June 8, 2000
FOR IMMEDIATE RELEASE Baum, Hedlund, Aristei, Guilford & Downey
12100 Wilshire Blvd., Ste. 950
Los Angeles, CA 90025
Contact: Robin McCall
bhagd@…
Day: (800) 827-0087 or (310) 207-3233
Night: (818) 558-5964
www.bhagd.com/media/prozacinformation.html
PROZAC MAKER, ELI LILLY AND COMPANY, COMMITTED FRAUD ON HAWAII COURT BY
CONCEALING CRUCIAL EVIDENCE AT TRIAL, FAMILY IN NEWLY FILED LAWSUIT ALLEGE
June 8, 2000, Hawaii — The plaintiffs in one of the only Prozac cases to
ever go to trial filed a new lawsuit yesterday against the pharmaceutical
giant and Prozac drug maker, Eli Lilly and Company. The new lawsuit
alleges Lilly committed fraud on a Hawaii Court by concealing potentially
damaging patent language for a new and improved Prozac during their civil
trial last year over Prozac’s alleged role in their parents’ deaths. That
trial ended in a verdict in Lilly’s favor. (An appeal is currently pending
in the Ninth Circuit Court of Appeals.)
The plaintiffs, Susan Forsyth, of California and her brother, William
Forsyth Jr., of Maui, have requested that the verdict be set aside based on
the alleged fraud. The Forsyths’ first suit alleged that, while under the
influence of Prozac, their father, a successful businessman and retiree
living on the island of Maui, stabbed his wife (their mother) to death and
then committed suicide by impaling himself on a kitchen knife after being
on Prozac for 10 days.
The new lawsuit alleges that, “unbeknownst to plaintiffs or their counsel
at the time that case went to trial, Eli Lilly and Company had recently
agreed to pay $90 million for exclusive rights to a patent for a new
formulation of the Prozac molecule which would reduce the following
side-effects of the original Prozac: “nervousness, anxiety, insomnia, inner
restlessness (akathisia), suicidal thoughts, self mutilation [and] manic
behavior,” the very side effects which plaintiffs’ claimed occurred with
their father and resulted in the brutal deaths of both parents.
MORE – MORE – MORE
The new suit alleges that an “in-house patent lawyer for Eli Lilly and
Company sat mutely in the courtroom during key portions of the Forsyth
trial without advising the Court or opposing counsel of these facts or
correcting the mis-impression created by Eli Lilly and Company’s trial
counsel and its witnesses.”
Attorney, Karen A. Barth, of the Los Angeles law firm, Baum, Hedlund,
Aristei, Guilford & Downey, represents the Forsyths along with Andy Vickery
of the Texas firm, Vickery & Waldner. Karen Barth stated of the new action:
“It is incredible that, on the one hand, Lilly vehemently argues to a
federal judge and jury that Prozac does not cause suicide and/or violence
(or akathisia which is a known precursor to suicide) while on the other,
pays $90 million for a patent for a ‘new and improved Prozac,’ which
clearly acknowledges Prozac’s propensity to increase the risk of suicide
and violent behavior and to cause akathisia! Lilly has consistently blamed
the individuals taking Prozac for these adverse reactions rather than
acknowlege any connection to Prozac.
“The new patent is an admission by Eli Lilly that the original Prozac
causes these side effects. If Lilly denies this, they’ve paid $90 million
for an invalid patent. (For a patent of a new product to be accepted, it
must be something new and useful. The ‘useful’ part of this patent is
reduced side effects.)”
FACT SHEET FOLLOWS
YOU CAN FIND THE NEW COMPLAINT AT:
WWW.BHAGD.COM/MEDIA/PROZACINFORMATION.HTML
# # # The Forsyths lawsuit contains the following claims, among others:
1. Under the influence of Prozac, the Forsyth plaintiffs’ father stabbed
their mother numerous times before impaling himself on a kitchen knife.
When the Forsyth children sought justice for these wrongful deaths in this
Court, Eli Lilly and Company repeatedly represented to this Court and to
its Jury that suicide is not a side effect of Prozac, and that Mr. Forsyth
could not have had a drug-induced “akathisia” because this condition
requires both “inner” feelings of restlessness and outward manifestations
of motor movement.
2. Unbeknownst to plaintiffs or their counsel at the time that case went to
trial, Eli Lilly and Company had recently agreed to pay $90 million for
exclusive rights to a patent for a new formulation of the Prozac molecule
which would reduce the following side-effects of the original Prozac:
“nervousness, anxiety, insomnia, inner restlessness (akathisia), suicidal
thoughts, self mutilation [and] manic behavior.”
