The Mensing Preemption

Numerous courts have dismissed failure-to-timely-update and failure-to-communicate claims because the plaintiffs did not allege that the failures were causally related to the injuries they suffered. In re Propoxphene, 2012 WL 718618, at *4 (emphasizing that complaints did not “explain how any alleged failure-to-update injured the plaintiffs”); Gross v. Pfizer Inc., 2011 WL 5865267, at *4-5 (failure‒to‒timely‒update claim did not give rise to a cause of action under state law); Grinage v. Mylan. Pharmaceuticals, Inc., 2011 WL 6951962, at *4 (dismissing failure-to-communicate claim because it did not plead causation). As a first line of defense, particularly in federal court, a Motion to Dismiss will often be well-taken where the plaintiff has pled such claims in a purely speculative manner, without laying the intricate factual groundwork necessary to support the claims.

Generic Manufacturers

Federal regulations generally discourage generic manufacturers from directly communicating with physicians except in very specific circumstances (such as when a manufacturing issue occurs in a specific lot of one generic manufacturer's product). Instead, to encourage uniformity of information provided, most communications with physicians about product risks originate through the brand manufacturer alone, and FDA regulations prohibit any communications by generic manufacturers that could inaccurately imply a therapeutic difference between the generic and the brand. See, e.g., 21 C.F.R. ' 201.100(d)(1); 21 U.S.C. ' 355-1(i)(2)(A); see also Mensing, 131 S.Ct. at 2576. Thus, any state law claims alleging a generic manufacturer's failure to communicate directly with physicians about product risks when they are legally directed not to do so are preempted by federal law. See Bell, 2012 WL 640742, at *4 (finding that plaintiff's failure-to-communicate claims were preempted because federal regulations prohibited generic manufacturer from communicating with physicians); Grinage, 2011 WL 6951962, at *4 (because generic manufacturer could not have sent “Dear Doctor” letter under federal law, any state law claim challenging failure to do so was preempted).

Several courts have suggested that generic drug manufacturers can never unilaterally communicate directly with physicians. Bell, 2012 WL 640742 at *4 (“Federal regulations, however, provide that only the brand-name, reference-listed product warning be disseminated to physicians”); Gaeta v. Perrigo Pharmaceuticals Co., 630 F.3d 1225, 1235 (9th Cir. 2011) (noting the generic manufacturer could have asked the FDA to send a “Dear Doctor” letter to healthcare professionals but could not do so independently); Demahy v. Actavis, Inc., 593 F.3d 428, 444-45 (5th Cir. 2010) (same). Although whether federal regulations entirely prevent generic manufacturers from communicating with physicians under any circumstance is debatable, federal regulations do explicitly prevent generic drug manufacturers from directly communicating with physicians in certain instances. For example, the FDCA provides that when a reference listed drug (RLD) is required to undergo a risk evaluation and mitigation strategy (REMS), the Secretary of the FDA itself will make any necessary communications to health care providers on the part of manufacturers of generic versions of the drug. See 21 U.S.C. ' 355-1(i)(2)(A).

Further, even in situations not explicitly covered by FDA regulations, FDA guidance documents still suggest Dear Doctor letters are appropriate methods of communicating with physicians to be employed by manufacturers of branded and reference listed drugs, but not generic drug manufacturers. For instance, FDA policies and instructions related to Dear Doctor letters are directed at pioneer drug companies, evident in the fact that such a manual is titled “NDAs: Dear 'Health Care Professional' [DHCP] Letters.” (NDAs ' or New Drug Applications ' are only filed by those companies seeking to manufacture a drug for which no similar drug exists.)

See NDAs: “Dear Healthcare Professional” Letters (July 2, 2003), www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/ucm082012.pdf. Likewise, in its amicus brief submitted in Mensing, the FDA recognized generic manufacturers “do not customarily send DHCP letters without coordinating with FDA.” See Br. of the United States as Amicus Curiae at 24, Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011).

