Class III Medical Device Product Liability Claims Under <i>Twombly</i> and <i>Iqbal</i>

Under Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007), and Ashcroft v. Iqbal' 556 U.S. 662, 678 (2009), complaints must allege “enough facts to state a claim to relief that is plausible on its face.” Twombly, 550 U.S. at 570. A claim is facially plausible “when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678. Accordingly, “formulaic” or “[t]hreadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice.” Id' Mere conclusions “[do] not unlock the doors of discovery. ' ” Id. at 678'79.

It is well founded that the pleading standard set forth in Twombly and Iqbal applies to claims involving Class III medical devices. In these actions, however, federal courts have taken different approaches to the application of Twombly and Iqbal. Some courts have concluded that plaintiffs do not need to allege product-specific information in their complaints to survive motions to dismiss on the grounds that the product-specific information about manufacturing is confidential under federal law and, therefore, is not available to a plaintiff until discovery. Other courts, when analyzing similar claims, have held that general pleading of violations of federal regulations is insufficient to state a viable claim under Twombly and Iqbal.

Background

The Medical Device Amendments (MDA) to the Food Drug and Cosmetics Act (FDCA) grant the Food and Drug Administration (FDA) the authority to regulate medical devices. The MDA provides three levels of scrutiny to medical devices before approval for marketing, with “Class III” medical devices receiving the highest level of scrutiny. A Class III medical device is one that is “purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury. ' ” 21 U.S.C. ' 360c(a)(1)(C)(ii). The pre-market approval process for these devices is rigorous, and it is only after this process that a manufacturer may begin to make and market a device.

All medical devices are subject to Current Good Manufacturing Practices (CGMPs) that “govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.” 21 C.F.R. ' 820.1(a)(1). The CGMPs are purposely flexible to allow each manufacturer to determine how best to implement the necessary controls specific to the medical device it produces.

Congress included in the MDA an express preemption provision preventing states from imposing any requirement that is different from, or in addition to, any requirement applicable under the MDA to the device, and that relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under the MDA. 21 U.S.C. ' 360k(a). Consistent with that provision, the Supreme Court in Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008), held that a plaintiff's state-law claims for strict product liability, breach of implied warranty, and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of an FDA-approved medical device were preempted by the MDA. Riegel noted, however, that “' 360k 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.

Courts at Odds

As a result of Riegel, design and warning claims pertaining to Class III medical devices are preempted by the MDA. Manufacturing defect claims may still survive under Riegel, however, and a state may provide a damages remedy for claims premised on a violation of FDA regulations; suits on this basis, if they survive, are considered “parallel” actions. Thus, when presented with a motion to dismiss a Class III medical device product liability claim, a court must determine whether the plaintiff plausibly alleges a parallel claim and whether the plaintiff's complaint satisfies the standard set forth in Twombly and Iqbal. Federal courts are divided as to what level of specificity is required in the plaintiff's complaint to plead a parallel claim sufficiently.

Pleading Standard Satisfied

In 2010, the Seventh U.S. Circuit Court of Appeals issued one of the leading cases regarding the sufficiency of pleading a parallel state claim. In Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), the court reversed a district court's dismissal of a plaintiff's claims for defective manufacture of a Trident hip replacement in violation of federal law. The complaint alleged that the product was unreasonably dangerous and set forth facts indicating that defendants knew or should have known prior to the surgery that the plaintiff's device was defective. The defendants had recalled certain Trident components in 2006 because of “dimensional anomalies” and in the following year, the FDA issued a letter to defendants stating that the Trident was adulterated due to manufacturing methods that were not in conformity with industry and regulatory standards. A device was then implanted in the plaintiff's body the following week. This device bore the same catalog number as the device allegedly not in compliance with regulations.

