MEMORANDUM OF DECISION GRANTING PLAINTIFFS MOTION TO REMAND [Dkt. # 23]
Plaintiff Linda Mihok, a citizen of Connecticut, brings claims in both her individual capacity and as Executrix of the Estate of Michael Mihok, against Defendants Medtronic Inc., Medtronic Puerto Rico Operations Co., Medtronic Neuromodulation (collectively the “Medtronic Defendants”), and Greenwich Hospital (“Greenwich”), for violations of the Connecticut Products Liability Act (“CPLA”), Conn. Gen.Stat. §§ 52-572m-q, Connecticut’s Unfair Trade Practices Act (“CUTPA”), Conn. Gen.Stat. §§ 42-110a, and loss of consortium. Mihok’s claims concern injuries suffered by her spouse, Michael Mihok, when a surgically-inserted catheter fractured, depriving him of necessary medication.
I. Backgrmmd
Michael Mihok, decedent, was diagnosed with Multiple Sclerosis (MS) in the year 2000. [Dkt. # 1-1, Compl. at ¶ 56]. While Mihok lost all function in his legs and some function in his arms and hands, Mihok retained sufficient use of his right arm and hand to successfully operate his motorized wheelchair and maintain his employment. [Id.l
On December 11, 2006, in an effort to manage his symptoms, Mihok underwent a procedure at Greenwich Hospital to implant the Medtronic’s SynchroMed® II Implantable Infusion System (the “System”), which administered medication to control muscle spasticity. [Id. at ¶ 57]. The System consisted of a Medtronic pump and a cathеter. [Id.]. In "addition to implanting the System, the Complaint alleges that Defendant Greenwich sold various medical products to patients, “including the ... System at issue in this claim.” [Id. at ¶ 11; see also id. at ¶ 14 (stating that Defendant Greenwich “sells the [System], which is a programmable infusion system implanted in the body for drug delivery”) ]. Following this procedure, and for several year's -thereafter, the medication delivered by the System effectively managed'Mihok’s symptoms. [Id. at ¶ 58].
On July'5, 2011, Defendant Medtronic Neuromedical issued a notification warning users óf the System that, as a result of a malfunctioning battery, the pump component might require replacement sooner than had originally been anticipated. [Id. at ¶ 59]. As a result, on July 6,. 2012, Mihok underwent a pump replacement procedure at Greenwich. [Id. at ¶60], The pump was replaced with no surgical complications, but the doctor did not remove the original catheter. [Id.].
Two weeks after the procedure, Mihok began to show-signs of withdrawal, and his spasticity returned; resulting in the loss of function in his hands and arms, along with painful and debilitating spasms. [Id. at ¶ 62]. Mihok-visited several different doctors following the onset of these symptoms. On September 7, 2012, after evaluating Mihok’s symptoms and the pump, Dr. Kenneth-Vives, a surgeon at Yale Neurosurgery, determined that the catheter had fractured. [Id. at ¶ 63]. Thereafter, another doctor, Dr. Kenneth Vines, of the Associated Neurologists of Southern Connecticut, replaced the catheter, and Mihok’s symptoms subsided. [Id. at ¶ 65].
The System is a 'Class III medical device, approved by the Food and Drug Administration (“FDA”) through the premarket approval (“PMA”) process. [Id. at ¶ 15]. At times before and after the System was implanted in Michael Mihok (December 11, 2006), the FDA issued Warning Letters to Medtronic stating that Medtronic violated various provisions of the Current Good Manufacturing Practice (“CGMP”) regulations -promulgated undеr the Food, Drug, and Cosmetic Act
II. Discussion
A. Motion to Remand
“It is a fundamental precept that federal courts are courts of limited jurisdiction and lack, the power to disregard such limits as have been imposed by the Constitution or Congress.” Durant, Nichols, Houston, Hodgson, & Cortese-Costa, P.C. v. Dupont,
Defendants assert that this Court has jurisdiction .on both federal-question and diversity grounds. Accordingly, the Court takes up each of these arguments.
