After DePuy issued its recall notice, it sent a letter to the surgeons who had conducted hip replacement surgeries using the ASR XL Acetabular System. In part, the letter informed the surgeons that DePuy was offering to pay for their patients' hip revision surgery.
In exchange, the company wanted just one minor thing: the hip implant (and its associated medical records).
What is not stated in the letter is that returning your explant could have serious consequences you may not be aware of…
On the face of it, this doesn't seem like an out-of-line request. After all, DePuy was offering to replace the faulty hip implants and told the surgeons that it wanted to see the explants to figure out what was wrong with the design and make improvements in future models. Many patients may very well have thought that returning the hip implant to DePuy was actually returning the device to its proper owner.
Not so. DePuy has no right to your hip implant - emphasis here on your. You bought and paid for the hip implant when you first had a hip replacement surgery. It belongs to you. The other problem, of course, is that handing over the explant is as bad as handing over the keys to your case.
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.
Following DePuy’s recall of their hip implants the company stated that patients who met specific criteria might be able to have some of their medical costs covered. Before any type of reimbursement is issued, however, DePuy will review patient’s medical records to determine whether the patient is eligible for reimbursement. The problem with this is that DePuy states the patient’s medical records must confirm a revision surgery is definitively related to the ASR recall rather than another cause such as a “traumatic fall.” In other words, the company is likely to attempt to blame the failure of the hip implant on a pre-existing condition, an underlying disease, physician error or misuse, therefore providing DePuy with sensitive medical records could well mean you would receive no money at all for the defective product implanted in your body.
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.
When archaeologists discover human bones buried thousands of years ago, they can discern amazing things about how those people lived, interacted, and died. Sometimes they can even determine the profession or position they held in society depending on the way the bones had been worn down over time.
Your hip implant tells a similar story. The way that it has deteriorated over time will reveal whether it is your behavior or DePuy's poor design that has caused the medical problems you and others have experienced as a direct result of the implant. DePuy would very much like to prove that your lifestyle since the surgery has caused the breakdown of your hip implant. Failing that, the company would like to prove that the way your doctor placed the implant has made it ineffective.
If DePuy holds the explant, it can attempt to imply that you caused your hip implant's failure. If you hold it, your legal representation can prove otherwise.
DePuy offered patients a free hip revision surgery as an enticement. For patients who are fearful that their hip implant is faulty and causing problems like metal sensitivity, metallosis, heavy metal poisoning, and bone deterioration, the offer of a no-cost revision is extremely appealing. Worried that the longer they retain the hip implant, the worse off they will be, those patients are likely to sign the consent forms presented to them without reviewing them properly. Even if they do review the forms, it's not likely the full ramifications will become clear until it's too late.
If DePuy lacked sufficient talent to properly design and engineer a functioning implant, they've made up for that shortcoming by perfecting the art of misdirection. Distracting patients with the offer of a free hip revision surgery, DePuy is making the removed hip explants disappear into thin air - or, at the very least, into the hands of their legal defense.
It's a clever con, and it is very easy to be taken in by it. Many patients have already signed away their own hip explants to DePuy in exchange for the free hip revision surgery, and have undermined their case by doing so. However, even if you have already signed the consent forms, there are ways to reverse the trick and bring the faulty hip implant out of the shadows and back into the light.
It is entirely possible that DePuy intends to use the explants to improve on their current model and produce a better ASR Acetabular System. However, the evidence thus far is not in favor of that story. Leaving aside the fact that DePuy never put the hip implant through clinical trials in the first place, in previous litigation on another implant case, the company's defense team used the explants to try to prove the plaintiff caused the problems himself.
In one particularly frightening story recounted to us by an attorney who referred a client to us, a hip explant was "lost" after a revision surgery. The hospital and surgeon's staff insisted that the explant was being held at the hospital after surgery. Another staff member said the explant had been thrown out along with other surgical waste, admitting later that a DePuy representative was present at the hospital on the day of the operation.
We cannot offer irrevocable proof of this story and we have no reason to believe that DePuy representatives are actively attempting to scoop up explants immediately after surgery. However, it is a troubling story and we have no reason to disbelieve the word of the attorney who recounted it. If nothing else, it would seem to indicate that DePuy's motives are not as benign as they claim.
Unless, of course, the representative merely wanted the explant to help the company's engineers improve the design. It must be a great comfort to the patient whose personal property was lost to know that her case was undermined for such a worthy cause.
You are entitled to a hip revision surgery without submitting your explant to DePuy. We believe you should be compensated for all medical costs related to the faulty hip implant, which would include the revision surgery. To put it another way, you can allow them to pay for the surgery now and lose a great deal of future compensation in the future - or you can retain your own explant and receive the compensation you are due, including the cost of the revision, after we have used your explant to make a strong case against DePuy in a mass action lawsuit.
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.
If you are asked to sign a document waiving your right to keep your own explant, we strongly advise you not to sign it. If you have already done so, please contact our offices immediately at 1-855-520-6644 or via our online contact form. We may be able to help retrieve the explant or show that DePuy obtained it improperly.
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.
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 1-855-520-6644 or contact us online. We're here to help.
If you have experienced any ill effects from your ASR hip replacement implant, there are several very real advantages to consulting with a highly experienced personal injury attorney. These ill effects could include pain or infection, loosening of the implant, fracture of the bone surrounding the implant or dislocation of your ASR implant. You may also be experiencing symptoms of cobalt or chromium toxicity which could require the knowledge and legal information an attorney can provide. Legal counsel can ensure your statute of limitations does not run out while determining whether you have a solid case against DePuy, and can protect your rights in the interim.
In these types of cases, evidence must be properly gathered and preserved, and speaking with a lawyer can help prepare you for the recordkeeping tasks you will need to begin right away. The DePuy Corporation may try to contact those patients who have suffered harm from an ASR implant, and it’s important that you not be taken advantage of or inadvertently give up your entitlement to compensation. Patients who require revision surgery can accumulate large amounts of medical expenses, and an attorney can advise you regarding these expenses and others related to your ASR implant.
Sullo & Sullo, LLP has an experienced team of attorneys who can help you to investigate your rights and your lawsuit options.
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