Under U.S. law, all drug and medical device companies are required to test for safety and efficacy as well as provide clear warnings about the potential risks and side effects of their products. While drugs and medical devices are subject to a stringent approval process under the U.S. Food and Drug Administration (FDA), flaws in the process and negligence on behalf of companies can put unsuspecting consumers in danger.
Bad drugs, tampered packaging, and faulty medical devices can cause health issues and injuries that can leave consumers with medical debt, impaired functioning, and a lower quality of life. In extreme cases, faulty or contaminated medical products can result in the loss of life.
Despite reports of safety issues, pharmaceutical and medical device companies continue to generate billions in revenue each year. According to the 2021 U.S. Prescription Drug Report, the average sample of popular prescription drugs in the country is 300% more expensive than the median global price while American consumers spend $1,011 annually on prescription drugs, nearly three times more than Swedish consumers, who spend $351 per year. The country is also the largest market for medical devices, with a market size of $140 billion, according to data from the U.S. Department of Commerce.
Fortunately, U.S. law allows consumers to seek remedies if they can prove that they have been harmed as a result of the manufacturer’s negligence. Consumers who have been harmed by drugs or medical devices, or whose loved ones who were harmed as a result of using these products, can seek legal counsel and file lawsuits to receive compensation. Small groups also have the option of working with a class action attorney in San Diego and elsewhere in California for legal remedies.
Grounds for legal action against pharmaceutical and medical device companies
Lawsuits pertaining to prescription drugs and medical devices fall under product liability. Consumers can file product liability lawsuits for physical, mental, and financial hardship caused by faulty product, such as:
- Ongoing medical treatment for physical injuries (i.e. hospital fees)
- Lost wages
- Diminished quality of life
- Loss of consortium or companionship
- Pain and suffering
- Losses related to a loved one’s death (i.e. hospital debt, funeral expenses)
Kinds of defects that can lead to a product liability lawsuit
When filing a lawsuit, the burden of proof lies with the plaintiff, who must show that the prescription drug or medical device is faulty. Product liability claims typically allege the product in question is defective in following ways:
- Manufacturing defects – The plaintiff can claim manufacturing defects if design and marketing are not faulty, but a manufacturing mistake results in a defective product.
- Design defects – This applies to cases in which the design or a drug or device causes harm because it is “defective and unreasonably dangerous.”
- Marketing or failure-to-warn defects – The common types of product liability cases cite marketing defects or flaws in the way the product has been marketed (i.e. improper labeling, insufficient safety warnings, insufficient instructions on how to safely use a product).