Court: Generic drug makers not liable for warnings

Source: businessweek

he Supreme Court says makers of generic drugs cannot be held responsible for warning consumers of the dangers of their drugs on the package's label when the brand-name equivalent doesn't.

The high court on Thursday ruled in a 5-4 decision against Gladys Mensing, who had sued PLIVA Inc. and other generic drug manufacturers.

She alleges that taking metoclopramide gave her a severe neurological movement disorder, but none of the generic drug's manufacturers and distributors made any effort to include warnings on the label.

Generic drug makers say government regulations require them to have the same label on metoclopramide as is on its brand-name equivalent, Reglan. Reglan did not have a warning about tardive dyskinesia. The drug is often taken for heartburn.

Read more: http://www.businessweek.com/ap/financialnews/D9O1L1601.htm

Generic drug companies must show equivalency of their generic version of a brand drug and must provide identical labeling per the FDA.

It doesn't make sense they'd list side effects for a generic not listed for a brand drug when the two are chemically identical.

That seems to be implication but the innovator may try to blame the generic product.

got this condition it doesn't mean it was caused by the drug.

Irregardless, this is almost a laughable way for all of these companies, name AND generic, to get out of harm that these drugs have caused.

Thanks again to the Five Activist Judges for siding AGAINST American citizens.

And the brand drug still doesn't list them?

Medical professionals do the reporting and the FDA monitors; when trends are seen then a drug can be pulled (Vioxx) or the package insert updated to include the new side effects.

BUT..
You just knew there has to be a but....


try wading thru the dense, multiple redirections on the FDA page to even FIND any adverse reports.

Plus, note that it is the patient who is, once again, the guinea pig for the drug companies.

Tardive dyskinesia is a known side effect of metoclopramide and has been for decades.

ETA: The FDA required a black box warning about TD two years ago.

From my understanding, the woman suffered from the side effect before then. From a legal standpoint, I still agree with the ruling. When it comes to what's listed on a drug's package insert, that's a different story. Remember Vioxx?

I just think it's odd that a side effect that's been known for decades wasn't required to be listed until 2009.

There is nothing preventing them from including warnings that they know about. If they know what they are labeling "identically" is incorrect, they are liable.

This is just more cover for the trillionaires provided by their whores on the bench.

The FDA requires (by law) that the labeling of a generic drug must be the same as the brand. The only thing the FDA allows to be different is the indication (the brand may still have a patent for a specific indication).

One of the first things the prescribing MD told me was that tardive dyskinesia (complete with full explanation) was a possible side effect associated with long-term use. Years later when giving another MD my history, I mentioned it and the very first thing he said was "Wow! Did you have any problems with &91#tardive dyskinesia]?"

I'd be willing to bet that Mensing's MD told her about TD as a side effect when prescribing the drug.

There's a certain amount of responsibility a physician (and pharmacist) have to inform patients about side effects. Drug interactions too, when taken with other drugs. Many times that 'education' doesn't happen.