Defective Medical Device Attorney

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Defective Medical Device Attorney

California Lawyers Holding Manufacturers Accountable for Medical Device Injuries

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.

Types of IVC Filters

Philips CPAP Lawsuit

Medtronic Infuse Bone Graft Lawsuit

IVC Filter Lawsuit

IVC Filter Complications

ECT Lawsuit

Defective Medical Devices Injuries FAQs

Cook IVC Filter Lawsuit

Bard PowerPort Lawsuit

Bard IVC Filter Lawsuit

Understand Medical Device Injuries

What to Do if You Were Injured by a Defective Medical Device

Taking immediate action can protect your health and your case:

Seek medical attention and document your diagnosis.
Preserve the device or any remaining parts.
Gather your medical records related to implantation, revision surgeries, or treatment.
Record your symptoms and complications in detail.
Keep receipts, bills, and insurance communications for expenses.
Contact a medical device injury attorney before speaking with any insurance company or manufacturer representative.

Who Is Liable in a Medical Device Lawsuit?

Liability often focuses on the manufacturer, but real-world cases can be more complex:

Device manufacturers: Accountable for product design, manufacturing defects, and failure to warn of risks.
Component part suppliers: Liable if a faulty part causes patient harm.
Distributors and sales reps: May share responsibility if they market the device knowing its defects.
Hospitals and healthcare professionals: Occasionally liable if negligent implantation or monitoring contributes to injury.

Sometimes, multiple entities share liability. An experienced attorney can help determine who should be named in your case.

FDA Medical Device Approval & Recall Process

The 510(k) Pathway – A Fast-Track to Market

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.

What is a Medical Device Recall?

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.

Class I Medical Device Recalls: There is a high likelihood that using or coming into contact with the recalled product will result in severe injuries or death.
Class II Medical Device Recalls: Using or coming into contact with the recalled product may lead to temporary or medically reversible health problems, or the risk of severe consequences is low.
Class III Medical Device Recalls: There is minimal risk of adverse health effects from using or coming into contact with the recalled product.

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.

Examples of Recalls by Classification

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:

Class I (Most Serious): The Philips CPAP recall was a Class I recall because foam degradation in the devices exposed users to toxic particles, creating a reasonable probability of severe injury or death.
Class II (Less Serious): Exactech's hip and knee replacement recalls were classified as Class II. While the devices were prone to premature wear and failure, the associated health risks were considered temporary or medically reversible.
Class III (Minimal Risk): A recent example includes a recall of Fresenius Kabi Ivenix Large Volume Pump (LVP) Primary Administration Sets due to incorrect assembly. While the defect was a violation of FDA regulations, it was not expected to cause adverse health consequences.

When Does the FDA Issue a Recall for a Medical Device?

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 there is a risk of serious injury or death associated with the use of the device.
If the device is found to be defective or not in compliance with regulatory standards.
If the device is mislabeled or misbranded.
If there are reports of adverse events or malfunctions related to the device.

How Do You Find Out if Your Medical Device Has Been Recalled?

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.

Does My Medical Device Need to be Recalled to File a Lawsuit?

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:

The medical device you received was defective.
The defective device caused your injuries.
The device manufacturer knew or should have known about the defect but failed to warn consumers.

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.

Companies Frequently Named in Medical Device Lawsuits

Patients often search for legal help linked to a specific brand. Major manufacturers involved in past or ongoing medical device litigation include:

Johnson & Johnson / DePuy Synthes: Hip and knee implant recalls, pelvic mesh litigation.
Stryker: Rejuvenate and ABG II hip implant recalls; metal-on-metal implant failures.
Medtronic: Infusion pump malfunctions, heart pump recalls.
3M: Bair Hugger surgical warming device claims and other product disputes.
C.R. Bard / Davol: Hernia mesh and IVC filter lawsuits.
Philips Respironics: CPAP device foam degradation, linked to cancer risk.
Allergan: Breast implants associated with BIA-ALCL cancer cases.
Exactech: Defective hip, knee, and ankle replacement recalls.

