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Elidel Lawyer wins pre-emption ruling with the FDA

Cancer-causing drug goes under the gavel.

Orlando, FL /OLM News/ Jan-17-07: In a landmark case ruling, (No. 05-530) Larry Roth, of law offices of Larry M Roth, PA, in cooperation with the law firm of Seeger Weiss, are the first lawyers to win an FDA pre-emption ruling sought by a drug manufacturer in an Elidel lawsuit. Elidel is a topical immunosuppressant drug linked to lymphomas.

When people suffer an injury, they are entitled to sue for damages. But many people have been denied their day in court. And by denying a citizen's right to sue also denies their constitutional rights. The nastiest tactic used to deny injured people their rights is pre-empted by federal law. When federal and state law have a conflict, the federal law pre-empts, or trumps, the state law. When people try to sue, they may find that they have no recourse after the federal government has invalidated the state law, or prevents a lawsuit or a state law claim from proceeding.

For example, cars need safety requirements and if they are made according to federal regulations, in some situations you cannot sue the car manufacturer. One example is for older vehicles not being able to sue a car company because they failed to install airbags.

As with safety standards in cars, a drug cannot be sold without the FDA approval. In terms of drugs, pre-emption is about warning a doctor and user of the known dangers and possible side effects and risk of a drug.

The manufacturer of Elidel, Novartis, is now warning about the risk of developing lymphomas and cancers -- a warning that was not in the original FDA approval in 2001. The Elidel lawsuit is based on this issue; Novartis should have warned doctors about these risks when the drug was approved in 2001 and it should have been warned on the label itself.

"We believe Novartis knew of these risks," says Larry Roth, "because studies they did in order to approve their drug showed incidents of people developing lymphomas and infections, which indicated their immune systems were compromised, particularly in children, from using Elidel."

(The same is true with a similar drug Protopic, manufactured by Astellas Pharma. Fujisawa Pharmaceuticals, now known as Astellas Pharma, are the makers of Protopic in Weiss v. Fujisawa filed in US District Court, Lexington, Kentucky, No. 5:05-527-JMH.)

But Novartis argued that, when Elidel was approved, the FDA didn't require the company to warn people about lymphomas, and therefore Novartis could be sued. "Pre-emption in the pharmaceutical field has been around a long time and generally in court there is a presumption against pre-emption, i.e. the drug company can be sued," says Roth.

Did the FDA expressly pre-empt a particular area or claim or by implication? This issue recently appeared after being dormant for 20 years. In January 2006 the FDA reissued a policy statement regarding warnings on prescription drugs. In their preamble, the agency said in essence that, if the FDA has approved a warning, the drug maker cannot be sued beyond what the FDA has approved. In other words, the drug company cannot be sued in court by people saying they were not adequately warned.

"In the Perry v. Novartis case, one of the arguments raised was that this is an advisory statement and cannot pre-empt our lawsuit," says Roth. "The lymphoma and cancer warning should have been given in 2001, not 2006. The FDA cannot retroactively go back to 2001 and preclude lawsuits because the original warnings were inadequate."

The court said that, unless the FDA specifically addressed this proposed warning, evidence that the FDA rejected, then there could be no pre-emption of making the claim. "This pre-emption issue came about because the defendant filed a motion to dismiss the claim. Now the lawsuit can proceed because of this warning -- the manufacturer was not successful in getting rid of the lawsuit," Roth goes on to say. "This pre-emption issue would not have been raised had it not been for the recent broad policy statement by the FDA -- Novartis thought it would get them off the hook. The rulings have now become specific to the drug.

In this case, the issue of a lymphoma or cancer was never addressed by the FDA so there could never be pre-emption.

The drug makers are trying to get out of these cases by filing the pre-emption motions, but for the most part they have been unsuccessful. The drug makers have only been successful in a single case -- anti-depressants. (These SSRI drug makers said that they didn't have to warn about suicides because the FDA had evaluated the drug on several occasions and rejected the fact that suicide warnings were required.)

In April 2006, Novartis filed a motion to have the Perry case thrown out. In October, the judge made his decision. "What made this ruling interesting was that, in the same Pensylvania federal courthouse months earlier, (but a different judge) pre-emption was found against the SSRIs, which led Novartis to believe that the Perry case would also be thrown out. But we thought our case was different because the FDA never rejected a claim that Elidel did not cause lymphomas or provide a risk," says Roth.

The FDA eventually required a black box warning for Elidel and its similar drug Protopic in January, 2006. After becoming aware of the risks, reports started coming in from people with lymphomas. And 20 percent of those taking Elidel and Protopic were under two years of age, for which neither drug was approved! Children who had not yet developed an immune system or skin barriers were exposed to this dangerous drug.

The Perry case has helped in other cases - the court in Kentucky ruled on the Eldidel case in the same way the PA judge ruled. What are the consequences of the Perry case? "It is the best articulation of how limited the FDA pre-emption is regarding prescription drugs," says Roth. "Even though the courts defer to the FDA, the agency must determine that a specific risk or warning was rejected."

Thanks to the Perry case, more cases against drug makers can go forward. "And in some other cases, this issue about preamble policy statement by the FDA will likely go to the Supreme Court." Novartis is not appealing.

The Perry case is being handled by lead co-counsel David Buchannan of Seeger Weiss along with Larry Roth.

Further information about Elidel

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