Endoscopy Ctr. of So. Nev., LLC, Nos. 08A572315, 08A576071, 09A583058, 2011 WL 4915174 (Nev. Dist. Ct. July 28, 2011) (same); Keck v. Endoscopy Ctr. of So. Nev., LLC, Nos. A575837, A579660, A582492, 2011 WL 3921690 (Nev. Dist. Ct. Aug. 19, 2011) (same).

Fundamental Problem

Most of these cases ignore a fundamental problem with failure-to-update and failure-to-communicate theories of liability, one that is unique to the generic drug industry: generally, doctors and other health care professionals do not see the labeling or package insert for generic drugs dispensed by pharmacies, and instead only learn of label changes through third-party publications that compile label information such as the Physician's Desk Reference (“PDR”) or by receiving communications from the brand manufacturer about the new labeling. As a result, plaintiffs' attorneys often focus on the hypothetical scenario where a brand manufacturer may have recently revised its labeling but generic manufacturers have not yet done so for their corresponding generic products, a scenario in which plaintiffs will argue physicians may potentially prescribe drug products without having seen the latest labeling for the actual product prescribed. However, to date, few courts have fully or accurately grasped the realities of how physicians receive information about the drugs they prescribe and, correspondingly, how the learned intermediary doctrine should affect the Mensing preemption analysis.

Sara K. Thompson is Of Counsel in Greenberg Traurig, LLP's Atlanta office. Sean P. Jessee is an Associate in the same office.

The Supreme Court's landmark decision in Pliva, Inc. v. Mensing , 131 S. Ct. 2567 (2011), has had a far-reaching effect on product liability litigation against generic drug manufacturers, with numerous federal and state courts having held in Mensing's wake that impossibility preemption essentially forecloses all potential product liability claims against generic drug manufacturers. See, e.g., Smith v. Wyeth, Inc. , 657 F.3d 420, 423 (6th Cir. 2011) (rejecting contention that claims for negligence, breach of warranty, design defect, and violation of state consumer protection laws survived preemption); In re Pamidronate Prod. Liab. Litig., No. 10-cv-1860-KAM-SMG, 2012 WL 272889 (E.D.N.Y. Jan. 30, 2012) (failure-to-warn, design defect, negligence, and breach of warranty claims are all preempted); Henderson v. Sun Pharm. Indus., Ltd., No. 4:11-cv-0060-HLM, 2011 WL 4015658 (N.D. Ga. Aug. 22, 2011) (all claims remaining are preempted).

However, a minority of courts have been hesitant to adopt this broad interpretation of Mensing, and have chosen instead to carve out claims that can survive a preemption challenge. Indeed, several courts have rejected preemption for claims alleging a generic drug manufacturer failed to timely update its labeling to correspond with label changes to the brand-name equivalent or reference listed drugs, while other courts have held that claims premised upon a purported failure to communicate a label change to health care providers through broader dissemination means such as a “dear doctor letter” are not preempted. See, e.g., Fisher v. Pelstring, No. 4:09-cv-00252-TLW, 2011 WL 4552464, at *10 (D.S.C. Sept. 30, 2011) (recognizing failure-to-update and failure-to-communicate claims); Couick v. Wyeth, No. 3:09-cv-210-RJC-DSC, 2012 WL 77670, at *3-5 (W.D.N.C. Jan. 11, 2012) (recognizing failure to update claim). However, while focusing on the Mensing preemption analysis and attempting to carve out remaining exceptions that the Mensing court never recognized, these courts have often overlooked the effect that the Learned Intermediary Doctrine and basic differences between the sales and marketing practices for generic and brand-name drugs have on these types of claims.

The Learned Intermediary Doctrine

Unlike most product liability actions in which a manufacturer owes a duty to warn end-users of product risks, in the prescription drug context, “the manufacturer's duty to warn extends only to the prescribing physician, who then assumes responsibility for advising the individual patient of risks associated with the drug or device.” Odom v. G.D. Searle & Co. , 979 F.2d 1001, 1003 (4th Cir. 1992). In other words, “a drug manufacturer discharges its duty to consumers by reasonably informing prescribing physicians of the dangers of harm from a drug.” Stahl v. Novartis Pharmaceuticals Corp. , 283 F.3d 254, 265'66 (5th Cir. 2002), cert. denied, 123 S.Ct. 111 (2002). “The rationale for the doctrine is that the treating physician is in a better position to warn the patient than the manufacturer, in that the decision to employ prescription medication involves professional assessment of medical risks in light of the physician's knowledge of a patient's particular need and susceptibilities.” Dietz , 598 F.3d at 815 (quotations omitted).

The vast majority of states recognize and apply the learned intermediary doctrine to prescription drug product liability actions. One court has noted the doctrine either applies or is recognized in 48 states, the District of Columbia, and Puerto Rico. See In re Norplant Contraceptive Prod. Liab. Litig., 215 F.Supp.2d 795, 806 (E.D.Tex. 2002). In fact, West Virginia is the only state that has completely rejected the Learned Intermediary Doctrine. See State ex rel. Johnson & Johnson Corp. v. Karl , 220 W.Va. 463, 647 S.E.2d 899, 906, 914 (2007).