These prohibitions on generic drug manufacturers' direct unilateral communications of product risks to physicians are important to the preemption analysis in failure-to-update and failure-to-communicate claims. In Mensing, the Supreme Court held that “when a party cannot satisfy its state duties without the Federal Government's special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.” Mensing, 131 S.Ct. at 2581. It is not enough that generic manufacturers could have asked the FDA or brand manufacturer to communicate to healthcare professionals on their behalf because “pre-emption analysis should not involve speculation about ways in which federal agency and third-party actions could potentially reconcile federal duties with conflicting state duties.” Id. at 2580.

Thus, because a generic drug manufacturer cannot send a Dear Doctor letter or similar correspondence warning physicians about a label change without the FDA's permission and acceptance ' which generally will not be granted where federal regulations prohibit such communications or specify they should come only from brand manufacturers or the FDA itself ' any claim asserting a state law duty to send such communications would be preempted by federal law under the same analysis applied in Mensing.

Proximate Cause Is Generally Lacking

Finally, any communication a generic manufacturer could send about a revised drug warning would likely be duplicative of warnings the physicians would also have received from other sources, most notably, the brand drug manufacturer that directly markets its products to physicians through marketing materials, sales representative contacts, and Dear Doctor letters. Because physicians rarely, if ever, see the labels or warnings specific to generic drugs, it is apparent that any failure of a generic manufacturer either to timely update or to broadly disseminate such warnings likely would have no bearing on a doctor's prescribing decision, which would leave the fundamental causation element of any failure-to-warn claim unproven. Put simply, if the physician generally never sees such materials and generally gets his or her information about product risks from other sources, then the lack of such materials could not possibly have affected his or her prescribing decision.

Several courts have recognized that the unique factual circumstances in which most drugs are prescribed would foreclose liability where the inquiry focuses on the physician's knowledge of product risks prior to the prescription, rather than focusing on the information disseminated by a specific manufacturer. As the court in Bell noted, “even though a patient might ultimately ingest a generic drug, her doctor will rely on the warnings and usage indications provided by the brand-name manufacturer.” Bell, 2012 WL 640742, at *4; see also Kellogg v. Wyeth, 762 F.Supp.2d 694, 705 -706 (D.Vt. 2010) (“[i]t is routine, therefore, and entirely foreseeable, that a physician will prescribe a drug in reliance upon information disseminated by the brand name manufacturer, and that the patient will receive and ingest a generic equivalent.”).

Most doctors prescribe a drug by its familiar brand name and never explicitly prescribe generic drugs. Allen Rostron, Prescription for Fairness: A New Approach to Tort Liability of Brand-Name and Generic Drug Manufactures, 60 Duke L.J. 1123, 1132 (2011). The decision about whether a patient receives a brand or generic drug is made by the pharmacist or patient, since most states either allow or require pharmacists to fill prescriptions written for the brand drug with a less expensive generic equivalent unless the doctor explicitly provides otherwise. See Mensing, 131 S.Ct. at 2581 (noting pharmacists who filled the plaintiffs' prescriptions acted in full accord with state law by substituting generic metoclopramide for Reglan); see, e.g., Vt. Stat. Ann. tit. 18, 4605(a) (requiring a pharmacist to substitute the lowest priced generic equivalent when filling a prescription for a drug, unless otherwise instructed by the prescriber); Minn. Stat. ' 151.21 (describing when pharmacists may substitute generic drugs).

Moreover, generic manufacturers have no indirect methods of communicating about drug risks with prescribing physicians. See Rostron, Prescription for Fairness, at 1132-33. Brand-name manufacturers undertake extensive promotion of their products through direct and media advertisements, utilize a sales force that regularly visits prescribing physicians to discuss their product lines, and publishes their FDA-approved labeling in the Physician's Desk Reference (PDR), an annual publication that has become many doctors' primary source of information about drug risks. Id. at 1333. In contrast, generic drug manufacturers often do not undertake any physician advertising or promotion efforts for their products, and often do not pay to have their product included in the PDR. Id. Instead, a generic
manufacturer's business model necessarily relies on brand-name manufacturers to promote the drug to prescribing physicians, while the generic drug manufacturers compete on the basis of price through marketing to pharmacy chains, distributors, and wholesalers. Id. The end result is that, because they are unlikely to have received any marketing or promotional materials from generic manufacturers, doctors are less likely to consider or be aware of generic alternatives for the brand name drugs they prescribe. See, e.g., Fisher, 2011 WL 4552464, at *9 (describing prescribing physician's testimony that he gained his information about the drug Metoclopramide by reading the Physician's Desk Reference insert for the brand-name drug Reglan, and he had never heard of the generic manufacturer, had never met with a representative of the generic manufacturer, and had never received any literature of any kind from the manufacturer).