B. The Court Lacks Federal-Question Jurisdiction Under Gunn-Grable
Federal courts have original jurisdiction over “all civil actions arising under the Constitution, laws, or treaties of the United States.” 28 U.S.C. § 1331. In the “vast bulk” of cases, a suit arises under federal law where the complaint pleads a federal cause of action. Gunn v. Minton,
[t]hree situations exist in which a complaint that does not allege a federal cause of action may nonetheless ‘arise under’ federal law for purposes of subject matter jurisdiction: first, if Congress expressly provides, by statute, for removal of state law claims ... second, if the state law claims are- completely prеempted by federal law ... and third, in certain cases if the vindication of a state law right necessarily turns on a question of federal law
Fracasse v. People’s United, Bank,
Here, the parties appear to acknowledge that only the third situation is potentially applicable, and the Court agrees. The Supreme Court recently opined on this third situation and found that only a “special and small” number of cases fall within it. Gunn,
[Fjederal 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.
id. at 1065 (quoting Grabble & Sons Metal Prods., Inc. v. Darue Eng’g & Mfg.,
Federal-question jurisdiction lies only “[w]here all four of these requirements are met.” Id. Applying the four-part Gunn-Grable test, the Court concludes that the third prong, substantiality of the federal issue, is lacking, and thus finds that federаl-question jurisdiction is absent.
1. The Complaint Necessarily Raises a Disputed Issue of Federal Law
As for the first two elements of Gunn-Grable, the Court agrees with Defendants that the Complaint necessarily raises a federal issue which the parties actually dispute. The allegations in the Complaint are plainly grounded in Defendants’ alleged violations of the federal CGMP. requirements. See [Dkt. # 1-1 Compl. at-¶¶ 23-55, 81-87, 91-97, 102, 104, 110]. As Defendants point out, if Plaintiffs state law claims “challenging the safety of an FDA-approved , medical device” were not “ ‘parallel’ claims, such as claims ‘premised on a violation of - FDA regulations’ where state law provides a damages remedy for such violations,” they would be preempted under. the FDCA. Otis-Wisher v. Medtronic, Inc.,
Equally clear is the fact that “Medtronic disputes that it violated federal law.” [Dkt. # 29, Defs.’ Opp. at 14]. Accordingly, the Court agrees with Defendants that the first two prongs of the Gunn-Grable test are satisfied.
2. The Issue of Federal Law is Not “Substantial” Within the Meaning of Gunn-Grable
In Gunn, the Supreme Court clarified the inquiry to be considered under the substantiality prong by explaining that “it is not enough that the federal issue be significant to the particular parties in the immediate suit.... The substantiality inquiry under Grable looks instead to the importance of the issue to the federal system as a whole.” Gunn,
Since Gunn, the Second Circuit has had four occasions on which to apply the Gunn-Grable test. In only one of those four cases did the Second Circuit (in a split decision) find that there was federal-question jurisdiction. In NASDAQ OMX Grp., Inc. v. UBS Sec., LLC,
In applying the substantiality prong, the majority focused on a statement by the SEC, which described “[n]ational securities exchanges,” like NASDAQ, as “critical
By contrast, in every other instance, the Second Circuit has found the substantiality prong under Gunn-Grable unmet. See Anghel v. Ruskin Moscou Faltischek, P.C.,
Here, Defendants’ primary argument under the substantiality prong is that the Complaint “contains numerous allegations of Medtronic’s violation of the FDA’s [CGMP regulations]” and that these “requirements, in certain cases, are plainly subject to interpretation.” [Dkt. # 29, Defs.’ Opp. at 15]. Thus, according to Defendants, because “Plaintiffs’ parallel claims will require this Court to interpret and construe FDA regulations as a matter of law and ultimately decide whether Medtronic violated those regulations” the claims are sufficient to raise a substantial issue of federal law under Gunn-Grable. [Id. at 17]., Defendants are mistaken for several reasons.
