Supreme Court sides with pharmaceutical industry in two decisions

[Guest guest]

Supreme Court sides with pharmaceutical industry in two decisions

Justices rule that generic drug makers cannot be sued by injured patients in

most cases and that drug manufacturers have a 1st Amendment right to buy private

prescription records to use for marketing purposes.

Reporting from Washington—

The Supreme Court gave the pharmaceutical industry a pair of victories,

shielding the makers of generic drugs from most lawsuits by injured patients and

declaring that drug makers have a free-speech right to buy private prescription

records to boost their sales pitches to doctors.

In both decisions Thursday, the court's conservative bloc formed the majority,

and most of its liberals dissented.

About 75% of the prescriptions written in this country are for lower-cost

generic versions of brand-name drugs. Federal law requires the makers of

brand-name drugs to label their products with FDA-approved warning information

and to update the warnings when reports of new problems arise.

But in a 5-4 decision, the high court said this same legal duty to warn patients

of newly revealed dangers did not extend to the makers of copy-cat generic

drugs.

Justice Clarence reasoned that the warning labels were the responsibility

of the brand-name makers and the Food and Drug Administration. He said that

because generics were just copies, their makers could not be sued for inadequate

warnings if those warnings didn't exist on the original.

said the federal regulatory law trumped the state liability law in this

instance and therefore shielded the generic makers. " We acknowledge the

unfortunate hand " that was dealt to the patients whose suits were dismissed

Thursday, he wrote in his majority opinion.

The patients, Gladys Mensing and Demahy, developed tardive dyskinesia, a

severe neurological disorder, after taking metoclopramide, a generic form of the

drug Reglan for digestive problems, including acid reflux. They sued, alleging

that the drug maker failed to warn them of the danger of taking this drug for

more than 12 weeks. Studies had suggested a potentially increased risk of the

condition — and Reglan was eventually required to carry a " black box " warning

about it. That wasn't the case at the time...

But the dissenters, led by Justice Sotomayor, said the generic drug maker

should have alerted the FDA to the danger and then updated its warning label.

" This outcome makes little sense, " she wrote. Justices Ruth Bader Ginsburg,

G. Breyer and Elena Kagan agreed.

A consumer rights lawyer said the ruling stripped many Americans of an important

legal right. " Three out of four patients just lost the right to sue " if they use

a generic drug and suffer complications for which they were not warned, said

Louis Bograd, counsel for the Center for Constitutional Litigation. These

patients " appear to be left without any legal remedy. " ...

In the second decision, the court by a 6-3 vote struck down a Vermont law that

barred pharmacies, drug makers and others from buying or selling prescription

records from patients for marketing purposes. Vermont's physicians had sought

passage of the law, arguing that their prescriptions were intended for private

use of patients and should not become a marketing tool.

Drug makers buy this data to gear their sales pitches to physicians. Several

data-mining firms have made a billion-dollar business out of buying and selling

the prescription data to drug makers and researchers...

http://www.latimes.com/news/science/la-na-court-drugs-20110624,0,749646.story?tr\

ack=rss & utm_source=feedburner & utm_medium=feed & utm_campaign=Feed%3A+latimes%2Fnew\

s%2Fscience+%28L.A.+Times+-+Science%29 & utm_content=My+