Americans expect drug and device companies to adequately test for safety and effectiveness before selling their products. But, this is not always the case. Manufacturer negligence and flaws in the U.S. Food and Drug Administration's approval process may put millions at risk of serious, debilitating injuries — including death. Injuries caused by bad drugs and devices may be worse than the condition that led to the prescription or device in the first place.
In spite of these safety issues, pharmaceutical and medical device companies make billions each year. In 2015, prescription drug sales reached an all-time high of $425 billion. Analysts predict that it will reach $610 billion by 2020. The U.S. remains the largest market for medical devices in the world with a market size of $148 billion, according to the U.S. Department of Commerce.
Fortunately, the law gives injured consumers remedies because of a manufacturer’s negligence, and people injured by faulty drugs and devices may choose to file lawsuits for compensation.
Product Liability Claims
Prescription drug and medical device lawsuits involve a special area of the law known as product liability. Manufacturers, distributors and sellers have a responsibility to the public to foresee potential risks and deliver products that are free of defects. Plaintiffs may file legal claims for injuries caused by product defects. Dangerous drugs and faulty medical devices account for many product liability claims. While each case is unique, product liability claims typically fall into three broad categories: design defects, marketing defects and manufacturing defects.
- 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.
Drug and device liability claims may fall under any of these categories. If a product has any of these defects, its manufacturer, seller or distributor may be financially liable for any resulting injuries.
Drug and Device Lawyers
While product liability is a broad category, there are lawyers that specialize in drug and device lawsuits. Product liability lawyers can help in a number of ways. They can explain legal rights and options in the event of drug or device recalls. They can evaluate the strength of the claim and file the lawsuit on behalf of the plaintiff. After filing a lawsuit, the lawyer can help negotiate a settlement in the case or take it to trial.
Product liability laws may vary depending on the state and product, and there may be a limited amount of time to file called a statute of limitations (SOL). Depending on the state where the plaintiff lives the SOL may vary. The time limit may also begin from the date of surgery, injury or when the plaintiff realized the product caused their injury. These are all questions to ask a lawyer.
In drug and device injury litigation, there is typically no fee for a consultation. These cases are also on a contingency fee agreement. This means the lawyers will not charge a client unless they obtain a settlement or jury verdict.
Class-Action Lawsuits vs. Multidistrict Litigation (MDL)
Class-action lawsuits form when individuals harmed by a drug or device combine cases into a single lawsuit. Multidistrict litigation cases occur when a panel transfers individual cases to a single court, but the court does not combine them into a single lawsuit.
Court systems use mass torts to manage large numbers of lawsuits to increase efficiency and decrease the costs of litigation. A tort is an action that causes harm to someone but is not a crime. A mass tort is an action that causes harm to a large number of people. Civil courts decide disputes over compensation for damages from torts and mass torts.
Mass torts can make the legal process easier for all parties involved. Class-action lawsuits and multidistrict litigation share some common characteristics. Both involve transferring several similar cases involving one or multiple questions of fact to a single court. However, there are many differences.
Class Action Lawsuits
A class-action lawsuit involves similar claims by a group of people injured by one or more common defendants. Rather than go it alone, the plaintiffs choose to join others in a class action.
An individual or small group of plaintiffs acts as a leader for a larger group of injured people. After filing a complaint in state or federal court, the lead plaintiffs — also called class representatives — ask the court to certify the lawsuit as a class action.
In deciding whether to certify a class action, the court considers whether:
- There are enough claims to warrant resolving them in a single lawsuit.
- There are common facts or legal questions.
- The lead plaintiffs’ claims are typical for the class.
- The named plaintiffs fairly represent the interests of the class.
A court is not required to certify a class or approve a settlement. Even if the plaintiffs and defendants are in agreement, the court can refuse to certify a class or reject a settlement if it doesn’t adequately resolve or compensate class members’ claims.
If the parties reach a settlement, their attorneys develop a plan for notifying potential class members and settling claims. Once the court approves the settlement, lawyers notify potential class members of their opportunity to submit a claim for a percentage of the settlement if they meet eligibility requirements.
Plaintiffs are not required to participate in class action lawsuits even if they meet all of the criteria. Those who do participate lose their right to file an individual lawsuit about the tort in the future, regardless of the outcome of the case. Those who choose not to participate keep their right to file an individual lawsuit and may have more input into a possible settlement.
Drug and device lawyers do not typically recommend class actions because severely injured plaintiffs may not have access to larger settlements because all participants get the same award regardless of individual damages.
