A hearing today before the House Committee on Oversight and Government Reform will address the question of immunity for drug companies. The drug companies want complete protection from lawsuits even when they fail to properly manufacture, market or package their drugs.

But a formerFood and Drug Administration commissioner told Congress today that FDA approval of a drug or medical device shouldn't bar suits against the product's manufacturer, saying the agency's lack of resources diminishes its ability to detect emerging risks.

"Even if the FDA's funding were doubled or tripled, its resources and ability to detect emerging risks on the thousands of marketed drugs and devices would still be dwarfed" by the resources of drug companies, according to David Kessler, FDA commissioner from 1990 to February 1997.

The Bush administration has followed a two-pronged strategy for protecting big pharma. First, seek legal immunity in the Supreme Court for companies on the basis that the FDA's approval amounts to a "preemption" of the rights of individuals injured or killed by the defective drugs to purse claims under state laws.

Second, the Bush administration intentionally underfunds the FDA, thereby preventing it from performing its obligation of inspection and enforcement.

Actor Dennis Quaid also testified today. His six-month-old twins, Thomas Boone and Zoe Grace, were accidentally given adult-doses of the blood thinner heparin in November 2007 because the product looked similar to another drug used to flush IV lines. The overdose of heparin was potentially lethal, but Quaid's children fully recovered.

Quaid said in opening testimony that the similarity of heparin to Hep-Lock, a weaker blood thinner used to flush IV lines, also led to the deaths of three infants in Indianapolis in 2006. Both Hep-Lock and heparin are made by Baxter International Inc. (BAX).

Quaid sued Baxter in November 2007, and the Deerfield, Ill., company has moved to dismiss the case, relying on the preemption doctrine.

Quaid said a federal ban on lawsuits "would relieve drug companies of their responsibility to make products as safe as possible, and especially to correct drug problems when they are most often discovered - years after their drugs are on the market."

Quaid and the former FDA Commissioner are right. Both the FDA and the manufacturers have absolute non-delegable duties to insure our drugs are safe. The preemption doctrine significantly diminishes the safety of our drugs, permitting companies to hide behind the fallacy that FDA approval amounts to a guarantee of safety.

We have learned the hard way that the FDA does not and cannot protect us from defective drugs. Drug companies that fail to perform their duties should be held to the same standard as every other corporation or person in America, and required to make good the harm caused by their breach of duty.

You can watch the hearing on C-Span here: Hearing: Should FDA Drug and Medical Device Regulation Bar State Liability Claims?

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