Because physicians generally rely on information received about the brand-name drugs they prescribe, two situations will frequently ' if not always ' occur when a generic manufacturer is required to implement a label change based on a corresponding change made by the brand name manufacturer. First, many physicians will never have any occasion to see any label change implemented by a generic manufacturer before they prescribe a drug to a patient. Under the Learned Intermediary Doctrine, if a physician would not have read the prescription drug product's warning before prescribing it, then there is no basis for finding a stronger warning would have affected their behavior.

Prior to Mensing, many courts routinely dismissed failure-to-warn cases where the prescribing physician had not read the defendant manufacturer's allegedly inadequate warning. See, e.g., Motus v. Pfizer Inc., 358 F.3d 659, 661 (9th Cir. 2004) (affirming summary judgment based on lack of causation; reasoning that stronger warnings would not have changed patient's treatment since prescribing physician “testified that he did not read the warning label”); Bartlett v. Mutual Pharmaceutical Co., 731 F. Supp.2d 135, 146 (D.N.H. 2010) (the “[prescriber] made clear that he never reviewed [defendant's drug] label before treating [plaintiff] and that nothing about it influenced his decision to prescribe the drug”); Fields v. Mylan Pharmaceuticals, Inc., 751 F. Supp.2d 1260, 1263 (N.D. Fla. 2009) (“[w]here a physician fails to review the warnings issued by the manufacturer, proximate cause cannot be established”). It follows that in cases where the doctor did not read the allegedly outdated label for the generic drug a patient ingested, liability cannot attach to the generic drug manufacturer because the content of its specific labeling could not have had any possible effect on the doctor's prescribing decision.

Second, federal regulations specify generic manufacturers may only incorporate changes made to the brand name drug's labeling once they are approved by the FDA. See Br. of the United States as Amicus Curiae at 6, Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514 (E.D. Pa. 2006) (No. 05-CV-05500-MMB) (“there is no statutory or regulatory provision permitting the [generic] manufacturer to make a labeling change to its generic drug without FDA approval. To the contrary, a generic manufacturer is required to conform to the approved labeling for the listed drug”). Thus, because generic manufacturers' incorporation of label changes into their own labeling will necessarily lag behind those of the brand name manufacturer, and because brand name manufacturers may disseminate that information to physicians in ways that generic manufacturers often cannot and do not, in many situations physicians will receive information about the brand name drug's label changes even before generic manufacturers have incorporated the change into their own labeling. Accordingly, because physicians would be adequately advised of any new warnings by virtue of the brand manufacturer's dissemination of its revised labeling, any failure by generic manufacturers to revise their labeling to conform to the brand will not affect a physician's knowledge about a drug's risks or the decision to prescribe it.

As numerous courts have recognized when applying the Learned Intermediary Doctrine, where a doctor already knows about a risk ' and prescribes the drug anyway ' a manufacturer cannot be liable for failing to warn about the risk because any such failure was not the proximate cause of the decision to prescribe. 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); Eck v. Parke Davis & Co., 256 F.3d 1013, 1022-23 (10th Cir. 2001) (where the doctor is aware of the risk that the warning would have imparted, there can be no liability under the Learned Intermediary Doctrine); Stanback v. Parke, Davis & Co., 657 F.2d 642, 645-46 (4th Cir. 1981) (“the manufacturer cannot be said to have caused the injury if the doctor already knew of the medical risk). Thus, where the Learned Intermediary Doctrine applies, in most instances the content of the generic manufacturers' warnings or their method of dissemination will be entirely irrelevant to the causation analysis, which will instead be focused upon the physician's awareness of risks either independent of all labeling or by virtue of having first read the warnings for the equivalent brand name drug.

