Comeau v. Heller, Civil A. No. 96-40021NMG.

Decision Date06 November 1996
Docket NumberCivil A. No. 96-40021NMG.
Citation945 F.Supp. 7
PartiesHazel COMEAU and Homer Comeau, Plaintiff, v. Louis HELLER, M.D., Commonwealth of Massachusetts By and Through Its Agent University of Massachusetts Medical Center, D.A.N. Mascarenhas, M.D., and SciMed Inc., Defendants.
CourtU.S. District Court — District of Massachusetts

Robert H. Bowen, Bowen & Bowen, Lunenburg, MA, for Hazel Comeau, Homer Comeau.

Raymond J. Kenney, Gail L. Anderson, Martin, Magnuson, McCarthy & Kenney, Boston, MA, for Louis Heller, M.D., Commonwealth of Massachusetts.

Robert V. Deiana, Mirick, O'Connell, DeMallie & Lougee, Worcester, MA, for D.A.N. Mascarenhas, M.D.

David F. Hassett, Healy & Rocheleau, Worcester, MA, for SciMed Inc.

MEMORANDUM AND ORDER

GORTON, District Judge.

On September 30, 1993, the plaintiffs in the above-entitled action, Hazel and Homer Comeau, filed their complaint in this tort action against Louis Heller M.D. ("Dr. Heller") in Worcester County Superior Court. The Commonwealth of Massachusetts ("the Commonwealth"), D.A.N. Mascarenhas ("Dr. Mascarenhas") and SciMed Inc. ("SciMed") were added as additional party defendants in August 1994, January, 1995 and October, 1995, respectively.

The plaintiffs allege that the defendants, Dr. Heller, Dr. Mascarenhas and the Commonwealth, were negligent in their medical care and treatment of Hazel Comeau at or about the time she underwent coronary angioplasty at the University of Massachusetts Medical Center. The claims asserted against SciMed are for product liability arising out of its manufacture and sale of a medical catheter used in connection with Mrs. Comeau's coronary angioplasty surgery. The plaintiffs seek to recover from SciMed on theories of negligence, breach of warranty, failure to warn and instruct, violations of M.G.L. c. 93A and for loss of consortium.

In January, 1996, SciMed removed the state court action to this Court based upon the preemption provisions of the Medical Devices Amendments of 1976 to the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360 et seq. ("the MDA"). SciMed premised removal upon the "complete preemption" doctrine which it contends provides this court with federal question jurisdiction because the SciMed catheter is a medical device subject to regulation under the MDA. The plaintiffs filed a motion to remand this action back to the state court. That motion was denied on February 27, 1996, based upon the holdings in Talbott v. C.R. Bard, Inc., 63 F.3d 25 (1st Cir.1995) and Fisher v. C.R. Bard, Inc., 1996 WL 33818 (D.Mass.1996).

Since this Court ruled on plaintiffs' motion to remand, the United States Supreme Court has rendered its decision in Medtronic, Inc. v. Lohr, ___ U.S. ___, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). That decision addresses the issue of "complete preemption" upon which this Court's subject matter jurisdiction in this action is based. Defendants Dr. Heller and the Commonwealth, have, consequently, moved to remand this case to the Worcester County Superior Court asserting that, after Medtronic, the "complete preemption" doctrine no longer affords this Court subject matter jurisdiction over these state law claims.

I. Factual Background

In or about October, 1992, Mrs. Comeau was hospitalized at Burbank Hospital with a question of myocardial infarction. She was referred to the University of Massachusetts Medical Center for cardiac catheterization.

On or about October 16, 1992, a cardiac catheterization was performed by or at the direction of Dr. Peter Wilson. Three days later, the first of two coronary angioplasties was performed on Mrs. Comeau. Dr. Heller and Dr. Mascarenhas participated in that procedure sometime after which the plaintiff began to experience chest pains. An angiography disclosed a filling defect initially suspected to be a clot.

On or about October 23, 1992, Mrs. Comeau underwent a second angioplasty procedure. Again, Dr. Heller and Dr. Mascarenhas participated in the process and during the procedure Mrs. Comeau went into cardiac arrest necessitating both defibrillation and intubation. The plaintiff contends that she also suffered a stroke at that time.

Following the second angioplasty, Mrs. Comeau underwent bypass surgery immediately. During the surgery, Dr. Vander Salm, who performed the operation, discovered the obstruction in the filling defect was not a clot as originally suspected, but rather the plastic protective sheath from the angioplasty catheter allegedly left from the angioplasty performed a week earlier.

II. Analysis
A. Removal Jurisdiction

Scimed contends that this Court's exercise of removal jurisdiction is authorized by the fact that the catheter involved in this case is a "Class III" medical device subject to the regulatory scheme established by the MDA.

