Article Link: https://www.icij.org/investigations/implant-files/patient-hopes-rise-and-fall-as-an-industry-balances-progress-and-profit/

Article Title: Patient Hopes Rise and Fall as An Industry Balances Progress and Profit

By Dean Starkman and Delphine Reuter

The article starts with a description of a 2008 sales meeting for DePuy Orthopaedics, Inc., a subsidiary of Johnson & Johnson. The sales gathering was more of a party than a meeting: sales executives were dressed up in costumes, music was blaring, and people were cheering, hooting and hollering.

The reason for the celebration? DePuy Orthopaedics had just made one billion dollars selling the DePuy Pinnacle, a hugely popular metal-on-metal hip implant.

At the gathering, Pinnacle inventor and celebrated orthopaedic surgeon Thomas Schmalzreid stood on stage, proudly calling his device a “billion-dollar baby” and “the market leader.”

Schmalzreid continued boasting about the product’s success to a crowd of cheering Pinnacle salesmen, “Did you know that the first billion is the hardest? Billion here, billion there. Pretty soon it adds up to some real money.”

It was later found that DePuy was not necessarily making an honest living from the Pinnacle device and its sister model, the ASR XL. In fact, the huge profits were driven by intense marketing and “bribes to surgeons.”

Between the Pinnacle and the ASR XL, DePuy made a jaw-dropping $5 billion in sales in 2008. But the company’s profits came at a huge cost to its consumers.

The authors state that, prior to hitting the market, the Pinnacle and the ASR XL had never been tested on a human. This is typical in medical device industry.

As a result of the lack of testing, DePuy’s ASR XL and ASR systems were both recalled in 2010. Additionally, DePuy received so many lawsuits for the Pinnacle device that it was completely removed from the market.

The authors note that DePuy was far from the only metal-on-metal implant company to face a huge backlash for its dangerous product. Other metal-on-metal manufacturers that pulled their products from the market include Zimmer Biomet, Smith & Nephew, Wright Medical, and Stryker. The companies pulled their products after reports from around the world found that the implants were poisoning their patients and “turn[ing] surrounding tissue to a liquefied black sludge.”

Despite the report, Johnson & Johnson and other metal-on-metal implant manufacturers say they stand by their products.

The authors interviewed Diana Zuckerman, who is in charge of the National Center for Health Research. She said the scandal with metal-on-metal implants is the result of underlying problems with the medical device industry and its poor regulations. There are lots of loopholes, shady connections between regulators and manufacturers, and an overall anti-regulation sentiment, which has let bad devices enter and stay in the market.

Zuckerman said the metal-on-metal controversy “was almost a perfect storm.”

The metal-on-metal hip scandal shows that, overall, the medical device industry is extremely profitable yet highly corrupt. And profits are even greater in developing countries, where there is poor regulation but increasing wealth.

Even though medical devices like hip implants have done amazing things for people, it is far too easy to shove a flawed product into the market. Implants can be approved with very little research to back them, and this research is often paid for by the industry itself. After they are approved, manufacturers persuade doctors and hospitals to use them “in ways that push – or break – legal and ethical barriers.”

 

Implant Files Victim Hope Fluctuating