Drug Injury Watch

Side Effects News & Reports

From 2005 to the present

Ortho-McNeil’s Response To April 2008 NYT Article About Ortho Evra And FDA / Federal Preemption

New York Times Reporters Gardiner Harris and Alex Berenson Bring Attention To How This Emerging Legal Issue Would Affect Drug Injury Cases

(Posted by Tom Lamb at DrugInjuryWatch.com)

To our pleasant surprise, we saw lots of notice and reaction being given to the April 6, 2008 New York Times (NYT) article, "Drug Makers Near Old Goal: A Legal Shield", wherein Times reporters Gardiner Harris and Alex Berenson explore the concept of "federal preemption" as regards some pending Ortho Evra lawsuits. 

The Harris – Berenson NYT "Ortho Evra" article is worth a read, especially if you have an interest in either the preemption issue or this particular drug injury litigation:

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 clots and strokes, according to internal company documents.

But because the Food and 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.

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now 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 F.D.A. is the only agency with enough 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 that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted….

What had not gotten as much attention was Ortho-McNeil’s written response to this April 6 NYT article that the drug company published on their website.  One reason for the lower profile might be that the company-statement item is a bit difficult to find: It goes by the obscure title of "April 2008 Employee Communication", and the link is found on what appears to be a new, specially created web page, i.e., it had no page title nor was it listed on the Sitemap when accessed at 4:20 p.m. on April 7, 2008.

Perhaps wanting to make sure that the word got out, however, the Ortho McNeil "retort" was the subject of an April 7 post, "The New York Times, Pre-Emption and ORTHO EVRA", found over at "About JNJ BTW" — the in-house blog for Johnson & Johnson (Editor: Marc Monseau).

As for the text of Ortho McNeil’s retort to this Ortho Evra – federal preemption story, here’s the gist:

While the [April 6 NYT] article deals predominantly with the issue of pre-emption, it also questions our commitment to patient safety and scientific integrity. And in so doing, it inaccurately depicts our actions leading up to approval of the patch by the U.S. Food and Drug Administration (FDA) in 2001, and the data reporting procedures we have followed since. I want to make sure you have our point of view, in part because some of the characterizations in the article, including references to internal company documents, are taken clearly out of context.

This April 2008 NYT report demonstrates how important it is to learn more about this issue of federal preemption.  As I wrote recently on this site, in this post, "Issue: Should We Be Prohibited From Filing Product Liability Lawsuits Against Medical Device Manufacturers And Pharmaceutical Companies?":

According to some critics, the prohibition of drug injury lawsuits by operation of the federal preemption doctrine may have some merit in an ideal world where the FDA was performing its drug-safety regulatory functions at 100%.  But that has not been the situation in the past, nor is it the case today.

Our thanks to two of the leading Pharma reporters, Gardiner Harris and Alex Berenson, for shining a light on this critical legal issue of preemption in the context of drug injury claims.

6 responses to “Ortho-McNeil’s Response To April 2008 NYT Article About Ortho Evra And FDA / Federal Preemption”

  1. Craig Niedenthal Avatar
    Craig Niedenthal

    Nice post Tom. Wrote something on this article yesterday on my blog. Take a look at my post from today about a Reader’s Digest article talking about how messed up the FDA is and the tie in with the preemption argument.

    Reply
  2. Tom Lamb Avatar
    Tom Lamb

    Craig,
    Thanks for letting us know.
    Here are the URL’s to Craig’s articles:
    http://www.alabamaproductinjurylawyer.com/2008/04/new_york_times_and_readers_dig_1.html
    http://www.alabamaproductinjurylawyer.com/2008/04/new_york_times_and_readers_dig.html
    Keep up the good work.
    Tom Lamb

