By Independent Staff Writer
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.
If
you have questions about the ASR XL Acetabular System hip recall or
you're concerned that you may have already signed a form giving DePuy
access to your medical records, give us a call at 1-800-730-7607 or contact us online. We're here to help.
