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Protective Orders in Drug Product Liability Litigation

After a drug product liability lawsuit is filed, both the plaintiff and the defendant engage in a process called discovery. The purpose of discovery is to allow a party to learn more about the important facts of the case before trial and the other party's evidence. The scope of discovery is very broad. It covers any information that is relevant to the case or which may lead to relevant evidence. Privileged information and the work product of the opposing party's lawyer (the lawyer's written observations, theories, opinions, and research) do not have to be disclosed. Privileged information includes oral and written communications between an attorney and his/her client.

Protective Orders
Protective orders are court orders that limit discovery. Protective orders are common in litigation involving drugs or medical devices. Protective orders cover information such as the drug or device company's trade secrets and other confidential information; information about the identity of patients (other than the plaintiff) and their doctors; the unpublished data of independent researchers; litigation databases; and, as noted above, the attorney's work product and privileged communications.

Trade Secrets and Other Confidential Information
Drug companies are generally granted protective orders for their trade secrets and other confidential research. A trade secret is information used in a company's business that gives it a competitive advantage. Trade secrets include formulas, patterns, manufacturing processes and customer lists. The courts, however, will not grant protective orders restricting disclosure of all documents. They require the drug company to specify documents or groups of documents they seek to protect.

Discovery of Patient Information
The drug company might be reluctant to disclose drug or device experience reports received by it unless it can protect the names of patients who filed such reports. Also, federal agencies, such as the Food and Drug Administration, collect patient information and medical records to conduct epidemiological studies (studies that show any association between the use of a drug or device and an injury or illness). In this situation, the federal agency might refuse to release the documents unless personal identifying information is removed from them.

Unpublished Research Data
Medical researchers generally do not release preliminary data collected in clinical studies on drugs or medical devices. After such data is collected, researchers analyze the data extensively before reaching any conclusions. Litigants sometimes seek access to raw data or preliminary results relating to scientific research. Access to such information is generally denied through a protective order because the data is incomplete and may be misleading.

Litigation Databases
The plaintiff and the defendant in drug product liability cases often set up litigation databases that are used in preparing the case. These databases include documents, transcripts of deposition and trial testimony, discovery requests, relevant medical and scientific literature, and information about expert witnesses and doctors. The plaintiff might seek disclosure of the defendant's database or vice versa. Such databases are generally considered attorney work product, and the opposing party cannot discover the information.