Between 1990 and 2008, U.S. spending on prescription drugs increased from $40 billion to $234 billion. Today, almost half of all Americans take at least one prescription drug. The sale of medical devices has grown into an $85 billion-per-year industry. But too many people are injured by severe side effects of dangerous drugs and defective medical devices. Often, the injuries are more debilitating than the condition that led to the prescription or device in the first place. Fortunately, the law gives injured consumers remedies if they are injured because of a manufacturer’s negligence.
Drugmakers and device manufacturers have a legal duty to ensure the safety of their products. They must also satisfy Food and Drug Administration (FDA) regulations before putting their products on the market. But manufacturer negligence and flaws in the approval process have exposed millions to hidden risks. The public has turned to product liability lawsuits to expose these risks and protect the injured.
But it hasn’t always been clear whether injured consumers could have their day in court. That’s because it hasn’t always been clear to what extent a consumer could sue the maker of a defective drug or product.
Prescription drug lawsuits and medical device lawsuits involve a special area of the law known as product liability. It can be traced back to the 1842 case of a mail coach driver who was injured when a poorly constructed coach collapsed. That driver lost his case. But in 1916, the landmark case of MacPherson v. Buick Motor Co. made clear that manufacturers of defective products are liable for foreseeable injuries caused by their negligence. In other words, manufacturers are responsible for protecting consumers by making their products reasonably safe.
History of Product Liability Laws
The law requires manufacturers to adequately test their products’ safety before they hit the market. Manufacturers and marketers are also required to warn the public of any risks associated with a particular drug or device. These duties to test and warn continue after a drug or device hits the market. Drugmakers and device manufactures face legal liability if they neglect these duties.
However, sometimes the law has limited manufacturers’ liability in order to get certain drugs on the market quickly. For example, in 1986, Congress responded to dwindling vaccine supplies by passing federal “no-fault” legislation. The legislation protected vaccine makers from legal claims, encouraging them to get vaccines on the market quickly. In 1998, Congress halted state court lawsuits over injuries caused by certain medical devices and implants. Some states, such as Michigan, have also passed their own laws limiting personal injury claims.
In addition, urgent health concerns like the AIDS epidemic fueled regulators’ interest in easing rules that were seen as slowing down drug innovation. But many critics believe flaws in current FDA regulations make it easier for companies to get approval for dangerous drugs or devices. They say that it’s too easy for drugmakers to get a drug approved for one purpose and later market it for new purposes. Too often, the drugs and devices aren’t adequately tested or drugmakers and manufacturers don’t adequately warn about serious risks.
There is little doubt that innovations in medical research can benefit society. But the desire to find new ways to treat illness must be balanced with public safety. Unfortunately, the rush to get a product on the market as soon as possible sometimes comes at the expense of safety. This is reflected by an increase in the number of recalled drugs in recent years. The total number of recalled drugs increased 309 percent between 2006 and 2009. And, according to the FDA, serious complications from medical device use have outpaced the industry’s growth by 8 percent each year since 2001.
It’s no surprise that product liability lawsuits are often necessary.
Product Liability Claims
Manufacturers, distributors and sellers have a responsibility to the public to foresee potential risks and deliver products that are free of defects. This responsibility is known as product liability. Plaintiffs may file legal claims for injuries caused by product defects. In fact, dangerous drugs and faulty medical devices account for many product liability claims.
Products liability claims fall under the following categories:
- Design Defects – These are cases where it is possible to foresee that a product will cause an injury due to its design. The manufacturer may be able to avoid or reduce the injury by changing the way the product is made.
- Marketing Defects – These are cases where the manufacturer or others give inadequate instructions or warnings or simply fail to warn consumers about a product’s foreseeable risks.
- Manufacturing Defects – These are cases where design and marketing are proper, but a mistake occurs during the manufacturing process that leads to a defect.
