Aaron v. Medtronic, Inc.

• Decision Date: 22 September 2016
• Docket Number: 1:13-cv-202,Case No. 1:13-cv-301 (lead case),1:13-cv-214,1:14-cv-483,1:14-cv-325
• Citation: 209 F.Supp.3d 994
• Parties: Frieda AARON, et al., Plaintiffs, v. MEDTRONIC, INC., et al., Defendants.
• Court: U.S. District Court — Southern District of Ohio

209 F.Supp.3d 994

Frieda AARON, et al., Plaintiffs,

v.MEDTRONIC, INC., et al., Defendants.

Case No. 1:13-cv-301 (lead case)

1:13-cv-202

1:13-cv-214

1:14-cv-325

1:14-cv-483

United States District Court, S.D. Ohio, Western Division.

Signed September 22, 2016

Robert Albert Winter, Jr., Fort Mitchell, KY, Eric C. Deters, Independence, KY, for Plaintiffs.

Jacob Deniro Rhode, James Eugene Burke, Bethany Palmer Recht, Keating Muething & Klekamp PLLP, Cincinnati, OH, Andrew E. Tauber, Mayer Brown, Pro Hac, Vice, Daniel Leslie Ring, Mayer Brown LLP, Chicago, IL, Nicholas M. Kouletsis, Pepper Hamilton LLP, Princeton, NJ, for Defendants.

ORDER GRANTING DEFENDANTS' MOTION TO DISMISS (Doc. 61)

Timothy S. Black, United States District Judge

This civil action is before the Court upon Defendants' motion to dismiss the Omnibus Complaint filed August 28, 2015 (Doc. 61). The Omnibus Complaint (Doc. 54) consolidates the claims from five cases brought against Defendants. See 4/20/15 Minute Entry and Notation Order. Plaintiffs filed a response to the motion to dismiss on October 26, 2015 (Doc. 63), and Defendants filed a reply on December 15, 2015 (Doc. 65).

I. BACKGROUND

Defendants Medtronic, Inc. and Medtronic Sofamor Danek, USA, Inc. (hereinafter referred to collectively as the singular "Medtronic") are medical device manufacturers. Medtronic manufactures many products, but the product at the center of this case is called Infuse. Infuse is used to stimulate bone growth in spinal fusion

surgeries.

Infuse, like all medical devices sold in the United States, is regulated by the Food and Drug Administration (FDA), which draws its regulatory authority in this area from the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act (FDCA). 21 U.S.C. § 360c et seq. Under the MDA, different types of devices receive different levels of FDA scrutiny. Devices that "support [ ] or sustain[ ] human life" or "present[ ] a potential unreasonable risk...of injury" are designated "Class III" devices.

21 U.S.C. § 360c(a)(1)(C)(ii). Infuse has been classified as a Class III medical device by the FDA. Class III devices like Infuse "incur the FDA's strictest regulation" and must receive Premarket Approval (PMA) from the FDA before being sold. Buckman Co. v. Plaintiffs' Legal Comm. , 531 U.S. 341, 344, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001).

"Premarket Approval is a ‘rigorous' process." Riegel v. Medtronic, Inc. , 552 U.S. 312, 317, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). To obtain PMA, a manufacturer "must submit a detailed PMA application" that contains, among other things, "specimens for the proposed labeling of the device." Riegel v. Medtronic, Inc. , 451 F.3d 104, 109 (2d Cir.2006), aff'd , 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). The FDA closely scrutinizes PMA applications, "weigh[ing] any probable benefit to health from the use of the device against any risk of injury or illness from such use." Riegel , 552 U.S. at 318, 128 S.Ct. 999 (quotation marks omitted). "The FDA spends an average of 1,200 hours reviewing each application" and "grants premarket approval only if it finds there is a ‘reasonable assurance’ of the device's ‘safety and effectiveness.’ " Id. If the FDA decides that the device's proposed design, manufacturing methods, or labeling is inadequate, the FDA can require revisions prior to approval. Id. at 319, 128 S.Ct. 999.

"Once a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness. § 360e(d)(6)(A)(i)." Id. A manufacturer which wishes to make such changes "must submit, and the FDA must approve, an application for supplemental premarket approval, to be evaluated under largely the same criteria as an initial application. § 360e(d)(6); 21 CFR § 814.39(c)." Id.

Infuse is one component of a medical device that was granted PMA by the FDA in 2002. The device itself consists of a collagen carrier sponge soaked with liquid protein rhBMP–2 (this is the portion of the device referred to by the parties and by this Order as "Infuse") and a metallic cage, the LT–Cage. (Doc. 54, at 86–87). The protein-soaked sponge is placed inside the LT–Cage which is inserted into the patient's spine. (Id. , at 87). The premarket approval specifies that the FDA-approved Infuse device consists of all component parts which must be used together. (Id. at 92). The Infuse device was approved only for use in a single-level fusion in the L4–S1 region of the lumbar spine via the Anterior Lumbar Interbody Fusion procedure and in combination with the LT–Cage. (Id. at 92–93). Use of the device in a manner not approved by the FDA is considered an "off-label" use. (Id. at 92). Nevertheless, medical practitioners are not prohibited from using a legally marketed device like Infuse in a manner that has not been approved by the FDA. See 21 U.S.C. § 396 ; Buckman, 531 U.S. at 341, 121 S.Ct. 1012.

