A.F. v. Sorin Grp. USA, Inc.

• Decision Date: 28 September 2018
• Docket Number: 17 Civ. 5903 (ER)
• Citation: 346 F.Supp.3d 534
• Parties: A.F., an Infant BY AND THROUGH Her Mother and Natural Guardian Yael FOGEL, and Yael Fogel, Individually, Plaintiffs, v. SORIN GROUP USA, INC., CarboMedics, Inc., Sorin Group Canada, Inc., and John Doe Manufacturing Companies and/or Corporations 1 Through 10, Whose Names are Unknown at this Time who Manufactured, Designed, Produced, Sold, or Distributed the Mitroflow LXA19 Aortic Pericardial Heart Valve and All its Component Parts Used During the August 5, 2013 Surgery Performed on the Infant Plaintiff, Defendants.
• Court: U.S. District Court — Southern District of New York

346 F.Supp.3d 534

A.F., an Infant BY AND THROUGH Her Mother and Natural Guardian Yael FOGEL, and Yael Fogel, Individually, Plaintiffs,

v.SORIN GROUP USA, INC., CarboMedics, Inc., Sorin Group Canada, Inc., and John Doe Manufacturing Companies and/or Corporations 1 Through 10, Whose Names are Unknown at this Time who Manufactured, Designed, Produced, Sold, or Distributed the Mitroflow LXA19 Aortic Pericardial Heart Valve and All its Component Parts Used During the August 5, 2013 Surgery Performed on the Infant Plaintiff, Defendants.

17 Civ. 5903 (ER)

United States District Court, S.D. New York.

Signed September 28, 2018

Victoria Elizabeth Phillips, District Attorney, New York County, Daniel John Woodard, Phillips & Paolicelli, LLP, New York, NY, for Plaintiffs.

Katy Koski, Jennifer Wang, Michael Thompson, Foley & Lardner, LLP, Boston, MA, Emily Anna Beer, Foley & Lardner LLP, New York, NY, for Defendants.

OPINION AND ORDER

Ramos, D.J.:

This case is about a young child who received a prosthetic heart valve

that failed and had to undergo surgery to replace it, during which she suffered a stroke, partial paralysis, and seizures. The infant, A.F., and her mother, Yael Fogel (collectively, "Plaintiffs"), brought this diversity action against Sorin Group USA, Inc.; CarboMedics, Inc.; and Sorin Group Canada, Inc. (collectively, "Defendants")¹ for injuries allegedly caused by the prosthetic Mitroflow Aortic Pericardial Heart Valve (the "Valve") that failed. Defendants have moved to dismiss the Complaint for failure to state a claim upon which relief can be granted pursuant to Federal Rule of Civil Procedure 12(b)(6). For the reasons set forth below, Defendants' motion to dismiss is GRANTED IN PART and DENIED IN PART.

I. Background²

Defendants are the manufacturers, sellers, and distributors of the Valve, which is a Class III medical device regulated by the Food and Drug Administration ("FDA") under the Medical Device Amendments of 1976 ("MDA").³ Compl. ¶ 48, Doc. 1. In late 2006 and through 2007, Defendants submitted an application and several amended applications for premarket approval of the Valve, which is the process by which the FDA evaluates the safety and effectiveness of Class III medical devices. Id. ¶ 49–50. As part of that process, Defendants submitted numerous types of information, including details on the device's components and manufacturing process, proposed indications for use that listed "no contraindications," and a clinical study of 699 patients that did not include any patients under the age of 27.⁴ Id. ¶¶ 4, 14, 51.

In October 2007, the FDA conditionally approved the Valve for commercial distribution subject to a number of requirements, including reporting to the FDA instances of adverse effects of the device in patients. Id. ¶ 52. Pursuant to that conditional approval, Defendants began distributing the Valve. Id. ¶ 54.

After its release, some patients who received the Valve experienced symptoms of valve deterioration and malfunction of the "leaflets," a component of the Valve that controls the flow of blood, as has been documented in medical and scientific literature. Id. ¶¶ 73, 75. In the spring of 2013, a child died after her Valve, implanted two years earlier, was severely obstructed and deteriorated due to excessive calcification. Id. ¶ 75.

Plaintiffs allege that upon learning of these adverse events, Defendants failed to timely report the information to the FDA and attempted to conceal it. Id. ¶¶ 9–11. For example, Plaintiffs allege that Defendants followed up on only a small number of 211 adverse event reports that they received, deflected blame for most of these adverse events, delayed production of adverse event reports to the FDA, and submitted insufficiently detailed annual reports that minimized problems. Id. ¶ 89.

Nonetheless, Plaintiffs allege that the evidence of Valves prematurely failing led Defendants to seek to change the product, and ultimately to discontinue the previous version. Id. ¶¶ 2, 72, 74. On July 1, 2013, Defendants applied to the FDA to change the Valve's manufacturing process to include an anticalcification treatment called phospholipid reduction treatment. Id. ¶¶ 64–65. On April 18, 2014, the FDA approved these changes to the Valve. Id. ¶¶ 66–67.