Conclusion

When defending against claims that a generic drug manufacturer failed to timely update its label or failed to communicate a label change to prescribing physicians, attorneys have a variety of defenses at their disposal. First and foremost, attorneys should argue Mensing preempts any claims on these grounds, citing the great weight of post-Mensing authority. However, in examining additional potential arguments, it may also be useful to brief the court on the Learned Intermediary Doctrine and how it applies practically, and to educate the court on some of the major differences between brand and generic drugs, including the unlikelihood that a specific generic drug's labeling will be seen by a physician or will influence his or her prescribing decisions. Because the statutory and regulatory framework under the FDCA places the burden on brand manufacturers to make and communicate label changes to healthcare professionals, the interplay of Mensing and the Learned Intermediary Doctrine operates to bar virtually all claims against generic drug manufacturers for failure-to-timely update labeling or failure-to-communicate label changes.

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

Because the vast majority of jurisdictions apply the Learned Intermediary Doctrine, failure-to-warn analysis in nearly all jurisdictions will be focused solely on the adequacy of the warnings provided to the prescribing physician. Such jurisdictions also generally require the plaintiff to prove that the physician was unaware of the risk experienced by the plaintiff, such that the purported failure to warn of that risk was a proximate cause of the physician's decision to prescribe the allegedly harmful drug. Because these fundamental concepts control in any state applying the Learned Intermediary Doctrine, the interplay between the Learned Intermediary Doctrine and the Mensing preemption should bar nearly any claim a plaintiff may assert against a generic manufacturer for failure-to-timely-update its label to correspond with the branded drug's label, or for failure-to-communicate such a change to healthcare professionals. Most of these claims will fail at the initial pleading stage, for three main reasons.

Application of Pleading Requirements

Failure-to-update claims are often deficient on their face because the plaintiff generally will lack sufficient facts to allege specifically how the failure-to-update played a direct and proximate role in the physician's decision to prescribe a drug. Even if a plaintiff can establish that a label change was not promptly made, this fact will be insufficient to support a product liability claim if the drug was not prescribed during the time between the brand label change and the generic label change, or if the label change deals with an issue that bears no logical relationship to the injury alleged. As a threshold matter, a plaintiff must allege that he or she would not have been prescribed the drug in the manner in which he or she ingested it if the label change had been timely made by the generic manufacturer, or else such claims will fail due to insufficient pleading. Similarly, failure-to-communicate claims must allege that the failure-to-communicate proximately caused the plaintiff's prescribing physician to prescribe the medication in a way that he or she would not have if the warning had been more fully disseminated or directly communicated. Plaintiffs must additionally allege the communication of the new warning to the prescribing physician would have been received and viewed prior to prescribing the drug and would have altered the physician's decision to prescribe the drug.

Numerous courts have dismissed failure-to-timely-update and failure-to-communicate claims because the plaintiffs did not allege that the failures were causally related to the injuries they suffered. In re Propoxphene, 2012 WL 718618, at *4 (emphasizing that complaints did not “explain how any alleged failure-to-update injured the plaintiffs”); Gross v. Pfizer Inc. , 2011 WL 5865267, at *4-5 (failure‒to‒timely‒update claim did not give rise to a cause of action under state law); Grinage v. Mylan. Pharmaceuticals, Inc., 2011 WL 6951962, at *4 (dismissing failure-to-communicate claim because it did not plead causation). As a first line of defense, particularly in federal court, a Motion to Dismiss will often be well-taken where the plaintiff has pled such claims in a purely speculative manner, without laying the intricate factual groundwork necessary to support the claims.

