The FDA's Role in Product Liability Litigation

The FDA does not mince words on this issue, as its then-Chief Counsel Margaret Jane Porter stated in 1997: “[T]he agency[] has a long-standing presumption against preemption in implementing … [' 360k of the FDCA (Sec. 360k of the FDCA generally prohibits a state from promulgating any requirement regarding a device intended for human use that is different from or in addition to any requirement of the FDCA or that relates to the safety or effectiveness of the device.)].” Margaret Jane Porter, “The Lohr Decision: FDA Perspective and Position,” 52 Food Drug L.J. 7 (1997) (emphasis added). Nevertheless, defense counsel faced with common law product liability claims in state court should argue for preemption under ' 360k in the hope of taking advantage of the limited remedies the FDCA provides in comparison with the traditional broad state common law tort remedies. Often, the FDA, via amicus curiae briefs, has involved itself in such disputes and has put its stance on the record. Below are some relevant examples and results.

Lohr and Duvall

In Medtronic Inc. v. Lohr, 518 U.S. 470 (1996), plaintiff, who had been implanted with a pacemaker manufactured by Medtronic, underwent emergency surgery due to the failure of the device. Plaintiff filed a complaint in state court, alleging negligence and strict liability, which Medtronic successfully removed to federal court. Medtronic filed a motion for summary judgment, arguing plaintiff's claims were preempted by ' 360k; the district court agreed, and plaintiff appealed. The U.S. Court of Appeals for the Eleventh Circuit also held that plaintiff's claims for negligent manufacturing and failure to warn were preempted by ' 360k and accompanying FDA regulations. The U.S. Supreme Court reversed, finding that plaintiff's common law claims for negligent design, manufacturing, and labeling were not preempted under the language of ' 360k because these general common law claims did not specifically conflict with the FDCA. Id. at 492-503.

In Duvall v. Bristol-Myers-Squibb Co., 65 F.3d 392 (4th Cir. 1995), vacated by 518 U.S. 1030, remanded to 103 F.3d 324 (4th Cir. 1996), plaintiff underwent a procedure to implant a “penile prosthesis as treatment for erectile impotence.” The device was manufactured by Bristol-Myers-Squibb Co. It ultimately failed and was removed 2 years after implant. Plaintiff sued Bristol-Myers in state court, claiming breach of express and implied warranties, strict liability, and negligence. Bristol-Myers removed the action to federal court, where the district court granted Bristol-Myers's motion for summary judgment, ruling that all Duvall's state-law claims were preempted by ' 360k. The U.S. Court of Appeals for the Fourth Circuit largely agreed, affirming summary judgment on all of Duvall's claims except his claim for breach of express warranty. Id. at 401. The Supreme Court granted certiorari and remanded the matter to the Fourth Circuit in light of its holding in Lohr. 518 U.S. 1030. Back in the Fourth Circuit, plaintiff and the FDA - via its amicus curiae brief - argued that Lohr precludes preemption of such state law tort claims concerning the device in question. Duvall, 103 F.3d at 325, 327. The Fourth Circuit agreed, holding that plaintiff's general state common law claims alleging strict liability, failure to warn, and breach of implied warranties were not preempted because they did not specifically conflict with federal law.

Since the Lohr and Duvall opinions, the FDA has continued to go on the record hailing Lohr as “an important victory for consumer protection.” Porter, supra note 4, at 7. More specifically, the FDA stated: “Since the passage of the Medical Device Amendments [to the FDCA] of 1976 (MDA), it has been the agency's position that the scope of preemption under section … [360k] should be interpreted narrowly, with a presumption against preemption. This is true particularly when the effect of preemption would be to override a state scheme offering greater consumer protection than that currently afforded by the FDCA. Consequently, FDA's position always has been that state and local requirements are not preempted and may be enforced until FDA establishes specific counterpart requirements applicable to a particular device or class or devices.” Id.

Because the FDA promulgates the “requirements” that often play a deciding role in triggering FDCA preemption under ' 360k, the FDA views itself as a quasi-gatekeeper or authority on what state law claims should and should not be preempted. Therefore, defense counsel should be familiar with FDA regulations, keep abreast of changes in the regulations, and remain in touch with FDA positions on these issues. Doing so will enable defense counsel to anticipate when they will have a potentially viable FDA-endorsed preemption argument, and when the FDA might intervene to argue against preemption in pending litigation.

