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Patterns Of Behavior: Stryker Encourages Off-Label Use

Stryker and many of its executives have been indicted on charges of wire fraud, conspiracy to defraud the United States Food and Drug Administration, distribution of a misbranded device, and making false statements to the FDA. The charges were made by the U.S. Attorney’s Office for the District of Massachusetts.

The allegation is basically that Stryker was fraudulently marketing their bone growth products, the OP-1 Implant and OP-1 Putty, which are used in spinal and long bone surgeries (long bones are the slender bones in the limbs). The inquiry began in 2008, but the indictment was just handed down yesterday. The products are approved by the FDA under a limited “humanitarian” exception. Under that approval, Stryker is only allowed to sell limited quantities of the products, and only for humanitarian reasons to treat a rare condition. Instead, they concocted “recipes” for a combination of those products with other bone void fillers, and promoted other uses not approved by the FDA.

Stryker is also the manufacturer of pain pumps. In the pain pump discovery we have obtained extensive information showing that manufacturers were encouraging orthopedic surgeons to use the pumps in or near the intra-articular joint space of the shoulder following arthroscopic shoulder surgery. Of course, the FDA never approved that indication (indeed, the FDA had denied that indication multiple times). These are classic situations of placing profits over safety.