Posted January 27, 2009 | 11:30 AM (EST)
FDA Criticized on Device Approvals"
"FDA Is Lax on Oversight During Trials, Inquiry Finds"
"In FDA Files, Claims of Rush to Approve Devices"
"Financial Disclosures on Drug Studies Found Lacking"
"Glaxo's Emails on Avandia Reveal Concern"
"FDA rule makes it easier for drugmakers to distribute scientific articles on off-label uses"
The headlines above paint a startling picture of the Food and Drug Administration and pharmaceutical industry.
You know what's even scarier?
Those stories are just from the last two weeks.
It has become devastatingly clear that the drug and medical device companies will do just about anything to make a buck, regardless of the effect on public health and safety. And the FDA is unable to police an industry that time and time again has engaged in dubious tactics and put lives at risk.
This begs the next question: why are we now giving drug and device companies, faced with only lax oversight, complete immunity from any liability if their products injure, or even kill, Americans?
That's exactly what's been going on the last eight years, and exactly what we need to turn back in this new administration.
It's called preemption, and it means negligent corporations that make dangerous products get complete immunity from lawsuits. The Bush administration decided that since the FDA approved the drug or medical device, the manufacturer should be immune if something goes wrong. Vioxx, Rezulin, fen-phen and Bextra (just to name a few) all injured or killed thousands of people. Should those people be left with no legal recourse while the drug company can keep billions of dollars in profit?
Preemption is not some hypothetical concept, but has real-world consequences. Earlier this month, a case in Minnesota was dismissed involving 1,400 individual with heart defibrillators attached by defective Medtronic leads. The leads have been known to malfunction and send repeated shocks to patients, sometimes for hours, until the device can be disabled. The judge indicated that Congressional action is needed to provide these people a legal remedy.
It's not the drug and device companies that are getting complete immunity. Preemption language has been silently inserted into regulations regarding mattresses, the roof crush strength of your car, and railroads carrying hazardous materials. Negligent corporations are being handed more rights than injured Americans. It's nonsensical and unjust.
Thankfully, the Obama administration issued an immediate stay on Tuesday to stop pending rules, many of which included preemption language. This stay will allow people like Kimberly Gueldenzoph of Lambertville, Michigan, to receive justice. Her daughter Kenndyl died from complications arising from a congenital heart defect Kimberly believes was caused by taking Paxil during part of her pregnancy. Neither Kimberly nor her doctor knew that taking Paxil during pregnancy is associated with an increased risk of birth defects, but the manufacturer of Paxil, GlaxoSmithKline ("GSK") did. Kenndyl was just two weeks old.
Major medical journals, attorneys general from nearly every state, and former FDA officials all agree that preemption is a bad idea. Of course, the powerful drug lobby is going to extraordinary lengths to preserve their pocketbooks, regardless of what it means to patient safety.
All people should have a fair chance to receive justice through the legal system when they are injured by the negligence or misconduct of others. Giving negligent corporations complete immunity when they make dangerous products just goes too far. We're hopeful this new Congress and administration will agree and act accordingly.