Generic Manufacturers

Federal regulations generally discourage generic manufacturers from directly communicating with physicians except in very specific circumstances (such as when a manufacturing issue occurs in a specific lot of one generic manufacturer's product). Instead, to encourage uniformity of information provided, most communications with physicians about product risks originate through the brand manufacturer alone, and FDA regulations prohibit any communications by generic manufacturers that could inaccurately imply a therapeutic difference between the generic and the brand. See, e.g., 21 C.F.R. ' 201.100(d)(1); 21 U.S.C. ' 355-1(i)(2)(A); see also Mensing, 131 S.Ct. at 2576. Thus, any state law claims alleging a generic manufacturer's failure to communicate directly with physicians about product risks when they are legally directed not to do so are preempted by federal law. See Bell, 2012 WL 640742, at *4 (finding that plaintiff's failure-to-communicate claims were preempted because federal regulations prohibited generic manufacturer from communicating with physicians); Grinage, 2011 WL 6951962, at *4 (because generic manufacturer could not have sent “Dear Doctor” letter under federal law, any state law claim challenging failure to do so was preempted).

Several courts have suggested that generic drug manufacturers can never unilaterally communicate directly with physicians. Bell, 2012 WL 640742 at *4 (“Federal regulations, however, provide that only the brand-name, reference-listed product warning be disseminated to physicians”); Gaeta v. Perrigo Pharmaceuticals Co. , 630 F.3d 1225, 1235 (9th Cir. 2011) (noting the generic manufacturer could have asked the FDA to send a “Dear Doctor” letter to healthcare professionals but could not do so independently); Demahy v. Actavis, Inc. , 593 F.3d 428, 444-45 (5th Cir. 2010) (same). Although whether federal regulations entirely prevent generic manufacturers from communicating with physicians under any circumstance is debatable, federal regulations do explicitly prevent generic drug manufacturers from directly communicating with physicians in certain instances. For example, the FDCA provides that when a reference listed drug (RLD) is required to undergo a risk evaluation and mitigation strategy (REMS), the Secretary of the FDA itself will make any necessary communications to health care providers on the part of manufacturers of generic versions of the drug. See 21 U.S.C. ' 355-1(i)(2)(A).

Further, even in situations not explicitly covered by FDA regulations, FDA guidance documents still suggest Dear Doctor letters are appropriate methods of communicating with physicians to be employed by manufacturers of branded and reference listed drugs, but not generic drug manufacturers. For instance, FDA policies and instructions related to Dear Doctor letters are directed at pioneer drug companies, evident in the fact that such a manual is titled “NDAs: Dear 'Health Care Professional' [DHCP] Letters.” (NDAs ' or New Drug Applications ' are only filed by those companies seeking to manufacture a drug for which no similar drug exists.)

See NDAs: “Dear Healthcare Professional” Letters (July 2, 2003), www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/ucm082012.pdf. Likewise, in its amicus brief submitted in Mensing , the FDA recognized generic manufacturers “do not customarily send DHCP letters without coordinating with FDA.” See Br. of the United States as Amicus Curiae at 24, Pliva, Inc. v. Mensing , 131 S. Ct. 2567 (2011).

These prohibitions on generic drug manufacturers' direct unilateral communications of product risks to physicians are important to the preemption analysis in failure-to-update and failure-to-communicate claims. In Mensing, the Supreme Court held that “when a party cannot satisfy its state duties without the Federal Government's special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.” Mensing, 131 S.Ct. at 2581. It is not enough that generic manufacturers could have asked the FDA or brand manufacturer to communicate to healthcare professionals on their behalf because “pre-emption analysis should not involve speculation about ways in which federal agency and third-party actions could potentially reconcile federal duties with conflicting state duties.” Id. at 2580.

Thus, because a generic drug manufacturer cannot send a Dear Doctor letter or similar correspondence warning physicians about a label change without the FDA's permission and acceptance ' which generally will not be granted where federal regulations prohibit such communications or specify they should come only from brand manufacturers or the FDA itself ' any claim asserting a state law duty to send such communications would be preempted by federal law under the same analysis applied in Mensing.

