Clinical trials are crucial to understanding the safety and effectiveness of medications and medical devices. While the U.S. Food and Drug Administration (FDA) uses clinical trial data to evaluate new drug and device applications, clinical trial data has not been very accessible to patients. Transparency of clinical trial data is incredibly important for patients – they’re the ones taking the medication or utilizing the medical device after all. Luckily for patients, the FDA announced it is taking steps to make more clinical trial data easily accessible to those who will be most affected by any dangers or side effects – the consuming public.

FDA commissioner, Dr. Scott Gottlieb, has stated the agency is going to take steps to increase transparency. The first step in making clinical trial data more accessible is launching a pilot program to evaluate how releasing summaries of clinical studies impacts the public’s access to drug approval information. This first step will help the FDA understand how patients consume information about certain drugs and studies, thus allowing the agency to better cater to patients. The summaries will also be incredibly valuable to patients. While there is clinical trial data available to the public, it is often difficult for patients to understand the medical jargon.

In addition to a pilot program, the FDA is taking huge strides by linking information from its own database of clinical studies to the communications it sends out regarding specific trials. The FDA posts certain clinical trial data online which is available to the public. The agency is going to add identifying numbers to all clinical trials in the online database. This identifying number will link to any and all FDA communications regarding that specific study.

Previously, clinical trial data and the FDA’s communications and warnings regarding certain trials have not been presented together. This means patients could look up clinical trial data, but not learn about FDA warnings regarding the trial. FDA communications regarding trials often include information about injuries suffered by patients as a result of the trial, the discovery of compromised trial data, or other serious situations.

Putting Patients First

Patients have a right to understand all of the risks associated with any drug or device before choosing to utilize it. For some patients, this means more than just reading the prescription label. Patients have a right to understand the history of the drugs they take, from the laboratory testing to clinical trials on humans. By obtaining this information, patients have a much better understanding of the risks associated with a drug or device.

When someone has been injured, sickened or killed as a result of taking a dangerous drug, they often turn to the court system and file suit against a pharmaceutical company in order to recover for the damages caused and, in most cases, these lawsuits are filed based on a principle known as failure to warn. The basis for this principle is the foundation of all products liability law, which looks at the condition of the product in question and asks whether that product was designed or manufactured in a way that makes it reasonably safe for its intended purpose.

Basically, a failure-to-warn lawsuit is based on an allegation that the company knew its drug possessed a number of specific risks but failed to disclose them to consumers. While there exists the assumption that many useful products contain certain inherent dangers that can’t be eliminated while still keeping the product functional, it is necessary that all potential dangers be made apparent to patients and doctors in the form of a warning label, so that doctors and patients can make informed decisions regarding the use of the drug. If there exist dangers that doctors and patients are not aware of, a tremendous amount of harm can result.

Millions of People Suffer Injuries From Dangerous Drugs

Every year, millions of patients suffer serious and potentially debilitating injuries because drug manufacturers fail to provide clear concise warnings on all of the dangers associated with these products. When a patient is injured through the use of a drug, manufacturers, distributors and retailers can be held strictly liable if they failed to provide adequate warnings for their product. Failure to warn is a strict liability claim, which means they can be held liable if they were involved in the selling our production of a dangerous drug, even if their company did not act completely negligently.

A failure to warn claim is not unlike any other personal injury claim, in that the plaintiff is required to show that the manufacturer knew about the danger posed by the product and that the consumer was hurt by that product.

In order to win a failure to warn lawsuit, the plaintiff has to prove several elements:

The defendant knew the product was dangerous.
The defendant had a duty to warn consumers of the danger.
The defendant was negligent with regard to their duty to warn.
The plaintiff was injured due to the missing or inadequate warning.

Alternately, there is a fifth element that may or may not be present. If the product warning was there, but it wasn’t readable by the consumer, the pharmaceutical company may be found negligent. The duty to warn does not apply to obvious dangers, but rather to dangers that are not apparent to a reasonable person. For example, if a product is used by the consumer as intended and the manufacturer provides sufficient warning about a side effect, if the patient is harmed by that side effect, they have no claim against the manufacturer.

On the other hand, if the patient uses that same drug and there is no warning of a specific side effect and the consumer uses the drug as intended and suffers harm from that side effect, the drug manufacturer can be held legally responsible for that. That is the basic premise behind failure to warn.

Quite often, failure to warn cases can sound very simple, but there are many potential legal mines in that minefield. Keep in mind, in any lawsuit against a pharmaceutical company, they will have a team of lawyers looking at every possible angle so as to avoid liability for injuries. You need an experienced personal injury lawyer on your team to help you avoid these pitfalls, in order to get you the compensation you deserve for your injuries and damages. If you or a loved one has been the victim of a defective drug, please contact the Defective Drug Attorneys at Blizzard Law PLLC today, so that we can help you protect your legal rights.