In jurisdictions recognizing the Learned Intermediary Doctrine, the doctrine generally applies to all theories of product liability, including negligence, strict liability, and breach of warranty. See Hill v. Searle Laboratories, Inc. , 884 F.2d 1064, 1070 (8th Cir. 1989). Further, the Learned Intermediary Doctrine forecloses a patient's failure-to-warn claim even if the warning did not include the specific risk complained of, so long as the doctor: 1) was aware of the information that allegedly should have been provided about the risk; or 2) would have taken the same action even if the manufacturer had included that information in its warnings. See, e.g., Odom, 979 F.2d at 1003 (“the manufacturer cannot be said to have caused the injury if the doctor already knew of the medical risk.”) (quotations omitted); Motus v. Pfizer Inc. , 358 F.3d 659, 661 (9th Cir. 2004) (“a product defect claim based on insufficient warnings cannot survive summary judgment if stronger warnings would not have altered the conduct of the prescribing physician”).

Pliva, Inc. v. Mensing

The consolidated lawsuits in Mensing “involve[d] state tort-law claims based on certain drug manufacturers' alleged failure to provide adequate warning labels for generic metoclopramide (“MCP”).” Mensing, 131 S. Ct. at 2572. Faced with the question of “whether federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, these state-law claims,” the Supreme Court held unequivocally and broadly that they do. Id. Finding compliance with both state tort law and federal law governing generic drug labeling to be impossible, the Supreme Court held:

[S]tate law imposed on the [generic] Manufacturers a duty to attach a safer label to their generic metoclopramide. Federal law, however, demanded that generic drug labels be the same at all times as the corresponding brand-name labels. Thus, it was impossible for the [generic] Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same.

Id. at 2572

The majority opinion recognized the decision would be dispositive of essentially all product liability claims against generic manufacturers, beyond just failure-to-warn claims, holding that “because pharmacists, acting in full accord with state law, substituted generic [for the branded], federal law pre-empts these lawsuits.” Id. at 2581 (emphasis supplied). The four dissenting justices also lamented the fatal effect of the decision on a plaintiff's entire cause of action against generic manufacturers, stating “[i]f a consumer takes a generic drug, as occurs 75 percent of the time, she now has no right to sue.” Id. at 2592 (Sotomayor, J., dissenting, joined by Breyer, Ginsburg, & Kagan, JJ.) (emphasis supplied).

'Failure-to-Timely-Update Labeling' and 'Failure-to-Communicate Label Change'

Courts have, for the most part, rejected attempts by creative plaintiffs' attorneys to plead around the preemption recognized in Mensing. However, several courts have carved out exceptions to Mensing's preemption requirement for particular claims. Many plaintiffs have begun characterizing their claims not as pure failure-to-warn claims that are undoubtedly preempted under Mensing, but rather as claims alleging that the generic manufacturer failed to timely update its drug label to correspond with changes to the brand-name or reference-listed drug (“RLD”) counterpart. Failure-to-update claims attempt to differentiate from typical failure-to-warn claims by asserting that a generic manufacturer would not be violating the federal duty of sameness by updating its label to incorporate label changes added by the branded drug, and therefore plaintiffs reason that impossibility preemption would not apply to bar such a claim.

While a handful of state and federal courts have recognized failure-to-update and failure-to-communicate claims as exceptions to Mensing preemption, a growing number of courts have found failure-to-timely-update claims still fall within Mensing's broad preemption holding. See, e.g., In re Darvocet, Darvon and Propoxyphene Prod. Liab. Litig. (“In re Propoxphene“), No. 2:11-md-2226-DCR, 2012 WL 718618, at *4 (E.D. Ky. March 5, 2012) (noting plaintiffs' failure-to-update claim was not only insufficiently pled, but also was likely preempted); Bell v. Pliva, Inc., No. 5:10-cv-00101-BSM, 2012 WL 640742 (E.D. Ark. Feb. 16, 2012) (finding even if the manufacturer did fail to incorporate a label change, any claim challenging this failure was still preempted); Gross v. Pfizer, Inc. , No. 10-cv-00110-AW, 2011 WL 5865267, at *4 (D. Md. Nov. 22, 2011) (the weight of authority suggests claims for a generic manufacturer's failure-to-timely-update are unavailing). In rejecting failure-to-update claims, these courts have often noted the Mensing Court. The Eighth Circuit on remand in Mensing, and the Sixth Circuit in Smith were presented with similar failure-to-timely update arguments, but nonetheless found the claims preempted. See, e.g., In re Propoxypyhene, 2012 WL 718618 at *4, n.8.

