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.

Comments

[Frank Mitchell]

Hey, I just wanted to tell you about that damn Drug and Device Law blog, over at http://druganddevicelaw.blogspot.com/. I once had the gross displeasure of listening to "Bexis" aka Jim Beck prattle on about what a terrible world we live in because of plaintiff lawyers and how wonderful the good old days were. He talked about the glory days, days that sounded like Beck had seen "It's a Wonderful Life" too many times. I just had to write to say what a phony, know-nothing that jerk is.

Remember in "It's a Wonderful Life" how that poor, distraught pharmacist Mr. Gower accidentally put poison in the capsules and how a young George Bailey saved the day by refusing to deliver them? That's the sort of negligence Beck thinks is really out there today. He thinks these big altruistic drug companies are always wrongfully accused of negligence when the problems (those problems, incidentally, do not really exist, I guess) with their life-saving products (of yes, they are all "life-saving" - even Propulsid!) maybe hurt a few people (but maybe those people are not really hurt at all). What a load of BS.

There are some giant multinational drug companies out there whose multi-billion dollar profits are being squeezed by bioequivalent generics. Their ex-marketing MBA multi-million dollar per year plus options CEOs push for more sales. So, the companies need to disparage other equally useful products, create junk (i.e., fraudulent) clinical research to bolster their own products, pay doctors to write these products into clinical guidelines, pay other doctors to give CME lectures, pay other companies to publish fake clinical study results in journal supplements that aren't actually peer-reviewed, and get those drugs prescribed to not one, but to millions of people, some of whom don't even need the drug in the first place. Of course, the one person who never knows the truth is the apocryphal "learned intermediary" - the doctor who has been so bamboozled and misled that he or she will defend their intellectual prowess to the last second by swearing that "even if I had know this drug would kill my patient, I still would have given it to him or her."

Beck doesn't realize that plaintiff lawyers didn't make bad drugs, they didn't injure patients needlessly, they didn't mislead doctors and the FDA, they didn't bolster their corporate profits on the backs of poorly educated, marginally ill people who are over-prescribed medicines they don't need. Some day Beck will wake up from the Bedford Falls-like world he lives in and realize that Pfizer is not Mr. Gower, and he is no George Bailey.

Now that Beck and Hermann have seen fit to make their little public blog, I would like to posting comments periodically to point out what BS they are frothing from their mouths. Unfortunately, their blog moderates comments, so you will never see anything there that disagrees with them. Alas, such is the "freedom" of the internet.