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My last "Tort Victim Tragedies" piece highlighted the negative effects of a Michigan drug company immunity law for those who may have been harmed by the painkiller drug Vioxx.

As I explain in "Tort Victim Tragedies: Third Edition - Tort Reformers Argue That Cheaper is Better Than Safer," the one of its kind Michigan blanket immunity law is incredibly overbroad and allows a great deal of pharmaceutical company misconduct to be precluded from sanction in the civil justice system such as:

"A company may submit raw data to the FDA, but the company's own interpretation of that data, and its potentially ominous significance, is left out."

"The company later acknowledges that an interpretation of data was faulty or incomplete. Or the most relevant safety data are present but camouflaged behind other data in a variety of ways, and certainly not red flagged."

"Deliberately misleading information about a drug is submitted, not to the FDA, but to physicians and the public."

"Negotiations over aiding or refining warnings on a drug's label are dragged out for months - not because of honest scientific disagreement, but because of pure market considerations."

"Going after academic researchers who question company claims, including the use of bald threat and intimidation."

"Manipulating endpoints and design studies after the fact in order to make the results look more favorable for the product than they were." (quotes taken from the testimony of Henry Greenspan, Founding Board Member of Justice in Michigan, to the Michigan State Legislature)

My August 11th "Tort Tragedies" piece is now buttressed by a recent ruling in the Vioxx trials. On August 17th:


The jury of eight men said Merck was negligent for failing to adequately warn doctors about the risks associated with the drug. The jury also found that Merck "knowingly misrepresented or failed to disclose" information about the drug to the plaintiff's doctors.
(more click here)

On the same day, another judge called for a new trial in light of new evidence:

"New Jersey state court judge Carol Higbee has thrown out the verdict in a Vioxx trial from November, citing new evidence. The jury had sided with Merck, finding that Merck wasn't liable for injuries to Frederick "Mike" Humeston, a postal worker and Vietnam War veteran who sued Merck over his heart attack."
(more click here)

Of course, if you live in Michigan, the only state in which drug companies have successfully pushed through full immunity for all drugs at some point approved by the FDA (even if subsequently withdrawn), you are legally precluded from suing because the FDA previously approved the drug.

Michigan residents might want to consider changing their law, or maybe they can just hope that the drug companies like Merck ( the producer of Vioxx) which can make enormous products when their product are approved by the FDA, will always be fully forthcoming with information which might jeopardize their drug's approval.

To take action, click here.

To see a complete listing of my previous posts on civil justice issues, click here.

If you or your organization is interested in learning more about or working on these types of civil justice issues, please feel free to contact me at cdugger@drummajorinstitute.org.

Cyrus Dugger
Senior Fellow in Civil Justice
Drum Major Institute for Public Policy Cyrus Dugger

Originally posted to cyrus dugger on Mon Aug 21, 2006 at 08:32 AM PDT.

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Comment Preferences

  •  Don't know how heartbroken I am. (0+ / 0-)

    Tort fraud appears to be alive and well with the Vioxx cases.

    •  How can you not be.... (0+ / 0-)

      The question of the existence of fraud is separate and apart from granting these companies IMMUNITY.

      If a person or entity gets criminal immunity.. i.e. they are no subject to our criminal laws/ there is no consequence if they break the laws... they are more likely to break them.

      Same with the civil immunity that these companies are getting. They are more likely to be less careful with the approval of drugs if they cannot be sued for their misconduct.

      Your reference to fraud, a claim I will not take on here, entirely distorts the issue.

      If there is fraud it is for the judge to find or by measures to address the filing of frivolous suits, not a blanket grant of immunity.

      The unrelated nature of your response to the issue...... is striking.

      Surely after the manufacturing company pulled their own product you don’t believe that there are no serious risks associated with the drug.

      •  After FDA authorization. (0+ / 0-)

        I'd be upset if they had blanket immunity, but the federal government already signed off on their drug.  I doesn't seem an unreasonable protection to me.

        The civil justice system has been amazingly unaffective in addressing rampant tort fraud, so it's no surprise a legislative solution is being attempted.

        •  They have gotten like 30 drugs wrong.. (0+ / 0-)

          Moreover, if you read my previous full Third Edition post closely and or go to the links you will see that business interests have pushed through a reduction in safegaurds of FDA review to speed up the process to the detriment of safety.

          If they are doing such a good job.. why did they approve Vioxx when the manufacturers' own tests showed the problems?

          •  Even the revealed problems were pretty minimal. (0+ / 0-)

            3.5% of the patients taking Vioxx (and 1.9% of the patients on the placebo) suffered heart attacks or strokes, a rate of 16 per 1,000 patients.

            Frankly, I don't think the drug should have been pulled at all, just properly labeled.  The increase in heart problems was statistically minimal.

            The changes in FDA regulation I also approve of, in part because drugs had been caught up in the regulatory process for ages while patients died untreated.  

            •  Fuzzy Math (0+ / 0-)

              The question isn't how many had them, the question is how many more had them than otherwise would have. It is the increased risk that is at stake.

              As I stated Merck also misled doctors as to the increased risk. This misleading is itself an offense regardless of the degree of increased risk.

              If it should not have been pulled... then why did Merck itslef voluntarily pull it?

              cyrus

              •  Probably in an attempt to protect themselves. (0+ / 0-)

                Which didn't work, obviously.  By using the Merck's voluntary recall as evidence of ill effect, you're creating a very perverse incentive for when drug makers discover a problem with their drugs.

                Recall themirosal was voluntarily recalled, and no problem was ever found with it.

                •  hmmmmmmmmmm (0+ / 0-)

                  And the jury's finding as described above? The named conduct doesn't seem wrong to you. What makes you so confident in the FDA. In this discussion you seem to have put the burden on me to prove that the FDA is not safe. In light of the revelations regarding the EPA, and the political nature of many recent agency decisions, it seems more appropriate or the onus to be on you to support WHY you feel the FDA's decision making process should be the end all and be all of safety. Indeed, reps of the FDA (as detailed in my blog) have said that they do not see the FDA's regulations operating in a vacuum.

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