Plaintiffs in this case are several hundred former patients of Dr. Atiq Durrani, M.D., an orthopedic surgeon operating in the Cincinnati area (in the past). The Omnibus Complaint alleges that Dr. Durrani either directly performed or ordered surgeries utilizing Infuse on Plaintiffs. The Complaint further alleges that each surgery was done using Infuse in a manner that was "off-label," meaning that Infuse was not used in the specific manner for which the FDA gave PMA to the device. Specifically, Plaintiffs allege that they were subjected to the following off-label uses of Infuse:

[s]ome of the Omnibus Plaintiffs were implanted with Infuse® without the LT–Cage. Some were subjected to a posterior surgical approach. Others had Infuse® implanted in multiple levels of the spine. And some Omnibus Plaintiffs had Infuse® implanted in their cervical or thoracic spines.

(Doc. 63, at 9–10). Plaintiffs further allege that, as a result of off-label use of Infuse, each Plaintiff has suffered injury.

The Omnibus Complaint raises the following claims against Medtronic on behalf of all Plaintiffs:

(1) fraudulent concealment, misrepresentation and fraud in the inducement;

(2) strict products liability (failure to warn);

(3) strict products liability (design defect);

(4) strict products liability (misrepresentation);

(5) products liability (negligence); and

(6) breach of express and implied warranties.

II. STANDARD OF REVIEW

A motion to dismiss pursuant to Fed. R. Civ. P. 12(b)(6) operates to test the sufficiency of the complaint and permits dismissal of a complaint for "failure to state a claim upon which relief can be granted." To show grounds for relief, Fed. R. Civ. P. 8(a) requires that the complaint contain a "short and plain statement of the claim showing that the pleader is entitled to relief."

While Rule 8 of the Federal Rules of Civil Procedure"does not require ‘detailed factual allegations,'...it demands more than an unadorned, the-defendant-unlawfully-harmed-me accusation." Ashcroft v. Iqbal , 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (citing Bell Atl. Corp. v. Twombly , 550 U.S. 544, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) ). Pleadings offering mere " ‘labels and conclusions' or ‘a formulaic recitation of the elements of a cause of action will not do.’ " Id. (citing Twombly , 550 U.S. at 555, 127 S.Ct. 1955 ). In fact, in determining a motion to dismiss, "courts ‘are not bound to accept as true a legal conclusion couched as a factual allegation[.]’ " Twombly , 550 U.S. at 555, 127 S.Ct. 1955 (citing Papasan v. Allain , 478 U.S. 265, 106 S.Ct. 2932, 92 L.Ed.2d 209 (1986) ). Further, "[f]actual allegations must be enough to raise a right to relief above the speculative level[.]" Id.

Accordingly, "[t]o survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’ " Iqbal , 556 U.S. at 678, 129 S.Ct. 1937. A claim is plausible where "plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Id. Plausibility "is not akin to a ‘probability requirement,’ but it asks for more than a sheer possibility that a defendant has acted unlawfully." Id. "[W]here the well-pleaded facts do not permit the court to infer more than the mere possibility of misconduct, the complaint has alleged—but it has not ‘show[n]’—‘that the pleader is entitled to relief,’ " and the case shall be dismissed. Id. (citing Fed. Rule Civ. P. 8(a)(2) )

III. ARGUMENT

A. Pleading Standards

An important issue argued by both parties, and relevant to all of Plaintiff's claims, is with what specificity these claims must be pleaded.

Generally, pleadings are governed by Rule 8 of the Federal Rules of Civil Procedure, which states in relevant part:

A pleading that states a claim for relief must contain:

(1) a short and plain statement of the grounds for the court's jurisdiction, unless the court already has jurisdiction and the claim needs no new jurisdictional support;

(2) a short and plaint statement of the claim showing that the pleader is entitled to relief; and

(3) a demand for the relief sought, which may include relief in the alternative or different types of relief.

Fed. R. Civ. P. 8(a).

As previously stated above, Federal Rule of Civil Procedure 8"demands more than an unadorned, the-defendant-unlawfully-harmed-me accusation." Iqbal , 556 U.S. at 678, 129 S.Ct. 1937 (citing Twombly , 550 U.S. at 555, 127 S.Ct. 1955 ). Thus, Defendants argue that:

Conclusory allegations that the defendant violated FDA regulations in the manufacture, labeling, or marketing of the premarket approved medical device are insufficient to state a parallel state-law claim and thereby avoid preemption under § 360k(a)." Ali v. Allergan USA, Inc. , 2012 WL 3692396, at *6 (E.D.Va.2012). Thus, "Plaintiffs cannot simply incant the magic words ‘Medtronic violated FDA regulations' in order to avoid

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