In This Issue:

- Can Experts Testify as to the Ethics or State of Mind of Corporate Defendants?

- Patent Reform for Biotech Companies

- United States v. Caronia and its Implications for Off-Label Marketing of Pharmaceuticals

- Excerpt from Can Experts Testify as to the Ethics or State of Mind of Corporate Defendants?:

In pharmaceutical litigation, plaintiffs routinely seek the admission of expert testimony as to what constitutes ethical or moral conduct for a pharmaceutical company as well as the motive, intent, and state of mind of company employees. These experts seek to opine that the pharmaceutical company endangered public safety by misrepresenting or not disclosing information. Or to allege that the pharmaceutical company did not perform scientific studies, or if it did conduct studies, that the company concealed or mischaracterized the studies’ results. These experts also purport to “know” that prescribing physicians and/or the public would have acted differently if the pharmaceutical company had been truthful. This type of corporate ethical conduct testimony is offered only to elicit an emotionally charged response and thereby prejudice the jury against the pharmaceutical company.

Courts trying drug and medical device cases have generally held corporate ethical conduct testimony inadmissible under Daubert v. Merrell Dow Pharms. Inc., 509 U.S. 579 (1993), its state counterpart, and other evidentiary rules, which require that experts be qualified and that their opinions be reliable, relevant, and the product of specialized knowledge based on sufficient facts and data. Such opinions, moreover, should be helpful to the trier of fact, proper subjects of expert opinions, and not unfairly prejudicial.

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Topics:  America Invents Act, Biotechnology, Daubert Standards, Ethics, Expert Testimony, FDA, FDCA, First-to-File, Free Speech, Off-Label Use, Patent Reform, Patents, Pharmaceutical, Prior User, Testimony

Published In: Civil Procedure Updates, Communications & Media Updates, Intellectual Property Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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