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 " 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 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!

Monday, January 03, 2005

Robert Reich is ahead of Pharmahost

Yes indeed, we must give credit to Mr Reich, who writes for the American Prospect. In his article about the perverted juxtaposition of tort reform for companies who follow FDA regs for their products, and the poor quality of FDA oversight at the office of Drug Safety, Mr Reich echoed my blog of December 27 ("Pfizer Exec tells all"). Except that he wrote his article on the 22nd. Like John Kerry, we have written to the American Prospect to offer our concession. And to ask that they link to Pharmablogger. T.A.P. ROCKS!!

For a different tale of Drug Safety, we offer you a link to an article in The New Yorker concerning the testing of drug in pediatric populations. The article is long, and makes several important points. We would like to focus on the idea that any drug under consideration for approval should be highly scrutinized in vulnerable populations for safety, and indeed we have seen this for the hepatically impaired in recent years. Liver failure has been one of the most common reasons for drug withdrawals or non-approvals (see Duract and Exanta). The Duract example is good because no one could get doctors to stop over-prescribing that drug. You have to wonder, does a company in that position really try to get a warning message across, right down at the sales rep level, even when the FDA is breathing down their necks?

Anyway, we would expect that real pediatric studies would be expected for whoever brings forth the next anti-depressant, based on recent bad publicity of Paxil and other SSRIs (studies in which no one actually committed suicide, but had events coded to the term "suicidal ideation"). This is still a scattershot approach, however. Scrutiny will only be brought to bear on the categories of drugs that have already been demonstrated to be a hazard.

Lastly, for our daily dose of re-importation nonsense, see this article from CIPA, a Canadian mail-order pharmacy group, that contends President Bush is behind a new effort by the Health Ministry to shut down shipments to US addresses. We love the way they make us sound like an underprivileged country in this bit:

"Dosanjh (health minister) drafted the new regulations that, if implemented,will make it illegal for Canadian mail-order pharmacies to fill prescriptions for non-citizens, and leave millions of Americans without access to affordable medications."

Oh wait, I forgot. For health care coverage, we ARE a third world country.