First, the allegations in the Complaint suggest that any state сourt analysis and application .of the FDA regulations will be limited. The Complaint is rooted in FDA Warning Letters which state that Medtronic failed to comply with the CGMP regulations. Thus, the relevant federal regulator has had an opportunity to consider and opine on the precise issue of federal law the parties dispute, and it was the FDA who first determined that
As to deference, Defendants cite a nonbinding case, Schering-Plough Healthcare Prods., Inc. v. Schwarz Pharma, Inc.,
With the issue of whether Medtronic violated the regulations likely in the background, the core remaining issue in this matter appears to be one of causation. See Giglio v. Conn. Light & Power Co.,
Second, the court’s analysis of the FDA regulations will take the form of a highly “fact-specific application” of the regulations to Medtronic’s conduct that is unlikely to substantially impact the federal system. David,
Third, the CGMP regulations, under which Plaintiff brings her claims, do not implicate a duty that comes close to the core duty identified by the Second Circuit in NASDAQ. It is significant that “[c]ourts have disagreed as to whether a plaintiff can plead a parallel claim by alleging that a defendant violated a CGMP requirement.” Gelber,
Fourth, Congress anticipated and approved of limited state court analysis and application of the FDA regulations when it decided not to completely preempt parallel state law claims. See Riegel,
Finally, each of the cases Defendants cite in support of their position that the Complaint raises substantial federаl issues are inapposite. For instance, in Broder v. Cablevision Sys. Corp.,
While Defendants contend that the Complaint also “assert[s] violations of federal statutes, including 21 U.S.C. §§ 351(h) and 360e(d)(6)(A)(i),” the two cited paragraphs in the Complaint indicate that any claims under these statutes are based entirely on violations of the CGMP regulations. [Dkt. # 1, Notice, of Removal, at ¶ 19]. Paragraph 23 simply quotes 21 U.S.C. § 351(h), which states that “[i]f a manufacturer fails to insure that the methods used in, or the facilities or controls used for, their manufacture, packing, storage or installation are not in conformity with the [CGMP] requirements ... then such products are adulterated.” [Dkt. # 1-1, Compl. at ¶ 23 (emphasis added) ]. Paragraph 55 cites 21 U.S.C. § 360e(d)(6)(A)(i) in support of Plaintiffs assertion that “all changes to [a PMA] device that affect its safety or effectiveness have to be approved as well.” [Id. at ¶ 55]. However, nothing in this paragraph, or in the ones immediately preceding or following it, suggests a cause of action separate from Medtronic’s failure to comply with the CGMP. Standing alоne, these citations and “passing references to a federal statute” are insufficient to raise a substantial federal issue. Fracasse,
In addition, the degree of impact of the plaintiffs claims in Broder on “the complex federal regulatory scheme applicable to television rates,” dwarfs that of the Complaint. Broder,
Similarly inapposite is In re Zyprexa Prods. Liab., Litig., Nos. 04-MD-1596, 07-CV-1933,
Finally, Defendants’ citation to Bowdrie v. Sun Pharm. Indus., Ltd.,
C. The Court Lacks Diversity Jurisdiction Because Defendant Greenwich is a Connecticut Citizen and is Not Fraudulently Joinеd
In addition to federal-question jurisdiction, Defendants assert that this Court has diversity jurisdiction over this case because the only non-diverse defendant, Greenwich, is fraudulently joined.
Under the fraudulent joinder doctrine, “courts overlook thé presence of a non-diverse defendant if from the pleadings there is no possibility that the claims against that defendant could be asserted in state court.” Briarpatch Ltd. v. Phoenix Pictures, Inc.,
The fraudulent joinder standard is strictly applied by courts in this Circuit. See In re Fosamax Prods. Liab. Litig., No. 09-CV-4061,
Applying this standard, the Court turns to Defendants’ contention that Plaintiff cannot recover against Defendant Greenwich under the CPLA.
1. Plaintiffs CPLA Claim Against Defendant Greenwich is Legally Possible.
Among the causes of action constituting a “[p]roduct liability claim” under the CPLA are “all actions based on ... strict liability....” Conn. Gen.Stat. § 52-572m(b). The elements of a strict liability action under Connecticut law are “(1) the defendant was engaged in the business of selling the product; (2) the product was in a defective condition'unreasonably dangerous to the consumer or user; (3) the defect caused the injury for which compensation was sought; (4) the defect existed at the time of the sale; and (5) the product was expected to and did reach the consumer without substantial change in condition.” Giglio v. Connecticut Light & Power Co.,
While the allegations in the Complaint are generally pled and are at times barebones, the Complaint may be construed to allege that Defendant Greenwich engaged in sales of the System to patients, sold Michael Mihok the System containing a defective catheter, performed a surgical implantation procedure for the sole purpose of delivering the System to Mihok, and the catheter later fractured, causing Mihok’s injuries. See [Dkt. # 1-1, Compl. at ¶¶ 11, 14, 31, 57, 63, 65, 103]. In addition, the Complaint contends that Defendant Greenwich “furthered the marketing of the [System] ... by serving as the party who made the final delivery of the product to .., Michael Mihok.” [Id. at ¶ 311. Acсordingly, these allegations may be construed to raise two theories of products liability against Defendant Greenwich: (i) a strict liability theory based on Greenwich’s initial sale of the System to Michael Mihok and (ii) a theory that Greenwich marketed the System when' it implanted it in him.
