A new lawsuit against Bethlehem-based medical device maker B. Braun’s prosthetic joint division alleges the company knew about a problem with its line of ceramic-coated replacement knees, but failed to correct it or warn users.
Aesculap Implant Systems holds a patent in Germany for a solution to the problem but did not incorporate the feature into its products, the suit on behalf of 30 knee replacement patients claims. As a result, glue that is supposed to adhere the implants to patients’ bones does not bond with the replacement knees and causes them to become loose, requiring additional surgeries to correct, the suit alleges.
Numerous surgeons, sales representatives and employees made Aesculap aware that during the follow-up surgeries, the knees could be easily removed without cutting away the bone cement, the suit claims. It alleges that Aesculap intentionally concealed the problem from physicians, salespeople and the U.S. Food and Drug Administration.
Attorney Kyle Johnston said that when Aesculap sought permission to market its “advanced surface” ceramic-coated replacement knees it did so without pursuing approval of the product from the FDA. Instead, Johnston said, Aesculap asked the FDA to clear the ceramic-coated implants for sale because they were substantially similar to products already approved by the FDA.
“When the FDA cleared the sale … it did not relieve Aesculap of its ongoing duty to report product failures and be honest with its customers about the safety of its implants,” Johnston said. “Our clients have been seriously injured by the advanced coating, and we’re going to hold Aesculap accountable for it.”
Spokespeople for Aesculap and B. Braun did not respond to messages Tuesday. B. Braun is a German company with its U.S. headquarters in Bethlehem.
Johnston, of San Juan, Puerto Rico, filed the suit in Philadelphia County Court on Tuesday with attorneys Anthony Buzbee of Houston and Frank Procyk of Allentown. It follows a lawsuit Johnston and Buzbee filed in November in Los Angeles Superior Court on behalf of 25 people who received the allegedly defective implants.
Johnston said Aesculap challenged whether the Los Angeles court has jurisdiction to hear the case, so he dismissed the case and refiled it in Philadelphia, where at least one of the plaintiffs underwent surgery after receiving an Aesculap implant. Three of the 31 plaintiffs in the new suit are from Pennsylvania, including one from Shenandoah, Schuylkill County and one from Kingston, Luzerne County.
According to the lawsuit, Aesculap developed the ceramic-coated implants to eliminate the loss of metal ions within the body. The coating, however, repels the moisture inside a patient’s body and causes it to accumulate on the surface of the implant underneath the bone cement that is supposed to attach it to a patient’s leg bones. As a result, the implants become loose, causing pain and difficulty walking.
The suit claims Aesculap should have known that the problem would occur and that applying an additional coating to the implants would improve their bond with bone cement. The lawsuit states that Aesculap applied for a patent in Germany for a process to apply the additional coating in 2012, and it received the patent in 2015. The additional coating was never incorporated into the ceramic coated implants, the suit alleges.
–Peter Hall, The Morning Call