Home -> Law Blog Directory -> Personal Injury Law Blogs -> Drug and Device Law

Personal Injury Law

: Drug and Device Law

California Scheming

By James M. Beck and Mark Herrmann

Or maybe just legislatively-assisted suicide for the pharmaceutical industry....

Out on the left coast, a bill has been introduced that would put the Golden State in the august company of ... West Virginia ... by abolishing the learned intermediary rule. We've got a copy of it here, but it's not very long at all - just one paragraph. Here's what it says, in its entirety:

1714.46. Manufacturers of prescription pharmaceutical products shall not be relieved of a duty to warn consumers of the risks and side effects solely because the product was prescribed to a patient by a physician.

That's it. No reasoning. No explanation of why anybody thinks this is a good idea. No modification of the rules governing physicians, pharmacists, or anybody else to require them to pass along whatever warnings that the pharmaceutical industry might send along with its products.

We were sent this by our colleagues over at Reed Smith (thanks Paul), so we gave one of their California lawyers a call.... After all, weird stuff is introduced in Congress and legislatures every day of the week. We were more than a little surprised to learn that, apparently, this bill might actually move.

We hope our clients have this on their radar screens. We're doing the best we can to get the word out.

If this bill actually has a chance, we're wondering what's being smoked out there in California - and not for legislatively approved "medicinal" reasons, either.

We think abolishing the learned intermediary rule is a bad idea whose time has passed. We've posted at (very, perhaps excessive) length about the sound policy reasons that have led courts in 47 states to follow the rule before. We're not going to go over all those reasons again, because we'd be here all day. Briefly,

• Prescription drugs are available only by a doctor's prescription - duh. The law of informed consent and medical ethics both require doctors to explain the benefits and risks of drugs to their patients.
• Patients don't and aren't expected to treat themselves. Drug warnings are often long, complex and full of technical terms intended to give precise information to doctors.
• Prescription drug manufacturers don't know who is using their products. In the absence of of any legal requirement imposed on physicians to pass along drug warnings, there is no practical way for manufacturers to ensure that warnings are passed along.
• Society values the physician-patient relationship. We want to get information about prescription drugs from doctors whose first duty to us rather than from the very same manufacturers that plaintiffs love to criticize as excessively influenced by profit motive.
• Our doctors know what risks are relevant to us as individuals - that's their job. Drug companies would only be able to give general information with lots of risks. Overwarning deters people from using drugs their physicians prescribe. That's by definition dangerous.

Most of all, though, the California proposal, like West Virginia's ill-considered common law deviation, simply does not reflect reality. The whole system of prescription drug distribution in the United States is based upon drug labeling being directed to trained medical professionals - not dumbed down so that morons like us can go off making our own independent risk-benefit analysis. You can't buy prescription drugs (legally, anyway) without pre-approval by a licensed physician. Federal law doesn't work that way. When the FDA thinks direct-to-patient warnings are a good thing, it requires them. Otherwise, no.

We're not sure what the sponsor means by "solely" either - but the implications are scary. Think ahout abolition of the learned intermediary rule would mean in the typical drug case. Doctor Kildare prescribes Joe Schmoe a drug based upon his medical evaluation of Schmoe's condition and the risks and benefits of the drug. "Take two of these every day, one in the morning and one at bedtime, and call me immediately if [X, Y, or Z] happen, because that may mean you are getting [A, B, or C] adverse reactions."

So Schmoe gets ahold of some drug warnings from the manufacturer. They warn not only of A, B, and C - the reactions Dr. Kildare thinks are relevant to Schmoe's condition - but also about three dozen other things.

What's Schmoe supposed to do?

Is he supposed to follow the instructions of his doctor?

Or is he supposed to make his own judgment call on the basis of what he read himself?

If Schmoe's choice is to do what his doctor says, then how does the information from the drug manufacturer, even if inadequate, cause anything bad to happen to Schmoe?

It can't.

The only way inadequate information passed directly from a drug manufacturer to a patient can be considered a "but for" cause of patient injury is if we're encouraging patients to IGNORE THEIR DOCTORS' INSTRUCTIONS and stop taking prescribed drugs.

In short, this bill is predicated on patients practicing medicine for (and upon) themselves. Prescription drugs would be no different, legally, than California's beloved medicinal marijuana.

We think that's a really, really bad idea.

Full post as published by Drug and Device Law on March 06, 2008 (boomark / email).