Practice Tip: Pleading of Parallel Claims After Riegel

In Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the U.S. Supreme Court held that most product liability claims against manufacturers of the riskiest, most critical, and most extensively regulated medical devices are preempted by federal law. The Court left open a small window for state law claims premised on violations of FDA regulations ' known as “parallel claims” ' but did not define the contours of such claims. After Riegel, the federal appellate and district courts have reached divergent conclusions regarding the level of specificity required to plead a parallel claim that survives a motion to dismiss. This article provides an overview of the case law on the topic.

Background

In 1976, Congress passed the Medical Device Amendments (MDA), 21 U.S.C. ' 360c et seq., which imposed detailed regulatory oversight of medical devices. The riskiest devices, known as Class III, receive the greatest oversight under the MDA. These devices must undergo a rigorous premarket approval (PMA) process prior to being sold. As part of the process, a manufacturer is required to submit a detailed PMA application containing information pertaining to the design, manufacturing, labeling, and safety and effectiveness of the device. ' 360e(c). The FDA approves the device for sale only after it is convinced of a “reasonable assurance” of the device's “safety and effectiveness.” ' 360e(d).

Medical devices subject to the MDA receive the benefit of an express preemption provision in the MDA. This provision prohibits a state from establishing or continuing “any requirement” relating to the medical device “which is different from, or in addition to, any requirement applicable” under the MDA and “which relates to the safety and effectiveness of the device or to any other matter included in a requirement applicable to the device” under the MDA. ' 360k(a).

In Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the U.S. Supreme Court addressed the MDA's express preemption provision as it pertains to medical devices approved through the PMA process. The Court gave sweeping effect to the provision, finding preemption of plaintiffs' state law claims premised on strict liability, negligence, and implied warranty because they imposed requirements “different from, or in addition to” federal requirements. Id. at 321-30. At the same time, however, the Court indicated that state law claims premised on the violation of FDA regulations might escape preemption because those claims would parallel federal requirements: “' 360 [of the MDA] does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case 'parallel,' rather than add to, federal requirements.” Id. at 330.

After Riegel, plaintiffs in PMA device cases have attempted to articulate their traditional state tort claims as parallel claims by alleging injury from a manufacturer's violation of FDA regulations. Manufacturers have typically responded with motions to dismiss, arguing that vague and conclusory allegations that a defendant violated FDA regulations are insufficient, particularly in light of the stricter pleading principles established by the U.S. Supreme Court in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) and Ashcroft v. Iqbal, 129 S. Ct. 1937 (2009). In Twombly and Iqbal, the Court held that to survive a motion to dismiss, a complaint cannot simply recite the elements of a cause of action, but rather, “must contain sufficient factual matter, accepted as true, 'to state a claim to relief that is plausible on its face.'” Twombly, 550 U.S. at 555-56, 570; Iqbal, 129 S. Ct. at 1949. If a complaint is deficient in this regard, a plaintiff “is not entitled to discovery, cabined or otherwise.” Iqbal, 129 S. Ct. at 1954.

Circuit Split

Federal appellate courts in four different circuits have issued opinions in PMA device cases addressing the level of specificity required to plead non-preempted parallel claims. The courts have not agreed on an appropriate standard, giving rise to a circuit split.

Eighth Circuit

The first circuit court to address the issue was the Eighth Circuit in Bryant v. Medtronic, Inc., 623 F.3d 1200 (8th Cir. Oct. 15, 2010). In Bryant, an Eighth Circuit panel affirmed a multidistrict litigation court's dismissal of product liability claims as preempted under Riegel and insufficiently pled under Twombly. The panel agreed on most claims, but divided on the issue of whether plaintiffs had adequately pled a parallel manufacturing defect claim by alleging that the defendant had violated the FDA's Current Good Manufacturing Practices (CGMPs). The latter serve as “an umbrella quality system” and provide “general objectives” for all device manufacturers, but give manufacturers flexibility to determine the best methods to meet quality objectives. Id. at 1206; In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F.Supp.2d 1147, 1157 & n.12 (D.Minn. Jan. 5, 2009). The district court had held that given the general, flexible nature of CGMPs, holding manufacturers liable for violating CGMPs would impermissibly impose requirements “different from or in addition to” those under federal law. Id. at 1158.

