Practice Tip: Pleading Medical Device Complaints

The heightened pleading requirements of Bell Atlantic Corp. v. Twombly, 550 US 544 (2007), require that practitioners who plan to file a complaint in a medical device case be even more cautious than usual. Otherwise, they may be subject to a dismissal on the pleadings. To begin with, a product liability case for the failure of a medical device is unlike other product cases. For Class III Medical Devices ' those that are most critical to human health and subject to extensive federal pre-market approval regulations ' a mere failure of the product is insufficient to bring an action. When “ordinary” products fail, the plaintiff can sue under state causes of action in negligence, strict liability in tort or breach of warranty; however, when a Class III device fails, such actions are expressly preempted by the Medical Device Act. 21 U.S.C. 360k(a).

State-Based Causes of Action

The statute expressly preempts state common law actions arising out of malfunctioning devices if they are “different from or in addition to any federal requirement applicable ' to the device.” This means that any state law ' whether a common law cause of action , state statute or regulation ' that would impose on a medical device subject to FDA regulation any standard of care, safety, effectiveness, manufacturing, labeling or any other requirement that goes beyond the responsibilities imposed by the FDA is “different from or in addition to” the federal requirements and thus preempted; Becker v. Optical Radiation Corp., 66 F.3d 18 (2nd Cir. 1995). In 1996, however, the Supreme Court held in Medtronic v. Lohr, 518 U.S. 470, that the statute did not preempt common law negligence and strict liability claims for Class III devices where the claims are premised on a violation of federal regulations. The statute only pre-empted cases based on common law actions and state regulations. Thus, state-based causes of action alleging a violation of federal regulations would be permitted as they “parallel” rather than add to the federal requirements. Riegel v. Medtronic Inc., 552 U.S. 312, 330 (2008). Even if state law required the plaintiff to prove that the violations of federal regulations were the result of negligence or a defective product, such additional state elements would make the state requirements narrower, not broader, than the federal requirement and thus be “parallel.”

Avoiding Dismissal on Pre-emption Grounds

Therefore, in order to avoid dismissal on pre-emption grounds in a medical device case, the state-based causes of action must allege conduct that is prohibited by FDA regulations and that such conduct was a cause of the plaintiff's injury. It is not necessary that a complaint allege facts to counter a preemption argument because a plaintiff is not required to rule out an affirmative defense. In such cases, it is a good idea first to identify in the complaint the conduct that violated the FDA regulations. Then one must plead how the violation rendered the product unsafe or defective and also, how the violation caused the injury.

For example, in Gelber v. Stryker, __F.Supp,2d__, 2010 WL 4740432 (S.D.N.Y. 2010) the complaint summarily alleged that the defendants failed “to act as required under the specific federal requirements'which are applicable to the defective device, including violating federal code and rule ' ” The court, in dismissing the suit, said that plaintiffs cannot simply incant the magic words that the “ defendant violated FDA regulations” in order to avoid a dismissal.

Another case amplifies a possible pitfall in pleading. In Ilarraza v. Medtronic, Inc., 677 F.Supp.2d 582 (E.D.N.Y. 2009), the plaintiff claimed an implanted pain medication pump was negligently manufactured in violation of 11 Current Good Manufacturing Practices (CGMP) regulations. (CGMPs are quality control regulations that must be followed by device manufacturers to ensure safety.) The court dismissed the complaint because the plaintiff failed to allege how the CGMPs relied upon referred specifically to the medical device at issue. Each of the regulations was nothing more than a general standard that was intended only to serve as “an umbrella quality system,” citing Horowitz v Stryker, 613 F.Supp. 271 (E.D.N.Y. 2009).

An example of sufficient pleading was presented in Purcel v. Advanced Bionics, 2008 WL 3874713 (N.D. Tex. 2008), in which an infant plaintiff sued the manufacturer of a cochlear ear implant, claiming that moisture levels in the device's circuitry were higher than allowed by the FDA. The plaintiff claimed the moisture levels were elevated due to a change in the mechanical design and configuration of a component part ' a feedthrough ' made by a supplier and that the infant suffered damages due to the higher moisture. The plaintiff pleaded that the defendant violated the federal regulations when it failed to notify the FDA that it had changed the supplier of the feedthroughs. The defendant's motion to dismiss causes of action for strict liability and implied warranty on the grounds of preemption was denied because, in the court's view, the injury was sufficiently pleaded to have been caused due to the violation of federal regulations.

