Opinion
Civil Action No. 19-37-HRW
03-26-2020
James HAYES, Plaintiff, v. ENDOLOGIX, INC., Defendant.
Janet G. Abaray, Melanie Sue Bailey, Pro Hac Vice, Burg Simpson Eldredge Hersh Jardine, PC, Cincinnati, OH, for Plaintiff. Katherine Elizabeth Shepard, Bowman and Brooke, Lake Mary, FL, Molly J. Given, Pro Hac Vice, Bowman & Brooke, Minneapolis, MN, for Defendant.
Janet G. Abaray, Melanie Sue Bailey, Pro Hac Vice, Burg Simpson Eldredge Hersh Jardine, PC, Cincinnati, OH, for Plaintiff.
Katherine Elizabeth Shepard, Bowman and Brooke, Lake Mary, FL, Molly J. Given, Pro Hac Vice, Bowman & Brooke, Minneapolis, MN, for Defendant.
MEMORANDUM OPINION AND ORDER
Henry R. Wilhoit Jr., United States District Judge
This matter is before the Court upon Defendant Endologix, Inc.'s Motion to Dismiss [Docket No. 11]. The matter has been fully briefed by the parties [Docket Nos. 13 and 14]. For the reasons set forth herein, the Court will overrule the motion.
I.
The following are alleged in Plaintiff's Complaint: In January 2004, Endologix submitted a premarket approval application ("PMA") to the United States Food and Drug Administration ("FDA") for a device it branded the Power Ink AAA System. [Complaint, Docket No. 1, ¶ 28]. In October 2004, Endologix received marketing approval from the FDA for its device. Id. , ¶29. The approval was subject to the FDA's requirements, including labelling, reporting adverse events, training and certain manufacturing conditions. Id. , ¶30.
This device is used to treat patients suffering from abdominal aortic aneurysm (AAA), which occurs when the wall of the body's largest blood vessel, the aorta, weakens, becoming stretched and thin, causing the vessel to bulge or expand. Id. , ¶10. Endovascular repair is a surgical technique often used to repair an AAA, wherein a surgeon implants an aneurysm graft device, such as the Endologix device. Id. , ¶11. Following endovascular repair, some patients experience complications known as endoleaks. Id. , ¶12. Endoleaks occur when blood continues to flow into the aneurysm cavity, despite the repair. Id. , ¶13. Endoleaks range in severity and cause and are classified as Types I-IV Id. , ¶14. Type III endoleaks are attributed to a failure of the graft, either a separation between the graft components or a tear or hole in the graft material. Type III leaks require emergency medical intervention.
In his Complaint, Plaintiff alleges that after Endologix received PMA, it developed what it perceived to be a new AAA repair device – the AFX Endovascular AAAA System. Id. , ¶31. The "new device" contained Strata, a type of graft material not used in the original device. The Strata material was originally developed for another device which never made it to the U.S. market due to what Endologix documents refer to as of "graft material wear and perforation." Id. , ¶ ¶ 37-38. The subject AFX was the first marketed device to contain Strata material. Id. , ¶39.
Endologix did not submit a separate PMA application for the AFX system. Id. , ¶32. Rather, it sought a 108-day Track PMA Supplement; which was approved on May 6, 2011. Id. , ¶ ¶ 32-33. In August 2011, Endologix began marketing this device. Id. , ¶33.
Within the first year of its introduction into the market, Endologix received 16 reports of Type III leaks associated with its device. Id. , ¶41. By the end of the second year, the number of reports was 89. Id.
In 2014 Endologix ceased the manufacturing the AFX with Strata. Id. , ¶45.
However, it was not until December 30, 2016, that Endologix recalled the device. Id. , ¶48. In its letter to physicians on the same date, Endologix revealed that its device was associated with more Type III endoleaks than other devices. Id. , ¶53.
The FDA identified the recall as "Class I", which refers devices that may cause serious injuries or death. Id. , ¶50.