The Bryant majority affirmed the district court's conclusion that plaintiffs, in alleging violation of CGMPs but failing to allege the violation of any specific PMA requirement, had failed to plead a parallel claim sufficiently. Bryant, 623 F.3d at 1206. In doing so, it rejected plaintiffs' argument that the court should relax the pleading standard on the basis of plaintiffs' claimed need for discovery to gain access to the PMA documents containing the specific manufacturing requirements. Id. at 1206-07. The majority found notable that plaintiffs had specifically disavowed the need for discovery in opposing the motion to dismiss. Id. The opinion suggested, however, that the court might be more receptive to such an argument in a case in which “a specific defective Class III device injured a consumer, and the plaintiff did not have access to the specific federal requirement in the PMA prior to commencing the lawsuit.” Id. The dissent, on the other hand, would have relaxed the pleading standard given the confidential nature of the PMA, and would have allowed plaintiffs cabined discovery (limited to the PMA) before requiring plaintiffs to plead a violation of a specific PMA requirement. Id. at 1209-10.

Seventh Circuit

The next appellate court to address the issue was the Seventh Circuit in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. Dec. 23, 2010). In reversing a district court's decision to dismiss the plaintiff's product liability claims, the panel created a split with the Eighth Circuit. The court held that a plaintiff need not “specify the precise defect or the specific federal regulatory requirements that were allegedly violated.” Id. at 560. Thus, the plaintiff's original complaint, which specified no federal requirement, was sufficient, and an amended complaint referencing CGMPs would be sufficient as well. Id. at 554-56, 559-60. The panel agreed with the dissent in Bryant that given the confidential nature of the PMA documents containing product-specific information, “[f]ormal discovery is necessary before a plaintiff can fairly be expected to provide a detailed statement of the specific bases for [a] claim.” Id. at 554, 558, 560-61. The plaintiffs' complaint had contained factual detail specifying that the FDA issued a warning letter to the defendant that its manufacturing methods were not in conformity with regulatory standards, and that the warning letter pertained to a device having the same catalogue number as the device later implanted in plaintiff. Id. at 559. The plaintiff also alleged that the device implanted in her was later recalled. Id.

Fifth Circuit

The Fifth Circuit, in Funk v. Stryker Corp., 631 F.3d 777 (5th Cir. Jan. 28, 2011), was the next court to address the pleading of parallel claims in PMA device cases. The panel affirmed the district court's dismissal of the plaintiff's manufacturing defect claim, in a case in which the plaintiff's complaint alleged only generally that the defendant violated unspecified FDA regulations, but did not provide factual detail. In doing so, the Fifth Circuit aligned itself with the Eighth Circuit majority in Bryant by holding that a plaintiff must plead the violation of a specific FDA requirement that caused the plaintiff's injury: “This complaint is impermissibly conclusory and vague; it does not specify the manufacturing defect; nor does it specify a causal connection between the failure of the specific manufacturing process and the specific defect in the process that caused the personal injury. Nor does the complaint tell us how the manufacturing process failed, or how it deviated from the FDA approved manufacturing process.” Id. at 782.

Eleventh Circuit

The most recent circuit court to address the pleading of parallel PMA device claims was the Eleventh Circuit in Wolicki-Gables v. Arrow International, Inc., 634 F.3d 1296 (11th Cir. Mar. 8, 2011). It widened the divide between circuits by setting a standard that requires the greatest level of specificity in pleading: “A plaintiff must allege that the defendant violated a particular federal specification referring to the device at issue. To allege parallel claims properly, the complaint must set forth facts pointing to specific PMA requirements that have been violated.” Id. at 1301 (internal citations and quotation marks omitted). The panel affirmed the district court's decision that plaintiffs' complaint, which had not alleged the violation of any federal regulation, was insufficient because it did not “set forth any specific problem, or failure to comply with any FDA regulation that can be linked to the injury alleged.” Id. at 1301-02 (internal citation and quotation marks omitted).

