In re Sabin Oral Polio Vaccine Products L. Lit.

• Decision Date: 20 September 1991
• Docket Number: No. MDL 780.,MDL 780.
• Citation: 774 F. Supp. 952
• Parties: In re SABIN ORAL POLIO VACCINE PRODUCTS LIABILITY LITIGATION.
• Court: U.S. District Court — District of Maryland

774 F. Supp. 952

In re SABIN ORAL POLIO VACCINE PRODUCTS LIABILITY LITIGATION.

No. MDL 780.

United States District Court, D. Maryland.

September 20, 1991.

Marc Moller, Kreindler & Kreindler, New York City, and Stanley Kops, Adler & Kops, Philadelphia, Pa., for plaintiffs.

Rupert Mitsch and Julie Zatz, Torts Branch, Civ. Div., U.S. Dept. of Justice, Washington, D.C., for defendants.

OPINION

MOTZ, District Judge.

This is the third in a series of opinions in this multidistrict litigation.¹ On July 12, 1990, I issued an opinion ruling upon summary judgment motions relating to the Government's "discretionary function" defense. In re Sabin Oral Polio Vaccine Products Liability Litigation, 743 F.Supp. 410 (D.Md.1990). On April 18, 1991, after a fifteen-day trial, I issued a second opinion finding that the Division of Biologic Standards ("DBS") violated the oral polio vaccine ("OPV") regulations in certain respects and that the United States would be liable under the Federal Tort Claims Act if the individual plaintiffs were able to meet their burden of proof on any issues of causation particular to them. In re Sabin Oral Polio Vaccine Products Liability Litigation, 763 F.Supp. 811 (D.Md.1991). This opinion addresses the causation issues in two of the cases, Miller v. United States and Musgrove v. United States.² It also decides the questions of whether the United States owed any duty of care to the plaintiffs and, if so, whether it breached that duty.³ The parties have stipulated to the amount of damages suffered by plaintiffs, and resolution of these remaining issues therefore makes Miller and Musgrove ripe for appeal.

I.

The first determination which must be made concerns the choice of law. 28 U.S.C. § 1346(b) confers exclusive jurisdiction in the federal courts over:

claims against the United States, for money damages ... under circumstances where the United States, if a private person, would be liable to the claimant in accordance with the law of the place where the act or omission occurred.

In Richards v. United States, 369 U.S. 1, 11, 82 S.Ct. 585, 592, 7 L.Ed.2d 492 (1962), the Supreme Court held that this provision "requires application of the whole law of the State where the act or omission occurred." Here, DBS's relevant acts and omissions occurred in Maryland.⁴ Thus, the whole law of Maryland governs Miller and Musgrove.

Maryland follows the lex loci delicti choice of law rule in tort cases. Hauch v. Connor, 295 Md. 120, 453 A.2d 1207 (1983). This rule "requires a tort action to be governed by the substantive law of the state where the wrong occurred." Id. at 123, 453 A.2d at 1209. "The place of injury is the place where the injury was suffered, not where the wrongful act took place." Johnson v. Oroweat Foods, Inc., 785 F.2d 503, 511 (4th Cir.1986) (Maryland law). Here, Mr. Miller contracted polio in Maryland, Mr. Musgrove in Florida. Thus, Maryland law applies to Miller and Florida law to Musgrove.

II.

The elements of negligence are axiomatic in Maryland: "a plaintiff must prove the existence of four elements: a duty owed to him (or to a class of which he is a part), a breach of that duty, a legally cognizable causal relationship between the breach of duty and the harm suffered, and damages." Jacques v. First Nat'l Bank, 307 Md. 527, 531, 515 A.2d 756, 758 (1986). The law of Florida is the same. See, e.g., Peeler v. Independent Life & Accident Ins. Co., 206 So.2d 34, 36 (Fla.Dist.Ct.App. 1967). Here, it is, of course, undisputed that the plaintiffs have suffered substantial damages, and, as indicated above, the parties have stipulated to the amount of those damages. Thus, only the questions of the existence of a duty, the breach of that duty and proximate cause remain.

A. Existence of Duty

As a threshold matter, it should be noted that the federal OPV regulations, standing by themselves, do not give rise to any legal duty under the FTCA. See, e.g., Baker v. United States, 817 F.2d 560, 566 n. 6 (9th Cir.1987), cert. denied, 487 U.S. 1204, 108 S.Ct. 2845, 101 L.Ed.2d 882 (1988); Art Metal-U.S.A. v. United States, 753 F.2d 1151, 1157-58 (D.C.Cir.1985); Schindler v. United States, 661 F.2d 552, 560 (6th Cir.1981). The OPV regulations create an FTCA duty only to the extent that they can be analogized to the applicable state tort law governing the conduct of private persons. Art Metal-U.S.A., 753 F.2d at 1158.

