Nine months after the FDA issued a Class I recall over its faulty leads, St. Jude Medical's ($STJ) Riata defibrillation debacle drags on. Now, as doctors work to remove the leads (even some that still work properly), affected patients are paying the price with mounting healthcare bills, The Wall Street Journal reports.
Patients who undergo the surgery are dealing with co-payments, travel costs and other related bills in the thousands of dollars to get the leads out of their bodies, the article notes. And while the company is informally covering many of those expenses beyond the warranty coverage for the leads themselves, it isn't advertising its policy, according to the article. What's more, many doctors aren't aware of the extra reimbursement.
It's not as if there aren't options for patients. Medicare and private insurers, importantly, are covering much of the price tag for the replacement surgeries. And St. Jude's 5-year warranty for Riata also pays $600 and provides a free Durata lead, considered to be a safer, next-generation alternative. But a company spokeswoman told the WSJ that using a defibrillator lead from a rival company would void the warranty. (Medtronic ($MDT) told the WSJ that it honors its own warranty, even when doctors use a rival's leads for replacement in the face of a similar recall.)
St. Jude said it is covering the added costs beyond the warranty on a case-by-case basis once the company learns of an individual patient's situation.
Meanwhile, St. Jude's troubles could grow in the face of a new study that says the company's Durata leads are creating problems similar to the recalled Riata devices.
- read the WSJ story (sub. req.)
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