Proximate Cause Is Generally Lacking

Finally, any communication a generic manufacturer could send about a revised drug warning would likely be duplicative of warnings the physicians would also have received from other sources, most notably, the brand drug manufacturer that directly markets its products to physicians through marketing materials, sales representative contacts, and Dear Doctor letters. Because physicians rarely, if ever, see the labels or warnings specific to generic drugs, it is apparent that any failure of a generic manufacturer either to timely update or to broadly disseminate such warnings likely would have no bearing on a doctor's prescribing decision, which would leave the fundamental causation element of any failure-to-warn claim unproven. Put simply, if the physician generally never sees such materials and generally gets his or her information about product risks from other sources, then the lack of such materials could not possibly have affected his or her prescribing decision.

Several courts have recognized that the unique factual circumstances in which most drugs are prescribed would foreclose liability where the inquiry focuses on the physician's knowledge of product risks prior to the prescription, rather than focusing on the information disseminated by a specific manufacturer. As the court in Bell noted, “even though a patient might ultimately ingest a generic drug, her doctor will rely on the warnings and usage indications provided by the brand-name manufacturer.” Bell , 2012 WL 640742, at *4; see also Kellogg v. Wyeth , 762 F.Supp.2d 694, 705 -706 (D.Vt. 2010) (“[i]t is routine, therefore, and entirely foreseeable, that a physician will prescribe a drug in reliance upon information disseminated by the brand name manufacturer, and that the patient will receive and ingest a generic equivalent.”).

Most doctors prescribe a drug by its familiar brand name and never explicitly prescribe generic drugs. Allen Rostron, Prescription for Fairness: A New Approach to Tort Liability of Brand-Name and Generic Drug Manufactures, 60 Duke L.J. 1123, 1132 (2011). The decision about whether a patient receives a brand or generic drug is made by the pharmacist or patient, since most states either allow or require pharmacists to fill prescriptions written for the brand drug with a less expensive generic equivalent unless the doctor explicitly provides otherwise. See Mensing, 131 S.Ct. at 2581 (noting pharmacists who filled the plaintiffs' prescriptions acted in full accord with state law by substituting generic metoclopramide for Reglan); see, e.g., Vt. Stat. Ann. tit. 18, 4605(a) (requiring a pharmacist to substitute the lowest priced generic equivalent when filling a prescription for a drug, unless otherwise instructed by the prescriber); Minn. Stat. ' 151.21 (describing when pharmacists may substitute generic drugs).

Moreover, generic manufacturers have no indirect methods of communicating about drug risks with prescribing physicians. See Rostron, Prescription for Fairness, at 1132-33. Brand-name manufacturers undertake extensive promotion of their products through direct and media advertisements, utilize a sales force that regularly visits prescribing physicians to discuss their product lines, and publishes their FDA-approved labeling in the Physician's Desk Reference (PDR), an annual publication that has become many doctors' primary source of information about drug risks. Id. at 1333. In contrast, generic drug manufacturers often do not undertake any physician advertising or promotion efforts for their products, and often do not pay to have their product included in the PDR. Id. Instead, a generic
manufacturer's business model necessarily relies on brand-name manufacturers to promote the drug to prescribing physicians, while the generic drug manufacturers compete on the basis of price through marketing to pharmacy chains, distributors, and wholesalers. Id. The end result is that, because they are unlikely to have received any marketing or promotional materials from generic manufacturers, doctors are less likely to consider or be aware of generic alternatives for the brand name drugs they prescribe. See, e.g., Fisher, 2011 WL 4552464, at *9 (describing prescribing physician's testimony that he gained his information about the drug Metoclopramide by reading the Physician's Desk Reference insert for the brand-name drug Reglan, and he had never heard of the generic manufacturer, had never met with a representative of the generic manufacturer, and had never received any literature of any kind from the manufacturer).

Because physicians generally rely on information received about the brand-name drugs they prescribe, two situations will frequently ' if not always ' occur when a generic manufacturer is required to implement a label change based on a corresponding change made by the brand name manufacturer. First, many physicians will never have any occasion to see any label change implemented by a generic manufacturer before they prescribe a drug to a patient. Under the Learned Intermediary Doctrine, if a physician would not have read the prescription drug product's warning before prescribing it, then there is no basis for finding a stronger warning would have affected their behavior.

