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:
- 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.”
- Stryker Biotech allegedly begins receiving reports of adverse events from the combination of the OP-1 products and Calstrux, including inflammation, drainage and impaired wound healing. Some patients required additional surgeries, which revealed that the mixture migrated from site of the procedure.
- In some of those cases, surgeons allegedly observed that the mixture resembled “oatmeal,” “grits” or “white sesame seeds.” In some cases, the mixture allegedly stimulated the growth of bone spurs where it migrated; some of those cases required surgical removal of the spurs.
- The company allegedly commissions a report from a surgeon analyzing the results of the combination. His report allegedly reveals an adverse event rate higher than with standard treatments for long-bone fractures.
- Later in 2006, the surgeon allegedly tells Stryker that the mixture is not effective.
- Stryker allegedly touts Calstrux as the “perfect carrier for OP-1” in a January sales meeting — despite the adverse event reports and the surgeon’s recommendation.
- In mid-February, a senior Stryker Biotech manager, not named in the indictment, allegedly sends a memo to colleagues including Philip detailing concerns about the adverse event reports, that “a variety of different ‘recipes’ are used” to mix the products and that Calstrux was being improperly promoted as the “preferred carrier” for OP-1.
- Heppner, Whitaker and other sales managers argue against the “dear doctor” letter, saying it would harm OP-1 sales, anger the surgeons who were duped into using the mixture because “many surgeons are just handed the product prior to implantation and think it’s all OP-1,” and cause the independent review boards charged with making sure treatments are safe for patients to rescind their approvals of the OP-1 product.
- In March, a Stryker Biotech VP allegedly told the sales force in a training session, including Heppner, Ard and Whitaker, that promoting the combination of the products could expose the company and its employees to criminal prosecution. The VP allegedly warned that such promotion could lead to a product recall, the FDA shutting down the company, criminal misbranding prosecution and “enormous criminal fines and civil penalties.”
- Also in early March, Philip allegedly nixes the “dear doctor” letter.
The manager allegedly recommends that Stryker stop “recommending, suggesting and preparing for use [of] Calstrux and OP-1 Implant as noted above” and that the company issue a “dear doctor” letter advising surgeons of the adverse events.
- The four defendants allegedly continue to promote the combination of OP-1 and Calstrux until roughly February 2008.
In a prepared statement, Stryker said it is “disappointed” about the indictment and “still hopes to be able to reach a fair and just resolution of this matter.”
“Conviction of these charges could result in significant monetary fines and Stryker Biotech’s exclusion from participating in federal and state health care programs, which could have a material affect on Stryker Biotech’s business,” according to the statement. “As a matter of company policy Stryker will not have any further comment on these allegations.”