Andrew Sullo is a Top 100 National Trial Lawyer (as named by the National Trial Lawyers 2013-2019).
Don’t Sign Allergan’s Waiver of Liability Until You Consult an Attorney - In early August, the FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the United States. This recall was based on Medical Device reports which reported global cases of BIA-ALCL (Breast Implant Associated - Anaplastic Large Cell Lymphoma), and even BIA-ALCL-related deaths associated with recalled Allergan breast implant devices. All the BIOCELL recalled breast implant devices have the same textured surface, or shell, which is unique to Allergan. The FDA requested the recall based on 481 BIA-ALCL cases among women with the Allergan devices, including 12 deaths.
An analysis placed the risk of a woman with a recalled Allergan breast implant device being diagnosed with BIA-ALCL (Breast Implant Associated - Anaplastic Large Cell Lymphoma) at six times the risk of an implant from another U.S. manufacturer. Allergan breast implants cancer, or BIA-ALCL, is not specifically classified as breast cancer, rather it is a type of non-Hodgkin’s lymphoma (cancer of the immune system). While BIA-ALCL (Breast Implant Associated - Anaplastic Large Cell Lymphoma) can spread throughout the body, it is generally found in the scar tissue and fluids near the implant. If BIA-ALCL is not diagnosed and treated promptly—usually through chemotherapy and/or radiation therapies—the disease can lead to death.
How Has Allergan Reacted to the Recall of Textured Breast Implants? Although Allergan voluntarily recalled the BIOCELL textured breast implants and tissue expanders, it appears the manufacturer has not fully committed to sending out written notifications of the recall. In fact, some women have mentioned they were “discreetly” contacted by their plastic surgeons, asked to come in and discuss a private, important matter. What occurred at these meetings is that the plastic surgeon would relay a proposal from Allergan to provide replacement surgery. Replacement surgery would remove the recalled, potentially dangerous implants from the patient, implanting another type of Allergan implant.
The ConfidencePlus™ Premier Warranty Release While this sounds reasonable on the surface, these women were asked to sign a Waiver of Liability. This Waiver of Liability provided for payment of breast implant replacement surgery for the patients up to $7500…in return for releasing Allergan of all responsibility for any harm or injury resulting from the recalled breast implants. In short, by agreeing to have the replacement surgery at a covered cost, the patient would forfeit her right to pursue monetary damages against Allergan. If the patient should develop ALCL cancer in the future—even if she currently has no ALCL symptoms—she would be unable to hold Allergan responsible.
Here is an example of the language one might see in a typical release, based upon language seen in an actual waiver:
ConfidencePlus™ Premier Warranty Release In consideration of payment for breast implant replacement surgery expenses up to the amount of $7,500.00, I, PATIENT NAME, hereby release and forever discharge Allergan, Inc. and ay related person and entities ("Releasees") from all claims arising out of the use of ALLERGAN BRAND NAME (Natrelle, Biocell, etc.) brand mammary implant (APPLICABLE CATALOG NUMBER), Allergan complaint record number.
I, PATIENT NAME, understand that payment is being made in accordance with the ConfidencePlus Premiere Warranty, which provides for a ALLERGAN BRAND NAME (Natrelle, etc.) brand replacement product of the same style free of charge or a ALLERGAN BRAND NAME (Natrelle, etc.) brand replacement product of a different style with possible upgrade charges. The undersigned further understands and agrees that neither the payment of any sum of money nor the execution of this Release shall constitute or be construed as an admission of any liability whatsoever by the Releasees who have consistently taken the position that they have no liability whatsoever to the undersigned.
PATIENT SIGNATURE; DATE
Further, it is likely that Allergan would keep or even discard the removed implants (which could be an essential component for pursuing legal action). Women who agree to this solution to have their Allergan recalled breast implants removed are essentially choosing to accept $7500 in surgery costs in exchange for giving up the right to pursue significantly greater monetary damages in the future should this very serious disease arise. If you have one of the Allergan textured surface breast implants or tissue expanders implanted in your body, consider the following questions:
- Has your plastic surgeon asked that you sign a Waiver of Liability in exchange for breast implant replacement surgery? If your plastic surgeon has called and asked that you come in to discuss your Allergan recalled breast implant, he or she may have asked that you sign a Waiver of Liability in exchange for a $7500 breast implant replacement surgery. If this is the case, and you have not yet signed the Waiver of Liability, it is extremely important that you speak to an experienced Allergan breast implant attorney prior to signing the Waiver. If you have already signed the Waiver, it is equally important that you speak to a knowledgeable attorney to understand where you go from here.
- Will you lose your rights if you sign an Allergan Waiver of Liability? You may wonder whether you will lose important rights if you sign an Allergan Waiver of Liability. While it may sound reasonable for you to agree to have your recalled Allergan textured breast implants removed and replaced with a safer version, in fact, if you were to later develop serious breast implant associated anaplastic large cell lymphoma (BIA-ALCL), you might find you had signed away your right to seek compensation.
