Brown & Crouppen is currently evaluating cases involving hospital beds manufactured by Vail Products Inc., which the U.S. Food and Drug Administration says has entrapped at least 30 patients, seven of which resulted in death.

On March 22, 2005, the FDA ordered U.S. Marshals to seize the hospital beds because they do not meet the Quality System regulations of the federal Food, Drug and Cosmetic Act, and pose significant risk for consumers. The seized models are the Vail 500, 1000 and 2000 Enclosed Bed Systems. Marshals also seized beds that were still in the manufacturing and distribution phase, as well as components, labeling and promotional materials.

Vail makes padded, mesh domes that fit over and "enclose" beds used in clinical and home-care situations. The dome can be zipped shut to prevent the patient from falling or wandering away. In a statement, the FDA said the beds pose a "significant health risk" because patients can become trapped and suffocate, and may result in brain damage or death.

The FDA has said that the enclosed bed systems are misbranded because they pose a health danger when used in the manner prescribed. Also mentioned were a lack adequate directions for use and necessary warnings.

Toledo, Ohio-based Vail has previously received two FDA Warning Letters outlining unacceptable practices. The firm was given an opportunity to correct the violations, but allegedly failed to take appropriate actions. In addition, the company was found to have failed or refused to furnish material or information to the FDA as required by Medical Device Reporting regulation and the Reports of Corrections and Removals regulation.

In August 2004, a 7-year-old girl with cerebral palsy died while using a Vail bed, having become lodged between the mattress and bed railing. Her parents filed a lawsuit against Vail, saying the company knew the bed had safety problems.

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