Lead paint, market share liability and due process

As you probably know, "market share liability" is a concept created to help a plaintiff establish the element of cause in fact when the plaintiff can't truly identify the specific person or entity who caused the injury. Originally, it was created to allow plaintiffs to recover in cases where the plaintiff joined as defendants the manufacturers of products that were chemically identical. For many years, the concept was used only in cases involving the drug "DES." That changed in Thomas v. Mallett, 701 N.W.2d 523 (Wis. 2005), one of only a couple of cases to recognize liability for injuries related to lead paint. Now, a new decision by the Federal District Court for the Eastern District of Wisconsin challenges the use of the market share liability doctrine in cases other than those for which it was originally created holding that the expansion of state common-law tort liability can be so overreaching and so contrary to settled legal expectations as to violate a defendant's right to due process. See Gibson v. American Cyanamid, Inc., (E.D. Wisc. June 15, 2010) (available here). In other words, Gibson declares unconstitutional the expansion of market share liability to non-fungible products. For a long comment on this case, go here.

Toyota Steering Problems Uncovered in Lawsuit Lead to NHTSA Probe

AboutLawsuits.coom is reporting that a wrongful death lawsuit over a fatal Toyota pick-up truck accident has brought documents to the surface that once again have federal investigators questioning whether Toyota dragged its feet on issuing an earlier recall over steering problems. For the full story and links to more information go here.

This Week's Top Stories

The editors of the TortsProf Blog weekly round-up of top stories are taking a well deserved break for the summer. My own selection of top news stories is available here, though.

"Female Viagra" pill update: FDA says NO

It's a "no go" for the so-called female viagra pill discussed in my previous post (see below this one). Here is the story (edited) as reported in Pharmalot: After weeks of anticipation and debate, an FDA advisory committee decided a Boehringer Ingelhim pill that was tested for treating Hypoactive Sexual Desire Disorder in women was neither safe nor effective. The voting was rather stark - all 11 panelists decided the side effects were unacceptable, and 10 ruled the pill, known as flibanserin, is not effective. The outcome is hardly surprising, given concerns outlined by FDA reviewers in briefing documents that were released prior to the meeting. . . . . . . . .The run up to the meeting was characterized by a full-scale promotional push and heated debate over the validity of using medication to treat HSDD, which some refer to as Female Sexual Dysfunction. Some critics even question the extent to which HSDD has been legitimatized in the Diagnostic and Statistical Manual of Mental Disorders . . . In any event, the FDA panel vote leaves US women without what some like to call a female equivalent to Viagra, at least for now. For the full story (including links to more information), go here.

(In)direct to consumer advertising?

I am sure you have heard of "direct to consumer advertising" -- the marketing of prescription drugs directly to consumers (on TV, radio, printed media and the internet, etc) even though the products can only be obtained by prescription. But how about "indirect advertising"? And how about promotion of a product which has not even been approved by the FDA yet?

Pharmalot is reporting that for the past month, The Discovery Channel has been running on its web site a four-part series called ‘Understanding Female Sexual Desire,’ the sponsor of which just happens to be Boehringer Ingelheim, which is trying to convince the FDA to approve a pill to treat a disorder related to female sexual desire it calls female sexual dysfunction. The program is careful to not mention any drugs or to suggest that the problem should be treated with drugs, particularly since there is no drug approved to treat the condition, but it seems to be designed to suggest that there is a need for such a drug. And since the sponsor of the program happens to be the company trying to get such a drug approved by the FDA.... well, you can draw your own conclusions.

Maybe it is a great company, seeking to help a great deal of women by providing a product that they truly need ... Or maybe not....

There is an ongoing debate as to whether the so-called dysfunction is really a medical condition/disorder or something the pharmaceutical industry came up with in order to convince women to buy a product they don't need.

