In re Tetracycline Cases, 83-0034-CV-W-O-A

• Decision Date: 29 March 1989
• Docket Number: 85-1577-CV-W-1,85-1294-CV-W-1,84-1062-CV-M-1 and 83-0393-CV-W-1.,85-1288-CV-W-1,85-1290-CV-W-1,85-1291-CV-W-1,No. 83-0034-CV-W-O-A,83-0801-CV-W-1,83-0394-CV-W-1,83-0432-CV-W-1,85-1296-CV-W-1,83-0034-CV-W-O-A
• Citation: 747 F. Supp. 543
• Court: U.S. District Court — Western District of Missouri
• Parties: In re TETRACYCLINE CASES. Janet Sue CAMBIANO, Plaintiff, v. AMERICAN CYANAMID COMPANY, et al., Defendants. Alicia GORDON, Plaintiff, v. E.R. SQUIBB & SONS, INC., et al., Defendants. Diane M. KLEMME, Plaintiff, v. AMERICAN CYANAMID COMPANY, et al., Defendants. Michael LUNDY, Plaintiff, v. AMERICAN CYANAMID COMPANY, et al., Defendants. Cynthia Sherer MILLER, Plaintiff, v. AMERICAN CYANAMID COMPANY, et al., Defendants. Gregory RUSHER, Plaintiff, v. AMERICAN CYANAMID COMPANY, et al., Defendants. Rebecca RUSHER, Plaintiff, v. AMERICAN CYANAMID COMPANY, et al., Defendants. Ellen SCHULTHEIS, Plaintiff, v. AMERICAN CYANAMID COMPANY, et al., Defendants. Shay Lynn SCHWARTZ, et al., Plaintiffs, v. AMERICAN CYANAMID COMPANY, et al., Defendants. Mark WARMINGTON, Plaintiff, v. AMERICAN CYANAMID COMPANY, et al., Defendants. Elizabeth D. WILLIAMS, Plaintiff, v. AMERICAN CYANAMID COMPANY, et al., Defendants.

747 F. Supp. 543

In re TETRACYCLINE CASES.

Janet Sue CAMBIANO, Plaintiff, v. AMERICAN CYANAMID COMPANY, et al., Defendants.

Alicia GORDON, Plaintiff, v. E.R. SQUIBB & SONS, INC., et al., Defendants.

Diane M. KLEMME, Plaintiff, v. AMERICAN CYANAMID COMPANY, et al., Defendants.

Michael LUNDY, Plaintiff, v. AMERICAN CYANAMID COMPANY, et al., Defendants.

Cynthia Sherer MILLER, Plaintiff, v. AMERICAN CYANAMID COMPANY, et al., Defendants.

Gregory RUSHER, Plaintiff, v. AMERICAN CYANAMID COMPANY, et al., Defendants.

Rebecca RUSHER, Plaintiff, v. AMERICAN CYANAMID COMPANY, et al., Defendants.

Ellen SCHULTHEIS, Plaintiff, v. AMERICAN CYANAMID COMPANY, et al., Defendants.

Shay Lynn SCHWARTZ, et al., Plaintiffs, v. AMERICAN CYANAMID COMPANY, et al., Defendants.

Mark WARMINGTON, Plaintiff, v. AMERICAN CYANAMID COMPANY, et al., Defendants.

Elizabeth D. WILLIAMS, Plaintiff, v. AMERICAN CYANAMID COMPANY, et al., Defendants.

Nos. 83-0034-CV-W-O-A, 83-0394-CV-W-1, 85-1577-CV-W-1, 85-1294-CV-W-1, 85-1288-CV-W-1, 83-0432-CV-W-1, 85-1290-CV-W-1, 85-1291-CV-W-1, 85-1296-CV-W-1, 83-0801-CV-W-1, 84-1062-CV-M-1 and 83-0393-CV-W-1.

United States District Court, W.D. Missouri.