On July 9, 2014, before Endologix's device was removed from the market, James Hayes underwent endovascular AAA repair surgery. Id. , ¶19. He received an implant of the Endologix AFX device made with Strata. Id. , ¶20. During a follow up with his physician, a CT scan revealed a Type III endoleak. Id. , ¶21. He had to undergo a second surgery to repair the failed device and prevent further rupture of his AAA. Id. , ¶23.
This lawsuit followed. In his Complaint against Endologix, Hayes alleges: 1) strict liability for manufacturing defect; 2) strict liability for design defect; 3) strict liability for defective warnings; 4) negligence; 5) negligence per se; 6) breach of express warranty; 7) breach of implied warranty; and, 8) negligent misrepresentation. He seeks compensatory as well as punitive damages, and attorneys' fees and costs.
Defendant seeks dismissal of all claims alleged herein pursuant to Fed.R.Civ.Proc. 12(b)(6). It argues that Plaintiff's claims are preempted by federal law and that the Complaint fails to adequately plead facts sufficient to entitle Plaintiff to any relief.
II.
In scrutinizing a complaint under Rule 12(b)(6), the Court is required to "accept all well-pleaded factual allegations of the complaint as true and construe the complaint in the light most favorable to the plaintiff." Dubay v. Wells , 506 F.3d 422, 426 (6th Cir.2007). A complaint need not contain "detailed factual allegations". However, it must allege more than "a formulaic recitation of the elements of a cause of action." Bell Atl. Corp. v. Twombly , 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). A complaint will withstand a motion to dismiss if it "contain[s] sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face." Ashcroft v. Iqbal , 556 U.S. 662, 129 S.Ct. 1937, 1949, 173 L.Ed.2d 868 (2009). A complaint has "facial plausibility" if the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Hensley Mfg. v. ProPride, Inc. , 579 F.3d 603, 609 (6th Cir.2009) (quoting Iqbal , 129 S.Ct. at 1949 ).
III.
A.
Congress passed the Medical Device Amendments ("MDA") to the Federal Food, Drug, and Cosmetic Act in 1976 as part of an effort to "sweep back some state obligations and impose a regime of detailed federal oversight." Riegel v. Medtronic, Inc. , 552 U.S. 312, 315-16, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). The MDA created a regulatory framework that classified medical devices into three tiers. Class I devices generally pose the lowest risk to the patient or user, Class II devices pose an intermediate risk, and Class III devices, including the Endologix device implanted in Plaintiff, pose the highest risk.
Manufacturers of Class III devices are required to obtain premarket approval ("PMA") from the FDA before they can make their products available to patients.
PMA process is "rigorous" and the FDA cannot approve a medical device unless "it is reasonably assured the device is safe and effective." Riegel , 552 U.S. at 317, 128 S.Ct. 999. A manufacturer's obligation does not end once the FDA grants premarket approval. The MDA imposes ongoing requirements, including requiring manufacturers to strictly adhere to the design, manufacturing, packaging, storage, labeling, distribution, and advertising specifications in the PMA approval order. 21 C.F.R. § 814.80. Manufacturers must continue to evaluate and periodically report on the safety, effectiveness, and reliability of the device for its intended use (§ 814.82(a)(2)); conduct ongoing, periodic batch testing (§ 814.82(a)(2)); implement and conduct post market surveillance "to reveal unforeseen adverse events, the actual rate of anticipated adverse events, and other information necessary to protect the public health" (§ 822.2); and report and investigate any adverse events if they "receive or become aware of information, from any source, that reasonably suggests that a device ... [m]ay have caused or contributed to a death or serious injury or ... [h]as malfunctioned ...." (21 U.S.C. § 803.50).
B.
With complex medical devices comes complex product liability. Federal preemption of state law claims is a constellation of confusing and, often, conflicting opinions. The MDA contains an preemption provision found at 21 U.S.C. § 360k. The guidelines of the MDA are referenced in Plaintiff's Complaint at ¶12 and include the following:
[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement--(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.