Federal District Court Decisions

Although the federal appellate courts have divided on the proper standard for pleading parallel claims in PMA devices cases, many federal district courts to have addressed the issue adopted a standard similar to that embraced by the Eleventh Circuit in Wolicki-Gables by requiring the pleading of a concrete violation of a FDA regulation linked to plaintiff's injury. For instance, in Horowitz v. Stryker Corp., 613 F.Supp.2d 271 (E.D.N.Y. Feb. 20, 2009), the court held that general allegations that defendants violated CGMPs were insufficient, and that a “plaintiff must demonstrate that a particular federal violation led to the injuries [plaintiff] sustained.” Id. at 280-84.

Similarly, in Covert v. Stryker Corp., 2009 WL 2424559 (M.D.N.C. Aug. 5, 2009), the court held that the plaintiff's complaint was insufficient because it failed to “point to a specific federal requirement, show how it was violated, and ' show how said violation resulted in the injury complained of.” Id. at *15-16 & n.10. Additionally, in Parker v. Stryker Corp., 584 F.Supp.2d 1298 (D.Colo. Oct. 22, 2008), the court held that “[t]o properly allege parallel claims, the complaint must set forth facts showing 'action or inaction in [defendants'] efforts to take part in the PMA process or implement its results.'” Id. at 1301 (citation omitted); see also, e.g., Bass v. Stryker Corp., 2010 WL 3431637, at *4 (N.D. Tex. Aug. 31, 2010) (dismissing complaint where “[t]he complaint does not allege a failure to comply with any particular regulation nor how that failure caused [plaintiff's] injuries”); Ilarraza v. Medtronic, Inc., 677 F.Supp.2d 582, 588-90 (E.D.N.Y. Dec. 28, 2009) (holding that the pleading of CGMP violations is insufficient to state a parallel claim, and that plaintiff must link the violation to an injury); Riley v. Cordis Corp., 625 F.Supp.2d 769, 784-85, 789 (D.Minn. June 5, 2009) (holding that plaintiff's factual allegations were conclusory and vague and without the necessary causal link to plaintiff's injury); but see Hofts v. Howmedica Osteonics Corp., 597 F.Supp.2d 830, 838, 841-42 (S.D.Ind. Feb. 11, 2009) (in an opinion authored by a judge on the Bausch Seventh Circuit panel, holding that alleged CGMP violations were sufficient to survive a motion to dismiss).

Other District Court Opinions

District court opinions finding that a complaint properly pled specific FDA violations and linked them to plaintiff's injury seem to be few and far between, although there are a couple of cases. For example, in Rollins v. St. Jude Medical, 583 F.Supp.2d 790 (W.D.La. Oct. 20, 2008), the court declined to dismiss the plaintiff's manufacturing defect claim where the plaintiff alleged the violation of FDA specifications requiring the manufacturer to package the device in a particular way, that the violation resulted in a recall, and that since the plaintiff's device malfunctioned in the same manner, it should have been included in the recall. Id. at 800-01. Additionally, in Purcel v. Advanced Bionics, 2008 WL 3874713 (N.D.Tex. Aug. 13, 2008), the court denied dismissal of a manufacturing defect claim where the plaintiff alleged that the device had been recalled, and that the FDA had issued warning letters and brought a voluntary enforcement action for CGMP violations. Id. at *1-3. Although the plaintiff's device was not part of the recall, the plaintiff alleged that the device was tested and suffered from the same issues as the recalled devices. Id. at *1.

Conclusion

Given the circuit split, U.S. Supreme Court review of the proper pleading of parallel claims in PMA device cases is an obvious possibility. In the meantime, courts will likely continue to reach disparate results in deciding motions to dismiss, although the weight of the case law indicates that properly pleading a parallel claim is an uphill battle for plaintiffs.

Allison M. Rovner is an associate in the Mass Tort and Product Liability group of Dechert LLP, resident in the Philadelphia office. She can be reached at [email protected] or at 215-994-2196.

