Wednesday, January 05, 2005

Malpractice shield redux

We discussed in an earlier post the possibility of Congress passing a tort reform bill that included a shield bor pharmaceutical companies who had complied with FDA regulations. Providence has given us spate of FDA deficiencies in the media that will help to prevent that bill from passing, but it already exists in at least two states - Michigan and Texas.

Today's Houston Chronicle discusses how Vioxx lawsuits in Texas may likely go nowhere, thanks to year-old tort reform legislation that protects drug companies "...as they can prove that any warnings of harmful side effects were approved by the Food & Drug Administration."

"To win against Merck in Texas, Vioxx plaintiffs will have to prove that the company withheld information or misrepresented it to the government. That will make litigation so expensive, some lawyers said, that they will accept only serious cases, in which plaintiffs were badly harmed and damage awards could be high. "

There is a possibility of combining the hundreds or thousands of Texas suits with suits from other states by the federal Judicial Panel on Multidistrict Litigation in Washington. This may be in Merck's favor however, as the litigation will become increasingly complex, and timelines will be stretched out for years. Remember, corporations may be "legal artificial persons" under the law, but they have the distinct advantage of not needing to age or die, unlike many of the "natural person" plaintiffs.

Here is a Law.com article about the other state with this protection, Michigan. Their law was passed in 1995, and withstood appeals to the Michigan Supreme Court.

"Jim O'Reilly, law professor at the University of Cincinnati and author of treatises on the FDA and product warnings, said the Michigan statute is unusual because states do not usually cede power to the federal government without pre-emption. A former associate general counsel at Procter & Gamble, O'Reilly added, 'the state is deciding to give away the rights of the individual" so that career federal agency employees in Washington "are now exercising the delegated power of a jury.'"

Jeff Trewhitt, spokesdude for PHRMA says that "the association has long supported an "FDA defense" to punitive damages if a drug company can prove that it followed all of the agency's rules and regulations in good faith." But frankly, even this is crap. The reality is that drug companies have to prove nothing. The plaintiffs will have to go through ridiculous amounts of discovery to prove that the drug companies did not follow regs in good faith. Do you know how much meaningless paper and garbled statistics a company can dump on a plaintiff to make discovery an impossible journey? We do. We've been instructed to hold all papers, emails, etc. with the name of certain drugs on it, in case of expected future litigation. We'll be able to bury any plaintiff with mountains of paper, should they dare to ask for it.

In today's mandatory Washington Post article on the subject of tort reform, pinhead "Victor E. Schwartz of the American Tort Reform Association. "If you have done everything the law requires, why should you be punished?" Victor missed the part in Torts class concerning the Common Law, and that regulations make up a tiny amount of what we call "the law." Let's just stuff the regulatory agencies with business people who don't care about patients or consumers, and then give those agencies the burden of deciding when the businesses subject to their regs can or cannot be found liable.

No thanks. The jury system can be found in the Constitution, while FDA deciding what is legally liable is not. Just call me a strict constructionist!

1 comment:

Anonymous said...

Vioxx health - Merck Earns Fall After Vioxx Withdrawal NEW YORK (Reuters) -

Merck Earns Fall After Vioxx Withdrawal
NEW YORK (Reuters) - Merck & Co. MRK.N on Thursday said first-quarter profit fell 15 percent following the withdrawal of its arthritis drug Vioxx last year. Link to original article
law recall suit vioxx