Desmarais v. Dow Corning Corp.

• Decision Date: 08 May 1989
• Docket Number: Civ. No. H-87-486 (PCD).
• Citation: 712 F. Supp. 13
• Parties: Louanna Wolff DESMARAIS v. DOW CORNING CORPORATION.
• Court: U.S. District Court — District of Connecticut

712 F. Supp. 13

Louanna Wolff DESMARAIS v. DOW CORNING CORPORATION.

Civ. No. H-87-486 (PCD).

United States District Court, D. Connecticut.

May 8, 1989.

Robert Shluger, Peck, Shluger, Coombes & O'Neil, Hartford, Conn., for plaintiff.

Robert B. Yules and Thomas H. Winslow, Yules & Yules, Hartford, Conn., for defendant.

RULING ON DEFENDANT'S MOTION FOR SUMMARY JUDGMENT

DORSEY, District Judge.

I. Background

On or about March 30, 1976, plaintiff underwent a bilateral augmentation mammoplasty in which two silicone Jel mammary implants manufactured by defendant were implanted in her breasts. Plaintiff suffered no problems with these implants until 1984, when she developed soreness in her left breast. On October 24, 1984, a lump of silicone was removed from that breast, having leaked from its envelope into the surrounding tissue. The entire left implant was then removed and replaced on November 21, 1984. Several months later, the right implant was also found to be leaking and it too was removed and replaced, on June 4, 1985.

Subsequently, plaintiff filed this diversity action seeking $350,000 in damages for defendant's alleged negligence, strict tort liability, failure to warn, and misrepresentation. Defendant has moved for summary judgment on all counts, claiming defenses of (1) federal preemption; (2) applicable statutes of limitation; and (3) the non-existence of a duty by medical device manufacturers to warn and/or instruct recipients of prescribed medical devices (the learned intermediary doctrine).

II. Discussion

A. Federal Preemption

Defendant argues that plaintiff's state law cause of action for failure to warn and/or instruct is preempted by the Federal Food, Drug and Cosmetic Act ("the Act"), 21 U.S.C. §§ 301-393, and the regulations promulgated thereunder. The Food and Drug Administration ("FDA") (part of the Department of Health and Human Services ("HHS"), the agency responsible for implementing the Act) regulates medical devices such as the breast implants at issue here.¹ Section 502 of the Act, 21 U.S.C. § 352, provides:

A drug or device shall be deemed to be misbranded—

... (f) Unless its labeling bears (1) adequate directions for use; and....

Provided, that where any requirement of clause (1) of this subsection, as applied to any drug or device, is not necessary for the protection of the public health, the Secretary of HHS shall promulgate regulations exempting such drug or device from such requirement.

"Adequate directions for use" has been defined as "directions under which the layman can use a device safely and for the purposes for which it is intended." 21 C.F. R. § 801.5. However, prescription medical devices are specifically exempted by the FDA from this labeling requirement when:

(a) The device is:

(1)(i) In the possession of a person, or his agents or employees, regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device; or

(ii) In the possession of a practitioner, such as physicians, ... licensed by law to use or order the use of such device; and

(2) Is to be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice.

(b) The label of the device, other than surgical instruments, bears:

(1) The statement "Caution: Federal law restricts this device to sale by or on the order of a _________", the blank to be filled with the word "physician", ..., or with the descriptive designation of any other practitioner licensed by the law of the State in which he practices to use or order the use of the device; and

(2) The method of its application or use.

21 C.F.R. § 801.109. This exemption became effective on February 13, 1976, just six weeks prior to the date plaintiff received her implants, and there is uncontroverted evidence in the record that the implants sold by defendant fully complied with the requirements of this exemption. Affidavit of Harvey L. Steinberg. Thus, the issue to be decided is whether or not these federal labeling requirements preempt state law.

The doctrine of preemption is grounded in the Supremacy Clause of the United States Constitution, Art. VI, cl. 2, which states that properly made laws of the United States "shall be the supreme Law of the Land." Federal preemption "encompasses both federal statutes themselves and federal regulations that are properly adopted." City of New York v. FCC, 486 U.S. 57, 108 S.Ct. 1637, 1642, 100 L.Ed.2d 48 (1988). The ordinary preemption inquiry requires an examination of congressional intent. Schneidewind v. ANR Pipeline Co., 485 U.S. 293, 108 S.Ct. 1145, 1150, 99 L.Ed.2d 316 (1988). Where Congress has not explicitly stated the extent of preemption intended, its implicit intent to occupy a given field to the exclusion of state law "may be inferred where the pervasiveness of the federal regulation precludes supplementation by the States, where the federal interest in the field is sufficiently dominant, or where `the object sought to be obtained by the federal law and the character of obligations imposed by it ... reveal the same purpose.'" Id., quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 67 S.Ct. 1146, 1152, 91 L.Ed. 1447 (1947).

