Problems with Generics

Did you know that when you take a generic drug, you essentially forfeit the ability to sue the company making the drug for damages if you experience an adverse event?

Today's NYTimes story, "Generic Drugs Prove Resistant to Damage Suits," begins by comparing the legal and financial outcomes of two women: Each suffered limb loss after an antinausea medication was accidentally injected into an artery instead of a muscle. The patient injected with the brand name drug won an $8.6 million verdict against the drug company while the patient injected with the generic version of the same drug had her case thrown out of court.

Why the different outcomes? A 2011 Supreme Court decision said makers of generics don't have control over what their labels say.

The problem dates back at least to 1984, when the Hatch-Waxman Act "allowed companies to skip the lengthy process required to approve new drugs if they could preove that the generic drug was equivalent to its brand-name counterpart."  [FDA approval process was discussed on my 12/13/11 post.]

Decades later, in 2010, the Supreme Court ruled that brand-name companies can be sued for failing to adequately warn patients of risks.

Factors shaping the legal battle over generics include:

• Claims by companies making generics that they would lose the ability to keep prices low if they became responsible for updating labels
• The reluctance of Congress and the FDA to do anything that makes it more difficult for patients to obtain needed medicines

Next: What's a Healthy Survivor to do? 

Comments

[Rosalyn Zakheim]

I just read about this in the NY Times and am glad you are highlighting it. With many health providers requiring generics (or you pay the whole price for brand names), this situation is frightening. Pharma can easily update the labels and should be required to do so if it will solve this problem.

[Jan Baird Hasak]

Wendy, I had no idea about this. What a dilemma--and tragedy. Congress and the FDA would never want to anger seniors in our current political and fiscal climate, so I don't see anything happening soon (if ever) to remedy this situation. Caveat emptor! XX

[sue chizeck]

that's horrible! Another problem I see is that generics are often not equivalent to the brand name. When I was switched to one generic, it made me dizzy and unable to drive or work, although the brand was fine. So I had to switch back at great cost. We have had others that were simply ineffective compared to the brand. So this is yet another glitch.

[weights]

Great post! Perfectly understandable about the generics..definitely have to keep your priorities straight. I’ve learned so much from reading your blog.