Federal Preemption: Not the Rite Aid Rx for Michigan's Joe and Dianne

Steve Lombardi
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Posted by Steve LombardiOctober 30, 2008 8:30 AM

Today I’m printing, with their permission, a Michigan husband and wife’s story about how a drug reaction coupled with federal preemption has affected their lives. Their last names are not given to protect their privacy. Every wife, husband and partner should know that if it’s your turn for Rx personal injury, just how the pharmaceutical industry has taken care to manage your civil rights to know what went wrong and to recover through justice that only the trial process can dispense.

Steve Lombardi

Joe and Dianne's Story of Federal Preemption

Hello, I am Joe’s wife, Dianne. The following is my experience with Michigan’s Drug Immunity Law, the precursor to FDA Preemption.

Our state has lived under preemption since 1995 when, under the Engler administration, our legislature granted pharmaceutical companies immunity from product liability. Engler asserted that the "

Michigan model'' was intended to be the law of the land. Currently, Michigan is the only state in the nation with such a law. If FDA Preemption is upheld this November 3 in the Supreme Court case Levine v Wyeth, Engler’s dream, Michigan’s nightmare, will become an American tragedy.

Joe’s and my sad journey began with a bad case of vertigo. Joe first felt dizzy after receiving tetanus and hep B vaccinations in December of 2000. He complained that the tetanus shot hurt his entire arm, and the pain lasted for weeks. The dizziness became worse while on a business trip to Japan and escalated during the trip and after his return home. The vertigo became so out of control that he had to take a medical leave of absence. They missed him at work. He was well loved and always a favorite with his great sense of humor. His co-workers couldn’t believe it when he didn’t return; they sent a card saying things weren’t fun anymore without him, and to “get over it” and “come back”.

We went to the best doctors. I prayed he didn’t have a brain tumor. We had no idea what was wrong. MRI’s and other tests were performed, physical therapy and acupuncture was tried and numerous medications were prescribed. In January of 2004, Joe started taking Celexa, a drug prescribed off-label, and the last medication he took for his dizziness. It seemed to help. But then, one day, I noticed his eyes. They were yellow. Alarmed, I said, “You need to see a doctor right away.”

He did, and that started us on a new and more terrible journey. Test reports came back that his liver enzymes were very high, further tests revealed he had autoimmune hepatitis with cirrhosis and, later, a doctor calmly told us he would probably need a liver transplant within ten years. I was numb. What was this doctor talking about? I remember he said we should look for a surgeon so we would be in line for a liver, and that U of M had less mortality. I couldn’t believe what the doctor was saying. How could this be? Cirrhosis? We were not “drinkers.” Joe was always healthy. This just couldn’t be true. It seemed to me that it was not all that important to the doctor. ow could this doctor be talking tous like this? HWe left his office holding hands, and I quietly prayed.

Now, new medications were required to treat the liver damage, one of which could cause leukemia. Another med, prednisone, lead to diabetes, a side affect that hospitalized Joe for several days. I wondered how all this happened. I asked the doctor if the meds Joe had been prescribed for vertigo could have caused the liver damage. His answered was, “Yes.” “They could have triggered it.”

We were never told that. On the Internet, I learned that many of the medications Joe had taken caused jaundice. Serzone, another of several medicines that were prescribed off-label, was linked to liver toxicity and, in some cases, failure. Serzone was voluntarily taken off the market by Bristol-Myers Squibb in 2004 because of, they said, decreased revenues. Many believed, however, the real reason was the mounting lawsuits over liver issues. Joe took Serzone for five weeks in 2002. While researching Celexa, I found an article from

Georgetown University Medical Center regarding SSRI’s, a class of drugs to which Celexa belongs. The piece, entitled, “Commonly Used Antidepressants May Also Affect Human Immune System,” stated, “… it is possible that they [SSRI’s] might also bolster immunity to the point that they trigger autoimmune disease.” (January, 2006.) He took Celexa for seven months.

When we sought legal help, we discovered we had been stripped of our civil right of due process. We were not aware of

Michigan’s law; it had and has been kept quiet and out of the media. Most folks are not aware of the law, until they need a lawyer.

In my heart, I believe this all started with the vaccinations. I also believe Joe was poisoned, continuously, for three years, by drugs toxic to the liver. I would like to know, what did the drug companies, and doctors, know about these medications when they were prescribed to Joe. I’ve read many articles stating how drug companies hide unfavorable information and hire “expert” witnesses, paid handsomely, to protect them from liability and keep their bottom line intact.

As residents of Michigan, we have been denied the right to find the truth. Joe’s health and our lives are forever changed. But we will never have our day in court. The vaccinations given and the drugs taken were all FDA-approved, and, therefore, under Michigan law, FDA-approved drugs are shielded from liability. Defenders of tort reform will tell you there is an exception to Michigan law: A drug company has to be found guilty--by the FDA--of fraud and of hiding evidence. Unfortunately, the FDA has failed to take such action in over 20 years, even though, since 1997, more than 16 FDA-approved drugs have been found to be unsafe after their approval and hundreds of thousands of victims have been injured or died from dangerous drugs.

Since this all began, Joe and I have become involved with bipartisan groups concerned with preserving American civil liberties and protecting the health and safety of the pubic. In 2007, the Michigan House passed a bill to rescind the Drug Immunity Law. However, the State Senate has stonewalled all such attempts. And, discouragingly, as one newspaper editor told Joe, “Why should we report on our law?” “What difference will it make if FDA Preemption passes?”

Joe and I have lost all faith in medicine and government. Courts throughout our country are ruling in favor of large corporations and against American citizens. The only hope for the restoration of our civil liberties is the American public, and they are not being told about this assault on our civil rights, health and safety.

We now see a holistic doctor. Thankfully, Joe is doing better. We have been together since high school, and, even after 42 years, we are still like “peas and carrots.” I start each day with a prayer asking that he will be well. As always, I leave everything to God.

If you are reading this, please help End FDA Preemption. And, please spread the word to everyone you know. Thank you.

Dianne

3 Comments

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david mittleman
Posted by david mittleman
October 30, 2008 8:57 AM

my heart goes out to the victims of engler/bush who put corporations and insurance companies before people.as a lawyer representing injured people in michigan i have and will continue to fight untill i can no longer fight to CHANGE this dreadful law designed to give immunity to drug companies.DIIME is an organization in MI dedicated to fight for victims so that MI residents can hold drug companies accountable in MI.

Devon Glass
Posted by Devon Glass
October 30, 2008 10:55 AM

i also agree that Michigan has gone too far for no good reason. the law protecting the drug companies did not even do what it's supporters claimed it would, bring drug company jobs to Michigan. Not that it would have made the law any better by any means. The legislators responsible for keeping Michigan residents from enforcing their rights are Wayne Kuipers and Mike Bishop, and their deplorable record was exposed at our blog in this post, More ...

Please help end preemption by contacting your local legislator. More ...

Tracey Patterson
Posted by Tracey Patterson
November 10, 2008 11:16 AM

The problem for these pharmaceutical companies is that tort litigants are in a better position than the FDA to keep drug companies honest. The FDA claims to bring balance but they truly believed that, they should actually be supporting ending preemption.

Comments for this article are closed.

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