Blanco v. Baxter Healthcare Corporation
Filed January 11, 2008, Fourth District, Div. Three,
Cite as 2008 SOS 177

Victim Of Faulty Medical Device Loses Claims In Torts Case

Claudia Blanco was diagnosed with a heart defect. In December 1987, her mitral valve was replaced with a valve manufactured by Baxter Healthcare Corporation. In 1989, the company suspended the product based on reports of defects in 39 of 20,000 devices, which led to the product’s recall and termination from the market.

When Claudia gave birth to her son in 1991, emergency surgery was performed for a blood clot by the valve. In 1993, she received notice of reported problems with the valve. Despite that, replacement was not recommended.

Ten years later, she experienced chest pain, nausea, and shortness of breath. Claudia Blanco died during an emergency surgery. Doctors found that there was acute failure of the implanted mitral valve due to leaflet escape caused by a fracture in the device.

Claudia Blanco's husband and son filed a lawsuit against Baxter Healthcare Corporation based on theories of negligence, strict liability, breach of implied and express warranty.

In response, Baxter filed a motion for summary judgment which was granted by the trial court. Blanco's relatives appealed.

In reviewing the case, the Fourth District Appellate Court has affirmed the judgment of the trial court based on the following grounds:

• The valve had gone through the pre-market approval (PMA) process and was approved by the Food and Drug Administration (FDA). It had been inspected, tested and certified for release. Therefore, it preempted the state’s requirements on safety and effectiveness.


• The plaintiff’s common law negligence and strict liability tort claims against manufacturer were preempted by Sec. 360k(a) of Title 21 of the United States Code because they would have required manufacturer to change its manufacturing process if plaintiff prevailed, subjecting manufacturer to state requirements that were higher than federal requirements

Further, the appellate court held that the FDA's approval of the PMA for the valve was a device specific federal requirement that could preempt any conflicting state requirements.

In disputing the claims, the appeals court rejected the plaintiff's (Blanco’s) argument that the section did not preempt state common law causes of action because a state law remedy for a manufacturing defect does not impose a state requirement "different from, or in addition to" a federal requirement relating to the device's safety or effectiveness.

In addition, the strict liability and the negligent cause of action failed for the same reasons.

Further, the appeals court ruled that the breach of implied warranty cause of action failed because there was no privity of contract on the grounds that there was no evidence that plaintiff relied on manufacturer’s judgment that device was right for her. The court explained; ‘there is no evidence Claudia relied on Baxter's judgment that the valve was appropriate for her. Rather, she relied on her physician's skill and judgment to select the valve.’

Finally, the judgment in favor of the company was affirmed.