A few days ago, we provided information on a preemption case which will be argued at the United States Supreme Court next week (click here to see that post). Yesterday the U.S. House Committee on Oversight and Government Reform issued a report saying FDA career staff objected to a change in preemption rules, even saying the central factual justifications for the agency’s new positions were false and misleading. According to the released by Chairman Henry A. Waxman, these officials warned that the changes would deprive consumers of timely information about drug hazards. The report highlights internal FDA documents which show high-ranking career officials repeatedly warned about the dangers of not allowing drug companies to add additional warnings to their labels without FDA approval.
Historically, the Food and Drug Administration (FDA) has viewed lawsuits brought by persons injured by a drug as a valuable complement to the agency’s regulatory efforts. Under the Bush Administration, however, the FDA has reversed this position and advocated in favor of preemption of individual state tort liability cases. FDA rewrote drug labeling regulations in 2006 and 2008 to restrict the ability of manufacturers to disclose new safety risks without prior FDA approval. The agency also added a lengthy preamble to the 2006 rule in favor of preemption of state lawsuits. The changes to the labeling rules (known as the “changes being effected” or CBE rules) and FDA’s preamble have become a cornerstone of drug industry preemption arguments, which limit the ability of consumers to seek redress for injuries.
The report cites Dr. John Jenkins, the highest official in FDA’s new drug review process, writing:
[M]uch of the argument for why we are proposing to invoke preemption seems to be based on the false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis. We know that such an assumption is false.”
Prior to the rule being issued one FDA career official asserted that the rule “is not as it purports to be, consistent with the agency’s role in protecting the public health…” As noted in the report, the FDA has an obligation to ensure the safety and effectiveness of drugs. In this case, however, the internal documents indicate that the Bush Administration weakened important drug safety regulations to shield manufacturers from liability. That is a serious abuse of the agency’s public health authorities.
A copy of the report can be viewed by clicking here. The Associated Press story on the report can be viewed by clicking here. The Los Angeles Times story on the report can be viewed by clicking here. The Wall Street Journal Report can be viewed by clicking here.
It’s billed as the business case of the century by the Chamber of Commerce. But for Diana Levine, a Vermont guitarist who lost her arm to gangrene caused by an improperly administered nausea drug, it’s a quest for justice. For consumers, it’s a vital test of the ability to seek redress against powerful drug companies.
On Monday, November 3, 2008, the United States Supreme Court will weigh in. In a case called Wyeth v. Levine, the Court will review a $6.7 million verdict delivered by a Vermont jury against Wyeth. As found by the jury, Ms. Levine’s arm was amputated because Wyeth failed to warn against using a method of administering its anti-nausea drug Phenergan that causes precisely the type of injury that Ms. Levine sustained. The issue before the Court will be whether federal law preempts state torts claims imposing liability on drug labeling that the Food and Drug Administration (FDA) had previously approved.
A win by Wyeth in this case could provide negligent corporations complete immunity from lawsuits, a sort of “get out of jail card” for manufacturers. The preemption of state law urged by Wyeth means complete immunity from lawsuits for corporations and a full escape from accountability when they have knowingly injured and endangered Americans. The civil justice system offers corporations a powerful incentive to make their products safer. 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—even when it means taking on the most powerful corporations.
The brief submitted by former FDA Commissioners Dr. Donald Kennedy and Dr. David A. Kessler highlight the importance of litigation to enhance drug safety. Failure-to-warn litigation has always played an important role in ensuring that manufacturers bear responsibility for the safety of their drugs. Failure-to-warn litigation does not challenge FDA’s decisions about labels; rather, it challenges a company’s failure to alert physicians and patients to risks that were unknown or poorly understood when FDA approved the drug’s label, but were evident to the company at the time the plaintiff sustained injury. Litigation of that sort complements, not undercuts, FDA’s job of protecting consumers from dangerous drugs. The full brief can be viewed by clicking here.
Even the editors of the New England Journal of Medicine submitted a brief in support of Ms. Levine. In their brief, the editors noted that the FDA is in no position to ensure the safety of prescription drugs. The full brief can be viewed by clicking here.
The New York Times report on the case can be viewed by clicking here. The Wall Street Journal report of the case can be viewed here. In addition, the Journal posted a three-minute video description of the case and issue which can be viewed by clicking here.
We can only hope that the Supreme Court will preserve the integrity of the American jury system by upholding the verdict from the state of Vermont. However, given the Court’s pro-business leaning (see our post “Will the little guy ever get ahead?”), consumer justice may be in jeopardy. We will keep you posted on the case and the decision once delivered by the court.
At the outset, I confess to being a gadget lover. But I recently discovered the Pulse Smartpen from Livescribe which is a very useful tool for the litigation bag. This little gadget has revolutionized the note taking experience, and I felt compelled to share this unsolicited info.
The pulse is essentially a writing implement with a small computer wrapped around it. The Smartpen uses a camera (just under and behind the pen) and custom paper with millions of microdots to capture every stroke and notation. And while you’re taking notes on paper, the pen simultaneously records every sound and connects the resulting audio to the captured image. All the captured material is timeline based, so turning back to any page in your notes and tapping the pen on a word will restart your audio at the precise moment your wrote that word.
I started using electronic pens several years ago with the Logitech ioPen. It was great having electronic copies of notes uploaded to my computer, but the Pulse’s added dimension of linking audio to the notes was a feature that was too good to pass up. I use the pen during meetings, depositions, and for client intakes. When I get back to the office, I plug the pen into its cradle, and the notes and audio upload to my PC for later use. Having the notes and audio in one location and easily accessible allows me to focus more during the meeting or deposition. And when I need to refer back to what was said, it’s just a click away.
My experience with the pen has been so positive that when I was asked several weeks ago to share my thoughts for a video that Livescribe was producing, I did not hesitate. You can view the video and see what others had to say about the pen by clicking here or on the video image.
If you are interested in learning more about the pen and how it works, the Livescribe web site has a great deal of information and video demos that you can view by clicking here.