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Lilly and Plaintiffs' Attorneys Enter Into an Agreement in
Principle to Settle Majority of Zyprexa(R) Product Liability Litigation
INDIANAPOLIS, Indiana, June 9 /PRNewswire-FirstCall/ -- Eli Lilly and Company
announced today that it has entered into an agreement in principle with
plaintiffs' attorneys involved in Zyprexa liability litigation to settle a
majority of the claims against Lilly relating to the medication.
"While we believe the claims are without merit, we took this difficult step
because we believe it is in the best interest of the company, the patients who
depend on this medication, and their doctors," said Sidney Taurel, chairman,
president and chief executive officer of Eli Lilly and Company. "We wanted to
reduce significant uncertainties involved in litigating such complex cases.
Our decision to resolve these claims does not change the fact that Zyprexa has
and will continue to improve the lives of millions of patients around the world
who are suffering from schizophrenia and bipolar disorder. This settlement
will enable Lilly to focus first and foremost on addressing unmet medical needs
through research, educational programs and partnerships with doctors and
patients."
When finalized, the settlement will resolve the majority of Zyprexa claims
pending in the United States. This includes federal and state lawsuits that
have been brought against Lilly, the filed nationwide class action lawsuits
(none of which had been certified by a judge), and the majority of
approximately 5,000 claims that were the subject of "tolling agreements" that
extended the deadline for potential claimants to file a lawsuit, as well as
other potential claims against Lilly. The agreement will also result in the
dismissal of claims against physicians and other health care professionals
named as co-defendants in any cases covered by this settlement.
According to the agreement, Lilly will establish a fund not to exceed $690
million for plaintiffs who agree to settle their claims. The settlement fund
will be overseen and distributed by claims administrators appointed by the
plaintiffs' steering committee. At this time, the exact number of claimants
covered by this settlement is unknown, but is estimated to be 8,000, comprising
approximately 75 percent of claims identified to Lilly.
"We believe that this settlement is in the best interest of our clients, as
well as patients, physicians and caregivers," said Christopher Seeger, member
of the plaintiffs' steering committee, which had been directing the federal
litigation for the claimants. "Our interest is in seeing that Zyprexa patients
get the best medical care available and that doctors and patients receive
accurate and meaningful information about the medications they use. We are
pleased with the manner in which Lilly handled these claims. The patient
population to which this drug is given has difficult medical histories.
Protracted litigation was in no one's interest."
Most of the lawsuits claimed that before September 2003, the information in the
medication label, which listed the risk of hyperglycemia and diabetes as an
infrequent adverse event since 1996, was not adequately displayed. In
September 2003, the FDA required label changes for all atypical antipsychotics
to warn against this risk. "Given the background rate of diabetes in the
population at large, and particularly in people with serious mental illness,"
said Seeger, "we are pleased with the label change and the additional
information being provided to physicians and their patients about both the
risks and benefits of the drug."
"The litigation stirred concern for physicians and spread fear among patients
and caregivers, which has interfered with the process of physicians making
treatment decisions," added Taurel. "We want physicians to feel comfortable
choosing the medication they believe best meets the treatment needs of their
patients with serious mental illness."
The agreement involves claimants who asserted that they developed
diabetes-related conditions from their use of Zyprexa. Claimants who are not
covered by the final settlement are those represented by attorneys who are not
participating in the agreement in principle. Lilly is prepared to continue its
vigorous defense of Zyprexa in the remaining cases.
Lilly advised investors that it anticipates taking at least a $700 million
pretax charge in the second quarter of 2005 to cover this settlement, as well
as other product liability claims not covered by the settlement. This second
quarter charge will be excluded from Lilly's adjusted second-quarter earnings.
Zyprexa(R) Background
Zyprexa(R) is indicated in the United States for the short- and long-term
treatment of schizophrenia, acute mixed and manic episodes of bipolar I
disorder, and maintenance treatment of bipolar disorder. Since Zyprexa(R) was
introduced in 1996, it has been prescribed to more than 17 million people
worldwide.
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 to
placebo. In addition, compared to 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.
Prescribing should be consistent with the need to minimize the risk of
neuroleptic malignant syndrome, tardive dyskinesia, seizures, and orthostatic
hypotension.
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 nonaggressive objectionable behavior), constipation,
akathisia, postural hypotension, dry mouth, asthenia, dyspepsia, increased
appetite, and tremor.
Full prescribing information, including boxed warning, is available at
http://www.zyprexa.com/ .
About Eli Lilly and Company
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/ . C-LLY
This press release contains forward-looking statements about Zyprexa(R). These
statements reflect management's current beliefs, however, as with any
commercial pharmaceutical product there are risks and uncertainties in the
process of commercialization and regulatory review. In addition, there are no
guarantees that the product will continue to be commercially successful. When
final, this settlement is expected to resolve the majority of the pending and
tolled claims as well as the potential claims of a large number of additional
individuals; however, there is no guarantee that the settlement will become
final. Also, the settlement does not resolve all pending cases and it is
possible that the company could receive a substantial number of new claims in
the future from individuals not subject to this settlement. For further
discussion of these and other risks and uncertainties, see Lilly's filings with
the United States Securities and Exchange Commission. Lilly undertakes no duty
to update forward-looking statements.
(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: Heather Lusk, +1-317-433-5600, or Tarra Ryker, +1-317-276-3787,
both of Eli Lilly and Company
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