Knee Implant Injury | Medical Device Defects

The law classifies a medical device as defective if it presents unreasonable risks during proper use. This can stem from flaws in design, such as a product inherently unsafe; manufacturing defects, where a safe design was improperly built; or marketing defects, where risks weren’t clearly explained. Take, for example, an implantable defibrillator that shocks patients unnecessarily or surgical tools lacking proper usage warnings. Courts review whether safer alternatives were possible and if the manufacturer failed in its duty to warn. A device becomes defective when it transforms from a tool meant to heal into one that causes harm.

• 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

Defective design medical device cases arise not because a mistake was made during the manufacturing process, but rather the original design of the product is unreasonably dangerous. A “risk-benefit analysis” is used to determine whether safer/less expensive alternative designs were available to the manufacturer (e.g. the metal on metal design, the porosity and stiffness of transvaginal mesh )

For these claims, the FDA Review process is critical on whether a pre-emption defense exists.  For devices that went through the PMA (pre-market approval process), rather than the 510K process, the case must be evaluated very carefully for any parallel claims under state and federal regulations (e.g., failure to warn or failure to disclose adverse events) that can advance the case forward.  Without a careful legal analysis, the case may be subject to dismissal even where the medical device design proves to be defective.

Risks:  The following factors are considered under Ohio law when determining the risks associated with the design of a medical device:  (1) the magnitude of the risk of injury; (2) ordinary consumer awareness of the risk for injury; (3) the likelihood of causing injury; (4) the violation of a private or public standard; and (5) the consumer’s expectation of the performance of the product and level of danger. Ohio Revised Code 2307.5 (B) Product Defective in Design or Formulation. These factors are considered in most other jurisdictions.

Benefits: The following factors are considered under Ohio law when determining the benefits associated with a medical device: (1) the utility of the product; (2) availability of an alternative design; (3) the magnitude of risks associated with an alternative design. Ohio Revised Code 2307.5 (c) These factors are considered in most other jurisdictions.

Defenses for Defective Design: (1) a pharmaceutical drug or medical device is not defective by design if it contains an adequate warning of an unavoidably unsafe aspect of the pharmaceutical or medical device; (2) the dangerous aspect is inherent to the product, recognizable, and cannot be eliminated without compromising the product’s usefulness; (3) a lack of a feasible alternative design. 2307.75 (d)(e)(f).

A manufacturing defect claim arises where the medical device is released from the factory in a manner that deviates from the intended design or specifications.

Most manufacturing defect cases are based on a products deviation from the intended specification, formula, performance standards, or design model. In such cases, it may be easy to determine the product did not comply with the intended design. In defective medical device cases, the manufacturing defect is often related to performance standards (e.g., the metal does not meet the strength specification or has microscopic fractures–these defects require an examination by a qualified metallurgist who can examine the medical device).

As a result of the deviation, the product enters the market in an unreasonably dangerous condition and the consumer is exposed to or purchases a product that is defective. Any personal injuries or economic loss that arise from the the defect are compensable under Ohio product liability law.

The product may be recalled as a specific lot is identified as being non-compliant and defective. A product may be defective in manufacture or construction, materials and assembly, and a manufacturer or distributor may be subject to strict liability, even though it exercised all possible care.  Ohio Revised Code 2307.74.

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)

These government agencies may initiate recalls of dangerous products but do not provide remedies or compensation for damages where an individual is injured due to the defective product. Only litigation can compensate patients injured by a defective medical device.

The Lyon Firm is a solid option because we have the experience, resources, and determination needed to take on powerful adversaries. Joe Lyon is nationally recognized for handling cases involving medical devices, toxic exposure, and complex consumer claims. He takes pride in representing individuals rather than corporations, giving clients a strong voice in the legal system. The firm is known for meticulous preparation, clear communication, and compassionate guidance throughout every step of a case.