The Bausch court concluded that the plaintiff's claims were not expressly preempted under ' 360k because they were based on alleged violations of federal law, and rejected the defendants' argument that the Quality Systems Regulations and CGMPs were too general to allow juries to enforce them. The court also rejected the defendants' implied preemption argument. It then turned to “the problem of how difficult it is to plead [a parallel] claim sufficiently” to survive a 12(b)(6) motion to dismiss. Id. at 558. The court reasoned that because of the confidentiality of the product-specific information about manufacturing, “[f]ormal discovery is necessary before a plaintiff can fairly be expected to provide a detailed statement of the specific bases for her claim.” Id. The court rejected the defendants' argument that the complaint did not specify the precise defect, concluding that it still complied with the federal pleading standards, that a plaintiff would need discovery to identify the specific defect, and that in the context of Class III medical devices, relevant information, such as specifications of the FDA's premarket approval, is kept confidential by federal law. Ultimately, the court relied on the principle that the “'plaintiff[s'] pleading burden should be commensurate with the amount of information available to them.'” Id. at 561 (citation omitted).

Bausch has been accepted by a number of district courts. For example, in Gelber v. Stryker Corp., 788 F. Supp. 2d 145 (S.D.N.Y. 2011), the court concluded that a plaintiff had plausibly stated a claim alleging that the Trident hip implant system was defective and that after conditional approval of the device, but before implantation into the plaintiff, the defendants modified the Trident. The court rejected the defendants' argument that the failure to state the specific provision of the CGMPs that the defendants violated in manufacturing the Trident was fatal to the plaintiff's claim. The plaintiff's allegations of the warning letter from the FDA to the defendants and a voluntary recall, along with their allegation of a theory ' excessive levels of manufacturing residue that the court found was subject of a CGMP requirement ' was sufficient. The court concluded, citing Bausch, that “[b]y pleading the conduct which plaintiffs alleged violated the CGMP requirements, describing evidence of the alleged violation, and directing plaintiffs to the CGMPs generally, plaintiffs have given defendants more than ample notice of the alleged violation of federal law.” Id. at 156.

Likewise, in Simoneau v. Stryker Corp., No. 3:13-CV-1200, 2014 U.S. Dist. LEXIS 43137 (D. Conn. Mar. 31, 2014), the court addressed an argument that the MDA preempted the plaintiff's claims that a Trident hip implant was defective, or, alternatively, the plaintiff had not plausibly pled a warranty parallel product liability claim. The plaintiff alleged that the manufacture of the Trident did not meet FDA regulations and premarket approval specifications and therefore was in an unreasonably dangerous and defective condition.

The plaintiff alleged the issuance of FDA warning letters and two related recalls by the defendants. Rejecting the defendants' argument that the plaintiff's allegations lacked the required specificity because they did not include any premarket approval specification referring the Trident Hip implant itself and instead cited only broad regulations and generalized CGMPs, the court concluded that the plaintiff stated a parallel product liability claim. The court found persuasive the reasoning in Bausch, which noted that the critical information ' including premarket approval specifications ' is confidential as a matter of law. To avoid preemption, a plaintiff's product liability claim “need only be plausibly premised on a violation of 'any requirement' applicable to the Trident Hip Implant under the FDCA.” Id . at *20. References in the complaint to violations of the CGMPs generally, and to the defendants' two recalls, met this standard. In addition to finding Bausch persuasive, the court found its reasoning “faithful” to Iqbal's direction to make “'context-specific' determinations rooted in 'judicial experience and common sense.'” Id. at *19-20 n.6 (quoting Iqbal, 556 U.S. at 679). See also Brooks v. Sanofi-Aventis U.S., LLC, No. 2:14-cv-976, 2014 U.S. Dist. LEXIS 174842, at *8'12 (S.D. Ohio Dec. 18, 2014) (finding Bausch persuasive, stating that to hold otherwise “would require too much to demand that Plaintiff allege specific defects that violate the FDA standards when such information is not necessarily within her control”).

