For The Defense, October 2010 - DRI Today

D R U G A N D M E D I C A L D E V I C Efines. The federal government alleged thatfrom 2005 until 2008 the defendants marketedand promoted mixing each of two ofits bone-growth stimulating products witha third product, a bone void filler, for bonerepairs, which the FDA had not approved,to boost sales. The two bone growth stimulatingproducts were approved only underFDA humanitarian device exemptionsThe FDA plans toexpand prosecutions ofpharmaceutical and foodindustry executives aspart of efforts to refocusits criminal division.(HDE) with a stated, permissible UnitedStates market of 4,000 people, and the otherproduct had clearance under section 510(k)of the Food, Drug, and Cosmetic Act.The government alleged that adverseevents resulted from the promoted offlabeluse of the products, which includedmigration of the combined products fromthe wound site, revision surgery, removalof bone growth, drainage, impaired woundhealing, and inflammation. The governmentfurther alleged that the promotion ofthe products to surgeons and surgical staffcontinued another two years, even thoughStryker knew about the adverse events,did not have FDA approval for the combineduse, which accounted for the vastmajority of sales of the products with theHDE approval, and admonitions of potentialexposure to the company and criminalprosecution of individuals for promotingthe mixture. The indictment also claimedthat despite a recommendation by a seniorsales manager that the company cease promotingthis use and notify surgeons in a“Dear doctor” letter about adverse experiences,two of the indicted sales managersargued against disclosure, in part, to avoidthe adverse effect on sales and the anger ofsurgeons, as well as to keep institutionalreview boards from pulling the products.50 n For The Defense n October 2010In addition, the indictment alleged thatthe president engaged in a scheme to concealthat Stryker sold the products withthe HDE approvals to more than 4,000patients per year. To that end, the governmentalleged that the president providedfalse information that Stryker could notaccurately estimate usage per patient to anoutside law firm to obtain a “bogus legalopinion” and obtained advice on how toword an annual report to the FDA, basedon the false information provided by thepresident. See Indictment in United Statesv. Stryker Biotech, LLC, et al., No. 09-CR-10330-GAO, Oct. 28, 2009 (D. Mass.). Theparties reported to the federal court onSeptember 14, 2010, that they had discussedthe possibility of an early resolutionof the case without trial but did notbelieve that any such resolution could beachieved. There have been various civillawsuits pending against Stryker since theinvestigation began. Stryker Biotech alsorecently agreed in a consent judgment topay $1.35 million to the Commonwealthof Massachusetts to resolve state allegationsof improper marketing of its bonegrowth products and related allegations,as reported by the Massachusetts AttorneyGeneral on August 26, 2010.Stryker executives are not the onlyexecutives facing criminal prosecution.In June 2009, another company, Synthes,Inc., a medical device manufacturer, andits wholly owned subsidiary, Norian Corporation,and four executives of Synthesentities, a president, senior vice presidentof global strategy, vice president of operations,and director of regulatory and clinicalaffairs, were indicted under allegationsof organizing and sponsoring an illegal testmarket for bone cement products for spinalrepairs rather than obtaining an investigationaldevice exemption (IDE) from theFDA. According to the indictment, in internalcommunications recommending thatSynthes pursue an IDE, which it did not,Synthes personnel stated that the company“is at an increased legal risk with regards toproduct liability and medical malpractice.”The allegations in this case include aclaim that three patients died after applicationof an unapproved mixture of thebone cement products to the spine duringprocedures when company sales representativeswere present. The governmentmaintains that Synthes failed and refusedto comply with the FDA’s Medical DeviceReporting (MDR) requirement regardingthe first death, concealing it from the FDA,spine surgeons, and from its own salesforce. The government further maintainsthat the company’s reports for the secondand third deaths were brief, vague, and didnot mention that the product was used offlabel,to conceal the off- label use from theFDA and spine surgeons. The indictmentalso notes that the defendants concealedthat the label of one of the products specificallymentioned that it was not intendedfor the test treatment.Norian also faces 52 counts of conspiracyto defraud the United States and its agenciesby impeding, impairing, and defeatingthe lawful functions of the FDA toprotect the health and safety of the public,making false statements, concealing materialfacts in connection with the FDA, andintroducing into interstate commerce adulteratedand misbranded medical deviceswith the intent to defraud. The parent company,Synthes, is charged with 44 countsof introducing into interstate commerceadulterated and misbranded products thatlacked adequate directions for use withoutqualifying for exemption and securing therequired premarket approvals permittingmarketing for the intended uses. The executiveswere each charged with one count ofintroducing adulterated and misbrandedproducts. The indictment was based onan investigation that began in 2006. SeeIndictment in United States v. Norian Corporation,Synthes, Inc., et al., No. 2:09-cr-00403-LDD, June 16, 2009 (E.D. Penn.).The FDA Plans to IncreaseCriminal ProsecutionsAs mentioned, the FDA plans to expandprosecutions of pharmaceutical and foodindustry executives as part of efforts torefocus its criminal division in response tocriticism in a recent government report. Ina recent letter to Senator Charles Grassley,the ranking member of the Senate FinanceCommittee, the FDA described how itplanned to respond to the GovernmentAccountability Office (GAO) report titled,Food and Drug Administration: ImprovedMonitoring and Development of PerformanceMeasures Needed to Strengthen Oversightof Criminal Misconduct Investigations.