Just before the US Presidential election, yet another story of how the health care system is rigged slipped just barely into public view. The only media report with any detail about it came from the Corporate Crime Reporter on November 7, 2016.
The Selling of an Unproven Invasive Device
The basics were:
Pennsylvania-based medical device manufacturer Biocompatibles Inc., a subsidiary of BTG plc, pled guilty to misbranding its embolic device LC Bead and will pay more than $36 million to resolve criminal and civil liability arising out of its illegal conduct.
Biocompatibles pled guilty to a misdemeanor charge in connection with the company’s misbranding of LC Bead, in violation of the Food, Drug and Cosmetic Act.
LC Bead was cleared by the U.S. Food and Drug Administration (FDA) as an embolization device that can be placed in blood vessels to block or reduce blood flow to certain types of tumors and arteriovenous malformations.
LC Bead has never been cleared or approved by FDA as a drug-device combination product or for use as a drug-delivery device or 'drug-eluting' bead.
In fact, while
The FDA sought assurances in 2004 that Biocompatibles would not use FDA clearance for the device for embolization to market the device for drug delivery, according to a statement of offense to which the company agreed.
Biocompatibles told the FDA that 'under no circumstance' would the company use the embolization clearance to market the device for drug delivery.
However, two years later, Biocompatibles began marketing LC Bead for drug delivery through the company it hired to carry out its sales and distribution in the United States.
The distribution company told its sales representatives that LC Bead was '[a] drug-delivery device' and trained its sales representatives to 'aggressively penetrate the chemoembolization market.'
Sales representatives subsequently told health care providers that the device increased the level of chemotherapy delivered to a liver tumor and resulted in “better tumor response rates,...”
In December 2009, Biocompatibles filed an application with FDA for approval of LC Bead as a drug-eluting bead combination product. However, FDA informed the company that it was not accepting the application because clinical studies did not provide adequate evidence of a therapeutic benefit.Summary
So to summarize, this device was approved for a specific use (embolization). The company was admonished not to market the device for drug delivery, as there was no evidence that it was safe and effective for this use. The company promised not to market it for drug delivery, but allegedly did exactly that, and rather aggressively. Since there was no evidence that the device was effective or safe in that application, patients were implanted with devices that at best may have been useless, or even directly harmful, and all implanted patients were at risk of the usual complications from such devices.
The penalty to the company appeared substantial, until it is compared with the company's revenue, which was 447.5 million pounds sterling last year (look here).
However, despite the fact that the company did what it promised the FDA it would not do, and the likelihood that patients may have been harmed by these actions, it was only charged with "misbranding." Note that at least it did actually admit to misbranding, as it pleaded guilty to this charge. Yet despite the apparent egregiousness of all this, no individual at the company who may have enabled, authorized, directed, or implemented these dishonest and likely dangerous behaviors suffered any negative consequences.
Health care professionals who lie to patients about the risks of the procedures they perform on them are liable to lose malpractice suits, if not face criminal lawsuits. People at big companies that act analogously face... usually nothing adverse. Thus they exhibit impunity.
Thus the system appears to be rigged to favor of leadership and management of large companies, as opposed to health professionals, and particularly as opposed to patients. For years now we have discussed stories like this, which include allegations of severe misbehavior by large health care companies affirmed by legal settlements, but which only involve paltry financial penalties to the companies, and almost never any negative consequences to any humans. Furthermore, as in this case, these stories are often relatively anechoic, noted often only briefly in the media, and have inspired no real action by the US government.