A district judge in Florida refused to exclude the testimony of a pharmaceutical expert witness despite allegations of fundamental flaws in the assumptions on which her calculations are based.
Defendant Aveva Drug Delivery Systems, Inc. of an Abbreviated New Drug Application (“ANDA”) No. 217221 to the U.S. Food and Drug Administration (“FDA”) sought approval to manufacture and sell a Lidocaine Topical System, 1.8% product (“Defendants’ ANDA Product”), a generic version of Scilex Pharmaceuticals Inc.’s ZTLIDO® (lidocaine topical system) 1.8% (“ZTlido®”), prior to the expiration of U.S. Patent Nos. 9,283,174 (the “’174 patent”), 9,925,264 (the “’264 patent”), and 9,931,403 (the “’403 patent”) (collectively “the Asserted Patents”).
Plaintiffs alleged that the Defendants’ ANDA Product will be marketed as a generic competing product to ZTlido®, a product developed by Plaintiffs for the relief of pain associated with post-herpetic neuralgia (PHN) in adults.
This patent infringement arises from Aveva’s notification to Scilex Pharmaceuticals Inc. by Notice Letter dated May 10, 2022, that it had filed an Abbreviated New Drug Application (“ANDA”) No. 217221.
Defendant Aveva proffered expert witness Dr. Maureen Donovan who stated that that the claims of the Asserted Patents were extremely broad, and therefore that they were not enabled because it would require undue experimentation to practice the claims.
Plaintiffs filed a motion to strike Donovan’s opinions and analysis regarding the breadth of the asserted claims from consideration at the bench trial in this case. Plaintiffs also accused her of improper supplementation and bolstering under Rule 26 in a separate motion.
Pharmaceutical Expert Witness
Maureen Donovan is a Professor of Pharmaceutical Sciences and Experimental Therapeutics at the University of Iowa College of Pharmacy. Donovan holds a Ph.D. in Pharmaceutics from the University of Minnesota College of Pharmacy and has over forty years of experience conducting research and consulting with companies in the field of pharmaceutical sciences.
Discussion by the Court
Rule 702
Plaintiffs argued that Donovan’s exemplary calculations, analysis of the breadth of the claimed concentration ranges, and her opinions relying thereon did not meet the requirements of Rule 702. Plaintiffs added there were fundamental flaws in the assumptions on which her calculations are
based.
As to experience and qualifications, Plaintiffs did not contend that Donovan was not sufficiently qualified to offer her proffered opinions in this case.
The Court determined that the proper remedy for any potential weaknesses identified is vigorous cross-examination and confrontation. In other words, Plaintiffs were not precluded from challenging the reliability of Donovan’s opinions at the bench trial. In conclusion, the Court may disregard any expert testimony at trial, if it “turns out not to meet the standard of reliability established by Rule 702.”
Rule 26
In a separate motion, Plaintiffs alleged that Donovan altered her written opinion to better align her opinion with another expert’s findings.
Donovan, having discovered an error in her calculations, was required to correct her findings. Defendants argued that the corrections favored Plaintiffs’ position.
The Court held that the revisions were both substantially justified and
harmless. The Defendants filed Donovan’s amended report well before the 30-day deadline contemplated for pretrial disclosures under Rule 26(a)(3). The Court, therefore, denied Plaintiffs’ arguments on the grounds
that any violation, should one exist, was substantially justified under the circumstances. Moreover, Defendants have both offered Plaintiffs the opportunity to re-depose Donovan and will not oppose supplemental reports from Plaintiffs’ expert.
The Court added that the decision not to exclude Donovan’s corrected report in no way prevented Plaintiffs from vigorously cross-examining her on her alleged mistakes.
Held
The Court denied both motions to exclude the testimony of Defendants’ expert Maureen Donovan.
Key Takeaway:
The Court determined that the proper remedy for any potential weaknesses identified is vigorous cross-examination and confrontation. In other words, Plaintiffs were not precluded from challenging the reliability of Donovan’s opinions at the bench trial and the decision not to exclude Donovan’s corrected report in no way prevented Plaintiffs from vigorously cross-examining her on her alleged mistakes.
Case Details:
| Case Caption: | Scilex Pharmaceuticals, Inc. Et Al V. Aveva Drug Delivery Systems, Inc., Et Al |
| Docket Number: | 0:22cv61192 |
| Court: | United States District Court, Florida Southern |
| Order Dates: | May 15, 2024 and May 23, 2024 |
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