Medical Device Link.

Originally Published MX March/April 2002

GOVERNMENTAL & LEGAL AFFAIRS

Be Prepared!

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 agreements.
• Legal counsel should review all Web-site material.
• Marketing and sales representatives, distributors, and dealers should be periodically trained in product-liability loss prevention.

Copyright ©2002 MX