Medical product liability claims may fall under any of the above categories. If a product has any of these defects, its manufacturer, seller or distributor may be financially liable for any resulting injuries.
Holding Drug and Medical Device Companies Accountable
U.S. consumers are familiar with the laundry list of warnings that often accompany drugs and medical devices. The companies that manufacture, sell and distribute these products usually anticipate that some injuries may occur. For this reason, they have many strategies for dealing with lawsuits. That is why it is wise to talk to a qualified attorney who is familiar with these cases if you think you have a claim.
If you have been injured by a drug or medical device, be sure to consult a lawyer about laws that may affect your legal rights. For example:
- The National Childhood Vaccine Injury Act establishes a claim procedure for vaccine-related injuries. Consult a lawyer about potentially filing a claim versus filing a lawsuit for these types of injuries.
- The Medical Device Amendments of 1976 often bars state court claims against products that receive FDA approval. However, a qualified attorney can help determine whether a company failed to comply with FDA regulations and caused your injury.
An experienced lawyer can also explain how drug and medical device companies defend themselves in lawsuits. For example, a lawyer can assist with the following legal issues:
- Unavoidably Unsafe Products: Some products, including many prescription drugs and medical devices, cannot be made safe for their “intended or ordinary use.” Although “unavoidably unsafe products” can cause serious injury, they are not considered defective or unreasonably dangerous. In other words, product liability law creates an exception for these products that often benefits drug and device companies. That is why it is difficult to challenge an unavoidably unsafe drug accompanied by an appropriate warning.
Experienced lawyers can help you challenge the adequacy of drug and device warnings. They can also help you show how a manufacturer could have taken steps to make the product safer or market it more appropriately.
- Medical Malpractice: Defendants sometimes argue that injuries that a medical professional’s mistake, rather than a product defect, caused the injury. A doctor or nurse may have ignored product warnings or properly instruct a patient. An experienced attorney can help you determine who is responsible for your injury.
The Role of Product Liability Lawsuits in Protecting Society
Negligence by drugmakers and device manufacturers has led to some high-profile legal claims in recent years. Too often, hundreds, sometimes thousands, of consumers are injured by a drug or device before it is recalled. It usually takes several lawsuits and consumer complaints to the FDA to bring attention to a product’s dangers.
In 1974, complications with Dalkon Shield intrauterine devices showed how effective lawsuits can be in safeguarding public health. The manufacturer marketed the device aggressively even though it was aware of safety problems. Litigation over the product resulted in millions of dollars of compensation for victims. It also brought attention to the manufacturer’s negligence and eventually helped take the product off the market.
Product liability lawsuits offer similar benefits. Whether claims are filed before or after the FDA gets involved, lawsuits put pressure on manufacturers and marketers to right their wrongs.
Examples of other high-profile prescription drug cases that have sparked attention over recent years include:
- Yasmin (2012): Bayer paid $110 million to settle more than 500 lawsuits. Consumers who took the prescription drug for birth control experienced blood clots.
- Preempro (2011): Pfizer agreed to pay $330 million to settle more than 2,200 lawsuits. The company was accused of hiding the menopause drug’s cancer risks.
- Avandia (2010): GlaxoSmithKline agreed to pay $460 million to settle 10,000 lawsuits. Claimants said the company hid heart attack risks associated with the diabetes drug.
- Vioxx (2008): Merck paid $4.85 billion to settle a reported 50,000 claims. People who took the painkiller suffered heart attacks and strokes.
If you or a loved one has suffered serious side effects from a prescription drug or medical device, you may also have a legal claim. Each case is different, so the potential for compensation varies.
You may be entitled to compensation for your injuries as well as punitive damages. For instance, you may be able to receive money for:
- Ongoing medical treatment for your injuries, including hospitalization costs.
- Lost wages.
- Diminished quality of life.
- Pain and suffering.
- Losses related to the death of a loved one, including funeral expenses.Contact a product liability attorney for more information about filing a claim and the types of damages that may be available.