California Personal Injury Law Firm
With locations throughout California, we have the resources and experience to take on any corporate opponent and win.
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Every year, sales from medical devices bring in a combined total of over $200 billion in revenue worldwide, making medical device manufacturing one of the most profitable sectors in the healthcare industry. But despite oversight from the U.S. Food and Drug Administration (FDA), which issues over 1,000 medical device recalls each year, many people are harmed by defective medical devices."
If you believe a defective medical device injured you, you should speak with an experienced medical device recall attorney as soon as you are able.
Product liability lawsuits against medical device companies are governed by your state’s statute of limitations, which serves as a deadline to file a lawsuit. Consulting with a defective medical device lawyer as soon as possible will help ensure you are not time-barred from filing a lawsuit.
Wisner Baum has represented thousands of clients in defective medical device and pharmaceutical cases. Our defective medical device lawyers take cases across the U.S. With extensive experience and a national reputation for success, we have what it takes to win big cases against any corporate defendant.
Taking immediate action can protect your health and your case:
Liability often focuses on the manufacturer, but real-world cases can be more complex:
Sometimes, multiple entities share liability. An experienced attorney can help determine who should be named in your case.
Most medical devices reach the U.S. market through the FDA’s 510(k) premarket notification pathway. Manufacturers can get devices cleared if they prove “substantial equivalence” to an existing approved product—often skipping full clinical testing.
What is “substantial equivalence”? The company must show its device performs as safely and effectively as its predecessor (“predicate device”), using engineering data, lab test results, and limited clinical data. Over time, small changes can accumulate—sometimes causing new risks that weren’t present in the original device.
FDA review timelines: The official goal for 510(k) review is 90 days (not counting company response time), but the average is about 3–6 months depending on complexity.
Risks and controversies: Many high-profile recalled devices—including pelvic mesh and several metal-on-metal hip replacements—were cleared using 510(k) and later found unsafe after widespread use. Recalls related to 510(k) devices are frequent and a central focus of device safety reform.
A medical device recall is the removal or correcting of medical devices that violate U.S. Food and Drug Administration (FDA) laws. The FDA classifies medical device recalls as Class I (most serious), Class II, or Class III, depending on the level of risk associated with the device.
Medical device recalls are typically initiated voluntarily by device manufacturers. However, in a small number of cases where a device poses an imminent threat to public health and the manufacturer refuses to take action, the FDA may step in and recall the device. This last-resort measure ensures that unsafe medical devices are swiftly removed from the market to protect consumers.
The FDA classifies recalls to help the public understand the potential for harm, with Class I being the most serious and Class III being the least. Below are some notable examples:
The FDA is charged with keeping Americans safe from dangers posed by defective medical devices. However, the agency cannot keep all defective medical devices from reaching the public.
If a medical device is deemed harmful, the FDA may issue recalls for medical devices under the following circumstances:
If you suspect there may be an issue with your medical device, the first thing you should do is review the FDA’s medical device recall page. The FDA recall webpage lists all device recalls at the bottom of the page under Recent Medical Device Recalls and Early Alerts.
If you are still unsure, contact your physician to see if you have a medical device that has been recalled.
No. if you sustained harm due to a defective medical device that has not been named in an FDA recall, you may still be able to pursue justice and compensation in a lawsuit. The challenge in cases where the product has not been recalled is proving liability, which is the process of demonstrating that the medical device manufacturer (or other entity) is legally responsible for the harm you suffered. This typically involves showing that the defendant(s) had a duty of care, breached that duty, and that breach directly caused injury or damages to you, the plaintiff.
An experienced medical device injury attorney will need to gather evidence to demonstrate the following:
If your device has not been recalled but you believe it injured you, it is in your best interest to speak with an attorney as soon as you are able. Proving liability in these cases can be difficult, so the sooner you consult with an attorney, the better.
Patients often search for legal help linked to a specific brand. Major manufacturers involved in past or ongoing medical device litigation include:
Below is a list of some of the largest ongoing medical device mass torts:
Medical device lawsuits can involve a wide variety of injuries. Some of the most common injuries cited in defective medical device claims are:
The compensation you receive in a medical device lawsuit is based on your claims for damages, which is the compensatory award granted by the court to rectify the harm or loss suffered as a result of the defendant's actions.
