JurisdictionUnited States

Discovery in conventional tort cases involving drugs, including classical older vaccines, is very involved and document intensive. Specifically, discovery will require obtaining documentation of clinical trials, safety studies, Adverse Event Reports, marketing information, FDA applications and correspondence, emails, and other materials, as well as depositions of multiple witnesses. Clinical trials and safety studies can help identify whether there were known safety issues with the drug. Adverse Event Reports similarly can indicate an issue with the drug. An adverse event is an unanticipated side effect or event that is associated with the use of a drug.1 Adverse events are reported to the FDA by physicians and patients.2 It is important to note that an Adverse Event Report does not establish causation, but rather a temporal relationship.3 Also, the reports cannot be used to establish occurrence rates because reporting is voluntary.4 However, a high number of similar adverse events can indicate an issue with the drug, which is why the FDA monitors the adverse advents databases.5

Marketing information, such as whether the company paid doctors to promote the drug and the marketing budget, can also be helpful. For example, in a drug that is discovered to be teratogenic (causes abnormal fetal development), marketing information showing that the drug was marketed specifically toward women after that risk was known would be helpful in not just proving negligence but potentially for punitive damages.

Information submitted to and received from the FDA is also vital to discovery. First, that information is needed to determine whether preemption applies. Second, it may reveal that the manufacturer engaged in shady conduct, such as withholding information from the FDA.

Discovery of electronically stored information is also vital to a drug case. For example, emails between corporate executives deciding how to "spin" results in a bad safety study (instead of fixing the issue) would be very helpful to not only prove a product liability claim, but could help to support a claim for punitive damages. Similarly, corporate documents and U.S. Securities and Exchange Commission filings showing the income generated by a drug, the amount spent on marketing it, and what percent of the manufacturer's overall revenue is produced by the drug in question can help explain why certain safety choices were not made.

In addition to discovery of documents, depositions of multiple fact witnesses are often required in pharmaceutical cases. Beyond the plaintiff and his or her prescribing physician, fact witnesses will always include representatives of the manufacturer. Thus, a deposition under Rule 30(b)(6) of the Federal Rules of Civil Procedure occurs in nearly every pharmaceutical case. Additionally, depending on the circumstances, other key players may need to be deposed as well. Indeed, in large pharmaceutical companies, there can be hundreds of people involved with the development, manufacturing, and labeling of one drug. Thus, multiple people may need to be deposed to discover information vital to a product defect claim. This quandary for plaintiffs is even worse when an Emergency Use Authorization (EUA) (discussed in chapter 14) excused the vaccine sponsor from methodically compiling years of research data.

Using Experts

Multiple experts may be needed in a conventional medical malpractice or product liability case to establish liability and damages. We will later discuss the differences in proof for the statutory vaccine claims process.

Experts on Liability

Medical malpractice and product liability cases are often very technical and beyond the knowledge of laypersons. Accordingly, expert testimony regarding liability is almost always required. Indeed, in a medical malpractice case, most states require testimony from a medical provider in the same or similar field as the defendant to establish the relevant standard of care, breach, and causation.6 Similarly, in most product liability cases involving a drug, an expert is generally needed to establish (1) that the drug can cause the injuries alleged, and (2) the drug did cause the injury alleged.7 In complex cases where causation is contested, an epidemiologist and/or a statistician may be needed to establish that the drug can cause the injuries alleged. For example, if a drug is relatively new and has been associated with a particular condition, an epidemiologist or other specialist may be needed to establish a causal relationship between the drug and the condition.

Because issues related to the design, manufacturing, and labeling of a drug are technical and very complex, an expert generally is also needed to explain how the product is "defective" compared to a standard or norm of performance. For example, in a product liability case involving a failure to warn case, a physician would need to testify about the...

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