Synthes gets warning letter from FDA

EAST GOSHEN — U.S. regulators warned Swiss medical device maker Synthes Inc. about violations at its Brandywine plant on Goshen Parkway and said the company may have to pay a fine if it fails to fix the problems. Synthes did not have a good way of monitoring and investigating complaints about its devices, the Food and Drug Administration said in a warning letter posted online on Tuesday.
The FDA inspected the Goshen Parkway plant from June 22 through Sept. 15, 2011, it said in a letter dated Feb. 16. The letter was addressed to Michael Orsinger, Synthes president and chief executive at the Synthes USA headquarters, 1302 Wrights Lane East, West Chester.
The agency said in the letter that Synthes failed to report serious complaints about its devices to the FDA within 30 days, as required by law. “Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice,” Kirk Sooter, director of the FDA’s Philadelphia district office, wrote in the letter. The FDA also found Synthes did not follow good manufacturing requirements. An e-mail sent to Synthes headquarters in Switzerland Tuesday afternoon from the Daily Local News was not responded to before deadline. Synthes makes artificial spinal disc implants and other products used in spine surgery, as well as plates, screws and rods used to repair the bones of trauma patients. The company generated sales of $4 billion last year. Synthes is in the process of being bought by Johnson& Johnson for $23.1 billion, J&J largest-ever acquisition. The deal must first gain approval from antitrust regulators. The acquisition would help to bolster the New Brunswick-based health-care giant’s medical device business. Synthes’ manufacturing issues come after J&J had its own series of high-profile product recalls and quality control problems with products such as infant Tylenol and artificial hips. The FDA said Synthes responded to its initial complaints on Sept. 29 but the agency did not have evidence that the company had corrected the problems. “We reviewed your firm’s response and conclude that it is not adequate,” the letter said. “Your firm did not provide evidence that its correction and corrective actions have been implemented.” Synthes has 15 days to respond to the FDA’s letter. In addition to fines, the company faces the possibility of a court injunction and delays in possible product approval if the violations are not corrected. The letter from the FDA came four days after the families of two elderly patients who died on the operating table during spine surgery involving the use of Synthes’ Norian XR bone cement sued the company and four former executives for wrongful death and elder abuse. The bone cement did not have FDA approval for that procedure. The lawsuit, filed in California Superior Court on March 2, was brought by the families of Ryoichi Kikuchi and Barbara Marcelino, both 83. They died after surgeons injected the bone cement during their procedures, but there is no definitive link between their deaths and use of the cement as a cause of death, according to published reports. Synthes paid about $24 million in fines and penalties to settle criminal charges brought by the U.S. Attorney’s Office in Philadelphia over the use of its product. Four Synthes executives – Michael Huggins, Thomas Higgins, Richard Bohner and John Walsh – are in federal prison now after pleading guilty to charges related to their role in the case.
Source:Gretchen Metz.http://dailylocal.com