Unidad de Análisis 1 ⸺UA1⸺

Certainly the trial lawyers have cashed in. Sheller has gotten a piece—maybe 5 percent, after all the referrals and costs are factored in—of some $5 billion in drug company suits and settlements from four major drug companies. And that doesn’t count the Risperdal personal injury

settlements about to come.

Which is appalling until one realizes that if he hadn’t encouraged, maybe even ambulance- chased, the whistleblowers, and if he and his fellow plaintiffs lawyers—including what Diane Sullivan might call the “1-800 crowd”—hadn’t trudged through millions of documents, the companies’ misconduct would have gone unchecked and their victims uncompensated. The government didn’t do that work.

Not a single qui tam case could have happened—none of those elite assistant U.S. attorneys would have had anything to add to their resumes—without the private plaintiffs lawyers gathering all of the initial evidence.

The FDA could have pulled the same data Johnson & Johnson regularly bought, and seen that Risperdal prescriptions were being written disproportionately by doctors who specialized in treating children and the elderly. But if someone there did, no one acted on it until the whistleblowers came forward.

Johnson & Johnson’s conduct—and that of at least eight other of the 10 largest drug companies that have been caught and are forced to operate under Corporate Integrity Agreements—may have been cured, for now, when it comes to off-label selling. But investigations continue into new avenues of possible misconduct, such as whether the companies, including Johnson & Johnson, are illegally inflating what they say are their average wholesale prices so that they can make more money off of Medicare. (Scan J&J’s latest SEC filing for a précis of these latest brushes with the law).

Beyond that, there’s the larger question of whether the honor system works to ensure that

companies with Johnson & Johnson’s Risperdal record, run by the same people who created that record, tell the FDA everything, good and bad, about all of their clinical studies. Every day we read another headline about billion-dollar M&A deals involving drug companies boasting potential new blockbusters whose tests so far look great. Can we know that for sure?

Every time Sheller thinks of the current Risperdal label, with its still-declared rate of 2.3 percent for gynecomastia, he thinks he knows the answer. He is now litigating an FDA “citizens

petition” he filed on his own behalf, demanding that the agency withdraw its approval of Risperdal (and its now-prevalent generics) for sale to children. He at least wants the FDA to issue a black box warning about gynecomastia and change the label to reflect a percentage of risk that is higher than what he argues is the fictitious 2.3 percent now on the label. After sitting on it for more than two years, the FDA denied Sheller’s petition, defending its decision about the label and denying that the drug poses the dangers Sheller claims. A federal judge then upheld the FDA’s decision, ruling that Sheller had no standing to bring the petition. Sheller is appealing. Meantime, Johnson & Johnson spokespeople point to the FDA’s rebuff of Sheller’s charge that the agency unduly acquiesced to J&J as vindication.

There’s no money in this petition battle for Sheller. “I’m just so angry about it,” he says. “It makes me crazy.”

If anything, the way the courts seem likely to handle these issues in the near future could make him crazier. The recent push from the bench, emanating from the Supreme Court, to expand the First Amendment rights of corporations could upend the core principle that a regulatory agency like the FDA can stop drug companies from spending whatever it takes to put their spin on what their products can be used for. That would not only allow promotion for off-label uses; it could ultimately threaten strict government control of the label itself. The country’s most deep- pocketed industry, which markets the world’s most important but potentially most dangerous products, would have finally been given the “sky’s the limit” freedom Senator Kefauver feared in the wake of the Thalidomide tragedy more than 50 years ago.

Some may read the saga of Johnson & Johnson and Risperdal as a story of a company getting off easy—with fines, verdicts and settlements not coming close to erasing the profit from the

company’s illegal conduct, and with no one held personally responsible. But despite the company’s guilty plea, nobody in the boardroom and executive suites at Johnson & Johnson seems to think Gorsky or anyone else did anything wrong when they deployed those ghostwritten “scholarly” articles, those “Bridge to Dementia” brochures or those Risperdal Legos to

encourage doctors to use this powerful antipsychotic to treat restless nursing home patients or children with behavior disorders. Whatever the small print on a label said or didn’t say about who should get the drug or about strokes, breasts or other side effects should not have been used to punish their passion for getting their drug to as many patients as possible.

Unless Risperdal becomes a cautionary tale, judges seem on their way to ratifying the view from the Johnson & Johnson boardroom.