State of Alaska and Eli Lilly and Company Reach Agreement to Settle Zyprexa Lawsuit
March 26 2008 - 1:23AM
PR Newswire (US)
INDIANAPOLIS and ANCHORAGE, Ala., March 26 /PRNewswire-FirstCall/
-- Eli Lilly and Company and the State of Alaska have agreed on the
following joint statement: Alaska Attorney General Talis J. Colberg
and Eli Lilly and Company (NYSE: LLY) today announced a settlement
of the lawsuit filed by the State of Alaska over use of Zyprexa(R)
(olanzapine) by the State's Medicaid program. The trial began March
3, 2008, in Superior Court in Anchorage. The agreement resulted
from ongoing mediation ordered by trial Judge Mark Rindner before
the trial began. Presiding Judge Morgan Christen renewed mediation
efforts with the parties last week. The settlement will include
payment by Lilly of $15 million plus a term that will ensure that
Alaska is treated as favorably as any other state that may settle
with Lilly in the future over similar claims. "I am very pleased
with the efforts by Assistant Attorney General Ed Sniffen and our
team of trial attorneys," Colberg said. "We believe this is a good
result for the State of Alaska and the Department of Health and
Social Services," he added. "We believe this settlement is in the
best interest of the company, the State, and, importantly, of the
patients, families and healthcare professionals for whom Zyprexa is
an important treatment option," said Robert A. Armitage, Lilly's
senior vice president and general counsel. In addition, Lilly
provided the following information: "While we had a strong defense,
we agreed with the State that the best result for everyone is an
amicable resolution," Armitage said. "A trial always involves
significant time and resources, especially a two-phase trial like
this one that posed additional legal hurdles. A settlement helps us
get back to what we want to focus on as a company: developing
important new medications through research and partnerships with
doctors and patients. "We appreciate all the time and energy the
jury invested over more than three weeks in such a complex case,"
Armitage added. The agreement involves no admission of wrongdoing
on Lilly's part. The March, 2006 lawsuit claimed the State and
healthcare providers were insufficiently warned about possible side
effects relating to weight gain, high blood sugar and diabetes,
causing harm to the State's Medicaid recipients and increased costs
to the State. The lawsuit asked that Lilly pay the State for those
costs and pay civil penalties under the Alaska Unfair Trade
Practices and Consumer Protection Act (UTPCPA). Prescribed for more
than 23 million people since its initial approval by the FDA in
1996, Zyprexa is regularly prescribed in the U.S. and in more than
80 other countries. One of a class of medications called "atypical
antipsychotics," it is approved to treat schizophrenia and bipolar
disorder. "Our decision to resolve this case does not change the
fact that Zyprexa can continue to improve the lives of patients
around the world who are suffering from schizophrenia and bipolar
disorder," Armitage said. Zyprexa Background Zyprexa is indicated
in the United States for the short- and long-term treatment of
schizophrenia, acute mixed or manic episodes of bipolar I disorder,
and maintenance treatment of bipolar disorder. Since Zyprexa was
introduced in 1996, it has been prescribed to approximately 23
million people worldwide. Zyprexa is not approved for patients
under 18 years of age. Zyprexa is not approved for the treatment of
patients with dementia- related psychosis. Elderly patients with
dementia-related psychosis treated with atypical antipsychotic
drugs are at an increased risk of death compared with those
patients taking a placebo. In addition, compared to elderly
patients with dementia-related psychosis taking a placebo, there
was a significantly higher incidence of cerebrovascular adverse
events in elderly patients with dementia-related psychosis treated
with Zyprexa. Hyperglycemia, in some cases extreme and associated
with ketoacidosis or hyperosmolar coma or death, has been reported
in patients treated with atypical antipsychotics, including
Zyprexa. While relative risk estimates are inconsistent, the
association between atypical antipsychotics and increases in
glucose levels appears to fall on a continuum and olanzapine
appears to have a greater association than some other atypical
antipsychotics. Physicians should consider the risks and benefits
when prescribing olanzapine to patients with an established
diagnosis of diabetes mellitus, or who have borderline increased
blood glucose levels. Patients taking olanzapine should be
monitored regularly for worsening of glucose control. Persons with
risk factors for diabetes who are starting on atypical
antipsychotics should undergo baseline and periodic fasting blood
glucose testing. Patients who develop symptoms of hyperglycemia
during treatment should undergo fasting blood glucose testing.
Undesirable alterations in lipids have been observed with
olanzapine use. Clinical monitoring, including baseline and
follow-up lipid evaluations in patients using olanzapine, is
advised. Significant, and sometimes very high, elevations in
triglyceride levels have been observed with olanzapine use.
Potential consequences of weight gain should be considered prior to
starting olanzapine. Patients receiving olanzapine should receive
regular monitoring of weight. As with all antipsychotic
medications, a rare and potentially fatal condition knows as
Neuroleptic Malignant Syndrome NMS has been reported with Zyprexa.
If signs and symptoms appear, immediate discontinuation is
recommended. Clinical manifestations of NMS are hyperpyrexia,
muscle rigidity, altered mental status and evidence of autonomic
instability (irregular pulse or blood pressure, tachycardia,
diaphoresis and cardiac dysrhythmia). Additional signs may include
elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis),
and acute renal failure. Also, as will all antipsychotic
treatments, prescribing should be consistent with the need to
minimize Tardive Dyskinesia (TD). The risk of developing TD and the
likelihood that it will become irreversible are believed to
increase as the duration of treatment and the total cumulative dose
of antipsychotic increase. The syndrome may remit, partially or
completely, if antipsychotic treatment is withdrawn. Other
potentially serious adverse events include low blood pressure,
seizures, elevated prolactin levels, elevated liver enzymes,
cognitive and motor impairment, body temperature elevation, and
trouble swallowing. The most common treatment-emergent adverse
event associated with Zyprexa in placebo-controlled, short-term
schizophrenia and bipolar mania trials was somnolence. Other common
events were dizziness, weight gain, personality disorder (COSTART
term for nonagressive objectionable behavior), constipation,
akathisia, postural hypotension, dry mouth, asthenia, dyspepsia,
increased appetite and tremor. Full prescribing information,
including a boxed warning, is available at http://www.zyprexa.com/.
About Lilly Lilly, a leading innovation-driven corporation, is
developing a growing portfolio of first-in-class and best-in-class
pharmaceutical products by applying the latest research from its
own worldwide laboratories and from collaborations with eminent
scientific organizations. Headquartered in Indianapolis, Ind.,
Lilly provides answers -- through medicines and information -- for
some of the world's most urgent medical needs. Additional
information about Lilly is available at http://www.lilly.com/.
Zyprexa(R) (olanzapine, Lilly) C-LLY (Logo:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO DATASOURCE:
Eli Lilly and Company CONTACT: Marni Lemons +1-317-532-7826, , or
Tarra Ryker, +1-317-332-7502, Web site: http://www.lilly.com/
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