Drug makers seek shield from lawsuits

[babylonsister]

Drug makers seek shield from lawsuits

In a case that could have broad implications for consumers, the Supreme Court this fall will consider barring liability claims involving medications approved by the FDA.

By David G. Savage, Los Angeles Times Staff Writer
September 7, 2008


WASHINGTON -- Bridget Robb was awakened last December by a powerful electric shock to her chest. "It was a jolt of electricity. It felt like being shot in the chest or being hit by lightning," said the 34-year-old mother from a Philadelphia suburb.

She knew the cause of her agony. A device implanted in her chest was supposed to shock her, but only if her heart had quit. Instead, because of frayed wires, it misfired 31 times in 13 minutes.

She underwent two operations to replace the defective device, requiring months of recovery.

Robb appears to be blocked from suing the manufacturer for compensation. Earlier this year, the Supreme Court reinterpreted a 32-year-old federal law as barring suits against makers of government-approved medical devices.

Now, in a case to be heard this fall, the court will consider whether to extend this shield against lawsuits to the makers of prescription medicines and over-the-counter drugs.

If so, it could make for a far-reaching change in the law, one brought about with little public debate. Having failed to persuade Congress or the states to limit such suits, the Bush administration and the pharmaceutical industry went to court, and now they stand on the verge of shutting down tens of thousands of lawsuits that have cost the industry billions of dollars in jury verdicts and settlements.

"This is a radical restructuring of the American civil justice system," said Georgetown law professor David C. Vladeck, formerly of the consumer advocacy group Public Citizen.

more...

http://www.latimes.com/news/nationworld/nation/la-na-scotus7-2008sep07,0,3843835.story?track=rss

[silverweb]

1. K&R

This is very important.

From joint replacements to flu shots, manufacturers will be permitted to charge whatever they can get away with, yet have zero liability for defective, dangerous, even deadly products.

More laissez-faire "free market" bullshit in action -- and the only people with any guaranteed benefit are the executives and shareholders.

[MannyGoldstein]

2. This Article Is Misleading

Speaking as a medical device designer...

The law does not allow a lawsuit if:
- the device works as the FDA was told it would when approved
- the FDA was not deceived
- the device was not advertised for something different than what the FDA allows it to claim
- the device was manufactured in accordance with FDA standards - these are actually very strict

Violate any of those, and you're open to a law suit.

As a practical matter, even before the law explicitly said that a device maker could not be sued unless the above were violated, it was, as a practical matter, impossible to win a law suit for any other reason - if a device maker can point to the FDA and say "they're the experts, and they said we could sell it", then the case was virtually impossible to win.