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An ethical dilemma that Pfizer faced was how to prove the efficacy of the device by clinical testing. The FDA regulates this process by giving its mark of approval to products that meet certain guidelines; but in this case, this process was not properly adhered to. It is very difficult to confirm an organ design’s efficacy when there are many differences between clinical testing and other factors in real life. When they learned about the defect of the strut design, Shiley made the necessary corrections for it. However, he kept this information secret from the FDA and doctors who used the valve to treat their patients.
So the ethical dilemma would be either to continue to promote the product because it satisfies the statistical requirements, or to recall the product in name of the dangerous liabilities it entails regarding patients; there are too many risks of other failures that may cause great pain for patients. On top of removal from the market, the Shiley heart valve case resulted endorsement of strong regulation requirements on medical devices by FDA which failed to take action on Bjork-Shiley heart valve in time .
Had the company conducted itself properly, it is likely that the Bjork-Shiley valve would still be on the market. Studies showed that the real problem was not the design of the heart valve itself. If the strut welding had only been made more secure, the whole ordeal might have been avoided . Plainly speaking, Pfizer’s deceptive practices in marketing, such as continuing to minimally refurbish defective models, resulted in many needless medical complications and deaths in its customers. This could have been avoided if Pfizer was honest with the FDA and medical professionals.
Without a doubt, it was not only Pfizer who was accountable. In this case, the FDA must also be included. Before going on the market, the new Bjork-Shiley heart valve was granted approval by the FDA, who would be responsible for monitoring the company’s manufacturing every two years. However, it was claimed that the FDA also did not test the pacemaker rigorously enough in the pre-market approval process. Furthermore, the FDA failed to inspect the plant according to schedule.

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