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FDA documents may clear Stryker in bone putty case

Stryker Corp.’s (NYSE:SYK) biotech subsidiary, its former president and three sales reps say Food & Drug Administration documents could clear them of criminal charges in a federal case alleging the illegal promotion of bone putty.

Stryker Corp.’s (NYSE:SYK) biotech subsidiary, its former president and three sales reps say Food & Drug Administration documents could clear them of criminal charges in a federal case alleging the illegal promotion of bone putty.

Hopkinton, Massachusetts-based Stryker Biotech, former president Mark Philip and the sales reps — national sales director William Heppner and regional managers David Ard and Jeff Whitaker — were indicted last year for allegedly promoting the off-label use of a pair of bone-growth products and lying to the Food & Drug Administration. Stryker and Philip were also charged with making false statements to the FDA.

Now their lawyers, from the Boston-based firm Ropes & Gray LLP, are asking federal prosecutors for a raft of documents they say could undercut the government’s case. After examining Food & Drug Administration documents already released by the feds, the attorneys say they found a “substantial number” from the FDA that “we consider clearly exculpatory,” according to court documents.

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“Specifically, we believe some of these documents undercut the Government’s core allegations that Defendants conspired to defraud the FDA,” according to a letter sent to the assistant U.S. attorneys handling the case.

The indictment alleged that the defendants created a scheme to bypass the narrow, provisional “humanitarian device exemption” granted to each product by the FDA. Combining the treatments and devices — the OP-1 Implant, OP-1 Putty and the bone void filler Calstrux — caused adverse effects in patients ranging from minor irritations to infections requiring follow-up surgeries. The indictment also charges that Stryker and Philip lied to the FDA about the number of patients treated each year with OP-1 Putty. The defendants’ lawyers want the feds to release any FDA documents that deal with the agency’s terminology for the bone-healing products the defendants are alleged to have encouraged physicians to combine:

  • Any documents involving “discussions regarding the use of ‘bone void fillers’ such as TCP/Calstrux as ‘bone graft substitutes;'”
  • Documents discussing “the use of the term ‘putty’ to describe bone void fillers such as TCP/Calstrux;”
  • Documents dealing with “any adverse events reported in surgeries using bone morphogenetic proteins and/or bone void fillers and any discussion about which adverse events should be reported as [Medical Device Reports];”
  • “Clarification and missing information” about some of the already-released documents, including a few that were illegible, the provenance of another and several that were mentioned in the prior release but not furnished at that time;
  • An arrest warrant for another former sales rep who already pleaded guilty and confirmation that some 14,000 files from his computer were deleted, or copies of the documents in the files if they exist;
  • And an unredacted version of one document.

The letter concludes with a caveat regarding a 10,000-document dump from the feds received Sept. 24: “We are reviewing these materials as quickly as possible. Having not completed the review, we cannot rule out the possibility that we may need to make additional requests based on this supplemental production.”

In September, Stryker, Philip, Heppner, Ard and Whitaker moved for the dismissal of 12 of the 16 counts against them, arguing that the U.S. District Court for Massachusetts doesn’t have jurisdiction over them.

The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.

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