James C. Cacheris, UNITED STATES DISTRICT COURT JUDGE.
Before the Court is Plaintiff Scott T. Carmine's ("Carmine") Motion to Remand
Carmine brought this suit in the Circuit Court for Prince William County, Virginia alleging various state-law theories of product liability and medical malpractice.
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
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")
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
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.
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.
"[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 must resolve issues of federal law to determine whether the Product Defendants' promotion of Infuse® included "off-label" uses. For example, MSD contends the Court must decide whether the FDCA prohibits off-label promotion at all (Mem. in Opp'n at 9), whether premarket approval extends to a product generally or only to specified uses of the product (id. at 10.), whether premarket approval applies to product components or only to the complete product (id.), and other similar issues. Under the well-pleaded complaint
MSD's argument that substantial federal question jurisdiction creates "an exception" to the well-pleaded complaint rule is not convincing.
MSD's second argument for the presence of a federal issue is, similarly, that federal law is inherent in Carmine's claims because he must prove a "parallel" violation of federal law as an element of his state law claims. (Mem. in Supp. at 7-9.) The Supreme Court has explicitly held,
MSD argues that Merrell Dow is not dispositive because that case involved a drug — not a device — and drugs are not governed by the express preemption clause of § 360k(a). (Mem. in Opp'n at 22.) MSD contends that Merrell Dow primarily relied on the fact that the FDCA regulation of drugs provided "no federal cause of action and no preemption of state remedies." Grable, 545 U.S. at 318, 125 S.Ct. 2363. Thus, according to MSD, the MDA's express preemption of state law remedies differentiates this case from Merrell Dow. Like many other courts to consider this argument, "[t]he Court is not persuaded by this line of reasoning." Anders v. Medtronic, Inc., No. 4:14cv194, 2014 WL 1652352, at *6 (E.D.Mo. Apr. 24, 2014) (quoting Goade, 2013 WL 6237853, at *5). "There is no authority suggesting that Merrell Dow depends on this distinction — or, for that matter, that the jurisdictional analysis depends on this distinction. The distinction is, in short, meaningless." Id. (quoting Goade, 2013 WL 6237853, at *5).
MSD's third argument for the presence of a necessary federal question is that Carmine's manufacturing defect claim alleges a violation of the FDA's Current Good Manufacturing Practices. (Mem. in Opp'n at 11.) Similarly, Carmine's negligence claim also alleges a violation of the FDCA and premarket approval requirements. (Compl. ¶ 144(j).) These allegations of federal law violations, however, are not "necessary" to Carmine's claims of manufacturing defect or common law negligence. In both claims, the alleged violation of federal law is only one of several arguments made to show a breach of the appropriate standard of care. In Pinney, the Fourth Circuit concluded that federal law is not necessarily raised when it serves as "only one factor" in assessing a defendant's liability. Pinney, 402 F.3d at 446. In other words, when "a plaintiff can establish, without the resolution of an issue of federal law, all of the essential elements of his state law claim, then the claim does not necessarily depend on a question of federal law." Id. at 442 (citing Franchise Tax Bd., 463 U.S. at 13, 103 S.Ct. 2841)). In this case, a violation of federal law would serve as only one, non-dispositive factor in both the manufacturing defect and negligence claims. Therefore, federal law is not necessarily raised.
