Products Liability Update

An individual who suffers personal injuries from a defective product is sometimes able to recover damages from the product's manufacturer. When a consumer product is dangerously defective, the manufacturer can be held "strictly liable" for injuries caused by the product. In such cases, it is not considered relevant or important whether the manufacturer was careless or knew that the product might cause injuries. Instead, the law holds a manufacturer completely responsible for injuries if it puts a dangerously defective product into the stream of commerce.

HeartMate Pump

The HeartMate is a medical pump that assists the blood flow between the heart's ventricle and the aorta in patients with cardiac conditions. The pump is surgically implanted inside the user's body but is connected by a tube to an external console that contains a small air compressor that powers the pump. Patients using the HeartMate must be hospitalized or cared for in a nursing home or assisted living facility.

A Pennsylvania man died when the HeartMate pump implanted in his body failed due to a defective component that attached parts of the tubing serving the pump. His widow sued the pump manufacturer. The HeartMate manufacturer did not admit or deny that the pump was defectively designed or manufactured. Instead, it defended the lawsuit simply by claiming that federal law prohibits any state court suits concerning FDA-approved medical products.

The widow acknowledged that state lawsuits cannot impose additional safety requirements on products already approved by the FDA, but she insisted that she was entitled to sue because the manufacturer (1) had failed to properly warn consumers of the risks posed by the pump, and (2) had defectively designed the part of the pump that had failed, causing her husband's death.

A federal court in Pennsylvania sided with the manufacturer and threw out all of the widow's claims. In part, the court decided the case based on how the manufacturer had secured FDA approval. Some products are "cleared" by the FDA, while others are "approved" by the FDA. It is much easier for a manufacturer to get a product cleared. A product can be cleared if the manufacturer proves that it is substantially equivalent to a product already in use in the market. A product is approved only after the manufacturer proves that the product is actually safe and effective. The court noted that in the previous year the FDA cleared 9,818 medical devices and approved only 54. The HeartMate manufacturer had completed the more rigorous process of securing FDA approval.

Federal law provides that state claims cannot be used to attack the safety or design of medical products authorized for sale by the FDA, especially those medical products that have withstood the more rigorous approval procedure. The court noted that the widow had not claimed that the manufacturer had failed to follow the FDA requirements or had deviated from any FDA specifications, statutes, or regulations. Instead, her claims that the pump was defectively designed flew in the face of the FDA's lengthy study and its determination that the pump was safe.

Federal law recognizes the tension between the need for consumer protection and the importance of encouraging the development and sale of innovative medical devices. Once a device has been approved by the FDA, federal law almost completely surrounds the manufacturer with an immunity to suit. This protection increases the responsibility of the FDA to engage in candid and thorough testing.

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