A doctor’s note to Johnson & Johnson (J&J) executives criticizing their marketing of a dangerous metal hip device was one of several memos that emerged during the first trial of more than 10,000 lawsuits against J&J. The note claimed the DePuy ASR hip device was poorly designed and the company should slow its marketing until they better examine why patients were suffering side effects such as hip replacement failure.
The doctor, who was also a paid J&J consultant, wrote the note nearly two years before the company recalled the ASR in 2010. Despite the fact that this was only one of several early warnings the executives received from consultants, J&J’s DePuy subsidiary continued to sell the device and no one alerted doctors who continued to implant it in patients’ bodies.
J&J insists it responsibly determined when to recall the ASR, but plaintiffs’ lawyers allege the executives put profits ahead of patients and even planned to fix the device instead a New York Times article explains. This conflict points to a bigger medical issue that involves physicians’ ethical obligations to warn about dangerous medical devices.
Why would doctors keep quiet, when they know people will get hurt? They may fear subsequent lawsuits against them; some claim to be too busy to file paperwork with the U.S. Food and Drug Administration (FDA); or they may believe that a product’s defect was their fault, the article explains. Another reason doctors remain silent is their financial ties to a drug or device maker. And breaking ties can carry a cost.
For example, when orthopedic specialist Dr. Lawrence D. Dorr wrote an open letter in 2008 to warn fellow surgeons a Zimmer Holdings hip implant was flawed, a whisper campaign questioned his skills as a surgeon. His practice suffered for a year.
Doctors have traditionally drawn attention to medical issues by publishing their research in a medical journal, which not only ensures the data’s credibility but also protects the researchers from attack. Unfortunately, studies often take a year or more to be published. For example, data were published about J&J’s flawed hip device, but most did not appear until after the recall.
The repercussions of not speaking out are playing out during the first J&J trial. The DePuy ASR multidistrict litigation (MDL) consolidates similar pending lawsuits into one case under one federal judge.
Many patients with the ASR hip have suffered from hip implant failure, which can cause pain, fatigue, walking difficulty, lack of flexibility, hip popping or squeaking, and swelling in the surrounding tissue. Some of these symptoms point to metal poisoning or substantial tissue loss that can never be restored.