Failure to Satisfy the Pleading Standard

In the years immediately following Twombly and before Bausch, two courts in the Eastern District of New York held that generalized allegations contained in complaints involving Class III medical devices were insufficient to survive a motion to dismiss. In Horowitz v. Stryker Corp., 613 F. Supp. 2d 271 (E.D.N.Y. 2009), the court concluded that the plaintiff's claims based on a defective Trident hip system were preempted because she failed to demonstrate a cognizable link between the defendant's federal violations and her injury. The plaintiff advanced eight causes of action: 1) Failure to warn (strict liability); 2) Defective manufacturing (strict liability); 3) Defective design (strict liability); 4) Negligence and recklessness; 5) Breach of express warranty; 6) Breach of implied warranty of fitness; 7) Breach of implied warranty of merchantability; and 8) Violations of New York's General Business Law.

The court dismissed the plaintiff's claims for failure to warn and defective design with prejudice, and dismissed the remaining claims with leave to replead. There are lengthy discussions about each of the theories and what needs to be alleged to survive. Notably, the recalls the plaintiff identified in her complaint did not include the Trident System or any of its parts. The plaintiff also failed to allege that her particular product was included in the FDA warning letters she cited. The plaintiff never alleged any enforcement action brought against the defendants involving her product. The court concluded that these generalized allegations lacked the “amplification” necessary to rise to the level of plausibility that Twombly requires. Id. at 283.

Similarly, in Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d 582 (E.D.N.Y. 2009), the plaintiff alleged in a single cause of action for “Negligence Per Se (a 'Parallel Action')” that his implanted Intrathecal Drug Delivery System (“Medication Pump”) broke after the defendant failed to manufacture the Medication Pump in a “reasonable and prudent manner” and in accordance with CGMPs. Id. at 583. The complaint alleged violation of eight general federal regulations, including management responsibility, personnel and distribution, and did not allege any link between a federal violation and plaintiff's injury.

The court concluded that the complaint failed to state a plausible claim because no regulation relied upon referred specifically to the medical device at issue; rather the regulations were general statements of CGMPs. The court concluded that the CGMPs were only “umbrella quality system[s]” and provided “ general objectives.” Id. at 588. Their “intentionally vague and open-ended nature” and the fact that they were open to interpretation by manufacturers further indicated that they could not serve as the basis of a parallel action under Twombly . The court concluded: “Where, as here, the plaintiff has done nothing more than recite unsupported violations of general regulations, and fails to tie such allegations to the injuries alleged, the complaint is properly dismissed.” Id.

More recently, a number of district courts have specifically rejected the holding in Bausch , concluding that it is contrary to Twombly and Iqbal. See, e.g., Gross v. Stryker Corp., 858 F. Supp. 2d 466, 496 (W.D. Pa 2012) (finding Bausch's rationale to be unpersuasive and declining to follow its holding, in part, because “such a liberal pleading standard is in conflict with Twombly and Iqbal “); Ali v. Allergan USA, Inc., No. 1:12-CV-115, 2012 U.S. Dist. LEXIS 121417, at *42 (E.D. Va. Aug. 23, 2012) (“This is precisely the sort of fishing expedition the Supreme Court sought to avoid ' [in deciding Twombly and Iqbal .]“). Similarly, in Bertini v. Smith & Nephew, Inc., No. 13 Civ. 0079, 2013 U.S. Dist. LEXIS 171021 (E.D.N.Y. July 12, 2013), the plaintiff alleged that the defendant's R3 acetabular hip liner (“R3 liner”) was defective in design or manufacture because of its increased risk of loosening. Less than a year after the plaintiff was implanted with an R3 liner, the FDA found that R3 liners produced at defendant's plant were adulterated in that certain CGMPs were being violated. The defendant then issued three mandatory recalls over the following three years.

