A defective medical device is one that poses unreasonable danger during its normal use. Legally, defects fall into three groups: design, manufacturing, and marketing. Design defects make the product inherently unsafe, while manufacturing errors occur when mistakes compromise safety. Marketing defects stem from incomplete warnings or unclear usage instructions. A defective device may include an implant that deteriorates too soon or a diagnostic tool that produces unreliable readings. Courts examine whether the risks were foreseeable and properly disclosed. If the device causes harm under expected use conditions, it may be classified as defective under product liability law.

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.

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)

The foregoing listed 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 utilized to compensate patients injured by a defective medical device. 

The Lyon Firm is an excellent choice for those seeking accountability and justice in difficult legal matters. Joe Lyon brings years of trial experience in cases involving defective products, toxic exposure, and consumer rights. The firm is well-regarded for its ability to take on corporations and win significant results for clients. Beyond results, The Lyon Firm values open communication and client trust. Joe Lyon personally guides clients through each step, ensuring they feel supported throughout the process. Hiring The Lyon Firm means partnering with a law practice dedicated to justice, fairness, and protecting those who need it most.