Medical Devices Lawsuits | Get the Right Lawyer

 

Defective medical devices have impacted countless lives, leading to severe injuries, additional surgeries, and financial burdens.

If you or a loved one has been affected by a faulty medical device, you may be eligible to pursue compensation for medical expenses, lost wages, and other damages.

Throughout 2024, notable settlements and FDA recalls have highlighted ongoing issues with widely used medical devices.

With over $5.1 million awarded in a single defective surgical tool case and numerous recalls for devices such as BioZorb and Cartiva, the legal landscape for medical device litigation continues to evolve.

This article will provide an overview of recent settlements, FDA recalls, and potential compensation avenues to help affected individuals understand their options and rights.

If you suspect your medical device is defective, consulting with an experienced legal team is essential to ensuring justice and fair compensation.

What's the Problem?

Dangerous or defective medical equipment can give rise to a potential liability claim if a person who undergoes surgery or uses a medical device is injured or dies as a result.

Although closely monitored by the U.S. Food and Drug Administration (FDA), medical devices can be defective in their design, manufacturing process, or marketing strategy.

In most instances, state lawsuits over federally-approved medical devices face stringent legal obstacles and often receive increased national attention.

Our Current List of Defective Medical Devices

Our lawyers are currently investigating defective device lawsuits on behalf of individuals who were injured by the following products:

1. B. Braun Aesculap Knee Replacement

2. Biomet Shoulder Replacement

Zimmer Biomet issued a Class I Recall in February 2017 for its Comprehensive Reverse Shoulder medical device.

This recall was prompted by reports of significant risks associated with the device, including fractures after surgery, which could result in severe health consequences.

Key Recall Details

• Reports of implants fracturing after surgery.
• Risks include permanent loss of shoulder function, infection, and even death.
• Recall Classification: Class I, the FDA's most serious recall category, indicates a risk of severe injury or death.

Device Purpose

• Intended Use: Designed to help restore arm movement in patients with rotator cuff tears, severe arthritis, or those who previously had failed shoulder joint replacements.
• Patient Demographics: Often used in patients with limited shoulder mobility due to chronic conditions.

3. Boston Innova Stent

4. Catheters

The recall was initiated after the Food and Drug Administration "... received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including deaths, serious injuries caused, and malfunction," the agency said in the recall letter. "Device failure modes reported in the MDRs include ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter."

The Venture Catheter Recall

Devices Affected:

• Rapid Exchange, Over-the-Wire, and Coronary Sinus versions of Venture Catheters.
• 4,679 units distributed in the U.S., associated with 72 different lot numbers.
• Product codes: 5820, 5821, and 5822.

Key Risks:

The excess material within the catheter posed significant dangers, including the risk of separation from the device.

This defect could lead to embolism and other severe injuries. The FDA highlighted the potential for adverse events or even death as a result of this issue.

Manufacturer Response:

Next Steps for Affected Individuals

If you have experienced harm from these catheter devices, it is essential to:

• Document your medical history and device usage.
• Consult legal representation specializing in defective medical device lawsuits to guide your claim.

5. Depuy Hip

In August 2010, DePuy Orthopedics voluntarily recalled the ASR XL Acetabular and ASR Hip Resurfacing hip implant systems.

These devices were found to fail at significantly higher rates than other hip implant types, such as metal-on-plastic models.

Design Concerns

DePuy's metal-on-metal hip implants feature metal balls and sockets designed to minimize wear and enhance durability.

However, this design presented critical issues:

• Friction and Wear: The metal components rubbing together created significant friction.
• Particle Shedding: The friction led to the release of metal particles into surrounding tissues and even the bloodstream.

Health Implications

The shedding of metal particles raised concerns about potential long-term health effects, including:

• Tissue Damage: Metal particles could cause inflammation and damage tissues around the implant site.
• Systemic Effects: Releasing these particles into the bloodstream poses risks of metal poisoning and other complications.

DePuy's recall underscored the importance of addressing design flaws in medical devices to prevent such adverse outcomes.

6. Essure Birth Control

An article published in the New York Times in May 2015 revealed that the Food and Drug Administration (FDA) received over 4,000 adverse event reports on the Essure contraceptive device.