In Riegel v. Medtronic, Inc. , 552 U.S. 312 (2008), the U.S. Supreme Court held that most product liability claims against manufacturers of the riskiest, most critical, and most extensively regulated medical devices are preempted by federal law. The Court left open a small window for state law claims premised on violations of FDA regulations ' known as “parallel claims” ' but did not define the contours of such claims. After Riegel, the federal appellate and district courts have reached divergent conclusions regarding the level of specificity required to plead a parallel claim that survives a motion to dismiss. This article provides an overview of the case law on the topic.

Background

In 1976, Congress passed the Medical Device Amendments (MDA), 21 U.S.C. ' 360c et seq., which imposed detailed regulatory oversight of medical devices. The riskiest devices, known as Class III, receive the greatest oversight under the MDA. These devices must undergo a rigorous premarket approval (PMA) process prior to being sold. As part of the process, a manufacturer is required to submit a detailed PMA application containing information pertaining to the design, manufacturing, labeling, and safety and effectiveness of the device. ' 360e(c). The FDA approves the device for sale only after it is convinced of a “reasonable assurance” of the device's “safety and effectiveness.” ' 360e(d).

Medical devices subject to the MDA receive the benefit of an express preemption provision in the MDA. This provision prohibits a state from establishing or continuing “any requirement” relating to the medical device “which is different from, or in addition to, any requirement applicable” under the MDA and “which relates to the safety and effectiveness of the device or to any other matter included in a requirement applicable to the device” under the MDA. ' 360k(a).

In Riegel v. Medtronic, Inc. , 552 U.S. 312 (2008), the U.S. Supreme Court addressed the MDA's express preemption provision as it pertains to medical devices approved through the PMA process. The Court gave sweeping effect to the provision, finding preemption of plaintiffs' state law claims premised on strict liability, negligence, and implied warranty because they imposed requirements “different from, or in addition to” federal requirements. Id. at 321-30. At the same time, however, the Court indicated that state law claims premised on the violation of FDA regulations might escape preemption because those claims would parallel federal requirements: “' 360 [of the MDA] does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case 'parallel,' rather than add to, federal requirements.” Id. at 330.

After Riegel, plaintiffs in PMA device cases have attempted to articulate their traditional state tort claims as parallel claims by alleging injury from a manufacturer's violation of FDA regulations. Manufacturers have typically responded with motions to dismiss, arguing that vague and conclusory allegations that a defendant violated FDA regulations are insufficient, particularly in light of the stricter pleading principles established by the U.S. Supreme Court in Bell Atlantic Corp. v. Twombly , 550 U.S. 544 (2007) and Ashcroft v. Iqbal , 129 S. Ct. 1937 (2009). In Twombly and Iqbal, the Court held that to survive a motion to dismiss, a complaint cannot simply recite the elements of a cause of action, but rather, “must contain sufficient factual matter, accepted as true, 'to state a claim to relief that is plausible on its face.'” Twombly, 550 U.S. at 555-56, 570; Iqbal, 129 S. Ct. at 1949. If a complaint is deficient in this regard, a plaintiff “is not entitled to discovery, cabined or otherwise.” Iqbal, 129 S. Ct. at 1954.

Circuit Split

Federal appellate courts in four different circuits have issued opinions in PMA device cases addressing the level of specificity required to plead non-preempted parallel claims. The courts have not agreed on an appropriate standard, giving rise to a circuit split.

Eighth Circuit

The first circuit court to address the issue was the Eighth Circuit in Bryant v. Medtronic, Inc. , 623 F.3d 1200 (8th Cir. Oct. 15, 2010). In Bryant, an Eighth Circuit panel affirmed a multidistrict litigation court's dismissal of product liability claims as preempted under Riegel and insufficiently pled under Twombly. The panel agreed on most claims, but divided on the issue of whether plaintiffs had adequately pled a parallel manufacturing defect claim by alleging that the defendant had violated the FDA's Current Good Manufacturing Practices (CGMPs). The latter serve as “an umbrella quality system” and provide “general objectives” for all device manufacturers, but give manufacturers flexibility to determine the best methods to meet quality objectives. Id. at 1206; In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F.Supp.2d 1147, 1157 & n.12 (D.Minn. Jan. 5, 2009). The district court had held that given the general, flexible nature of CGMPs, holding manufacturers liable for violating CGMPs would impermissibly impose requirements “different from or in addition to” those under federal law. Id. at 1158.

