A Stitch in Haste

In case you missed it, late last week an FDA panel recommended the return of Vioxx, Celebrex and other COX-2 inhibitors to the pharmaceutical formulary:

It was a stunning turnaround for Vioxx, which was withdrawn in September by Merck after a study showed the drug doubled heart attack and stroke risk compared with a placebo in patients who took it for at least 18 months.

Celebrex and Bextra, which had been under the same cloud of elevated risks of heart problems, also could stay on the market, the panel said. Most members felt all three drugs should have "black box" warnings -- the strongest warnings used for prescription drugs -- explaining their heart risks.

Many urged restrictions if Vioxx is sold again, such as limiting sales to the lowest dose and recommending it be a second choice after patients try another pain reliever.

John Cush, a rheumatologist at Presbyterian Hospital in Dallas, said the risk of heart problems with Vioxx was "still very small" and he wanted "as many options for my patients as possible."

Exactly as it should be. It's not clear whether the COX-2 hysteria was begun, or just catalyzed, by the over-eager personal injury bar. But what is clear is that there will be a lingering fear, probably unwarranted, over these -- by all accounts very effective -- painkillers. And of course these pro-COX-2 developments will not stop the class action juggernaut already set in motion. Stay tuned...

Meanwhile:

Most panelists wanted to forbid drug makers from advertising the COX-2 drugs. The FDA cannot order an advertising ban but will consider asking the manufacturers to do so voluntarily, said Dr. John Jenkins, head of the FDA's Office of New Drugs.

The relatively new phenomenon of direct-to-patient advertising opens new questions, and challenges, regarding pharmaceutical -- and physician -- liability. Before "purple pill" and "gotta go" and other "ask your doctor about..." ads began flooding the airwaves and print media, the patient could realistically claim near-total ignorance and, by proxy, immunity from even a hint of comparative fault in cases of serious side effects from pharmaceuticals, or medical malpractice, from the doctor -- "My doctor said take these and I took them..."

But now the compulsion often goes the other way: it's the patient who demands anti-Digger pills or happy-bean-creature pills or who wants the Patrick Stewart cholesterol pill instead of the Dan Reeves cholesterol pill. What responsibility, if any, does the patient now bear if something bad happens? Does "The ad said take these and I took them..." carry the same weight as "My doctor said take these and I took them..."?

As is often the case, the law often has to play catch-up with new fact patterns. So what? Is it true at all that "pharmaceuticals are somehow different," and if so, is it true to such an extent that pre-emptive regulation is warranted (especially regulation from the FDA -- which hardly has a stellar track record these days)?

I don't know. But I do know this: Doctor Cush, quoted above, is exactly right -- the more options we have, the better.

More thoughts at Legal Underground.

The COX-2 Archives:
Will COX-2 Be the Next Asbestos?
COX-2 Update: "Heart Attack for an Ulcer"
COX-2 Update: Other.Shoe.Dropping.
COX-2 Update: "Consumer" Group Calls for Celebrex Ban

Here's an interesting if sad story:

Dr. David Cox is a stay-at-home dad, but not by choice. Cox is recovering from a stroke -- a condition he blames on Vioxx.
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Cox was taking Vioxx at the time of his stroke, and claims the controversial painkiller -- which drugmaker Merck pulled from the market in September due to serious safety concerns -- triggered the stroke.

He is not the first Vioxx user to blame Merck for health problems related to the drug; more than 1,500 Vioxx related personal injury lawsuits have been filed against Merck. But Cox's case won't be among them because Michigan law doesn't permit the lawsuit. A 1996 state law prohibits lawsuits against drug makers if the drug in question is approved by the Food and Drug Administration.
...
Meanwhile, it's just not Michigan offering to shield drugmakers from lawsuits. Medical liability reform has been introduced in Congress. A bill in the house would limit a pharmaceutical company's liability for FDA-approved medications -- though it doesn't go as far as Michigan's law in banning outright lawsuits.

There are actually two distinct issues here. First is the question of whether FDA approval of a pharmaceutical should constitute a safe harbor against product liability. I have blogged about this subject repeatedly -- the chained post below has the archive at my old blog.

Bottom line: I'm amenable to the idea of a safe harbor, assuming we have a competent FDA and also assuming that the quite novel issue of "direct-to-patient" advertising ("Ask your doctor whether Kiptriol may be right for you...") is fully vetted beforehand. Two very big assumptions.

But there's a second question -- why are we yet again worshipping the false god of federalism in a situation like this? How can it possibly be fair for people in one and only one state to be denied the right to sue? The drug companies should either be liable or not be liable. Why some states and not others?

Here we go again -- we endlessly debate "states rights" (which is an oxymoron -- only individuals have rights...states have powers that may or not be infringed by federal encroachment, but not "rights" properly defined). Yet no one stops to think about Dr. Cox' rights. Maybe he should have the right to sue, maybe not -- that's among the most unsettled of questions right now.

But it cannot possibly make sense that Dr. Cox is precluded from suing in Michigan while Dr. Dicks can sue in Wisconsin and Dr. Peckers can sue in Indiana. Imagine the befuddlement if a law said that Michiganers ("Michuganas"?) in the upper peninsula could sue but those in the lower state could not. It simply wouldn't make sense, and neither does a state-by-state policy.

Federal pre-emption, whether for or against liability, is the proper policy here. National market, national advertising, national laws -- it's that simple. Federalism has no place here.