March 29, 1989.

Baker & Sterchi, C. Philip Rouse, Kansas City, Mo., for defendants.

Stoup & Thompson, Devin House, Kansas City, Mo., for plaintiffs.

ORDER

WHIPPLE, District Judge.

On July 15, 1988, defendants in these actions filed a joint motion for summary judgment on the grounds that federal statutes and regulation preempted state law which would permit plaintiffs to bring claims against these defendants. All but three of the plaintiffs filed a joint response in opposition to the motion on July 29, 1988. Defendants filed a joint reply brief on September 9, 1988, in support of their motion. By a letter dated November 4, 1988, defendants alerted this court to a ruling in a case which had been on appeal when the briefs were prepared. Plaintiffs responded by letter dated November 22, 1988. For the reasons set forth below, the motion will be denied.

Also on July 15, 1988, defendants in these actions filed a joint motion for summary judgment on the claims for punitive damages in these civil actions. Plaintiffs filed their response in opposition to the motion on July 29, 1988. Defendants filed a reply brief on August 5, 1988, in support of the motion. For the reasons set forth below, the motion for summary judgment on the claims for punitive damages will be granted.

I. PREEMPTION

A. Standard of Review

The principal judicial inquiry required by Rule 56, Fed.R.Civ.P., is whether there exists any genuine issue of material fact for resolution. See, Vette Co. v. Casualty & Surety Co., 612 F.2d 1076, 1077 (8th Cir. 1980); Moats v. United States, 564 F.Supp. 1330, 1344 (W.D.Mo.1983). The party opposing the motion must receive the benefit of all reasonable inferences to be drawn from the facts. Fitzgerald v. Williamson, 601 F.Supp. 92, 94 (E.D.Mo.1984), aff'd, 787 F.2d 403 (8th Cir.1986). Summary judgment should be entered only if the movant has established a right to judgment with such clarity as to leave no room for controversy, and the other party is not entitled to recover under any discernible circumstances. See, Poolman v. Nelson, 802 F.2d 304, 307 (8th Cir.1986); Mandel v. United States, 719 F.2d 963, 965 (8th Cir. 1983).

With this standard in mind, this court turns to the issues raised by defendants' motion for summary judgment. This court is aware that similar issues were raised by defendant the Upjohn Company in a virtually identical case, Cynthia K. Hoover, Jill McKinney, et al. v. The Upjohn Company, et al., Civil Action No. 87-0420-CV-W-9. After a thorough discussion, Magistrate Richard H. Ralston denied summary judgment in his order dated February 22, 1988.

B. Statement of the Case

The plaintiffs in these actions allegedly ingested antibiotic drug products known generically as tetracyclines at some time after the defendant manufacturers were required to disseminate a warning about the products. Beginning in 1963, manufacturers were required to inform that use of tetracyclines during tooth development (last trimester of pregnancy, neonatal period, and early childhood) could cause tooth discoloration.

Defendants submitted voluminous evidence supporting their statement that the warning requirement was imposed after extensive expert study by the Food and Drug Administration (FDA) and communication between FDA and the manufacturers. Ultimately a warning statement was devised by FDA, which required manufacturers to issue that statement without deviation in the product packages.

Plaintiffs claim they developed tooth discoloration after ingesting the products despite the warning. They seek actual and punitive damages on claims of negligence, strict liability and failure to provide adequate warning.

Defendants pose several arguments supporting their assertion that plaintiffs' claims are precluded by federal preemption. Acknowledging there is no express preemption, defendants urge that the extent of federal regulation impliedly preempts any state laws, including tort litigation, which concern tetracycline products. Defendants argue that the pervasive regulation by a fully informed agency effectively shows an intent to occupy the field completely, and to preclude any action (other than federal government action) which might be inconsistent or have an inconsistent effect. For example, defendants argue that the manufacturers could not be required by any state to use a warning that was different or broader than the specifically prescribed warning statement which the FDA required to be used without change. The regulations include strict requirements about labeling, and certifying each batch of products which is manufactured.

