Baron & Budd Secures $13.25 Million to Settle Texas Whistleblower Lawsuit Against Endo Pharmaceuticals for Fraudulently Marketing Lidoderm for Unapproved Uses

Today, the national law firm of Baron
& Budd announced that Endo Pharmaceuticals Inc. (“Endo”) has
agreed to pay $13.25 million to settle a whistleblower lawsuit brought
by the State of Texas under the Texas Medicaid Fraud Prevention Act
(“TMFPA”). The suit alleged that Endo misrepresented and concealed
information about the safety, efficacy and appropriate use of the drug
Lidoderm® to the Texas Medicaid Program. This illegal conduct is alleged
to have caused Lidoderm to be promoted in violation of federal and state
law, and rendered false Endo’s sworn certifications of compliance to
Texas Medicaid, which are required for drugs to be listed on the Texas
Medicaid formulary.

This case follows a 2014 settlement, in which Endo agreed to pay
$192.7 million to federal and state governments to resolve a lawsuit
which alleged that the company marketed Lidoderm for uses not approved
as safe and effective by the FDA. The state of Texas opted out of the
federal fraud litigation and chose to bring a separate action under
Texas law. Classified as a whistleblower lawsuit, information to support
the allegations of the fraud was brought forth by a former Endo sales
representative, Max Weathersby, and two other individuals, under MK
Litigation Partnership LLC, who had extensive and detailed information
about the sales and marketing tactics of the drug.

“We often read headlines about cases where a drug does more harm than
good, but as taxpayers paying for programs like Medicaid, we should be
outraged at having to pay for a drug that does nothing at all to help
the patient because that wastes precious resources,” said Scott
Simmer, of the law firm Baron & Budd and the attorney representing
the whistleblowers in the case. “In this case, our clients alleged that
Endo deliberately chose to suppress the findings of five clinical trials
it had sponsored, all of which showed Lidoderm was no more effective
than a placebo for treating various types of pain.”

From 2002 to 2006, Lidoderm was approved by the FDA only for the relief
of pain associated with shingles, a disease which the Centers for
Disease Control says affects around one million Americans per year.
Similar to the federal case, the suit brought by the State of Texas
alleged that Endo deliberately chose to withhold information about
negative outcomes in five clinically rigorous trials. Those clinical
trials showed that Lidoderm was no more effective than a placebo in
treating low back pain, carpal tunnel syndrome and neuropathic pain
generally. Instead, Endo is alleged to have promoted demonstrably
inferior and materially misleading studies to support the off-label use
of the drug. The suit also alleged that the pharmaceutical giant
improperly targeted physicians who were not likely to prescribe Lidoderm
for the FDA-approved indication and shipped free Lidoderm samples to
formulary executives to illegally induce them to provide preferential
formulary treatment for the drug.

“The Texas Attorney General’s Office is very diligent in its prosecution
of Medicaid fraud under the TMFPA,” Simmer said. “The state’s
prosecutors led by Cynthia O’Keeffe and Kris Kennedy are very dedicated
to this task. We thank them for their hard work and support of the role
whistleblowers played in exposing this Lidoderm fraud.”

In addition to Simmer, the whistleblowers were also represented by Baron
& Budd shareholder Andrew
Miller. Baron & Budd’s whistleblower practice brings more than 33
years of combined experience investigating and prosecuting multiple
precedent-setting fraud and abuse cases on behalf of whistleblowers and
private payors.


Baron & Budd, P.C. is among the largest and most accomplished
plaintiffs’ law firms in the country. With more than 40 years of
experience, Baron & Budd has the expertise and resources to handle
complex litigation throughout the United States. As a law firm that
takes pride in remaining at the forefront of litigation, Baron & Budd
has spearheaded many significant cases for hundreds of entities and
thousands of individuals. Since the firm was founded in 1977, Baron &
Budd has achieved substantial national acclaim for its work on
cutting-edge litigation, trying hundreds of cases to verdict and
settling tens of thousands of cases in areas of litigation as diverse as
dangerous pharmaceuticals and defective medical devices, asbestos and
mesothelioma, environmental contamination, fraudulent banking practices,
motor vehicles, employment, and other consumer fraud issues.

View source version on

Leave a Comment

Your email address will not be published. Required fields are marked *