Mendez v. Shah

• Decision Date: 27 June 2014
• Docket Number: Civil Action No. 13–1585.
• Citation: 28 F.Supp.3d 282
• Parties: Maria MENDEZ, Plaintiff, v. Rahul V. SHAH, M.D., et al., Defendants.
• Court: U.S. District Court — District of New Jersey

28 F.Supp.3d 282

Maria MENDEZ, Plaintiff

v.Rahul V. SHAH, M.D., et al., Defendants.

Civil Action No. 13–1585.

United States District Court, D. New Jersey.

Signed June 27, 2014.

Michael T. Rooney, Rooney & Rooney, Philadelphia, PA, for Plaintiff.

John F. Brenner, Melissa Anne Chuderewicz, Pepper Hamilton, LLP, Princeton, NJ, for defendants Medtronic Sofamaor Danesk USA Inc., Medtronic Spine LLC, Medtronic USA Inc., and Medtronic Inc.

OPINION

HILLMAN, District Judge:

Before the Court is a motion to dismiss the second amended complaint filed by defendants Medtronic Sofamaor Danesk USA Inc., Medtronic Spine LLC, Medtronic USA Inc., and Medtronic Inc. (collectively “Medtronic”). For the reasons stated below, the motion will be granted in part and denied in part.

I. BACKGROUND

Plaintiff, Maria Mendez, suffered from chronic back pain. Defendant Dr. Shah performed surgery on her back on March 21, 2011 and implanted various medical devices in her back that plaintiff alleges failed and caused her injury. Plaintiff's allegations against the Medtronic defendants concern the implantation of Medtronic's “Infuse Bone Graft

/LT–Cage Lumbar Fusion” device as well as “the Capstone Spinal System, Infuse Bone Graft, MasterGraft Matrix, CD Horizon Legacy screws, Cancellous chips, and surgical putty.” Plaintiff states that Capstone cages and Infuse bone graft were inserted into the spaces between her fourth and fifth lumbar vertebrae (L4/L5) and between the fifth lumbar vertebra and the sacrum (L5/S1). Plaintiff asserts that a Medtronic sales representative, “Ken,” was present in the operating room.

Due to increasing pain and disability over several weeks post-operatively, films were taken that showed that the cages had migrated. A revision surgery was performed on May 18, 2011 and similar products in a smaller size were implanted. Plaintiff states that the L5/S1 hardware had allegedly failed, with the L4/L5 implant remaining well fixed. The second surgery involved “shav[ing] the space of the L5/S1” joint, “remov[ing] the loose and migrated Capstone interbody spacer,” and “insert[ing]” a “new larger Capstone spacer.” Plaintiff alleges she sustained “drop foot,” and other complications resulting from these surgeries. She alleges that she is disabled and suffers excruciating pain every day. It is not expected that any further treatment will help her.

Plaintiff brought claims of negligence, medical malpractice, battery, lack of informed consent, breach of the implied warranty of fitness for a particular purpose, breach of express warranty, breach of contract, fraudulent concealment, fraud and misrepresentation, as well as claims pursuant to the New Jersey Product Liability Act (“PLA”) and a third party beneficiary claim. Plaintiff seeks compensatory and punitive damages.

The Medtronic defendants argue that claims against one of the devices, the “Infuse Bone Graft

/LT–Cage Lumbar Fusion” device, is preempted by federal law because it received premarket approval from the Food and Drug Administration. They also seek to dismiss plaintiff's claims for implied and express warranties, third party beneficiary, fraud, and claims brought pursuant to the PLA. Finally, they request to have plaintiff's request for punitive damages stricken.

II. JURISDICTION

This Court exercises jurisdiction pursuant to 28 U.S.C. § 1332(a), diversity of citizenship. Plaintiff is a citizen of the Commonwealth of Pennsylvania and the defendants, are citizens of either the States of New Jersey, Tennessee, Delaware, or Minnesota. The amount in controversy exceeds the jurisdictional limit exclusive of interest and costs.

A Court exercising diversity jurisdiction must apply the law of the forum state within which it sits, and therefore, New Jersey law will apply to plaintiff's state law claims. See Chemical Leaman Tank Lines, Inc. v. Aetna Casualty and Surety Co.,

89 F.3d 976, 983 (3d Cir.1996) (stating that “[a]s a federal court sitting in diversity, we must apply the substantive law of New Jersey.”) (citing Borse v. Piece Goods Shop, Inc., 963 F.2d 611, 613 (3d Cir.1992) ).

III. DISCUSSION

A. Standard for Motion to Dismiss

When considering a motion to dismiss a complaint for failure to state a claim upon which relief can be granted pursuant to Fed.R.Civ.P. 12(b)(6), a court must accept all well-pleaded allegations in the complaint as true and view them in the light most favorable to the plaintiff. Evancho v. Fisher, 423 F.3d 347, 351 (3d Cir.2005). It is well settled that a pleading is sufficient if it contains “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed.R.Civ.P. 8(a)(2). Under the liberal federal pleading rules, it is not necessary to plead evidence, and it is not necessary to plead all the facts that serve as a basis for the claim. Bogosian v. Gulf Oil Corp., 561 F.2d 434, 446 (3d Cir.1977). However, “[a]lthough the Federal Rules of Civil Procedure do not require a claimant to set forth an intricately detailed description of the asserted basis for relief, they do require that the pleadings give defendant fair notice of what the plaintiff's claim is and the grounds upon which it rests.” Baldwin County Welcome Ctr. v. Brown, 466 U.S. 147, 149–50 n. 3, 104 S.Ct. 1723, 80 L.Ed.2d 196 (1984) (quotation and citation omitted).