3. In-house patent counsel for Eli Lilly and Company sat mutely in the
courtroom without advising the Court or opposing counsel of these facts or
correcting the mis-impression created by Eli Lilly and Company’s trial
counsel and its witnesses. Under the prevailing case law in this Circuit,
this conduct constitutes a “fraud on the Court” and mandates that the
Court’s prior judgment be set aside. See Pumphrey v. K.W. Thompson Tool
Co., 62 F.3rd 1128 (9th Cir. 1995) (affirming trial judge’s decision in
independent action to set aside defense verdict and judgment in products
liability, wrongful death, case based on fraud on the court).
14. Several months prior to the trial of the action, Lilly purchased the
exclusive license to U.S. Patent No. 5,708,035 (“the patent”) from
Sepracor, Inc. (fn3 Sepracor Inc. is a specialty pharmaceutical company with
a unique strategy to develop and commercialize potentially improved versions
of widely-prescribed drugs referred to as Improved Chemical Entities (ICEs).
Sepracor’s ICE Pharmaceuticals are differentiated, proprietary, single-isomer
or active-metabolite versions of currently marketed drugs.) The patent
abstract states: “A method and composition are disclosed utilizing the pure
R(-) isomer of fluoxetine which is a potent antidepressant and appetite
suppressant substantially free of adverse effects.” As further explained in
the Background section of the patent: “This invention relates to a novel
composition of matter containing optically pure R (-) fluoxetine. This
composition possesses potent antidepressant and appetite suppressant activity
as a serotonin uptake inhibitor while avoiding the usual adverse effects
associated with the racemic mixture of fluoxetine.” The adverse effects
listed include thoseexact same adverse effects that were at issue in trial
of the action, i.e.,
akathisia and suicidal thoughts and behavior, and mutilation; side effects
which Lilly consistently and repeatedly told the Court and jury did not
exist. As set forth below, such a position by Lilly during the trial of
the action was a fraud on this Court.
15. Though, during discovery of the underlying case, Plaintiffs
specifically asked for such information such as that contained in the
patent, Lilly never supplemented its discovery responses to provide such
information.
16. In December 1998, Lilly entered into an agreement to pay approximately
$90 million for the exclusive license to U.S. Patent 5,708,035. A true and
correct copy of the patent [is] available online from the U.S. Patent Office
at www.uspto.gov. On its company website at www.lilly.com, Lilly announced
its intention to market this new type of Prozac. [ ]
17. As exclusive licensee, to enforce patent rights against third parties,
Lilly must necessarily stand in privity with the inventors with respect to
their representations to the Patent Office, particularly representations
about “usefulness” which could affect the validity of the patent. See e.g.
Abbott Laboratories v. Diamedix Corp., 33 U.S.P.Q.2d 1771, 47 F.3d 1128
(Fed.Cir. 1995). (fn6 A licensee who is adverse to the inventor or
patent owner can challenge the validity of the patent. Lear, Inc. v.
Adkins, 395 U.S. 653 (1969). But to enforce the patent, Lilly must
necessarily accept the fact that its statutory usefulness hinges on
reducing these side effects of Prozac.)
18. Further, Lilly acknowledged, adopted and ratified the information
contained within the patent in its 1999 Annual Report: “And, pending U.S.
Federal Trade Commission approval, we’re in-licensing Sepracor’s
R-fluoxetine, a compound that may offer broader efficacy and fewer side
effects than existing therapies.” (Emphasis added).
19. Under the Patent Act there are two essential requirements for
patentability of an invention, i.e. it must be both “new” and “useful.” 35
USC §101. As the patent itself demonstrates, fluoxetine is a racemic
mixture or stereo-isomer. What this means in lay terms is that the Prozac
molecule is like a pair of gloves, with both a right hand and a left hand.
The patent discloses a method for separating the stereo-isomer and creating a
one-handed or R(-) version of fluoxetine, i.e. with only one of the two
isomers. This is what is “new.”
20. What the patent claims as “useful” is the propensity of the new R(-)
fluoxetine molecule to reduce side effects. The side effects which the
patent claims will be reduced include: “nervousness, anxiety, insomnia,
inner restlessness (akathisia), suicidal thoughts, self mutilation [and]
manic behavior.”