A.F. is an infant born with cardiac birth defects

. Id. ¶ 5. On August 5, 2013, about a month after Defendants applied to change the Valve but before the new version was approved, A.F. underwent surgery at New York Presbyterian Columbia University Medical Center to replace her pulmonary heart valve with the Valve. Id. ¶¶ 5, 59–60. Because the implanted Valve was the prior version, it did not have the anticalcification treatment. Id. ¶ 60, 68.

Two years later, A.F.'s Valve prematurely failed due to deterioration and stiff leaflets that obstructed the flow of blood, causing drops in the level of oxygen in her blood. Id. ¶¶ 70–71. Although these conditions increased the risk of surgical complications, on November 16, 2015, A.F. again underwent surgery to replace the failing Valve. Id. ¶¶ 70, 77. A.F. suffered complications, including a bilateral stroke

causing partial paralysis of the left side of her body and seizures, resulting in permanent physical and mental injuries. Id. ¶¶ 5, 78.

On August 4, 2017, Plaintiffs filed the instant action, asserting claims for negligence, strict products liability, negligent failure to warn, and loss of A.F.'s services. Id. ¶¶ 80–143. Plaintiffs assert their state-law claims "only to the extent that they are parallel to and not different from or in addition to the requirements of federal law." Id. ¶ 16. On November 28, 2017, Defendants moved to dismiss the Complaint for failure to state a claim under Rule 12(b)(6). Doc. 18.

II. Legal Standard

When ruling on a motion to dismiss pursuant to Rule 12(b)(6), the Court must accept all factual allegations in the complaint as true and draw all reasonable inferences in the plaintiff's favor. Wilson v. Merrill Lynch & Co. , 671 F.3d 120, 128 (2d Cir. 2011). However, the Court is not required to credit legal conclusions, bare assertions, or conclusory allegations. Ashcroft v. Iqbal , 556 U.S. 662, 678, 681, 686, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (citing Bell Atl. Corp. v. Twombly , 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) ). "To survive a motion to dismiss, a complaint must contain sufficient factual matter ... to ‘state a claim to relief that is plausible on its face.’ " Id. at 678, 129 S.Ct. 1937 (quoting Twombly , 550 U.S. at 570, 127 S.Ct. 1955 ). 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." Id. (citing Twombly , 550 U.S. at 556, 127 S.Ct. 1955 ). The plaintiff must allege sufficient facts to show "more than a sheer possibility that a defendant has acted unlawfully." Id. If the plaintiff has not "nudged [her] claims ... across the line from conceivable to plausible," the complaint must be dismissed. Id. at 680, 129 S.Ct. 1937 (quoting Twombly , 550 U.S. at 570, 127 S.Ct. 1955 ).

III. Discussion

The MDA, which amended the Federal Food, Drug, and Cosmetic Act ("FDCA"), imposed a regime of federal oversight on medical devices by the FDA. Riegel v. Medtronic, Inc. , 552 U.S. 312, 316, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). In doing so, the MDA expressly preempted certain state laws through the following provision:

Except as provided in subsection (b), no 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).⁵

In sum, "[s]tate requirements are pre-empted under the MDA only to the extent that they are ‘different from, or in addition to’ the requirements imposed by federal law." Riegel , 552 U.S. at 330, 128 S.Ct. 999 (quoting 21 U.S.C. § 360k(a)(1) ). State "requirement[s]" subject to preemption include common-law causes of action for negligence and strict liability. Id. at 323–24, 128 S.Ct. 999 (alteration in original). Thus, in Riegel , the Supreme Court held that the MDA preempts "[s]tate tort law that requires a manufacturer's [devices] to be safer ... than the model the FDA has approved." Id. at 325, 128 S.Ct. 999. By the same token, " § 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. at 330, 128 S.Ct. 999 (quoting Medtronic, Inc. v. Lohr , 518 U.S. 470, 495, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) ).

In addition to the express preemption provision of § 360k, state claims can also be impliedly preempted based on a conflict with the FDA's enforcement authority. In Buckman Co. v. Plaintiffs' Legal Committee , 531 U.S. 341, 351, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001), the plaintiffs brought state claims asserting that a company made fraudulent representations to the FDA in violation of FDCA requirements in the course of obtaining approval to market a medical device. Id. at 343, 352, 121 S.Ct. 1012. The Supreme Court held that "the plaintiffs' state-law fraud-on-the-FDA claims conflict with, and are therefore impliedly pre-empted by, federal law."⁶ Id. at 348, 121 S.Ct. 1012. The Court explained that "the federal statutory scheme amply empowers the FDA to punish and deter fraud against the Administration," and the FDA uses this authority "to achieve a somewhat delicate balance of statutory objectives." Id. The Court held that this balance would be upset by state claims that "exist solely by virtue of the FDCA ... requirements" rather than "traditional state tort law which had...