Johnson & Johnson rumored to be paying as much as $2.2 billion to settle U.S. drug marketing charges

Company has announced it expects to incur a special charge in Q2 2012 of some $600 million toward the potential settlement of civil litigation related to Risperdal, Invega and Natrecor, but sources inside say that’s not the whole amount

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Jeffrey Bouley

NEW BRUNSWICK, N.J. & WEST CHESTER, Pa.—A fewdays, a few hundred million? That's what it feels like as Johnson & Johnsonannounced June 8 that it expects to incur a special charge in the secondquarter of 2012 of approximately $600 million to increase its accrual for thepotential settlement of previously disclosed civil litigation matters relatedto the drugs Risperdal (risperidone), Invega (paliperidone) and Natrecor (nesiritide)and to dealings with Omnicare Inc.—followed three days later by media outlets,Bloomberg most notably, citing two unnamed insiders as saying the company hasagreed to pay as much as $2.2 billion to settle U.S. probes of the marketing ofthe three medications.

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Reportedly, the settlement could be announced thisweek and would likely include a misdemeanor plea and criminal penalty of asmuch as $600 million, according to those sources, which perhaps-not-coincidentallymatches up with the amount announced on June 8 by Johnson & Johnson.

The alleged settlement also reportedly wouldresolve civil claims that Johnson & Johnson paid kickbacks to Omnicare Inc.,a company that dispenses drugs for nursing homes.

While the agreement, if it is real, might end thecompany's legal tussle with the United States, it won't necessarily put an endto claims by some states. In fact, Johnson & Johnson may not even belooking to settle with everyone who has claims against it; in May of this year,for example, Johnson & Johnson and the state of Texas returned to courtover a $158 million settlement agreement regarding accusations over thecompany's marketing of Risperdal.

Plaintiff Allen Jones, a whistleblower on thecompany's marketing practices, said the return to court is an effort on Johnson& Johnson's part to "produce a chilling effect on the ability ofwhistleblowers to come forward." In a similar case, an Arkansas judge orderedthe company to pay $1.1 billion after a jury ruled the company's Janssen unitviolated the Medicaid Fraud False Claims Act in its Risperdal marketing andengaged in "false or deceptive acts." Arkansas has sought damages in the caseand more than $1.2 billion in penalties, and 11 states have sued Johnson & Johnsonand Janssen with claims related to Risperdal.

In brighter news for Johnson and Johnson,sandwiched on June 10 between its own $600 million announcement and theBloomberg story about the presumed settlement, the company announced resultsfrom the first feasibility study of an advanced first-generation artificialpancreas system.

Findings from the study indicated that theHypoglycemia-Hyperglycemia Minimizer (HHM) System was able to automaticallypredict a rise and fall in blood glucose and correspondingly increase and/ordecrease insulin delivery safely. The HHM System included a continuous,subcutaneous insulin pump, a continuous glucose monitor (CGM) and specialsoftware used to predict changes in blood glucose. The study was conducted byAnimas Corp. as part of an ongoing effort toadvance the development of a closed-loop artificial pancreas system forpatients with type 1 diabetes.

"The successful completion of this study using theHHM System in a human clinical trial setting is a significant step forward inthe development of an advanced first-generation artificial pancreas system,"said Dr. Henry Anhalt, Animas' chief medical officer and medical director ofthe artificial pancreas program. "It lays the foundation for subsequentclinical trials, bringing us one step closer to making the dream of anartificial pancreas a reality for millions of people living with type 1diabetes."

In additional diabetes news just a day after that, anexperimental treatment for type 2 diabetes developed by Johnson & Johnson,canagliflozin, reportedly demonstrated greater reduction in blood sugar thanMerck & Co.'s Januvia and an older common treatment, glimepiride, accordingto data from a pair of late stage clinical trials. Use of canagliflozin alsomay lead to significantly greater weight loss than both of the other drugs and fewerincidents of hypoglycemia than glimepiride.

Johnson & Johnson rumored to be paying as much as $2.2 billion to settle U.S. drug marketing charges

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Jeffrey Bouley

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