Waiting for my plane at La Guardia, I see that the NYT has an article on page one about the disparity between suing brand name vs. generic drug makers for failure to adequately warn of serious side effects on their drug labels. Can it be that no one is responsible for monitoring/updating drug label warnings once a drug becomes generic?
Debbie Schork, a deli worker at a supermarket in Indiana, had to have her hand amputated after an emergency room nurse injected her with an anti-nausea drug, causing gangrene. She sued the manufacturer named in the hospital’s records for failing to warn about the risks of injecting it. Her case was quietly thrown out of court last fall.
That result stands in sharp contrast to the highly publicized case of Diana Levine, a professional musician from Vermont. Her hand and forearm were amputated because of gangrene after a physician assistant at a health clinic injected her with the same drug. She sued the drug maker, Wyeth, and won $6.8 million.
The financial outcomes were radically different for one reason: Ms. Schork had received the generic version of the drug, known as promethazine, while Ms. Levine had been given the brand name, Phenergan.
“Explain the difference between the generic and the real one — it’s just a different company making the same thing,” Ms. Schork said.
Across the country, dozens of lawsuits against generic pharmaceutical companies are being dismissed because of a Supreme Court decision last year that said the companies did not have control over what their labels said and therefore could not be sued for failing to alert patients about the risks of taking their drugs.
Generic drug companies, spared the years of costly research for initial drug approvals*, are able to sell generic versions much more cheaply than the brand-name drug company, once the initial patent expires (generally after 20 years), but they must use the same label as the brand-name company used. So, how can they be blamed, they argue, for a label that they had no choice but to use? That, at any rate, was the basis for the Supreme decision last summer. What about suing the brand name company for the faulty label? It is argued that they cannot be blamed when the actual drug the patient took wasn’t even sold by them. They might even have stopped selling the drug altogether.
You’d think the side-effects/complications would have been noted in the years before losing patent status, but it seems clear that there needs to be a way for the FDA to require label updates from one or both of the companies.
Where possible, I try to avoid generics because of a problem I once had with the coating used (see illustration of “simulating errors” in EGEK, p. 6); but there may be soon be no choice: given that insurance companies require using generics, some (many?) brand-name versions may disappear. Given also the large number of drugs losing patent status, and the upshot of this recent ruling is bound to be increasingly common.
My knowledge on brand vs. generic regulations is largely limited to following drug stocks; I’d be interested to hear what others know/think of this thorny situation and the associated rulings.
*(aside from the need to show “bioequivalence”)
This seems to me to be exactly the type of situation that requires “administrating” on the part of the FDA (a supposedly “neutral government” body that could negotiate between companies)–and should never have had to go to the Supreme Court to begin with! I am really surprised that they did not have the foresight to take care of this type of labeling snafu as soon as generics came on the scene but surely it should have been taken care of by the time generics became popular and, as you point out, mandatory under many insurance plans–mine included! The idea that a label is potentially 20 years out of date is a bit of unnerving, to say the least! Of course, it would be interesting to see what sort of deal the FDA would have to cut to get initiating research companies to share their info/data with generics (a token royalty, perhaps?)
Well, it’s more complicated; the recent decision was just an upshot of the earlier Supreme court decision from last summer: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2011/06/supreme-court-issues-decision-on-generic-drug-preemption-to-borrow-from-harry-caray-holy-cow-generic.html.
The catch 22 that allows generics to avoid being held responsible for any inadequacies of labeling is that they are required to use the exact same label that the brand name company used, so if the generics updated labels to reflect new warnings, they’d be in violation of this existing requirement. I’m curious as to how this will be settled. The generics will become more expensive if they are liable, but maybe brand name drug companies will be allowed to retain their patent, but sell at lower costs after the 20 years are up. Else, maybe there will simply be no liability for such things (although the FDA could post any new warnings). Incidentally, the label wouldn’t be 20 years old if there had been updates. But I know that brand name companies tend to negotiate with generics over a period, to extend the time they can sell the brand name drug. During that interim period, it wouldn’t seem to be in the interest of either drug company to seek additional warnings to a label. Then, once they free themselves of selling the drug under the brand name, no one is liable, or so it would seem. But again, I’ve little inside knowledge here.
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