1. The Well-Pleaded Complaint Rule

Defendants, Dr. Heller and the Commonwealth, consistent with the Plaintiff's original motion to remand, maintain that a straightforward application of the "well-pleaded complaint" rule leads ineluctably to the conclusion that this Court lacks removal jurisdiction over the lawsuit. As a general rule, only state actions that originally could have been filed in federal court may be removed to federal court by a defendant. Caterpillar Inc. v. Williams, 482 U.S. 386, 392, 107 S.Ct. 2425, 2429-30, 96 L.Ed.2d 318 (1987). Moreover, removal premised upon federal question jurisdiction generally is available only "when a federal complaint is presented on the face of the plaintiff's properly pleaded complaint." Id. The well-pleaded complaint rule thus ordinarily prohibits removal based upon a federal defense, even when the defense is preemption. See Metropolitan Life Insurance Co. v. Taylor, 481 U.S. 58, 63, 107 S.Ct. 1542, 1546, 95 L.Ed.2d 55 (1987); Fisher v. C.R. Bard, Inc., 1996 WL 33818, at *2 (D.Mass., Jan. 3, 1996). Defendants, Dr. Heller and the Commonwealth, contend that SciMed's federal defense cannot therefore serve as the basis for removal jurisdiction.

2. The Complete Preemption Doctrine

The Supreme Court has determined that an "independent corollary" of the well-pleaded complaint rule exists: "if a federal cause of action completely pre-empts a state cause of action, [in which case] any complaint that comes within the scope of the federal cause of action necessarily `arises under' federal law." Franchise Tax Bd. of Calif. v. Construction Laborers Vacation Trust, 463 U.S. 1, 22-24, 103 S.Ct. 2841, 2854, 77 L.Ed.2d 420 (1983). Under the so-called "complete preemption" doctrine, therefore, a defendant may, in certain limited instances, remove a case to federal court even if no federal claims are presented on the face of the complaint. Fisher, 1996 WL 33818, at *2.

3. Application of the Relevant Law Pre-Medtronic

Defendants Dr. Heller and the Commonwealth acknowledge the existence of the "complete preemption" corollary to the well-pleaded complaint rule. They maintain, however, as did the plaintiffs in their original motion to remand, that the complete preemption doctrine is not applicable in the context of the MDA, citing this court to the recently-decided Supreme Court decision in Medtronic, Inc. v. Lohr. Upon careful consideration of that opinion, this Court concludes that, the First Circuit's previous determination of the MDA's preemptive scope has been seriously curtailed.

The MDA includes the following preemption provision:

[N]o 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).

In Talbott v. C.R. Bard, Inc., 63 F.3d 25 (1st Cir.1995), the First Circuit held that the preemptive effect of the above-quoted clause is broad, observing that:

To avoid the possibility of disuniform treatment, Congress placed enforcement authority in the FDA.... Centrally situated and with the requisite expertise, the FDA is in the best position to determine whether the provisions of the MDA have in fact been violated and to ensure that the law is applied in a uniform manner. (citation omitted). Given the FDA's central enforcement role, the preemptive scope of § 360k(a) becomes clear ... the express preemption provided by [that section] manifests a decision by Congress to replace completely the private rights of action usually available under state law with civil and criminal enforcement of the federal government when thoroughly regulated devices ... are at issue.

Talbott, 63 F.3d at 29-30 (internal quotation omitted; emphasis added).

In January 1996, Judge Wolf issued memoranda and orders in three related cases, Fisher v. C.R. Bard, Inc., 1996 WL 33818 (D.Mass., January 3, 1996), Shumaker v. C.R. Bard, Inc., 1996 WL 33828 (D.Mass., January 3, 1996), and Turpin v. C.R. Bard, Inc., 1996 WL 33830 (D.Mass.1996). Each of those cases involved suits in which plaintiffs alleged various state law causes of action against the defendant catheter manufacturer. Relying on Talbott, Judge Wolf determined that the "complete preemption" doctrine applied to the plaintiffs' state law claims. Accordingly, the defendant in those cases "had a right to remove [the] inherently federal case[s] to a federal forum." Fisher, 1996 WL 33818 at *2.1 Consistent with the clear prescription of the First Circuit in Talbott therefore, this Court denied plaintiff's original motion to remand on May 5, 1996.

B. The Medtronic Decision

The plaintiff in Medtronic, Inc. v. Lohr, ___ U.S. ___, 116 S.Ct. 2240, 135 L.Ed.2d 700, was the recipient of a pacemaker which is a Class III medical device approved for marketing under the MDA as a device "substantially similar" to devices already on the market. The question presented in Medtronic was whether...

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