Breathing Space for Plaintiffs

While most courts have dismissed cases where the pleading alleged nothing more than the violation of a federal regulation in support of a parallel claim, the most recent case on this subject has given plaintiffs some breathing space. In Bausch v. Stryker, ___F.3d___, 2010 WL 5186062 (7th Cir. 2010), a hip implant case, the court reversed the lower court's dismissal of a complaint and its refusal to permit the plaintiff to file an Amended Pleading. The Seventh Circuit reaffirmed that the federal standard of notice pleading is applicable, so long as the plaintiff alleges facts sufficient to meet the new “plausibility” standard applied in Ashcroft v. Iqbal, ___U.S.___,129 S. Ct. 1937 (2009) and Twombly, supra (“claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.”). The complaint alleged that prior to implantation, the FDA had written to the defendant warning it that the hip implant was “adulterated due to manufacturing methods not in conformity with industry and regulatory standards.” The defendant convinced the lower court to dismiss the case because the complaint failed to specify the precise defect or the specific federal regulatory requirement what was violated; however, in reversing, the Seventh Circuit ruled that although the complaint would have been stronger had it done so, the absence of such details was not a failure to comply with the pleading requirements of Federal Rules of Civil Procedure (FRCP) 8, nor are such details required by FRCP 9, such as in fraud claims. The court went on to say that, although the failure to comply with “industry standards” was not actionable, there was no reason to dismiss the entire complaint with prejudice and without leave to replead.

Conclusion

These examples show how muddled the state of the law is today. If you are planning to start a medical device case, read the most recent decisions before filing the Complaint. Product liability cases are difficult enough; medical device cases are worse.

Larry Goldhirsch, a member of this newsletter's Board of Editors, is Trial Counsel at Weitz and Luxenberg. Kendra Goldhirsch, an Associate in the firm's Mass Torts Department, assisted in the research and writing of this article.

The heightened pleading requirements of Bell Atlantic Corp. v. Twombly , 550 US 544 (2007), require that practitioners who plan to file a complaint in a medical device case be even more cautious than usual. Otherwise, they may be subject to a dismissal on the pleadings. To begin with, a product liability case for the failure of a medical device is unlike other product cases. For Class III Medical Devices ' those that are most critical to human health and subject to extensive federal pre-market approval regulations ' a mere failure of the product is insufficient to bring an action. When “ordinary” products fail, the plaintiff can sue under state causes of action in negligence, strict liability in tort or breach of warranty; however, when a Class III device fails, such actions are expressly preempted by the Medical Device Act. 21 U.S.C. 360k(a).

State-Based Causes of Action

The statute expressly preempts state common law actions arising out of malfunctioning devices if they are “different from or in addition to any federal requirement applicable ' to the device.” This means that any state law ' whether a common law cause of action , state statute or regulation ' that would impose on a medical device subject to FDA regulation any standard of care, safety, effectiveness, manufacturing, labeling or any other requirement that goes beyond the responsibilities imposed by the FDA is “different from or in addition to” the federal requirements and thus preempted; Becker v. Optical Radiation Corp. , 66 F.3d 18 (2nd Cir. 1995). In 1996, however, the Supreme Court held in Medtronic v. Lohr , 518 U.S. 470, that the statute did not preempt common law negligence and strict liability claims for Class III devices where the claims are premised on a violation of federal regulations. The statute only pre-empted cases based on common law actions and state regulations. Thus, state-based causes of action alleging a violation of federal regulations would be permitted as they “parallel” rather than add to the federal requirements. Riegel v. Medtronic Inc. , 552 U.S. 312, 330 (2008). Even if state law required the plaintiff to prove that the violations of federal regulations were the result of negligence or a defective product, such additional state elements would make the state requirements narrower, not broader, than the federal requirement and thus be “parallel.”

