Protective Orders - Are They Enough?


When faced with the prospect of defending parallel civil and criminal proceedings, companies and their attorneys must evaluate a number of important issues to develop an effective overarching defense strategy. The reach of a grand jury subpoena is one such issue that drug and medical device companies embroiled in civil litigation must consider carefully – particularly if the commencement of a criminal investigation is a reasonable possibility. Given the Food and Drug Administration's (FDA) recent pronouncements confirming its intent to increase the use of misdemeanor criminal prosecutions to hold company officials accountable for company activities, this issue presents an even greater challenge for drug and medical device companies as well as their employees.

Grand Jury Subpoenas vs Civil Protective Orders: The Tension Is Real

Pursuant to the Federal Rules of Civil Procedure, parties are entitled to "obtain discovery regarding any non-privileged matter that is relevant to any party's claim or defense." Fed. R. Civ. P. 26(b). Federal courts, however, are empowered to issue protective orders for "good cause" "to protect any party or person from annoyance, embarrassment, oppression, or undue burden or expense" including: to limit the scope of disclosure or discovery to certain matters, to require that a deposition be sealed and opened only on court order, or to require that "a trade secret or other confidential research, development, or commercial information" not be revealed or only be revealed only in a specified way. Fed. R. Civ. P. 26(c). Civil protective orders play a very important role in the judicial process. Not only do they help mitigate the effects of liberal discovery rules, but they also help safeguard parties who are increasingly concerned with protecting their privacy and confidentiality, as well as reduce the risk of future litigation.

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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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