{"id":19955,"date":"2012-03-17T16:38:20","date_gmt":"2012-03-17T20:38:20","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=19955"},"modified":"2012-03-17T22:02:41","modified_gmt":"2012-03-18T02:02:41","slug":"an-unacknowledged-history","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2012\/03\/17\/an-unacknowledged-history\/","title":{"rendered":"an unacknowledged history…"},"content":{"rendered":"
In case you haven’t noticed my flurry of postings lately are the ones I never finished because I was so preoccupied with those Gibbons’ papers. Here’s another oldie I finished<\/em>: <\/div>\n
\n
J&J Wins First Risperdal Product Liability Case<\/font><\/a><\/u><\/strong>
Pharmalot<\/font><\/strong>
By Ed Silverman
February 17th, 2012<\/div>\n

<\/p>\n

In the first lawsuit to go to trial over personal injuries attributed to the Risperdal antipsychotic, a New Jersey jury decided in a 5-to-1 vote that the Johnson & Johnson drug was not a substantial factor in causing a 56-year-old man to develop diabetes. However, the jury also voted 5-to-1 that the health care giant failed to adequately warn that about the risk that the med could cause the illness, Bloomberg News<\/font><\/a><\/strong><\/u> writes.<\/p>\n

Nonetheless, Gary Skala was not awarded damages, handing J&J a welcome victory in what is likely to be closely watched litigation, given the controversy surrounding Risperdal marketing. J&J has reportedly reached a tentative deal to pay up to $1 billion to settle a federal probe into Risperdal marketing and resolve civil charges, and also agreed to a misdemeanor charge over the same issues…<\/p>\n

Last month, J&J agreed to pay $158 million to settle a lawsuit filed by the Texas attorney general, who charged the Janssen pharmaceutical unit orchestrated a controversial program called the Texas Medication Algorithm Project, which was allegedly designed to boost the use of the Risperdal antipsychotic in the public sector throughout the country.<\/p>\n

Despite the related setbacks, J&J is widely expected to fight the more than 400 product liability lawsuits over Risperdal, at least for now. The drugmaker, in fact, only settled the Texas lawsuit after overwhelmingly damaging testimony was given by various witnesses for the state about marketing practices during the first few days. The move was seen as an attempt to prevent additional evidence from becoming public<\/font><\/strong> [read this<\/font><\/strong><\/u><\/a>]…<\/sup><\/div>\n<\/blockquote>\n

Silverman’s post goes on to describe the case further. This patient had many other preconditions to develop Diabetes clouding the issue and putting the jury into the region that begged the question of "reasonable doubt."<\/div>\n
\n
In the latest trial, J&J attorneys convinced the jury that Skala, who is 5′8″ and 240 pounds, developed diabetes because he was an obese “couch potato,” and developed the illness thanks to his weight, heavy drinking, sedentary lifestyle and other risks, according to Bloomberg. Skala, who has chronic major depression, took the pill in 1996 after attempting suicide by taking an overdose of anti-anxiety medicine, and later drank up to 10 beers a day. But J&J lawyers argued that anxiety, stress, sleep problems and family history contributed to his diabetes.<\/sup><\/div>\n<\/blockquote>\n
It was a poor "test case." Besides the other risk factors in this case, Mr. Skala took Risperdal in 1996. The first reference<\/font><\/strong><\/u><\/a> I found for <depression+risperodone> in PubMed was 1998. And the studies Jannssen suppressed confirming Diabetes Risk came later. So this was, at best, a very muddy case.<\/div>\n

It’s as easy to over-generalize from court cases as it is to over-generalize from a Clinical Trial – as if either defined the truth. There is plenty of evidence from the Texas Trial that Risperdal can induce Diabetes, that Janssen knew it, and that they actively suppressed the information [see Dr. Glenmullen’s Testimony<\/font><\/strong><\/u><\/a>]. There is ample evidence scattered throughout the testimony that minimizing or denying the Diabetes potential of Risperdal was company policy. Watching the incriminating internal documents dance across the screen and listening to what the Sales Reps were doing, I was kind of surprised that Janssen didn’t settle before that trial even started. Although this may be true,<\/p>\n