Why was a pharmaceutical company whistleblower fired?
Posted: Tuesday, June 5th 2007
What happens when the public learns that "dissolving" medical sutures failed to timely dissolve if they dissolved at all? Apparently, the whistleblower gets fired, that's what. The sutures were made by Ethicon, a subsidiary of Johnson & Johnson. They were designed to actively support internal healing for six months and then break down over the next one to two years. However, the sutures didn't always dissolve. Ethicon received complaints from surgeons and patients. These sutures partially dissolved, but remained in pieces. Small parts of the suture and infected tissue continued to linger around the surgery site, sometimes working their way through the patient's skin. Some patients required repeated surgeries to remedy the infections.
The FDA forced a recall of Panacryl in 2006. Two months later Ethicon fired Dr. Joel Lippman.
The FDA forced a recall of Panacryl in 2006. Two months later Ethicon fired Dr. Joel Lippman. Lippman sued Ethicon for wrongful termination and because it punished him ... because he blew the whistle.
Dr. Joel Lippman recently testified under oath to the following. First, the FDA approval process was painless. Panacryl sutures were put on the market without any clinical trials. Ethicon told the FDA that Panacryl was just like another long lasting suture, when in reality it was a different chemical compound. Ethicon had learned that the sutures were not dissolving in one to two years, but were taking three years, some never dissolving at all. Panacryl left a foreign substance in the patient's body. The braided structure design of the suture would become a site that attracted and harbored bacteria. Despite the evidence, which led Ethicon to quietly stop production on Panacryl in 2002, Ethicon did not issue a written warning about these problems. Ethicon was concerned that if Panacryl were recalled it would harm sales of another suture anchor sold by Johnson & Johnson, called Mitek.
So, Ethicon knew of the problem and failed to warn consumers. Apparently, Lippman learned of the problem and tried to help consumers. It looks like Ethicon then fired Lippman. Where does all this leave you? Hopefully, not with Panacryl sutures. Regardless, this course of events once again demonstrates how the current regulatory scheme, which relies too much on corporate self-disclosure, fails to protect consumers.