Carmine v. Poffenbarger

• Decision Date: 29 December 2015
• Docket Number: Case No. 1:15-cv-1207
• Parties: Scott T. Carmine, Plaintiff, v. Glen Jeffrey Poffenbarger, MD, et al., Defendants.
• Court: U.S. District Court — Eastern District of Virginia

154 F.Supp.3d 309

Scott T. Carmine, Plaintiff,

v.Glen Jeffrey Poffenbarger, MD, et al., Defendants.

Case No. 1:15-cv-1207

United States District Court, E.D. Virginia, Alexandria Division.

Signed December 29, 2015

Robert Taggart Hall, Samantha Karyn Sledd, Hall & Sethi PLC, Reston, VA, for Plaintiff.

Brent Ryan Gary, Reed Smith LLP, Falls Church, VA, for Defendant.

MEMORANDUM OPINION

James C. Cacheris, UNITED STATES DISTRICT COURT JUDGE

Before the Court is Plaintiff Scott T. Carmine's (“Carmine”) Motion to Remand this product liability and medical malpractice case to Virginia state court. (Mem. in Supp. [Dkt. 2].) One of the product manufacturer defendants, Medtronic Sofamor Danek USA, Inc. (“MSD”), filed a memorandum in opposition to remand. (Mem. in Opp'n [Dkt. 5].) For the following reasons, the Court will remand the entire case.

I. Background

Carmine brought this suit in the Circuit Court for Prince William County, Virginia alleging various state-law theories of product liability and medical malpractice.¹ (Compl. [Dkt. 1-4].) The case arises from injuries Carmine allegedly sustained during and after his spinal fusion

surgery on February 29, 2012. Spinal fusion is a procedure comparable to welding, whereby “one or more of the vertebrae of the spine are united together, or ‘fused,’ so that motion no longer occurs between them.” (Id. ¶ 29.) The “fusion” is achieved by surgically inserting a bone graph between the vertebrae. The Product Defendants² in this case manufacture and promote an FDA-approved medical device called Infuse^®, which is used in spinal fusion surgeries to facilitate bone growth.

Infuse^® includes two components. (Id. ¶ 40.) The first component is a collagen sponge that absorbs a protein engineered to promote fusion when applied to a bone graph. (Id. ) The second component is a thimble-sized hollow metal cylinder

or “cage” that holds two vertebrae in place and houses the collagen sponge. (Id. ) The two components are sold separately, but the initial FDA-approved label allegedly indicated that they must be used together. (Id. ) Furthermore, Carmine contends that Infuse^® is approved for only surgeries conducted through an incision in the abdomen and involving the fusion of one tier of vertebrae. (Id. ¶ 42.) Defendant Glen Jeffrey Poffenbarger, MD (“Poffenbarger”) allegedly did not follow these approved uses when he performed Carmine's surgery.

Carmine's surgery involved several alleged “off-label” uses of Infuse^®. For example, Poffenbarger inserted the Infuse^® collagen sponge and protein into a cage produced by a different manufacturer. (Id. ¶ 106.) Poffenbarger also allegedly performed the surgery through an incision in Carmine's back, rather than in his abdomen. (Id. ¶¶ 101, 109.) Additionally, the surgery involved the fusion of multiple tiers of vertebrae, instead of just a single tier. Carmine alleges that the Product Defendants promoted such “off-label” uses, which are known to create a “significantly enhanced risk” of post-surgery complications and violate the Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 360c et seq.

(Id. ¶¶ 110-12.)

The MDA imposes degrees of oversight for medical devices that vary depending on the risks associated with the device. See Riegel v. Medtronic, Inc. , 552 U.S. 312, 316, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008)

. Infuse^® is a Class III device, the most heavily regulated. (Compl. ¶ 23.) To replace unmanageable and conflicting state regulation of such devices, Congress included the following express preemption provision within the MDA:

Except as provided in subsection (b) of this section, 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)

. This preemption clause, however, “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 are ‘parallel,’ rather than add to, federal requirements.” Riegel , 552 U.S. at 330, 128 S.Ct. 999. Additionally, Congress explicitly chose not to provide a private cause of action to consumers harmed by violations of the FDCA. 21 U.S.C. § 337(a) ( “Except as provided in subsection (b) of this section, all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.”). Thus, federal law impliedly preempts private claims based “solely” on a violation of FDCA requirements. See

Sanchez v. Boston Scientific Corp. , 38 F.Supp.3d 727, 744 (S.D.W.Va.2014) (“The FDCA impliedly preempts private claims that seek to enforce FDCA provisions against a manufacturer.” (citing Buckman Co. v. Plaintiffs' Legal Comm. , 531 U.S. 341, 349 n. 4, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) )).

