The Stryker Broadspire Letter and Stryker PER Letter

Stryker, one of the medical device “giants,” announced in November of 2012 they would be bringing former DePuy CEO David Floyd on as the new president of the orthopedics division. This decision came on the heels of a Stryker hip implant recall— both the Rejuvenate and ABGII—in July of 2012. Floyd left DePuy—a subsidiary of Johnson & Johnson—amid a considerable level of controversy following the recall of the ASR metal-on-metal hip implants. Johnson & Johnson is currently facing over 8,000 legal claims over the ASR hip implant and 2,900 due to the Pinnacle hip implant.

As for Stryker, it is estimated that over 20,000 of the recalled hip devices were implanted and it is believed Stryker will be facing lawsuits from those suffering metal toxicity or poisoning as a direct result of the defective implants. After the Johnson & Johnson subsidiary issued its 2010 recall notice, a letter—known as the “Broadspire letter”—was sent to surgeons who had implanted the ASR hip system in their patients. This letter offered to pay for the costs of revision surgery for any patients who had suffered serious, adverse health issues from the implants. The company wanted something in return, however: the removed hip implant and all medical records associated with the implant.

The Broadspire letter was later sent to recipients of the recalled hip implants as well. This letter alarmed many attorneys on behalf of the patients who had been harmed by a recalled ASR or Pinnacle hip implant. Just because a company manufactures a hip implant, they do not have the right to have the explant returned to them following revision surgery. You—the patient—bought the hip implant and it belongs only to you. Turning over the explant to a company you will likely end up having to sue is essentially handing them your case.

Broadspire is a subsidiary of Crawford & Company—the largest insurance and claims adjuster in the world. The motivation in retaining Broadspire for the Stryker cases is likely the same as for the previous Johnson & Johnson cases—to protect the company’s interests rather than those of the consumers affected by the hip implant recalls. Many attorneys believe the goal of the original Broadspire letter was to gain unrestricted access to patients’ medical records thereby reducing the potential liability of the company (and reducing the amount claimants will be able to recover).

As of January, 2013, many recipients of the Stryker Rejuvenate or ABGII hip implant had received a Product Experience Report or PER. These letters appeared—at least on the surface—to be relatively harmless, simply thanking the patient or surgeon for submitting any issues related to their hip implants. Just as with the J&J Broadspire letter, the PER letter asked patients to grant permission to obtain personal medical records in order to “conduct an investigation of the issue.” The PER letter did not offer to pay for revision surgery or that explants be turned over to them, however allowing Stryker access to highly personal medical records can only be a mistake in the long run.

Because no third party oversight is involved in the PER letter, Stryker is free to reply with a vague “best assessment” of the performance of the Rejuvenate or ABGII while gaining access to sensitive patient medical records. Just as with a Broadspire letter, it is extremely important that recipients of a PER letter consult with an attorney and consider all aspects of a future lawsuit carefully before signing an authorization to release your medical records.

According to reports, following the PER letters, Broadspire sent out thousands of letters asking patients to sign medical authorization forms as well as other forms of personal information. Signing such authorizations could give Stryker unlimited access to patient’s medical providers as well as allowing the company to inquire about unrelated medical conditions with no notification to the patient. Signing such a letter with no safeguards in place could effectively waive your rights to medical privacy. Later, the information in your medical records could be used as evidence against you—Stryker could claim that your medical problems were not due to a recalled hip implant, rather to your pre-existing health condition or conditions.

In fact, in other hip implant lawsuits the manufacturer has taken these medical records and essentially blamed the patient for the serious medical problems they have be subjected to following their implant surgery. The manufacturer of the hip implant could try to blame the hip implant failure on an underlying disease such as diabetes, physician error, misuse of the implant or a pre-existing condition in order to avoid paying a settlement to the victim of the implant. In other words, Stryker may claim your hip implant failed because you were over-active, overweight or had fallen at some point. The surgeon who performed the hip implant could also be blamed for improper placement of the hip implant device

Stryker, through Broadspire will likely offer to reimburse patients for necessary testing, treatment, revisions surgery, if necessary, and other costs related to the recalled hip implants however there will be no clear definition of what will be considered “necessary.” The “catch” is obvious: No costs will be covered unless the patient agrees to provide x-rays, explants and any other requested medical records following the procedure and it is unlikely that any money will be paid out for lost wages, pain and suffering or other damages not directly related to the medical treatment. While the assertion is that your medical records will be used to process claims more efficiently, it is doubtful this is actually the true motivation behind the request.

Every time human bones are discovered by archeologists, it becomes possible to discern many different things about how the person lived, interacted with others and died. Depending on the condition of the bones, it may even be possible to determine what type of job the person did. Think of your removed hip implant in the same way—it has a story to tell. If Stryker ends up with the removed hip implant, then that story is forever gone. A surgeon can look at a removed hip implant device and clearly see where the corrosion and fretting occurred along with the degree of corrosion the implant underwent.

Since the ABGII and the Rejuvenate were recalled because of issues with fretting and corrosion, being able to tell how much corrosion your implant has undergone can be extremely important to an eventual case against Stryker. Once you have given up such crucial evidence you will never be able to get it back, and the evidence could well be “lost,” therefore gone forever. While your surgeon may be able to testify as to the condition of the removed implant, actually being able to see the areas of corrosion and fretting which led to your adverse health conditions are much more convincing to a jury. Retaining your right to your explant allows your attorney to prove it was your recalled hip implant which caused your ill health symptoms or metal toxicity.

