
■ Mr. Lennartz also billed Medicaid for transporting a patient for rehabilitation claiming the distance was 220 miles when, in fact, it was only 33 miles.
Thoughts And Articles From Attorneys At Green and Associates Who Represent Professionals In Administrative, Civil, Business, Regulatory, Criminal and Litigation Matters In California


On April 14, 2009, Shane Doyle, who worked as a territory manager for Stryker Biotech (a publicly traded medical device company based in Hopkinton, Massachusetts), pled guilty before U.S. District Judge Woodlock in Boston, Massachusetts to one count of felony misbranding. The medical device at issue, OP-1 (Osteogenic Protein -1), is designed to promote bone growth and was approved by the FDA only pursuant to a Humanitarian Device Exemption (“HDE”), which is quite narrow and restrictive. It is approved in 28 other countries however.
At the plea hearing, the prosecutor told the Court that had the case proceeded to trial the Government’s evidence would have proven that Mr. Doyle, in his capacity as a territory manager for his employer, promoted the use of these devices in a manner that was different from its FDA approved use. Specifically, he promoted a combination of the HDE devices with a bone void filler, and in furtherance of that promotion provided mixing instructions to surgeons, medical technicians and others.
Sentencing is set for July 23, 2009, and Doyle faces up to 3 years imprisonment, to be followed by 1 year of supervised release and a $250,000 fine.
Attorney Comment: This is the third Stryker sales representative to have entered a guilty plea. On March 6, 2009, the U.S. Attorney's Office sent Stryker a letter that they are the target of a federal grand jury investigation for the alleged illegal promotion of OP-1 and Calstrux. The question will be how high up does this go? Sometimes corporations plea rather than individuals and here it looks like they're working from the bottom up.
Prior to this criminal investigation and guilty pleas from sales representatives, Stryker had received a "No" recommendation for approval from the FDA Ortho Panel and FDA warning letters for their plant in Massachusetts. For a product that had not been approved by the FDA, the sales representatives and company put a lot on the line and took a lot of risks.
For those who are working for corporations, this case is a reminder not to put short-term sales ahead of one's career or liberty. With one of these felony convictions, apart from the risk of prison time, one collateral consequence for the Stryker sales reps will be OIG exclusion from most health care related jobs for 5 years. Seek independent counsel if your 6th sense tells you that corporate policies are violating the law. For businesses and individuals, compliance is the key. Stryker is a large orthopedics company and the fact that even it can come under criminal investigation should be a sign as to how aggressive the government can and will be in health care cases -- especially where FDA non-approved devices or products are at issue.
Any questions or comments should be directed to: tgreen@greenassoc.com or aschneider@greenassoc.com. Tracy Green is a principal at Green & Associates and Ann Schneider is a senior associate at Green & Associates in Los Angeles, California. They focus their practice on the representation of licensed professionals and businesses in civil, business, administrative and criminal proceedings, with a specialty in health care providers.




Any questions or comments should be directed to: tgreen@greenassoc.com or aschneider@greenassoc.com. Tracy Green is a principal at Green & Associates and Ann Schneider is a senior associate at Green & Associates in Los Angeles, California. They focus their practice on the representation of licensed professionals and businesses in civil, business, administrative and criminal proceedings, with a specialty in health care providers.



An arrest warrant affidavit contains only allegations against an individual and all defendants must be presumed innocent unless and until proven guilty.
The arrest warrant declaration further stated that Donsbach’s clinic advised one patient to inject herself with “neuropeptides” to treat arthritis, saying it would “re-program” her body’s T-cells. FDA tests revealed the “neuropeptide” contained a steroid not disclosed on the packaging or labels. The patient paid thousands of dollars for the drugs and injected herself for six years, leading to severe bone density loss.




California law specifically addresses foreclosure consultants and restricts their activities; among other things, they are prohibited from collecting upfront fees for their work. (See California Civil Code Section 2945 and following). However, because attorneys are permitted to accept advance fees, they are in demand by some loan modification businesses. (Licensed brokers also may accept advance fees under certain circumstances.)
Attorney Commentary: Companies or individuals who are engaged in this business need to be aware of the law and ensure that they are compliant with federal and state law. The FTC is not waiting for consumer complaints and sent the warning letter to companies that were discovered on the Internet by a review of their advertisements or websites. Anyone working in the area of loan modification should be especially careful to be fully compliant with the law. Attorneys working in this area with loan modification consultants should also be mindful of fee splitting issues, referral fee issues and the aiding and abetting of the unlicensed practice of law. Licensed brokers should have similar concerns about being compliant with the law.
