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Supreme Court Hears Diana Levine Case (Part Two)

Posted by Jane Akre
Monday, November 03, 2008 2:57 PM EST
Category: Major Medical
Tags: Federal Pre-emption, Diana Levine, Tort Reform

Diana Levine case SCOTUS  part 2

Simon Heller of the Alliance for Justice

Simon Heller, Legal Director of Alliance For Justice

Diana levine

Diana Levine, was in the courtroom

Diana Levine case before the Supreme Court


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The Diana Levine case went before the U.S. Supreme Court this morning.

Simon Heller of the Alliance for Justice has sat in many Supreme Court arguments and has no impression which way the court will go, toward consumers or corporations, when they issue their opinion sometime, perhaps early next year. (see Part One)

He talked to IB News Editor, Jane Akre.

Simon Heller, Alliance for Justice: “So the overall impression I got was the argument was that this case might very well be decided on the details of the correspondence between Wyeth and the FDA about proposed changes to the warnings on the label. In the end it may be somewhat specific to the circumstances what happened to Diana Levine and the historical record about this particular drug."

Q: Did both sides provide correspondence?

A: “I believe that was contained in the written documents presented to the court, so the court can look at it themselves. I think another thing that happened was the lawyer from the Solicitor General’s Department kept pointing to the things the FDA has done recently. For example, increasing its staff by several hundred people, instituting new mechanisms to monitor drug safety, and issuing new guidance that tells the public that tort lawsuits like Diana Levine’s are pre-empted.

“The court wasn’t really impressed by that I think because all of that happened many years after the tragedy that happened to Diana Levine. And really doesn’t tell us why it shouldn’t be held responsible for something that happened years earlier. So I think the government argument that the FDA has made great strides in improving monitoring drug safety was very unpersuasive, both because those improvements happened only recently. And the fact that they’ve taken some steps doesn’t tell the American people they are doing an excellent job monitoring 10,000 prescription drugs.”

Q: How many lawyers were sitting there?

A: “My guess is between 100 to 150, and this is a group of lawyers that is very interested in pre-emption and where it’s going to take us in the future. Is it going to be a situation where the drug manufacturer has an absolute immunity to any of the harms their drugs because after all, the drug manufacturers could tell the FDA we’ve seen one in one-thousand cases of gangrene, but the FDA’s capacity to respond is still very, very limited, even though there have been some additional resources added.

“Unless the FDA is significantly expanded, I think this could lead, if this case goes against Diana Levine, in essence, to immunity from lawsuits for all but the most unscrupulous drug manufacturers. If there are drug manufacturers who provide fraudulent data to the FDA, they might still be liable, but that’s not the bigger problem. Hopefully that doesn’t happen often.

“The big problem is when drugs are approved they are approved based on clinical studies involving hundreds of people. Once approved, thousands and hundreds of thousands or millions use the prescriptions, doctors and patients see the less common complications of drugs.

“That information is first of all not necessarily getting to the FDA, and even if it does, the FDA does not have the resources to take action.

“I thought it was also interesting how the government lawyer tried to back away from what had been the policy of the FDA up until quite recently. That the FDA recognized that tort suits like Levine’s were an important supplement to the FDA regulatory authority, because both the FDA and the product manufacturer would become aware of the dangers when a lawsuit is filed.

“And I thought the government’s lawyer did not have a good explanation for why that longstanding policy was abandoned by the Bush administration. The obvious answer is they want to help big business, but that’s not the kind of answer you can give in court. So I think there was no explanation given for that change in policy.

“I think that was an answer to a question from Justice (Ruth Bader) Ginsberg, who dissented earlier this year from the medical devices cases, Riegel v. Medtronic Inc. case which the court gave a kind of absolute immunity to manufactures of medical devices it approved."

Q: Did she ask about losing the right to sue?

A: “All of the justices have that in their mind to some extent or another. But most of the justices questions were about things like, what sort of new information was there about Phenergan, did it get to the FDA? Is it the case only that the manufacturer only is liable if it has new information and doesn’t give it to the FDA? Or it is liable if it has new information and gives it to the FDA and the FDA does nothing.

The bigger question about are people harmed by drugs going to have a remedy I think was mostly touched on with that interchange with Justice Ginsburg about the FDA’s policy which previously in a sense, favored tort lawsuits as a way to augment the FDA’s responsibilities and why did that change?

“Not only was there a real answer for the change, but I don’t think there is a good answer other than to help huge corporations so they don’t have to any longer be responsible.

“The Wyeth lawyer was pushing for a notion that the FDA approved label is the end of the story. And only when pressed did he or the lawyer representing the government (Mr. Kneedler), did begrudgingly agree if there was some new information, maybe there was an obligation on the manufacturer to do something.

“In the brief submitted by Wyeth they said even if there is new information and therefore Wyeth could have changed the label without FDA action. But even that does not mean Diana Levine’s lawsuit could go forward. Even that is not enough to create tort liability for the manufacturers. So he was trying to argue for the broadest possible immunity from lawsuits."

Q: So it may come down to a technical question?

A: “It may well be in the end, the court speaks to some broader principles. Even the technical questions are very important because drug manufactures get new information about the risks of the drugs they make all the time. They get reports from physicians and hospitals, and there is data collected. Whether that new information or new analysis of old information is something they have to take action on is a very, very important question.

“If what the FDA knew when it approved a drug label was the end of the story, we would never have recalls or drugs pulled from the market. Even though it’s somewhat technical, it may turn on that question that is really crucially important to Americans who use prescription drugs.”

Q: Either way we are going to have some sort of indication from this court combined with a new president that could change the landscape for product liability and failure-to-warn lawsuits.

A: “And the election could determine more about this in some sense than what the court does because the election could put a new Congress and those things, the president and Congress can decide to eliminate this kind of pre-emption and make it so a case such as Diana Levine can go forward, because in the end this case about federal statutory law and not the Constitution. So Congress through legislation has the last word.

“And of course there’s already been legislation to undo the effect of the Riegel case and depending on the outcome of the Diana Levine’s case we may see additional legislation introduced next year.”

Q: With a decision not until next year, is there anything consumers can do in the meantime?

A: “I think they can contact their representatives, members of Congress or Senators and remind them that if in the hands of Congress to make it clear consumers who seek health care, like Diana Levine, should be protected by Congress. That it is more important to protect those people than to protect the giant pharmaceutical corporations with billion dollar profits.” #


Posted by Darren Wilson
Monday, November 03, 2008 5:37 PM EST

The initial transcript of today's hearings regarding Case 06-1249, Wyeth v. Levine, can be found here:


Anonymous User
Posted by Dianne
Monday, November 03, 2008 5:46 PM EST

Thank you, Jane, for this very informative piece. I am quite certain that if and when the American public is made aware of FDA preemption they will be contacting their representatives in Congress.

Comments for this article are closed.

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