Given the advanced nature and reach of our medical system, it should come as no surprise that the United States is home to the most prescription drug and medical device consumers in the world. Drug and medical device manufacturers spend billions of dollars every year marketing their products to physicians, patients, hospitals and clinics. To be sure, in many cases, these drugs and devices have the potential for tremendous good and benefits to the patients who consume or use them. However, in some cases, despite testing and review by authorities such as the Food and Drug Administration (FDA), these drugs and devices can cause severe pain, illness or life-altering injuries and even death. This leads to the need for legal relief & compensation for drug and medical device injuries.
It is important for consumers to know that they have options if they have been injured by a drug or medical device. Throughout the United States, consumers have rights under product liability laws that enable them to seek legal remedies against negligent manufacturers of pharmaceuticals and medical devices. However, the first step toward compensation for injuries suffered may involve filing a lawsuit or other legal action in a court of law.
What is the Process for Seeking Compensation?
Liability for harm caused by a manufacturer’s pharmaceutical and medical device has its roots in the laws of each state. Typically, this requires a plaintiff (the consumer) to bring a defective product claim for damages against a manufacturer for injuries sustained while using the drug or device. The normal range of damages available for these claims are:
- Recovery of Medical Expenses
- Disability
- Pain and Suffering
- Lost Earnings and Earning Capacity
- Property Damage
- Emotional Harm
Within the realm of drug and medical device litigation, there are general three types of civil claims that can be pursued against manufacturers:
Manufacturing Defect
A manufacturing defect occurs during the manufacturing process and causes the drug or device to fail to meet the design specifications established by the manufacturer itself. This defect in turn causes an injury to the consumer (or even third party). This type of claim only involves contesting the manufacturing quality of single unit of a drug or device, as opposed to the entire product line. These types of cases hold the manufacturer to a standard of “strict liability” to the injured party.
Design Defect
A design defect is a mistake in the drug or device’s intended design that caused injuries to the consumer which could have been prevented by an alternative design. Unlike manufacturing defect claims, a design defect claim examines the safety of an entire family of pharmaceuticals or medical devices.
Warning Defects
Warning Defects, also known as “Failure to Warn” or “Marketing Defects” are the result of when a drug or device manufacturer fails to provide appropriate information about a product’s known hazards and how to avoid them, and these hazards represent an undue risk of harm to consumers.
Engaging Counsel and Filing a Lawsuit
With all of this in mind, if a consumer believes that she has been injured through the negligence of a drug or device manufacturer, then the first step toward receiving compensation through our legal system is to file a lawsuit in court. Although consumers can always represent themselves in civil lawsuits, given the case management complexities involved in this type of litigation, it is generally recommended that consumers seek the assistance of counsel with expertise in this field to file their lawsuit and guide their case. Furthermore, consumers should remember that the drug and device manufacturers will undoubtedly have their own counsel representing them at all stages of your case backed by billions of dollars in insurance coverage.
A qualified attorney can also advise injured consumers about important pre-requisites to filing lawsuits. Perhaps most significantly, there are time limits on an injured party’s ability to file a lawsuit. These limits, known as “Statutes of Limitation” can preclude a potential plaintiff from their day in court if a lawsuit is not initiated within a window of time following injury. These limits vary from state to state, but are nonetheless important to any case an injured consumer might contemplate.
What Will Hiring a Lawyer Cost?
Typically in cases involving drug and device manufacturer liability, lawyers representing injured consumers (plaintiffs) will not charge an up-front fee or hourly fees. They will operate under “contingency fee agreements” which entitles them to a portion of the plaintiff’s recovery for their fees and expenses. Put simply, the attorney only gets paid if you do.
In addition to alleviating the obstacles associated with the expense of upfront retainers and hourly rates, contingency fees give consumers the added reassurance that their attorneys are just as motivated to win cases and recover the highest amount possible for their clients.
What is Multi-District Litigation?
Through your own research or encounters with legal professionals, you may have heard about “Multi-District Litigation” or MDL as it concerns cases involving drug and device manufacturers. MDL is a procedure used to consolidate and/or coordinate lawsuits which are pending before various district federal courts (in this case, manufacturing defect lawsuits). Cases are considered ideal for MDL when there are numerous cases with common questions of fact pending.
A seven-member panel of judges selected by the Chief Justice of the U.S. Supreme Court, known as the “Panel on Multi-district Litigation” reviews cases for selection to MDL status, determines if they are eligible for MDL, and then selects a “transferee court” in which to host or consolidate the cases. Thereafter a single judge will oversee all of the MDL cases. If a drug and device manufacturer decides to settle a case once it has reached MDL status, plaintiffs may participate in the settlement or elect to proceed with their own case to trial.
What is a Class Action?
Similar to, but not exactly like MDL, the rules governing civil procedure in federal courts allow cases, with similar legal and factual circumstances to to be “certified” as a “class” and heard together. Some of the most famous cases to be certified as a class action lawsuit involve:
- Asbestos
- Agent Orange
- The Dalkon Shield IUD
Although class actions were popular tools for attorneys in the past, their popularity has waned in recent years for two main reasons: 1) the increasing difficulty with respect to the ability to get a case certified in district courts; and 2) the blanket settlement policy in class actions that requires all class members to accept the same settlement amount regardless of the severity of injury. For these reasons, product liability lawyers generally tend to prefer individual lawsuits that may evolve to MDL as opposed to seeking outright certification as a class.
Sources Cited (11)
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Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.