Thursday, March 22, 2012
NYT article on causes of action vs manufacturers of generic drugs
The New York Times has published an article called Generic Drugs Proving Resistant to Damage Suits (available here) discussing the effects of the Supreme Court's decision in Pliva v. Mensing. For the background on that case, go here.
HR 5 bill limiting patients' rights approved by the House -- UPDATED
Day on Torts is reporting that the House of Representatives has passed HR 5 by a vote of 223-181. Ten Republicans voted against the legislation, and 7 Democrats crossed over to support the Republicans. Four Republicans voted "present." As I have discussed many times before (see here) the bill attempts to limit the right of victims of medical malpractice to recover for their injuries by making it difficult for them to find representation and by limiting their possible recovery. It also provides protection to pharmaceutical and medical devices companies in cases of injuries caused by defective products.
UPDATE April 13: AboutLawsuits has a comment here.
UPDATE April 20: The Blog of the Legal Times has more on the story (and some interesting comments) here.
UPDATE April 13: AboutLawsuits has a comment here.
UPDATE April 20: The Blog of the Legal Times has more on the story (and some interesting comments) here.
Comments on the recent decisions on the constitutionality of the cigarette warnings regulations -- UPDATED
Three days ago I reported on two recent decisions on the constitutionality of the regulations that require cigarette manufacturers to place graphic images as part of the required warnings in cigarette packages. Professor Jonathan Turley has a detailed comment on the topic here.
UPDATE (March 22): The FDA Law Blog has posted its analysis of the decision of the Court of Appeals for the 6h Circuit here.
UPDATE (March 22): The FDA Law Blog has posted its analysis of the decision of the Court of Appeals for the 6h Circuit here.
Wednesday, March 21, 2012
Debate on federal medical malpractice/immunity to pharmaceutical companies and more bill
The Pop Tort is reporting today that Congress is beginning its debate on HR 5, a bill that, among other things, attempts to limit the right of victims of medical malpractice to recover for their injuries by making it difficult for them to find representation and by limiting their possible recovery. Given the level of medical malpractice errors reported, it is scary to think what would happen if the bill were adopted.
My first impressions of the bill, which has been around for over a year now, can be found here. Since then, I have posted comments and updates on the bill here, here, here, here, here, here, here, here, here and here.
Today's Pop Torts comment is available here. In it they point out how peculiar it is that although the proponents of the bill are generally "anti-federal government", they apparently trust the federal government to get it right every time when it comes to the safety of drugs and medical devices. They also remind us that the FDA continues to fall down on the job.
My first impressions of the bill, which has been around for over a year now, can be found here. Since then, I have posted comments and updates on the bill here, here, here, here, here, here, here, here, here and here.
Today's Pop Torts comment is available here. In it they point out how peculiar it is that although the proponents of the bill are generally "anti-federal government", they apparently trust the federal government to get it right every time when it comes to the safety of drugs and medical devices. They also remind us that the FDA continues to fall down on the job.
Minnesota lowers caps to pre-2008 level
The TortsProf blog is reporting today that new legislation in Minnesota restores caps in wrongful death cases against state or local governments to pre-2008 levels. StarTribune Politics has more.
Comments on the recent decisions on the constitutionality of the cigarette warnings regulations
Two days ago I reported on two recent decisions on the constitutionality of the regulations that require cigarette manufacturers to place graphic images as part of the required warnings in cigarette packages (here). Professor Jonathan Turley has a detailed comment on the topic here.
The FDA Law Blog has posted its analysis of the decision of the Court of Appeals for the 6h Circuit here.
The FDA Law Blog has posted its analysis of the decision of the Court of Appeals for the 6h Circuit here.
Monday, March 19, 2012
Court's continue to reject challenges to the current state of the law regarding generic drug labeling in failure to warn cases
Last year, the US Supreme Court held that a cause of action against a manufacturer of generic drugs is preempted if the claim is based on the manufacturer's failure to update or strengthen its warnings unless the manufacturer of the same brand name drug was obligated to do it. Go here for details on this decision and go here and scroll down for much more on the background before the case was decided and links to much more information since the case was decided. (I thnk the first post on this subject is on Nov 2, 2010).
Since then, a series of legal challenges have been filed, but all have been rejected. Today Pharmalot is reporting on the most recent example. The FDA Law Blog has also posted a good summary of the state of the law.
Since then, a series of legal challenges have been filed, but all have been rejected. Today Pharmalot is reporting on the most recent example. The FDA Law Blog has also posted a good summary of the state of the law.
Court of Appeals for 6th Circuit upholds regulation requiring new graphic warnings for cigarettes -- UPDATED
We have been following the developing saga of the FDA's attempt to impose new warning labels on cigarette packages that include graphic images. See (in chronological order) here, here, here, here, here and here. The last report was that a federal district court in Washingon DC declared the regulations unconstitutional.
Today, however, the Wall Street Journal law blog is reporting that a federal appeals court in Cincinnati has upheld the portion of the regulations that requires that large graphic warnings comprise the top 50% of the front and back of cigarette packs. Go here for a copy of the opinion. According to the report, the Court held that the labels “serve as disclaimers to the public regarding the incontestable health consequences of using tobacco” and do not unconstitutionally restrict tobacco companies’ speech.
UPDATE (March 21): Professor Jonathan Turley has a detailed comment on the topic here.
Today, however, the Wall Street Journal law blog is reporting that a federal appeals court in Cincinnati has upheld the portion of the regulations that requires that large graphic warnings comprise the top 50% of the front and back of cigarette packs. Go here for a copy of the opinion. According to the report, the Court held that the labels “serve as disclaimers to the public regarding the incontestable health consequences of using tobacco” and do not unconstitutionally restrict tobacco companies’ speech.
UPDATE (March 21): Professor Jonathan Turley has a detailed comment on the topic here.
First Amendment and the pharmaceutical industry
Max Kennerly has published a very interesting comment on the increasing use of the First Amendment as the basis for arguments by the pharmaceutical industry in an attempt to limit the reach of possble regulation by the FDA. Given that marketing of drugs is a form of commercial speech, the pharmaceutical companies' approach is not entirely surprising. But the social and health costs of an unregulated pharmaceutical industry can be very dangerous. His conclusion: "In time we hope the pendulum will swing the other way, and the First Amendment will return to its roots of protecting free speech on the topics that really matter, rather than serving as a mere tool by which politically connected interests can keep their market position. But how many people will have to suffer without any legal recourse before that time?" Go here to read the full comment.
Recall: Study on suicide and anti-depressants recalled by authors
Pharmalot is reporting today that a famous study on the relationship between the use of anti-depressants and suicide has been recalled by the authors. Go here for the details.
Eight years ago, the FDA decided to require Black Box warnings on labeling for anti-depressants for teenagers and children. Critics of that decision, have apparently used as support a 2010 paper which reviewed data on the toxicological detection of antidepressants in nearly 19,000 suicides in Sweden between 1992 and 2003 that were linked to registers of psychiatric hospitalization. As Pharmalot reports today, however, now the paper has been retracted by the authors due to “unintentional errors in the analysis of the data presented.”
Eight years ago, the FDA decided to require Black Box warnings on labeling for anti-depressants for teenagers and children. Critics of that decision, have apparently used as support a 2010 paper which reviewed data on the toxicological detection of antidepressants in nearly 19,000 suicides in Sweden between 1992 and 2003 that were linked to registers of psychiatric hospitalization. As Pharmalot reports today, however, now the paper has been retracted by the authors due to “unintentional errors in the analysis of the data presented.”
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