Not all state-law claims are preempted. "Nothing in § 360k denies [a state] the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements." Medtronic Inc. v. Lohr , 518 U.S. 470, 495, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). A claim premised upon a violation of FDA regulations provides a gap through which a plaintiff's claim can escape preemption. Id.
After Lohr , the United States Supreme Court decided two other MDA preemption cases - Buckman Co. v. Plaintiffs' Legal Committee , 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) and Riegel v. Medtronic, Inc. , 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). Together, these three cases provide the framework for preemption analysis. Yet, the issue of "parallel" claims – what is and what is not – continues as a cause of consternation in the lower courts. Although all courts appear to agree that "[s]imply incanting that a manufacturer violated federal regulations does not pass Iqbal / Twombly muster." Kitchen v. Biomet , 2014 WL 694226 (E.D. Ky. Feb. 21, 2014). Yet, the question remains: in the context of a 12(b)(6) motion to dismiss, what degree of particularity is required to establish a parallel claim and avoid preemption?
Although our Circuit has not definitively spoken in this regard, cases from the two federal districts in Kentucky provide guidance and points of comparison: Waltenburg v. St. Jude Medical, Inc. , 33 F.Supp.3d 818 (W.D. Ky. 2014). White v. Stryker Corp. , 818 F.Supp.2d 1032 (W.D. Ky. 2011), Steiden v. Genzyme Biosurgery , 2012 WL 2923225 (W.D. Ky, July 18, 2012) and the undersigned's opinion in Kitchen v. Biomet. Collectively, these cases establish that in order to overcome the 12(b)(6) hurdle, there must be specific allegations as to how the Defendant deviated from the specifications in the PMA. In other words, referring to a broad category of regulations without alleging how the device violated a particular regulation is not enough.
IV.
Defendant argues that Plaintiff's claims are preempted and do not sufficiently plead "parallel" claims. However, Plaintiff's Complaint is replete with citations to pertinent federal regulations and how, specifically, the device at issue deviated from or violated. [Docket No. 1, ¶¶ 60-88]. What Defendant blithely refers to as "flotsam and jetsam" are actually detailed allegations of violation of the MDA's regulations.
Plaintiff's claims of manufacturing defect, design defect, failure to warn, negligence, negligent misrepresent and breach of warranties are predicated on violations of federal regulations. See e.g. Waltenburg v. St. Jude Medical Inc. , 33 F.Supp.3d 818, 833-838 (W.D. Ky. 2014). As such preemption does not apply. Id.
However, Plaintiff's fifth cause of action, negligence per se per KRS 446.070, does not escape preemption. Id. at 837. The law of Kentucky is clear that "[v]iolations of federal laws and regulations and the law of other states do not create a cause of action based on KRS 446.070.". Id. citing St. Luke Hospital, Inc. v. Straub , 354 S.W.3d 529, 534 (Ky. 2011).
The Court is mindful that this litigation has yet to proceed to discovery. As Judge Russell cogently stated in Waltenburg , "the Court notes that if after the completion of discovery it appears that Plaintiffs cannot maintain its claims based on state requirements that parallel federal requirements, Defendants are certainly free to move for summary judgment, at which point the Court will reevaluate the issue of preemption." Id.
However, at this early stage in the litigation and taking the allegations in the Complaint as true, the Court finds that Plaintiffs have successfully alleged parallel claims sufficient to survive preemption under § 360k(a).
V.
Accordingly, IT IS HEREBY ORDERED that Defendant Endologix, Inc.'s Motion to Dismiss [Docket No. 11] is SUSTAINED insofar as it pertains to Plaintiff's claims for negligence per se alleged in paragraphs 169-178 of the Complaint and OVERRULED as to all other claims alleged in the Complaint.
IT IS FURTHER ORDERED that Plaintiff's claims for negligence per se alleged in paragraphs 169-178 of the Complaint are DISMISSED WITH PREJUDICE .
This is an INTERLOCUTORY and NON-APPEALABLE Order.