Diana Levine Testimony

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Statement of Diana Winn Levine Before the House Oversight and Government Reform Committee

Today, big business, led by the drug manufacturers, is seeking to stop everyday citizens who have been hurt by a dangerous product that was approved by the federal government from being able to hold those powerful corporations accountable through the application of a legal theory known as “pre-emption."

The companies, supported in many cases by the Bush Administration, argue that, if the federal government approves a product that goes on to hurt somebody, the victims of the product cannot use the legal system to hold the company behind the product accountable – even in cases where a company knows, and does not disclose to the federal government or public, that its products will harm people.

I am one of those people.

Almost eight years ago, I was wheeled into a Vermont health clinic with a severe migraine headache and nausea. I ended up having my hand and half my forearm amputated because of the failure of Wyeth Pharmaceuticals to change its label so that only the safe ways of administering the anti-nausea drug Phenergan were provided to the medical caregivers – even though Wyeth was aware that the drug was being administered improperly.

The loss of my body parts ended my 30-year career as a professional musician. It is nearly impossible to play the guitar, bass, or piano with only one hand. In 2004, I took Wyeth to court to hold the company accountable for their conduct. A Vermont jury ruled in my favor, requiring Wyeth to compensate me for my economic losses, damages, and medical expenses.

Wyeth, in the appeal of the Vermont court’s decision, has argued that, since the Food and Drug Administration (FDA) had approved the drug’s labeling instructions, victims such as myself are barred – what they call “pre-empted” – from being able to hold them accountable regardless of the fact that the company knew its warnings were not adequate.

In other words, Wyeth’s argument boils down to the idea that since the FDA approved of the drug and warning label – I am out of luck despite the fact Wyeth’s action caused me to lose my hand through absolutely no fault of my own and despite the fact that the company knew its instructions were causing injuries to the public.

The case is now before the United States Supreme Court where it will be determined whether claims like mine are pre-empted or not.

Historically, courts have considered government-issued warnings on a product as reflecting a minimal standard of care – the baseline, not the top line. Victims of dangerous products have long had the right to hold companies accountable through our court system. Not only does this well established system allow individual victims to hold businesses accountable when they do wrong, it is the primary way that society has encouraged companies to use reasonable care in designing and marketing products. If you put out something that will hurt people, you can be held responsible.

However, if the Supreme Court rules for the drug company in my case, it will mean that big business will be given immunity when it sells products that hurt people so long as they have been “approved” by a federal agency – even in cases where companies know for a fact that their products are unsafe and will cause fatal injuries.

Given the performance of the FDA under the Bush Administration, I for one am not ready to give up my individual rights to hold a company accountable merely because a government agency has issued a minimal safety standard for a product.

Over the last several years, we have seen report after report of drug companies impacting the approval process of the FDA to produce a label warning that is inherently flawed. In some cases, it was through a cozy relationship with the regulators issuing the approvals. In other matters, a political relationship existed between a company and a political appointee at FDA that helped grease the wheels for the approval. And there have been times where drug companies simply did not disclose negative information about a drug’s safety record, while it was going through the approval process.

The Supreme Court’s decision will have enormous ramifications far beyond my case, my hand, my musical career or even the drug industry. It will mean that virtually every industry that has a product that requires federal approval could be given protection from lawsuits. Essentially, a decision for Wyeth will be akin to giving corporate America a “get out of jail free” card – and it will leave everyday Americans exposed. Congress must prevent that result, which would be devastating for victims of unsafe products.

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