Revision Surgery Injury Litigation

A defective medical device is one that does not meet the safety expectations of its intended use, creating preventable harm for patients. Devices may be deemed defective due to poor design, errors in production, or lack of adequate instructions and warnings. For example, a knee replacement implant that fails early or an insulin pump that malfunctions may qualify as defective. The legal test often considers whether safer alternatives were available and if manufacturers failed to communicate risks. Even FDA approval doesn’t guarantee immunity. If a device compromises patient safety under normal use, the law may consider it defective.

• Hernia Mesh
• Breast Implants
• Transvaginal Mesh Implants
• Catheters
• Hip Replacements
• Knee Implants
• Shoulder Replacements
• Heater Coolers
• Bone Grafts
• Ventilators
• Defibrillators
• IUD
• IVC Filters
• Da Vinci Robot Surgery System
  

Medical Device Manufacturers

• Atrium Hernia Mesh
• Bard Hernia Mesh
• Bard IVC Filters
• Covidien Hernia Mesh
• Depuy Hip Implants
• Arthrex knee replacement
• Exactech knee replacement
• CareFusion ventilators
• Essure Birth Control System
• Ethicon hernia mesh
• Infuse Bone Grafts
• LivaNova Heater-Coolers
• Stryker Hip Implants
• Smith & Nephew Hip Systems
• Zimmer Biomet Shoulder Systems
• Wright Medical Hip Implants

All medical device products come with  warnings and instructions for use that are provided to the physician. If the company does not provide the physician with all the relevant safety data so that the physician adequately understand the risks and benefits of the product, then the medical device is defective.

The physician must be in a position to pass the appropriate safety data onto the patient, so the patient can make an informed decision on whether they wish to have the medical device implanted.  Patient informed consent is critical because many devices are designed to be permanent.  

Litigation arises where there is evidence the medical device manufacturer failed to timely update a warning in light of new data or simply ignored the risk and failed to conduct sufficient research to identify and then disclose the risk.

In determining whether a medical device is defective due to inadequate warning or instruction, evidence must be presented to prove:

• The medical device manufacturer knew, or in the exercise of reasonable care, should have known about a risk
• A reasonable medical device manufacturer would have provided a warning of the risk
• The medical device manufacturer failed to provide the warning
• The patient was injured due to a lack of warning. The same elements apply whether the claim is based on a warning present during the marketing or post-sale warnings.
  

Defenses to Failure to Warn Claims: (1) the risk was open and obvious or a matter of common knowledge; and (2) in cases of a pharmaceutical drug or medical device, the warning was provided to the prescribing physician (“Learned Intermediary Doctrine”).

Design and manufacturing defects result in medical device product recalls each year in the United States, initiated by federal safety agencies.

• The Food and Drug Administration (FDA)
• The Consumer Product Safety Commission (CPSC)

You should hire The Lyon Firm because of our proven ability to handle complex cases against large corporations. Joe Lyon has successfully represented clients nationwide in product liability, environmental exposure, and serious personal injury lawsuits. What sets the firm apart is its dedication to transparency and client communication. The Lyon Firm doesn’t just focus on legal outcomes, we prioritize the well-being of clients and their families. By hiring The Lyon Firm, you gain a lawyer who thoroughly investigates every detail, fights aggressively for your rights, and provides compassionate support during a challenging time. Justice and advocacy are our hallmarks.