Philadelphia Inquirer

2012-09-28

Public companies file documents with the U.S. Securities and Exchange Commission all the time, and the chief executive officer signs them to say they are true. Shareholders and others can look at the statements at sec.gov.

But showing particular documents to a jury is not so automatic.

On Thursday, attorneys representing a 17-year-old youth, whose mother is suing health-care giant Johnson & Johnson in Philadelphia’s Court of Common Pleas because she says he grew breasts after taking the company’s antipsychotic drug Risperdal, asked the judge for permission to show jurors SEC documents in which the company says it is close to pleading guilty to a misdemeanor criminal charge in a federal investigation of off-label marketing.

Doctors can legally prescribe anything, but drug companies can’t promote a drug for anything not on the official FDA-approved label. Doing so is referred to as off-label marketing.

It is unclear when Common Pleas Court Judge Mark Bernstein will rule on the motion.

Attorney Laura Smith, who is leading the J&J legal team in the lawsuit by the boy, declined to comment after court recessed Thursday.

Companies are expected to describe their view of pending litigation in so- called 10- Q reports, which are watched by Wall Street analysts and investors for the profits or losses for the preceding quarter.In filings in 2011 and 2012, J&J said it has an “agreement in principle” with federal prosecutors in Philadelphia and Washington to resolve criminal charges related to a single misdemeanor violation of federal law.

By “resolve,” the healthcare giant means admit guilt, but nothing is finalized in the federal investigation and the spokeswoman for the U.S. Attorney’s Office in Philadelphia declined to comment Thursday.

The pending federal case is the biggest of the many pieces of litigation for J&J over Risperdaland allegations of inappropriate marketing. Janssen Pharmaceuticals is the wholly owned subsidiary that makes Risperdal.

The drug was approved in 1993, but only to treat adults with schizophrenia and bipolar disorder, which have small populations, and that makes generating huge profits difficult. The common allegation across all the suits is that Janssen promoted Risperdal for unapproved uses, including for treating children for several mood disorders.

Aside from the SEC filings, J&J has denied wrongdoing.

J&J faces hundreds of individual suits from patients claiming harm. Though it defeated the Commonwealth of Pennsylvania’s individual suit, J&J has been on the losing side of multi-million-dollar judgments in state-led Medicaid cases in Louisiana, South Carolina, and Arkansas. The company is appealing those decisions. It paid $158 million to stop a trial in Texas.