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The consequences of a defective medical device in California

In most cases involving serious injury involving a medical implant, a person is unable to research a product before it is used. Consumers in California and elsewhere rely on these products to be tested and approved before being used. Any side effects or risks involved are expected to be addressed and resolved before the devices are made available. A defective medical device can cause serious harm to a person's health, and in some cases it can be fatal.

A recent lawsuit has been filed in federal court in a neighboring state by a woman who was implanted with an interior vena cava filter. The filter was approved by the FDA in 2010, but did not undergo clinical trials because it was very similar to its predecessor. Common sense suggests that any medical device should be subject to trials before being approved, especially if there are known problems with previous versions.

An interior vena cava filter is a small cone-shaped device that is implanted right below the kidneys to capture blood clots, preventing them from reaching the heart or lungs. They are removed after any risk of clotting has been resolved. These filters run a very small risk of fracturing, which can subsequently lead to embolization. In recent studies of the manufacturer's previous filters, fracturing occurred in up to 40 percent of patients.

A faulty device that is used in a high-risk scenario can lead to serious health issues. A company may be held accountable for failure to properly test such a product. A person who is injured by a defective medical device can choose to file a product liability suit against the manufacturer and/or other parties in the supply chain to the consumer. People in California who have been injured by such a device often seek the advice of an attorney to pursue claims for compensation for any harm inflicted.

Source:, "Michigan Woman Files Bard Eclipse IVC Filter Lawsuit", Jan. 3, 2017

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