FDA QUESTIONS ST. JUDE MEDICAL
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
by Thamanna Hussain
The Food and Drug Administration released a report that raises concern about the medical devices that St. Jude, a medical device company, produces. After this release, many individuals question the company's reputation and the health of patients as they were alleged of covering a product's name in a public document. The FDA report criticized St. Jude's testing of the Duratta, which is a term for wires that connect an implanted defibrillator to a patient's heart.
According to the FDA, St. Jude blocked out all 20 references to the Duratta in the report filed with the Securities and Exchange Commission. The company argues that they had done so out of "good faith" and out of fear that the FDA would react negatively if names of products were mentioned. Nonetheless, both an FDA spokeswoman and a lawyer who specializes in medical devices, countered those arguments by stating that names of approved products do not qualify as information that the FDA would redact. The company's earlier heart wire named "Riata" has also begun failing early in some of the 128,000 patients worldwide who received the wire. On the other hand, the Durata has already been implanted in 278,000 people.
This poses as a significant challenge for several patients who now have to decide whether to leave the heart wire in place or have it surgically removed, which involves possible risks and dangers.