doctor at lincoln hospital performed "experimental" knee replacement surgery on hispanic patient without telling him

In August 2004, the Law Office of Anthony T. DiPietro learned that a certain doctor at Lincoln Hospital in the Bronx was implanting non-FDA approved prosthetic knees into patients that were manufactured by a foreign corporation which goes by the names PLUS ORTHOPEDICS, PLUS ENDOPROTHETIK AG, and ENDOPLUS. An investigation is currently underway to determine how many other unsuspecting patients were enrolled in this "experiment" in the company's cold-harted attempt to gain US Food and Drug Administration approval, without ever telling their patients about the experimental nature of this device.

On July 9, 2002 one of our clients went to a doctor at Lincoln Hospital to have his knee replaced after suffering from arthritis for many years. It wasn't until several months after the surgery, a time that was wrought with even more pain, that our client first learned the artificial knee implanted in him was not approved by the United States Food and Drug Administration (USFDA) for use in this country.

All companies who manufacture medical devices for sale in the United States must first obtain approval from the United States Food and Drug Administration prior to distributing these devices to doctors and hospitals. In order to obtain USFDA approval, a manufacturer must be able to demonstrate that the device has a proven track record of being both safe and effective for its intended use. This is typically done by the manufacturer performing studies on a large group of patients and documenting the results.

When a device is not yet approved, the USFDA requires that the device manufacture obtains the express written consent of the patient acknowledging that the patient knows the device is not approved, and that the patient nevertheless desires to proceed with the experimental procedure. Yet despite these clear and rigid regulations, the foreign manufacturer in this case, Lincoln Hospital, and the defendant doctors all completely ignored these requirements and implanted this experimental device into this particular patient without ever telling him about the experimental nature of the procedure.

It is currently unknown how many other unsuspecting patients were used as virtual "guinea pigs" in the quest to gain governmental approval for the ENDOPLUS device. If you, or someone you know, has undergone a knee replacement procedure at Lincoln Hospital between 2000 and the Present, and you have experienced complications with the device, you may be entitled to financial compensation. If so, you may contact our office for a free consultation and evaluation.