A district court, in weighing a motion to dismiss, asks “ ‘not whether a plaintiff will ultimately prevail but whether the claimant is entitled to offer evidence to support the claim.’ ” Bell Atlantic v. Twombly, 550 U.S. 544, 127 S.Ct. 1955, 1969 n. 8, 167 L.Ed.2d 929 (2007) (quoting Scheuer v. Rhodes, 416 U.S. 232, 236, 94 S.Ct. 1683, 40 L.Ed.2d 90 (1974) ); see also Ashcroft v. Iqbal, 556 U.S. 662, 129 S.Ct. 1937, 1949, 173 L.Ed.2d 868 (2009) (“Our decision in Twombly expounded the pleading standard for ‘all civil actions'....”); Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir.2009) (“Iqbal ... provides the final nail-in-the-coffin for the ‘no set of facts' standard that applied to federal complaints before Twombly .” ).

Following the Twombly/Iqbal standard, the Third Circuit has instructed a two-part analysis in reviewing a complaint under Rule 12(b)(6). First, the factual and legal elements of a claim should be separated; a district court must accept all of the complaint's well-pleaded facts as true, but may disregard any legal conclusions. Fowler, 578 F.3d at 210 (citing Iqbal, 129 S.Ct. at 1950 ). Second, a district court must then determine whether the facts alleged in the complaint are sufficient to show that the plaintiff has a “ ‘plausible claim for relief.’ ” Id. (quoting Iqbal, 129 S.Ct. at 1950 ). A complaint must do more than allege the plaintiff's entitlement to relief. Id.; see also Phillips v. County of Allegheny, 515 F.3d 224, 234 (3d Cir.2008) (stating that the “Supreme Court's Twombly formulation of the pleading standard can be summed up thus: ‘stating ... a claim requires a complaint with enough factual matter (taken as true) to suggest’ the required element. This ‘does not impose a probability requirement at the pleading stage,’ but instead ‘simply calls for enough facts to raise a reasonable expectation that discovery will reveal evidence of’ the necessary element”). A court need not credit either “bald assertions” or “legal conclusions” in a complaint when deciding a motion to dismiss. In re Burlington Coat Factory Sec. Litig., 114 F.3d 1410, 1429–30 (3d Cir.1997). The defendant bears the burden of showing that no claim has been presented.

Hedges v. U.S., 404 F.3d 744, 750 (3d Cir.2005) (citing Kehr Packages, Inc. v. Fidelcor, Inc., 926 F.2d 1406, 1409 (3d Cir.1991) ).

Finally, a court in reviewing a Rule 12(b)(6) motion must only consider the facts alleged in the pleadings, the documents attached thereto as exhibits, and matters of judicial notice. Southern Cross Overseas Agencies, Inc. v. Kwong Shipping Group Ltd., 181 F.3d 410, 426 (3d Cir.1999). A court may consider, however, “an undisputedly authentic document that a defendant attaches as an exhibit to a motion to dismiss if the plaintiff's claims are based on the document.”Pension Benefit Guar. Corp. v. White Consol. Indus., Inc., 998 F.2d 1192, 1196 (3d Cir.1993). If any other matters outside the pleadings are presented to the court, and the court does not exclude those matters, a Rule 12(b)(6) motion will be treated as a summary judgment motion pursuant to Rule 56. Fed.R.Civ.P. 12(b).

B. Premarket Approval of The Device

The parties do not dispute that the device, Medtronic's “Infuse Bone Graft

/LT–Cage Lumbar Fusion” device (the “Infuse/LT–Cage device”) is a Class III medical device that received pre-market approval (“PMA”).¹ Premarket approval imposes “requirements” under the Medical Device Amendments of 1976 (“MDA”) and is specific to individual devices. Riegel v. Medtronic, Inc., 552 U.S. 312, 322–23, 128 S.Ct. 999, 1007, 169 L.Ed.2d 892 (2008). “[I]t is federal safety review.” Id., 552 U.S. at 321, 128 S.Ct. 999. The MDA “... expressly pre-empts only state requirements ‘different from, or in addition to, any requirement applicable ... to the device’ under federal law....” Id. (citing 21 U.S.C.A. § 360k(a)(1) ).

“[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.” Id.

A Class III medical device presents a “potential unreasonable risk of illness or injury,” or purports or represents “to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health.” See 21 U.S.C. § 360c(a)(1)(C)(ii). “Before a new Class III device may be introduced to the market, the manufacturer must provide the FDA with a ‘reasonable assurance’ that the device is both safe and effective.” Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700...