Bolen v. United States

727 F. Supp. 1346, 1989 U.S. Dist. LEXIS 15883, 1989 WL 160192
CourtDistrict Court, D. Idaho
DecidedDecember 15, 1989
DocketCiv. 86-4039
StatusPublished
Cited by1 cases

This text of 727 F. Supp. 1346 (Bolen v. United States) is published on Counsel Stack Legal Research, covering District Court, D. Idaho primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Bolen v. United States, 727 F. Supp. 1346, 1989 U.S. Dist. LEXIS 15883, 1989 WL 160192 (D. Idaho 1989).

Opinion

FINDINGS OF FACT AND CONCLUSIONS OF LAW

CALLISTER, Senior District Judge.

A court trial was held in the above-entitled matter on November 6, 7, and 8, 1989. At the conclusion of the testimony, the Court ordered further briefing which has been received. The case is now at issue and ready to be resolved. This written decision shall constitute the Court’s findings of fact and conclusions of law rendered pursuant to Fed.R.Civ.P. 52(a).

*1347 The plaintiff Clarence Bolen brought this suit against the United States on April 2, 1986. He claims to suffer from an affliction known as Tardive Dyskinesia caused by his use of a Phenothiazine drug called Stelazine for over ten years without proper monitoring by the Veterans Administration (V.A.) doctors who prescribed the drug for him. Two issues must be resolved in this lawsuit:

(1) Was the suit filed within the statute of limitations?

(2) If the suit was timely filed, did plaintiff carry his burden of proving that the Government physicians were negligent in failing to properly monitor him while he was taking Stelazine?

With this background in mind, the Court will proceed to make its factual findings.

FINDINGS OF FACT

The advent of Phenothiazine drugs ushered in “[a] signal advance in the care of the mentally ill.” SCHMIDT AND JAR-CHO, Persistent Dyskinesias Following Phenothiazine Therapy, 14 Archives of Neurology, April 1966 at p. 369 (Plaintiffs Exhibit 11). Unlike traditional sedatives, these drugs could calm an agitated patient without inducing sleep or impairing motor control. Drug Treatment in Psychiatry (Veterans Administration, January 1970) at p. 2 (Plaintiffs Exhibit 16). The number of psychiatric patients needing hospitalization plummeted dramatically with the introduction of these drugs. See unnumbered chart attached to back of Plaintiffs Exhibit 16. Dr. Jess Groesbeck, a board certified psychiatrist, testified that Phenothiazines were a revolutionary drug that emptied mental institutions, allowing treatment on an outpatient basis.

The Phenothiazine drug involved in this case is Trifluoperazine known by its United States trade name, Stelazine. The testimony of experts was united that Stelazine was a potent Phenothiazine with side-effects. A national publication known as “The Physicians Desk Reference” (PDR) details these side-effects. Defendant’s Exhibit 107. Published annually, the PDR contains information provided by the drug manufacturers concerning the properties of drugs approved by the Food and Drug Administration (FDA).

The 1963 PDR noted that Stelazine was “outstanding” for treating anxiety. Plaintiff’s Exhibit 7. In its listing of side-effects, the 1963 PDR notes that Stelazine may cause “pseudo-Parkinsonism” with symptoms including tremors, drooling, and shuffling gait. This PDR also warned of “dystonias” such as neck spasms, protrusion of the tongue and back muscle rigidity, but also noted that these problems occur “suddenly” and are “promptly reversible and need not cause undue alarm.” Plaintiff’s Exhibit 7.

Dr. Harold Klawans, 1 a board certified neurologist, testified about the terms used to describe the onset of these side effects. He testified that “acute” side-effects are those which occur within about 72 hours from administration of the drug. “Sub-acute” side-effects occur within a few weeks to a few months and would include drug-induced Parkinsonism or tremors. Finally, those side-effects that occur only after years of drug therapy are known as late-onset or Tardive-type symptoms. Dr. Klawans did testify that in the “exceptionally rare” case, a Tardive-type symptom could occur in about three months time.

Dr. Klawans went on to testify that the PDR in 1963 was warning about acute and *1348 sub-acute side-effects; that is, effects that would manifest themselves within a few weeks to a few months from the administration of the drug. While the 1963 PDR noted that these acute or sub-acute side-effects were promptly reversible, the 1965 PDR warned of acute and sub-acute side-effects that might linger:

Therapy should be stopped at the first appearance of dystonic and Parkinson-ism-like symptoms, since following the administration of some Phenothiazine derivatives there have been rare cases where such symptoms have lasted months and even years.

Here, the 1965 PDR is essentially saying that symptoms that may manifest themselves within a few weeks or months of administration of the drug might last longer than previously suspected. There was, however, no warning in the 1965 PDR that the long term used of Stelazine could cause side-effects that became manifest only after the drug had been taken for many years. The first warning of this type in the PDR occurred in the 1972 supplement which warned of a side-effect known as Tardive Dyskinesia. As discussed earlier, the word “Tardive” refers to late-onset, while the term “Dyskinesia” is a general term meaning abnormal movement or the impairment of the power of voluntary movement. Some typical symptoms of Tar-dive Dyskinesia include abnormal movements of the tongue, odd positions of the head or jaw, involuntary chewing movements, and a general sense of agitation. Dr. John Davis, a member of the American Psychiatric Association task force on Tar-dive Dyskinesia, testified that Tardive Dyskinesia generally occurs after several years of Phenothiazine drug treatment. Defendant’s Exhibit 108 at p. 20, lines 17-18. Dr. Davis went on to testify about the growing awareness within the medical profession about the link between long term use of Phenothiazine drugs and Tardive Dyskinesia:

In the early ’60’s nothing was known about it. And reports started appearing in, I would say, in the mid-’60’s. I first became interested in it in the late-’60’s. And at that time I became interested in it because it was highly controversial. Some people said it didn’t exist____ During the early ’70’s I think more people were becoming aware of it. Around ’73 there were several editorials relating to it. And there was a lot of discussion in the mid-’70’s.
The American Psychiatric Association formed a task force which published a report in 1980 which indicates at that time the American Psychiatric Association recognized it [the link between Phenothiazine use and Tardive Dyskinesia]. The American Psychiatric Association has become more concerned. And in the late-’80’s, around ’86 or ’87 they sent a letter to all psychiatrists warning them about Tardive Dyskinesia.
QUESTION (by Government counsel): At what point in time, if you can identify any point specifically would you say that the psychiatric community should have been put on notice of the potential Tar-dive Dyskinesia side-effect to long term Stelazine or Thorazine [another Phenothiazine drug] use by their patients?
ANSWER (by Dr. Davis): I don't think there is a single point in time.

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727 F. Supp. 1346, 1989 U.S. Dist. LEXIS 15883, 1989 WL 160192, Counsel Stack Legal Research, https://law.counselstack.com/opinion/bolen-v-united-states-idd-1989.