Defective Medical Devices

Defective Medical Device Lawyers — Implant, Catheter & Surgical Device Claims

Medical devices — from joint replacements to surgical robots to implantable catheters — injure thousands of patients annually. Manufacturers knowingly sell devices with design flaws, inadequate warnings, and insufficient testing. Trial Lawyers United represents patients injured by defective medical devices.

Types of Defective Medical Devices

Medical device litigation encompasses products across the healthcare spectrum:

• Implantable ports and catheters: Used for medication delivery, nutrition, dialysis.
• Joint replacement components: Hip, knee, and shoulder implants; metal-on-metal bearings.
• Surgical robots: Da Vinci and competing systems; software failures, poor ergonomics, inadequate training.
• Mesh implants: Hernia, pelvic, and abdominal wall mesh; fragmentation, erosion, chronic pain.
• Breast implants: Rupture, silicone leakage, capsular contracture.
• Artificial heart pumps: Ventricular assist devices; thrombosis, infection, mechanical failure.
• Pacemakers and defibrillators: Battery depletion, lead fracture, electromagnetic interference.
• Orthopedic hardware: Screws, rods, plates; migration, breakage, non-union.

Understanding FDA Clearance vs. PMA Approval

A critical misconception is that FDA ‘approval’ or ‘clearance’ means a device is safe. Understanding the difference is essential:

510(k) Clearance (Most Devices)

The 510(k) process (named for the relevant regulation) allows a manufacturer to market a device if it is ‘substantially equivalent’ to a previously cleared device. Key features:

• No clinical trials required: Manufacturers demonstrate equivalence to a predicate device, not safety in humans.
• Low bar for equivalence: ‘Substantial equivalence’ focuses on intended use and technological characteristics, not clinical performance.
• Rapid process: 510(k) clearance can occur in 90 days or less.
• Example: A new hip implant material is cleared based on equivalence to an existing material, without clinical trials demonstrating long-term performance.

PMA (Premarket Approval)

PMA is required for high-risk devices (Class III). Requirements:

• Clinical trials: Manufacturers must conduct and submit rigorous clinical trials.
• FDA review: Detailed examination of trial data, manufacturing processes, labeling.
• Higher scrutiny: FDA assesses whether benefits outweigh risks for the intended population.
• Longer process: PMA approval takes 1–3 years typically.

Even PMA-approved devices can be dangerous if manufacturers misrepresent trial data or fail to disclose adverse events.

Common Defects in Medical Devices

Design defects

The device as designed is inherently unsafe:

• Inadequate biocompatibility: Material degrades in the body, causing tissue reaction.
• Mechanical flaws: Stress concentration points; inadequate fatigue resistance; failure under foreseeable use conditions.
• Inadequate sterilization design: Device cannot be properly sterilized; traps bacteria.

Manufacturing defects

The device deviates from the approved design:

• Quality control failures: Contamination, improper assembly, substandard materials.
• Process variations: Manufacturing changes not validated for safety.
• Batch contamination: Bacterial or particulate contamination in specific production runs.

Failure to warn

Manufacturers fail to inform physicians and patients of risks:

• Omitted warnings of known adverse effects.
• Inadequate instructions for insertion, use, or removal.
• Failure to update warnings as new adverse event data emerges.
• Insufficient physician training: Surgeons operate devices without adequate training.

Regulatory Context: FDA Surveillance and Post-Market Reporting

After a device is cleared or approved, manufacturers must:

• Report serious adverse events to the FDA (MDR — Manufacturer and User Facility Device Experience reporting).
• Conduct post-market surveillance as required by the FDA.
• Update labeling if new safety information emerges.
• Notify physicians and patients of recalls or important safety information.
• Violations of these obligations create additional liability beyond the underlying device defect.

Evidence in Defective Device Cases

• Device retrieval and testing: We obtain the actual implanted or failed device; engineering experts analyze it.
• FDA MAUDE database: Public database of adverse events linked to specific device lot numbers and serial numbers.
• Manufacturer documents: Internal testing, design changes, customer complaints.
• Clinical and surgical records: Detailed documentation of implantation, complications, explantation.
• Expert engineering testimony: Biomechanical engineers reconstruct failure mechanisms.
• Physician testimony: Surgeons explain standard of care for device selection and implantation.

Current TLU Defective Device Dockets

Bard PowerPort catheter litigation We also evaluate cases and other emerging device defect claims.

Frequently Asked Questions

The device was FDA-cleared. Doesn’t that protect the manufacturer from liability?

No. FDA clearance is based on manufacturer submissions; fraud or concealment in those submissions undermines the clearance. Additionally, post-market adverse events not contemplated during clearance may create liability for failure to warn or recall.

My device works fine. Do I still have a claim?

Device defect claims may proceed even if your device has not yet failed. A design defect that poses substantial risk of failure and serious injury supports a claim, even if yours has not manifested yet. We evaluate each case.

How is liability allocated if my doctor also bears fault?

Physicians may bear some responsibility for patient selection or surgical technique. However, manufacturers bear primary responsibility for safe device design and adequate warnings. We evaluate comparative fault according to your jurisdiction’s rules.

What compensation is available?

Recovery includes medical expenses (original surgery, explantation, revision surgery, treatment of infection), lost income, pain and suffering, and for permanent disability or shortened life expectancy, substantial general damages.