Tag Archives: park doctrine

Medical Device Executives Found Guilty

Go Directly to Jail (23/366)

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Three of the four former Synthes executives who pled guilty to charges under the Park Doctrine were sentenced to jail time and large fines recently. The four men were charged for training and supplying doctors with bone cement to repair fractured vertebrae in spinal surgery, an indication that was off-label according to FDA. Continue reading

FDA Ready to Rumble: 3 To Dos for CEOs

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For CEOs of companies regulated by the Food and Drug Administration (FDA), the message is clear: If you aren’t working to seek out and prevent off-label marketing within your company, you could be charged with a crime.

Rick Blumberg, Deputy Chief Counsel for Litigation at FDA, recently  spoke at the 7th Annual Medical Device and Diagnostic Compliance Congress. He said the FDA is looking for opportunities to prosecute individuals — and he gave CEOs as examples – using the Park strict liability doctrine. Continue reading

FDA Issues Non-Binding Criteria for Executive Crimes

Author:  Mary Holloway

One big question arises when considering the implications of the Park Doctrine: what factors will the government consider in selecting misdemeanor prosecution cases? The FDA released their answer last month. Its Regulatory Procedures Manual asserts that when considering misdemeanor prosecution against “a corporate official,” the individual’s position, relationship to the violation, and whether they could have prevented it are relevant issues. The following criteria are also listed as considerations. Continue reading

Doctors’ Off-Label Tightrope

Author:  Sean McCarthy

When a drug, biologic, or medical device is used “off-label”, what does this mean? FDA clears/approves a given use or indication. Physicians are then free to make their own decisions based on how a device is used based on their best judgment. In other words, it is perfectly legal in the United States for a physician to use a drug or device for “off-label” use. However, it is unlawful to market, advertise or otherwise promote the off label use of a device or drug. Well, we already know this right? Based on the flurry of DOJ activity and the FDA aggressively pursuing the Park Doctrine, companies must keep the practices of their marketing and sales department in check to ensure compliance.

However, read that closely, “it is unlawful to market, advertise or otherwise promote off label use of a drug.” What if the hospital or physician group is doing the marketing themselves, not the company? We’ve all seen the billboards or newspaper ads promoting a latest treatment option from their physicians. Hospitals are competing harder than ever to bring patients to their doors, what’s to stop them from stepping over the same lines that the companies may have, either willingly or not? Continue reading

Sales Management? FDA Will Hold You Responsible for Your Reps’ Actions

Author:  Sean McCarthy

It was reported last week in various media outlets that a little known doctrine could be used by FDA to come after company CEOs who have no knowledge or intent of illegal behavior.  The Park Doctrine would potentially allow FDA to hold company CEOs responsible for the actions of their underlings, such as promoting their products for off-label use.  So imagine a sales rep doing something they may not even realize is wrong because compliance isn’t sufficiently strong, or they just don’t know exactly how to convey the proper information to their customer.  Who is at fault?  If FDA pursues this line it could be your CEO…and also every management person in between the sales rep and the CEO. Continue reading