Chief Medical Officer Blows Whistle On Johnson & JohnsonDec 13, 2006 | www.courthousenews.com
Johnson & Johnson subsidiary Ethicon fired its chief medical officer because of his insistence that unsafe medical products be recalled, Dr. Joel Lippman claims in Middlesex County Court. Lippman claims that during 15 years in high-ranking medical positions at Ethicon and Ortho McNeil, another J&J subsidiary, Johnson & Johnson repeatedly released or refused to recall dangerous products to which he objected, including the Ortho-Evra birth control patch and Intergel.
Both products have spurred numerous product liability lawsuits. Lippman says he objected to the release of the Panacryl suture, “whose use resulted in numerous adverse events,” but Ortho released it anyway and continued to receive reports of “adverse events.” He says he objected to the release of ProCeed, a “mesh product,” but Ortho released it anyway, until the FDA forced a recall. He says he told Ethicon it must inform surgeons that an endoscopic applicator leaks chromium during use, but Ethicon refused. He says he was fired less than a month after insisting that Ethicon recall a product called DFK24, used in heart bypass surgery, because its tip fell off and had to be fished out of the aorta.
Lippman has been an assistant professor of obstetrics and gynecology at Tufts, director of the clinical development division of medical affairs for Wyeth-Ayerst Laboratories, and worked for Ortho McNeil from 1990 to 2000, leaving that company as vice president of clinical trials.
He worked for Ethicon from July 2000 until May 15, 2006. He got his M.D. at New York Medical College and has a Master’s degree in public health from Harvard.
He claims that from 1998 to 2000, his last two years at Ortho, he “raised serious health concerns about two pharmaceutical products: Ortho-Prefest, a hormonal menopausal product, which did not have adequate safety data to prove that it protected against uterine cancer as did other therapies, and the Evra patch, which released dangerously high levels of estrogen into patients.”
Lippman claims, “The clinical research had revealed that the estrogen dose released by the Evra patch as a means of birth control may increase the risk of deep venous thrombosis and pulmonary embolisms.”
Ortho faces hundreds of lawsuits making precisely those claims – including 12 filed Tuesday in Newark Federal Court.
Lippman says he “advised Ortho that it should conduct further research to understand the impact of the hormones released by the patch and if necessary modify the package insert before introduction to the marketplace. (But) Ortho disregarded Dr. Lippman’s concerns and launched the product. J&J transferred Dr. Lippman to Ethicon in 2000, shortly after Dr. Lippman made his complaints about the menopausal product and the Evra patch.”
Soon after joining Ethicon in July 2000, Lippman says, he objected to the release of its “Corlink” device because data showed it “caused occluded arteries”. He says he also objected because of the “lack of adequate studies to justify the product’s release” and because a competing company had released a similar product, which had to be recalled and resulted in “numerous product liability suits.” Lippman says his boss told him that “if he continued to oppose the launch of Corlink, his action could affect his bonus and standing with the company.” His bonus could be as much as 50 percent of his annual salary, the suit states.
Lippman says that in 2002 he “insisted on the recall of a product known as Intergel” which “had caused serious injuries and was related to a number of deaths.”
Intergel also has been the basis of numerous product liability suits, which claim the product spreads infection during surgery, rather than prevent it.
Lippman says that he demanded for more than a year that Intergel be recalled, and that after “a decision to recall the product was made,” he was summoned to the officer of Michael Dormer, “Chairman of Medical Devices and Diagnostics for J&J in New York City,” where Dormer and four attorneys attacked him “for the decision to recall Intergel”.
Lippman claims he also objected to the release of Panacryl, “a suture whose use resulted in numerous adverse events,” and ProCeed, a “mesh product.” He says that despite his objections, Ethicon refused to recall Panacryl “and Ethicon continued to receive reports of adverse events.” And he says, “The FDA later required Ethicon to recall ProCeed.”
He says Ethicon ignored his advice, in late 2005, to warn physicians that a device called FS2 was not sterile because of two holes in it. In response, he says, “a member of Ethicon’s Quality Assurance Board stated that ‘surgeons are like five year olds. We need to control what is said to them.’”
He says he learned in April this year that an endoscopic applicator “was leaking chromium, a toxic heavy metal,” and that he “insisted that Ethicon notify physicians who had used the applicator during recent clinical usage that the applicator oozed chromium during use. (But) Ethicon ignored his objections.”
And in the case that he claims led directly to his illegal firing, Lippman says that by April this year he had received three complaints that an Ethicon arterial cannula called DFK24, a life-sustaining device used in heart bypass surgery, lost its tip during surgery, and had to be retrieved from the patient’s aorta. He says he and the vice president of medical operations, a cardiac surgeon, decided in April that the DFK 24 must be recalled because “the risk of serious injury or intra-operative death was very high.” Ethicon’s Quality Assurance Board decided to recall it on April 14, but Ethicon refused, and still had not recalled it when it fired him on May 15, Lippman says.
Lippman seeks punitive damages.