Defendants argue that manufacturers could not comply with both federal regulation and conflicting state regulation or tort law. To permit individual states' laws to interfere with the federal regulation, defendants argue, would destroy the nationwide and industrywide uniformity which federal regulation was invoked to promote. Conflicting state laws would frustrate the FDA's ability to make decisions, and leave manufacturers trying to conform to the inconsistent findings of each state or jury, defendants argue.

Plaintiffs respond that, if Congress intended to preempt all non-federal regulation, it could say so expressly—as it has done in other instances. They assert that even pervasive regulation does not require preemption, particularly in the area of a state's police powers over health, safety and welfare which historically have been reserved to local governments. Plaintiffs argue that federal regulations set minimum standards which may be below more rigid supplementary requirements of a state. States may regulate further, plaintiffs argue, if they do not conflict directly with federal regulations. Plaintiffs claim that the defendants are urging a sort of immunity from liability for drug manufacturers. Finally, plaintiffs suggest this litigation does not impede the federal regulatory policy but, rather, promotes the policy by showing manufacturers whether they should expand their warnings.

C. Discussion

The doctrine of preemption arises from the Supremacy Clause in Article VI of the United States Constitution:

This Constitution, and the Laws of the United States which shall be made in Pursuance thereof, and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land; and the Judges in every state shall be bound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.

The Supreme Court has interpreted this clause to authorize Congress to enact laws under its enumerated powers that preempt state laws governing the same subject. Gibbons v. Ogden, 22 U.S. (9 Wheat.) 1, 211, 6 L.Ed. 23 (1824). State law can be preempted by federal regulations as well as by federal statutes. See, Hillsborough County, Fla. v. Automated Medical Laboratories, Inc., 471 U.S. 707, 713, 105 S.Ct. 2371, 2375, 85 L.Ed.2d 714 (1985). If Congress evidences an intent to occupy a given field, any state law falling within that field is preempted. Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 104 S.Ct. 615, 78 L.Ed.2d 443 (1984).

State law preemption may be found in different ways. Congressional intent to preempt may be set forth expressly. Jones v. Rath Packing Co., 430 U.S. 519, 525, 97 S.Ct. 1305, 1309, 51 L.Ed.2d 604, reh'g denied, 431 U.S. 925, 97 S.Ct. 2201, 53 L.Ed.2d 240 (1977). The intent may be implied where a scheme of regulation is so comprehensive in an area as to leave no room for supplemental state legislation. International Paper Co. v. Ouellette, 479 U.S. 481, 491, 107 S.Ct. 805, 811, 93 L.Ed.2d 883 (1987); Hillsborough, supra, 471 U.S. at 713, 105 S.Ct. at 2375; Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 67 S.Ct. 1146, 1152, 91 L.Ed. 1447 (1947). Alternately, if Congress has not completely displaced state law in a field, state law is preempted only to the extent it actually conflicts with federal law. Silkwood, supra, 464 U.S. at 248, 104 S.Ct. at 621. Conflict arises when "compliance with both federal and state regulations is a physical impossibility," Florida Lime & Avocado Growers, Inc., v. Paul, 373 U.S. 132, 142-143, 83 S.Ct. 1210, 1217, 10 L.Ed.2d 248 (1963), or when state law "stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress," Hines v. Davidowitz, 312 U.S. 52, 67, 61 S.Ct. 399, 404, 85 L.Ed. 581 (1941).

A good example of a direct conflict between federal and state regulation can be found in Cosmetic, Toiletry & Fragrance Ass'n Inc. v. Minnesota, 575 F.2d 1256, 1257 (8th Cir.1978) (per curiam). In that case, a Minnesota statute and the FDA required an identical warning in the labeling of pressurized containers with certain chlorofluorocarbon propellants. However, the Minnesota sta...