Public Citizen petitions FDA to amend regulations to counter effect of Supreme Court decision

In PLIVA Inc. v. Mensing (available here), the US Supreme Court held that federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus preempt, state tort-law claims based on drug manufacturers’ alleged failure to provide adequate warning labels for their products. The regulations essentially require generic drug manufacturer to have the exact same labeling as the brand-name drug, which means that these manufacturers can't update their labels about new known risks unless the brand name manufacturers do so first or unless they get special permission from the FDA.  Brand name manufacturers are allowed to update their warning without having to seek special permission of the FDA.

In order to counter the effect of the Supreme Court's decision, prominent consumer advocacy group Public Citizen has filed a petition urging the FDA to revise regulations that prevent generic drug makers from updating their warning labels to include information about known risks associated with their drugs. The petition is available here.

For more on this story go to Pharmalot, AboutLawsuits and the FDA Law Blog.

For more on the US Supreme Court decision on the subject go here.

DC Circuit Court of Appeals may reconsider application of Alien Tort Statute to corporations; next stop: the US Supreme Court

Back in July I reported that the Washington, D.C. Circuit Court of Appeals issued a ruling that recognized the right of Indonesian villagers to sue Exxon Mobil for alleged killings and torture committed by Indonesian soldiers guarding the company’s natural-gas operations in Indonesia.

The blog of the Legal Times is now reporting, however, Exxon Mobil Corp. asked the full U.S. Court of Appeals for the D.C. Circuit to reject the panel decision arguing that the panel's decision vastly expanded the statute to find that corporations can be liable for violent acts committed abroad, an allegation that is difficult to understand given the history of the Alien Tort Statute. Exxon is apparently also asking the court to “reject the notion that the ATS can be used as a vehicle to bring suit in U.S. courts for alleged misconduct that occurred abroad," which is also contrary to the interpretation of the statute by all courts to date.  Exxon's petition can be found here.

Although there aren't that many US Supreme Court cases on the ATS, there is a long line of cases from lower federal courts that have interpreted its application over the years.  Only one of these cases has ever decided that the statute should not apply to corporations and a cert petition in that case is now pending before the US Supreme Court.  That case, decided by the Court of Appeals for the Second Circuit is available here.  Given the split in the circuit courts, it is almost inevitable that the Court will review the issue this term.

To catch up with this very interesting and important issue, go to my section on the Alien Tort Statute, scroll down and read up (in chronological order).

Med mal awards at an all time low and other stats about med mal

Malpractice awards may be at an all time low in the United States, according to Public Citizen's 2010 report (available here) which was based on data obtained from the National Practitioner Data Bank (NPDB). The report concludes that the number of malpractice payments made on behalf of doctors in 2010 was the lowest on record since the NPDB began keeping track in 1990. The total number of payments made on behalf of physicians dropped to 10,195 in 2010, down from a high of 16,566 in 2001. The majority of the payments were for injuries resulting in death or permanent injury.  Interestingly, although not surprisingly to anyone paying attention to the facts, the costs of health care continue to rise and medical malpractice payments only amounted to 0.13% of overall health care costs.  According to the report, total health care costs rose 90% between 2000 and 2010, while medical malpractice payment dropped 11.9%.

One important question that remains unanswered is exactly why was there such a drop in malpractice payments.  Obviously, it has not been due to a decrease in medical errors but probably due to a combination of factors including the effects of successful tort reform measures which continue to be approved throughout the states. For recent news on this go to my tort reform section, here.  And, of course, Rick Perry, who appears to have taken the lead in the Republican primary, keeps talking about tort reform as a major campaign issue.  For a comment on how some of Perry's claims are questionable, go here.

Documentaries

In my post about the West Memphis Three earlier today I mentioned the documentary "Paradise Lost,"  which I highly recommend.  It was also included in the list of "50 Documentaries to See Before You Die."  This is the title of a series in the Current TV cable channel that has been running this month.  I am a big fan of documentaries and the selection of "the 50" so far has been very good, but I don't think they are going to include all of my favorites.  So here is my list of the best law related documentaries I have seen, in no particular order.  I encourage you to look them up.

Four Little Girls

William Kunstler: Disturbing the Universe

Paradise Lost

Brother's Keeper

Incident at Oglala (here)

Waco: rules of engagement

Cheney’s Law (here)

The Thin Blue Line

The Trials of Henry Kissinger (here)

Terror’s Advocate (here and here)

The U.S. vs. John Lennon

The Most Dangerous Man in America: Daniel Ellsberg and the Pentagon Papers

The Chair

Chicago 10
 
 
Now is your turn.  What law related documentaries do you recommend?  There are two more documentaries I would like to mention but I have not seen them yet:  The Trials of Darryl Hunt and Hot Coffee.  They are on my list of movies to see soon...

Is this one of your favorite blogs?

The ABA Journal has started its annual search for the 100 best legal blogs.  You can nominate your favorite blogs by filling out a short form here.   I would be honored if you would consider nominating this blog and/or my Professional Responsibility blog.

I started this blog a few years ago thinking I would use it to keep my students informed of recent news, but I quickly realized a lot more people have been paying attention to it! One of the most rewarding things about blogging is getting unexpected e-mails from time to time from lawyers, judges, professors and other bloggers with comments, suggestions and ideas.  Needless to say, I will continue to do my best to bring you news and commentary and hope you continue to enjoy the blog.

New study on medical malpractice

A new study published in the New England Medical Journal (available here) concludes that only a very small fraction of patients who could file a claim actually pursue a lawsuit. In addition, only about 20% of claims actually resulted in a monetary award or settlement, with average payouts of about $111,749.  For more on the story go here.

Recent articles on med mal

Here is a link to a list of recent articles on medical malpractice from around the web.

More on the recently approved damages cap in South Carolina

A few weeks ago I reported that South Carolina approved a new law capping punitive damages with what some called a "flexible cap."  I posted a quick comment here, essentially thinking that the cap seemed so flexible it was difficult to think when it would apply at all.  The folks at the Abnormal Use blog are wondering the same thing....  plus they point out the fact that because the act leaves so many questions unanswered, it actually encourages more litigation.

Jury awards $2.2 million in damages for pit bull attack

I have posted many stories about animal attacks and, in particular, cases about pit bulls before (see here).  AboutLawsuits is reporting today that a Washington woman who was mauled by a pitbull has been awarded $2.2 million in damages.  Her claim partially blamed the county where she lived for not taking action against the animal which was allegedly a known threat. Go here for the full story.

Comment on possible tort reform and the debt debate

Here is a recent comment on med mal reform and the debt debate.   For more on this issue, go to my section on medical malpractice and scroll down.