Recently the FDA has issued new rules about when a manufacturing company can be sued if one of their products causes injury. The new rules say that if that product had previously passed FDA testing standards and been approved for marketing to the U.S. public, you may not sue that company. For example, if a medication causes severe side effects not listed in the paperwork which accompanies each bottle of tablets, eyedrops, etc., and you have to seek medical help, you cannot sue the manufacturer if that medication was previously FDA-approved.

The reasoning behind this change?

Getting a new product FDA approved costs millions or even billions of dollars in research and testing, and many years of salaries paid and research expenses met. If a company goes through all this, and succeeds in having the product approved for whatever use it was tested for in the three FDA testing Phases, then that company should not be held liable if somebody unexpectedly develops some other reaction to the product, or is injured by it in some unusual or unanticipated way.

“Life Happens”, is the summary of this, perhaps. The researchers can’t foresee every human response that might conceivably happen on planet Earth. If the drug or product hurts you, stop using it. Use your health insurance and get medical care if necessary. But don’t try to blame the company which created this product and went to so much trouble to get it approved and available to you.

This approach pleases corporate defense attorneys. It doesn’t necessarily please potential plaintiffs’ attorneys. Some of them are calling it “silent tort reform”. When state and federal laws clash, federal laws prevail, per Article Six of the Constitution. However, if there is no federal law then federal courts have to go by whatever state law there is.

This tension is built into our system

There are a great many active lawsuits against product manufacturers, especially pharmaceutical companies, where arguments go back and forth:

• Is the FDA-mandated labeling on a product adequate? (suit against Baxter Healthcare Corp. re heparin labels; also Vioxx cases against Merck & Co.)
• Should Wyeth Pharmaceuticals have to pay $6.8 million to a man given a Wyeth drug in an artery instead of a vein?
• Who is responsible if the FDA refuses to let a company strengthen its product label? (another Wyeth case, presently in appeal before the Supreme Court)

If you have been injured by a product and wonder whether you have a valid legal claim, please contact us for a free consultation. Determining your legal position must be done by an experienced and qualified attorney. So don’t spend any time fretting and worrying. Just give us a call or send an email.