Medical Device Failures in New Jersey: When Implants and Equipment Cause Harm

Your pacemaker stopped working. Your hip implant is poisoning you. Medical devices promise healing—but when they fail, the results can be catastrophic.

Modern medicine depends on an array of implanted devices: cardiac devices that regulate heartbeat, orthopedic implants that replace failing joints, surgical mesh that reinforces weakened tissue, and countless other technologies designed to restore function and save lives. These devices are supposed to be rigorously tested and safe. But design defects, manufacturing errors, and inadequate warnings lead to device failures that cause serious injury and death.

At Gencarelli & Rimassa Law, our New Jersey attorneys represent victims of defective medical devices. We pursue claims against manufacturers, hospitals, and healthcare providers when device failures cause harm. If you or a loved one suffered from a failed medical device, we can help you understand your rights and pursue compensation.

Call (201) 549-8737 today for a free case evaluation. You pay nothing unless we win.

The Medical Device Industry and New Jersey Patients

The medical device industry is massive, with billions in annual revenue and millions of devices implanted in patients each year.

Types of Medical Devices

Cardiac Devices:

• Pacemakers
• Implantable cardioverter-defibrillators (ICDs)
• Cardiac resynchronization therapy devices
• Artificial heart valves
• Stents

Orthopedic Implants:

• Hip replacements (metal-on-metal, ceramic, polyethylene)
• Knee replacements
• Shoulder replacements
• Spinal implants and fusion hardware

Surgical Mesh:

• Hernia mesh
• Transvaginal mesh (for pelvic organ prolapse and incontinence)
• Surgical support mesh

Neurological Devices:

• Deep brain stimulators
• Spinal cord stimulators
• Vagus nerve stimulators

Other Implanted Devices:

• Cochlear implants
• Breast implants
• Intraocular lenses
• Insulin pumps
• Implantable contraceptives

FDA Oversight of Medical Devices

The U.S. Food and Drug Administration regulates medical devices through several pathways:

Premarket Approval (PMA): Rigorous review requiring clinical trials and extensive safety data for high-risk devices

510(k) Clearance: Less stringent pathway for devices “substantially equivalent” to previously approved products—often requiring minimal testing

De Novo Classification: Pathway for novel low-to-moderate risk devices

Many defective devices reach market through the 510(k) pathway, which has been criticized for inadequate safety review.

Common Types of Medical Device Failures

Device failures occur through various mechanisms, each causing distinct harms to patients.

Design Defects

Design defects occur when the device’s inherent design makes it unreasonably dangerous:

Metal-on-Metal Hip Implants: Designed with metal ball-and-socket components that generate metallic debris, causing:

• Metallosis (metal poisoning)
• Tissue necrosis
• Bone loss (osteolysis)
• Implant loosening
• Systemic toxicity

Prominent examples include DePuy ASR and Stryker Rejuvenate hips, subject to thousands of lawsuits.

Transvaginal Mesh: Designed with synthetic materials that can:

• Erode through vaginal tissue
• Cause chronic pain
• Lead to infection
• Result in organ perforation
• Require multiple revision surgeries

Defective Pacemakers and ICDs: Design flaws causing:

• Premature battery depletion
• Failure to deliver needed shocks
• Inappropriate shocks
• Electrical lead fractures

Manufacturing Defects

Manufacturing defects occur when properly designed devices are made incorrectly:

• Component failures: Defective parts that fail prematurely
• Contamination: Devices contaminated during manufacturing causing infection
• Assembly errors: Mistakes in putting devices together
• Sterilization failures: Inadequate sterilization allowing infection
• Packaging defects: Contamination or damage during packaging

Inadequate Warnings and Instructions

Even properly designed and manufactured devices can cause harm when users aren’t adequately warned about risks:

• Failure to warn: Not providing adequate information about risks
• Inadequate instructions: Unclear or incomplete directions for use
• Contraindication failures: Not warning against use in certain patient populations
• Drug interaction warnings: Failing to warn about interactions with medications

Failure to Warn About Known Risks

Manufacturers have ongoing duties to warn about risks discovered after market approval:

• Post-market surveillance failures: Not adequately monitoring for adverse events
• Delayed warnings: Waiting too long to warn about discovered risks
• Inadequate recall efforts: Failing to effectively recall dangerous devices

High-Profile Medical Device Failures

Understanding major device failures helps contextualize the risks patients face.

Hip Replacement Failures

DePuy ASR Hip Recall (2010): Metal-on-metal hip implants recalled worldwide after reports of premature failure and metallosis. Johnson & Johnson has paid billions in settlements.

Stryker Rejuvenate and ABGII Recall (2012): Similar metal-on-metal design caused metallosis and tissue damage. Thousands of lawsuits filed.

Wright Medical and Zimmer Biomet: Other manufacturers facing litigation over metal-on-metal hip failures.

Transvaginal Mesh Complications

Ethicon (Johnson & Johnson): Multiple mesh products withdrawn from market after reports of severe complications including erosion, pain, and infection.

Boston Scientific and C.R. Bard: Other manufacturers facing thousands of lawsuits over mesh complications.

Cardiac Device Failures

Medtronic Sprint Fidelis Leads: Defibrillator leads prone to fracture, causing inappropriate shocks or failure to deliver needed therapy. Thousands of patients required lead extraction procedures.

St. Jude Medical Riata Leads: Similar lead insulation failures causing dangerous malfunctions.

Medtronic HVAD Heart Pump: HeartWare ventricular assist device recalled due to risk of death and serious injury.

Hernia Mesh Complications

Physiomesh (Ethicon): Flexible composite mesh withdrawn after reports of higher revision rates compared to other products.

Atrium C-Qur: Mesh with omega-3 fatty acid coating linked to allergic reactions and adhesions.