In a personal injury lawsuit involving a defective medical device, the plaintiff may seek various types of damages to compensate for the harm they have suffered, including:
Economic Damages: These are meant to reimburse the injured party for any financial losses incurred as a result of the defective medical device, including medical expenses, lost wages, rehabilitation costs, and more.
Pain and Suffering: Designed to compensate the plaintiff for the physical and emotional pain they endured due to the defective medical device. These damages may include both immediate and long-term pain and suffering.
Punitive Damages: In some cases where the defendant's actions were particularly egregious or reckless, punitive damages may be awarded. These damages are meant to punish the defendant and deter others from engaging in similar conduct.
A settlement from a medical device claim can range from a few thousand dollars to millions. Below, we highlight some of the average settlement values from past medical device lawsuits:
Stryker Rejuvenate and ABG II Medical Device Recall Settlement: After years of litigation, the manufacturer of a recalled hip replacement device paid billions. Bloomberg reported that the average settlement for each patient in the litigation was $300,000.
DePuy Pinnacle Medical Device Recall Settlement: According to Bloomberg, thousands of DePuy hip replacement lawsuits were resolved with each individual in the multidistrict litigation receiving an average settlement of $125,000.
As we discussed above, the amount of compensation received in a medical device settlement depends on your claims for damages and the allegations in the case. If you want to better understand what you might expect in a settlement, we recommend consulting with an attorney.
Wisner Baum is a California law firm that represents over 20,000 people throughout the country in personal injury and wrongful death cases, including claims for people harmed by defective medical devices. Since 1985, our attorneys have won more than $4 billion in verdicts and settlements across a broad range of practice areas. We have the experience and resources to take on any corporate defendant and win.
We understand that finding the right medical device attorney can be overwhelming, especially when you're dealing with injuries from a device you trusted as safe and effective.
Our firm offers free, confidential case evaluations for all defective medical device claims. During our initial consultation, you can ask questions about your case and our experienced legal team. We handle medical device lawsuits on a contingency fee basis—you pay nothing unless we win your case. You have nothing to lose by reaching out to us.
Taking immediate action can protect your health and your case:
Liability often focuses on the manufacturer, but real-world cases can be more complex:
Sometimes, multiple entities share liability. An experienced attorney can help determine who should be named in your case.
Most medical devices reach the U.S. market through the FDA’s 510(k) premarket notification pathway. Manufacturers can get devices cleared if they prove “substantial equivalence” to an existing approved product—often skipping full clinical testing.
What is “substantial equivalence”? The company must show its device performs as safely and effectively as its predecessor (“predicate device”), using engineering data, lab test results, and limited clinical data. Over time, small changes can accumulate—sometimes causing new risks that weren’t present in the original device.
FDA review timelines: The official goal for 510(k) review is 90 days (not counting company response time), but the average is about 3–6 months depending on complexity.
Risks and controversies: Many high-profile recalled devices—including pelvic mesh and several metal-on-metal hip replacements—were cleared using 510(k) and later found unsafe after widespread use. Recalls related to 510(k) devices are frequent and a central focus of device safety reform.
A medical device recall is the removal or correcting of medical devices that violate U.S. Food and Drug Administration (FDA) laws. The FDA classifies medical device recalls as Class I (most serious), Class II, or Class III, depending on the level of risk associated with the device.
Medical device recalls are typically initiated voluntarily by device manufacturers. However, in a small number of cases where a device poses an imminent threat to public health and the manufacturer refuses to take action, the FDA may step in and recall the device. This last-resort measure ensures that unsafe medical devices are swiftly removed from the market to protect consumers.
The FDA classifies recalls to help the public understand the potential for harm, with Class I being the most serious and Class III being the least. Below are some notable examples:
The FDA is charged with keeping Americans safe from dangers posed by defective medical devices. However, the agency cannot keep all defective medical devices from reaching the public.
