Plexxikon Inc. v. Novartis Pharmaceuticals Corporation

Background

Novartis Pharmaceuticals Corporation moved to exclude the testimony of Plexxikon Inc.’s clinical expert, Dr. Susana Ortiz-Urda. Novartis argued that her opinions were speculative and did not rest on a reliable method.

Dr. Ortiz-Urda offered opinions about melanoma treatment and about how doctors would respond in a hypothetical situation where Tafinlar and Mekinist were unavailable as a combination therapy. She stated that patients with BRAFV600E metastatic melanoma who otherwise would receive Tafinlar and Mekinist would receive another targeted therapy, including Plexxikon’s Zelboraf in combination with Cotellic. She also opined that some doctors would prescribe Zelboraf and Cotellic outside their approved uses for certain cancers for which Tafinlar and Mekinist were approved.

Legal Standard

Federal Rule of Evidence 702 permits qualified experts to give opinions when their specialized knowledge will help the jury, their testimony is based on sufficient facts or data, their methods are reliable, and they reliably applied those methods to the case. Under Daubert, the court acts as a gatekeeper by deciding whether expert testimony is relevant and reliable; the jury ultimately decides how persuasive admissible testimony is.

Analysis

For metastatic melanoma, the court rejected Novartis’s argument that Dr. Ortiz-Urda’s opinions were too speculative because she was less familiar with prescribing practices outside her own practice group at the University of California at San Francisco. The court found that her opinions were supported by more than ten years of clinical experience treating melanoma, her work creating a multidisciplinary melanoma program, published data, documents about treatment effectiveness and side effects, and conversations with physicians outside her practice group. The court also noted that Rule 702 and Daubert did not require a nationwide survey before a medical expert could offer an opinion about treatment practices.

The court therefore allowed Dr. Ortiz-Urda to testify from her own experience about the standard of care for treating metastatic melanoma and about how she anticipated treatment would change if Tafinlar and Mekinist were unavailable.

The court reached a different conclusion about the proposed testimony concerning other cancers and off-label prescribing. Dr. Ortiz-Urda did not provide data about the prevalence or effectiveness of using Zelboraf or Cotellic for those cancers. She acknowledged that drugs with the same mechanism of action are not necessarily clinically equivalent and can be effective for different conditions. The court also found that she appeared to lack experience treating non-small cell lung cancer or anaplastic thyroid cancer and did not address what alternative treatments would be available if Tafinlar and Mekinist were unavailable.

The court consequently barred Dr. Ortiz-Urda from testifying about whether, or to what extent, doctors would prescribe Zelboraf and Cotellic outside their approved uses for indications other than metastatic melanoma, including non-small cell lung cancer and metastatic anaplastic thyroid cancer.

Disposition

The court GRANTED IN PART and DENIED IN PART Novartis’s motion to exclude Dr. Ortiz-Urda’s expert testimony.