Where federal regulatory agencies are involved, the Supreme Court has "recognized that `a federal agency acting within the scope of its congressionally delegated authority may pre-empt state regulation' and hence render unenforceable state or local laws that are otherwise not inconsistent with federal law." City of New York, 108 S.Ct. at 1642, quoting Louisiana Public Serv. Comm'n v. FCC, 476 U.S. 355, 369, 106 S.Ct. 1890, 1898, 90 L.Ed.2d 369 (1986).

We have emphasized that in a situation where state law is claimed to be preempted by federal regulation, a "narrow focus on Congress' intent to supersede state law is misdirected," for "a preemptive regulation's force does not depend on express congressional authorization to displace state law." Fidelity Federal Sav. & Loan Ass'n. v. De la Cuesta, 458 U.S. 141, 154 102 S.Ct. 3014, 3023, 73 L.Ed.2d 664 ... (1982). Instead, the correct focus is on the federal agency that seeks to displace state law and on the proper bounds of its lawful authority to undertake such action. The statutorily authorized regulations of an agency will pre-empt any state or local law that conflicts with such regulations or frustrates the purposes thereof. Beyond that, however, in proper circumstances the agency may determine that its authority is exclusive and pre-empts any state efforts to regulate in the forbidden area....

City of New York, 108 S.Ct. at 1642.

In the instant case, Congress did in fact create an express preemptive provision in the Act—two months after plaintiff received her implants.² The FDA has interpreted this provision to preempt "any state requirement with respect to a medical device intended for human use having the force and effect of law (whether established by statute, ordinance, regulation, or court decision)." 21 C.F.R. § 808.1 (emphasis added). Thus, there is no question that, after May 28, 1976, plaintiff's state-based cause of action for failure to warn would be preempted.³

Plaintiff argues, however, that the preemptive provisions of the Act cannot apply retroactively, so that on March 30, 1976, when plaintiff received her implants, the Act and its regulations had no preemptive effect. At least one court has found that the preemptive provisions of the Act do not apply retroactively. Tetuan v. A.H. Robins Co., 241 Kan. 441, 738 P.2d 1210 (1987). There is no relevant basis for retroactive application of the preemptive clauses. That does not end the inquiry, however. A determination must still be made as to whether or not the Act impliedly preempted plaintiff's failure to warn claim.

Absent express language to the contrary, there is ordinarily a presumption against preemption, Maryland v. Louisiana, 451 U.S. 725, 746, 101 S.Ct. 2114, 2128, 68 L.Ed.2d 576 (1981), especially regarding state or local matters related to health and safety. Hillsborough County v. Automated Med. Laboratories, Inc., 471 U.S. 707, 713, 105 S.Ct. 2371, 2375, 85 L.Ed. 2d 714 (1985). Review of the Act and the regulations promulgated thereunder reveals no intent to preempt state tort claims prior to enactment of § 360k(a). The regulations are not so pervasive, nor the federal interest sufficiently dominant, so as to preclude supplementation by the states. The primary purpose of the Act is to protect the public from unsafe products and "safeguard ... the public health by enforcement of certain standards of purity and effectiveness." United States v. Diapulse Corp. of America, 457 F.2d 25, 28 (2d Cir.1972). See also United States v. Bacto-Unidisk, 394 U.S. 784, 798, 89 S.Ct. 1410, 1418, 22 L.Ed.2d 726 (1969) ("The Act's overriding purpose is to protect the public health."). The medical device amendments were themselves "intended to assure that medical devices ... meet the requirements of safety and effectiveness before they are put in widespread use throughout the United States." S.Rep. No. 33, 94th Cong., 2d Sess. 2, reprinted in 1976 U.S.Code Cong. & Admin.News 1070, 1071. A state law requirement that warnings additional to those mandated under the Act be provided would not conflict with, or frustrate the purposes of, the Act or its regulations. Such a requirement would merely further the goal of protecting the public health. The fact that different states might impose different substantive standards does not change this conclusion, since the Act is not concerned with promoting uniform national standards (other than minimum standards); the sole purpose of the Act is to protect and preserve the public health. Thus, prior to Congress' and the FDA's express pronouncements of federal preemption, a state-based caused of action for failure to warn would not be preempted.⁴

B. Statutes of Limitation

Defendant contends that plaintiff's...