Ongoing Medical Device Injury Lawsuits

Below is a list of some of the largest ongoing medical device mass torts:

Hernia Mesh Lawsuit: The hernia mesh litigation involves allegations from patients who experienced complications after hernia repair surgeries where a mesh implant was used. The complications cited in lawsuits include infections, chronic pain, bowel obstructions, mesh migration, and more. Defendants in hernia mesh lawsuits include C.R. Bard / Davol Inc., Atrium Medical Corp., Covidien, Ethicon (Johnson & Johnson subsidiary), and others.
IVC Filter Lawsuit: Lawsuits allege C.R. Bard and Cook Medical produce defective IVC blood clot filters that can cause severe health complications. Patients have filed lawsuits stating that the IVC filters fractured, migrated, or caused blood clots to form, leading to injuries and death.
Exactech Hip Replacement Lawsuit: The Exactech hip medical device lawsuits involve allegations of design defects and failure to warn of potential risks associated with Exactech's hip replacement products. Plaintiffs allege they experienced serious complications such as fractures, severe pain, bone loss, metallosis (metal debris spreading into bloodstream), and more. devices.
Allergan Breast Implant Lawsuit: The breast implant lawsuits involve claims that Allergan implants caused health complications in many patients, including a rare form of cancer known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). More than 1,000 women have filed lawsuits against Allergan seeking compensation.
Philips CPAP Lawsuit: Lawsuits have been filed against Philips alleging its defective CPAP devices caused patients to inhale carcinogenic substances from foam particles, resulting in various forms of cancer.
Bard PowerPort Lawsuit: The Bard PowerPort lawsuits involve allegations that the company's port catheters, which are implanted underneath the skin to deliver medication or draw blood, have caused serious complications, including infection, cardiac problems, and more. Patients allege the company failed to adequately warn about these risks and that the devices are defective.

Types of Medical Device Injuries

Medical device lawsuits can involve a wide variety of injuries. Some of the most common injuries cited in defective medical device claims are:

Metallosis from metal-on-metal hip implants and joint replacements
Mesh erosion from surgical mesh products
Device loosening or migration causing internal organ damage
Revision surgeries
Cancer from toxic components
Infection and chronic pain from implant failures
Cardiac complications from pacemaker malfunctions
Respiratory issues from CPAP device contamination

What is the Payout for a Defective Medical Device Injury?

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.

What is the Average Settlement for a Medical Device Lawsuit?

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 | California Medical Device Attorneys Filing Lawsuits Nationwide

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.

What to Do if You Were Injured by a Defective Medical Device

Taking immediate action can protect your health and your case:

Seek medical attention and document your diagnosis.
Preserve the device or any remaining parts.
Gather your medical records related to implantation, revision surgeries, or treatment.
Record your symptoms and complications in detail.
Keep receipts, bills, and insurance communications for expenses.
Contact a medical device injury attorney before speaking with any insurance company or manufacturer representative.

Who Is Liable in a Medical Device Lawsuit?

Liability often focuses on the manufacturer, but real-world cases can be more complex:

Device manufacturers: Accountable for product design, manufacturing defects, and failure to warn of risks.
Component part suppliers: Liable if a faulty part causes patient harm.
Distributors and sales reps: May share responsibility if they market the device knowing its defects.
Hospitals and healthcare professionals: Occasionally liable if negligent implantation or monitoring contributes to injury.

Sometimes, multiple entities share liability. An experienced attorney can help determine who should be named in your case.

FDA Medical Device Approval & Recall Process

The 510(k) Pathway – A Fast-Track to Market

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.

What is a Medical Device Recall?

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.

Class I Medical Device Recalls: There is a high likelihood that using or coming into contact with the recalled product will result in severe injuries or death.
Class II Medical Device Recalls: Using or coming into contact with the recalled product may lead to temporary or medically reversible health problems, or the risk of severe consequences is low.
Class III Medical Device Recalls: There is minimal risk of adverse health effects from using or coming into contact with the recalled product.

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.