MSD's fourth argument is that the Complaint's background section alleges the FDA misclassified Infuse® as a device rather than a drug. (Mem. in Opp'n at 12.) In that section, the Complaint states that "[b]y approving the Infuse components as a device, the FDA abused its discretion, thus requiring reclassification." (Compl. ¶ 99.) Even MSD acknowledges, however, that this argument is merely an attempt to "avoid the preemption of [Carmine's] claims under 21 U.S.C. § 360k(a) — which applies only to devices, not drugs." (Mem. in Opp'n at 12.) The misclassification of the device is not even mentioned in the sections of the Complaint actually asserting the theories of relief. Thus, the misclassification argument is, again, an argument in anticipation of the defense of preemption and not part of the well-pleaded complaint. Furthermore, Carmine need not prove misclassification to establish an element of any of his ten counts. Therefore, the question
Although MSD does not make the argument, there is one count that necessarily raises an actually disputed issue of federal law. Count five alleges negligence per se, which requires proof that "the defendant violated a statute that was enacted for public safety," "that [plaintiff] belongs to the class of persons for whose benefit the statute was enacted, and that the harm that occurred was of the type against which the statute was designed to protect," and "that the statutory violation was a proximate cause of his injury." Halterman v. Radisson Hotel Corp., 259 Va. 171, 523 S.E.2d 823, 825 (2000.) Thus, a negligence per se claim necessarily requires a violation of some statute. And in this case, Carmine alleges a violation of a federal statute, the FDCA. (See Compl. ¶ 147 ("Product Defendants had a duty to comply with the applicable FDCA and PMA requirements referenced above."). Negligence per se alleging a violation of federal law as the source of duty and negligence is "[t]he paradigmatic example of a state claim with an embedded (though not necessarily significant) federal issue." Dillon, 992 F.Supp.2d at 756. Furthermore, MSD vigorously asserts that it did not violate the FDCA. Therefore, Count five raises a necessary and actually disputed issue of federal law, but it is the only count to do so.
It requires more than the presence of a necessary and disputed federal issue to create substantial federal question jurisdiction; the federal issue must also be substantial. In the recent case of Gunn v. Minton, the Supreme Court clarified that substantiality does not mean "significant to the particular parties in the immediate suit; that will always be true when the state claim `necessarily raise[s]' a disputed federal issue." ___ U.S. ___, 133 S.Ct. 1059, 1066, 185 L.Ed.2d 72 (2013). Substantiality requires something more. "The substantiality inquiry under Grable looks instead to the importance of the issue to the federal system as a whole." Id. "[T]his degree of importance has been found only when the Government's operations are affected by the federal issue." Goade, 2013 WL 6237853, at *6 (discussing Grable, 545 U.S. at 315, 125 S.Ct. 2363 and Smith v. Kansas City Title & Trust Co., 255 U.S. 180, 41 S.Ct. 243, 65 L.Ed. 577 (1921)).
It is telling that MSD's discussion of substantiality never cites Gunn (See Mem. in Opp'n at 13-18.) Instead, MSD contends that the Court should judge substantiality under a four-factor test that predates Gunn and appears to be applied only in the Sixth Circuit. See Mikulski v. Centerior Energy Corp., 501 F.3d 555, 570 (6th Cir.2007).
The parties have cited many district court cases discussing whether the legal issues raised in state-law claims against Infuse® for off-label promotion are "substantial." All the post-Gunn cases finding substantiality that MSD cites, however, come from district courts in the Sixth Circuit applying Mikulski and three of those cases were authored by the same district court judge. Arrington v. Medtronic, Inc., No. 2:14-cv-02473, 130 F.Supp.3d 1150, 1162-64, 2014 WL 10384579, at *10-11 (W.D.Tenn. Sept. 2, 2014); H.R. ex rel. Reuter, 996 F.Supp.2d 671, 679-80 (S.D.Ohio 2014); Jenkins v. Medtronic, Inc., 984 F.Supp.2d 873, 880-81 (W.D.Tenn.2013); see also Hafer v. Medtronic, Inc., 99 F.Supp.3d 844, 850 (W.D.Tenn.2015) (noting prior denial of remand motion).
When looking outside the Sixth Circuit, district courts in the Eighth and Eleventh Circuits have interpreted Gunn to mean that substantiality did not exist in Infuse® product liability cases like this one. See Hilyard v. Medtronic, Inc., 21 F.Supp.3d 1012, 1018-20 (E.D.Mo.2014); Anders v. Medtronic, Inc., No. 4:14cv194, 2014 WL 1652352, at *5-7 (E.D.Mo. Apr. 24, 2014); Mooney v. Henkin, No. 8:13-cv-3213, 2014 WL 523034, at *3-4 (M.D.Fla. Feb. 9, 2014); Goade v. Medtronic, Inc., No. 13-5123, 2013 WL 6237853, at *4-6 (W.D.Mo. Dec. 3, 2013). Additionally, at least one district court in the Sixth Circuit concluded that substantiality did not exist in a similar Infuse® case and distinguished several of its sister courts as failing to acknowledge Gunn in their analysis. See Schilmiller v. Medtronic, Inc., 44 F.Supp.3d 721, 731 (W.D.Ky.2014) (noting that H.R. ex rel. Reuter and Jenkins "failed to address the Court's concerns in Gunn"). The Court finds the conclusions reached in Schilmiller, Hilyard, Anders, Mooney, and Goade more closely align with the standards articulated in Gunn and joins those courts in concluding that any federal issues necessarily raised in this case are not substantial.