The defendant moved to dismiss, arguing that the allegations were conclusory and did not indicate how the product was defectively designed or manufactured. The court agreed, finding the plaintiff's allegations that the R3 liner was defective and deviated in a material way from manufacturing standards, conclusory. The court reasoned that pleading only that the device did not perform as intended was not enough to reach the plausibility threshold of Twombly and Iqbal. The court rejected the plaintiff's argument that relied on Bausch that the court was subjecting them to a higher pleading standard by forcing them to supply information about a particular defect that they could not identify. The court distinguished Bausch , finding the complaint there more sufficiently pled in that it included allegations of “dimensional anomalies” whereas the plaintiff pled only that the device was defective. Id. at 11-12. The court also noted that other courts had rejected Bausch.

Interestingly, the court did not give much weight to the recalls issued by the defendant in its analysis, finding that the plaintiff failed to provide sufficient connection from the recall to the liner implanted in the plaintiff. See also Burkett v. Smith & Nephew GmbH, No. CV 12-4895, 2014 U.S. Dist. LEXIS 43995 (E.D.N.Y. Mar. 31, 2014) (decided the same day as Simoneau, granting motion to dismiss all claims premised on defective R3 liner where no allegation of violation of federal requirement specific to R3 liner, only CGMPs, and no link between purported violation and alleged injury).

An Unsettled Area

As the cases discussed above indicate, the application of Twombly and Iqbal to Class III medical device defect claims is still unsettled. The tensions involved in applying the pleading standard established by Iqbal and Twombly and the preemption rule established by Riegel against the possible dismissal of potentially meritorious claims before allowing discovery have resulted in a number of conflicting district and circuit court decisions. To date, in deciding these cases, the district and circuit courts have focused on a number of different factors in reaching their decisions, including the specificity of the alleged violations of the CGMPs, and the connection alleged between the CGMPs, warning letters or recalls and the product and/or injury in the case.

James Rotondo, a member of this newsletter's Board of Editors, represents a broad range of corporate clients in product liability, negligence, insurance coverage, and commercial litigation matters at Day Pitney LLP in its Hartford, CT, office. Kaitlin Canty and Michael Pohorylo are associates at the firm, practicing in the areas of product liability and torts law.

Under Bell Atlantic Corp. v. Twombly , 550 U.S. 544, 570 (2007), and Ashcroft v. Iqbal ' 556 U.S. 662, 678 (2009), complaints must allege “enough facts to state a claim to relief that is plausible on its face.” Twombly , 550 U.S. at 570. A claim is facially plausible “when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678. Accordingly, “formulaic” or “[t]hreadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice.” Id' Mere conclusions “[do] not unlock the doors of discovery. ' ” Id. at 678'79.

It is well founded that the pleading standard set forth in Twombly and Iqbal applies to claims involving Class III medical devices. In these actions, however, federal courts have taken different approaches to the application of Twombly and Iqbal. Some courts have concluded that plaintiffs do not need to allege product-specific information in their complaints to survive motions to dismiss on the grounds that the product-specific information about manufacturing is confidential under federal law and, therefore, is not available to a plaintiff until discovery. Other courts, when analyzing similar claims, have held that general pleading of violations of federal regulations is insufficient to state a viable claim under Twombly and Iqbal.

Background

The Medical Device Amendments (MDA) to the Food Drug and Cosmetics Act (FDCA) grant the Food and Drug Administration (FDA) the authority to regulate medical devices. The MDA provides three levels of scrutiny to medical devices before approval for marketing, with “Class III” medical devices receiving the highest level of scrutiny. A Class III medical device is one that is “purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury. ' ” 21 U.S.C. ' 360c(a)(1)(C)(ii). The pre-market approval process for these devices is rigorous, and it is only after this process that a manufacturer may begin to make and market a device.

All medical devices are subject to Current Good Manufacturing Practices (CGMPs) that “govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.” 21 C.F.R. ' 820.1(a)(1). The CGMPs are purposely flexible to allow each manufacturer to determine how best to implement the necessary controls specific to the medical device it produces.