Stryker, like most large medical device companies who have been forced to recall products, will likely offer a “free” hip revision surgery as an enticement to implant recipients. In return, those recipients will unwittingly give up their private medical records as well as evidence which could be used against Stryker to prove their case. Many patients may be anxious and worried once they realize their hip implant has failed. Patients may be facing metal sensitivity, metallosis, heavy metal poisoning and bone deterioration. There are many serious symptoms of metal poisoning including gastrointestinal, cardiovascular, neurological and renal issues, loss of vision or hearing, memory loss, DNA disruption, irritability, anxiety, depression, skin disorders, chronic headaches and vertigo.

Because revision surgeries are typically much more complex, dangerous and expensive than the original surgery, it can be frightening to face such a procedure. The recovery time for a revision surgery can be as long as six weeks, causing the patient to be off work for an extended period of time with no income coming in. Therefore, when Stryker offers to pay for revision surgery, many patients may sign any form Stryker presents to them without properly reviewing the forms. It is not until much later that the ramifications become clear. Even if you have already signed a form giving Stryker the right to your explant and your medical records, there are ways an experienced attorney can help you regain access to your recalled hip implant.

Despite the fact that Stryker will likely claim they intend to use patient explants to improve their next model of hip implant, that story is not very probable. After all, Stryker—like many other manufacturers of metal hip implants—couldn’t even be bothered to properly test the safety of their implants prior to marketing them to an unsuspecting public. Because the devices gained FDA approval through a process known as the 510(k), there were no clinical trials mandated and the manufacturer only had to show that the devices were “substantially equivalent” to a device already on the market. The problem with this process is that the device the approval is based on may have had problems of its own, yet the new device can still gain approval despite those problems. In other words, if the Stryker designers had any interest in designing and marketing a safer hip implant, they would have ensured the ones they marketed had been properly tested.

Should you receive a Broadspire or PER letter regarding the Stryker recalled hip implants, it is extremely important that you sign nothing without first speaking to an attorney. If your Stryker hip implant failed, you are entitled to a revision surgery without having to submit your explant to Stryker or give up your private medical records. You deserve to be compensated for the harm you have suffered from a device you and your surgeon believed to be safe. You could be entitled to a settlement that includes compensation for revision surgery medical expenses, lost wages, other damages and pain and suffering.

In other words, you could let Stryker pay for your revision surgery now—maybe—and potentially lose a great deal of future compensation or you can hang on to your explant and have your attorney fight for the compensation you are truly owed. Signing any agreement put before you by Stryker may waive your rights to future litigation as well as giving a large medical manufacturer unlimited access to your medical records. If you receive a Broadspire or PER letter asking you to sign a document which waives your right to keep your removed hip implant or gives Stryker access to your medical records you are strongly advised not to sign it. If you have already signed such a document, it could be in your best interests to call the offices of Sullo & Sullo or through our online contact form. We may be able to help you recover your explant or show that Stryker obtained the explant improperly.

Stryker’s Broadspire letters to physicians who implanted the recalled Rejuvenate or ABGII hip implants may be called an Authorization to Use or Disclose Information and will effectively sign over all medical records, explants and x-rays from the original surgery as well as records from follow-up visits. Records can include everything related to your implant such as lab work, physical therapy reports, doctor’s notes, even telephone message slips. If your surgeon received one of these forms on your behalf he or she may ask you to sign it, not realizing how damaging it could be to a future case.

Further, because there is typically quite a lot of paperwork surrounding any kind of surgery, such a form could be accidentally signed and it would not be until much later that you would realize the damage one signature could cause. Some believe the large manufacturers of hip implants would even go so far as to offer surgeons a financial incentive for each form they are able to get a patient to sign, but the majority of surgeons would never “sell out” their patients in that manner. Your surgeon may not even be aware of the ulterior motives of Stryker and may truly believe the company is only attempting to find out what went wrong with the Rejuvenate and ABGII in order to design a safer hip implant.

Don’t despair if you inadvertently signed a medical release form sent out by Stryker or Broadspire. There are certain steps we can take to assist you in regaining your medical and legal rights. We can have you sign a revocation of authorization to use or disclose your medical information which will not only force Stryker to cease asking for new information but to return all medical records they have already received.

Of course it is difficult to “un-ring a bell,” meaning Stryker may or may not “forget” what they have already learned however if they refuse to comply that refusal may actually work in your favor during a lawsuit. If you have questions or concerns regarding any forms you have received or signed, call us today at 281-377-4750 for a comprehensive consultation which will help you see what options are available.

Many recipients of a recalled Stryker Rejuvenate or ABGII hip implant have suffered serious injury from the device. There are many advantages to consulting one of our experienced personal injury attorneys; we can help you determine what level of harm you have suffered, whether you are experiencing symptoms of metal poisoning or if your implant is loosening due to infection, causing you constant pain. Speaking to a Sullo & Sullo attorney can help ensure your statute of limitations does not run out while protecting your rights.

Evidence will be gathered and preserved and you will have a good idea of the important record-keeping tasks you will need to engage in to obtain a successful outcome. We will make sure you are not taken advantage of and that you don’t accidentally give up your rights to compensation for the harm you have suffered. Our highly experienced team of personal injury attorneys will help you through this difficult time, allowing you to heal while we handle the legalities of your case. Fill out our Free Consultation Box or call Sullo & Sullo today!

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