Defendants assert that Plaintiffs CPLA claim fails as a matter of law because Defendant Greenwich cannot constitute a “product seller” within the statutory meaning of the term. See [Dkt. #29, Defs.’ Opp. at 3]. Under the CPLA, a “product seller” is “any person or entity, including a manufacturer, wholesaler, distributor or retailer who is engaged in the business of selling such products whether the sale is for resale or for use or consumption.” Conn. Gen.Stat. § 52-572m(a). Defendants claim that “all Connecticut Appellate Court decisions that have addressed this issue have determined that in situations where the hospital is providing medical services — even when it sells the medical product in connection with providing those services — it is not a product seller as a matter of law.” [Dkt. # 29, Defs.’ Opp. at 3 — 4]. In support of their statement of law, Defendants rely on three cases involving hospital defendants, a Connecticut Supreme Court decision, Ziehichi, an intermediate appellate decision, Zbras v. St. Vincent’s Med. Ctr.,
In Ziehichi, the Connecticut Supreme Court held that the plaintiffs products liability claim against the defendant hospital, based on the purported sale of blood in the course of a blood transfusion, was precluded as a matter of law because such sales do not constitute the sale of a product. See Ziehichi,
For the same reasons, the other appellate decision to which Defendants cite, Zbras, does not support their broad categorical rule. In Zbras, during the course of a surgical proсedure, a doctor employed medical implants which were brought in by the manufacturer’s representative for use at the doctor’s discretion. Zbras,
Defendants also cite an unreported trial court decision, O’Dell v. Greenwich Healthcare Servs., Inc., No. CV116008364S,
Finally,, Connecticut law does not clearly establish that a hospital cannot be the seller of a medical device implanted in a patient on its premises. The Plaintiff identifies several decisions which post-date the appellate decisions raised by Defendants and suggest that a products- liability claim against a hospital defendant based on the sale of a medical device that the hospital subsequently implanted- would survive a motion to dismiss. See Basso v. Boston Scientific, Corp., No. CV 0760001429S,
Given the allegations in.the Complaint, the fact that significant discovery remains to be taken in this matter, and the reasonable possibility that a claim against a hospital defendant for the sale of a medical device that is surgically implanted in a
III. Conclusion .
This ease does not raise a substantial federal issue and it has not been clearly and convincingly established that there is no reasonable possibility for Greenwich Hospital to bе liable to the Plaintiff under the Connecticut Products Liability Act. Accordingly, the Plaintiffs Motion to Remand is GRANTED. The case is ordered REMANDED back to the Connecticut Superior Court for further proceedings. The clerk is directed to close this case.
IT IS SO ORDERED.
Notes
. Michael Mihok was originally a plaintiff in this action. See [Dkt. # 1-1]. On June 15, 2015, the Court granted Linda Mihok’s motion to substitute party, upon notice of Mr. Mihok’s death. See [Dkt. # 39], Accordingly, Plaintiff Linda Mihok proceeds as the sole plaintiff.
., The CGMP "requirements set forth a quality-control system and 'govern the methods used - in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human usé.’ ” Gelber v. Stryker Corp.,
. 21 U.S.C. § 3601c(a) states, in full:
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.
. As the Court concludes that it lacks subject matter jurisdiction over this case, it does not reach the issue of whether any or all of Plaintiff's claims are preempted under the FDCA.
. 21 C.F.R. § 820.30(c) states:
Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete; ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature qf the individual(s) approving the requirements, shall be documented.
. Moreover, as has been pointed out by other courts, Broder was decided without the benefit of Gunn, which clarified the substantiality prong of the Gunn-Grable test. See Knox v. Mazuma Credit Union, No. 15-0288-CV-W-ODS,
. "The language 'no possibility’ has been interpreted as meaning no ‘reasonable possibility' or 'no reasonable basis.’ ” Doe v. Fed. Express Corp., No. 3:05-cv-1968 (WWE),
. The Court considers the allegations against Defendant Greenwich only under the fraudulent joinder standard articulated above. See supra at 34-35. It neither considers nor reaches the question of whether the allega
. Defendants’ reliance on Lambert v. Charlotte Hungerford Hosp., No. CV054002013S,
. At most, the opinion indicates that the treating hospital "may have made a very small profit ... for pharmacy services” in connection with the medication. O’Dell,
. While the O'Dell plaintiffs asserted that they had not taken discovery prior to the defendants’ motion for summary'judgment, the court addressed this argument, stating that there "ha[d] been ample opportunity for discovery’’ and plaintiffs did not file an affidavit stating their belief that more discovery was required. O’Dell,
. Both the O’Dell court and Defendants here cite Truglio v. Hayes Constr. Co., 66 Conn. App. 681,
. As the Court has determined that Plaintiff’s CPLA claim is not legally impossible, and therefore, that non-diverse Defendant Greenwich was not fraudulently joined, the Court lacks subject matter jurisdiction and does not reach the issue of the viability and sufficiency of Plaintiff’s CUTPA claim. See [Dkt. # 29, Defs.’ Opp. at 10-11; Dkt. #31, PL’s Reply at 2].
