Bush Wants to Shield Drug Companies from Liability

This morning I read a distressing article in my morning paper, the Baltimore Sun.  According to the article, Bush and his five hacks on the Supreme Court are about to prohibit law suits against drug companies once FDA has approved the drug.  Sorry, I can't find the article posted online, but here's an excerpt from this morning's Baltimore Sun:

For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood cots and strokes, according to internal company documents.

But because the Food & Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product - even though its old label inaccurately described the amount of estrogen it released. . . .  After decades of being dismissed by courts, the tactic appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

The Bush administration has argued strongly in favor of the doctrine which holds that the FDA is the only agency with the expertise to regulate drug makers and that its decisions should not be second-guessed by courts.  The Supreme Court is to rule on a case next term. . . . .

Documents and email messages from Johnson & Johnson, made public as part of the lawsuits against the company, show that even before the drug agency approved the product in 2001, the company's own researchers found that the patech delivered far more estrogen each day than low-dose pills.  When it reported the results publicly, the company reduced the numbers by 40 percent. . . .

The FDA does not test experimental medicines but relies on drug makers to report the results of their own tests completely and honestly.  Even when companies fail to follow agency rules, officials rarely seek to punish them.  "These are scientists, not cops," said David Vladeck, a professor at Georgetown law school.

So now the drug companies will be free to lie to the FDA to get unsafe drugs, that they know to be unsafe, approved.  People using these drugs will get sick and die.  CEO's will laugh all the way to the bank.  And there won't be a damn thing that the victims, and their suvivors, will be able to do.

This needs to be part of the health care debate.  Both Senators Obama and Clinton need to state that they won't stand for this new form of legalized murder.  And they, and we, need to corner McCain on this issue.

•  Tip Jar

  by Navy Vet Terp on Sun Apr 06, 2008 at 09:15:38 AM PDT

  •  here's a link to an article about this

    http://www.nytimes.com/...

    by yet another liberal on Sun Apr 06, 2008 at 09:25:25 AM PDT

    •  Thanks n/t

      by Navy Vet Terp on Sun Apr 06, 2008 at 09:38:31 AM PDT

  •  President Obama needs to nominate 6

    new Supreme Court justices bringing the total to 15 and diluting the fascist 5[or is it 6?].

    by daliscar on Sun Apr 06, 2008 at 09:31:40 AM PDT

•  The idea of pre-emption is not new in the law

  especially for products that are tightly regulated and are on a national market.  Furthermore, there is no protection for companies that submit fraudulent information to FDA.  And finally, in the most recent case on the matter, Riegel v. Medtronics, the Court ruled 8-1 (with only Justice Ginsburg dissenting) in favor of pre-emption.

  by Drgrishka1 on Sun Apr 06, 2008 at 09:21:50 AM PDT

  •  the fraud standard

    as applied is IMHO too damn high for that to be a fair resolution.

    by decafdyke on Sun Apr 06, 2008 at 09:33:36 AM PDT

    •  That doesn't change the fact that

      the direction the Court is taking on this is not being taken by a tiny majority, but rather by almost unanimity.  Nor does it change the fact that federal regulatory pre-emption is not new.

      by Drgrishka1 on Sun Apr 06, 2008 at 09:38:32 AM PDT

•  Stop TV Ads!

  Where is the debate on whether to stop the Pharmaceutical companies from direct advertising to consumers?  Wake UP people! This isn't a right guaranteed under the Freedom of Speech amendment.  Until 1989, it was ILLEGAL to market prescription drugs to the public. Public health has declined and health costs have risen since that legislative faux pas.  Where is the candidate with the gumption to debate this action that has had such a catastrophic effect on public health? Cigarretttes aren't advertised on tv.  Liquor isn't.  Prescription drug mis-use is the number one cause of teen addiction, as well.

  by duncansc on Sun Apr 06, 2008 at 09:23:59 AM PDT

•  I thought myself immune to those ads

  until one day I found myself asking my doctor about a drug with a brand name.  He said it was not anywhere near appropriate to my problem.  Whew.  What if my doctor had just had a visit from a pharm rep with golf clubs?

  We are not immune to the power of marketing.  This needs to be studied and fairly presented to get any action.  I for  one hesitate to prohibit any speech but if it is warranted and the pharms can still advertize appropriately maybe there is something that can be done.

  But we have to be careful.  Sugary soda's are probably the leading cause of youth obesity.  Can coke still advertise?

  by dogheaven on Sun Apr 06, 2008 at 09:34:20 AM PDT