The Bryant majority affirmed the district court's conclusion that plaintiffs, in alleging violation of CGMPs but failing to allege the violation of any specific PMA requirement, had failed to plead a parallel claim sufficiently. Bryant, 623 F.3d at 1206. In doing so, it rejected plaintiffs' argument that the court should relax the pleading standard on the basis of plaintiffs' claimed need for discovery to gain access to the PMA documents containing the specific manufacturing requirements. Id. at 1206-07. The majority found notable that plaintiffs had specifically disavowed the need for discovery in opposing the motion to dismiss. Id. The opinion suggested, however, that the court might be more receptive to such an argument in a case in which “a specific defective Class III device injured a consumer, and the plaintiff did not have access to the specific federal requirement in the PMA prior to commencing the lawsuit.” Id. The dissent, on the other hand, would have relaxed the pleading standard given the confidential nature of the PMA, and would have allowed plaintiffs cabined discovery (limited to the PMA) before requiring plaintiffs to plead a violation of a specific PMA requirement. Id. at 1209-10.

Seventh Circuit

The next appellate court to address the issue was the Seventh Circuit in Bausch v. Stryker Corp. , 630 F.3d 546 (7th Cir. Dec. 23, 2010). In reversing a district court's decision to dismiss the plaintiff's product liability claims, the panel created a split with the Eighth Circuit. The court held that a plaintiff need not “specify the precise defect or the specific federal regulatory requirements that were allegedly violated.” Id. at 560. Thus, the plaintiff's original complaint, which specified no federal requirement, was sufficient, and an amended complaint referencing CGMPs would be sufficient as well. Id. at 554-56, 559-60. The panel agreed with the dissent in Bryant that given the confidential nature of the PMA documents containing product-specific information, “[f]ormal discovery is necessary before a plaintiff can fairly be expected to provide a detailed statement of the specific bases for [a] claim.” Id. at 554, 558, 560-61. The plaintiffs' complaint had contained factual detail specifying that the FDA issued a warning letter to the defendant that its manufacturing methods were not in conformity with regulatory standards, and that the warning letter pertained to a device having the same catalogue number as the device later implanted in plaintiff. Id. at 559. The plaintiff also alleged that the device implanted in her was later recalled. Id.

Fifth Circuit

The Fifth Circuit, in Funk v. Stryker Corp. , 631 F.3d 777 (5th Cir. Jan. 28, 2011), was the next court to address the pleading of parallel claims in PMA device cases. The panel affirmed the district court's dismissal of the plaintiff's manufacturing defect claim, in a case in which the plaintiff's complaint alleged only generally that the defendant violated unspecified FDA regulations, but did not provide factual detail. In doing so, the Fifth Circuit aligned itself with the Eighth Circuit majority in Bryant by holding that a plaintiff must plead the violation of a specific FDA requirement that caused the plaintiff's injury: “This complaint is impermissibly conclusory and vague; it does not specify the manufacturing defect; nor does it specify a causal connection between the failure of the specific manufacturing process and the specific defect in the process that caused the personal injury. Nor does the complaint tell us how the manufacturing process failed, or how it deviated from the FDA approved manufacturing process.” Id. at 782.

Eleventh Circuit

The most recent circuit court to address the pleading of parallel PMA device claims was the Eleventh Circuit in Wolicki-Gables v. Arrow International, Inc. , 634 F.3d 1296 (11th Cir. Mar. 8, 2011). It widened the divide between circuits by setting a standard that requires the greatest level of specificity in pleading: “A plaintiff must allege that the defendant violated a particular federal specification referring to the device at issue. To allege parallel claims properly, the complaint must set forth facts pointing to specific PMA requirements that have been violated.” Id. at 1301 (internal citations and quotation marks omitted). The panel affirmed the district court's decision that plaintiffs' complaint, which had not alleged the violation of any federal regulation, was insufficient because it did not “set forth any specific problem, or failure to comply with any FDA regulation that can be linked to the injury alleged.” Id. at 1301-02 (internal citation and quotation marks omitted).

