Drug Industry to Revise Marketing Code | Medtronic Sprint Fidelis Lead Recall Lawsuit Attorney

Given the growing number of reported problems involving fractures and shocks with the Medtronic Sprint Fidelis leads and the increasing lawsuits filed by Medtronic recall patients throughout the United States it is instructive to look at the drug industry’s latest voluntary marketing guidelines that are expected to be announced this week. Although the guidelines do not apply to medical device companies it reveals the close relationship between the drug and device manufacturers and doctors.

This Thursday the Pharmaceutical Research and Manufacturers of America (PhRMA) Board of Directors is expected to announce their new marketing code. This voluntary guideline drafted by the industry’s trade association (PhRMA) will ask the chief executives of large drug manufacturers to provide written certification that “they have policies and procedures in place to foster compliance with the code.”

The new marketing code is supposed to ban pharmaceutical marketing campaigns that in the past have provided doctors with gifts such as mugs, pens and pads. The code requires drug companies to set annual limits on the amounts they pay doctors for educational lectures. However, the industry code fails to define any limits on money spent on speaking and consulting arrangement between the drug makers and doctors throughout the country. Furthermore, these new guidelines do not apply to biotechnology or medical device companies.

PhRMA Chairman and Chairman and CEO of Merck & Co., Inc., Richard Clark, stated “Informative, ethical and professional relationships between healthcare providers and America’s pharmaceutical research companies are instrumental to effective patient care”.

Among its changes, the revised Code:

- Prohibits distribution of non-educational items (such as pens, mugs and other “reminder” objects typically adorned with a company or product logo) to healthcare providers and their staff. The Code acknowledges that such items, even though of minimal value, “may foster misperceptions that company interactions with healthcare professionals are not based on informing them about medical and scientific issues.”

- Prohibits company sales representatives from providing restaurant meals to healthcare professionals, but allows them to provide occasional meals in healthcare professionals’ offices in conjunction with informational presentations. The Code also reaffirms and strengthens previous statements that companies should not provide any entertainment or recreational benefits to healthcare professionals.

- Includes new provisions that require companies to ensure that their representatives are sufficiently trained about applicable laws, regulations and industry codes of practice — including this Code — that govern interactions with healthcare professionals. Companies are also asked to assess their representatives periodically and to take appropriate action if they fail to comply with relevant standards of conduct.

- Provides that each company will state its intentions to abide by the Code and that company CEOs and Compliance Officers will certify each year that they have processes in place to comply, a process patterned after the concept of Sarbanes-Oxley compliance mechanisms. Companies also are encouraged to get external verification periodically that they have processes in place to foster compliance with the Code. PhRMA will post on its Web site a list of all companies that announce their pledge to follow the Code, contact information for company compliance officers, and information about the companies’ annual certifications of compliance.

For more information on Medtronic recall lawsuits and Sprint Fidelis medical and legal news please visit injurygroup.com

Why are the Sprint Fidelis leads being recalled?

Sprint Fidelis leads are manufactured by Medtronic, the medical device manufacturer headquartered in Minnesota. Medtronic’s Spring Fidelis leads consist of cardiac electrodes which are thin wires. These electrodes connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) to the heart.

The Sprint Fidelis leads were recalled by Medtronic due to the potential for lead fractures. Following reports of fractured leads and at least 5 patient deaths, Medtronic recalled their Sprint Fidelis lead. Patients may be at an increased risk of having their leads fracture or break. If this happens the defibrillator could deliver painful shocks or jolts or fail to operate at all.

The following Sprint Fidelis lead model numbers have been recalled:
• Sprint Fidelis 6930
• Sprint Fidelis 6931
• Sprint Fidelis 6948
• Sprint Fidelis 6949

For more information please visit the Fields Law Firm Medtronic class action lawsuit website.

Medtronic Sprint Fidelis Recall | Medtronic Heart Device Patient Letter

On October 15, 2007, Medtronic sent a letter to Medtronic heart patients. As you can see in the letter, patients are left with the difficult problem of either leaving a potentially defective lead implanted or undergoing another operation to remove the leads which runs the risk of complications. Here is the full text of that letter.

Important Patient Information
Sprint Fidelis^® Lead Performance

October 15, 2007

Dear Medtronic Heart Device Patient:

Medtronic recently provided doctors with important information about our Sprint Fidelis defibrillation leads (Models 6930, 6931, 6948, 6949). We have informed doctors who, according to our records, manage the care of patients with Sprint Fidelis leads. A defibrillator system consists of a device implanted near the shoulder and one or more leads connecting the device to the heart. This information applies to Sprint Fidelis leads only, not implanted defibrillation or pacemaker devices. If you have a Sprint Fidelis lead, your Patient ID card should contain one of the following 4 sets of numbers: 6930, 6931, 6948, 6949. These numbers may be shown at the beginning of a longer set of numbers on your ID card.   

We have found that there is a small chance of fractures in particular locations on the Sprint Fidelis lead. If you have a Sprint Fidelis lead, the chance there is a problem with your lead is small. Patients with a Sprint Fidelis lead are more likely to experience complications from removal than from a problem with a Sprint Fidelis lead. However, doctors may choose to change the way a device is programmed to help reduce any potential problems. An independent panel of physician experts recommends against removing Sprint Fidelis leads except in very unusual circumstances.

If you have a Sprint Fidelis lead, you may have already heard from your doctor’s office regarding this matter. We encourage patients with Sprint Fidelis leads to contact their doctor’s office with any questions about their leads or the information in this letter. The information we provided doctors is more detailed, since they are in the best position to know how to manage patient care in light of specific health considerations.

We sincerely apologize for any difficulties this may cause you and your family. We are committed to answering your questions, keeping you informed, and continuously improving our products. If you have additional questions or would like to inquire if you have a Sprint Fidelis lead, please contact Medtronic Patient Services at 1 (800) 551-5544 x41835 (7am to 9pm CST).

Sincerely,

Reggie Groves
Vice President, Quality and Regulatory
Medtronic Cardiac Rhythm Disease Management
Medtronic, Inc.