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FDA Sends J&J Warning Letter for K-Y Liquibeads, O.B. Tampons

FDA Sends J&J Warning Letter for K-Y Liquibeads, O.B. Tampons

May 31, 2012 — The U.S. Food and Drug Administration (FDA) has sent Johnson & Johnson a warning letter for numerous failings tied to its tampons and vaginal moisturizers. The FDA cited the company for failing to adequately follow up on consumer complaints, including reports of serious medical problems. They also found that K-Y Liquibeads Vaginal Moisturizer is an adulterated product, because J&J did not gain approval or tell the FDA before selling the product.

The FDA cited the company for failing to establish or maintain a filing system for complaints with the products, as well as failing to follow up with complaints. J&J received 227 complaints about the K-Y Liquibeads Vaginal Moisturizer product between June 2010 and December 2011. Of these, 68 were medical complaints, and yet the company never followed up or investigated the problem. Reports of serious problems with the product were ignored without justification. When defective lots of the product were identified, the company failed to follow-up on injuries associated with the defective products.

The FDA also cited J&J for lacking a system to report adverse medical events to the FDA. This is in spite of the fact that a previous inspection identified the problem in 2009, which suggests that the company failed to take corrective action.

Much of the warning letter expressed concerned with the K-Y Liquibeads Vaginal Moisturizer. The product consists of soft capsules that are inserted into the vagina, where they are supposed to dissolve and provide lubrication. Although the product differs significantly from other vaginal moisturizing products, J&J never submitted an approval application to the FDA or notified the agency that they would be selling a new product.

The FDA was also concerned that K-Y Liquibeads may not actually be compatible with latex condoms, although the package specifically says that they are compatible. J&J never conducted a study which tested the Liquibeads with latex condoms. Coconut oil is an ingredient in the shell of the Liquibead ovule. Oil-based products are known to degrade latex condoms, increasing the risk of breakage.

Furthermore, the long-term study to determine the shelf life of the K-Y Liquibeads had major flaws — including the temperature at which the product is supposedly stable.

The FDA also identified problems with the way J&J handled reports of problems with O.B. Tampons and dental floss. The company failed to notify the FDA when a woman reported toxic shock syndrome after using the tampons, as well as an incident where a man lost a tooth after using the dental floss.

The FDA said that J&J must respond to the warning letters within 15 days and explain how it will address the issues. If they do not, they risk seizure of its products or a fine.

The latest issue follows a rash of problems for Johnson & Johnson. In 2010, the company recalled more than 13 million packages of Rolaids because they could have metal and wood particles. In 2011, more than 100 women sued the company for problems with its Gynecare Prolift vaginal mesh. In March of 2011, the company recalled thousands of bottles of Tylenol 8 Hour Extended Release Caplets.

Do I have a K-Y Liquibead Lawsuit?

The Schmidt Firm, PLLC is currently accepting K-Y Liquibead injury cases in all 50 states. If you or somebody you know has been injured by this product, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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