There are more product liability lawsuits filed against prescription drug manufacturers than against all other industries combined. Under strict product liability laws, drug manufacturers may be held liable for ANY serious injuries or deaths caused by their products regardless of the care they took to prevent defects.

Hazardous waste presents serious problems not only to humans but to the environment as well. Environmental law matters are particularly complex, not only due to the maze of federal, state and local laws involved but also because these laws are often highly technical in nature.

Brent Cordell

Attorney at Law

Board Certified Specialist in Personal Injury Trial Law

1 844 - 8LEGAL8 (1 844 853-4258)

Medical Device Liability Claims


PLEASE NOTE: This is not a comprehensive list of FDA medical device recalls. For current information on devices recalled by the U.S. Food and Drug Administration visit FDA.gov.

In the past 10 years more than 150 major medical devices have been recalled due to significant risk of injury or death.

The FDA defines medical device recalls in Subchapter 7.1 of the Investigators Operators Manual as "...a firm's removal or correction of a matter that FDA considers to be in violation of the laws it administers." Recalls are classified in different ways depending upon whether they are voluntary by the manufacturer, requested by the FDA or ordered under section 515(e) of the FD&C Act. Recalls are also classified based on the risk to the patient.
When any type of recall is ordered or voluntarily undertaken by a manufacturer, a strategy is chosen regarding the depth of the recall, the need to warn the public and the extent of checks to determine the effectiveness of the recall. When a Class I or significant Class II recall is ordered, the FDA also mandates an inspection to determine the root causes of the problems.

When a medical device is discovered to be defective, it's the manufacturer's responsibility to inform the FDA and the public about any potential risks that may arise. If the manufacturer does not properly inform the public and the FDA in a timely manner about the defect, the company may be liable for injuries, illnesses or deaths that may occur due to the faulty device.

Unfortunately, even products that have been approved by the Food and Drug Administration can have serious design flaws or defects that result in the device failing. Medical devices encompass a broad range of equipment ranging from complicated machines that are only used in a hospital to items such as denture cream or blood testing equipment that are used by patients at home.


 

LifeCell AlloDerm hernia  product liability attorneyAlloderm®

AlloDerm is a surgical mesh used in hernia repair and breast reconstruction surgery. It was originally developed in 1994 by LifeCell as a graft for burn patients and is intended to promote tissue growth in the areas where it is surgically inserted so that a patient's cells will effectively repopulate the treated area. AlloDerm is made from donated human cadaver skin. The donated skin goes through a process to remove all of the cells in the top layer and the entire dermis, leaving the collagen and elastin framework of the skin.
When used in hernia repair, AlloDerm has been linked to serious complications including hernia recurrence, abscess and infection due to mesh tear and adhesion problems. In many cases victims of AlloDerm hernia repair complications must undergo additional surgical procedures to correct the problem.

Alloderm is manufactured by LifeCell, and has only recently been marketed for hernia repair. Much of the information supporting this use of AlloDerm was actually funded by LifeCell and few long term studies have followed people who received AlloDerm for hernia repair. Unfortunately, when AlloDerm has been used for hernia repair, it appears to be failing at an alarming rate.

A study published in the journal Hernia in 2008 reported that the overall complication rate associated with AlloDerm hernia repairs among patients at one institution was as high 24 percent. Most of the complications seen in that study involved hernia recurrence, while one rejection and two infections were reported. According to another study app. 8 percent of AlloDerm patients require explant surgery, compared to 1.6 percent in control groups. Serious AlloDerm complications can cause injuries to nearby organs, nerves and blood vessels and may require patients to undergo mesh explant, or the removal of the graft.

LifeCell began promoting Alloderm for hernia repair and abdominal reconstruction surgery in 2000 without adequately testing the product, providing instructions on the proper use or warning consumers and the medical community about the risk of AlloDerm patch complications with hernia repair. A number of serious problems have occurred where the mesh has begun to stretch, expand, thin out or sag once implanted. Although the manufacturer knew that the AlloDerm graft should be "pre-stretched" if it was going to be used during a hernia repair, they failed to adequately share this information with surgeons.
AlloDerm lawsuits allege that LifeCell knew or should have known that the patch was not suitable for hernia surgery as marketed, and that it did not have proper warnings and instructions that may have reduced the risk of complications. As a result of LifeCell's decision to place profits before consumer safety, thousands of people were needlessly exposed to a risk of painful and debilitating injury following hernia repair, which may permanently impact their quality of life.


 

Bard G2 Filter System product liability attorney Bard G2 Filter System

The Bard G2 IVC Filter System is a medical device created by C.R. Bard and approved by FDA in 2005. It was introduced as a successor or replacement for the Bard Recovery IVC Filter system, which was associated with a high number of fractures and other problems that occurred when the retrievable filter was left in place for extended periods of time. Unfortunately, the Bard G2 IVC filter has also been linked to a high rate of fractures and migrations.
The filter is designed to stop or catch blood clots travelling through the inferior vena cava, to prevent a pulmonary embolism. They are implanted in patients at risk for a pulmonary embolism, who are unable to take a medication to reduce the risk of blood clots or if such anticoagulants have failed.

