What Are Dangerous Drugs and Medical Devices?
Any medication that causes significant harm to a person taking it as instructed by a doctor may be considered a dangerous drug. The U.S. Food and Drug Administration (FDA) approves new medications that have been rigorously tested in laboratory studies and clinical trials.
All drugs have some risk of side effects, but researchers and the FDA have evaluated them and determined the benefits outweigh the risks. Despite this careful evaluation, some drugs still cause significant harm that researchers didn’t expect or that manufacturers knew of but failed to warn the public.
A medical device is a product—an implant, machine, or instrument—used to diagnose, prevent, or treat medical conditions. Medical devices can do a lot of good, but they can cause significant harm when they fail. For instance, metal joint replacement systems have caused pain, metal poisoning, and more.
Doesn’t the FDA Ensure Drugs and Devices are Safe?
The FDA’s Center for Drug Evaluation and Research (CDER) is responsible for approving and regulating the safety of prescription drugs, over-the-counter drugs, and medical devices. In spite of the processes in place, people continue to suffer harm and injuries from defective or dangerous drugs and devices.
Drug Approval Process
The CDER follows a process for ensuring drugs are safe and that the benefits outweigh the risks:
- Drug companies must first test their products in laboratory and animal studies.
- They then must test the drugs for safety and efficacy in human clinical trials
- The CDER evaluates the data provided by the company.
- The CDER does not perform its own tests on a drug, except for limited studies as needed.
- Based on the evaluation of the study data, the CDER may approve a drug.
- In some cases, the FDA may accelerate approval, such as when a drug could help with a life-threatening condition or fill an unmet need.
Approved drugs come with extensive notes to warn prescribers and patients about risks and potential side effects. These warnings are important to help consumers, and their doctors evaluate benefits and risks.
It is important to note that the FDA does not evaluate or regulate herbal supplements or vitamins. The companies making and selling these products make claims that may or may not be accurate. The products may be harmful.
Approval and Regulation of Medical Devices
The FDA approves medical devices differently. The testing requirements for medical devices are much less rigorous than for drugs. Furthermore, the FDA allows for the grandfathering of a new device similar to an existing, approved device. The company simply files paperwork with the FDA and pays a fee with no testing.
How Do Dangerous Drugs and Medical Devices Enter the Market?
With FDA oversight, consumers often assume that all approved drugs and devices are safe and low-risk. But the system can, and does, fail. There are several ways a dangerous device or medication can get into the hands of consumers and cause harm:
- Unexpected side effects not seen in trials show up later in consumers
- A manufacturer lies about study results or downplays risks and side effects
- A defect in the design of a medical device causes harm and is not caught because of the minimal FDA approval requirements
- A manufacturing defect in an otherwise safe device or product leads to harm
- A company markets a drug or a device defectively, downplaying risks or failing to warn of them entirely
In legal terms, these are cases of product liability. Filing a lawsuit over a defective product, whether through manufacturing, design, or marketing, may result in damages awarded to the victim. You do not need to prove negligence in these cases, only that the product harmed you, resulted in damages, and that the defendant made it.
Examples of Dangerous Drugs and Devices
You can find many, many examples of drugs and medical devices that have caused unexpected harm. Some of these have been recalled by the manufacturers or the FDA, while some remain on the market. In some instances, victims have been able to sue and recover damages.
An example of a dangerous drug that led to thousands of lawsuits and over $1 billion paid by the manufacturer is the birth control Yaz. Made by Bayer, Yaz caused life-threatening blood clots in some women. The plaintiffs took Bayer to court over defective marketing and a failure to warn of the risks and won.
DePuy, a division of Johnson & Johnson, harmed thousands of people with hip replacement systems. These metal-on-metal hips failed in some patients and caused metal blood poisoning in others. Multidistrict litigation resulted in a $2.5 billion settlement.
What to Do if a Drug or Device has Harmed You
It isn’t always easy to know if a drug or a device caused symptoms or injuries. If you suspect this is the case, talk to your doctor right away. Your priority should be your health and correcting the harm caused.
- Ask your doctor to preserve as much evidence as possible, which may include photographing your injuries or saving an implant that must be removed.
- Talk to your doctor about reporting the faulty device or harmful drug. The FDA has a consumer reporting system that helps them regulate and possibly even recall faulty products.
- Keep a record of your symptoms and ongoing medical problems related to the drug or device.
- Gather all your related medical records and bills.
- Contact a drug and medical device lawyer to find out what you can do next. You may be able to get a settlement or file a lawsuit to recover damages related to the harm you have suffered.
Harmful drugs and devices cause billions of dollars in damage to patients who trusted doctors and companies to provide safe medical solutions. If you have suffered because of a drug or device claiming to be safe, talk to a lawyer about legal options.