When it comes to evaluating the safety and effectiveness of a drug or medical device, clinical trials are one of the best tools at a consumer's disposal. Data from clinical trials provide specific evidence of the impact a drug or medical device has on the people who use it.In mass torts, however, clinical trial data can be especially helpful, as it can be leveraged by the plaintiff's attorney to prove the plaintiff's claims. In fact, clinical data may even mean the difference between a win and a loss.
About Clinical Trials
A clinical trial is a scientific study designed to explore the effects a specific drug or medical device has when used as intended. For example, the trial may follow a group of people who take a specific medication for several months to determine whether the medication works as intended. These trials also look for side effects or unintended consequences that may be associated with using a certain medication or medical device.
Based on the results of clinical trials, manufacturers decide whether to sell the medication or device tested. They may also use this information to create warning labels that include potential side effects, interactions, and other important information.
How Plaintiffs Can Use Clinical Trial Data
In many cases, plaintiffs will be able to use clinical trial data to their advantage during mass tort litigation. This data may allow plaintiffs to demonstrate the following:
1. Hidden clinical trial data
Manufacturers have a responsibility to be honest about the results of their clinical trials. However, in order to get a drug or medical device cleared by the FDA, manufacturers may hide the negative results of a clinical trial. When plaintiffs discover that data from a clinical trial has not been used properly, they can bring the facts to light in court and provide support for their case. For example, if the clinical trial data includes evidence of potential side effects but the manufacturer failed to disclose this information to the FDA and/or include this information on the product's warning label, plaintiffs can use the data to show negligence.
2. Failure to conduct appropriate clinical trials
In some cases, manufacturers may not conduct appropriate clinical trials at all. Manufacturers may be more focused on getting a drug or medical device approved, or they may simply be concerned about receiving unfavorable results. If plaintiffs can show that the manufacturer did not conduct the proper testing to uncover potential risks, the court is more likely to see the manufacturer as negligent.
3. Misrepresented clinical trial data
Manufacturers sometimes twist or misrepresent clinical trial data to make medications or medical devices appear safer and/or more effective than they actually are. If plaintiffs can prove misrepresentation of data, they have a better chance of winning the case.
The Bottom Line
Clinical trials are essential and beneficial for manufacturers and consumers alike, but the resulting data can be a critical component in mass tort litigation. When representing plaintiffs in any mass tort case, be sure to explore the possibility of using clinical data to the plaintiffs’ advantage.