Texas Files Lawsuit against J&J over Risperdal

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 http://www.statesman.com/news/content/news/stories/local/12/16/

16drugs.html

Lawsuit claims state official pushed drug, was rewarded with money.

 

By Embry and W. Gardner Selby

AMERICAN-STATESMAN STAFF

     Saturday, December 16, 2006

 

A major corporation and several subsidiaries misrepresented the safety

and effectiveness of an anti-psychotic drug and unduly influenced at

least one state official to make it a standard treatment in public

mental health programs, according to a lawsuit the state has joined.

 

Attorney General Greg Abbott joined a lawsuit filed in County

district court by , a former investigator for the state of

Pennsylvania, against & Inc. and five related

companies. says in the lawsuit that he learned of payments to at

least one Texas mental health official in interviews he conducted as an

investigator. No official is named in the lawsuit.

 

The lawsuit, which came to light Friday, seeks to recover for the state

untallied alleged overcharges to the state's Medicaid program, which

pays for health care for low-income people.

 

' lawsuit alleges that the companies launched a drug named

Risperdal in 1994 to treat schizophrenia. About the same time, the

state was developing a protocol, or treatment guidelines, for which

drugs should be used in public mental health programs. The defendants

" provided substantial financial contributions to and improperly

influenced the development " of the protocols, the lawsuit said, and

Risperdal took precedence in the protocols over cheaper, equally

effective medicines.

 

The drug later received recommendations as the medicine of choice in

the state's mental health protocol for treating children and

adolescents, even though it lacked a Food and Drug Administration

indication for those age groups, the lawsuit says. It says side effects

and health risks include increased chance of stroke, renal failure and

hyperglycemia.

 

The companies pushed Risperdal in other states through paid consultants

on expert panels, peer-to-peer marketing strategies and " administrative

decisions made by a select few public officials, " the lawsuit says. The

companies sent an unnamed Texas official around the country as a

spokesman for the drug, and they hired third-party contractors to

conceal their control and funding of medical education programs,

speakers' bureaus and clinical research that promoted the benefits and

safety of Risperdal, the lawsuit says.

 

The lawsuit says at least 17 states, including Texas, have implemented

the protocol or are doing so.

 

" We allege it's a scheme whereby they passed off as medical science

phony representations and misleading facts about the efficacy and

appropriateness of these drugs, " said Melsheimer, a lawyer for

.

 

Abbott's office declined to comment on the lawsuit, as did spokesmen

for & and the state's Health and Human Services

Commission, which oversees the Medicaid program. A commission spokesman

did say Texas paid 308,000 claims totaling $73.5 million for Risperdal

in 2005.

 

Melsheimer described as a " classic whistle-blower " who filed the

lawsuit in 2004 on behalf of Texas to recover the companies'

overcharges. Because of his whistle-blower status, the lawsuit was

sealed from public view until Abbott joined it.