And Speaking of John Engler...

Detroit's Metro Times has an article that theorizes why John Engler is the current President of NAM:

"Let’s suppose your doctor prescribes some spiffy new drug for your pimples, say, or your aching back. Unfortunately, it turns out to have some minor side effect, like it makes you totally blind. Or kills you.

Whoops. Guess the drug company didn’t experiment enough on those rabbits. Or maybe it didn’t work the same on people. It’s always something. But, hey, you can sue the pharmaceutical firm for what it did to you or yours, right?

Sure you can — in every state in the union except one. That’s right. Mississip— uh, Michigan! That’s right. Big pharmaceutical companies have total immunity in this state — as long as their drugs have been approved by the FDA, the U.S. Food and Drug Administration...

We can thank Gov. John Engler for that. Ten years ago, he rammed through a law that prevents us from suing any pharmaceutical company whose drug has been approved by the FDA.

Wonder why he now has a cushy, high-paying job as head of the National Association of Manufacturers?"

The article also describes the efforts of Republican Ed Gaffney to undo the damage done by Engler:

"He was shocked when he learned Michigan wouldn’t allow damaged residents to sue drug companies. “This is tort reform run amok,” Gaffney says. (Emphasis added.)

He has introduced his own legislation. Drug companies would be presumed innocent, but if you could prove their product had harmed you, you could successfully sue. Yet so far, he can’t get the time of day from House Speaker Craig DeRoche, a Novi Republican who’s young enough to be his son.

“I’m sure this would pass if we can ever get it to the floor for a vote,” Gaffney says. Republicans have only a 58-51 majority, and a number of them feel as Gaffney does. As far as I can tell, all the Democrats want the change."

As a former staffer for a Democratic legislator here in Michigan, I can assure you this bill will get a floor vote over Craig DeRoche's dead body.

It's also worth noting that many tort reformers want federal legislation that mirrors Michigan's.  In their eyes, you should never be able to sue a drug manufacturer if the FDA approved the drug - even if it is revealed that the manufacturer falsified data to get the drug approved. 

Comments

[Ted]

Justinian prints misinformation once again. Name one tort reformer that proposes that drug companies should have immunity "if it is revealed that the manufacturer falsified data to get the drug approved." Every reform proposal imposes liability in such a circumstance.

There are very good reasons for immunity for FDA approval. E.g., http://www.aei.org/publications/pubID.23513/pub_detail.asp

Justinian apparently doesn't believe he can refute these reasons, because he addresses his only argument at a fictional proposal that never existed.

It would be interesting if this site ever did actual analysis, rather than just repeating trial lawyer propaganda. Justinian seems to be an intelligent person--if he actually looked at what he's espousing, and both sides of the argument, he might change his mind, rather than going to bat regularly for the most corrupt political lobby in the US.

[Justinian]

Every tort reform proposal includes liability exceptions in case a manufacturer defrauded the FDA? What about the Homeland Security Act of 2002? Are you unaware that the bill immunized manufacturers of FDA-approved smallpox (and other) vaccines from suit? Under the act, injured individuals are forced to bring any suits against the Federal government, under the Federal Tort Claims Act. Under no circumstances may an individual bring suit directly against the manufacturer.

Perhaps you meant to say “most,” or “the majority of,” or even “some” tort reform bills impose liability upon manufacturers that conceal information from the FDA. But clearly, “every” bill does not. You should know better than to make a universal generalization. Or, as my father often said, “I’ve told you a million times: Don’t exaggerate!” But let’s move on to something far more important: the reason why your proposal is bad public policy.

The FDA operates under the assumption that drug manufacturers neither omit nor falsify data submitted during the approval process. In almost every case, that’s a safe assumption. But from time to time, a drug manufacturer breaks the law to get a drug approved. Because the FDA isn’t the FBI, it rarely uncovers such fraud. Instead, trial lawyers do.

A relevant example is this post about Oraflex. http://www.go666.com/corpreform/questions_answers/

For those too lazy to click, here’s a brief recap: During the 1970’s, Eli Lilly developed Oraflex, a drug designed to relieve arthritis symptoms. (Just like Vioxx.) The drug hit the shelves in Europe while the FDA was still going through the approval process. At least 29 people in Europe died from Oraflex, and Eli Lilly broke the law by concealing those deaths from the FDA. Consequently, the drug was approved for sale in the U.S. Sadly, people in America died from Oraflex, too.

This deadly fraud was uncovered not by a diligent FDA employee, but by a “greedy trial lawyer” during the same type of lawsuit you want to do away with. As a direct result of a product liability lawsuit, the FDA investigated the drug and pulled it from the market. Additionally, an Eli Lilly Vice-President was convicted of 25 misdemeanors. Would the public have been better off without this lawsuit?

Your argument that FDA approval of a drug should immunize the drug manufacturer from suit is based upon the faulty premise that the FDA is infallible – which they certainly are not. When the FDA fails, trial lawyers use the tort system in to correct them. Eliminating product liability lawsuits puts live at risk… just to protect profits.

That said, I do believe that manufacturers who meet their legal obligations to the FDA should be immune from punitive damages. But if the drug manufacturer fails to follow the law, I would allow punitive damages, and impose mandatory treble damages as a fine to be paid to the FDA. Additionally, if (as in the case of Oraflex) any employees were found to be criminally liable, those employees should be subject to liability as well.

But there’s another argument not to end product liability lawsuits over FDA-approved drugs. As you may know, Michigan enacted such a law in 1995, and that means that the many victims of Vioxx, Zyprexa, etc. in Michigan can’t even recover the cost of their medical bills. So who pays for them? In many cases, such as individuals covered by Medicare or Medicaid, the taxpayers are forced to. Ted, why on Earth should *I* have to pay for the medical bills of an individual injured by Vioxx? And its not just medical bills, either. What happens if that person becomes disabled and goes on public assistance? I end up having to pay for that, too.

Ted, you once attempted to lecture me about basic economic principles, but it appears you forgot the first thing your professor probably told you in Econ 101: “There’s no such thing as a free lunch.” Simply ridding the courts of product liability suits will not rid society of injuries caused by FDA-approved drugs. Instead, your proposal forces taxpayers to pay for the injuries caused by drug manufacturers.

Please explain to me why forcing taxpayers to pay for those injuries doesn’t constitute a true tort tax.

[Frivolous in Michigan]

Ted has it wrong. All relevant appeals decisions have shown that the "fraud clause" in Michigan's law is meaningless. The FDA can sue. Not individual citizens. Drug companies enjoy absolute tort immunity, with no exceptions.

Even if the clause was meaningful, it covers only fraud during the process of approval. The majority of injuries, and the great majority of lawsuits, concern failure to warn based on suppressed, denied, or falsified data _post_ FDA approval. So the alleged exception is meaningless on this count as well.

It is, indeed, the case that fraud has been shown through a number of legal actions, the Oraflex cases being only one instance. In the meantime, Alan Goldhammer, an associate VP of PhRMA, has himself testified before a federal committee that is precisely the threat of potential lawsuit that is critical in comapanies paying due attention to safety.

Companies that do that have nothing to fear from the legal system. Companies that do not _ought_ to fear it.