The federal issues in dispute here, while important to the individual litigants, are not significant to the federal system as a whole. None of the issues in this case would affect the Government's operation. The disputes relate to whether medical manufacturers designed, manufactured, and promoted an unreasonably dangerous product. These questions are clearly important to the Product Defendants, but do not affect the operation of the federal system in the way that was evident in Smith v. Kansas City Title & Trust Co. or in Grable. Therefore, any federal issues raised here are not substantial.
Although the absence of substantiality is dispositive, the Court will also address the balance between federal and state judicial responsibilities. As other courts considering this factor in Infuse® cases have noted, it is "telling that Congress chose to neither permit federal jurisdiction, nor completely preclude state jurisdiction, over claims alleging violations of the MDA." Schilmiller, 44 F.Supp.3d at 731. "The combination of no federal cause of action and no preemption of all state remedies, while not dispositive, is an important clue to Congress's conception of the scope of jurisdiction to be exercised under § 1331." Anders, 2014 WL 1652352,
MSD's argument that only a "small percentage" of a "tiny faction" of medical devices is as heavily regulated as Infuse® is not convincing. As a general matter, the raw number of products receiving premarket approval each year is not as important as the breadth of the product's use in the marketplace. For example, Infuse® alone has already provoked 800 lawsuits against Medtronic and the company estimates over 4,500 claimants have not yet filed. See Medtronic, Inc. Annual Report (Form 10-K), at 119 (June 23, 2015). Additionally, as other courts have found, MSD's "legal analysis would not be confined to Class III medical devices. It would apply, minimally, to all medical devices, and arguably would apply further." Anders, 2014 WL 1652352, at *7 (quoting Goade, 2013 WL 627853, at *6). Thus, accepting MSD's argument poses a real risk of upsetting the balance of state and federal judicial responsibilities that Congress contemplated.
In sum, only one of Carmine's ten counts necessarily raises an actually disputed federal issue. That federal issue, however, is not substantial under the Gunn standard and therefore does not create substantial federal question jurisdiction in this case. Additionally, accepting federal jurisdiction over this case would upset the balance between state and federal judicial responsibilities. Accordingly, the case must be remanded.
As an alternative position, MSD contends that the Court should sever the nondiverse Medical Defendants in an attempt to bring this case within the Court's § 1332 diversity jurisdiction. MSD argues that severance would be proper under Federal Rule of Civil Procedure 21 because the "claims against the Medical Defendants are distinct from [Carmine's] claims against the Product Defendants, are predicated on different standards of care, and alleged different conduct." (Mem. in Opp'n at 27.) Thus, MSD contends the Medical Defendants are dispensable and severance would not prejudice Carmine. MSD also cites several recent cases in which a district court severed nondiverse medical defendants in cases alleging similar claims of medical product liability. See Sullivan v. Calvert Mem. Hosp., No. PJM 15-1188, 117 F.Supp.3d 702, 2015 WL 4614467 (D.Md. July 30, 2015); H.R. ex rel. Reuter v. Medtronic, Inc., 996 F.Supp.2d 671, 682-83 (S.D.Ohio 2014).
Carmine rebuts that severance is not proper because the claims against all Defendants are "inextricably bound to the same core set of facts and issues." (Mem. in Supp. at 5.) Additionally, Carmine asserts that the Medical Defendants are likely to blame the Product Defendants for Carmine's injuries, and vice versa. Thus, severance would "severely prejudice Plaintiff's ability to prosecute his claims." (Id. at 6.)
