J&J Continued to Sell Defective Hip Implant After FDA Issued “Nonapproval”


Based on internal safety studies, Johnson & Johnson’s hip replacement device wasn’t safe. The “all-metal hip socket cup” design – initially thought to be revolutionary – was faulty, and the implants were failing prematurely at a high rate in patients around the world. The FDA rejected the defective model, known in the medical field as an “articular surface replacement” (ASR) device, for sale in the United States. Yet J&J’s orthopedic division, DePuy, continued to aggressively market the device to doctors and patients overseas. And if that doesn’t push the ethical envelope enough for you, the health-care products giant continued to sell a second, related model – one very similar to the FDA-rejected device – here in the United States using a regulatory loophole.

Johnson & Johnson’s mercenary approach to health care has resulted in the needless pain and suffering of thousands of patients – many of them elderly – including those “crippled by tiny particles of metallic debris shed by the implants.” From a Feb. 14 New York Times report by Barry Meier:

It is not known how many people overseas received the replacement hip after the [F.D.A.] decided in 2009 not to approve it, nor the number who received the closely linked implant sold in this country. During some eight years on the market, the two implants were used in about 93,000 patients worldwide, about one-third of them in the United States. Both models were based on the same component, an all-metal hip socket cup that experts say was faulty in design.

In November 2009, DePuy began phasing out the faulty models, citing flagging sales. In August 2010, amid soaring failure rates of both devices, the company officially recalled them.

Adding to J&J’s already enormous legal exposure, is that it seems the company kept the FDA “nonapproval letter” secret from an array of need-to-know stakeholders, including patients, clinical researchers and overseas regulators. More from the NYT report:

A spokeswoman for DePuy confirmed that the company had received the agency’s so-called nonapproval letter. But the spokeswoman, Mindy Tinsley, declined to release the letter or to respond to questions about when, or if, DePuy disclosed the ruling to doctors, patients, investors or regulators abroad.

A principal researcher on the clinical studies submitted by the company to the F.D.A. said he was not informed of the agency’s decision. Also, a review of publicly available information indicates that the company did not discuss the agency’s nonapproval letter in financial reports or in presentations to analysts while the device remained on the market.

Although it’s doubtful that Johnson & Johnson broke any laws, its behavior has been highly unethical and negligent – which could cost the company dearly in upcoming lawsuits. And it appears the company is preparing for the worst. From the Times:

…the F.D.A.’s rejection may further deepen the company’s legal and financial problems surrounding the ASR. Last month, the company took a special $3 billion charge, much of it related to anticipated legal and medical expenses associated with the recall. An estimated 5,000 lawsuits involving the device are pending…

Sadly, it seems medical-device companies aren’t much different than oil companies (a much more frequent target of this blog). They both value profits over people – whether old, young, sick or healthy, it just doesn’t matter.

Read the New York Times report by Barry Meier: http://www.nytimes.com/2012/02/15/business/hip-implant-the-fda-rejected-was-marketed-abroad.html?_r=1

© Smith Stag, LLC 2012 – All Rights Reserved

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Stuart H. Smith is an attorney based in New Orleans fighting major oil companies and other polluters.
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