Shouldn't we ban lawsuits over products approved by the Federal government?
No.
Many tort reformers want to prevent lawsuits over products that the Federal government approved. They argue that any product that meets government safety standards can’t be unsafe or defective. If we were to assume that was true – a big assumption – at least one problem remains: Corporate executives have been known to lie or conceal information to get products approved by the government. Often, the only way their illegal actions are revealed is through product liability lawsuits.
Here’s just one example:
During the 1970’s, Eli Lilly spent a great deal of money to develop Oraflex, a drug designed to relieve arthritis symptoms. (Just like Vioxx.) Oraflex was put on the market in Europe about two years before the FDA approved it for sale in the U.S. In those two years, 29 people died from using Oraflex.
Eli Lilly was legally obligated to tell the FDA about those deaths. But an Eli Lilly Vice-President decided to conceal the deaths from the FDA, because he knew that if the FDA found out Oraflex was deadly, it wouldn’t approve the drug. Relying upon Eli Lilly’s false data, the FDA approved Oraflex for sale in the U.S. Predictably, Oraflex killed people here, too.
The family of an American victim of Oraflex filed suit against Eli Lilly over the drug. The attorney in that case discovered that Eli Lilly concealed the European deaths from the FDA, and was instrumental in getting the FDA to launch an investigation. Due to this lawsuit, the FDA pulled Oraflex from the market just a few months after it was approved. More importantly, the Federal government brought 25 criminal charges against the Eli Lilly Vice-President, to which he pled guilty. Sadly, the charges and penalties were barely a slap on the wrist: Each of the 25 charges brought were misdemeanors, and carried only a $1,000 fine.
Several facts are clearly illustrated by the Oraflex story:
- When millions of dollars are on the line, some corporate executives will lie to get a product approved by the Federal government – even if that means people will die.
- Federal regulatory agencies have neither the time nor the resources to independently verify the data submitted by product manufacturers. But “greedy lawyers” do.
- The penalties for submitting fraudulent data to regulatory agencies aren’t large enough to deter this kind of behavior.
No one is yet certain whether Merck executives lied to the FDA to get Vioxx approved. But what is certain is that ending product liability lawsuits over products that meet Federal standards will quite literally enable corporations to get away with murder.

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