Following recent high-profile recalls of implanted medical devices like the defibrillators made by Guidant Corp. and a drug-injection port from Boston Scientific Corp., some doctors are pushing for device-makers to be required contact affected patients directly, according to The Boston Globe.

The Food and Drug Administration often requires companies with defective products to contact providers, putting the onus on individual physicians to contact patients.

Physicians are not typically set up for rapid communication with a detailed database of patients by what products and drugs they have used or are using, so physician notification can be time consuming and potentially may miss specificl patients who should have been notified. Patients learn of recalls through the news.

Doctors who favor company notifications point out that the company is better equipped to identify and warn patients, just as automanufacturers do with safety recall notices. Companies typically maintain warranty databases of all patients receiving their products .

Delays caused by the current process could result in harm to a patient and could be avoided by requiring direct manufacturer notifications to patients. Any risk of adverse outcomes due to delay in notification would be the responsibility of the company causing the product problem and not a source of potential malpractice claims against physicians who were not equipped to track and notify patients.

"We've already seen problems where physicians aren't getting in touch with patients quickly," said Stephen Seller, a Philadelphia attorney who represents a number of patients who received a Guidant device, according to The Boston Globe.

Industry opponents of the proposal, however, fear that patients will panic when they receive notification of a recall. They suggest that a meaningful conversation with their doctor is the better way to learn of the recall, according to The Boston Globe.

That argument, however, appears a little thin when many patients are already learning of the actual recall by way of the news media, and any panic will have already set in. Company notifications to the patient actually have the potential to state the facts and make recommendations to contact the patient's physician. In many cases, this will expedite patient contact with the physician. It also offers the Company an opportunity to educate the patient on the source and implications of the problem to help alleviate panic.

The crux of the issue though is that the company has the data and means of direct contact to assure that all patients are promptly notified in a systematic approach that minimizes the risk that a delay may harm a patient. They are uniquely able to provide notification, and it is appropriate that the burden of the effort should rest with the company with the potentially defective product, and not on the physician that relied upon the product to help a patient.

If I were the attorney for the company, I would look at direct notification as something the company should do to manage their risk of adverse outcomes, minimize corporate PR and stock impact, and minimize any products liability claims that could occur.

Company direct notification appears to serve the best interests of the company, the physician, and the patient.