A Medical Device Daily

Still another class action lawsuit has been filed against Medtronic (Minneapolis) on behalf of all Californians implanted with Sprint Fidelis leads, the wiring that connects a defibrillator to the heart, related to the lead recall issued in mid-October (Medical Device Daily, Oct. 16, 2007).

California resident Rashid Hunter is seeking a court order holding Medtronic responsible for all diagnostic and medical charges and any corrective surgical expenses caused by Medtronic’s allegedly faulty device, according to Lieff Cabraser Heimann & Bernstein (San Francisco), the law firm representing Hunter.

The lawsuit, Hunter v. Medtronic, Inc., was filed in federal court in San Francisco at the end of December, alleging that Medtronic misrepresented the safety of its Sprint Fidelis leads and failed to warn that the leads were prone to breakage.

Wolf Popper, a New York law firm, filed a lawsuit against Medtronic in November (Medical Device Daily, Nov. 12, 2007) in the U.S. District Court for the District of Minnesota, on behalf of investors who purchased Medtronic common stock from June 25, 2007, through Oct. 15, 2007.

Prior to that, multiple lawsuits were filed against the med-tech giant, with those implanted with the leads claiming injuries received as a result — just days after the recall.

Medtronic suspended sales and recalled all unused Sprint Fidelis Leads on Oct. 15 of last year after receiving reports of at least five fatalities linked to lead fractures.

Hunter said that he lives “in constant fear, wondering if my lead will malfunction and kill or cause me severe pain as it has done to others. My family also lives in fear that the device will fail and I won’t be able to get help in time to save my life. It would be a great relief to me and my family if Medtronic was required to fund a program to monitor the health of every patient with the recalled leads.”

The FDA approved the Fidelis defibrillation leads in September 2004 (MDD, Sept. 3, 2004). At 6.6 Fr in size, the leads were the world’s smallest right ventricular defibrillation leads, allowing for compatibility with 7 Fr introducers, according to Medtronic. The small size of the leads was intended to help improve passage into a patient’s venous system for an easier implant, and minimize venous obstruction.

The reports of lead failures led Medtronic to send a letter dated March 21, 2007, to physicians treating patients with the Sprint Fidelis leads, describing the nature of the failures and attributing those failures to physician error, or “variables within the implant procedure.”

One of the suits says that Medtronic continued to receive reports of lead failure after March 21 and that the number of lead failures grew from 795 injuries reported by April 30, 2007, to a total of 1,053 injuries reported by June 30, 2007.

In other court news: Sharps Compliance (Houston) and Medical Depot (d.b.a. Drive Medical Design & Manufacturing; Port Washington, New York) reported that they have settled a patent dispute related to the Sharps Pitch-It IV Poles.

With the settlement, Drive Medical will be the exclusive manufacturer and Sharps will be the exclusive seller of the poles.

Burton Kunik, president/CEO of Sharps, said, “We look forward to a successful relationship with Drive Medical whereby we can leverage their metal manufacturing expertise with our customer base and ability to sell the product across many industries including home healthcare.”

Sharps says that its Pitch-It IV Poles are designed to eliminate the frustration of retrieving, cleaning, bagging and tagging old IV poles.