Santoro v. Endologix Inc.

• Decision Date: 06 October 2020
• Docket Number: Case No. 3:19-cv-01679-YY
• Parties: RONALD SANTORO, an Oregon citizen, Plaintiff, v. ENDOLOGIX INC., a Delaware corporation, Defendant.
• Court: U.S. District Court — District of Oregon

RONALD SANTORO, an Oregon citizen, Plaintiff, v. ENDOLOGIX INC., a Delaware corporation, Defendant.

Case No. 3:19-cv-01679-YY

UNITED STATES DISTRICT COURT DISTRICT OF OREGON PORTLAND DIVISION

October 6, 2020

FINDINGS AND RECOMMENDATIONS

YOU, Magistrate Judge:

FINDINGS

PlaintiffRonald Santoro("Santoro") has brought suit against defendantEndologix Inc.("Endologix") alleging state law claims of strict products liability and negligence for defective manufacturing, design defect, and failure to warn; negligence per se; and fraud.Compl., ECF #1.Plaintiff also alleged a claim of conscious misrepresentation, but has dismissed that claim.Joint Stipulation, ECF #25 (dismissing Claim VII).This court has diversity jurisdiction pursuant to 28 U.S.C. § 1332.

Endologix has filed a Motion to Dismiss(ECF #8) in which it asserts that (1)plaintiff's state law claims are preempted by federal law and therefore should be dismissed under Federal Rule of Civil Procedure 12(b)(6);(2)plaintiff has failed to allege plausible claims under Federal Rule of Civil Procedure 8(a); and (3)plaintiff has failed to allege his fraud claim with sufficient particularity as required by Federal Rule of Civil Procedure 9(a).The motion to dismiss should be DENIED for the reasons set forth below.¹

I.Plaintiff's Allegations

Plaintiff suffered an abdominal aortic aneurysm ("AAA"), a potentially fatal weakening in the wall of the aortic artery.Compl.¶¶ 7-9, 19-21, ECF #1.AAAs are treated by endovascular repair, a common surgical technique wherein a repair graft device is inserted into the aneurysm, which allows blood to flow through the device, thus avoiding the damaged artery wall and preventing rupture.Id.¶¶ 10-11.

Some patients experience complications known as endoleaks, where blood continues to remain in or flow into the aneurysm cavity.Id.¶¶ 12-14.One form of endoleak, called the Type III endoleak, is attributed to device failures and occurs when there is either a separation between the graft components or a tear or hole in the graft material.Id.¶ 17.The condition is serious and requires urgent medical attention.Id.

In 2004, Endologix secured premarket approval ("PMA") from the Food and Drug Administration ("FDA") of its PowerLink AAA System to treat AAAs.Id.¶¶ 29-30.The approval was subject to FDA requirements, including post-approval conditions imposed by a PMA order.Id.¶ 31; PMA Order 6-8, ECF #13-2.Endologix later developed a new repair graft device called the Endologix AFX Endovascular AAA System ("AFX System") but did not prepare a separate PMA application, and instead submitted a 180-Day Track PMA Supplementfor the PowerLink AAA System.Id.¶¶ 32-33.Endologix also developed Strata, a propriety graft material, for use in a different device that never made it to market because testing revealed a high rate of failure attributed in part to the Strata material.Id.¶¶ 37-39.Endologix employed Strata in the AFX System.Id.¶ 40.Endologix began marketing the new device in August 2011.Id.¶ 34.Within two years of use, Endologix received nearly five times more reports of Type III endoleaks from the AFX System than the PowerLink AAA System.Id.¶¶ 41-43.

Despite these reports and internal research, Endologix advertised the AFX System as having "advanced clinical performance," representing in marketing materials that its "new proprietary Strata graft materials" were a "durable highly conformable ePTFE that enhances seal."Id.¶¶ 44-45.Endologix stopped making the AFX System with Strata graft material in 2014 but made no reference to the higher failure rate when it submitted a 30-day process change notice to the FDA.Id.¶ 46.Endologix did not notify physicians of the change in material or of the increased risk of Type III endoleaks from the AFX System.Id.¶ 47.

Santoro underwent endovascular repair in October 2014.Id.¶ 19.His AAA was treated with the AFX System with Strata graft material.Id.¶ 20.He required corrective surgery in 2019 because he suffered a Type III endoleak.Id.¶¶ 22.In December 2016, Endologix recalled the AFX System and notified physicians.Id.¶ 49.The FDA classified the recall as Class I, meaning use of the device may cause serious injury or death.Id.¶¶ 51-53.

