Determining who may be responsible for an injury or illness associated with a defective drug or medical device can be incredibly complex. First off, it can be difficult to determine if a particular symptom is associated with a drug/device or if it is associated with an underlying medical condition. If a symptom is associated with a drug or device, the follow-up treatment required can often be time-consuming and costly. Getting adequate compensation to cover these costs can be a top priority for victims and their families. What parties are legally responsible, or liable, in these types of claims? This article explores the basic who, what, when, and where of liability as it relates to defective pharmaceutical drugs and medical devices.
Liability in Defective Drug Cases: What
Millions of Americans take pharmaceutical drugs and use medical devices on a daily basis. While the majority of these drugs and devices help us to live longer, healthier lives, they do pose some degree of risk. When drugs or devices are faulty in some way, they can lead to worsening of the underlying condition or adverse events that can cause illness or injuries far greater than the initial condition-including death.
The United States government has recognized the serious risk that a defective drug could pose to the general public and has therefore set out a rigorous system to test pre-market drugs. All drugs and devices are regulated by the US Food and Drug Administration (FDA). Before a drug is submitted to the FDA for approval, it must be thoroughly tested by the pharmaceutical company. The company must submit all the results of these tests to obtain approval. Next, the FDA will examine the results, and many request additional information or additional testing. If a drug is approved for sale, there are strict guidelines covering marketing and labeling. Once a drug hits the market, governmental monitoring continues. The FDA collects data related to adverse reactions and may intervene if a drug or device may be unsafe for the public.
If a dangerous drug or device does hit the market and causes harm, the patient may require substantial care. Some adverse reactions can cause such extensive harm that the patient may require lifelong care. In order to fairly compensate victims and their families, those who have been harmed by defective drugs or devices have the ability to file a lawsuit for the costs that they've encountered and expect to incur in the future. But who is ultimately responsible for these losses? Many parties may play a role in getting the product to the patient, including the pharmaceutical company, the FDA, physicians, hospitals, pharmacists and more.
Liability in Defective Drug Cases: Who
One of the most common actions in the case of defective drugs or devices is an action against the manufacturer. In the United States, a manufacturer can be liable for delivering a defective product to a consumer, if that defective product causes injuries to the consumer when used in the matter it was intended to be used. This includes pharmaceutical drugs and medical devices.
Defects Related to Dangerous Side Effects
All pharmaceutical drugs have some type of side effects. The FDA requires that pharmaceutical manufacturers thoroughly test every prescription drug that is intended to be released on the market and to fully document every unintended consequence. The FDA itself will then test the substance and likewise document any associated side effects. The manufacturer is required to include any potential side effects in the labeling and educational materials that accompany the pharmaceutical drug or medical device so that physicians can be adequately trained as to what to expect and can likewise counsel their patients. If a patient takes a drug or uses a device and experiences an adverse reaction that falls within the range of the documented side effects, this will probably not be adequate grounds for any legal action.
However, there have been many documented cases in which the testing process is ineffective, and a device or drug hits the market that causes serious adverse reactions. The testing procedure may be ineffective for a variety of reasons. A drug or device may have been tested on a certain population that is not adequately representative of the general population. For example, a drug may have been tested on adult males, but pregnant women and/or their fetuses may experience serious adverse reactions. Additionally, some drugs are tested on adults but have adverse reactions in a child population. The serious adverse reactions to some drugs and devices may not be present until a patient has taken a drug or used a device for a significant period of time.
Whatever the reason, if a drug or device causes an adverse reaction, a manufacturer may be liable. The FDA maintains a database where patients, caretakers health care workers, and the general public can submit reports of adverse events related to pharmaceutical drugs and medical devices. The FDA monitors these reports, and, if it is found to be warranted, will issue a recall. However, this will obviously be far too late for any patients who have been taking the drug or using the device. In cases where a patient has taken a pharmaceutical drug or used a medical device and experiences an adverse reaction, the manufacturer may be liable for the injuries or illnesses suffered as a result.
Defects in Manufacturing or Shipping
Drugs and devices must be adequately tested before hitting the market, but the risks do not end there. Even if a drug or device poses no additional risks to patients, it is a long and complicated process from manufacturer to a patient. Each step of this process must be secure to ensure that the drug or device meets the patient in the manner in which it was intended to. A manufacturer may also be liable to a patient if a product was designed properly but encountered a defect at some point in the manufacturing or shipping process.
