Laser Companies Won't/Don't Share Blame for Mishaps w/Docs

Safety Concerns Regarding IPL, Lasers, and Other Cosmetic Medical Devices

Laser Companies Won't/Don't Share Blame for Mishaps w/Docs

PostPosted by DCNGA » Fri Dec 03, 2010 3:56 pm ... ail/696828

This is a hypothetical situation presented by the author of this article (although this doctor (IMO) is not one of the good guys, at least he put this out there). I think this is the same doc the guy on Spa MD got into verbal battle with:

Learned intermediary doctrine stipulates that a drug or device manufacturer has duty to inform physician of basic characteristics of product
Physician may feel he wasn't adequately trained by a device rep, but responsibility for treatments is his

David Goldberg, M.D., J.D.

Dr. Light has been in practice for 25 years. He has always prided himself on the quality of his dermatologic care. He is known as a medical dermatologist with expertise in the treatment of acne, psoriasis, inflammatory dermatoses and skin cancer. He has never considered himself a "cosmetic dermatologist."

Over the past several years, however, Dr. Light has become wary of the decreasing insurance reimbursement he receives in his practice of medical dermatology. He finds himself working more hours and seeing more patients, and yet he cannot keep up with his increasing overhead.

Dr. Light makes the decision to learn more about cosmetic procedures. He feels that if he treads slowly and approaches the learning process of cosmetic dermatology the same way he approached medical dermatology, he can't go wrong.

He attends cosmetic sessions at the annual American Academy of Dermatology meeting and joins the American Society for Dermatologic Surgery and the American Society for Lasers in Medicine and Surgery.

For three years, he attends numerous cosmetic sessions at all of these meetings. He learns much about techniques, safe approaches and the avoidance of complications before he finally he purchases his first laser.

At the in-service for this device, Dr. Light realizes that his three years of studies ultimately do not provide him with what he needs to use the new device successfully. A representative from the company from which he bought the laser spends two days with him and his staff, and together he and the laser representative treat five patients. Dr. Light writes down all of the treatment parameters, and he feels he is finally ready to treat his own patients.

Three days later, Dr. Light treats his first paying patient, doing exactly what the laser representative told him to do. Unfortunately, this patient is burned by the device and has terrible facial scarring. Dr. Light is sued.

It turns out that his patient's skin was different than those of the initial five patients. The laser representative had forgotten to mention the appropriate treatment parameters for this skin type. The representative apologizes to Dr. Light, but Dr. Light tells his attorney that the laser company (through its representative) should be liable. At the very least, he suggests, they should share liability. Is Dr. Light correct?

Legal doctrine

Looking at similar situations with physicians prescribing medications or using devices such as that used by Dr. Light, courts will often invoke the learned intermediary doctrine.

The learned intermediary doctrine stipulates that a drug or device manufacturer has a duty to inform the physician about the basic characteristics and qualities of the medication sold or the device being used. The manufacturer or its representative needs to provide basic instructions. This would apply to both tetracycline antibiotics and a laser device. Once this training has occurred, the physician then becomes the "learned intermediary" between the seller and the patient.

The physician, using his or her knowledge of the medication prescribed or laser used (as well as the knowledge of the patient's needs and condition), would then be the one upon whom the patient relies, rather than the manufacturer or the manufacturer's representative. At this point, the physician is in the best position to determine which medications or laser settings are suitable for the patient, based on knowledge of the risks and the needs of the patient.

Laser parameter information with regard to fluences, pulse durations and cooling and the known and defined risks of the procedure is necessary for the dermatologist to make a reasonable decision about the risks and benefits of treating a particular patient. Given the complexity of this information, most courts have determined that the manufacturer does not share the physician's duty.

Dr. Light may feel that he was not adequately trained by his laser rep, but ultimately, the responsibility for treatments is his.

"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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