Executive Summary
Successful malpractice suits against physicians for complications arising from medications or devices that were pulled from the market are unlikely.
A provider might be found liable if there is evidence that a provider was aware that products violated federal and state regulations.
The plaintiff generally has to demonstrate that an average provider would have known the product was about to be pulled from the market.
Physician practices should create an inventory of equipment and devices.
Most likely, a physician will not be liable for damages a patient incurs from a medication or device that was pulled from the market, says Mary C. DeBartolo, JD, an attorney in the Chicago office of McGuireWoods.
Many clinics and practitioners were sued after the fungal meningitis outbreak in October 2012 as a result of the tainted compounded products provided by the New England Compounding Center in Framingham, MA.
"Although it may be unlikely that the providers will be found liable, if there is evidence that a provider was aware that the compounded products violated federal and state regulations or that the products were substandard products, then there is a possibility that a provider may be found liable," says DeBartalo.
Plaintiff has uphill battle
The plaintiff can argue that the physician should have known a medication or device was about to be pulled from the market and, therefore, the physician should not have prescribed it to the patient. "But the plaintiff would have to produce evidence supporting this argument, which may be difficult," DeBartolo says.
The plaintiff would most likely have to demonstrate that the provider should have known that the product was about to be pulled from the market and that an average provider would have known this information. "This seems like an uphill argument to make, and very much dependent on the facts and circumstances," says DeBartolo.
To prevail on such a claim at trial, a plaintiff will have to present expert opinion testimony that establishes a "standard of care" for the physician under the specific facts and circumstances of the case, says Madelyn S. Quattrone, Esq., senior risk management analyst at ECRI Institute, a Plymouth Meeting, PA-based organization that researches approaches to improving the safety, quality, and cost-effectiveness of patient care.
"The question is what information, if any, is a physician required to know with regard to a potential recall action of the FDA." asks Quattrone. "The reliability of information from secondary sources’ may be called into question."
Strategy needed
Whether a physician would be held liable depends on the plaintiff’s theory of liability as applied to the unique facts and circumstances of the case, whether the manufacturer is also a defendant in the lawsuit, and the theory of liability against the manufacturer, says Quattrone.
ECRI Institute is aware of at least one case in which recall information about an affected device did not reach all areas of the organization where the device was used.
"Organizations must therefore, have comprehensive risk management strategies to identify recalled medical devices and medications and to safeguard against using the affected medical device or medication," says Quattrone. She gives these recommendations:
• Physician practices should create an inventory of equipment and devices.
For each device, the practice should list the manufacturer, model, and serial number; the software version if applicable; acquisition and warranty expiration dates; the maintenance provider and contract dates, if applicable; and contact information for requesting maintenance.
"The practice should also maintain an inventory of all vaccines, medications, and biologics maintained within the practice," says Quattrone. "Document information such as drug strength, drug lot numbers, and expiration dates."
• The practice should have a process for receiving and communicating drug hazard and recall information regarding any medications, vaccines, and biologics used within the practice.
"When a physician practice receives a recall or hazard notice from a manufacturer or distributor, it becomes responsible for taking appropriate corrective action," Quattrone explains.
If the practice fails to take appropriate action after receiving such notice and a patient is injured by the defective device or affected medication, the physician might be found negligent.
"It may also bear legal responsibility for improper modifications made to a medical device as a result of a recall notice," says Quattrone.
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Mary C. DeBartolo, JD, McGuireWoods, Chicago. Phone: (312) 849-8192. Fax: (312) 920-6160. Email: [email protected]
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Madelyn S. Quattrone, Esq., Senior Risk Management Analyst, ECRI Institute, Plymouth Meeting, PA. Phone: (610) 825-6000 Ext. 5151. Fax: (610) 834-1275. Email: [email protected]