However, a handful of state and federal courts have recognized an exception to Mensing preemption for failure-to-timely-update claims. See, e.g., Fisher v. Pelstring, No. 4:09-cv-00252-TLW, 2011 WL 4552464, at *10 (D.S.C. Sept. 30, 2011) (recognizing failure to update and failure -to -communicate claims); Couick, 2012 WL 77670, at *3-5 (recognizing failure-to-update claim); Lyman v. Pfizer, No. 2:09-cv-262, 2012 WL 368675, at *5 (D. Vt. Feb. 3, 2012) (same). These courts have generally focused on the fact that once a branded drug or RLD changes its labeling, generic companies are no longer barred from unilaterally changing their own labeling to correspond with the RLD's changes. See Couick, 2012 WL 79670, at *5. Thus, these courts have held, because federal law requiring generic labeling to be identical to brand labeling, it no longer conflicts with state law claims challenging the sufficiency of the generic drug's labeling, and thus such claims are not barred by impossibility preemption. In the same vein, “failure-to-communicate” claims generally assert that a generic drug manufacturer could have communicated or disseminated changes to its warnings to health care professionals, provided such communications were consistent with and were not additional to the labeling itself. See, e.g, Moretti v. Pliva, No. 2:08-cv-00396-JCM, 2012 WL 628502, at *5 (D. Nev. Feb. 27, 2012) (addressing claim alleging defendant's “'failure-to-communicate' warnings about metoclopramide by 'tools' other than labeling”). One of the most common avenues that plaintiffs assert drug manufacturers could have utilized are “Dear Doctor” or “Dear Health Care Professional” letters. These types of letters are a common means by which drug manufacturers sometimes disseminate information about their drug products to health care professionals.

Numerous courts have held that claims alleging that a generic defendant failed to communicate warnings to health care professionals are preempted by Mensing. See, e.g., Guarino v. Wyeth LLC, No. 8:10'cv'2885, 2011 WL 5358709, at *3 (M.D.Fla. Nov. 7, 2011) (Mensing rejected failure-to-communicate claim based on “Dear Doctor” letters); Grinage v. Mylan Pharm., Inc., No. CCB-11-1436, 2011 WL 6951962, at *3-4 (D. Md. Dec. 31, 2011) (rejecting argument that generic drug manufacturer could have more effectively communicated warnings to healthcare professionals through “Dear Doctor” letters, training programs, or notifications); Kellogg v. Wyeth, No. 2:07-cv-82, 2012 WL 368658, *4-5 (D.Vt. Feb. 3, 2012) (plaintiff's claim alleging that defendants could have provided warning through dissemination of nonpromotional information was preempted). As one federal court has recognized, “[a]ny claim based on the errors in the label ' or omissions in labeling or communications with health providers ' is pre-empted by the FDA regulations for the same reason that failure-to-warn claims are pre-empted.” Coney, 2012 WL 170143 at *7 (emphasis added).

These courts have often relied heavily on the Mensing Court's discussion of Dear Doctor letters. In Mensing, the Court recognized that, because Dear Doctor letters constituted labeling under FDA regulations, a “Dear Doctor letter that contained substantial new warning information would not be consistent with the drug's approved labeling.” Mensing, 131 S.Ct. at 2576. The Supreme Court further reasoned that “if generic drug manufacturers, but not the brand-name manufacturer, sent such letters, that would inaccurately imply a therapeutic difference between the brand and generic drugs.” Id.

Despite Mensing's clear directive on Dear Doctor letters, a handful of state and federal courts have also recognized a failure-to-communicate exception to preemption. See, e.g., Fisher, 2011 WL 4552464, at *10 (recognizing failure-to -update and failure -to -communicate claims); Brasley-Thrash v. Teva Pharmaceuticals USA, Inc., No. 10-100031-KD-N, 2011 WL 4025734, *3 (S.D. Ala. Sept. 12, 2011) (recognizing failure-to-communicate claim); Sacks v. Endoscopy Ctr. of So. Nev., LLC, Nos. 08A572315, 08A576071, 09A583058, 2011 WL 4915174 (Nev. Dist. Ct. July 28, 2011) (same); Keck v. Endoscopy Ctr. of So. Nev., LLC, Nos. A575837, A579660, A582492, 2011 WL 3921690 (Nev. Dist. Ct. Aug. 19, 2011) (same).

Fundamental Problem

Most of these cases ignore a fundamental problem with failure-to-update and failure-to-communicate theories of liability, one that is unique to the generic drug industry: generally, doctors and other health care professionals do not see the labeling or package insert for generic drugs dispensed by pharmacies, and instead only learn of label changes through third-party publications that compile label information such as the Physician's Desk Reference (“PDR”) or by receiving communications from the brand manufacturer about the new labeling. As a result, plaintiffs' attorneys often focus on the hypothetical scenario where a brand manufacturer may have recently revised its labeling but generic manufacturers have not yet done so for their corresponding generic products, a scenario in which plaintiffs will argue physicians may potentially prescribe drug products without having seen the latest labeling for the actual product prescribed. However, to date, few courts have fully or accurately grasped the realities of how physicians receive information about the drugs they prescribe and, correspondingly, how the learned intermediary doctrine should affect the Mensing preemption analysis.

Sara K. Thompson is Of Counsel in Greenberg Traurig, LLP's Atlanta office. Sean P. Jessee is an Associate in the same office.