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Dangerous Drugs & Medical Devices

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Assisted Individuals in Litigating and Settling Claims

Wallace & Graham has assisted individuals throughout the United States in litigating and settling claims involving a variety of defective and dangerous medical devices and drugs. Our Defective Drugs and Defective Medical Devices department evaluates a wide range of drug and device claims. Below are some of the drugs and medical devices that our firm is currently investigating.

If you have taken or used the devices or drugs listed below and experienced the symptoms identified, please contact our office immediately at (800) 849-5291 and ask to speak with our dangerous drugs & medical devices attorneys. Attorneys Bill Graham and Whitney Wallace are highly experienced defective drugs and medical devices lawyers who will evaluate the information you provide to determine if you have a claim. For your continued health and safety, you should speak with a doctor regarding your future use of the drugs and devices identified.

In addition, Wallace & Graham’s attorneys can advise you regarding a variety of work-related injuries, including chemical exposure and toxic exposure in North Carolina. Don’t hesitate to discuss your case with a dedicated personal injury attorney as often legal action must be initiated within a certain time window.

Medical Devices 

Metal-on-Metal hip replacement manufacturers have been under heavy scrutiny over the past few years regarding the dangers of their metal on metal hip devices. 

The main hip devices under scrutiny are:

(1) Johnson & Johnson/DePuy: ASR Total Hip Replacement and ASR Resurfacing System hip (Recalled on August 24, 2010);  
(2) Johnson & Johnson / DePuy: Pinnacle metal-on-metal hip;  
(3) Zimmer: Durom Cup hip;  
(4) Stryker: Rejuvenate and ABG II Stems (Recalled on July 4, 2012);  
(5) Biomet: M2a and 38 Diameter hips,  
(6) Wright: (a) Conserve, (b) Dynasty, (c) Lineage and (d) Profemur (femur fracture) hips; and  (7) Smith and Nephew: R3 Liner hips (Recalled on June 1, 2012).  

Metal-on-metal hip patients from the above manufactures have similarly reported problems after their initial implant surgery resulting in revision surgery. All have reported a variety of symptoms, including pain, swelling and problems walking. These symptoms are normal for patients following a hip replacement, but can be a sign that something is wrong if they continue or come back frequently. Additionally, metal debris spreading in the hip area has been reported due to the metal on metal friction involved from the metal components moving together. 

We would like to review any cases involving individuals who have had any of the above metal on metal hip devices implanted and all individuals unsure of the type of hip device implanted if the person has had revision surgery, or the person is experiencing hip pain, hip swelling or difficulty walking. 

Mirena® is an IUD that was originally approved by the FDA as an intrauterine contraceptive. It was later approved as a treatment for heavy menstrual bleeding. It works by slowly releasing a low dose of levonorgestrel (a synthetic progestin hormone) directly into the uterus.  Serious adverse side effects and potentially life-threatening complications have been reported following the implantation of the device.  These complications include organ perforation, migration of the IUD to outside the uterus, expulsion of the IUD, and embedment in the uterus, among others.  

The Power Morcellator is a surgical instrument used to divide and remove masses during hysterectomies, fibroid removal and other laparoscopic surgeries.  The device is inserted through small incisions and removes tissue after aggressively cutting and shredding it.  The device can put women at increased risk for a number of deadly uterine cancers. According to FDA analysis, 1 in 350 women undergoing surgical treatment for fibroids has an unsuspected uterine sarcoma that cannot be reliably detected before surgery.  During power morcellation, there is a chance pieces of tissue may be left behind.  If the tissue is malignant, cancer may be spread.  The FDA issued a safety alert in April 2014 discouraging the use of these devices in uterine and fibroid removal procedures.   

The FDA has issued an updated safety communication warning doctors, health care professionals and patients that the placement of surgical mesh through the vagina to treat pelvic organ prolapse and stress urinary incontinence may present greater risk for the patient than other non-mesh procedures. This is also called transvaginal mesh. According to the FDA, reported complications from the transvaginal placement of the mesh include erosion of the mesh into the vaginal tissue, organ perforation, pain, infection, painful intercourse and urinary and fecal incontinence. Often women require surgery to remove the mesh.  In some cases, this can require multiple procedures without successful removing all of the mesh.  Currently, we are investigating cases involving mesh manufactured by American Medical Systems, Bard, Boston Scientific, Caldera, Coloplast and Johnson & Johnson.  

Since 2003, more than 150,000 Zimmer NexGen Flex-Knee implants have been sold.  Several different components used as part of the Zimmer NexGen Flex-Knee replacement system have been associated with increased risk of complications, including pain, swelling, loosening of component parts, and the need for follow-up/revision surgery.  Several prominent surgeons want a Zimmer NexGen knee replacement recall to be issued.  At a March 2010 conference of the American Academy of Orthopedic Surgeons, two knee surgeons presented data suggesting that the Zimmer NexGen Flex-Knee failure rate could be as high as 9%, and that the actual number of complications that require revision surgery could be even higher.  The lead author of the study, Dr. Richard Berger, described the failure rate of the Zimmer NexGen CR-Flex Porous Femoral Component as “unacceptably high.”  

We would like to review any cases involving individuals who have had a Zimmer NexGen knee device implanted, or individuals unsure of the type of knee device implanted, if that individual has had revision surgery.