A good example of this type of product defect is what happened with the Synvisc-One knee injections in 2017. These injections, formulated to treat osteoarthritis, encountered an issue during the manufacturing process. One lot of vials were found to be contaminated with bacteria, which the manufacturer eventually identified as Methylbacterium thiocyanatum. Patients who received an injection from the contaminated vial faced the risk of antibiotic-resistant infection and other adverse events. In these types of cases, the entirety of the drugs or devices are not necessarily defective or dangerous, but one (or more) produced lots may be. In cases where a pharmaceutical drug or a medical device was damaged, contaminated, or otherwise adulterated at any point between manufacture and use and results in harm to the patient, a manufacturer may be liable.
Defects in Labeling
Above, we discussed the process by which manufacturers test pharmaceutical drugs. All side effects must be documented so that they can be incorporated into the labels/educational materials that accompany the drug or device. This empowers physicians to accurately educate their patients about all known risks. However, when a manufacturer fails to disclose a risk or fails to accurately disclose a known risk (for example, minimizing the seriousness of a risk) it may be liable for damage caused by the drug or device.
One high profile case of a defect in labeling involves the painkilling drug OxyContin. Purdue Pharma, the pharmaceutical company behind OxyContin, marketed the drug as having lower abuse potential than immediate-release oxycodone because of its time-release properties. It was eventually revealed that there was insufficient scientific backing for such claims, and that the company was aware of the abusive potential of the painkiller, often cited as having a pivotal role in the current opioid epidemic. Ultimately, Purdue Pharma and individual company executives pleaded guilty to mislabeling OxyContin and will pay more than $634 million in fines, according to a U.S. prosecutor.
Liability in Defective Drug Cases: Where
If a victim or his or her loved ones might have a claim against a manufacturer for a defective drug or device, where would the claim be filed? This may depend on the type of case involved. Generally, if a case involves one victim filing a claim against one or more defendants, it is highly possible that the case may be filed in a court in the state in which the victim resides. Even if a drug manufacturer is based in a foreign country, if it conducts business activities in the United States, it is likely that it will be subject to the jurisdiction(s) in which that business is conducted.
In many cases involving pharmaceutical drugs, large groups of victims have suffered the same or a similar injury. In such cases, the victims may form one group against a single defendant or small group of defendants. However, for many claims involving defective pharmaceutical drugs or medical devices, a large group of people experience the same or similar injuries. In these cases, victims will join a group that will serve as one party to the lawsuit. If a claim like this is successful, compensation will be awarded to the group in a lump sum, which will be divided between individual victims and/or their families.
Liability in Defective Drug Cases: When
Claims for defective drugs and devices, like all civil personal injury claims, are subject to what is known as a "statute of limitations." A statute of limitations is a time period set by law during which an individual may bring a claim against another party. These laws were created to motivate parties with potential claims to act in a timely manner, to ensure that evidence and witnesses to the events will still be available so that courts may make an informed and fair decision.
Each jurisdiction sets its own statute of limitations for certain types of cases. Many jurisdictions have a two-year statute of limitations for defective products claims, including drugs and devices. However, particularly important in these types of cases is "when the clock is set" on the statute of limitations. As you might imagine, the injuries and illnesses that stem from defective drugs and devices are quite diverse. Some might be acute (such as a stroke or heart attack) while others, such as cancer, may take much longer to develop. Not only might some adverse events take longer to discover, but it might take even longer for the victim to connect the illness or injury to the actual cause. The law recognizes that it is not always immediately evident how an actionable injury or illness occurred. As such, the statute of limitations does not "start the clock" in many jurisdictions until an injury has been discovered by a victim.
Representation for Defective Drugs and Devices
A claim for a defective pharmaceutical drug or medical device can involve many players, can play out over an incredibly long timeframe and can involve complex legal matters. The team at Gilman & Bedigian has extensive legal experience as well as the extensive resources necessary to investigate these types of cases and take on major players with deep pockets. Contact us for a free consultation to discuss the specifics of your case.