According to a study published in the Archives of Internal Medicine, the fracture rate for the legs/struts on the Bard G2 IVC filter is 12%. Researchers concluded that the incidence of Bard IVC filter fractures was proportional to the length of time that the retrievable device was left in place, meaning that the rate of problems and complications may increase as time passes. When the Bard IVC filter is left in place after the risk of a pulmonary embolism has passed, the legs may fracture or break allowing pieces to travel through the bloodstream and lodge in other parts of the body, usually the heart or lungs. Symptoms of problems from a Bard G2 filter fracture or migration may result in severe and persistent chest pain and shortness of breath. In some of the cases, fractured pieces of the Bard G2 filter migrated to the hepatic vein or the lung.

In 2010, the Food and Drug Administration decided to take the step of warning the public of the potential for serious and dangerous Bard IVC filter defects, and the notice covered all of these tendencies and the risks faced by patients who used them. While this was seen as a positive step for future patients, the fact that the filter was already inside the body of thousands of people created risk for all of them. There is little that can be done other than to monitor the situation closely. Experts estimated that more than 250,000 Americans every year had used this Bard IVC filter at one point.


 

da Vinci surgical robot product liability attorney da Vinci Surgical Robots

The da Vinci surgical robot was introduced to the medical world with much fanfare and promise, and surgical robotics overall have surged in popularity across the country in recent years. The da Vinci Surgical System is a robotic surgical system made by the American company Intuitive Surgical. Approved by the Food and Drug Administration (FDA) in 2000, it is designed to facilitate complex surgery using a minimally invasive approach, and is controlled by a surgeon from a console. The system is commonly used for prostatectomies, and increasingly for cardiac valve repair and gynecologic surgical procedures.

The manufacturer of the system, Intuitive Surgical, has been criticized for short-cutting FDA approval by a process known as "pre market notification," which claims the product is similar to already-approved products. Intuitive has also been accused of providing inadequate training, and encouraging health care providers to reduce the number of supervised procedures required before a doctor is allowed to use the system without supervision. As of 2013, the FDA is investigating problems with the da Vinci robot, including deaths during surgeries that used the device; a number of related lawsuits are also underway. Complications or errors that have been referred to in lawsuits and through witness interviews include burns, punctured vessels and organs, uterus lacerations, intestinal tearing and excessive bleeding. Complications from the surgery may not be evident until days after the procedure is completed.

In November 2013 Intuitive Surgical issued a warning that devices used in its robotic surgery system may momentarily stall during procedures and endanger patients. The warning dealt with the propensity of these machines to stall out during surgery as doctors were using them. When these machines stalled, they would eventually start moving again but would do so at unpredictable times and would lead to troubling uncertainty for the doctors who were attempting to manipulate the arms of these tools. The FDA classified the issue as a Class II recall, meaning that Intuitive's da Vinci robot could cause "temporary or medically reversible" health problems, with a remote potential for serious complications.


 

DePuy ASR XL Acetabular System and DePuy ASR Hip Resurfacing System product liability attorney DePuy ASR XL Acetabular System and DePuy ASR® Hip Resurfacing System

On August 27, 2010 DePuy Orthopaedics issued a worldwide recall of all components for the ASR XL Acetabular System and DePuy ASR® Hip Resurfacing System. DePuy Orthopedics is a subsidiary of Johnson & Johnson. Beginning in 2008 the FDA has received as many as 400 complaints by patients implanted with this system ranging from swelling, pain and movement problems to serious consequences including the need for surgical replacement. This recall means additional testing and monitoring are necessary.

The DePuy ASR hip implant consists of a cup implanted into the hip with a ball joint that connects to the leg. It is a metal-on-metal device made of chromium and cobalt. According to a March 2010 report published in the New York Times, metal-on-metal hip implants are used in about one-third of the approximately 250,000 hip replacements performed annually in the USA. However, these devices can cause severe tissue and bone damage and many of the nation's leading orthopedic surgeons have reduced or stopped their use. The FDA has also received more than 1,300 reports of adverse side effects relating to the DePuy Pinnacle implant, but the device has not been recalled.

Many of the complications linked to the DePuy ASR XL Acetabular hip implant are believed to be caused by wear in the metal components, allowing metal shavings to make their way into patients' bloodstreams which then lead to tissue breakdown, bone loss, and even the formation of non-cancerous tumors. These metal shavings can also cause cobalt poisoning, a disorder that can put patients at risk of tinnitus, vertigo, deafness, blindness, optic nerve atrophy, cardiomyopathy, and hypothyroidism.

