Details emerge in federal case against Stryker Biotech

October 29, 2009 by MassDevice staff

A federal indictment of the Hopkinton, Mass.-based company and some of its top managers sheds light on the charges against them and the company.

Details emerge in federal case against Stryker Biotech

A federal indictment brought by a Boston grand jury against Stryker Biotech sheds light on the charges against the company and the four managers charged with a two-year campaign to promote the off-label combination of two bone growth products and lying to the FDA.

The Hopkinton, Mass.-based firm and its former president, Mark Philip, along with sales managers David Ard, Jeff Whitaker and William Heppner, were indicted by a grand jury on charges of wire fraud and conspiracy. Stryker and Philip were also charged with making false statements to the FDA.

Heppner was the company's national sales director; Ard and Whitaker were regional managers for the western and central territories, respectively.

The indictment alleges that the defendants were part of a scheme to promote the combined use of a pair of separate bone-healing products, each granted a narrow, provisional "humanitarian device exemption" 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.

Here's a timeline of the alleged misdeeds, according to a copy of the indictment obtained by MassDevice:

Early 2005:

  • Stryker launches Calstrux after winning 510(k) approval from the FDA for its use as a bone void filler — and not for use in combination with the OP-1 products. Nevertheless, Stryker allegedly presents Calstrux to its sales force as a "carrier" or "extender" for those products. Philip notes that Calstrux should "accelerate" OP-1 sales
  • Philip, Heppner, Ard and Whitaker allegedly promoted "recipes" for combining the products to surgeons. The mixing instructions varied, with some recommending surgeons form "cigars," some advising "Tootsie rolls," "bricks" or "Vienna sausages." The alleged recipes also vary according to the type and amount of liquid (blood or saline solution) and how much Calstrux to use. As one sales rep allegedly wrote to senior Stryker managers, "Like any product if we have 30+ people doing something different with regards to mixing, dosing, etc. we are going to see different results."