These reports detailed a range of injuries, including:

• Severe back and pelvic pain.
• Heavy menstrual periods.
• Coils that pierced Fallopian tubes and became lodged in patients’ bodies.

Clinical Trial Findings

During a pre-approval clinical trial involving 269 women aged 23 to 45:

• Successful Insertions: Essure devices were successfully implanted in 200 participants.
• Complications:
  • Perforation: In 9 cases, the device perforated the Fallopian tube.
  • Displacement: The device was expelled or stuck in other body parts.

Additional Reported Issues

Women who used Essure also experienced other significant side effects, particularly within the first three months after implantation:

• Painful Intercourse: Reported by nearly 1 in 10 women.
• Painful Menstrual Periods: Affected 1 in 8 women, highlighting a pattern of discomfort and adverse reactions.

7. Ethicon Physiomesh Hernia Mesh Patch

The Ethicon Physiomesh hernia patch was withdrawn globally in May 2016 after reports linked it to high failure rates and a frequent need for revision surgeries.

This decision marked a significant acknowledgment of the device’s risks to patient health.

FDA Approval and Market Introduction

Ethicon Physiomesh Flexible Composite Hernia Mesh Patch entered the U.S. market in 2010 through the FDA’s 510(k) approval process.

This regulatory pathway allows devices to be approved if deemed "substantially equivalent" to existing products, bypassing more rigorous testing requirements.

Types and Intended Use

Ethicon introduced various types of Physiomesh devices designed for:

• Hernia Repair: Addressing abdominal wall weaknesses.
• Fascial Deficiencies: Supporting damaged connective tissues.

Design and Manufacturing Issues

Despite its intended use, the Physiomesh products were later found to be:

• Defectively Designed: Leading to complications in many patients.
• Poorly Manufactured: Posing an unreasonable risk of severe complications, such as hernia recurrence and tissue damage.

8. IVC Filters

Since August 2010, the FDA has raised concerns about patients who suffered complications associated with IVC filter medical devices.

Hundreds of reports have been filed with the agency involving incidents where parts of the device fractured or migrated to other body parts, particularly the heart and lungs.

Our lawyers are reviewing potential medical device lawsuits for people who the following brands of IVC filter medical devices injured:

Bard IVC Filter

• Bard Recovery
• Bard G2
• Bard G2 X
• Bard G2 Express
• Bard Eclipse
• Bard Meridian

Cook IVC Filter

• Cook Gunther Tulip
• Cook Celect

Other Retrievable IVC Filter Medical Devices

• Argon Medical OptionELITE IVC Filter
• ALN IVC Filter
• B. Braun IVC filters (Tempofilter IVC filter, Tempofilter II IVC filter, VenaTech LGM IVC filter and VenaTech LP IVC filter)
• Cordis OptEase IVC Filter
• Crux Vena Cava Filter

9. Philips HeartStart Defibrillator

The FDA in December 2013 warned that thousands of defibrillators made by Philips Healthcare may not work correctly during medical emergencies because of an electrical component failure.

According to the Wall Street Journal, the agency received approximately 1,100 complaints and 580 adverse event reports associated with the Philips Healthcare HeartStart Defibrillator medical devices.

10. Morcellators

Medical device lawsuits are being filed against manufacturers of power morcellators, which are used during hysterectomy and myomectomy surgeries.

These devices have been linked to the spread of undetected cancer cells into other parts of the body, significantly impacting the health of affected women.

FDA Warnings and Safety Communication

• April 2014: The FDA issued a Safety Communication advising surgeons against using laparoscopic morcellators during hysterectomy or myomectomy procedures.
• Reason: These devices can spread cancerous uterine tissue, particularly in cases of unsuspected uterine sarcoma.

Cancer Risk Data

According to the FDA, approximately 1 in 350 women undergoing these surgeries for uterine fibroids have an unsuspected form of cancer called uterine sarcoma. If morcellators are used, the risk of spreading cancerous tissue to the abdomen and pelvis is significant.

Hysterectomy Statistics

Out of the 600,000 hysterectomy surgeries performed annually in the U.S.:

• 30% are laparoscopic in women under 40.
• 44% are laparoscopic in women aged 40 to 49.
• 16% are laparoscopic in women aged 50 to 59.