In fact, there is a new documentary in limited release around the country called Orgasm, Inc. (go here for more information, including screening schedules) that apparently argues that a pharmaceutical company, along with a cadre of other medical companies, are trying to take advantage of women (and potentially endanger their health) in pursuit of billion dollar profits. Here are two trailers for the movie:

 

 


UPDATE: Two days before of the controversial FDA advisory committee meeting to discuss what is now being referred to as the "female Viagra pill", a team of agency reviewers found the Boehringer Ingelheim pill, which was tested to treat Hypoactive Sexual Desire Disorder, failed to meet agreed-upon criteria to establish effectiveness in two company studies. According to Pharmalot, there was no statistically significant improvement on the co-primary endpoint of sexual desire, although the pill did show a statistical difference in generating sexually satisfying experiences when compared to a placebo (read the report here). The FDA meeting is TODAY (Friday June 18). I will continue to update this post with more reports as I see them....

FDA Draft Study Concludes Avandia Side Effects May Have Hurt or Killed 100,000 People

A draft study by an FDA scientist (available here) has linked side effects of Avandia to tens of thousands of heart problems among elderly users, and suggests that more than 100,000 Americans may have suffered heart attacks, strokes or other problems from Avandia since the drug was introduced. Go here for the full story.

Radiation Exposure Concerns Lead To New Industry Standards

AboutLawsuits.com is reporting that radiation therapy equipment manufacturers have launched an initiative to implement new industry-wide safety standards in the face of FDA scrutiny and growing concern over the radiation risks of CT scans and radiation-emitting medical devices. Go here for the full story.

FDA issues warning against Pfizer for failure to report side effects

In response to a six week long audit of Pfizer’s New York headquarters last summer, the FDA has recently issued what has been decribed as a "stinging" 12-page letter scolding Pfizer for failing to meet regulatory deadlines for reporting serious side effects with many of its drugs, including Lipitor, Selzentry, Lyrica, Camptosar and Viagra. Go here for the full story. Go here for a copy of the letter.

Three new TV shows (with trailers)

With the recent demise of the original "Law & Order" and "Raising the Bar," the major networks are apparently feeling the need to introduce new law related shows. Here are the trailers. One is called "Outlaw" about a Supreme Court Justice who decides to retire and go into private practice. Another is called "The Defenders" and is about a pair of criminal defense lawyers. The third one is "Harry's Law" about people brought together by fate to form a law firm. I enjoy watching law related shows and movies and reading "legal thrillers" as much as anyone, but I often wish they were much better than what they usually are. I will give all of these a chance but from what I can see in these trailers at least two of them appear to be based on tired old stereotypes: either every client is innocent (Outlaw) or criminal defense lawyers are sleazy (The Defenders), aside from the fact that apparently all lawyers are young, beautiful, fit, sexy and have lots of sex in the office and law libraries. Outlaw also seems to have the stereotypical "team" of characters (common to so many "heist" type movies): the outlaw, the rebel, the intellectual, the smartass, the computer genius, etc. If they add a demolitions expert maybe they could compete with the A-team. The Defenders looks like it might be more of a comedy "detective" show; more about trying to figure out "who did it" than about legal issues. Harry's Law seems to escape the mold - or at least part of it. This one is produced by David E. Kelley, producer of three relatively successful law related shows. The trailer has some pretty funny lines and Kathy Bates is always entertaining. But, given that I didn't like any of the three previous David E. Kelley shows, I will have to wait and see... But I am getting way ahead of myself. Let's give them all a chance.... Maybe they will last longer than the last few attempts ... Does anybody remember "Shark" or "Eli Stone"?

Will a criminal investigation of the oil spill affect civil cases?

Law.com is reporting that the U.S. Justice Department's decision to open a criminal investigation into the Gulf Coast oil spill is threatening to complicate scores of lawsuits brought by people seeking compensation for the disaster. Read the full story here. I think, though, that what is going to affect the civil claims the most is BP itself. I am very pessimistic about this. I fear BP will find a way to avoid paying compensation for the damages caused. It will claim caps, delay payments or make it difficult for people to access their payments (there are reports of this already) or, when all else fails, file for bankruptcy. I hope I am wrong.