Torts Fulfill Important Role in Regulating Medical Device Safety

Published on November 22, 2016, by Matthew Sharp

Product Liability

Torts Fulfill Important Role in Regulating Medical Device Safety

Tort liability fulfills an important role in discouraging companies from rushing to market medical devices that are unready for wide release, thus saving lives and money. Medical devices are regulated by two systems: public administration and tort liability. Public oversight is primarily fulfilled by federal and state government agencies, like the Food and Drug Administration.

The Historical Role of Torts

Medicines, including devices, have been regulated since historical times through criminal and civil actions. Romans imposed quality controls for food and drink. English common law permitted individuals to sue sellers for substandard food, and restaurant owners were subject to strict liability for the quality and safety of their food and drink. But, despite these protections, lawsuits based on products liability rarely occurred, likely due to the high cost of litigation.

Tort law in the United States steadily evolved due to pressure by consumers. Producers and other companies in the supply chain could evade responsibility because they were not in “privity” of contract with the victims, i.e. they did not directly sell to the consumer. Consumers were thus left to sue only the retailer of the good who could argue that they were not ultimately responsible because the defect arose in the manufacturing process. Plaintiffs were therefore left with little or no avenues of recovery.

Torts Impact on Medical Device Safety

In response, state governments began passing a series of laws called “products liability” suits which imposed strict liability on producers and sellers. In the 1960s and 70s, these laws were hailed as critical to ensuring that manufacturers sell safe goods to the public. By the 1980s and 90s, public opinion turned against many of these laws. Some experts questioned whether these suits changed habits or if it only drove up prices and discouraged innovation.

To date, torts fulfill four objectives in protecting the public:

  1. Safer products;
  2. Compensation for victims;
  3. Driving out substandard products due to increased costs; and
  4. Innovation.

Torts increase cost on companies for releasing substandard products. It, therefore, creates an economic incentive to produce safer products. Administrative systems are designed to product the public from harm. Conversely, tort systems aim to ensure that victims receive compensation for the harm they suffer. Compensation is crucial because many of these victims may suffer severe injuries.

Torts, by increasing costs, forces companies to reduce the product lines that result in fewer unsafe products. Finally, tort liability pushes companies to innovate safer products.