Like a game of whack-a-mole, no matter how many times Johnson & Johnson attempts to put to rest lawsuits over the marketing of its Risperdal antipsychotic, another claim pops up. The latest is a lawsuit filed this week by the Kentucky attorney general, who like others before him in federal and state governments, charge the health care giant with illegally promoting the widely prescribed pill.
The charges are familiar: J&J is accused of hiding and minimizing side effect data about diabetes and weight gain, and concealing evidence that Risperdal causes increased levels in children of a hormone that stimulates breast development and milk production. Last fall, J&J began settling lawsuits charging the pill causes gynecomastia, which is the abnormal development of large mammary glands in males (here is the lawsuit).
In the scheme of things, this is just one more lawsuit that, as noted, covers familiar ground, but underscores the extent to which Risperdal marketing practices continue to haunt the health care giant, which is struggling to overcome the negative impression caused by manufacturing gaffes that led to countless product recalls and a scandal over the safety of its hip replacement devices.
J&J, in fact, is haggling with the feds over the terms of a $2.2 billion settlement. Specifically, the drugmaker is trying to avoid admitting to conduct that could negatively affect the outcome of the personal injury lawsuits involving gynecomastia. The feds want J&J to admit data played down the risks from increased prolactin, while J&J wants the feds to agree not to continue to pursue the allegation (read more here).
As noted, many other states succeeded in forcing J&J to pay for Risperdal marketing practices. Last year, J&J agreed to pay $181 million to resolve claims by 36 states (see this), an Arkansas judge fined the health care giant $1 billion (look here) and J&J (JNJ) agreed to pay $158 million to settle a lawsuit brought by the Texas attorney general (back story). And two years ago, J&J was ordered by a South Carolina judge to pay $327 million for deceptive marketing, which he called detestable (see here).
Risperdal marketing has been a special kind of albatross for J&J ceo Alex Gorsky as well. Last year, the feds tried unsuccessfully to compel him to provide a deposition in a widely publicized kickback case involving the Omnicare nursing home pharmacy. At issue were charges Omnicare received kickbacks – in the form of rebates, educational grants and payments for marketing data – so that Risperdal would be prescribed more often. As we wrote last year, from October 1998 to October 2001, Gorsky was vp of marketing at the Janssen unit that sold the drug, and from October 2001 to early 2003 he was the Janssen president. During that time, he was responsible for selling Risperdal, and Omnicare was the biggest Risperdal customer.
Moreover, according to the feds, his resume noted that Gorsky instituted a Janssen compliance program for regulatory and legal issues. He also regularly received monthly reports on J&J’s Long Term Care Group, including reports which had details about Omnicare efforts to promote Risperdal prescribing of Risperdal. And Gorsky met repeatedly with senior Omnicare execs to discuss those efforts (read more here).
Conway, by the way, has raised the ire of drugmakers in other ways in the past. After filing a similar lawsuit alleging Merck (MRK) violated state consumer protection laws two years ago, the drugmaker turned around and filed a lawsuit of its own, charging the attorney general inappropriately retained outside counsel to assist in the litigation. Merck contended that a contingency-fee arrangement could lead to a biased and overzealous prosecution (back story). UPDATE: This case is ongoing.