Overruled


Drug Company’s Immunity Claim is a Bridge Too Far For the Justices
March 4, 2009, 12:36 pm
Filed under: Ian | Tags: ,

Diana Levine was a successful musician, until a toxic drug took away her right hand. The drug, an anti-nausea medicine made by the company Wyeth, causes irreversible gangrene if injected into a patient’s artery. Because Wyeth failed to adequately warn doctors of this poisonous effect, however, a physician’s assistant used an unsafe method to inject the drug into Levine. Her hand and her livelihood were the casualties.

After a Vermont jury found that Wyeth was liable for failing to warn doctors of the dangers presented by its drug, Wyeth claimed that it was immune to accountability for its failure, and that Diana Levine was entitled to nothing as a result. Specifically, Wyeth argued that, because the FDA has to approve new drugs before they enter the market, FDA approval of a drug or its labeling “preempts” any state law which also effects drugs or labels.  Needless to say, if Wyeth had won today, it would have been a massive giveaway for the drug companies—total lawsuit immunity.

Instead, today’s Supreme Court decision upheld the basic American value that no one is immune from the law.

Since the 1930s, the federal government and the states have worked together to protect American consumers from unsafe drugs and fraudulent marketing by drug companies.  The federal Food and Drug Administration screens new drugs before they enter the market, and the states have always protected consumers by holding drug companies accountable when an FDA approved drug nevertheless injures a patient.  As Justice Stevens explained for the Court, the FDA alone cannot adequately protect American consumers from dangerous drugs, state tort claims play an essential role in preserving public health:

In keeping with Congress’ decision not to pre-empt common-law tort suits, it appears that the FDA tradition-ally regarded state law as a complementary form of drug regulation. The FDA has limited resources to monitor the 11,000 drugs on the market, and manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge. State tort suits uncover unknown drug hazards and pro-vide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come for-ward with information.

In other words, the FDA can’t catch everything, and they frequently do approve a drug or a drug label despite as-yet-undiscovered dangers to the American consumer.  State tort law is the mechanism to protect American consumers when such a danger results in tragedy.  Had the Justices sided with Wyeth, they would have destroyed this protection for consumers, and many more Americans would have wound up like Diana Levine.

Unsurprisingly, the Bush Administration took the drug company’s side in this case, but their arguments to the Justices on Wyeth’s behalf was only a small part of their efforts to shield drug companies from accountability under the law.  In 2006, the Bush Administration sneaked, without warning to the public, language into the preamble to a regulation which said that FDA approval of a drug establishes both a “ceiling” and a “floor” for regulation of drug companies.  In other words, the Bush Administration tried to make Wyeth’s self-serving argument into the law—establishing that so long as a drug company complies with FDA regulations, they are free to ignore state law.

Today’s decision smacked down that effort.  As a general rule, agencies cannot create new regulations without first giving notice of their intent to the public, and then allowing the public a chance to comment on the proposed regulation.  Because the Bush Administration tried to sneak the drug company’s fondest desires into a regulatory preemble, the Court said it was free to ignore this preamble.  And it did.  So one that’s one less George W. Bush giveaway to the corporate interests that we need to worry about.

I’ll probably write more about this case in the days to come, but my initial impression is that it is an earthquake, completely eviscerating many of the drug industry’s efforts over the past several years to immunize itself against the law.  I take no small amount of glee in the thoughts offered by Drug and Device Law, a blog written by drug industry lawyers for drug industry lawyers: “Levine isn’t good news for our side by any means . . . .”

Advertisements

5 Comments so far
Leave a comment

[…] I’ll probably write more about this case in the days to come, but my initial impression is that it is an earthquake, completely eviscerating many of the drug industry’s efforts over the past several years to immunize itself against the law.  I take no small amount of glee in the thoughts offered by Drug and Device Law, a blog written by drug industry lawyers for drug industry lawyers: “Levine isn’t good news for our side by any means . . . .” via overruledblog.com […]

Pingback by Wait, You Mean Drug Deale– Companies Aren’t Above The Law? Thanks SCOTUS - Jack & Jill Politics

[…] I’ll probably write more about this case in the days to come, but my initial impression is that it is an earthquake, completely eviscerating many of the drug industry’s efforts over the past several years to immunize itself against the law.  I take no small amount of glee in the thoughts offered by Drug and Device Law, a blog written by drug industry lawyers for drug industry lawyers: “Levine isn’t good news for our side by any means . . . .” via overruledblog.com […]

Pingback by Wait, You Mean Drug Deale– Companies Aren’t Above The Law? Thanks SCOTUS at goodCRIMETHINK

[…] Drug companies beware. The U.S. Supreme Court ruled yesterday against the drug manufacturers in the lawsuit Wyeth v. Levine, which upheld $6.7 million in damages awarded to Vermont musician Diana Levine who had to have her […]

Pingback by Lunchbox: Gillispie’s honeymoon is over - FatLip

[…] Justice Stevens just reminded us, “[s]tate tort suits uncover unknown drug hazards and provide incentives for drug […]

Pingback by FDA Rolls The Dice on Untested Medical Device « Overruled

[…] immune from state laws so long as their drugs and drug labels are approved by the FDA, the Justices declared the claim to be a bridge too far. The Supreme Court recognized the simple truth that state consumer protection laws play an […]

Pingback by PoliTrix » Blog Archive » Ian Millhiser: Big Pharma’s Loss is America’s Gain: Obama’s Outstanding First Choice for the Federal Bench




Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s



%d bloggers like this: