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If you have any kind of medical device in your body, such as an artificial hip or a defibrillator, and you hear that a new and improved model is now being manufactured, does that mean that your older model device is defective? 

That is the implication that critics fear will happen due to the FDA's recently proposed draft guidelines for medical device enhancements. Under the proposed guidelines, medical device manufacturers would be required to report incremental cosmetic (changes in appearance) and perfunctory functionality improvements to products. While the stated purpose of the proposed guidelines is to help ensure that the product change does not create a health risk for users, some people worry that reporting these changes will expose existing products to product liability claims.

If the proposed guidelines are adopted, persons injured by defective products may be able to use the change in the product design or manufacture to show that the version of the product they received is defective. This argument is rooted in the FDA's use of the word "correction" in the draft guidelines, because any change or improvement to "correct" a previous model implies that the older model is flawed. Plaintiffs in product liability cases could conceivably present evidence of the new change in the product to prove that the older product was defective.

The proposed guidelines, however, do not change the elements of a product liability case. To prove a product liability claim against a medical device manufacturer or distributor, a person injured by the product must show that it: 1) was defectively manufactured; 2) was defectively designed; or 3) was marketed defectively. Further, any person or entity involved in the manufacture or distribution of the product (such as the manufacturer, sales representative, or testing laboratory) can face liability.

It will be interesting to follow whether the FDA's draft guidelines on the medical device enhancements are adopted. In the meantime, if a medical device has injured you, consult with an experienced product liability attorney today.

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