If a medical device is deemed harmful, the FDA may issue recalls for medical devices under the following circumstances:
If you suspect there may be an issue with your medical device, the first thing you should do is review the FDA’s medical device recall page. The FDA recall webpage lists all device recalls at the bottom of the page under Recent Medical Device Recalls and Early Alerts.
If you are still unsure, contact your physician to see if you have a medical device that has been recalled.
No. if you sustained harm due to a defective medical device that has not been named in an FDA recall, you may still be able to pursue justice and compensation in a lawsuit. The challenge in cases where the product has not been recalled is proving liability, which is the process of demonstrating that the medical device manufacturer (or other entity) is legally responsible for the harm you suffered. This typically involves showing that the defendant(s) had a duty of care, breached that duty, and that breach directly caused injury or damages to you, the plaintiff.
An experienced medical device injury attorney will need to gather evidence to demonstrate the following:
If your device has not been recalled but you believe it injured you, it is in your best interest to speak with an attorney as soon as you are able. Proving liability in these cases can be difficult, so the sooner you consult with an attorney, the better.
Patients often search for legal help linked to a specific brand. Major manufacturers involved in past or ongoing medical device litigation include:
Below is a list of some of the largest ongoing medical device mass torts:
Medical device lawsuits can involve a wide variety of injuries. Some of the most common injuries cited in defective medical device claims are:
The compensation you receive in a medical device lawsuit is based on your claims for damages, which is the compensatory award granted by the court to rectify the harm or loss suffered as a result of the defendant's actions.
In a personal injury lawsuit involving a defective medical device, the plaintiff may seek various types of damages to compensate for the harm they have suffered, including:
Economic Damages: These are meant to reimburse the injured party for any financial losses incurred as a result of the defective medical device, including medical expenses, lost wages, rehabilitation costs, and more.
Pain and Suffering: Designed to compensate the plaintiff for the physical and emotional pain they endured due to the defective medical device. These damages may include both immediate and long-term pain and suffering.
Punitive Damages: In some cases where the defendant's actions were particularly egregious or reckless, punitive damages may be awarded. These damages are meant to punish the defendant and deter others from engaging in similar conduct.
A settlement from a medical device claim can range from a few thousand dollars to millions. Below, we highlight some of the average settlement values from past medical device lawsuits:
Stryker Rejuvenate and ABG II Medical Device Recall Settlement: After years of litigation, the manufacturer of a recalled hip replacement device paid billions. Bloomberg reported that the average settlement for each patient in the litigation was $300,000.
DePuy Pinnacle Medical Device Recall Settlement: According to Bloomberg, thousands of DePuy hip replacement lawsuits were resolved with each individual in the multidistrict litigation receiving an average settlement of $125,000.
As we discussed above, the amount of compensation received in a medical device settlement depends on your claims for damages and the allegations in the case. If you want to better understand what you might expect in a settlement, we recommend consulting with an attorney.
Wisner Baum is a California law firm that represents over 20,000 people throughout the country in personal injury and wrongful death cases, including claims for people harmed by defective medical devices. Since 1985, our attorneys have won more than $4 billion in verdicts and settlements across a broad range of practice areas. We have the experience and resources to take on any corporate defendant and win.
We understand that finding the right medical device attorney can be overwhelming, especially when you're dealing with injuries from a device you trusted as safe and effective.
Our firm offers free, confidential case evaluations for all defective medical device claims. During our initial consultation, you can ask questions about your case and our experienced legal team. We handle medical device lawsuits on a contingency fee basis—you pay nothing unless we win your case. You have nothing to lose by reaching out to us.
Symptoms vary by device but may include sudden or worsening pain near the implant site, swelling, infection signs, difficulty with movement, device malfunctions like irregular heartbeat (for cardiac devices), breathing issues (for respiratory devices), or symptoms caused by device fragments migrating within the body.
Immediately seek medical care to diagnose and document your injury. Preserve any device components if possible, gather all medical and financial records, and contact a qualified defective medical device attorney before discussing your case with insurers or manufacturers.
The time you have is governed by your state’s statute of limitations, which ranges from 1 to 6 years from the date of injury or when the injury was discovered. Because timelines for medical device claims differ and can be complex, it’s important to consult with a medical device attorney promptly to protect your rights.
