Lilly and Plaintiffs' Attorneys Enter Into an Agreement in Principle to Settle Majority of Zyprexa(R) Product Liability Litigati
10 June 2005 - 10:30AM
PR Newswire (US)
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 x
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