Originally
Published MX March/April 2002

GOVERNMENTAL &
LEGAL AFFAIRS

The best way for
medical device manufacturers to avoid product-liability litigation is to anticipate
claims well in advance. Following is a quick self-diagnostic checklist that
device manufacturers can use in assessing their vulnerability to product-liability
claims arising from advertising and overpromotion.

• Product warning
  labels should meet all applicable medical device industry standards.
• Product labels
  and warnings should effectively warn against all hazards of which the end-user
  may be unaware.
• All product
  warnings should be made conspicuous.
• Product instruction
  manuals should be useful, understandable, and available to end-users.
• There should
  be a product-safety committee.
• The product-safety
  committee and legal counsel should review all labels, warnings, and instructions.
• Any changes
  in warnings, labels, and instructions should be reviewed by legal counsel.
• The reasons
  for such changes should be documented.
• Legal counsel
  should review all advertising materials, warranties, guarantees, and sales