The FDA's Expertise in Drug Labeling and Advertising

The FDA has substantial expertise regarding drug labeling and advertising content, and it expects the courts to listen. Daniel Troy, the current Chief Counsel of the FDA, has said, “FDA's legal authority over drug labeling and advertising is broad, and its expertise is unmatched. The agency's decisions on the content of these communications deserve substantial deference from courts applying state tort law in product liability cases that challenge the adequacy of drug warnings.” Daniel Troy, “FDA Involvement in Product Liability Lawsuits,” Update, Jan./Feb. 2003 at 4 (emphasis added). As Troy points out, however, “not all courts have accorded FDA's decisions such deference.” Id. Needless to say, defense counsel involved with similar product matters should take heed, as joining the voice of the FDA in these instances could be beneficial. The following are some examples of FDA intervention in this area.

In re Paxil Litigation

In re Paxil Litigation, 2002 U.S. Dist. LEXIS 24621 (C.D. Cal. Oct. 16, 2002), involved the district court's review of defendant Glaxo Smithkline Beecham's (GSK) motion for reconsideration of a prior order granting preliminary injunction against GSK and barring GSK from continuing to air television commercials claiming that GSK's prescription drug, Paxil(R), is “not habit forming.” In preparing to decide the matter, the district court asked the FDA to file a supplemental brief and participate in oral argument.

The FDA and GSK argued that the “comprehensive nature of the [FDCA,] … when taken together with FDA's expertise, evidences a Congressional intent to preempt state law … [and that] control and regulation of these advertisements are within FDA's exclusive domain.” The district court found this argument “unpersuasive” and held it lacked “common sense” because “FDA and GSK invite the court to find that in enacting the FDCA for the purposes of protecting public health, Congress not only declined to provide for a private cause of action, but also eliminated the availability of common law state claims.” Needless to say, the FDA was displeased with the decision, as Troy later wrote: “Where FDA has reviewed a particular prescription drug advertisement and determined that it is not false or misleading, state [and presumably federal] courts should not second-guess that judgment.” Troy, supra note 22, at 6.

Dowhal v. SmithKline Beecham Consumer Healthcare

In Dowhal v. SmithKline Beecham Consumer Healthcare, 122 Cal. Rptr. 2d 246 (Cal. Ct. App. 2002), review granted, 56 P.3d 1027 (Cal. 2002), appellant/plaintiff originally filed an action challenging the failure of respondents/defendants to place health warnings, mandated by California's Safe Drinking Water and Toxic Enforcement Act of 1986, Cal. Health and Saf. Code '' 25249.5 to 25249.13 (2003) (Proposition 65), on their nicotine-delivery products, marketed over-the-counter as aids for people to quit smoking. The trial court granted summary judgment to respondents, ruling that certain aspects of Proposition 65 are impliedly preempted by the FDCA. The California Court of Appeal reversed, holding that the FDCA contained a provision expressly exempting Proposition 65 from federal preemption.

The FDA, in its amicus curiae brief filed with the California Court of Appeal, joined the respondents in arguing for preemption, specifically asserting that “the labeling sought by Dowhal was preempted by the FDCA because it would be impossible for the defendant to comply with Proposition 65 (as interpreted by the plaintiff) and with the FDCA (as applied by the FDA). In essence, if the defendants were to adopt the warning language advocated by Dowhal, they would be in violation of the prohibition in the FDCA against selling misbranded drugs.” Troy, supra note 22, at 5 (citations omitted). As noted, defendants petitioned the Supreme Court of California for a review of the decision, which was granted. The FDA submitted a letter brief in support of the petition, and the matter is pending.

