Nan Aron Op-Ed Makes Portland Press Herald

Drug manufacturers shouldn't be immune if products cause harm

The Portland Press Herald

Merely citing federal approval for some uses doesn't mean all possible ones are protected.

NAN ARON and SHARON TREAT
December 30, 2008

Imagine that you went to an emergency room for treatment of a migraine headache and were given a drug that caused gangrene so that your arm had to be amputated.

And then the drug company, supported by the Bush administration, claimed that the right to recover damages that has existed in your state for hundreds of years has been eliminated?

This is exactly what happened to Diana Levine, a professional musician in Marshfield, Vt.

Now, Maine's two senators, Susan Collins and Olympia Snowe, will play a key role in the new Congress as it decides whether this could happen to any user of prescription drugs or medical devices in Maine and other states.

In Levine's case, a Vermont jury and the state's Supreme Court ruled that Wyeth Pharmaceutical, the company that made the drug, should be held accountable for its failure to warn doctors about the risk of gangrene when administering the medicine by an intravenous push injection.

This intravenous injection had led to serious complications in at least 20 previous patients.

The U.S. Supreme Court, however, has now agreed to rule on a new legal theory put forward by Wyeth. Wyeth claims that Levine can't sue because the U.S. Food and Drug Administration approved the drug for marketing.

This isn't much different from saying that if your car is rammed on Tukey's Bridge, the other driver can't be held accountable in court because he or she has a driver's license giving permission to be on the road.

So far, the U.S. Supreme Court has sent mixed messages on whether it will take away our traditional right to hold the makers of unsafe products accountable in the state courts.

On Dec. 15, the court by a 5-4 vote upheld the right of three Maine residents to sue Philip Morris and its parent company for deceptive marketing of "light" or "low tar" cigarettes.

In that case, Attorney General Steven Rowe successfully argued that regulation of such sales falls under the state of Maine's public-health police powers.

The tobacco manufacturers had maintained that federal labeling laws pre-empt, or bar, such lawsuits at the state level.

This ruling was in stark contrast to a similar case decided earlier this year. In that decision, the high court ruled that Americans can no longer sue corporations that manufacture medical devices such as defibrillators, heart pumps, artificial heart valves, hips and knees if the FDA gave permission to market the product.

Corporations' attack on Americans' long-established legal rights has been supported by the Bush administration, even though the FDA's own experts wrote in a 2003 memo that agency approval to market is based only on the evidence available at the time. Much of that comes from the manufacturers themselves and is based on very short clinical trials.

Many drugs and medical devices that were marketed with federal permission were later found to have caused serious health damage, including Vioxx, Zoloft, Fen-Phen, Avandia and Celebrex.

The Bush administration has inserted this new "hit and run" protection for big corporations into more than 60 regulations during the past eight years – removing a powerful incentive for manufacturers to make sure a medication, car seat, crib, toy or other product is safe.

Fortunately, as soon as the new Congress convenes, Collins and Snowe, along with President-elect Barack Obama, will have the opportunity to help enact legislation to make it even clearer that federal regulators' approval to market does not relieve manufacturers of responsibility to make safe products nor remove their accountability in court for injuries such as those suffered by Diana Levine.

Obama also will have the opportunity to appoint – with support from Collins and Snowe – federal judges at all levels, including the Supreme Court, who understand that our legal system is supposed to protect the rights and health of everyone in Maine and the rest of America and not just corporate special interests.