Can People Harmed in Clinical Trials Sue for Medical Malpractice?

Originally published August 24, 2020.

Yes, people who are harmed in clinical trials can pursue compensation for their injuries, illnesses, and other expenses—but doing so almost always requires the help of an experienced lawyer.

That’s because participating in a clinical trial typically involves signing reams of paperwork that absolve the pharmaceutical company and the administering hospital or clinic from many aspects of liability in the event of a serious adverse reaction or complication.

What Is a Clinical Trial and Why Are They Necessary?

The research, development, and testing process for a new medication can take many years. It’s not uncommon for medications to take more than a decade to go from research and development to being sold in pharmacies and supermarkets. Part of that delay is due to the extensive testing process that all drugs must undergo before they receive approval from the U.S. Food and Drug Administration (FDA).

Before a drug is released to the public, it must undergo three rounds of clinical trials (and in some cases, a fourth trial). Each new trial involves more participants than the one before, which allows the pharmaceutical company and the FDA access to more data to determine the drug’s efficacy and safety.

If the drug proves ineffective or dangerous, trials may end long before it’s approved for sale, which means the manufacturer will either have to scrap it or revise its formula, dosage, and ingredients.

The 4 Phases of Clinical Trials

Clinical trials involve three main phases before drugs are allowed to be sold in pharmacies and hospitals:

• Phase I—During this phase, only a small number of healthy volunteers and sick patients who need the treatment are allowed to participate. Because this is the first time the drug may be tested on humans, the risks of injury or illness may be high, as some or all its effects are likely unknown.  Participants may be particularly vulnerable during Phase I.
• Phase II—If Phase I is deemed successful and the drug appears to be safe and have therapeutic value, more volunteers will be recruited for Phase II. This phase involves anywhere from 20 to 300 people and like Phase I, has participants being closely monitored and researchers looking for evidence of efficacy and potential danger.
• Phase III—This phase is much larger than previous phases and can involve thousands of participants. It can also be the longest phase, with some Phase III trials lasting anywhere from one to four years. During Phase III, researchers look at immediate, short-term, and  ong-term effects the drug has on participants.

If a medication shows both efficacy and lack of risk during all three phases of clinical trials, the FDA may approve it to be sold to the public. Once that happens, a fourth phase may occur:

• Phase IV—During Phase IV, the drug manufacturer will have access to significantly more data due to the drug being taken by potentially thousands or even millions of patients. Phase IV typically involves the study of long-term risks.

What Risks Are Involved in Clinical Trials?

Patients face many risks when they volunteer to participate in a clinical trial, including:

• Risk of taking a dangerous medication—Whether they’re participating in Phase I or Phase IV, patients, their doctors, and the pharmaceutical company itself may not fully understand the drug and its risk factors—especially when it comes to long-term effects and complications. Patients may experience severe health problems immediately or years later.
• Risk of taking an ineffective medication—Many clinical trial participants are sick and need medication to improve their conditions. When they participate in a clinical trial, they may forgo other proven medications to give researchers a better understanding of the efficacy of the medication being tested. If the medication is ineffective, they may go months or even years getting inadequate treatment, which can worsen their health.
• Risk of taking the wrong dosage—Determining the right dosage to give to patients is critical for establishing a new drug’s safety and efficacy. Those decisions are typically made during the clinical trial process. That means some patients may receive dosages that are far too high or low, while other patients may receive placebos that don’t contain any active ingredients.

How Do You Know If Your Rights Were Violated in a Clinical Trial?

Clinical trials are an important part of the drug development process. However, they should always be conducted as safely as possible.

Unfortunately, that doesn’t always happen, and sometimes volunteers, including those who are already sick, suffer severe complications due to negligence.

These factors can play a big role in determining whether you have a medical malpractice claim after participating in a clinical trial:

• You didn’t receive proper explanation of the clinical trial’s risks.
• You didn’t receive guidance or clarification on paperwork and consent forms.
• You were coerced into participating in the clinical trial.
• Your health significantly worsened as a result of taking part in the clinical trial.

We Know How to Help Medical Malpractice Victims

Filing a claim after suffering a negative outcome in a clinical trial can be difficult. Pharmaceutical companies, doctors, and administering clinics are already well-protected from such claims, and they may seem untouchable after you signed paperwork and consent forms. However, negligence is negligence, and you shouldn’t have to pay out of pocket if you were harmed because of someone else’s mistake.

The Ohio medical malpractice lawyers at Nurenberg, Paris, Heller & McCarthy know what you’re going through, and we want to help. Contact us today for a free consultation.

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