21. A Lilly in-house patent lawyer was present in the courtroom during
portions of the trial of the Forsyth case, including the opening statements
and some of the testimony. Although he did not appear as trial counsel,
he was nonetheless an “officer of the court” for fraud on the court
purposes. See Pumphrey, supra at 1132.
22. In the trial of the wrongful death case, Lilly defended against the
general causation contentions, i.e. that Prozac causes some people to
become violent or suicidal, by arguing that any violent or suicidal
thoughts experienced by people on Prozac was because of their underlying
depression or other life “stressors.” It specifically and repeatedly
represented in both testimony and argument that treatment emergent
suicidality was not a side effect of Prozac.
23. Neither Mr. Norman nor other Lilly counsel ever brought it to the
attention of the Court or Jury that Lilly had agreed to pay $90 million for
a patent, whose validity hinges on the truthfulness of the notion that
“akathisia, suicidal thoughts [and] self-mutilation” are side effects of
Prozac. Rather, they allowed the mis-impression to continue.
29. Lilly is no stranger to claims that it has “protected Prozac”, inter
alia, by conduct which could be branded as a “fraud on the court.” Potter v.
Eli Lilly & Co., 926 S.W.2d 449Ky.1996) was a writ of prohibition case
against Judge John Potter, the trial judge of the first Prozac/wrongful death
case to go to trial in this country. The case resulted in a defense verdict.
Judge Potter entered a final judgment which stated “dismissed pursuant to
jury verdict.” However, when he learned later that there had been a
mid-trial secret settlement, that evidence had been withheld from the jury,
and that the attorneys for both parties had misrepresented facts to him
concerning their dealings, Judge Potter issued a show cause order, requiring
the parties to demonstrate why the judgment should not be modified to read
“dismissed as settled.” The judgment was ultimately
corrected to “dismissed as settled” as Judge Potter had proposed in the
first place.
The Kentucky Supreme Court, citing Hazel-Atlas Glass Co. v. Hartford Empire
Co., 322 U.S. 238 (1944) held that, not only did the judge have the right,
but, indeed, he had the duty to investigate a potential fraud on his court.
It wrote:
“there was a serious lack of candor with the trial court and there may
have been deception, bad faith conduct, abuse of the judicial process or
perhaps even fraud.” Id. at 454.
See also Winkler v. Eli Lilly & Co., 101 F.3d 1196, 1203 (7th Cir. 1996).
30. Plaintiffs did not discover the fraud on this Court until it came to
their attention via a May 7, 2000 article in the Boston Globe newspaper
entitled “Prozac Revisited”.
32. One of two things must be true. Either “inner restlessness
(akathisia), suicidal thoughts, [and] self-mutilation” are side effects of
the original Prozac, or Lilly has paid $90 million for an invention that
is not “useful” and a patent that is not valid. But regardless of which
one it is, by knowingly adducing evidence and making arguments which
created a false impression, and knowingly withholding the patent from
discovery supplementation, Lilly has perpetrated a fraud upon this Court.
33. Thus, based upon the foregoing, a fraud was committed on this Court. The
nature of this fraud was such that it harmed “the integrity of the judicial
process” within the meaning of Pumphrey v. K.W. Thompson Tool Co., 62 F.3rd
1128, 1132-33 (9th Cir. 1995).
34. Accordingly, the Judgment entered in the action entitled Susan K.
Forsyth, individually and as Personal Representative of the Estates of
June M. Forsyth and William D. Forsyth, and William D. Forsyth, Jr. v. Eli
Lilly and Company, Case No. 95-00185ACK should be set aside and a new trial
should be ordered.
PRAYER
WHEREFORE, Plaintiffs pray judgment against defendant Eli Lilly and
Company, as follows:
1. That the Judgment entered in the action entitled Susan K. Forsyth,
individually and as Personal Representative of the Estates of June M.
Forsyth and William D. Forsyth, and William D. Forsyth, Jr. v. Eli Lilly
and Company, Case No. 95-00185ACK be set aside and a new trial ordered.
2. An award for reasonable attorneys’ fees, including all attorneys’
fees incurred in the trial of the action entitled Susan K. Forsyth,
individually and as Personal Representative of the Estates of June M.
Forsyth and William D. Forsyth, and William D. Forsyth, Jr. v. Eli Lilly
and Company, Case No. 95-00185ACK.
3. An award of costs incurred in the underlying trial and herein;
4. An award of such other and further relief as the court deems just and
equitable.