- Why would you not want Allergan to have access to your removed breast implant (explant)? It is extremely important that if you have your recalled Allergan textured breast implants removed, you retain possession of the removed implants. These are your implants—you bought and paid for the implants during your original implantation surgery. As such, Allergan does not have the right to the explants. It is also extremely important that you consult an Allergan Breast Implants Cancer Lawyer about how to properly maintain the chain of custody of your explants, as well as getting a preservation letter out to your doctor and/or hospital about keeping any tissue or fluid samples that may have been taken during your replacement surgery.
- Why is the breast explant likely valuable to your potential Allergan claim? Should you allow Allergan to keep your breast explants, you have essentially lost a potentially important component to a future textured breast implant lawsuit. While Allergan is probably billing their offer as extremely generous as they offer to cover costs associated with removing your recalled textured implants and having a safer alternative implanted, there may actually be no altruism involved. You are entitled to keep your Allergan explants in the event you need them as evidence in a future breast implant cancer lawsuit. In short, your Allergan breast explant tells a story; if Allergan retains or discards the explants, it is entirely possible that the company could attempt to imply the dangers were related to a faulty process of implantation, or even something you did “wrong.”
- Is Allergan practicing the art of misdirection? It is possible that Allergan asking women—through their plastic surgeons—to undergo replacement surgery at no expense is merely an enticement with ulterior motives. Allergan may be worried that the longer women have the recalled textured breast implant, the more likely they are to develop serious BIA-ALCL (Breast Implant Associated - Anaplastic Large Cell Lymphoma). Women who have the recalled breast implants removed on their own, retaining the explants, would have a much better claim against Allergan in the future. Allergan likely believes that women who have heard of the recall are nervous and want to have the recalled breast implants removed as quickly as possible. Because of this, women may be signing waiver forms without properly reviewing them. The legal ramifications of signing a waiver may not become totally clear until it is too late.
- Why would Allergan require women to be re-implanted with another Allergan breast implant? It is possible that the reason Allergan requires women to be re-implanted with another (non-recalled) breast implant is so they can show their company has manufactured many safe breast implants. Unfortunately, this takes away a woman’s choice, leaving her at the mercy of Allergan so far as what is re-implanted into her body.
- Why would you not be allowed to simply have the recalled implants removed? Many women wonder why Allergan requires that another Allergan breast implant be re-implanted—in other words, why is Allergan not allowing women to simply have the recalled textured breast implants removed? Since breast implants are cosmetic, rather than necessary for the body to function, it is unclear why Allergan is not offering a simple removal option. One possible answer to this question relates to the cost of correcting breast deformities based on stretching—the cost of revision to another implant may be less expensive than the cost of breast reconstruction following removal of the recalled textured breast implants, but this is speculative.
- Is Allergan asking you to sign your rights away? When you sign the Allergan Waiver of Liability, what Allergan is asking is that you sign away your rights—both current and future. Because BIA-ALCL may not have been diagnosed in many women—but could be in the future—accepting Allergan’s offer can result in a serious loss of rights for many women. Further, Allergan may be offering to cover costs associated with replacement. When you agree to sign the Allergan Waiver of Liability and undergo replacement surgery to remove your recalled breast implants, you may be consenting to provide Allergan with your x-rays, your explants, and all other medical information related to your replacement surgery. You could actually be signing away private medical records, allowing Allergan to examine those records. Remember this—the “professionals” who might examine your private medical records will not be doctors or engineers; they will be lawyers. And those lawyers have one goal in mind: reducing any liability in the future for Allergan should you develop BIA-ALCL or have other problems with your recalled Allergan breast implants.
- Why you should consider consulting an experienced Allergan breast implant lawyer—If you have experienced any ill effects from your recalled Allergan breast implants, you could experience several very important advantages from consulting with a highly experienced personal injury attorney. Perhaps you have already experienced pain or other symptoms associated with a defective breast implant or have already been diagnosed with BIA-ALCL (Breast Implant Associated - Anaplastic Large Cell Lymphoma). Or perhaps you have not yet experienced issues associated with your recalled Allergan breast implants. In either case, you could benefit from the knowledge and legal information an experienced Breast Implant Cancer attorney can provide. A well qualified Allergan Breast Implant Cancer Attorney can help you ensure your statute of limitations does not expire, as well as help you determine whether you have a valid claim against Allergan.
If you need help determining whether you have a claim against Allergan, or if you have already signed an Allergan Waiver of Liability, we can help. Our Allergan Breast Implant Cancer Lawyers can help ensure all evidence in your case is properly gathered and preserved, including your recalled Allergan explant, when applicable. We will prepare you for the record keeping you will need to begin right away—and continue throughout the process. If you receive a phone call from your plastic surgeon asking that you come in and discuss removal of your recalled Allergan breast implants, we ask that you strongly consider contacting an experienced Allergan Breast Implants Cancer attorney. We never want you to be taken advantage of, or to inadvertently relinquish your entitlement to compensation. Our experienced team of attorneys can investigate your rights and inform you of potential options for an Allergan breast implant lawsuit.