Miscellaneous FDA Involvement in Litigation

The FDA sometimes becomes involved in ongoing litigation between two parties when it views that its rules have been violated. For example, in Breckenridge Inc. v. Solvay Pharmaceuticals Inc., 174 F.3d 1227, (11th Cir. 1999) - a dispute alleging trade dress infringement over a drug allegedly patterned after another drug that had been on the market for some time - the FDA filed an amicus curiae brief enlightening the Eleventh Circuit that neither drug was legally on the market because neither had ever been approved by the FDA. “Trade Dress Infringement: Florida Breckinridge Inc. v. Solvay Pharmaceuticals Inc.,” Intellectual Property Litigation Reporter, Vol. 15, No. 21, at 12, June 9, 1999.

The Eleventh Circuit admonished the attorneys on both sides for not bringing this information to its attention, stating, “[The attorneys] owe duties of complete candor and primary loyalty to the court before which they practice. These duties are never subservient to a lawyer's duty to advocate zealously for his or her client. In this case, the attorneys for both parties have frustrated the system of justice, which depends on their candor and loyalty to the court, because they wanted to avoid an unpleasant truth about their clients' conduct. In short, they have sold out to the client.” Breckenridge Inc., 174 F.3d at 1232 (citations omitted). Thus, even when the outcome of a case won't directly affect FDA policy, the FDA may be watching and may take action where it deems it necessary.

Conclusion

The FDA's mission is to both promote and protect the public health, and it will venture to do so by getting involved in litigation, often on its own initiative. FDA recommendations traditionally carry great weight with the courts and, as such, defense (and plaintiff's) counsel should educate themselves about the FDA's stances on various issues that could impact their own product liability cases. Counsel's sustained study of the FDA's evolving opinions on issues that may prove important in present or future cases is encouraged.

Aside from promulgating regulations, imposing rigorous standards on myriad product manufacturers, and conducting research and studies on all such products, the FDA also takes an active role in participating in an array of product liability litigations both on the state and federal levels. Often, the FDA's position and “expertise” on an issue carry great weight with the courts and consequently can affect the outcome of litigation. Thus, defense counsel involved in product liability matters in which the FDA historically has had an interest should keep abreast of the FDA's positions on the relevant issues.

Three areas of product liability litigation in which the FDA has involved itself are cases in which 1) the question was presented whether the Food, Drug, and Cosmetic Act, 21 U.S.C. '' 301 to 399 (2003), (FDCA) broadly preempts state common law tort claims; 2) there was an issue as to what deference courts should accord to the FDA's “expertise” in matters of drug labeling and advertising; and 3) the FDA brought matters regarding a party's compliance with federal law, or lack thereof, to the courts' attention. (These areas of the FDA's involvement in product liability litigation are by no means exhaustive. Therefore, the reader is encouraged to investigate further the FDA's evolving positions on other relevant issues.)

The FDCA's Preemption of State Common Law Tort Claims

The FDA does not mince words on this issue, as its then-Chief Counsel Margaret Jane Porter stated in 1997: “[T]he agency[] has a long-standing presumption against preemption in implementing … [' 360k of the FDCA (Sec. 360k of the FDCA generally prohibits a state from promulgating any requirement regarding a device intended for human use that is different from or in addition to any requirement of the FDCA or that relates to the safety or effectiveness of the device.)].” Margaret Jane Porter, “The Lohr Decision: FDA Perspective and Position,” 52 Food Drug L.J. 7 (1997) (emphasis added). Nevertheless, defense counsel faced with common law product liability claims in state court should argue for preemption under ' 360k in the hope of taking advantage of the limited remedies the FDCA provides in comparison with the traditional broad state common law tort remedies. Often, the FDA, via amicus curiae briefs, has involved itself in such disputes and has put its stance on the record. Below are some relevant examples and results.

Lohr and Duvall

In Medtronic Inc. v. Lohr , 518 U.S. 470 (1996), plaintiff, who had been implanted with a pacemaker manufactured by Medtronic, underwent emergency surgery due to the failure of the device. Plaintiff filed a complaint in state court, alleging negligence and strict liability, which Medtronic successfully removed to federal court. Medtronic filed a motion for summary judgment, arguing plaintiff's claims were preempted by ' 360k; the district court agreed, and plaintiff appealed. The U.S. Court of Appeals for the Eleventh Circuit also held that plaintiff's claims for negligent manufacturing and failure to warn were preempted by ' 360k and accompanying FDA regulations. The U.S. Supreme Court reversed, finding that plaintiff's common law claims for negligent design, manufacturing, and labeling were not preempted under the language of ' 360k because these general common law claims did not specifically conflict with the FDCA. Id. at 492-503.