"[I]t is well settled that Rule 21 invests district courts with authority to allow a dispensable nondiverse party to be dropped at any time." Newman-Green, Inc. v. Alfonzo-Larrain, 490 U.S. 826, 833, 109 S.Ct. 2218, 104 L.Ed.2d 893 (1989). Whether to grant such severance, however, "is committed to the discretion of the trial court, and it does not follow as a matter (of) right that a party can be dropped at the mere desire" of another party. Caperton v. Beatrice Pocahontas Coal Co., 585 F.2d 683, 692 (4th Cir.1978) (internal quotation omitted). In addition to determining whether a party is indispensable,
At the outset, it is important to note that MSD is not arguing for severance under two other distinct legal doctrines that permit the court to disregard the citizenship of nondiverse parties and retain jurisdiction. First, MSD does not argue that the Medical Defendants were fraudulently joined, which would permit severance where there is "no possibility of success against those defendants." Stephens v. Kaiser Found. Health Plan of the Mid-Atl. States, Inc., 807 F.Supp.2d 375, 379 (D.Md.2011). Second, MSD does not argue that the Medical Defendants were fraudulently misjoined, which some courts have found permits severance where "claims against certain defendants, while provable, have no real connection to the claims against other defendants in the same action and were only included in order to defeat diversity jurisdiction and removal."
A recent case from the Western District of Virginia presenting similar facts provides compelling reasons for declining to sever nondiverse defendants in a case simultaneously alleging medical malpractice and product liability.
Even assuming the Medical Defendants are dispensable parties, something Carmine does not appear to dispute, severance is not appropriate. Broadly stated, Carmine's Complaint alleges a failure to warn him of the foreseeable and known dangers of the off-label use of Infuse® and the injuries he sustained when the Medical Defendants used Infuse® in that way. Although the specific elements of each theory of relief are distinct, his entitlement to damages on all theories arises from the surgery in which the Medical Defendants implanted the Product Defendants' device into his body. Thus, as in Tinsley, there is a real concern that each group of defendants could attribute Carmine's injuries to the other group's conduct. The Product Defendants could argue that Infuse®, if properly used, does not have an increased risk of injuries even if the use is off-label. Similarly, the Medical Defendants could argue that the surgery was properly performed, but the product was defectively designed. The potential risk of this "empty chair" defense cautions against severing the defendants in this case.
Furthermore, separate trials would increase the risk of inconsistent verdicts. As the court noted in Tinsley, "if the court were to sever the claims in this case, a jury in the state court action may find that the [medical defendants] were not negligent in treating Kaylee because the [product defendants] failed to warn them of the risks of developing SJS/TEN." Tinsley, 143 F.Supp.3d at 463, 2015 WL 7009488, at *10. In a later federal trial on product liability, "a jury may find that the [product defendants] properly warned of the connection between SJS/TEN and acetaminophen usage." Id. The same concern would be unnecessarily injected into this case if the Court severed the defendants.
MSD's citation to Sullivan v. Calvert Memorial Hospital does not persuade the Court to sever. In Sullivan, the plaintiff raised medical malpractice and product liability claims related to the surgical implant of a defective transvaginal sling into her pelvic region and the failure to properly remove a catheter used during that surgery. No. PJM 15-1188, 117 F.Supp.3d 702, 702-05, 2015 WL 4614467, at *1-2 (D.Md. July 30, 2015). The product liability defendants removed the case, arguing that the nondiverse medical defendants should be severed under Rule 21. The court first found that the medical defendants were not necessary parties under Rule 19 because the medical malpractice and product liability claims involved different legal and factual inquiries and resolution of one set of claims would not necessarily resolve the remaining claims. That analysis, however, only determined that the medical defendants
Unlike in Sullivan, there is no competing efficiency policy promoted by dividing Carmine's case between two separate jurisdictions. Severance would instead require duplicative presentation of at least some common factual and legal issues in separate judicial forums. Furthermore, the Court declines to find that the mere fact that a party is not necessary under Rule 19 justifies a discretionary remedy that should "be exercised sparingly." As such, the Court declines to sever the medical defendants in this case.
For the foregoing reasons, the Court will grant Plaintiff's motion to remand and deny Defendant MSD's motion to sever the nondiverse defendants.
An appropriate order will follow.
Mikulski, 501 F.3d at 570.
