Product liability issues cover the increasing number of products that you distribute, use or prescribe. There are many areas within product liability that can expose your practice to legal claims. Claims may arise from negligent use of a product; such claims are typically covered by your malpractice policy. However, the misuse of a product, or altering it by placing your private label (white labeling) on a product may give rise to claims that are not covered by your malpractice policy. Any device, product, or prescription that is given to a patient should include full instructions, risks, hazards, and alternatives.
A key factor in this area is that liability is created in the foreseeable stream of commerce. For example, if you give a sample of a skincare product to your patient, it is reasonably foreseeable that they might share that product with family members and friends. So it is incumbent on you to provide good safety instructions on using the product, the potential for allergies to a product, and any medical concerns over its use. When their friend uses the product and has an adverse reaction, you may be held responsible even though that third party was never your patient.
White labeling products, which is a common marketing practice by physicians, carries its own product liability risks. Adding private labels to the product may hide important ingredients and instructions. You should be careful to maintain such important information on any products that you sell or distribute through your practice. Altering the product, even as simply as putting your name on it, may eliminate the manufacturer’s responsibility to defend you even when you are using it appropriately.
Be careful and investigate the FDA approved uses for the product and/or device. Be cautious when industry reps suggest a different use without providing you with written approvals. A physician has the ability to prescribe products off-label, but some precautions are necessary. The three necessary elements for off-label use are: (1) that the product is approved by the FDA for such use; (2) that the proposed use is not experimental; and (3) there should be written confirmation of the patient accepting and understanding the off-label use.
Doctors are typically aware of their exposure to malpractice claims when a patient has a poor outcome; it is equally important to be cognizant of the possibility that you may also face claims for product liability, even for the use and distribution of rather common products.