In Duvall v. Bristol-Myers-Squibb Co. , 65 F.3d 392 (4th Cir. 1995), vacated by 518 U.S. 1030, remanded to 103 F.3d 324 (4th Cir. 1996), plaintiff underwent a procedure to implant a “penile prosthesis as treatment for erectile impotence.” The device was manufactured by Bristol-Myers-Squibb Co. It ultimately failed and was removed 2 years after implant. Plaintiff sued Bristol-Myers in state court, claiming breach of express and implied warranties, strict liability, and negligence. Bristol-Myers removed the action to federal court, where the district court granted Bristol-Myers's motion for summary judgment, ruling that all Duvall's state-law claims were preempted by ' 360k. The U.S. Court of Appeals for the Fourth Circuit largely agreed, affirming summary judgment on all of Duvall's claims except his claim for breach of express warranty. Id. at 401. The Supreme Court granted certiorari and remanded the matter to the Fourth Circuit in light of its holding in Lohr. 518 U.S. 1030. Back in the Fourth Circuit, plaintiff and the FDA - via its amicus curiae brief - argued that Lohr precludes preemption of such state law tort claims concerning the device in question. Duvall, 103 F.3d at 325, 327. The Fourth Circuit agreed, holding that plaintiff's general state common law claims alleging strict liability, failure to warn, and breach of implied warranties were not preempted because they did not specifically conflict with federal law.

Since the Lohr and Duvall opinions, the FDA has continued to go on the record hailing Lohr as “an important victory for consumer protection.” Porter, supra note 4, at 7. More specifically, the FDA stated: “Since the passage of the Medical Device Amendments [to the FDCA] of 1976 (MDA), it has been the agency's position that the scope of preemption under section … [360k] should be interpreted narrowly, with a presumption against preemption. This is true particularly when the effect of preemption would be to override a state scheme offering greater consumer protection than that currently afforded by the FDCA. Consequently, FDA's position always has been that state and local requirements are not preempted and may be enforced until FDA establishes specific counterpart requirements applicable to a particular device or class or devices.” Id.

Because the FDA promulgates the “requirements” that often play a deciding role in triggering FDCA preemption under ' 360k, the FDA views itself as a quasi-gatekeeper or authority on what state law claims should and should not be preempted. Therefore, defense counsel should be familiar with FDA regulations, keep abreast of changes in the regulations, and remain in touch with FDA positions on these issues. Doing so will enable defense counsel to anticipate when they will have a potentially viable FDA-endorsed preemption argument, and when the FDA might intervene to argue against preemption in pending litigation.

The FDA's Expertise in Drug Labeling and Advertising

The FDA has substantial expertise regarding drug labeling and advertising content, and it expects the courts to listen. Daniel Troy, the current Chief Counsel of the FDA, has said, “FDA's legal authority over drug labeling and advertising is broad, and its expertise is unmatched. The agency's decisions on the content of these communications deserve substantial deference from courts applying state tort law in product liability cases that challenge the adequacy of drug warnings.” Daniel Troy, “FDA Involvement in Product Liability Lawsuits,” Update, Jan./Feb. 2003 at 4 (emphasis added). As Troy points out, however, “not all courts have accorded FDA's decisions such deference.” Id. Needless to say, defense counsel involved with similar product matters should take heed, as joining the voice of the FDA in these instances could be beneficial. The following are some examples of FDA intervention in this area.

In re Paxil Litigation

In re Paxil Litigation, 2002 U.S. Dist. LEXIS 24621 (C.D. Cal. Oct. 16, 2002), involved the district court's review of defendant Glaxo Smithkline Beecham's (GSK) motion for reconsideration of a prior order granting preliminary injunction against GSK and barring GSK from continuing to air television commercials claiming that GSK's prescription drug, Paxil(R), is “not habit forming.” In preparing to decide the matter, the district court asked the FDA to file a supplemental brief and participate in oral argument.

