NEW BRUNSWICK, N.J. & WEST CHESTER, Pa.—A few days, a few hundred million? That’s what it feels like as Johnson & Johnson announced June 8 that it expects to incur a special charge in the second quarter of 2012 of approximately $600 million to increase its accrual for the potential settlement of previously disclosed civil litigation matters related to 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 has agreed to pay as much as $2.2 billion to settle U.S. probes of the marketing of the three medications.  

 

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

 

The alleged settlement also reportedly would resolve 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 the company’s legal tussle with the United States, it won’t necessarily put an end to claims by some states. In fact, Johnson & Johnson may not even be looking 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 court over a $158 million settlement agreement regarding accusations over the company’s marketing of Risperdal.  

 

Plaintiff Allen Jones, a whistleblower on the company’s marketing practices, said the return to court is an effort on Johnson & Johnson’s part to “produce a chilling effect on the ability of whistleblowers to come forward.” In a similar case, an Arkansas judge ordered the company to pay $1.1 billion after a jury ruled the company’s Janssen unit violated the Medicaid Fraud False Claims Act in its Risperdal marketing and engaged in “false or deceptive acts.” Arkansas has sought damages in the case and more than $1.2 billion in penalties, and 11 states have sued Johnson & Johnson and Janssen with claims related to Risperdal.   

 

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

 

Findings from the study indicated that the Hypoglycemia-Hyperglycemia Minimizer (HHM) System was able to automatically predict a rise and fall in blood glucose and correspondingly increase and/or decrease insulin delivery safely. The HHM System included a continuous, subcutaneous insulin pump, a continuous glucose monitor (CGM) and special software used to predict changes in blood glucose. The study was conducted by Animas Corp. as part of an ongoing effort to advance the development of a closed-loop artificial pancreas system for patients with type 1 diabetes.  

 

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

 

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