Congress included in the MDA an express preemption provision preventing states from imposing any requirement that is different from, or in addition to, any requirement applicable under the MDA to the device, and that relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under the MDA. 21 U.S.C. ' 360k(a). Consistent with that provision, the Supreme Court in Riegel v. Medtronic, Inc. , 552 U.S. 312, 330 (2008), held that a plaintiff's state-law claims for strict product liability, breach of implied warranty, and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of an FDA-approved medical device were preempted by the MDA. Riegel noted, however, that “' 360k 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.

Courts at Odds

As a result of Riegel, design and warning claims pertaining to Class III medical devices are preempted by the MDA. Manufacturing defect claims may still survive under Riegel, however, and a state may provide a damages remedy for claims premised on a violation of FDA regulations; suits on this basis, if they survive, are considered “parallel” actions. Thus, when presented with a motion to dismiss a Class III medical device product liability claim, a court must determine whether the plaintiff plausibly alleges a parallel claim and whether the plaintiff's complaint satisfies the standard set forth in Twombly and Iqbal. Federal courts are divided as to what level of specificity is required in the plaintiff's complaint to plead a parallel claim sufficiently.

Pleading Standard Satisfied

In 2010, the Seventh U.S. Circuit Court of Appeals issued one of the leading cases regarding the sufficiency of pleading a parallel state claim. In Bausch v. Stryker Corp. , 630 F.3d 546 (7th Cir. 2010), the court reversed a district court's dismissal of a plaintiff's claims for defective manufacture of a Trident hip replacement in violation of federal law. The complaint alleged that the product was unreasonably dangerous and set forth facts indicating that defendants knew or should have known prior to the surgery that the plaintiff's device was defective. The defendants had recalled certain Trident components in 2006 because of “dimensional anomalies” and in the following year, the FDA issued a letter to defendants stating that the Trident was adulterated due to manufacturing methods that were not in conformity with industry and regulatory standards. A device was then implanted in the plaintiff's body the following week. This device bore the same catalog number as the device allegedly not in compliance with regulations.

The Bausch court concluded that the plaintiff's claims were not expressly preempted under ' 360k because they were based on alleged violations of federal law, and rejected the defendants' argument that the Quality Systems Regulations and CGMPs were too general to allow juries to enforce them. The court also rejected the defendants' implied preemption argument. It then turned to “the problem of how difficult it is to plead [a parallel] claim sufficiently” to survive a 12(b)(6) motion to dismiss. Id. at 558. The court reasoned that because of the confidentiality of the product-specific information about manufacturing, “[f]ormal discovery is necessary before a plaintiff can fairly be expected to provide a detailed statement of the specific bases for her claim.” Id. The court rejected the defendants' argument that the complaint did not specify the precise defect, concluding that it still complied with the federal pleading standards, that a plaintiff would need discovery to identify the specific defect, and that in the context of Class III medical devices, relevant information, such as specifications of the FDA's premarket approval, is kept confidential by federal law. Ultimately, the court relied on the principle that the “'plaintiff[s'] pleading burden should be commensurate with the amount of information available to them.'” Id. at 561 (citation omitted).

Bausch has been accepted by a number of district courts. For example, in Gelber v. Stryker Corp. , 788 F. Supp. 2d 145 (S.D.N.Y. 2011), the court concluded that a plaintiff had plausibly stated a claim alleging that the Trident hip implant system was defective and that after conditional approval of the device, but before implantation into the plaintiff, the defendants modified the Trident. The court rejected the defendants' argument that the failure to state the specific provision of the CGMPs that the defendants violated in manufacturing the Trident was fatal to the plaintiff's claim. The plaintiff's allegations of the warning letter from the FDA to the defendants and a voluntary recall, along with their allegation of a theory ' excessive levels of manufacturing residue that the court found was subject of a CGMP requirement ' was sufficient. The court concluded, citing Bausch, that “[b]y pleading the conduct which plaintiffs alleged violated the CGMP requirements, describing evidence of the alleged violation, and directing plaintiffs to the CGMPs generally, plaintiffs have given defendants more than ample notice of the alleged violation of federal law.” Id. at 156.

