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Matthew J. Edlund M.D.
Matthew J. Edlund M.D.
Career

Hiding the Facts

What happens when drugs and devices don't work?

Deny, Delay, Pay the Fine

Treasure your hips. Regenerate them well. Keep them whole.

Or you may face a series of nightmares.

That’s what happened to many who received metal hip implants made by DePuy. DePuy Orthopaedics is a division of Johnson and Johnson, one of America’s “great companies.” And the Articular Surface Replacement, one of its main products, broke apart. A lot.

The massive misery caused by these failed implants is just another, textbook example of how “errors” are handled in corporate America.

First, deny the problem. Next, investigate – on your own. Follow with judicial delay and obfuscation. Last, pay the fine.

And nobody but a few fall guys ever goes to jail.

ASR

Metal hip implants were the rage some years ago. They were meant to be tougher and last longer.

Except they did not last. They broke up. And their metal parts – both large and microscopic – want all over the place.

According to reports in the NY Times by Barry Meier and others, Johnson and Johnson knew something was up by 2007-8. In 2009 they quietly stopped production and sold off their ASR inventory.

The next year they “voluntarily” withdrew the product from the market.

Yet when the British declared that one third of the devices were breaking down within 5 years – when the expected yearly fairly rate was thought to be 1%, or 5% at 5 years – the company called foul. They said it was nowhere near that high.

Recent court records show the company had its own estimates of failure. It was 37% at five years.

So what did that 37% failure rate really mean?

People with hip replacements cannot move much for months. Their physical therapy is difficult. However, the severe pain many experience is frequently far more troublesome.

Many have never known what chronic pain could be like.

Most patients get over it. But with the ASR and other implants, the pain just grew.

Pieces broke off. Metallic ions ground out and went into soft tissue. People hurt and hurt.

And then were often told that they or their surgeon had done “something wrong.” They had “moved riskfully” or “done too much too fast.” Or the implant had been “placed incorrectly.”

The FDA had approved it. Everything should work fine.

And with patients and surgeons at fault, the next question was malpractice and lawsuits. Who was going to pay for taking out the broken pieces and putting in another implant?

So take it from the patient’s point of view. Your promised a very good shot at good range of motion, the ability to walk again.

Instead you have pieces of metal falling through your leg. You hurt all the time.

And to fix it costs tens of thousands. The surgeon may be very willing, but who will pick up the cost?

Do you get another surgery with the possibility of further disaster? Do you spend weeks and months in sheer, agonizing pain training your body to a new hip? Do you know who will pay for it?

What are your choices?

Johnson and Johnson owned up to replacing the hips. It’s also taken a $3 billion dollar “reserve” to pay for the medical and legal “damage”.

And one of the lead marketers for the original ASR product is now running DePuy.

Getting Away With It

This sad story is sadder because it’s repeated, over and over.

Vioxx and Celebrex made billions and billions – until the companies admitted they’d lied about data demonstrating more heart attacks.

They paid fines. They paid legal fees. Billions.

New antipsychotics like olanzapine were rapidly marketed for bipolar disorder and depression – beyond the schizophrenics for whom they were approved. The companies paid fines. They’re paying legal fees. Billions of dollars.

Purdue Pharma admitted it had “oversold” its new formulation of oxycontin. It paid $612 million in fines. It’s owners were banned from securities work for 15 years.

They were shocked, and quickly sued to get their “security rights” back.

The format is simple – you pay the fine. You keep the profits.

And nobody goes to jail.

Breast Implants

In France the manufacturer of a popular breast implant fled the country when it was clear he had used sub-standard industrial silicone. Thousands of women faced a similar problem to the ASR. Pieces broke off, pain occurred, no one wanted to fix the disaster.

The manufacturer was nabbed overseas. Chances are overwhelming he will go to jail.

But in America, people don’t go to jail. And often people forget.

The division chiefs are not fired but retired early. A few low level employees who knew their livelihood would disappear if they didn’t shave the facts might see a few months jail time.

But the benefits can be huge. When Goldman Sachs knew it held huge positions in toxic mortgages, it used the help of a hedge fund manager to pick the worst, package them to sell to managers around the globe, and bet against the position at the same time.

Win-win.

And now Morgan Stanley bankers are up in court for doing exactly the same thing – taking “toxic garbage” and selling it to the unsuspecting – people like us – while betting the mortgage bonds will fail.

Yet things did not work out so well for Morgan Stanley. They imagined some “higher” bits of the toxic stuff would actually pay off. When they didn’t they took a huge hit, leading the global financial system to approach collapse. Which did not happen - because taxpayers everywhere paid the price.

And these folks knew what they were selling was toxic trash. They called the mortgage packages names like “Hitman”, “Nuclear Holocaust” and “Mike Tyson Punchout.”

You can be pretty funny when you know you can’t get hurt – and someone else pays to fix the damage.

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About the Author
Matthew J. Edlund M.D.

Matthew Edlund, M.D., researches rest, sleep, performance, and public health. He is the author of Healthy Without Health Insurance and The Power of Rest.

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