August 2nd, 2011

Massachusetts Sues J&J Over Risperdal Marketing

Pharmalot

Yet another state has filed a lawsuit alleging that Johnson & Johnson illegally marketed its Risperdal antipsychotic to the detriment of its citizens. This time, Massachusetts alleges J&J promoted the drug to treat elderly dementia and various unapproved uses in children and adolescents. The state also claims J&J failed to disclose serious risks such as the possibility of excessive weight gain, diabetes and, for elderly dementia patients, an increased risk of death.

“Manufacturers should not promote uses of their pharmaceutical products that have not been established to be safe and effective,” Massachusetts Attorney General Coakley says in a statement. “Janssen put profits ahead of patient safety by promoting Risperdal for uses that had not been approved and by failing to disclose serious risks associated with Risperdal’s use.”

The state also charged the health care giant with making misleading and deceptive statements to prescribers about Risperdal safety, especially such side effects as weight gain and developing diabetes; paying docs to participate in “sham consulting programs” that were “thinly disguised” marketing programs touting unapproved uses; and targeting docs who rarely, if ever, prescribed Risperdal for FDA-approved uses which are schizophrenia and bipolar mood disorder (read the lawsuit here).

The lawsuit comes as J&J holds talks to to resolve a raft of litigation and investigations related to Risperdal marketing. Four months ago, J&J set aside an unspecified amount of money to be used to settle some of the litigation. The Office of the Inspector General of the United States Office of Personnel Management, the US Department of Justice, the US Attorney in Philadelphia and Attorneys General of multiple states have been probing off-label Risperdal marketing for years (see this).

Although reports have suggested J&J may wind up settling much of the litigation for $1 billion or so, the tab may be mounting. In June, a South Carolina judge that J&J must pay $327 million for deceptive Risperdal marketing, and last fall, a Louisiana jury ordered J&J to pay $257.7 million in damages for making misleading safety claims (read here), although $73 million in legal fees were later added. In explaining his decision, the South Carolina judge labeled J&J actions “detestable” (look here).

J&J has scored a couple of victories. A lawsuit brought by Pennsylvania officials, who charged J&J hid the risk of diabetes and misled state regulators into paying millions more than they should have for the medicine, was dismissed (see here). And two years ago, a West Virginia judge awarded $3.95 million, after finding J&J misled doctors about risks and benefits, although the state dropped its claim after J&J won an appeal. Nonetheless, the average loss has so far cost about $150 million (four state lawsuits) or roughly $300 million (when considering two actual defeats).

As we have noted previously, J&J will appeal the losses in Louisiana and South Carolina, and could possibly pay much less than the penalties awarded. By suggesting a global deal might total $1 billion or so, the health care giant may try to get the amounts reduced on a proportionate basis, and use the same argument in talks with any state that does not join a settlement. But if more states file lawsuits, the costs could rise. Perhaps the timing of the Massachusetts lawsuit is not a coincidence.

One looming case is scheduled to go to trial this November in Texas. And J&J potentially faces a much bigger liability in that Texas has a much larger population than Louisiana and South Carolina and, therefore, would encounter a heftier payout. This case, by the way, also involves statutory and common law fraud issues that were not raised in the other states. The focus is on the so-called TMAP program that was allegedly designed to boost Risperdal prescriptions by unduly influencing University of Texas professors and state officials to endorse the effort and promote it nationally.

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