The U.S. Supreme Court heard oral argument in the Wyeth vs. Levine case on November 3rd and will be making a decision by April of 2009 according to court watchers. There have been some interesting developments that should have a bearing on what the Court does in this important case. Documents released in late October by the FDA in a Congressional investigation reveal that career officials at the agency don’t believe the FDA’s approval of drug labeling should block consumer lawsuits.
The Wall Street Journal reported that internal memos contradict the FDA’s current position as stated in the Wyeth case. The FDA said – in its briefs to the Supreme Court in contradiction to its prior position – that federal drug approval and warning label standards prohibit state laws. However, two FDA officials said in the memoranda that were uncovered that it’s wrong to assume that FDA-approved drug labels are adequate or that they fully disclose the safety risks of the drugs. One of the memos, written in 2003 by Dr. John Jenkins, the top official in the drug approval section, states:
Much of the argument for why we are proposing to invoke pre-emption seems to be based on a 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.
As we previously reported, preemption language inserted into the rules by persons at the FDA was never published to the public or allowed to be debated in public forums as is required by law. Unfortunately for American citizens, the Bush Administration is not limiting its preemption push to the FDA. It has inserted preemption language in over fifty federal agencies’ rules without making the pre-emption language subject to public hearings. This is nothing but a blatant payback to political buddies by a lame duck Administration and is believed to be the work of Dick Cheney and his gang.
Top scientists and career employees at the Food and Drug Administration have in the past consistently opposed agency regulations that would take away consumers’ ability to sue drug makers. As we have reported, at issue is language included in a drug-labeling rule in 2006 at the request of the Bush White House that effectively limits when people can sue in state court over injury claims involving medications. The FDA now contends federal regulations prevail when there is a conflict with state law. This change in position is contrary to what the FDA has consistently said over the years.
Internal agency documents reveal that career officials opposed this approach, according to a report released by Rep. Henry Waxman, chairman of the House Oversight and Government Reform Committee. In the past, the agency had viewed private suits as an additional layer of protection against unsafe drugs, the report said. Patients injured by drugs have won suits against drug manufacturers for failing to warn against certain dangers. I have great difficulty understanding how any Justice on the High Court would have any problem rejecting Wyeth’s argument in this case. Wyeth’s claim that it was protected from lawsuits in state court is without any legal basis.
Public Citizen, the strongest consumer advocacy group around today, correctly says the Bush Administration is pushing preemption clauses in a wide array of regulations. Brian Wolfman, director of Public Citizen’s litigation group, says: “This effort to prevent injured citizens from using the courts and holding negligent companies accountable must be stopped.”
The report said the FDA has yet to provide a complete set of documents that would show communications between the White House and the agency, but some documents suggested the agency and the White House would not go forward with a rule on labeling until the preemption changes were included.
Source: Wall Street Journal and Public Citizen
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