Food and Drug Administration Responsibility

Manufacturers may be held responsible for product liability if their products are unsafe. People who are injured by a dangerous medical device are often entitled to compensation for their injuries.
The Food and Drug Administration (FDA) is responsible for monitoring the safety of medical devices for patient use. If a product is not approved by the FDA, that means the product’s safety has not yet been proven or that it may be a dangerous product.
A federal court in Oregon will allow an injured patient to continue in his product liability lawsuit against Stryker Corporation, a medical device manufacturer. The product in question is a local anesthetic infusion pump that was designed to be used to limit pain after surgery.
The patient underwent arthroscopic surgery on his shoulder in 2004. The surgeon placed the pain pump into the shoulder joint. However, doing so resulted in more pain and destroyed the patient’s cartilage in his shoulder.
In 2008, the injured patient filed a product liability lawsuit against Stryker for selling the pain pumps without warning doctors that the FDA had not approved its use. The lawsuit also alleges that Stryker knew the risks involved with injecting anesthesia directly into joint space.
Stryker Corporation asked that the case be dismissed. The medical device manufacturer said that at the time of the surgery, the joint space risk was unknown. Stryker thus argues that the case should not proceed because under Oregon law the company only had a duty to warn about known dangers.
The Oregon court, however, disagreed. In allowing the lawsuit to proceed, the court reviewed a 1985 clinical study of risks associated with injecting anesthesia into joint space. The court also looked to Stryker’s own documents indicating the company was concerned over the lack of FDA approval. Additionally, there was a statement from the doctor who says that she would not have used a product that was not approved by the FDA.
This personal injury¬†case will now proceed to determine whether the manufacturer is responsible for the patient’s injuries.

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