CALIFORNIA TRIAL COURT ADDRESSES NEW FDA STATEMENT ON
PREEMPTION AND DISQUALIFIES PLAINTIFFS' EXPERT

GORDON & REES PREVAILS ON BEHALF OF DRUG MANUFACTURER IN CALIFORNIA TRIAL COURT

Tom Packer and Stephen Lawniczak of Gordon & Rees' San Francisco office successfully obtained significant rulings on preemption and disqualification of the plaintiffs' primary expert after three days of pre-trial hearings and testimony in a pharmaceutical liability case in a Northern California trial court. This was only days after the January 24, 2006 Federal Register announcement of the FDA final rule announcing amendments to labeling regulations, and its strong language in support of preemption of state tort law claims. The court also dealt a blow to a plaintiffs' expert who had been extremely critical of the client's dealings with the FDA and publicizing his opinions about the product.

THE PRODUCT: A dental anesthetic approved for use by the FDA in the United States in 2000 and which had gained considerable market share as a leading local anesthetic.

THE CLAIM: The plaintiff received an injection of the anesthetic and developed a permanent lingual paresthesia with throbbing pain, electrical-like feelings and other debilitating symptoms in her tongue. The company denied the claims and contended that the procedure, although properly performed, not the drug, was the cause of the injury.

THE PLAINTIFFS' EXPERT: The plaintiffs' expert witness was a professor of anesthesia at a well regarded dental school. He had extensively researched the drug and had an article published in a national dental journal which was critical of the drug and concluded that it had an excessive rate of causing paresthesias compared to the more commonly used drug.

THE DEFENSE TRIAL PLAN:

1. Move to prevent the plaintiffs from attacking the FDA drug approval process. The plaintiffs' expert had accused the company of improper conduct during the IND/NDA period. Motions were filed at the time of trial seeking rulings from the court that these types of claims were preempted based on the authority of Buckman Co. v. Plaintiffs' Legal Committee (2001) 531 U.S. 341.


2. Persuade the court that the entire action was preempted based on case law and the recent FDA statement on preemption.


3. Move to exclude the plaintiffs' primary expert from testifying on failure to warn and other issues based on the unreliability of his research and conclusions. The key areas of attack were that his opinions were mostly based on collections of case reports, lacked statistical significance and some of the literature on which he relied had been considered by the FDA during the approval process.

1. The court ruled that all claims of misrepresentations to the FDA, and any other claims having to do with the IND/NDA process, were preempted. The plaintiffs were prohibited from "going behind" the language in the package insert.


2. The court ruled that the entire claim was not preempted. Although the court found the recent FDA pronouncement on preemption in the Federal Register persuasive, it noted that the amended regulation was not to become effective until June 30, 2006 and there has not yet been a California appellate decision finding preemption in a personal injury case involving an FDA approved pharmaceutical product. However, the judge predicted that such a decision will probably appear in the near future.


3. The court ordered a pretrial evidentiary hearing at which time the plaintiffs' expert was examined by counsel in order to determine whether or not he had a sufficient foundation on which to base his opinions that the company should have recognized increased risks with the product and taken steps to warn health care providers beyond what was stated in the product package insert.


4. After extensive testimony and argument, the court disqualified the plaintiffs' expert from testifying as to the failure to warn cause of action. The court stated that under the Kelly-Frye test used in California to evaluate whether the expert's opinion is generally accepted in science and reliable, the plaintiffs had not demonstrated that their expert met the threshold requirements.

THE RESULT: The plaintiffs' case against the drug manufacturer collapsed and the case was resolved. The plaintiffs' continued their case against the co-defendant health care provider.