Avoiding Dismissal on Pre-emption Grounds

Therefore, in order to avoid dismissal on pre-emption grounds in a medical device case, the state-based causes of action must allege conduct that is prohibited by FDA regulations and that such conduct was a cause of the plaintiff's injury. It is not necessary that a complaint allege facts to counter a preemption argument because a plaintiff is not required to rule out an affirmative defense. In such cases, it is a good idea first to identify in the complaint the conduct that violated the FDA regulations. Then one must plead how the violation rendered the product unsafe or defective and also, how the violation caused the injury.

For example, in Gelber v. Stryker, __F.Supp,2d__, 2010 WL 4740432 (S.D.N.Y. 2010) the complaint summarily alleged that the defendants failed “to act as required under the specific federal requirements'which are applicable to the defective device, including violating federal code and rule ' ” The court, in dismissing the suit, said that plaintiffs cannot simply incant the magic words that the “ defendant violated FDA regulations” in order to avoid a dismissal.

Another case amplifies a possible pitfall in pleading. In Ilarraza v. Medtronic, Inc. , 677 F.Supp.2d 582 (E.D.N.Y. 2009), the plaintiff claimed an implanted pain medication pump was negligently manufactured in violation of 11 Current Good Manufacturing Practices (CGMP) regulations. (CGMPs are quality control regulations that must be followed by device manufacturers to ensure safety.) The court dismissed the complaint because the plaintiff failed to allege how the CGMPs relied upon referred specifically to the medical device at issue. Each of the regulations was nothing more than a general standard that was intended only to serve as “an umbrella quality system,” citing Horowitz v Stryker, 613 F.Supp. 271 (E.D.N.Y. 2009).

An example of sufficient pleading was presented in Purcel v. Advanced Bionics, 2008 WL 3874713 (N.D. Tex. 2008), in which an infant plaintiff sued the manufacturer of a cochlear ear implant, claiming that moisture levels in the device's circuitry were higher than allowed by the FDA. The plaintiff claimed the moisture levels were elevated due to a change in the mechanical design and configuration of a component part ' a feedthrough ' made by a supplier and that the infant suffered damages due to the higher moisture. The plaintiff pleaded that the defendant violated the federal regulations when it failed to notify the FDA that it had changed the supplier of the feedthroughs. The defendant's motion to dismiss causes of action for strict liability and implied warranty on the grounds of preemption was denied because, in the court's view, the injury was sufficiently pleaded to have been caused due to the violation of federal regulations.

Breathing Space for Plaintiffs

While most courts have dismissed cases where the pleading alleged nothing more than the violation of a federal regulation in support of a parallel claim, the most recent case on this subject has given plaintiffs some breathing space. In Bausch v. Stryker, ___F.3d___, 2010 WL 5186062 (7th Cir. 2010), a hip implant case, the court reversed the lower court's dismissal of a complaint and its refusal to permit the plaintiff to file an Amended Pleading. The Seventh Circuit reaffirmed that the federal standard of notice pleading is applicable, so long as the plaintiff alleges facts sufficient to meet the new “plausibility” standard applied in Ashcroft v. Iqbal, ___U.S.___,129 S. Ct. 1937 (2009) and Twombly, supra (“claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.”). The complaint alleged that prior to implantation, the FDA had written to the defendant warning it that the hip implant was “adulterated due to manufacturing methods not in conformity with industry and regulatory standards.” The defendant convinced the lower court to dismiss the case because the complaint failed to specify the precise defect or the specific federal regulatory requirement what was violated; however, in reversing, the Seventh Circuit ruled that although the complaint would have been stronger had it done so, the absence of such details was not a failure to comply with the pleading requirements of Federal Rules of Civil Procedure (FRCP) 8, nor are such details required by FRCP 9, such as in fraud claims. The court went on to say that, although the failure to comply with “industry standards” was not actionable, there was no reason to dismiss the entire complaint with prejudice and without leave to replead.

Conclusion

These examples show how muddled the state of the law is today. If you are planning to start a medical device case, read the most recent decisions before filing the Complaint. Product liability cases are difficult enough; medical device cases are worse.

Larry Goldhirsch, a member of this newsletter's Board of Editors, is Trial Counsel at Weitz and Luxenberg. Kendra Goldhirsch, an Associate in the firm's Mass Torts Department, assisted in the research and writing of this article.