J&J Hid Risks Risperdal Makes Boys’ Breasts Grow: Lawyer

Johnson & Johnson officials knew the antipsychotic drug Risperdal could cause boys to grow female breasts and hid those risks from doctors and patients, a lawyer for a Texas teen-ager suing the company told a jury.

J&J executives knew Risperdal could cause increased hormone levels that prompted female breast development in males and trained salespeople to downplay or hide that fact in marketing calls on doctors, Bob Hilliard, a lawyer for Andrew Bentley, told a state-court jury in Philadelphia in the first case over the claims to go to trial.

“A drug that was never meant for kids was illegally marketed to kids,” Hilliard said in opening statements today. “Johnson & Johnson knew about this side effect, did not warn about it and actually covered up evidence about it.”

Bentley’s case is one of about 420 lawsuits against J&J and its Janssen unit that allege personal injuries caused by Risperdal, the company said in a regulatory filing last month. The teen was able to bring his case in Pennsylvania because J&J has operations in the state.

The 17-year-old Houston resident claims he took Risperdal to treat problems related to Asperger’s Syndrome during times when federal regulators hadn’t approved the drug for use in children, according to court filings. His lawyers argue J&J illegally marketed the pills to rack up more than $1 billion in sales.

Normal Development

J&J’s lawyer countered today that Bentley’s breast development was normal for a teen going through puberty and Risperdal played no role in it.

Bentley’s breast growth “was totally consistent with” the idea that the teen developed breasts as part of puberty, Laura Smith, one of the company’s attorneys, told the jury. She said that the company denied illegally marketing the drug.

J&J and Janssen’s marketing of Risperdal has also been the subject of government investigations and lawsuits.

The U.S. has been investigating Risperdal sales practices since 2004, including allegations the company marketed the drug for unapproved uses, J&J executives said in a regulatory filing.

J&J officials reached an agreement with the U.S. Justice Department to pay as much as $2.2 billion to resolve probes of its sales of drugs, including Risperdal, according to people familiar with the matter, Bloomberg News reported earlier this year.

The company last month agreed to pay $181 million to resolve claims by 36 states that it improperly marketed and advertised Risperdal and Invega, another antipsychotic.

Risperdal Fines

In April, a judge in Arkansas ordered the drugmaker to pay $1.2 billion in fines over Risperdal marketing. That verdict came three months after J&J decided to end a trial in Texas over the drug’s sales with a $158 million settlement. The Texas case included claims that the company marketed the drug for children while lacking approval by regulators for such use.

In June 2011, a judge in South Carolina ordered J&J to pay $327 million in penalties for deceptively marketing the medicine. The company on Aug. 31 lost a bid to have a Louisiana appeals court throw out an award of almost $258 million that a jury ordered it to pay over Risperdal marketing in that state.

The drug’s global sales peaked at $4.5 billion in 2007 and declined after the company lost patent protection. It generated $3.4 billion in sales in 2008, or 5.4 percent of J&J’s revenue, according to company filings. Sales of the drug fell to $527 million in 2010, according to earnings reports.

The case is A.B., a minor v. Janssen Pharmaceuticals, 00649, Philadelphia Court of Common Pleas, January Term 2010.

(Updates with details from J&J’s opening statements starting in sixth paragraph.)
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