Film: Access Denied Chronicles Levine Pre-emption Case, Hosts Live Chat

Access Denied? The Fight for Corporate Accountability is a new documentary set for release to the public, Tuesday, November 18th from the nonprofit group, Alliance for Justice.

Produced by 12-time award-winning producers/directors Jon Alpert and Matt O’Neill, the premiere will include a live discussion with the film’s subject, Diana Levine.

Levine, 63, is the Vermont musician who recently faced off with drug maker, Wyeth in front of the U.S. Supreme Court after winning a lower court victory and a jury award of $7 million. Levine sued for Wyeth’s failure to properly label the drug, Phenergan.

The film tells Levine’s story and helps put a human face on the rather dry, legal issue of federal pre-emption - the presumption that if a medical drug or device has FDA oversight and approval, it precludes a person from filing a state court action for damages.   

Wyeth is arguing that Levine's court judgment should be reversed on the basis of federal pre-emption.

When Levine went into a Marshfield, Vermont emergency room for treatment of a migraine headache in 2000, she was given demerol at first, then Phenergan, made by Wyeth, to stop the nausea associated with demerol. 

A second injection of Phenergan was given more aggressively through something called an IV push that punctured an artery and sent the drug into the right arm.

It turned gangrenous and had to be amputated just below the right elbow. Six weeks later she lost her arm, devastating her both personally (she still feels the “phantom” arm) and professionally since Levine made her living creating music and playing the piano and guitar.

The problem is the label, says Levine. It does not warn health professionals against administering by IV push and no separate contact was made with doctor’s offices, even though Wyeth acknowledges it knows of 20 cases of gangrene resulting in amputations from an IV push of Phenergan.

Wyeth stopped making the drug several years ago.

“Wyeth Pharmaceuticals says because it says ‘FDA approval’ on it, even though it’s totally inadequate and can cause something like this, that they’re off the hook. I’ve lost my right to go to court to say this should not have happened, it’s your fault, say you’re sorry, help me out, and change the label so it doesn’t happen to anyone else,” Levine says.

Wyeth appealed Levine’s lower court victory all the way to the Supreme Court where it was heard November 3. The high court has yet to issue its ruling.  Wyeth refused to be interviewed for the film.

And Levine is not alone.

Don Hickey, a retired pastor from Kansas, has a Medtronic lead in his heart defibrillator.  When it shorted out, he thought he was dying, but he too is precluded from taking Medtronic to court because of federal pre-emption.  That case was established earlier this year by the U.S. Supreme Court in the Riegel v. Medtronics.(Read the appeal here Riegel v Medtronic Appeal).

You might assume the FDA would follow in lock-step with manufacturers, but former FDA Commissioner, David Kessler, tells Congress that even if FDA’s funding was doubled or tripled, the agency cannot possibly have the resources to detect the emerging risks of thousands of drugs and devices.  

“For that reason the tort system has historically provided a critical incentive to drug and device companies to disclose important information to physicians, patients and the FDA about newly emerging risks,” Kessler says in the film.

“Unfortunately a lot of corporate entities are trying to escape accountability and liability,” says consumer advocate John Bowman. 

Family members of Levine suggest her story is bigger than Diana. Pre-emption affects everyone in the country.  

Alliance for Justice is a non-profit coalition of public interest and civil rights groups that funded the film. 

Levine, who the Alliance has made available Tuesday for a live chat, summarizes the issue at the end of the film, “I just hope they don’t take my right away because if they take my rights away- you’re next!” #