Novartis Pays $422M For Off-Label Marketing

From Pharmalot by Ed Silverman Another week, another drugmaker agrees to settle off-label marketing charges brought by the federal government. This time, Novartis will pay $422.5 million for illegally promoting its Trileptal epilepsy med for unapproved uses, such as bipolar disorder and neuropathic pain... Go here to read the full story. UPDATE 10/1/10: More on this story at Law.com and The Wall Street Journal Law Blog. UPDATE: 10/8/10: More on the story from AboutLawsuits.com

FDA approves yet another new birth control pill; are they paying attention?

The FDA has approved a new birth control pill from Bayer Healthcare Phamaceuticals, Inc. The new pill, which will be marketed as Beyaz, was approved amid growing concerns about the increased risk of blood clots and other injuries from side effects of similar birth control pills Yaz and Yasmin which contain the same “fourth” generation progestin that will be used in Beyaz and the birth control patch Ortho Evra, about which I blogged recently (here).

Maryland Damage Cap Upheld

The Maryland Court of Appeals has rejected a challenge to the state’s cap on non-economic damages, which limits the amount of compensation plaintiffs can be awarded for pain and suffering in Maryland injury lawsuits. Go here for the full story.

Class action against Abbott for contaminated baby formula

A class action lawsuit has been filed against Abbott Laboratories by a mother who says that the company deceptively promoted Similac infant formula as safe, despite the fact that it may be infested with small beetles, which could cause gastrointestinal problems and difficulty feeding. The Similac class action lawsuit was filed by Kathleen A. Bradner in federal court in New Orleans. The lawsuit came the day after the announcement of a Similac recall for 5 million units of baby formula due to the possible presence of the bugs. For the full story go to AboutLawsuits.com.

Public Citizen criticizes FDA for not removing Avandia from the market

As reported five days ago, the FDA recently decided not to ban the diabetes drug Avandia. In response, Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group has issued a statement in which he argues that "[b]y failing to ban the dangerous diabetes drug, Avandia, . . . the Food and Drug Administration (FDA) again caved to industry pressure. Although the FDA has made progress highlighting the risks of using Avandia by severely restricting the drug, it did not go far enough. Too many people could still be exposed to this dangerous product. Rather, the FDA should have acted with its European counterpart and outright banned Avandia from the market." Read the full statement here. For more on the story go to AboutLawsuits here.

Med mal update pt 2

Here is a comment from the Tort Deform blog on the contradiction between the fact that diagnostic errors are the leading cause of malpractice suits, accounting for as many as 40% of cases and costing insurers an average of $300,000 per case to settle, while tort reformers continue to claim that doctors order more tests and procedures than needed to protect themselves against malpractice suits. In other words, as they point out "40,000 to 80,000 people die every year because doctors aren’t ordering enough tests. But on the other hand, 91% of physicians say that doctors are ordering too many tests." Read the comment here.

Med mal reform update

The PopTort blog is reporting that the Center for Justice & Democracy has just published two new articles that warn of some serious problems with state-based litigation “alternatives.” CJ&D Legal Director, Amy Widman, also just published an article in The Circuit, the online edition of prestigious California Law Review, which analyzes some of these proposals, concluding: None of the litigation alternatives currently proposed enhance patient safety while ensuring that injured patients are compensated. Limiting patients’ access to courts and compensation for their injuries does nothing to increase patient safety. Reducing financial accountability on hospitals when errors occur will likely negatively impact patient safety. And allowing hospitals to control the fact-finding process surrounding medical errors also reduces transparency and, ultimately, accountability. While there is much to praise in the health care reform bill, awarding grants to reinstitute litigation “alternatives” that have been already been tried and rejected by both courts and patients makes little sense. For more on this story go to The PopTort.

What's with all the lawyer shows on tv?!

I don't watch a lot of TV, but I try to check out shows about lawyers just in case they raise issues I can discuss in class. There have always been shows about lawyers, although many of them were (or are) disguised "detective" stories - more interested in the drama of figuring out "who did it" than on the legal issues that surround the case. But I don't remember so many lawyer shows running at the same time. Right now there are four new lawyer shows on - three of them at the same time on Wednesday nights. At some point there were promos going around about a fifth one, but I suspect that one may have been dropped since I have not seen or heard anything about it since it was announced back in the summer. In any case, the new lineup includes Outlaw, about which I have written before and which every report I have read agrees is crap, The Defenders, The Whole Truth and Law and Order LA. These last three run against each other on Wednesday nights. Here is a quick review of the Defenders by one of the law blogs I read regularly. In a nutshell, this appears to be just another disguised "detective" show (with a comic tone to it, I guess) in which lawyers do the detecting in order to help their clients. Last Wednesday I opted to watch The Whole Truth instead and here is my quick review: The show tries to be more serious than the others. It follows the work of a district attorney and a defendant's lawyer as they prepare for and try a criminal case. The editing is done so that you get to see the work of each side separately which is interesting, although perhaps not the best narrative model. Given time constraints, the pace of the show is a bit too fast or frantic and the defendant's lawyer (and his firm) follow a familiar Hollywood mold. What the producers are trying to sell as "different" about this show is that the lawyers never really know "the truth." Now, this is realistic, but unfortunately, the show then feels the need to fill the void for the audience by "solving" the uncertainty at the end. In other words, the audience will know in the end what really happened, even if the characters in the show do not. That's too bad. I think the show would be better if it left everyone with that realistic uncertainty of not really knowing, but I guess I understand this would not make for a popular choice among TV producers who want a happy audience....

FDA decides not to remove Avandia from the market

In a move that many anticipated, the FDA is leaving the controversial Avandia diabetes pill on the market, but with restrictions for patients who are unable to control their illness by using other meds. The statement of FDA commissioner Margaret Hamburg is available here. At the same time, though, the European Medicines Agency is suspending use of Avandia but not revoking approval. That statement is available here. For a lot more on this go to AboutLawsuits, The PopTort and Pharmalot, which has two additional articles on the topic: Did FDA Make The Right Decision About Avandia? and Avandia: Lessons Learned & Unanswered Questions. UPDATE 9/30/10: Here is a comment from Abnormal Use blog

Today Show segment on the dangers of birth control patch

Last week, the TV show "The Today Show" had a segment on Johnson & Johnson's birth control patch Ortho-Evra that cites court documents showing J&J knew the patch is more than 12 times likely to cause strokes and 18 times more likely to cause blood clots than birth control pills. You can see the segment here. Interestingly, some of J&J's comments seem to be based on a preemption argument which is not frivolous and may find support in the courts. Yet, to date, J&J has preferred to quitely pay at least $68 million to settle hundreds of lawsuits filed by women who suffered blood clots, heart attacks or strokes in exchange for confidentiaility agreements. Meanwhhile, Public Citizen health research director Dr. Sid Wolfe has reiterated remarks filed in a 2008 citizen petition that the patch should be banned. The FDA, not surprisingly, has dragged its feet and claims the issue "is complicated." For more on this story go to Pharmalot and The PopTort.