Pharmacology Expert Witness Testimony Not Allowed

Plaintiff filed suit against defendant related to a patent infringement claim.  Plaintiff hired a Pharmacology Expert Witness to provide testimony.  Defendant filed a motion to exclude this expert from testifying.  The court denied the motion to exclude.

Facts:  This case (Par Pharmaceutical, Inc. et al v. Hospira, Inc. – United States District Court – District of Delaware – June 6th, 2019) involves a patent infringement claim.  The plaintiff manufactures and sell a brand name epinephrine injection, which is used for emergency treatment of allergic reactions.  The defendant is seeking approval from the FDA to market a generic version of this product prior to the expiration of the plaintiff’s patents.  The plaintiff alleges that the defendant’s product infringes on the plaintiff’s patents.  The plaintiff has hired Dr. Karen Becker (Pharmacology Expert Witness) to provide testimony.  The defendant has filed a motion to exclude this expert from testifying.

Discussion:  Dr. Becker is expected to testify about the regulatory framework in the context of the defendants statements and actions in front of the FDA.  The defendants allege that Dr. Becker’s testimony is speculative and irrelevant.  The defendant also challenges Dr. Becker’s qualifications, alleging that she is unqualified as an expert in the case because she has never been employed by the FDA or by a pharmaceutical company.  In addition, the defendant’s argue that she is not qualified because she has advised on medical devices or combination drug/device products, but not drug products.

The plaintiff contends that Dr. Becker’s testimony will assist the court in evaluating the weight, credibility, and meaning of the defendant’s statements and actions before the FDA.

The court notes that Dr. Becker has a Ph.D. in pharmacology from the University of North Carolina School of Medicine.  In addition, the court states that Dr. Becker is an FDA regulatory consultant whose clients have included pharmaceutical and multi-national healthcare companies.  She has held positions in FDA consulting firms for 25 years.

The court opines that the defendant’s motion to exclude should be denied.  The court notes that the defendants arguments about the speculative and irrelevant nature of Dr. Becker’s opinions lack force because this is a bench trial.

In addition, the court opines that Dr. Becker is qualified to offer an opinion in this case based on her education and experience. Since she has a Ph.D. in pharmacology and is familiar with the topics written about in her report.  In addition, she uses her 25 years of training, knowledge, and usage of FDA regulations, policies, procedures, and practices.  The court opines that her knowledge and experience is a reliable basis for her opinions.

The court last opines that any arguments about Dr. Becker’s qualifications can be addressed at trial.

Conclusion:  The motion to exclude the expert witness testimony of Dr. Karen Becker is denied.