Likewise, in Simoneau v. Stryker Corp., No. 3:13-CV-1200, 2014 U.S. Dist. LEXIS 43137 (D. Conn. Mar. 31, 2014), the court addressed an argument that the MDA preempted the plaintiff's claims that a Trident hip implant was defective, or, alternatively, the plaintiff had not plausibly pled a warranty parallel product liability claim. The plaintiff alleged that the manufacture of the Trident did not meet FDA regulations and premarket approval specifications and therefore was in an unreasonably dangerous and defective condition.

The plaintiff alleged the issuance of FDA warning letters and two related recalls by the defendants. Rejecting the defendants' argument that the plaintiff's allegations lacked the required specificity because they did not include any premarket approval specification referring the Trident Hip implant itself and instead cited only broad regulations and generalized CGMPs, the court concluded that the plaintiff stated a parallel product liability claim. The court found persuasive the reasoning in Bausch, which noted that the critical information ' including premarket approval specifications ' is confidential as a matter of law. To avoid preemption, a plaintiff's product liability claim “need only be plausibly premised on a violation of 'any requirement' applicable to the Trident Hip Implant under the FDCA.” Id . at *20. References in the complaint to violations of the CGMPs generally, and to the defendants' two recalls, met this standard. In addition to finding Bausch persuasive, the court found its reasoning “faithful” to Iqbal's direction to make “'context-specific' determinations rooted in 'judicial experience and common sense.'” Id. at *19-20 n.6 (quoting Iqbal, 556 U.S. at 679). See also Brooks v. Sanofi-Aventis U.S., LLC, No. 2:14-cv-976, 2014 U.S. Dist. LEXIS 174842, at *8'12 (S.D. Ohio Dec. 18, 2014) (finding Bausch persuasive, stating that to hold otherwise “would require too much to demand that Plaintiff allege specific defects that violate the FDA standards when such information is not necessarily within her control”).

Failure to Satisfy the Pleading Standard

In the years immediately following Twombly and before Bausch, two courts in the Eastern District of New York held that generalized allegations contained in complaints involving Class III medical devices were insufficient to survive a motion to dismiss. In Horowitz v. Stryker Corp. , 613 F. Supp. 2d 271 (E.D.N.Y. 2009), the court concluded that the plaintiff's claims based on a defective Trident hip system were preempted because she failed to demonstrate a cognizable link between the defendant's federal violations and her injury. The plaintiff advanced eight causes of action: 1) Failure to warn (strict liability); 2) Defective manufacturing (strict liability); 3) Defective design (strict liability); 4) Negligence and recklessness; 5) Breach of express warranty; 6) Breach of implied warranty of fitness; 7) Breach of implied warranty of merchantability; and 8) Violations of New York's General Business Law.

The court dismissed the plaintiff's claims for failure to warn and defective design with prejudice, and dismissed the remaining claims with leave to replead. There are lengthy discussions about each of the theories and what needs to be alleged to survive. Notably, the recalls the plaintiff identified in her complaint did not include the Trident System or any of its parts. The plaintiff also failed to allege that her particular product was included in the FDA warning letters she cited. The plaintiff never alleged any enforcement action brought against the defendants involving her product. The court concluded that these generalized allegations lacked the “amplification” necessary to rise to the level of plausibility that Twombly requires. Id. at 283.

Similarly, in Ilarraza v. Medtronic, Inc. , 677 F. Supp. 2d 582 (E.D.N.Y. 2009), the plaintiff alleged in a single cause of action for “Negligence Per Se (a 'Parallel Action')” that his implanted Intrathecal Drug Delivery System (“Medication Pump”) broke after the defendant failed to manufacture the Medication Pump in a “reasonable and prudent manner” and in accordance with CGMPs. Id. at 583. The complaint alleged violation of eight general federal regulations, including management responsibility, personnel and distribution, and did not allege any link between a federal violation and plaintiff's injury.

