FDA Proposes New Dangers: Removing the Right to Sue

FDA officials ate crow last week as actor Dennis Quaid spoke before the House Oversight panel. Quaid, whose newborn twins nearly died after being given unsafe heparin, spoke passionately against FDA officials’ claims that FDA-approval was the ultimate, end-all proof that a drug’s safe. Quaid supported personal injury lawyers of dangerous drug lawsuits, stating:

“I used to think lawsuits were frivolous. Now I know the courts are the only path.”

The hearing, called “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?”, heard medical and drug injury figures, such as the Institute of Medicine’s estimate that 1.5 million U.S. citizens suffer injury from medication mistakes every year. In the case of Quaid’s 14-day old children, the unsafe dosage was given because Baxter, the heparin manufacturers, had not changed the labels to clearly identify the heparin dosage levels–a measure the drug company drug its feet on until it faced lawsuits for the deaths of three infants in an Indiana hospital.

The House hearing was in response to a Bush Administration initiative that would eliminate the ability to sue for recoveries in drug injury lawsuits. The Administration has argued (and recent Supreme Court decision suggests) that drug and medical device companies should not be held liable for injuries caused by their drugs or medical products if they are FDA approved. The House hearing was to evaluate this insane proposal. But perhaps even more maddening that the FDA’s own statement that any product that meets its standards for approval should not subject to state liability laws.

This is not merely a matter of big pharmaceutical companies being in bed with the FDA or simply more rhetoric of tort reforms that distort the purpose of personal injury law (i.e. making those found liable in court for injuring innocent people pay for the real cost of those injuries), but represents a larger and graver matter: the rights of individual American citizens over those of powerful corporations.

Readers of the Tennessee Law Blog do not need to be reminded of the various failings of the FDA over the decades to see why denying the right to sue for medical device, food, or drug injury damages is just darn ludicrous. That these discussions can even be thought reasonable to occur is insulting to those who in the past three years have been fatally injured by defective infusion pumps, permanently blinded by fungal infections from recalled ReNu contact lenses, or potentially fatal fentanyl overdose from duragesic pain patches. And what of Vioxx and the slew of other FDA-approved drugs that have killed or injured Tennesseans because of their negligence?

Even David Kessler, ex-FDA commissioner (1990-97), testified that the FDA does not have the resources to detect emerging risks from approved (but dangerous) drugs or medical devices and that states should not be told that their citizens cannot sue drug and medical manufacturers for recoveries.

If you or a Tennessee loved one has suffered a medical device or prescription drug injury, you deserve compensation from those responsible for your injury. Contact HHP today to speak with a TN prescription drug/medical device injury attorney.