    Reply
  3. Dan Avatar
    Dan

    Harmed and Helpless
    The Food and Drug Administration approves, for purposes of this article, pharmaceuticals and medical devices for use by American Citizens, theoretically, due to their flawless expertise and excellent judgment regarding the safety and quality of such items, as determined by this Department of Health and Human Services division. Considering the progressive acknowledgement of potentially deadly aspects of such approved meds and devices, more are getting removed from the market or are receiving very strict limitations on their use, which are called black box warnings, the FDA appears to not even exist for its original purpose.
    The drug companies, for example, presumably in a rush to get their new med to market because of its patent life limitations, has for close to 20 years now paid the FDA to speed up the approval process with so much money that the pharma industry now provides nearly half of the FDA’s budget. This occurs due to the Prescription Drug Users Fee Act, which began in 1992. In my opinion, this creates a relationship between the two as client and provider. So clearly fallacies exist with the FDA’s approval process, as noted with the damage that has been done by the products it has approved to ideally benefit human health. Unfortunately, there is a standard, legal, and judicial doctrine called Pre-emption that protects the makers of damaging products from responsibility and exonerates them from any liability from the damage they may have caused to those who used their products.
    Here’s why this happens: Pre-emption means that federal law is and will always be supreme over state law due to the U.S. constitution and its supremacy clause, yet the FDA lacks such a clause itself. So what does this term have to do with pharma companies avoid being charged by the victims for the liability from those harmed? The FDA is a Federal Administration. Since the FDA are flawless experts and a Federal Administration, the FDA and the makers of harmful products cannot be blamed for the damage they may have caused others, because the so called experts, the FDA, approved such products. And Federal Law along with the Supreme Court and the Bush Administration agree that the drug makers should not be liable. I smell cronyism with this arrangement.
    The FDA has itself admitted it cannot do what it is required to do because of lack of resources, they say, which is to manage, supervise, and regulate with thorough and complete oversight the pharma and med. device companies. This in itself should raise the attention of the government to replenish this association because of their importance to the public. Since this is not the case, the FDA depends on the good faith of the saints of the pharma industry to disclose their product flaws once discovered and immediately. If this was done, then harmful drugs would likely cause less damage to others. Certainly, patients and doctors cannot be completely aware of such risks as the environment described exists presently, as they can be and are uninformed possibly of the knowledge and information of the drugs available.
    However, patients do head to court for relief, rightfully so, for compensation from their suffering from such flawed products. A plus to this activity, regardless of its success, is that it becomes a catalyst for discovery and disclosure of the collusive ones, which are the pharma industry and the FDA, one could conclude.
    On a more positive note, a recent pre-emption case involving Medtronic came to light which displeased the U.S. citizens thanks to certain media sources free of fear, apparently, so congress has pledged to pass a bill reversing this removal patient rights regarding such situations, which were both announced earlier this year, so the harmed ones can respond without the restrictions of their government, as they should.
    Our Health Care System is too important to accept wrongdoing and allow corruption regardless of the amount or severity. Awareness and action by U.S. citizens in time, I hope, will not allow such things to occur in the future again of a similar nature. Because presently, it appears apathy is our greatest weakness for such evil to exist.
    “Justice shines by its own light.” — Cicero

    Reply
  4. Tom Lamb Avatar
    Tom Lamb

    You should take a few minutes to read Dan’s comment below, which is really his essay about why federal preemption is bad for American consumers when it comes to prescription drugs and medical devices approved by the FDA.
    We hope more people let us know their opinion about federal preemption, as it is an issue which deserves public attention.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  5. IRWIN GOODMAN Avatar
    IRWIN GOODMAN

    IT NOW APPERARS YOUN HAVE ANOTHER SEROUIOUS PROBLEM WITH LEVIQUIRE

    Reply
  6. Tom Lamb Avatar
    Tom Lamb

    Thank you for your Comment.
    My firm is not handling Levaquin drug-injury cases, but there are other firms around the country that are taking some cases involving tendon damage.
    We wish you the best in all aspects.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply

Leave a Reply to Craig Niedenthal Cancel reply

Your email address will not be published. Required fields are marked *