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Chelly v. Knoll Pharmaceuticals

December 2, 1996

JACQUES E. CHELLY, PLAINTIFF-APPELLANT,
v.
KNOLL PHARMACEUTICALS, A UNIT OF BASF K&F CORPORATION (BASF GROUP), DEFENDANT-RESPONDENT, AND EDWARD B. KIRSTEN, DEFENDANT.



On appeal from Superior Court of New Jersey, Law Division, Morris County.

Approved for Publication December 2, 1996.

Before Judges Keefe, Conley and Loftus. The opinion of the court was delivered by Conley, J.A.D.

The opinion of the court was delivered by: Conley

The opinion of the court was delivered by CONLEY, J. A. D.

From December 8, 1988 to March 6, 1989 when he was fired, plaintiff was an at-will employee of defendant Knoll Pharmaceuticals as its Director of Cardiovascular Research. Subsequently, plaintiff sued Knoll alleging a wrongful discharge under Pierce v. Ortho Pharmaceutical Corp., 84 N.J. 58, 417 A.2d 505 (1980). *fn1 The parties stipulated to a determination by the trial Judge on the threshold issue of whether the conduct for which plaintiff - claimed he was discharged was in objection to a violation of a "clear mandate of public policy" on the part of Knoll. That is, was there a "clear mandate of public policy" that Knoll had violated and in response to which plaintiff had taken some action implicated in his discharge. See Warthen v. Toms River Community Mem. Hosp., 199 N.J. Super. 18, 25, 488 A.2d 229 (App. Div.), certif. denied, 101 N.J. 255 (1985). Following a bench trial on that issue, the trial Judge concluded not. The trial Judge also concluded that defendant's belief that Knoll's conduct was violative of a clear mandate of public policy was not reasonable. We are convinced that the trial Judge correctly resolved the threshold issue and affirm on that basis. We, thus, need not and do not consider any issues concerning plaintiff's belief that the objectionable employer's conduct constituted a violation of a clear mandate of public policy. *fn2

Plaintiff's wrongful discharge claim here is premised upon an allegation that Knoll's conduct was violative of public policy in three respects. The first two arise out of information obtained from clinical investigators (doctors) concerning instances of elevated liver enzyme readings in patients participating in clinical trials on a new drug, Gallopamil. *fn3 It was plaintiff's belief that that information should have been immediately disclosed to the FDA and to the clinical investigators under the applicable federal regulations.

The third area of alleged violation concerns a letter from Edward Kirsten, Knoll's Director of Clinical Research and a subordinate of plaintiff, offering to pay a medical investigator for publication of a paper on an unapproved drug and also offering the assistance of a Knoll employee. As to this, plaintiff contended that the letter was unethical, but the trial Judge found no federal regulations, code of ethics or any other source that a clear mandate of public policy that was violated by the letter. Rather, he concluded that plaintiff simply "was angry that somebody beneath him in the structure of the company dared to make this offer without clearing it with him . . . ." We are convinced plaintiff's claim of error as to this in point III of his brief is without merit and requires no further Discussion. R. 2:11-3(e)(1)(A), (E).

Further, as to the dispute concerning disclosure to the clinical investigators and the common law informed consent principles, see Largey v. Rothman, 110 N.J. 204, 540 A.2d 504 (1988), and Febus v. Barot, 260 N.J. Super. 322, 616 A.2d 933 (App. Div. 1992), raised sua sponte by the trial Judge, *fn4 counsel conceded during oral argument that the proper focus, in terms of the Pierce threshold issue, must be the federal regulations that govern disclosure of necessary information to the clinical investigators. We, therefore, focus our analysis upon those regulations in considering plaintiff's claim here that he did prove a "clear mandate of public policy" violated by Knoll in its, in plaintiff's view, tardy disclosure to the clinical investigators. To the extent, in any event, that the more general common law informed consent principles can be a basis for a Pierce cause of action under the circumstances here, we would affirm the trial Judge's Conclusion that defendant did not establish a violation of those principles as amply supported by the record before him.

a.

As we have said, the controversy here arises out of clinical trials on Gallopamil, a new drug manufactured by Knoll for the treatment of hypertension, and reports of elevated liver enzyme readings in connection with that drug. It is critical, in this respect, to note, as did the trial Judge, that the issue involved not whether Knoll should report the adverse readings at all, but when it should do so. It is also important to recognize, in terms of the informed consent issue, i.e. disclosure to the clinical investigators, that the clinical brochure for the drug initially sent to the clinical investigators and required under FDA regulations, informed the investigators at the outset of the clinical trials that an initial testing of the drug in Germany had produced an elevated liver enzyme reading in one patient out of a trial of 4000 patients. The brochure further included as a protocol of the trials that during the treatment period liver enzyme tests must be regularly performed to monitor the liver function of the patients. There is no evidence to suggest that as far as Knoll was aware at the time of the initial brochure the information in the brochure was not accurate and it is conceded by plaintiff that the brochure did alert the clinical investigators to a potential adverse affect upon a participating patient's liver. Both plaintiff and his experts also conceded that this information was adequate and that it would be the clinical investigator's judgment as to whether the patient should be so informed.

The clinical trials at issue here commenced in January 1988 with 750 hypertensive patients. As we have said, plaintiff commenced his employment with Knoll on December 12, 1988. As Director of Cardiovascular Research, his job responsibilities included preparation and presentation of data to the FDA to obtain approval of new or "investigational" drugs. His job description, in that respect, stipulated that he was to work under company policies and within the constraints of federal regulations for the development of drugs."

The series of events triggering, plaintiff claims, his firing commenced on December 23, 1988 when he received a memo dated December 22 from one of his clinical research associates stating that a participating patient, who had been taking 150 milligrams of Gallopamil daily since November 18, was discontinued because of elevated liver enzymes. The memo included the pertinent laboratory results showing increases in two types of the enzyme transaminase (SGPT and SGOT) from fourteen and nine units per liter on November 14 to ninety-seven and 121 units per liter on December 21. The normal enzyme reading is between twelve and forty.

Plaintiff was aware of the prior experience in Germany. At a monthly tracking meeting on January 16, 1989, he "indicated very strongly and very firmly to everyone that I felt we had an obligation to both the patient and FDA investigator" to institute a system to track safety information on clinical trials. Establishing a better monitoring system was his concern at that time. However, on January 24, 1989, plaintiff received a memo based upon a report from a clinical investigator that another patient, who had been taking 150 milligrams per day of Gallopamil for two weeks, was discontinued by his clinical investigator because of elevated liver enzymes of 880 and 318 from 30 to 28 over two weeks. At that point, plaintiff believed the second report was "a very serious adverse reaction"; he had never seen levels this high. He thought that this substantial "release of enzyme from the liver into the general circulation constituted a risk for major hepatic injury." However, he conceded that he had no information that the elevated readings ...


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