Monday, May 21, 2012

DePuy Asks Hip Implant Patients to Sign Away Their Legal Rights

If you received an ASR XL Acetabular System, your doctor has probably already informed you that DePuy is offering to pay for hip revision surgery.

What they may not have mentioned - and what they may not themselves realize - is that agreeing to DePuy's hip revision offer means that you must agree to sign a waiver that essentially waives your rights in litigation and allows the Johnson & Johson-owned company to access your medical records.

They want to use your own medical records to show that they don't owe you anything for the serious repercussions of the faulty hip implants they allowed to get to market without sufficient testing.

Hip Revision Dependent on Loss of Patient Rights

DePuy sent a letter to health care professionals explaining the recall and informing the doctors and surgeons that they needed to contact their patients about the problems with the ASR XL Acetabular System. In the letter, DePuy said they intended "to cover reasonable and customary costs of monitoring and treatment for services, including revisions, associated with the recall of ASR."

Laying aside for the moment that "reasonable and customary" probably does not mean the same thing to DePuy as it does to the patients, the real problem comes in the next paragraph.

Eligibility for this medical treatment, DePuy says, is dependent on the patient having "consented to provide DePuy with x-rays, explants, and any other requested medical information after the revision surgery."

In other words: DePuy won't pay for your revision surgery unless you sign away your private medical records so they can examine them.

What do they plan to do with your medical records? DePuy states that they will use this information "to process claims efficiently and to help DePuy to better understand the causes of the problems with the ASR Hip System."

If this were true, then the information would surely be scrutinized by their engineers to determine exactly what went wrong with the design of this hip implant. That's commendable, but unfortunately it is far from the most likely scenario, as the history of DePuy's previous encounters with faulty implants shows.

The DePuy professionals that will be scrutinizing your medical information aren't engineers, nor even doctors.

They're lawyers.

What's Wrong With DePuy Having Access to Your Hip Implant Records

To give you an idea of what you can expect from DePuy in litigation about the ASR XL Acetabular System, it may help to look at a previous case about another medical device: the DePuy Limb Preservation System. It's a knee replacement approved by the FDA using the same loophole in the 510(k) process that the ASR hip implant slipped through: DePuy claimed the knee replacement to be "substantially equivalent" to another product.

It later transpired that the product to which the knee replacement was supposed to be substantially equivalent was completely different. The LPS system was never tested. It also had serious design defects.

If all of these problems sound familiar, it's because they are identical to the issues with the ASR XL Acetabular System: cleared through the 510(k) process, claimed "substantially equivalent" to a device that was nothing like the new hip implant, clinically tested by the FDA, and serious design problems.

In the knee replacement case, DePuy's defense avoided talking about any of these issues.

Instead, they pointed the blame at the patients.

The device failed because the patient was overweight. Because the patient was over-active. Because the patient had fallen. Sometimes, they also blamed the surgeon - for improper implementation.

But mostly, they blamed the patient.

What are they going to do with your medical records? They're going to use them to build a case that they did nothing wrong.

They're going to claim that you did.

Where Is This Form Going to Come From?

DePuy sent copies of their Medical Release Form, also called the Authorization to Use or Disclose Information, to each medical professional who implanted an ASR XL Acetabular System.

The form signs over all medical records, explants and x-rays from the original surgery that implanted the ASR XL Acetabular System, the hip revision surgery, and "all follow up visits and records." Records include "telephone message slips," "copies of lab work," "physical therapy reports," "progress records," and other private medical information.

This means your surgeon is likely going to be the one who asks you to sign the form, which in turn means you must stay alert. There is a lot of paperwork surrounding any surgery, and it is important that you make sure you don't accidentally sign a form that loses you legal rights.

There are accusations that DePuy has offered the surgeons money for every Medical Release Form they can get signed. They have good reason to offer incentives: all of this information can be used to build a case against you. More importantly, giving DePuy the explant means that your lawyer no longer has access to it and cannot use that evidence to build a solid case against DePuy.

The surgeon who placed the implant may not be aware that these are DePuy's intentions. In fact, all the communications we have seen between DePuy and the medical professionals who implanted the ASR XL Acetabular System claim that the only reason they want this information is to improve their medical devices. This means your surgeon may have no idea that by encouraging you to sign the form, he or she is also encouraging you to sign away your chance for legal compensation.

Please don't blame your doctor. We certainly don't. They're doing their best to make sure you get the hip revision surgery you need right now.

We're doing our best to make sure you get everything else you need - including just compensation.

Have You Already Signed a Medical Release Form for Your DePuy Hip Implant?

You may have already signed one of these forms. If you have, please don't panic. There are measures we can take to help you get your medical and legal rights back. For example, we can put out a revocation of authorization to use or disclose your medical information, which compels DePuy to stop asking for new information and to return the information they've already received.

If they don't comply, we can use that refusal to respect your rights in the case against them.

Recommended Readings:

Hip Implant Risks May Include Premature Failure

How the ASR XL Acetabular System is Constructed

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Author: Andrew Sullo
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