II.Rule 12(b)(6),Rule 8(a), and Preemption Framework

Defendant contends that because federal law preempts all of plaintiff's state law claims, they must be dismissed pursuant to Rule 12(b)(6).A motion to dismiss for failure to state a claim under Rule 12(b)(6) may be granted where there is no cognizable legal theory to support the claim or when the complaint lacks sufficient factual allegations to state a facially plausible claim for relief.Shroyer v. New Cingular Wireless Servs., Inc., 622 F.3d 1035, 1041(9th Cir.2010).A Rule 12(b)(6) motion is a proper vehicle to argue that a state law claim is preempted by federal law and should be dismissed.SeeWilliamson v. Gen. Dynamics Corp., 208 F.3d 1144, 1149(9th Cir.2000).

In analyzing defendant's motion, it is helpful to provide some context regarding the Medical Device Act and its preemption provisions.Historically, states have regulated citizen health and safety through the exercise of their police powers.Medtronic, Inc. v. Lohr, 518 U.S. 470, 475(1996).However, over time, "the Federal Government has played an increasingly significant role in the protection of the health of our people."Id. at 475.In 1976, "[i]n response to the mounting consumer and regulatory concern,"Congress enacted the Medical Device Amendments ("MDA"), 21 U.S.C. §§ 360c et seq., to the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 301 et seq., to "provide for the safety and effectiveness of medical devices intended for human use."Id. at 474.The MDA "swept back some state obligations and imposed a regime of detailed federal oversight."Riegel v. Medtronic, Inc., 552 U.S. 312, 316-17(2008).

Under the MDA, the FDA may "approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives."Id. at 318.The MDA classifies medical devices into three categories based on their risk.Lohr, 518 U.S. at 476.Class III medical devices, such as the AFX System, receive the most scrutiny and are subject to a "rigorous" premarket approval process.Id. at 477."[T]he FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application, for the reason that the FDA has determined that the approved form provides a reasonable assurance of safety and effectiveness."Riegel, 552 U.S. at 323;21 U.S.C. § 360e(d)(6)(A)(i)).

The MDA "expressly preempts state law regulation of medical devices."Weber v. Allergan, Inc., 940 F.3d 1106, 1110(9th Cir.2019), cert. denied, No. 19-869, 2020 WL 1326110(U.S.Mar. 23, 2020)(citing21 U.S.C. § 360k(a)).The pertinent portion of the MDA, § 360(k)(a), provides:

"[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.

21 U.S.C. § 360k(a)(emphasis added).

Thus, to be preempted, "[s]tate requirements must be 'with respect to' medical devices and 'different from, or in addition to,' federal requirements."Lohr, 518 U.S. at 500."[T]he MDA does not preempt state law requirements that ''parallel,' rather than add to, federal requirements.'"Weber, 940 F.3d at 1111(quotingRiegel, 552 U.S. at 330);see alsoStengel v. Medtronic Inc., 704 F.3d 1224, 1228(9th Cir.2013)(en banc)(holding that "the MDA does not preempt a state-law claim for violating a state-law duty that parallels a federal-law duty under the MDA");Perez v. Nidek Co., 711 F.3d 1109, 1120(9th Cir.2013)(recognizing the "'narrow gap'" through which a state-law claim must fit to escape preemption by the FDCA")."State requirements must also relate 'to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device. . . .'"²Lohr, 518 U.S. at 500."Moreover, federal requirements must be 'applicable to the device' in question, and, according to the regulations, pre-empt state law only if they are 'specific counterpart regulations' or 'specific' to a 'particular device.'"Id."The statute and regulations, therefore, require a careful comparison between the allegedly pre-empting federal requirement and the allegedly pre-empted state requirement to determine whether they fall within the intended pre-emptive scope of the statute and regulations."Id.

Importantly, there is "a presumption against federal preemption of state laws that operate in traditional state domains."Stengel, 704 F.3d at 1227(en banc)."Parties seeking to invalidate a state law based on preemption 'bear the considerable burden of overcoming the starting presumption that Congress does not intend to supplant state law.'"Id. at 1227-28(quotingDe Buono v. NYSA-ILA Med. & Clinical Servs. Fund, 520 U.S. 806, 814(1997)).

"In Riegel, the Supreme Court held that § 360k preempted state law claims challenging the safety and effectiveness of a Class III medical device that had received pre-market approval from the FDA."Weber, 940 F.3d at 1111(citingRiegel, 552 U.S. at 321-25).Premarket approval imposes requirements under the MDA and is specific to individual devices.Riegel, 552 U.S. at 322-23.

The Supreme Court also held that all claims, including those sounding in tort, are subject to preemption if the "claims are based upon [state] requirements with respect to the device thatare 'different from, or in addition to,' the federal [requirements], and that relate to safety and effectiveness."Id. at 322(quoting21...