Federal District Court Decisions

Although the federal appellate courts have divided on the proper standard for pleading parallel claims in PMA devices cases, many federal district courts to have addressed the issue adopted a standard similar to that embraced by the Eleventh Circuit in Wolicki-Gables by requiring the pleading of a concrete violation of a FDA regulation linked to plaintiff's injury. For instance, in Horowitz v. Stryker Corp. , 613 F.Supp.2d 271 (E.D.N.Y. Feb. 20, 2009), the court held that general allegations that defendants violated CGMPs were insufficient, and that a “plaintiff must demonstrate that a particular federal violation led to the injuries [plaintiff] sustained.” Id . at 280-84.

Similarly, in Covert v. Stryker Corp., 2009 WL 2424559 (M.D.N.C. Aug. 5, 2009), the court held that the plaintiff's complaint was insufficient because it failed to “point to a specific federal requirement, show how it was violated, and ' show how said violation resulted in the injury complained of.” Id. at *15-16 & n.10. Additionally, in Parker v. Stryker Corp. , 584 F.Supp.2d 1298 (D.Colo. Oct. 22, 2008), the court held that “[t]o properly allege parallel claims, the complaint must set forth facts showing 'action or inaction in [defendants'] efforts to take part in the PMA process or implement its results.'” Id . at 1301 (citation omitted); see also, e.g., Bass v. Stryker Corp., 2010 WL 3431637, at *4 (N.D. Tex. Aug. 31, 2010) (dismissing complaint where “[t]he complaint does not allege a failure to comply with any particular regulation nor how that failure caused [plaintiff's] injuries”); Ilarraza v. Medtronic, Inc. , 677 F.Supp.2d 582, 588-90 (E.D.N.Y. Dec. 28, 2009) (holding that the pleading of CGMP violations is insufficient to state a parallel claim, and that plaintiff must link the violation to an injury); Riley v. Cordis Corp. , 625 F.Supp.2d 769, 784-85, 789 (D.Minn. June 5, 2009) (holding that plaintiff's factual allegations were conclusory and vague and without the necessary causal link to plaintiff's injury); but see Hofts v. Howmedica Osteonics Corp. , 597 F.Supp.2d 830, 838, 841-42 (S.D.Ind. Feb. 11, 2009) (in an opinion authored by a judge on the Bausch Seventh Circuit panel, holding that alleged CGMP violations were sufficient to survive a motion to dismiss).

Other District Court Opinions

District court opinions finding that a complaint properly pled specific FDA violations and linked them to plaintiff's injury seem to be few and far between, although there are a couple of cases. For example, in Rollins v. St. Jude Medical , 583 F.Supp.2d 790 (W.D.La. Oct. 20, 2008), the court declined to dismiss the plaintiff's manufacturing defect claim where the plaintiff alleged the violation of FDA specifications requiring the manufacturer to package the device in a particular way, that the violation resulted in a recall, and that since the plaintiff's device malfunctioned in the same manner, it should have been included in the recall. Id. at 800-01. Additionally, in Purcel v. Advanced Bionics, 2008 WL 3874713 (N.D.Tex. Aug. 13, 2008), the court denied dismissal of a manufacturing defect claim where the plaintiff alleged that the device had been recalled, and that the FDA had issued warning letters and brought a voluntary enforcement action for CGMP violations. Id. at *1-3. Although the plaintiff's device was not part of the recall, the plaintiff alleged that the device was tested and suffered from the same issues as the recalled devices. Id. at *1.

Conclusion

Given the circuit split, U.S. Supreme Court review of the proper pleading of parallel claims in PMA device cases is an obvious possibility. In the meantime, courts will likely continue to reach disparate results in deciding motions to dismiss, although the weight of the case law indicates that properly pleading a parallel claim is an uphill battle for plaintiffs.

Allison M. Rovner is an associate in the Mass Tort and Product Liability group of Dechert LLP, resident in the Philadelphia office. She can be reached at [email protected] or at 215-994-2196.