The court concluded that the complaint failed to state a plausible claim because no regulation relied upon referred specifically to the medical device at issue; rather the regulations were general statements of CGMPs. The court concluded that the CGMPs were only “umbrella quality system[s]” and provided “ general objectives.” Id. at 588. Their “intentionally vague and open-ended nature” and the fact that they were open to interpretation by manufacturers further indicated that they could not serve as the basis of a parallel action under Twombly . The court concluded: “Where, as here, the plaintiff has done nothing more than recite unsupported violations of general regulations, and fails to tie such allegations to the injuries alleged, the complaint is properly dismissed.” Id.

More recently, a number of district courts have specifically rejected the holding in Bausch , concluding that it is contrary to Twombly and Iqbal. See, e.g., Gross v. Stryker Corp. , 858 F. Supp. 2d 466, 496 (W.D. Pa 2012) (finding Bausch's rationale to be unpersuasive and declining to follow its holding, in part, because “such a liberal pleading standard is in conflict with Twombly and Iqbal “); Ali v. Allergan USA, Inc., No. 1:12-CV-115, 2012 U.S. Dist. LEXIS 121417, at *42 (E.D. Va. Aug. 23, 2012) (“This is precisely the sort of fishing expedition the Supreme Court sought to avoid ' [in deciding Twombly and Iqbal .]“). Similarly, in Bertini v. Smith & Nephew, Inc., No. 13 Civ. 0079, 2013 U.S. Dist. LEXIS 171021 (E.D.N.Y. July 12, 2013), the plaintiff alleged that the defendant's R3 acetabular hip liner (“R3 liner”) was defective in design or manufacture because of its increased risk of loosening. Less than a year after the plaintiff was implanted with an R3 liner, the FDA found that R3 liners produced at defendant's plant were adulterated in that certain CGMPs were being violated. The defendant then issued three mandatory recalls over the following three years.

The defendant moved to dismiss, arguing that the allegations were conclusory and did not indicate how the product was defectively designed or manufactured. The court agreed, finding the plaintiff's allegations that the R3 liner was defective and deviated in a material way from manufacturing standards, conclusory. The court reasoned that pleading only that the device did not perform as intended was not enough to reach the plausibility threshold of Twombly and Iqbal. The court rejected the plaintiff's argument that relied on Bausch that the court was subjecting them to a higher pleading standard by forcing them to supply information about a particular defect that they could not identify. The court distinguished Bausch , finding the complaint there more sufficiently pled in that it included allegations of “dimensional anomalies” whereas the plaintiff pled only that the device was defective. Id. at 11-12. The court also noted that other courts had rejected Bausch.

Interestingly, the court did not give much weight to the recalls issued by the defendant in its analysis, finding that the plaintiff failed to provide sufficient connection from the recall to the liner implanted in the plaintiff. See also Burkett v. Smith & Nephew GmbH, No. CV 12-4895, 2014 U.S. Dist. LEXIS 43995 (E.D.N.Y. Mar. 31, 2014) (decided the same day as Simoneau, granting motion to dismiss all claims premised on defective R3 liner where no allegation of violation of federal requirement specific to R3 liner, only CGMPs, and no link between purported violation and alleged injury).

An Unsettled Area

As the cases discussed above indicate, the application of Twombly and Iqbal to Class III medical device defect claims is still unsettled. The tensions involved in applying the pleading standard established by Iqbal and Twombly and the preemption rule established by Riegel against the possible dismissal of potentially meritorious claims before allowing discovery have resulted in a number of conflicting district and circuit court decisions. To date, in deciding these cases, the district and circuit courts have focused on a number of different factors in reaching their decisions, including the specificity of the alleged violations of the CGMPs, and the connection alleged between the CGMPs, warning letters or recalls and the product and/or injury in the case.

James Rotondo, a member of this newsletter's Board of Editors, represents a broad range of corporate clients in product liability, negligence, insurance coverage, and commercial litigation matters at Day Pitney LLP in its Hartford, CT, office. Kaitlin Canty and Michael Pohorylo are associates at the firm, practicing in the areas of product liability and torts law.