Examples of Recalls by Classification

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:

Class I (Most Serious): The Philips CPAP recall was a Class I recall because foam degradation in the devices exposed users to toxic particles, creating a reasonable probability of severe injury or death.
Class II (Less Serious): Exactech's hip and knee replacement recalls were classified as Class II. While the devices were prone to premature wear and failure, the associated health risks were considered temporary or medically reversible.
Class III (Minimal Risk): A recent example includes a recall of Fresenius Kabi Ivenix Large Volume Pump (LVP) Primary Administration Sets due to incorrect assembly. While the defect was a violation of FDA regulations, it was not expected to cause adverse health consequences.

When Does the FDA Issue a Recall for a Medical Device?

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 there is a risk of serious injury or death associated with the use of the device.
If the device is found to be defective or not in compliance with regulatory standards.
If the device is mislabeled or misbranded.
If there are reports of adverse events or malfunctions related to the device.

How Do You Find Out if Your Medical Device Has Been Recalled?

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.

Does My Medical Device Need to be Recalled to File a Lawsuit?

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:

The medical device you received was defective.
The defective device caused your injuries.
The device manufacturer knew or should have known about the defect but failed to warn consumers.

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.

Companies Frequently Named in Medical Device Lawsuits

Patients often search for legal help linked to a specific brand. Major manufacturers involved in past or ongoing medical device litigation include:

Johnson & Johnson / DePuy Synthes: Hip and knee implant recalls, pelvic mesh litigation.
Stryker: Rejuvenate and ABG II hip implant recalls; metal-on-metal implant failures.
Medtronic: Infusion pump malfunctions, heart pump recalls.
3M: Bair Hugger surgical warming device claims and other product disputes.
C.R. Bard / Davol: Hernia mesh and IVC filter lawsuits.
Philips Respironics: CPAP device foam degradation, linked to cancer risk.
Allergan: Breast implants associated with BIA-ALCL cancer cases.
Exactech: Defective hip, knee, and ankle replacement recalls.

Ongoing Medical Device Injury Lawsuits

Below is a list of some of the largest ongoing medical device mass torts:

Hernia Mesh Lawsuit: The hernia mesh litigation involves allegations from patients who experienced complications after hernia repair surgeries where a mesh implant was used. The complications cited in lawsuits include infections, chronic pain, bowel obstructions, mesh migration, and more. Defendants in hernia mesh lawsuits include C.R. Bard / Davol Inc., Atrium Medical Corp., Covidien, Ethicon (Johnson & Johnson subsidiary), and others.
IVC Filter Lawsuit: Lawsuits allege C.R. Bard and Cook Medical produce defective IVC blood clot filters that can cause severe health complications. Patients have filed lawsuits stating that the IVC filters fractured, migrated, or caused blood clots to form, leading to injuries and death.
Exactech Hip Replacement Lawsuit: The Exactech hip medical device lawsuits involve allegations of design defects and failure to warn of potential risks associated with Exactech's hip replacement products. Plaintiffs allege they experienced serious complications such as fractures, severe pain, bone loss, metallosis (metal debris spreading into bloodstream), and more. devices.
Allergan Breast Implant Lawsuit: The breast implant lawsuits involve claims that Allergan implants caused health complications in many patients, including a rare form of cancer known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). More than 1,000 women have filed lawsuits against Allergan seeking compensation.
Philips CPAP Lawsuit: Lawsuits have been filed against Philips alleging its defective CPAP devices caused patients to inhale carcinogenic substances from foam particles, resulting in various forms of cancer.
Bard PowerPort Lawsuit: The Bard PowerPort lawsuits involve allegations that the company's port catheters, which are implanted underneath the skin to deliver medication or draw blood, have caused serious complications, including infection, cardiac problems, and more. Patients allege the company failed to adequately warn about these risks and that the devices are defective.

Types of Medical Device Injuries

Medical device lawsuits can involve a wide variety of injuries. Some of the most common injuries cited in defective medical device claims are:

Metallosis from metal-on-metal hip implants and joint replacements
Mesh erosion from surgical mesh products
Device loosening or migration causing internal organ damage
Revision surgeries
Cancer from toxic components
Infection and chronic pain from implant failures
Cardiac complications from pacemaker malfunctions
Respiratory issues from CPAP device contamination

What is the Payout for a Defective Medical Device Injury?

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.

What is the Average Settlement for a Medical Device Lawsuit?

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 | California Medical Device Attorneys Filing Lawsuits Nationwide

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.