Plaintiffs contend that DBS's obligation under the regulations is analogous to the duty owed by private persons under the Good Samaritan doctrine. The Restatement (Second) of Torts § 324A (1965), defines that doctrine as follows:

One who undertakes, gratuitously or for consideration, to render services to another which he should recognize as necessary for the protection of a third person or his things, is subject to liability to the third person for physical harm resulting from his failure to exercise reasonable care to perform his undertaking, if

(a) his failure to exercise such care increases the risk of such harm, or

(b) he has undertaken to perform a duty owed by the other to the third person, or

(c) the harm is suffered because of reliance of the other or the third person upon the undertaking.⁵

It is undisputed that the doctrine is part of the tort law both of Maryland and Florida. See Brady v. Ralph M. Parsons Co., 82 Md.App. 519, 534, 572 A.2d 1115, 1123 (1990); Krieger v. J.E. Greiner Co., Inc., 282 Md. 50, 72, 382 A.2d 1069, 1081 (1978) (Levine, J., concurring);⁶State Dep't of Highway Safety & Motor Vehicles v. Kropff, 491 So.2d 1252, 1255 (Fla.Dist.Ct. App.1986); Barfield ex rel. Barfield v. Langley, 432 So.2d 748, 749 (Fla.Dist.Ct. App.1983).

Other federal courts have indicated that the Good Samaritan doctrine is applicable in FTCA cases such as this one. As the D.C. Circuit has stated, "FTCA claims involving inspection and certification activity commonly rely ... on the good samaritan doctrine." Art Metal-U.S.A., 753 F.2d at 1159 n. 13. More specifically, in Loge v. United States, 662 F.2d 1268, 1273-74 (8th Cir.1981), cert. denied, 456 U.S. 944, 102 S.Ct. 2009, 72 L.Ed.2d 466 (1982), the court found that a viable claim based upon the Good Samaritan doctrine could be stated against the United States for the FDA's release of OPV in violation of the governing regulations. See also Schindler, 661 F.2d at 561-62; cf. Griffin v. United States, 351 F.Supp. 10, 34 (E.D.Pa.1972), aff'd in relevant part, 500 F.2d 1059, 1069-70 (3d Cir.1974) (holding the United States liable under Restatement § 281(b) for having created a "recognizable risk of harm" by the improper release of OPV).

Brady v. Ralph M. Parsons Co., 82 Md. App. 519, 572 A.2d 1115 (1990) is also instructive. There, the Maryland Mass Transit Administration contracted with the Parsons Company to ensure safety at a subway construction site in Baltimore. Parsons was supposed to ensure compliance with all occupational safety regulations. Id. at 525, 572 A.2d at 1119. It was empowered to inspect the project and, if necessary, order a work stoppage to ameliorate unsafe conditions. Id. at 526, 572 A.2d at 1119. A worker at the site was injured. The Maryland Court of Special Appeals held that Parsons was potentially subject to liability to the worker's survivors under Restatement § 324A because it rendered services for his protection. Id. at 534, 572 A.2d at 1123.

DBS stands in a position substantially similar to that which was occupied by Parsons. It undertook to regulate a potentially hazardous condition for the benefit of others. Although it was not paid for its services, under § 324A that fact is not material. Therefore, assuming DBS breached its duty to exercise due care (the issue next to be addressed), the United States is liable if the failure to exercise such care increased the risk of harm to the plaintiffs or if the plaintiffs relied upon DBS's undertaking to regulate the release of OPV. As to the latter, it is self-evident that plaintiffs, as the parents of OPV recipients, relied upon DBS officials to comply with the law in approving OPV for use and distribution. Likewise, although there is no necessary or definitive correlation between the results of monkey neurovirulence tests and a vaccine's neurovirulence when administered to humans, monkey neurovirulence testing provides as precise a measure for determining neurovirulence in humans as can reasonably be devised. The law can do no more than adopt the best available scientific standard, and therefore it must be concluded that by releasing vaccine lots whose monkey neurovirulence test results exceeded the regulatory criteria, DBS increased the risk of harm to persons who were vaccinated and to those, like Messrs. Miller and Musgrove, who were exposed to the shed virus.

B. Breach of Duty of Care

The Government secondarily argues that assuming that DBS was under a duty to plaintiffs, it did not breach that duty. In support of this argument the Government relies upon the findings which I made in my earlier opinion that "DBS officials made judgments on extremely difficult questions which, strictly from the standpoint of public health, appeared to have been entirely proper," 763 F.Supp. 811, 813 (D.Md.1991); that "the OPV used in the United States has always been `state of the art' vaccine," id.; and that vaccine derived from seed 45 B 165 (such as that involved in the Musgrove case) was "the safest and most efficacious manufactured," id. at 821.

The answer to the Government's contention in the Musgrove case — which is governed by Florida law — is clear. In deJesus v. Seaboard Coastline R.R. Co., 281 So.2d 198, 201 (1973), the Florida Supreme Court held that where (1) a statute establishes "a duty to take precautions to protect a particular class of persons from a particular injury or type of injury," (2) the plaintiff falls within the class intended to be protected by the statute, and (3) the plaintiff "suffered injury of the type the statute was designed to...