Ennis & Ennis is dedicated to helping victims of defective and recalled traditional stents as well as the newer drug eluting stents throughout the country. If you or a loved one have been injured as a result of stent malfunction you may be entitled to compensation. For more information about your legal rights or to find out the latest recall information or for a free legal consultation contact our stent injury attorneys today.

- HeartWire

08/14/2007 - The US House of Representatives Committee on Energy and Commerce has sent letters to the FDA commissioner and to the CEO of Johnson & Johnson (J&J) requesting a slew of documents relating to an April 2004 warning letter sent by the FDA to Cordis/J&J regarding manufacturing of its Cypher drug-eluting stent (DES).

As previously reported by heartwire, the April 2004 letter was prompted by inspections of manufacturing sites the previous year. Most of the FDA's concerns pertained to a lack of appropriate documentation of control tests, manufacturing processes, packing and storing of the devices, and handling of complaints; in some cases, complaints to the company about stent thromboses were not addressed until the inspection took place, several months after the complaints were received. At the time, both the FDA and Cordis reassured physicians and the public that the warning letter had no bearing on stents already implanted and that there were no safety concerns about existing stents.

Energy and Commerce committee chair Rep John D Dingell (D-MI), and Rep Bart Stupak (D-MI), chair of the Subcommittee on Oversight and Investigations, sent the letters to the FDA and Cordis/J&J August 13, 2007.

The letter to J&J CEO William Weldon questions why the company was permitted to continue marketing its Cypher stent and asks for copies of all records relating to the 2004 warning letter; emails, telephone call notes, and meeting minutes from any discussion and correspondence between the company and the FDA between September 2003 and June 2007; any documents supplied by J&J to the FDA; and any internal J&J communications relating to any FDA inspections.

The letter to the FDA commissioner Dr Andrew C von Eschenbach asks for the FDA's version of the same documents, as well as all reports from the manufacturing site visits and all documents and correspondence produced by the FDA's Center for Devices and Radiological Health, by the FDA's Office of Regulatory Affairs, and by the commissioner's office relating to the inspections.

To heartwire, a Cordis spokesperson confirmed that the company had received the letters and would be cooperating with the committee's requests. She also noted that the 2004 FDA warning had been lifted in June 2007, when all of the items outlined in the warning were deemed resolved. "Consistent with typical FDA practice for warning letters related to quality issues, Cordis continued to manufacture the Cypher stent while it addressed the Good Manufacturing Practice deficiencies raised in the warning letter."

If you or a loved one have been injured during surgical placement of a stent or have been injured as a result of an implanted drug eluting stent (drug coated stent) such as the Boston Scientific Taxus stent or the Johnson & Johnson Cypher stent you may be entitled to compensation. To learn more about the stent recalls, for information regarding your legal rights, or the possiblilty of a class action lawsuit contact our stent lawyers for a free, confidential, case evaluation today. Fill out our online case evaluation form or call us toll free at 1-800-856-6405.