Saturday, May 29, 2010
Friday, May 21, 2010
Tuesday, May 18, 2010
Here is a link to a story about a doctor who is currently facing hundreds of criminal accusations and torts claims over inappropriate sexual conduct with patients while other doctors knew or should have known about it and did nothing. According to the reports, under Delaware law, physicians who "reasonably believe" another doctor has been involved in misconduct or could be unfit to practice medicine have a duty to report this to a disciplinary board. Should there be liability on the doctors who failed to take action?
Sunday, May 16, 2010
Here is a link to a podcast on the latest on the Toyota litigation. I have not had time to listen to it yet, but I thought I'd post the link so you can try it out.... (You can also try this link which should play the podcast using windows media player directly).
GlaxoSmithKline reportedly agreed to settle the first batch of lawsuits that allege its Avandia diabetes pill causes heart attacks and strokes. The deal comes as Glaxo faces its first Avandia trial in state court in Philadelphia in July and about 4,000 lawsuits that have been filed so far. For more on this story go to Pharmalot and Bloomberg News.
Here is Pharmalot's version of the story on the FDA attempts to get doctors to report bad advertisements by pharmaceutical companies.
Saturday, May 15, 2010
Federal drug regulators are hoping to recruit doctors in the hunt for misleading drug advertisements through a new initiative aimed at marketing materials that provide inaccurate or misleading information, or make statements that downplay or omit the negative side effects of drugs. Go here for the full story. For a comment from the right wing Washington Legal Foundation on this topic go here.
A prominent consumer advocacy group and a leading Canadian researcher are calling on federal regulators to bring an immediate halt to a diabetes drug trial due to the risk of heart problems from Avandia, suggesting that it is unethical and dangerous for the FDA-sanctioned study to continue. Go here for the full story.
Saturday, May 8, 2010
Thursday, May 6, 2010
As oil continues to spread over the Gulf Coast, so do lawsuits. At least three wrongful-death suits have been filed because of the oil rig explosion and several others related to environmental and economic damages. For more on these stories go to Law.com here and here.
So what is the issue with this "off label marketing" thing?", you ask. Okay, here it is in a nutshell: on the one hand, because the FDA has a duty to protect public safety, it regulates what manufacturers can claim about their products in their marketing campaigns. On the other hand, manufacturers claim the right to freely discuss what they claim are the virtues of their products even if the products have not been approved by the FDA for the purposes the manufacturers want to talk about. As you would expect, consumer and safety advocates side with the FDA's position, while manufacturers, tort reformers and right wing organizations side with the pharmaceutical companies. For more on this go to this short post on Pharmalot; for a comment from the right wing Washington Legal Foundation go here. The WLF has filed briefs challenging the FDA's authority to regulate the manufacturers' statements about their products' non-approved uses. (PS: For readers of the blog who took Professional Responsibility with me in law schoool: you may remember the Washington Legal Foundation as the organization that challenged IOLTA programs to fund legal aid services for the poor.)
Wednesday, May 5, 2010
AboutLawsuits is reporting today taht at a House Agriculture Appropriations subcommittee hearing last week, representatives and senators from both sides of the aisle expressed dismay and concern that the FDA has not recalled Avandia, given a number of reports, studies and even concerns from FDA officials that the drug could be responsible for tens of thousands of heart attacks and deaths. Go here for more on that story.
Every now and then, the "unreasonable dangerous products liability blog" posts brief interviews with law professors, practitioners and other commentators in the field of products liability law. Here is a link to the most recent one. And here is a list of the questions addressed: 1. What do you think is the most significant new development in products liability of the last year? 2. What rule or concept in modern products liability jurisprudence is the most outdated? How would you change it and why? 3. Generally, how would you characterize the media coverage of products liability? 4. What advice would you give to lawyers practicing products liability in 2010. What should they be looking out for? 5. What federal or state court opinion has been the biggest surprise for you of late and why? 6. What do you believe is the most interesting depiction of a products liability lawsuit in popular culture?
As reported in the Drug Recall Lawyer Blog: CNN reports on the Tylenol recall and the FDA's investigation into the quality control issues and security lapses at Johnson & Johnson's Pennsylvania manufacturing facility. An FDA representative has stated "This is yet another example of when a company has to take full accountability for the quality of its drugs [with] severe consequences for not doing so." As new evidence comes to light, it appears that Johnson & Johnson has not timely addressed customer complaints since June 2009 about foreign substances in the medicine. Here's a link to the FDA's press release, and a link to the 17-page FDA plant inspection report.
I hate to brag (well, maybe not so much...) but I have to say "I told you so!".... At the end of last year I predicted that the issue of "off label marketing" would become the "hot" topic in 2010 (here and here), and it is certainly starting to look like it. Recent reports continue to come in about fines and settlements for violations of regulations related to "off label marketing." (See here, here and here, for example.) Today, Pharmalot is reporting two stories related to marketing of pharmaceuticals. Neither is related to a torts claim per se, but I am reporting them here because they do relate to pharmaceutical products and to the conduct of the manufacturers in how the market those products. The first news item is that two units of the drugmaker Novartis have agreed to pay a $72.5 million fine in order to resolve civil False Claims Act charges over the marketing of a cystic fibrosis medicine. Pharmalot has a link to a copy of the settlement here. The federal government will get $43.5 million and various states will receive $29 million. The second news item reported today is that the Utah Attorney General has filed a lawsuit against Johnson & Johnson and AstraZeneca over allegations they failed to disclose side effects, notably diabetes, caused by their antipsychotics - Risperdal and Seroquel, respectively - and improperly marketed the pills, therefore, causing the state’s Medicaid program to overpay for the medications. Go here for more on that story.