Scirex Corp v. Fed Ins Co

CourtCourt of Appeals for the Third Circuit
DecidedDecember 23, 2002
Docket02-1172
StatusPublished

This text of Scirex Corp v. Fed Ins Co (Scirex Corp v. Fed Ins Co) is published on Counsel Stack Legal Research, covering Court of Appeals for the Third Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Scirex Corp v. Fed Ins Co, (3d Cir. 2002).

Opinion

Opinions of the United 2002 Decisions States Court of Appeals for the Third Circuit

12-23-2002

Scirex Corp v. Fed Ins Co Precedential or Non-Precedential: Precedential

Docket No. 02-1172

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Recommended Citation "Scirex Corp v. Fed Ins Co" (2002). 2002 Decisions. Paper 803. http://digitalcommons.law.villanova.edu/thirdcircuit_2002/803

This decision is brought to you for free and open access by the Opinions of the United States Court of Appeals for the Third Circuit at Villanova University School of Law Digital Repository. It has been accepted for inclusion in 2002 Decisions by an authorized administrator of Villanova University School of Law Digital Repository. For more information, please contact Benjamin.Carlson@law.villanova.edu. PRECEDENTIAL

Filed December 23, 2002

UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT

No. 02-1172

SCIREX CORPORATION,

Appellant

v.

FEDERAL INSURANCE COMPANY

On Appeal From the United States District Court For the Eastern District of Pennsylvania (D.C. Civil Action No. 00-cv-1129) District Judge: Honorable John P. Fullam

Argued: October 15, 2002

Before: BECKER, Chief Judge, ROTH and ROSENN, Circuit Judges.

(Filed December 23, 2002)

JOSEPH F. RODA (ARGUED) Roda & Nast 801 Estelle Drive Lancaster, PA 17601

Counsel for Appellant

ALFRED W. PUTNAM, JR. (ARGUED) Drinker, Biddle & Reath 18th & Cherry Streets One Logan Square Philadelphia, PA 19103

Counsel for Appellee

OPINION OF THE COURT

BECKER, Chief Judge.

Plaintiff Scirex Corp. ("Scirex"), a firm specializing in clinical testing of new drugs for pharmaceutical companies, brought this suit against defendant Federal Insurance Company ("Federal") in the District Court for the Eastern District of Pennsylvania, seeking payment under Federal’s "Blanket Employee Dishonesty" policy, which covered losses caused by Scirex employees’ fraudulent and dishonest acts. Although the protocols for the four clinical trials at issue required Scirex’s nurses to observe patients for eight hours and record their observations every thirty minutes, in many cases the nurses sent patients home after as little as an hour, yet they recorded and submitted observations allegedly covering the full eight hours. Their misrepresentations made it impossible for supervisors to discover the breaches of protocol until a former employee tipped them to the practice, at which advanced point the four studies were unfit for Food and Drug Administration review, and therefore were worthless.

Scirex replicated the studies, which cost a combined $1.2 million, at no charge to the sponsors. Federal, however, refused to cover Scirex’s losses. It defended on the ground that the nurses’ actions were not dishonest because they had acted on their belief that strict adherence to protocol was unnecessary, and that while their actions might have been negligent, "dishonesty" implies a cognizance of one’s wrongdoing that they did not possess. Federal also maintained that even if the nurses’ actions were dishonest, its policy covered only "direct" losses, and Scirex’s losses more strongly resembled ordinary business expenses from failed ventures than losses, such as false claims of working overtime, due directly to employee dishonesty. Finally, Federal contended that even if it were liable for Scirex’s losses, it would be liable only in the amount of $280,000, the policy limit for one occurrence, because the losses across the four ruined studies were related.

Following a bench trial, the District Court held that Scirex could not recover against Federal because "dishonesty" implies a culpable intent, and the nurses’ "stubborn belief that the drug companies . . . were imposing unnecessary requirements" did not equate to dishonesty. Scirex Corp. v. Fed. Ins. Co., 2001 U.S. Dist. LEXIS 19088, *8-9 (E.D. Pa. 2001). It therefore denied Scirex’s claim, but noted in dicta that, were the nurses’ actions to be found dishonest, the losses they caused would be direct, and therefore Federal’s policy would cover them. Id. at *11. It also opined that, at all events, the policy would limit Federal’s liability to $280,000, the ceiling for one occurrence. Id. at *14.

Because we conclude that the nurses’ actions were dishonest, as well as negligent, we hold that they are covered by Federal’s policy, and we reverse the District Court’s holding to the contrary. We are satisfied that, whatever may be said of the decision to send patients home early in violation of protocol, the nurses’ practice of submitting records containing observations they did not make is ineluctably and irrefutably dishonest. However, we agree with the District Court that the nurses’ actions directly caused Scirex’s losses. Pennsylvania law equates "direct cause" with "proximate cause," Jefferson Bank v. Progressive Casualty Ins. Co., 965 F.2d 1274, 1281-82 (3d Cir. 1992), and the nurses’ conduct rendered those studies worthless to their sponsors, and therefore worthless to Scirex. Finally, although we believe that Federal’s policy covers Scirex’s losses, we agree with the District Court that Federal’s liability is limited to $280,000 for the four studies.

I. Background Facts and Procedural History

In 1997 and 1998, Scirex conducted four clinical studies for three different sponsors. Each tested a pain medication for patients who had undergone dental surgery, and each had a protocol, written by the pharmaceutical company sponsoring the study, which specified in great detail the procedures to be followed in that study. The four protocols required patients to remain under the observation of Scirex nurses, at Scirex’s clinic, for at least eight hours after being given the first medication dose. Because the effects of pain

medication to some extent vary by individual, the pharmaceutical companies anticipated that there would be a certain number of test subjects for whom the medication would be ineffective, and for these subjects, the protocols mandated providing supplemental pain medication. Subjects who received such supplemental medication were termed "rescued," while those who took only the drug being studied were termed "unrescued."

Although the protocols provided for rescuing certain subjects, they did not provide for treating those subjects otherwise differently; specifically, they stated that "[s]ubjects are required to remain at the study facility for the entire eight-hour postdosing observation period, even if the supplemental analgesic medication is taken." (R.W. Johnson Protocol.) During one of the four studies, however, Algos, the study’s sponsor, told Scirex that rescued patients did not have to remain in the clinic for the full eight hours. That excepting instruction applied only to Algos’s study, and even then, only to rescued subjects. The other three studies were to proceed strictly according to protocol.

During the course of a subject’s eight-hour stay, the protocols required Scirex’s nurses to observe the subject and record their observations. The records had to be "timely, accurate and complete," because they were what the FDA evaluated: "[t]imely, accurate, and complete reporting and analysis of safety information from clinical trials is crucial for the production of subjects, investigators, and the sponsor, and is mandated by regulatory agencies worldwide." (R.W. Johnson Protocol.) Nurse Mary Ellen Conforto, a Scirex supervisor and tenured employee, testified that she understood the need for the records to be accurate, and agreed that if a patient were released early, the records should have reflected the change.

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