The FDA and GSK argued that the “comprehensive nature of the [FDCA,] … when taken together with FDA's expertise, evidences a Congressional intent to preempt state law … [and that] control and regulation of these advertisements are within FDA's exclusive domain.” The district court found this argument “unpersuasive” and held it lacked “common sense” because “FDA and GSK invite the court to find that in enacting the FDCA for the purposes of protecting public health, Congress not only declined to provide for a private cause of action, but also eliminated the availability of common law state claims.” Needless to say, the FDA was displeased with the decision, as Troy later wrote: “Where FDA has reviewed a particular prescription drug advertisement and determined that it is not false or misleading, state [and presumably federal] courts should not second-guess that judgment.” Troy, supra note 22, at 6.

Dowhal v. SmithKline Beecham Consumer Healthcare

In Dowhal v. SmithKline Beecham Consumer Healthcare , 122 Cal. Rptr. 2d 246 (Cal. Ct. App. 2002), review granted, 56 P.3d 1027 (Cal. 2002), appellant/plaintiff originally filed an action challenging the failure of respondents/defendants to place health warnings, mandated by California's Safe Drinking Water and Toxic Enforcement Act of 1986, Cal. Health and Saf. Code '' 25249.5 to 25249.13 (2003) (Proposition 65), on their nicotine-delivery products, marketed over-the-counter as aids for people to quit smoking. The trial court granted summary judgment to respondents, ruling that certain aspects of Proposition 65 are impliedly preempted by the FDCA. The California Court of Appeal reversed, holding that the FDCA contained a provision expressly exempting Proposition 65 from federal preemption.

The FDA, in its amicus curiae brief filed with the California Court of Appeal, joined the respondents in arguing for preemption, specifically asserting that “the labeling sought by Dowhal was preempted by the FDCA because it would be impossible for the defendant to comply with Proposition 65 (as interpreted by the plaintiff) and with the FDCA (as applied by the FDA). In essence, if the defendants were to adopt the warning language advocated by Dowhal, they would be in violation of the prohibition in the FDCA against selling misbranded drugs.” Troy, supra note 22, at 5 (citations omitted). As noted, defendants petitioned the Supreme Court of California for a review of the decision, which was granted. The FDA submitted a letter brief in support of the petition, and the matter is pending.

Miscellaneous FDA Involvement in Litigation

The FDA sometimes becomes involved in ongoing litigation between two parties when it views that its rules have been violated. For example, in Breckenridge Inc. v. Solvay Pharmaceuticals Inc. , 174 F.3d 1227, (11th Cir. 1999) - a dispute alleging trade dress infringement over a drug allegedly patterned after another drug that had been on the market for some time - the FDA filed an amicus curiae brief enlightening the Eleventh Circuit that neither drug was legally on the market because neither had ever been approved by the FDA. “Trade Dress Infringement: Florida Breckinridge Inc. v. Solvay Pharmaceuticals Inc.,” Intellectual Property Litigation Reporter, Vol. 15, No. 21, at 12, June 9, 1999.

The Eleventh Circuit admonished the attorneys on both sides for not bringing this information to its attention, stating, “[The attorneys] owe duties of complete candor and primary loyalty to the court before which they practice. These duties are never subservient to a lawyer's duty to advocate zealously for his or her client. In this case, the attorneys for both parties have frustrated the system of justice, which depends on their candor and loyalty to the court, because they wanted to avoid an unpleasant truth about their clients' conduct. In short, they have sold out to the client.” Breckenridge Inc., 174 F.3d at 1232 (citations omitted). Thus, even when the outcome of a case won't directly affect FDA policy, the FDA may be watching and may take action where it deems it necessary.

Conclusion

The FDA's mission is to both promote and protect the public health, and it will venture to do so by getting involved in litigation, often on its own initiative. FDA recommendations traditionally carry great weight with the courts and, as such, defense (and plaintiff's) counsel should educate themselves about the FDA's stances on various issues that could impact their own product liability cases. Counsel's sustained study of the FDA's evolving opinions on issues that may prove important in present or future cases is encouraged.