Pelvic Mesh Injury Lawsuits

When a medical device has the potential to fail and cause injury, companies should voluntarily issue a recall. When a company injures patients with defective medical devices, a medical device lawyer may help you recover financial losses, medical expenses and other damages incurred through litigation.

Defining a defective medical device means identifying when it puts patients at risk beyond what is reasonably expected. Design defects affect the entire product line, while manufacturing defects result from mistakes during production. Marketing defects occur when instructions or warnings are insufficient. A defective device may be an infusion pump that administers the wrong dosage or a hip replacement that wears down too quickly. Courts consider whether the device met industry standards and whether safer designs existed. The key factor is whether the device delivered on its intended medical purpose without compromising patient safety in unacceptable ways.

Risks:  The following factors are considered under Ohio law when determining the risks associated with the design of a product:  (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.

Benefits: The following factors are considered under Ohio law when determining the benefits associated with product design: (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)

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).

EXAMPLES:

• Metal on Metal Hip Implants
• Lap Belt Only Seat Belts
• Transvaginal Mesh
• FMK Fast Action Trigger
• Lack of Insulating Link on Cranes

• A manufacturing defect is based on a defect that occurred during the manufacturing process. Many auto companies have been involved in this kind of product liability lawsuits in recent years, due to defective airbags, software defects, tire failure, and other dangerous manufacturing errors.

  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.

  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.

  ---

  Manufacturing Defect Examples:

  • Contaminated Food
  • Defective Medical Devices
  • Contaminated Pharmaceuticals
  • Defective Handguns
  • Defective Auto Components

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

• The manufacturer knew, or in the exercise of reasonable care, should have known about a risk
• A reasonable manufacturer would have provided a warning of the risk
• The manufacturer failed to provide the warning
• The person 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”).

Many pharmaceutical companies have been targeted in failure to warn lawsuits for either failing to place warnings on medication guides and packaging or failing to properly test their product before putting it to market.

Design and manufacturing defects result in thousands of product recalls each year in the United States, initiated by federal safety agencies. Following injury and illness, regardless of recall status, victims and plaintiffs may pursue legal action and contact a product liability lawyer to begin the litigation process. Rightful compensation can be sought and help plaintiffs recover medical costs and other related damages.

Product liability law overlaps with regulatory law, which are the systems of legislative rules and administrative agencies, and part of federal and state governments. These agencies regulate the safety of the products sold to the public. Examples include:

• The Food and Drug Administration (FDA)
• The National Highway Traffic Safety Administration (NHTSA;)
• The Consumer Product Safety Commission (CPSC)

The listed government agencies, however, 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.

Hiring The Lyon Firm is a smart decision because of its strong history of fighting for justice in challenging cases. Joe Lyon has represented clients nationwide in lawsuits involving defective medical devices, environmental hazards, and consumer protection issues. The firm provides not only legal knowledge but also compassion for those facing medical and financial hardships. The Lyon Firm emphasizes thorough investigation, trial readiness, and transparent communication. Clients can trust they are receiving the highest level of representation. If you need an attorney who is both tough in the courtroom and caring in client relationships, The Lyon Firm delivers.