These statistics highlight the widespread use of power morcellators and the potential risk they pose to thousands of women each year.

Grounds for Lawsuits

Women whose cancer spread throughout their bodies after undergoing surgery with a laparoscopic power morcellator are pursuing legal action. These lawsuits aim to hold manufacturers accountable for the risks associated with their devices.

11. Stryker Hip

Stryker Corp. in June 2012 announced a recall for its Rejuvenate and ABG II modular-neck hip devices due to the risk of corrosion, which could result in tissue damage, pain, swelling, and other hip surgery complications.

The company said the recall cost between $190 and $390 million for patient testing and treatment, revision surgeries, replacement hip lawsuits, and insurance payments.

In May 2017, at least 95% of eligible patients registered for a settlement program to resolve product liability lawsuits filed over injuries alleged from Stryker Rejuvenate and ABG II Modular-Neck hip stems. The company indicated that it would soon begin making payments to eligible parties.

12. Transvaginal Mesh

Transvaginal mesh implants have been associated with severe complications, affecting tens of thousands of women.

These issues include:

• Mesh erosion: Breakdown or degradation of the mesh material.
• Infections: Severe infections around the implant site.
• Perforation: Damage to the bowel, bladder, or blood vessels.

13. Zimmer Hip Implants

There have many reports of failure and prior results in patients implanted with Zimmer Durom Acetabular Components (“Durom Cup”), which were recalled in 2008.

Device manufacturer Zimmer suspended the marketing and distribution of the Durom Cup after some U.S. surgeons reported higher-than-normal revision surgery rates (up to 5.7%) using the Durom Cup.

Since it was first sold in the United States in 2006, the Durom cup has been implanted in more than 12,000 patients.

The orthopedic device maker has since poured tens of millions of dollars into settlements, setting aside money for future lawsuits.

14. Zimmer Knee Replacement

Zimmer also faces numerous complaints against the newer High Flex version of NexGen knee implants. To date, over 700 Zimmer High Flex NexGen knee lawsuits have been filed against the large medical device manufacturer.

The defective High Flex knee implants caused increased pain, loosening of the device, premature knee implant failure, and expensive revision surgery.

While most knee replacement systems are designed to last up to 15 years with prior results, there have been reports of device failure in the Zimmer NexGen knee system in two years or less.

According to a recent study, 36 percent of these implants were loose and nearly 10 percent required revision surgery due to looseness and serious pain.

15. Zimmer Shoulder

Zimmer Biomet, in February 2017, issued a Class I Recall for its Comprehensive Reverse Shoulder because the implants may fracture after surgery, which may cause permanent loss of shoulder function, infection, or even death.

Zimmer initiated the recall after receiving a higher-than-expected number of reports of its Comprehensive Reverse Shoulder implant fracturing.

The Zimmer Reverse Shoulder is a shoulder replacement device designed to help restore arm movement in patients with rotator cuff tears who have severe arthritis or similar outcome and previously failed shoulder joint replacement.

Can I Sue Over a Defective Medical Device?

FAQs

What types of injuries can lead to a medical device lawsuit?

Injuries that can lead to a medical device lawsuit include severe complications such as infections, organ damage, device malfunctions, allergic reactions, and other life-threatening conditions caused by defective or improperly designed medical devices.

Who can file a medical device lawsuit?

Individuals who have been injured or suffered complications due to a defective medical device can file a lawsuit. Family members of deceased patients may also be eligible to file wrongful death claims related to the device.

What compensation is available in a medical device lawsuit?

Compensation in a medical device lawsuit may include medical expenses, lost wages, pain and suffering, rehabilitation costs, and in some cases, punitive damages to hold the manufacturer accountable for negligence.

What are the common grounds for filing a medical device lawsuit?

Common grounds for filing a medical device lawsuit include defective design, manufacturing defects, failure to warn, improper marketing, and lack of proper testing before the device was released to the market.

Related article: Cochlear Implant Lawsuit

Get a Free Medical Device Lawsuit Evaluation With Our Lawyers

The Medical Device Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus exclusively on the legal rights of plaintiffs in a product liability lawsuit. Our law firm is handling individual litigation nationwide and currently filing product liability claims in all 50 states.