What motivates action? There are many answers, but in the case of medical devices it should not be first and foremost profit. Rather well medical ethics should dictate that healing and the improvement of health for the public should be the top priority. As an ethics expert who does lots of work in the medical field, this article should be one that raises multiple ethical questions.
If you were about to buy a new car and you heard that “every once in a while” the brakes failed at highway speeds, would you buy it? My guess is, you would say “probably not.” Suppose the car company decided to change the name of the automobile but didn’t do a thing to fix the brakes, would you buy it then? I think I know your answer to that as well! To that end, there was a disturbing story carried by NBC News on December 31, 2015 entitled: “Why Did Firm Keep Selling Problem Blood-Clot Filters?”
According to the article:
“A company that made a blood-clot filter associated with 27 deaths and hundreds of problems replaced the device with a modified version that it knew had similar and potentially fatal flaws soon after it was put on the market.
Confidential company records…show that New Jersey-based medical device giant C.R. Bard was concerned about reports of failures for its G2 series filters, designed to replace the company’s Recovery filter, within four months of being cleared to sell the G2 by the Food and Drug Administration.
Instead of recalling the G2 filter, and the virtually identical G2 Express, the medical device manufacturer decided to keep them on the market for five years, until 2010, selling more than 160,000 of them.”
It has now come to light that at least 12 patients have died who were using the “new and improved” product. A surgeon who specializes in removing the filters, Dr. William Kuo, a world-renown interventional radiologist who runs Stanford Health Care’s IVC Filter Clinic stated: “The number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.”
An experiment that failed
The Bard filters were designed to stop blood clots from entering the heart and lungs. They are one of 11 companies making such devices and it is estimated, according to the article that about 250,000 filters are in use. Bard’s product was approved by the FDA in 2002 but “reports of deaths and injuries associated with it moving and breaking steadily climbed.” Of all of their competitors, the Bard device had the most problems.
Here is where the questionable ethics on the part of the company take over. The company never recalled its original product. In 2005, they replaced it with a new and improved model that was still not been successful in addressing the original problems. The following quotation from the article is, I believe, extremely important to include here:
“A confidential memo written in December 2005 by a Bard vice president soon after the G2 was cleared by the FDA shows his concern about “problems with…migration,” “tilting” and “perforation.” He also noted that Bard had another filter on the market that had virtually no complaints. “Why shouldn’t doctors be using that one rather than the G2?” he asked.
In other words, the company knew that there might be problems associated with the product. They had yet another blood filter product that caused no problems, but they didn’t “push it.” We can only surmise that either it wasn’t profitable enough to do so or pure ego did not allow the marketers and research teams to admit product failures. Either choice is an extremely arrogant and unethical decision. Meanwhile, Dr. Kuo has by now removed 1,000 of these failed filters! Had not his team come up with an advanced technique for removal I shudder to think how many fatalities might have occurred.
However, the case is far deeper and more wide-reaching than Bard’s seeming lack of ethics. The FDA needed – and still needs – to step in and protect patients from this device. So far, they have failed to do so. To admit they approved a device that had as many problems as the original does not resonate well in the halls of bureaucracy.
Not surprising, Bard has declined to be interviewed on this matter, but predictably they issued the usual trite commentary about how committed they are to the lives and welfare of their patients. I have long called for comprehensive ethical training in both the medical device and pharmaceuticals industries. This case appears, once again, to support my argument.
Your Comments are welcome!