Prior to Mensing, many courts routinely dismissed failure-to-warn cases where the prescribing physician had not read the defendant manufacturer's allegedly inadequate warning. See, e.g., Motus v. Pfizer Inc. , 358 F.3d 659, 661 (9th Cir. 2004) (affirming summary judgment based on lack of causation; reasoning that stronger warnings would not have changed patient's treatment since prescribing physician “testified that he did not read the warning label”); Bartlett v. Mutual Pharmaceutical Co. , 731 F. Supp.2d 135, 146 (D.N.H. 2010) (the “[prescriber] made clear that he never reviewed [defendant's drug] label before treating [plaintiff] and that nothing about it influenced his decision to prescribe the drug”); Fields v. Mylan Pharmaceuticals, Inc. , 751 F. Supp.2d 1260, 1263 (N.D. Fla. 2009) (“[w]here a physician fails to review the warnings issued by the manufacturer, proximate cause cannot be established”). It follows that in cases where the doctor did not read the allegedly outdated label for the generic drug a patient ingested, liability cannot attach to the generic drug manufacturer because the content of its specific labeling could not have had any possible effect on the doctor's prescribing decision.

Second, federal regulations specify generic manufacturers may only incorporate changes made to the brand name drug's labeling once they are approved by the FDA. See Br. of the United States as Amicus Curiae at 6, Colacicco v. Apotex, Inc. , 432 F. Supp. 2d 514 (E.D. Pa. 2006) (No. 05-CV-05500-MMB) (“there is no statutory or regulatory provision permitting the [generic] manufacturer to make a labeling change to its generic drug without FDA approval. To the contrary, a generic manufacturer is required to conform to the approved labeling for the listed drug”). Thus, because generic manufacturers' incorporation of label changes into their own labeling will necessarily lag behind those of the brand name manufacturer, and because brand name manufacturers may disseminate that information to physicians in ways that generic manufacturers often cannot and do not, in many situations physicians will receive information about the brand name drug's label changes even before generic manufacturers have incorporated the change into their own labeling. Accordingly, because physicians would be adequately advised of any new warnings by virtue of the brand manufacturer's dissemination of its revised labeling, any failure by generic manufacturers to revise their labeling to conform to the brand will not affect a physician's knowledge about a drug's risks or the decision to prescribe it.

As numerous courts have recognized when applying the Learned Intermediary Doctrine, where a doctor already knows about a risk ' and prescribes the drug anyway ' a manufacturer cannot be liable for failing to warn about the risk because any such failure was not the proximate cause of the decision to prescribe. 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); Eck v. Parke Davis & Co. , 256 F.3d 1013, 1022-23 (10th Cir. 2001) (where the doctor is aware of the risk that the warning would have imparted, there can be no liability under the Learned Intermediary Doctrine); Stanback v. Parke, Davis & Co. , 657 F.2d 642, 645-46 (4th Cir. 1981) (“the manufacturer cannot be said to have caused the injury if the doctor already knew of the medical risk). Thus, where the Learned Intermediary Doctrine applies, in most instances the content of the generic manufacturers' warnings or their method of dissemination will be entirely irrelevant to the causation analysis, which will instead be focused upon the physician's awareness of risks either independent of all labeling or by virtue of having first read the warnings for the equivalent brand name drug.

Conclusion

When defending against claims that a generic drug manufacturer failed to timely update its label or failed to communicate a label change to prescribing physicians, attorneys have a variety of defenses at their disposal. First and foremost, attorneys should argue Mensing preempts any claims on these grounds, citing the great weight of post-Mensing authority. However, in examining additional potential arguments, it may also be useful to brief the court on the Learned Intermediary Doctrine and how it applies practically, and to educate the court on some of the major differences between brand and generic drugs, including the unlikelihood that a specific generic drug's labeling will be seen by a physician or will influence his or her prescribing decisions. Because the statutory and regulatory framework under the FDCA places the burden on brand manufacturers to make and communicate label changes to healthcare professionals, the interplay of Mensing and the Learned Intermediary Doctrine operates to bar virtually all claims against generic drug manufacturers for failure-to-timely update labeling or failure-to-communicate label changes.

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