Lilly and Plaintiffs' Attorneys Enter Into Agreements to Settle Zyprexa(R) Product Liability Litigation
January 04 2007 - 7:00AM
PR Newswire (US)
INDIANAPOLIS, Jan. 4 /PRNewswire-FirstCall/ -- Eli Lilly and
Company announced today that it has entered into settlement
agreements with 14 plaintiffs' firms (or groups of plaintiffs'
firms) involved in Zyprexa liability litigation to resolve the vast
majority of remaining product liability claims against Lilly
relating to the medication. These settlement agreements follow a
master settlement agreement Lilly entered into in June 2005 that
covered approximately 8,000 claimants in the United States, as well
as additional settlements of approximately 2,500 claims. "While we
remain confident that these 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
physicians," said Sidney Taurel, chairman of the board 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 the 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. These settlement agreements will enable Lilly
to focus first and foremost on addressing unmet medical needs
through research, educational programs and partnerships with
doctors and patients." These settlements include federal and state
product liability lawsuits that have been brought against Lilly,
and claims that were the subject of "tolling agreements" that
extended the deadline for potential claimants to file a lawsuit, as
well as other unfiled claims against Lilly. The agreements also
will result in the dismissal of claims against physicians and other
healthcare professionals named as co-defendants in any cases
relating to the prescription of Zyprexa covered by this settlement.
At this time, the exact number of claimants covered by this
settlement cannot be determined, but is estimated to be more than
18,000, representing the vast majority of existing Zyprexa product
liability litigation. Approximately 1,200 claims that have been
identified to Lilly are not included in this settlement. For
several months, plaintiffs' lawyers have been discussing a possible
settlement that would resolve a substantial number of Zyprexa
cases. "We are happy that we have been able to negotiate a
settlement agreement that we believe is in the best interest of our
clients, as well as patients, physicians and caregivers," said
Richard Meadow, New York office of the Lanier Law Firm. "Prolonging
this litigation further is in no one's best interest." Taurel said,
"The litigation stirred concern for physicians and spread fear
among patients and caregivers, which has interfered with the
process of physicians making treatment decisions. We want
physicians to feel comfortable choosing the medication they believe
best meets the treatment needs of their patients with schizophrenia
and bipolar disorder." Most of the lawsuits claim that before
September 2003, the information in the package insert, which listed
the risk of hyperglycemia and diabetes as an infrequent adverse
event since 1996, was not adequately displayed. In September 2003,
the Food and Drug Administration required label changes for all
atypical antipsychotics that added information about the confounded
relationship between these medicines and diabetes. The FDA did not,
however, find that a causal relationship exists. The Honorable Jack
Weinstein of the Federal District Court for the Eastern District of
New York, the judge supervising the Zyprexa multidistrict
litigation, stated recently: "The change in Zyprexa's label in
September 2003, as ordered by the federal Food and Drug
Administration, makes less viable, on statute of limitations
grounds, such future cases." Lilly will continue to vigorously
defend Zyprexa in the remaining product liability cases,
third-party payer and state cases. Lilly is not disclosing the
terms of the settlement agreements other than to state that the
amount to be paid for over 18,000 claims in these settlements is
substantially less than the $700 million paid for over 8,000 claims
in the June 2005 settlement. As a result of these new settlements,
Lilly will record a fourth-quarter 2006 charge for product
liability litigation. The amount of the charge is currently under
review, but it is not expected to exceed $500 million. Visit
http://www.zyprexafacts.com/ for additional information about the
product liability litigation. Zyprexa Background Zyprexa 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 was introduced in 1996, it has been prescribed to
approximately 20 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 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. As with all antipsychotic
medications, a rare and potentially fatal condition known as 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
with all antipsychotic treatment, 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.
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 a 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 vast 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: Tarra Ryker, +1-317-276-3787, or
Marni Lemons, +1-317-433-8990, or Phil Belt, +1-317-276-2506, all
of Eli Lilly and Company
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