Multidistrict Litigation (MDL)
When dangerous drug and medical devices harm large numbers of people, personal injury claims can clog court dockets across the nation. In order to increase efficiency by allowing a single judge to oversee similar cases, a panel can consolidate the cases in a process called multidistrict litigation (MDL).
MDL is not the same as class action, although an MDL can lead to a class-action lawsuit.
Examples of drug and devices included in MDLs include:
- Transvaginal mesh
- DePuy ASR Hip implants
- Stryker Rejuvenate and ABG II hips
- IVC Filters
A class action is a single lawsuit with several similar claimants. MDL cases remain separate lawsuits. The court does not consolidate MDL cases for a common outcome in the same way that class-action members share in the same settlement or verdict.
In the federal system, the Judicial Panel on Multidistrict Litigation decides when to transfer cases to an MDL. It usually occurs when there are large numbers of cases against common defendants and the courts expect more plaintiffs to file lawsuits. At the state level, a similar body or a state Supreme Court can decide to consolidate similar cases.
A single judge oversees and administers cases in an MDL. This usually involves grouping cases with common factual or legal issues together for discovery, pre-trial hearings, trial scheduling and settlement conferences. This allows the court to address common issues that affect many cases at once.
Companies may choose to settle multiple MDL cases based on early trial results. Each plaintiff can choose to participate in the settlement or not. Plaintiffs who suffer more serious injuries — such as those that require surgery or extensive future medical treatment — may be eligible for more compensation than those with minor injuries.
History of Drug and Device Lawsuits
Several historic laws, rulings and cases gave patients more protection against drug and device companies. However, sometimes the law limits manufacturers’ liability in order to get certain drugs or devices on the market quickly. Some states, such as Michigan, passed their own laws limiting personal injury claims.
The Pure Food and Drugs Act of 1906 legislation was passed to protect Americans from harmful substances and deceptive practices. But, it did not include medical devices.
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.
Congress passed the Food, Drug, and Cosmetic Act giving the U.S. Food and Drug Administration the authority to oversee drugs.
1938 to early 1960s
Only the FDA could sue medical device companies if it deemed a device was unsafe or defective, but there was still no requirement for pre-market testing.
The 1976 Medical Device Amendments became law. The amendments classified medical devices, but only required pre-market testing of life-saving devices, such as artificial hearts. This began the 510(k) clearance process.
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.
Congress halted state court lawsuits over injuries caused by certain medical devices and implants.
In the case of Riegel v. Medtronic, Inc., the Supreme Court found that language from the 1976 Medical Device Amendments prevented an injured patient from suing Medtronic in state court for harm related to a cardiac catheter.
In Wyeth v. Levine, the Supreme Court ruled that companies cannot use FDA approvals as a complete defense against injury claims. It ruled that individual states may supersede federal law and choose to say if a stronger warning on a drug is needed.
High Profile Drug and Device Lawsuits
Negligence by drugmakers and device manufacturers 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. Sometimes, the FDA or manufacturers do not take action until a number of plaintiffs come forward with lawsuits.
In 1974, complications with Dalkon Shield intrauterine devices showed how effective lawsuits can be in safeguarding public health. Lawsuits claimed 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 lawyers file claims before or after the FDA gets involved, lawsuits put pressure on manufacturers and marketers to right their wrongs.
Examples of high-profile prescription drug and medical device cases include:
- Actos (2015): Takeda settled about 9,000 lawsuits for about $2.37 billion. Plaintiffs blamed the drug for causing bladder cancer.
- Stryker Rejuvenate and ABG II Hips (2014): Stryker paid $1.4 billion to settle thousands of Rejuvenate and ABG II modular hip stem lawsuits. Plaintiffs claimed the hip implants failed early leading to additional surgeries.
- DePuy ASR Hip (2013): Ethicon agreed to settle more than 7,000 claims for more than $4 billion. Patients implanted with DePuy ASR implants suffered infections, fractures, bone and tissue death and needed additional surgery to replace failed implants.
- Yasmin (2012): Bayer paid $110 million to settle more than 500 lawsuits. Consumers who took the prescription drug for birth control said they experienced blood clots.
- Prempro (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 linked to the drug.
Compensation for Drug and Device Lawsuits
In drug and device lawsuits, plaintiffs may claim certain injuries and damages caused by the faulty product. In addition to the actual injury, there are a few basic damages lawsuits claim.
- Ongoing medical treatment for your injuries, including hospitalization costs
- Loss of companionship or consortium
- 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.