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No state court has addressed whether there are FDCA-related private rights of action under Connecticut law.

In Connecticut, there can be no private right of action for breach of a duty established by statute without express statutory authorization. E.g. Middleton v. Hartford Electric Light Co., 192 Conn. 591, 596, 473 A.2d 787 (1984). The Supreme Court of Connecticut has concluded that “a statute which creates a liability where formerly none existed should receive a strict construction and is not to be extended, modified . . . or enlarged in its scope by the mechanics of construction.” Nowak v. Nowak, 175 Conn. 112, 394 A.2d 716 (1978). The trial court in Parker v. Nelson, 1997 WL 345617 (Conn.Super. 1997), acknowledging Nowak, granted the defendant’s motion to strike the plaintiff’s statutory claim because the absence of explicit statutory language creating a private right of action was fatal to the claim. Nevertheless, despite the unavailability of a private right of action under the statute, the Parker court allowed a claim of negligence per se because the plaintiff alleged a violation of the statute and pleaded facts sufficient to allege a causal link between the statutory violation and the alleged injury. Id.

Connecticut recognizes negligence per se as an independent cause of action that may be pleaded separately from common law negligence. See Commercial Union Ins. Co. v. Frank Perrotti & Sons, Inc., 20 Conn.App. 253, 258, 566 A.2d 431 (1989), citing Wu v. Fairfield, 204 Conn. 435, 438, 528 A.2d 364 (1987). However, no court has discussed whether negligence per se applies to claims of FDCA violations.

Legislative intent is important to whether a civil claim pursuant to a negligence per se theory is available under Connecticut law, since state courts consider whether the legislature, in adopting a statute, “anticipated the plaintiff to be a member of [a] protected class and intended to prevent the harm that resulted.” Gore v. People’s Savings Bank, 235 Conn. 360, 368-9, 665 A.2d 1341 (1995); accord Commercial Union Ins. Co. v. Frank Perrotti & Sons, Inc. at 20 Conn.App. 258, 566 A.2d 431 (adding the condition of establishing a causal connection between such negligence and the injuries sustained).

Negligence per se claims have been permitted by the courts only where a statute provides no civil remedy for a statutory violation, because there is no “point of establishing a negligence per se rule to allow a civil action in negligence when a civil action is already provided for in the statute[.]” Hartt v. Schwartz 1996 WL 434452, at 8 (Conn.Super. 1996).

Gore v. People’s Savings Bank at 235 Conn. 376, 665 A.2d 1341 (1995); see also Wendland v. Ridgefield Construction Services, Inc., 184 Conn. 173, 181, 439 A.2d 954 (1981)(“our holding that regulations . . . furnish a basis for a jury instruction on negligence per se does not preclude the admission of these regulations, if applicable, as evidence of the standard of care”). However, in a later case involving environmental regulations, a trial court was reluctant to permit a negligence per se claim for the violation of administrative regulations, reasoning that “the specific regulations are imposed not by the popularly elected legislature but by state agencies not open to as much public scrutiny or public debate over their actions.” Connecticut Water Company v. Town of Thomaston, 1996 WL 168051, at 4 (Conn.Super. 1996)(emphasis added).

A plaintiff’s state law tort claim is preempted only if “(1) the FDA has established regulations specific to the medical device at issue in the particular case; (2) the state law claim constitutes a requirement different from, or in addition to, any requirement the FDA has made applicable to the device at issue; and (3), the claim relates to either the safety or effectiveness of the device or to any other matter included in a requirement made applicable to the device by the [Medical Device Amendment of 1976 to the FDA].” Lamontage v. E.I. Du Pont De Nemours & Co., 834 F.Supp. 576, 583 (D. Conn. 1993); see also Desmarais v. Dow Corning Corp., 712 F.Supp. 13, 16, n4 (D. Conn. 1989)(“[t]here is no indication that the preemptive provision was intended to codify preexisting law; rather, it appears to be intended to alter the scope and operation of the Act”).

Evidence of FDA approval is admissible in product liability cases as relevant to whether medical product manufacturers have a duty to warn physicians. See LaMontagne v. E.I. Du Pont at 834 F.Supp. 593-4 (D. Conn. 1993); cf. Vitanza v. The UpJohn Co., 2000 U.S. App. LEXIS 8928, at 17-8 (2d Cir. 2000)(the appellate court certified to the Connecticut Supreme Court the question of the status of the learned intermediary doctrine in Connecticut).

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