"Victory against the psych empire"
Press Release on Eli Lilly Case

From BAGHD partner William Downey, as posted to TNX:

Here is the press release that we sent out last night. Dow Jones has already picked up the story. Watch your local papers, and see if you can get more coverage for this victory against the psych empire.

January 8, 1998
FOR IMMEDIATE RELEASE
Baum, Hedlund, Aristei, Guilford & Downey
12100 Wilshire Blvd., Ste. 950 Los Angeles, CA 90025
Contact: Robin McCall or William J. Downey III Day: (800) 827-0087 or (310) 207-3233 Night: (818) 558-5964
E-mail - bhagd@bhagd.com

PLAINTIFFS PREVAIL AGAINST ELI LILLY IN PRELIMINARY STAGE OF PROZAC SUIT

Honolulu, Hawaii, January 8, 1998 - - On January 5, 1998, Judge Alan C. Kay, Chief United States District Court Judge for the District of Hawaii, rejected Prozac manufacturer Eli Lilly's attempts to dismiss wrongful death claims for suicides caused by Prozac ingestion. While noting that Prozac had a suicide rate two times that of other antidepressants, the court ruled that the claimants had presented sufficient evidence to allow them to try nearly all claims, including claims for punitive damages, before a federal jury.

When asked what he thought of the judge's ruling, Forsyth's attorney, William J. Downey III, of Baum, Hedlund, Aristei, Guilford & Downey, stated, "The judge's ruling is consistent with our investigation indicating that Prozac can cause or increase suicidal ideation and violent behavior which, in this case, led to the deaths of William and June Forsyth. We are pleased that the judge is giving us the opportunity to present this scientific evidence to a Hawaii jury."

FACT SHEET

This case arises from the deaths of Maui residents William and June Forsyth, on March 4, 1993. Mr. Forsyth had no history of violent or suicidal thoughts or actions before taking Prozac. Two weeks after starting to take Prozac, Mr. Forsyth stabbed his wife, June, fifteen times, then, propping a kitchen knife up on a stool, killed himself. He was being treated with Prozac for depression. The plaintiffs, Susan and Bill Forsyth, the couple's surviving son and daughter, filed a lawsuit against Eli Lilly in 1995.

The Forsyth's suit alleges that Eli Lilly & Company, an Indianapolis-based manufacturer of pharmaceutical drugs, was strictly liable for failure to warn about Prozac's life-threatening side effects, including an increased likelihood of suicide and violent behavior. In addition, the suit claimed that Lilly was negligent in testing, marketing, and failing to provide adequate warnings; that Lilly negligently or intentionally misrepresented the nature and extent of dangerous side effects; and breached express and implied warranties. Plaintiffs also claimed that Lilly should be liable for punitive damages.

Lilly filed motions last summer to have the case dismissed. Lilly claimed that the drug, Prozac was an "unavoidably unsafe product." The drug maker further claimed that plaintiffs' claims should be thrown out because there was insufficient scientific evidence to show that Prozac was dangerous, and that any attempt to show that Prozac caused suicidal or homicidal thoughts was invalid under the United States Supreme Court's decision in Daubert v. Merrill Dow Pharmaceuticals, 113 S.Ct. 2786 (1993).

Judge Kay, in a 31-page opinion, rejected most of Lilly's claims. As a result, the case is scheduled to be tried before a federal jury in Honolulu, Hawaii, in June.

Judge Kay stated that "material issues of fact exist as to whether Lilly provided an adequate warning for Prozac." Citing warning labels used by the drug maker in Europe, the judge noted "The warnings for Prozac in these foreign countries tend to indicate a stronger link between Prozac and suicide than Lilly suggests. For instance, the Swedish warning for Prozac states that the risk of suicide from ingesting Prozac 'may increase initially.'"

In denying Lilly's claim that there was no evidence that would allow a claim for punitive damages, the federal judge relied on evidence produced by the plaintiffs that indicated Lilly may have deliberately suppressed unfavorable clinical studies, falsified clinical trials, and deliberately failed to report adverse events to the United States Food and Drug Administration (FDA). The ruling stated: "The Court finds that Plaintiffs have presented sufficient evidence to show that Lilly may have acted wantonly, oppressively, or with such malice as implies a spirit of mischief or criminal indifference."

Lilly claimed that the Forsyths relied on "junk science." In opposition to that contention, the plaintiffs submitted an extensive analysis by Dr. David Healy, a prominent British Professor of Psychiatry and an expert in psychiatric drugs such as Prozac, of the scientific evidence indicating that Prozac causes suicide and violent behavior. The court noted that "Dr. Healy has authored medical articles on Prozac and suicidality and published a review of the literature on this topic. His published articles were subjected to peer review and appear to have a particular degree of acceptance within the scientific community."

The court focussed on Dr. Healy's analysis of a large study of the effects of Prozac as compared to other antidepressant drugs, called the "Jick Study". The court's ruling stated "The results are telling. The Jick Study reported that Prozac had the highest adjusted relative risk estimate of suicide amongst 172,598 subjects. . . [T]he risk of suicide in the subjects exposed to Prozac population was more that double the risk in the unexposed or control population."

Based on that analysis, and other factors detailed in the opinion, Judge Kay ruled that the evidence relied upon by plaintiffs' experts was scientifically reliable and satisfied the criteria imposed by the Supreme Court's Daubert decision. Lilly's "junk science" claim was thus firmly rejected.

Following is additional detailed discussion of some of the charges in the Plaintiffs' lawsuit against Eli Lilly:

Deliberate Suppression of Unfavorable Studies The Plaintiffs presented declarations of Dr. David Healy and William J. Downey III (the plaintiffs' attorney), which stated that Lilly suppressed research by Taiwanese doctors which showed that patients who took Prozac were more likely to make suicide attempts than patients who took another antidepressant drug called maprotoline. Downey also presented a letter from Belgian doctor, Robert Bourguignon, describing how Lilly attempted to suppress his research regarding Prozac and suicide by suing him.

The court stated that, "material issues of fact exist as to whether Lilly deliberately suppressed adverse studies."

Alleged Falsification of Clinical Trial Results Plaintiffs submitted evidence to the court in the form of memos and E-mail obtained from Lilly subsidiaries overseas complaining that Lilly falsified reports of side effects of suicide attempts by reporting them as overdoses.

In its opinion, the court noted, "Lilly may have improperly classified suicide attempts in a deliberate fashion."

Deliberate Failure to Report Adverse Events To the F.D.A.

In their opposition Lilly's motion, plaintiffs submitted letters and internal Lilly correspondence showing that the B.G.A. (the F.D.A. of Germany) notified Lilly in 1985 that it intended to disapprove Lilly's application to market Prozac in Germany because there was an increased risk of suicide. Lilly was required to report the B.G.A.'s specific findings to the F.D.A., but failed to do so. Because of that evidence, Judge Kay found that, "Plaintiffs have raised a triable issue of fact as to whether Lilly deliberately failed to report adverse events to the F.D.A."

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