Legal Theories in Medical Device Cases

Medical device litigation involves multiple legal theories depending on the circumstances.

Strict Product Liability

Manufacturers are strictly liable for defective products—meaning victims don’t need to prove negligence, only that:

• The device was defective
• The defect existed when it left the manufacturer’s control
• The defect caused injury

Strict liability applies to design defects, manufacturing defects, and failure to warn claims.

Negligence

Negligence claims require proving the manufacturer failed to exercise reasonable care:

• Inadequate testing before marketing
• Failure to conduct proper clinical trials
• Inadequate quality control
• Failure to monitor post-market safety
• Delayed response to known risks

Breach of Warranty

Manufacturers may be liable for breaching express or implied warranties:

• Express warranties: Specific promises about device safety or performance
• Implied warranties: Implied promises that devices are fit for ordinary use

Medical Malpractice

Healthcare providers may be liable for malpractice in device cases:

• Inadequate informed consent: Failure to warn about device risks
• Improper implantation: Surgical errors during device placement
• Failure to monitor: Not tracking device function and patient response
• Delayed revision: Waiting too long to remove failed devices

Proving Medical Device Cases in New Jersey

Medical device litigation requires proving the device caused harm through defect or inadequate warning.

Establishing the Defect

Design Defects: Evidence that:

• Alternative designs were feasible and safer
• The manufacturer knew or should have known of risks
• The risks outweighed the benefits

Manufacturing Defects: Evidence that:

• The specific device differed from intended design
• The defect caused the failure
• Quality control failed to catch the defect

Failure to Warn: Evidence that:

• Adequate warnings would have prevented the harm
• The manufacturer knew or should have known of risks
• Warnings were inadequate or absent

Causation Requirements

Plaintiffs must prove the device defect directly caused their injuries:

• The device failed or caused harm
• The failure resulted from the defect
• The harm wouldn’t have occurred without the defect

Causation can be complex when patients have underlying medical conditions.

Damages in Medical Device Cases

Victims of defective devices may recover:

Economic Damages:

• Revision surgery costs
• Medical expenses for treating complications
• Lost income during treatment and recovery
• Future medical costs
• Out-of-pocket expenses

Non-Economic Damages:

• Pain and suffering
• Emotional distress
• Loss of enjoyment of life
• Disfigurement

Punitive Damages: In cases of egregious misconduct, courts may award punitive damages to punish manufacturers

Class Actions and Multidistrict Litigation

Many medical device cases proceed as mass torts:

Class Actions: When large numbers of victims suffered similar harm from the same defect

Multidistrict Litigation (MDL): Cases from multiple jurisdictions consolidated for pretrial proceedings

State Court Consolidations: New Jersey’s multicounty litigation program consolidates similar cases

Participating in mass torts can provide advantages but also requires careful evaluation of individual circumstances.

Frequently Asked Questions About Medical Device Failures

Can I sue if my medical device was recalled?

A recall doesn’t automatically entitle you to compensation, but it may support your claim. Recalls indicate the manufacturer or FDA identified safety issues. If you were injured by the defect that prompted the recall, you likely have a valid claim.

What if my doctor didn’t warn me about device risks?

You may have claims against both the manufacturer (for inadequate warnings) and your physician (for failure to obtain adequate informed consent). The healthcare provider has a duty to explain material risks of any implanted device.

How long do I have to file a medical device claim?

Generally, two years from when you discovered (or should have discovered) the injury and its connection to the device. The discovery rule often applies because device failures may not be immediately apparent. However, statutes of repose may apply. Consult an attorney promptly.

Can I sue if my device hasn’t failed yet but I’m worried it will?

Probably not. Product liability law typically requires actual injury. However, if you have a recalled device or one with known defects, consult an attorney about your options—some jurisdictions allow medical monitoring claims for asymptomatic patients with increased risk.

What if my device was implanted years ago?

The discovery rule may extend your time to sue if you only recently discovered the device failure. However, statutes of repose provide absolute deadlines regardless of discovery. An attorney can evaluate whether your claim is still viable.

How Gencarelli & Rimassa Law Handles Medical Device Cases

Our approach to defective device litigation combines product liability expertise with medical knowledge.

Investigation Process

1. Device identification: Determining manufacturer, model, and lot numbers
2. Medical record review: Analyzing implantation, complications, and treatment
3. Research: Investigating known defects, recalls, and litigation history
4. Expert consultation: Engaging biomedical engineers and physicians
5. Causation analysis: Connecting device defects to specific injuries

Litigation Strategy

• Individual evaluation: Assessing whether individual litigation or mass tort participation is appropriate
• Coordination: Working with national litigation when beneficial
• Aggressive prosecution: Pursuing maximum compensation for each client

Why Choose Gencarelli & Rimassa Law

• Product liability expertise: Experience with complex device litigation
• Medical knowledge: Understanding of devices and their failure modes
• Resources: Access to leading experts in biomedical engineering and medicine
• Proven results: Track record in complex product liability cases
• No fee unless we win: Contingency representation eliminates financial risk

Conclusion

Medical devices save countless lives—but when they fail due to design defects, manufacturing errors, or inadequate warnings, patients suffer devastating harm. The law provides recourse for victims, holding manufacturers accountable for putting profits over patient safety.

If you or a loved one was harmed by a defective medical device, the attorneys at Gencarelli & Rimassa Law can help. We understand the complex medical and legal issues in device failure cases and have the resources to pursue justice against even the largest manufacturers.

Don’t let a defective device destroy your health without consequences. Call Gencarelli & Rimassa Law at (201) 549-8737 for a free consultation. We’ll evaluate your device, explain your rights, and fight for the compensation you deserve.