Thirty-five days after Carmine filed his state-court Complaint, and before any defendant was served, MSD removed the case to this Court under a theory of federal question jurisdiction. (See Notice [Dkt. 1] ¶¶ 9, 24-25.) Carmine timely filed a motion to remand, which MSD opposed. In its memorandum in opposition, MSD asks the Court to deny remand or to alternatively sever the nondiverse medical malpractice defendants (“Medical Defendants”)³ and retain diversity jurisdiction over the product liability counts. The Court will address these issues in turn.

II. Standard of Review

A state court case is removable under 28 U.S.C. § 1441(a)

only when “the district courts of the United States have original jurisdiction.” 28 U.S.C. § 1441(a). Because removal raises “significant federalism concerns,” courts must construe removal jurisdiction strictly. Mulcahey v. Columbia Organic Chems. Co. , 29 F.3d 148, 151 (4th Cir.1994). Accordingly, “[i]f federal jurisdiction is doubtful, a remand is necessary.” Id. The party seeking removal bears the burden of demonstrating jurisdiction. Id.

Federal district courts have original jurisdiction over “all civil actions arising under the Constitution, laws, or treaties of the United States.” 28 U.S.C. § 1331

. When considering whether an action arises under federal law, “ ‘the well-pleaded complaint rule’ demands that we confine our inquiry to the ‘plaintiff's statement of his own claim ... unaided by anything alleged in anticipation or avoidance of defenses which it is thought the defendant may interpose.”’ Flying Pigs, LLC v. RRAJ Franchising, LLC , 757 F.3d 177, 181 (4th Cir.2014) (quoting Christianson v. Colt Indus. Operating Corp. , 486 U.S. 800, 809, 108 S.Ct. 2166, 100 L.Ed.2d 811 (1988) ). “Most of the cases brought under § 1331 federal question jurisdiction ‘are those in which federal law creates the cause of action.”’ Mulcahey , 29 F.3d at 151

(quoting Merrell Dow Pharm. Inc. v. Thompson , 478 U.S. 804, 809, 106 S.Ct. 3229, 92 L.Ed.2d 650 (1986) ). There is, however, a slim category of cases that arise under state law but implicate a significant federal issue. See

Grable & Sons Metal Prod., Inc. v. Darue Eng'g & Mfg. , 545 U.S. 308, 312, 125 S.Ct. 2363, 162 L.Ed.2d 257 (2005). Such cases create a narrow basis for jurisdiction called “substantial federal question jurisdiction.” Gunn v. Minton , ––– U.S. ––––, 133 S.Ct. 1059, 1065, 185 L.Ed.2d 72 (2013) ; Flying Pigs , 757 F.3d at 182.

To fall within this narrow basis for jurisdiction, the state-law cause of action must implicate a federal issue that is necessarily raised, actually disputed, substantial, and capable of resolution in a federal court without disrupting the federal-state balance of power. Flying Pigs , 757 F.3d at 183 n. 8

(quoting Gunn , 133 S.Ct. at 1065 ). “Where all four of these requirements are met ... jurisdiction is proper because there is a serious federal interest in claiming the advantages thought to be inherent in a federal forum, which can be vindicated without disrupting Congress's intended division of labor between state and federal courts.” Gunn , 133 S.Ct. at 1065 (internal quotations omitted). The application of these factors is a “litigation-provoking problem.” Merrell Dow , 478 U.S. at 810, 106 S.Ct. 3229. That problem is readily apparent in cases alleging violations of FDCA requirements. Because of the large number of cases addressing this issue, the Court had the benefit of many well-reasoned opinions to guide its analysis.

III. Analysis

A. Motion to Remand

As described above, the Supreme Court has articulated a four-factor test for determining whether substantial federal question jurisdiction exists. Under that test, “federal jurisdiction over a state law claim will lie if a federal issue is: (1) necessarily raised, (2) actually disputed, (3) substantial, and (4) capable of resolution in federal court without disrupting the federal-state balance approved by Congress.” Gunn , 133 S.Ct. at 1065

. The Court will address those factors in turn.

(1) Necessarily Raised and Actually Disputed

“[A] plaintiff's right to relief for a given claim necessarily depends on a question of federal law only when every legal theory supporting the claim requires the resolution of a federal issue.” Flying Pigs , 757 F.3d at 182

(quoting Dixon v. Coburg Dairy, Inc. , 369 F.3d 811, 816 (4th Cir.2004) ). Under this standard, the Court finds that only Carmine's count of negligence per se necessarily raises an issue of federal law. In all the remaining counts, “the most one can say is that a question of federal law is lurking in the background.” Pinney v. Nokia, Inc. , 402 F.3d 430, 446 (4th Cir.2005) (quoting Gully v. First Nat'l Bank , 299 U.S. 109, 117, 57 S.Ct. 96, 81 L.Ed. 70 (1936) ). The Court will now address each of MSD's many arguments for why a federal issue is necessarily raised.

First, MSD argues that the Court...