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The United States Supreme Court opened the door for legitimate litigation concerning unreasonably dangerous pharmacuticals when it rejected the preemption defense based on FDA approval. Several drugs are now involved in litigation. The following are a few:

1.  Fentanyl Patch is used for chronic pain but can easily be overdosed, causing death. It is critical to rule out misuse since this medicine is used by patients in significant pain. Misuse can be eating, injecting and smoking the medication. If an attorney is considering such a case he needs to locate the patch.This can be hard since it may have been taken off by EMS or in ER. Check the written report and photos in autopsy.

This litigation is not yet in an MDL

2.  Hydroxy cut is used for weight loss but can cause heart and liver damage. Since the drug is used by people who are over weight, it is important to rule out confounding variables before taking the case. Of course it isn't necessary to prove that this medicine is the sole cause of heart or liver damage.

3.  Fosmax is used for osteoprosis. Unfortunately it can cause osteonecrosis of the jaw. This basically bad blood flow to the bone. The risk is literally losing the jaw. The unusual danger is that the drug has a half life of ten years. This means that those who have taken the drug are at risk for many years. There is a MDL in New York.

4.  Kugal Mesh is a medical device used in hernia repair. The danger is two fold: The ring can spring loose causing internal damage. Also the adhesive side can become dislodged, adhering to organs.

5.  Prempro is used by menapause. It is derived from horse urine. The medication causes breast cancer. This risk should have been emphasis in a "black box" warning on the package. Wythe did not follow up on studies after it was introduced into the market so the black warning was not on the packaging until about five years ago. There is a MDL in Littlerock.

6.  Reglan is used for Acid Reflux. It cause a bazarre condition called Tardive Dyskinesia. It is important not to use the product for more than ninty days. Warnings have been totally inadequate. There is no MDL on this product.

7.  Avandia is used for Diabetes. It can cause heart attacks. It is in a MDL.

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Preemption: Pharmaceuticals

For thousands of years humans have carried forward information about plants that have medicinal value. This intelligence has helped us survive and populate the earth. About 100 years ago the first efforts at manufacturing drugs to fight disease and promote well being began. When I was born the only medicine doctors really had at their disposal was sulfur drugs. Now new drugs are born continuously. Pharmaceutical companies are under intense pressure to create the next “blockbuster” before the patent on the last expires.

Now we rely upon the FDA to monitor the natural motivation of the industry giants to get their products in the market with a kickoff of massive consumer advertising. The FDA doesn’t have the budget to do its own testing and must rely upon the representations of the very companies that stand to gain from a quick approval.

The problem with these new drugs is that they are not born with the intelligence and communication abilities the cells in our bodies possess. If you take an antibiotic it kills the good bacteria as well as the bad since it doesn’t know how to “talk” to the white blood cells that know the difference. We end up eating yogurt for a couple of weeks after the killing takes place. Unfortunately the downside of taking many of the new drugs is much more significant than having to eat some yogurt.

Once on the market consumers are exposed to advertisement calculated to motivate them to suggest the drug’s use to their treating physicians. Pharmaceutical reps have already met with the doctors and deposited free samples. Success! Now it is merely a matter of routine prescription renewal to lock in the market share.

This system gives rise to over half of the medicines approved by FDA later requiring stronger warnings for patients or being removed from the shelf altogether.

Ironically, the cause for many of the more dangerous drugs being reexamined is brought about by plaintiff’s trial lawyers who take up the cause for their clients. The department with FDA in charge of follow-up of approved drugs has little or no power to enforce its determinations. Since fighting a technical battle with some of industry’s largest giants is too much for the common man, the lawyers are handling the litigation on a contingent fee and are covering the costs up front. If the lawyers are wrong, they eat the cost and receive no fee.

Now the last vestige for protection outside of efforts by the out-gunned FDA is under attack by legislation preempting litigation if the drug is approved by FDA, even if it is proved that the approval was based on false and misleading data presented by the manufacturer to FDA.

We must not allow this to happen.

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