Archive for the ‘Wyeth v. Levine’ Category

Occasionally we will report here on the ConsumerInjuryLawyers.com blog some of the good deeds and hard work we are doing for our clients and consumers generally.  One of the many ways that Bernstein Liebhard looks out for our consumers is to stay active on issues important to them, their families and their legal rights.  We even do this sometimes without getting paid or the prospect of getting paid.  Ms. Levine, whose case was argued before the U.S. Supreme Court yesterday, is not our client.  But, earlier this Summer, Bernstein Liebhard, pro bono (we did not get paid for our work), filed an amicus (friend of the court) brief with the U.S. Supreme Court on behalf of third party payor clients (union health and welfare funds) and doctors supporting Ms. Levine’s position before the U.S. Supreme Court.  Our clients on the brief share our fundamental belief that consumers should have the right to sue drug companies when they are injured by dangerous drugs in a way that could be avoided had drug companies provided the proper warnings to patients and doctors.  The Wyeth case has been widely reported as the “business case of the century” and the Chamber of Commerce has sunk millions of dollars framing the issues for a win for drug companies in FDA preemption cases such as Wyeth.  The case is important to Big Pharma because it represents the strongest attempt in history by big business to eliminate consumer rights and protect them from lawsuits.  

Bernstein Liebhard’s briefing was led by Ann Lipton, a former Bernstein Liebhard associate and former law clerk to U.S. Supreme Court Justice David Souter.  Ann and the team did a brilliant job putting together the brief with the clients.  Our brief traced out a long history of the drug at issue in the case, Phenergan, and how it was marketed and sold by Wyeth without a contraindiciation on its label warning not to inject Phenergan directly into the vein.  In plain English, it means that Wyeth knew that Phenergan given to a patient in an IV could escape the vein and kill tissue — causing gangreen and potentially requiring amputation.  In the Levine case, Ms. Levine, a professional musician, was administered the drug by IV push, the drug went outside the artery and caused gangreen, necessitating the amputation of her arm.  For Ms. Levine, she luckily at least able to sue in her home state of Vermont alleging that the pharmaceutical company failed to warn doctors that they should not administer Phenagren by IV push.  This right is what Wyeth is looking to the U.S. Supreme Court to take away from consumers.

Like many of the consumers who come to us on a daily basis, Ms. Levine was injured by a product and looked to her attorneys to help her recover compensation that would cover her losses (she lost her job as a musician) and pain and suffering.  Ultimately, a jury sided with Ms. Levine, awarding her $6.7 million.  Wyeth claims, however, that because the FDA had approved the warning label for the drug, individual consumers should not be allowed to sue the company.  Wyeth’s argument undoubtedly placed corporate profits and distractions from lawsuits ahead of individual consumers.  Unfortunately, however, the Bush administration’s FDA, counter to long standing FDA policy supporting consumers, filed a brief supporting Wyeth and opposing Ms. Levine.  This news was of course shocking and horrifying to Ms. Levine, who lost her arm, and also to many other consumers out there who look to the FDA to keep them safe.  All too often, the FDA has failed and it seems to lack the legal teeth or resources to keep the pharmaceutical industry in tact.  

David Frederick, Ms. Levine’s counsel, cited to the amicus brief that Bernstein Liebhard drafted a number of times when arguing the case to the Supreme Court.  You can read the full transcripts here, but excerpts from the argument transcript where the amicus brief prepared by Bernstein Liebahrd is cited include:

MR. FREDERICK [in response to a question from Justice Scalia]: That was not our burden and that was not how the testimony came in at trial. But as the amicus brief by Dr. Budhwani, et al. at pages 54 establishes had Wyeth been a reasonably prudent manufacturer over the years, it would have known that the risks of IV push so far outweigh any bearing negligible benefits, that it would have offered a stronger instruction, it would have moved to revise its label either with FDA approval or - 

(11/3/08 Argument Transcript at 28)

MR. FREDERICK [in response to a question by Justice Scalia]: I think that the dispute is — is what constitutes new information, because we don’t take issue with the notion that new information can be new analysis of prior submitted data; and what the amicus brief by Dr. Budhwani et al. points out is that there was a lot of unpublished information about the harms of Phenergan that was known to Wyeth or should have been known to Wyeth in the ’80s and ’90s that would have justified a change under the CEE regulations.

(11/3/08 Argument Transcript at 33)