In May 2013 DePuy Orthopaedics Inc. announced that they will discontinue its Ultamet metal-on-metal and its Complete ceramic-on-metal implants citing proposed changes by federal health regulators. The company issued a statement that "The decision to discontinue these products is not related to safety or efficacy, and is not a recall," but the devices required little to no clinical testing because they received approval through the 510(k), which exempts the need for clinical safety and efficacy tests if the manufacturer can prove that the product is "substantially equivalent" to a previously approved device. A device approved under 510(k) rules does not have to be shown to be effective. The DePuy Ultamet, Complete, Pinnacle, ASR, and other metal-on-metal hip implants have raised safety concerns due to reports suggesting that such devices tend to fail early in the post-operative period. Because of this, the FDA has sought to propose stricter guidelines for the approval process of all-metal hip implants. Even patients who are not experiencing physical complications from their DePuy ASR hip implant may still be at risk for future complications. DePuy ASR hip implant patients have been advised to have their blood cobalt level tested, and such individuals may require medical monitoring for years to come.


 

Medtronic Infuse product liability attorney Medtronic Infuse Bone Grafts

The Medtronic Infuse Bone Graft is used during surgery to stimulate bone growth and replace damaged spinal disks. It was marketed and sold as one of the alternatives to harvesting a bone graft from the hip. The Medtronic bone graft contains recombinant human Bone Morphogenetic Protein (rhBMP), which is a genetically engineered version of a protein that is naturally released by the body. Use of the Bone Morphogenetic Protein initiates bone growth in specific areas of the spine, giving surgeons some control over where the bone re-growth occurs.
In 2002 the FDA granted Medtronic approval for its Infuse Bone Graft, but for limited use in the lumbar spine, or lower back, and for some oral and dental procedures. Specifically, the agency approved the Infuse Bone Graft to treat degenerative disc disease and open fractures on the tibia. The FDA also approved Medtronic Infuse Bone Graft for use in sinus augmentation and localized alveolar ridge augmentation.

The Medtronic Infuse bone growth stimulator in the cervical spine has been associated with many serious problems, including difficulties in breathing, swallowing or speaking; compression of the airway, respiratory depression and nerve damage. The FDA notes that most complications occurred between two and 14 days following surgery, and can include the need for respiratory support, insertion of feeding tubes, anti-inflammatory medications, tracheotomies and additional surgery.

In June 2011, the U.S. Senate launched an investigation into the allegations that journal entries written by doctors who were paid by the company failed to reveal dangerous, life-threatening side effects. The Senate is considering legislation called the Physician Payment Sunshine Act that forces drug companies to make all doctor payments public. Even before Dr. Carragee's article was published, the U.S. Department of Justice (DOJ) was already investigating Medtronic. In a civil suit, the DOJ accused the company of paying kickbacks to doctors as an incentive to use INFUSE and other spinal products between 1998 and 2003. Medtronic reportedly set up sham consulting agreements and royalty agreements and even paid for "lavish trips to desirable locations," according to the suit. In 2006, the company paid $40 million to settle the civil case.


 

Mirena Intrauterine Device product liability attorney Mirena Intrauterine Device (levonorgestrel-releasing intrauterine system)

The Mirena IUD consists of a small, T-shaped container of flexible plastic that releases continuous doses of the hormone levonorgesterel, commonly found in oral contraceptives. The hormone presumably thickens the wall of mucous lining the uterus and decreases the motility and survival rates of sperm entering the uterus, thus reducing the chances of pregnancy -though even Bayer claims that they are unsure of how Mirena really works.

Mirena IUDs have been used in Europe since 1991 and were approved by the FDA in 2000. According to FDA reports, there have been more than 45,000 adverse events reported, including device expulsion, device dislocation and vaginal hemorrhage.
In some women, Mirena can cause serious complications, including life-threatening ectopic pregnancy, perforation of the uterine wall and a serious condition known as pelvic inflammatory disease (PID). Women who have suffered after using Mirena are pursuing legal action against Bayer Pharmaceuticals, claiming the device is defective and seeking compensation for medical expenses, lost wages, and pain and suffering.
Perhaps the most disturbing of the complications that may result from use of Mirena involves its potential to cause uterine perforations which may cause patients to experience bloating, vomiting, lower abdominal pain, heavy vaginal bleeding and other symptoms. Bayer Healthcare Pharmaceuticals estimates that Mirena perforation complications may occur in one per 1,000 to 10,000 placement procedures. Infections that may result from Mirena perforations may lead to diminished fertility or a woman's inability to conceive a child.

If you received the intrauterine birth control device and are now unable to locate the Mirena IUD string, or you are experiencing lower abdominal pain, heavy vaginal bleeding, nausea, bloating and pain in the abdomen, rapid heartbeat, fever and/or chills, it is urgent that you contact a doctor right away. These may be signs of Mirena perforation.

In July 2008 the U.S. Food and Drug Administration updated the labelling on Mirena to include the warning: "Delayed detection of perforation may result in migration outside the uterine cavity, adhesions..." In 2009, The FDA issued two warning letters to Bayer Pharmaceuticals stating that the manufacturer "presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena." These warning letters were issued in response to Mirena online advertisements and videos published on the social networking website Mom Central.


 

Zimmer NexGen product liability attorney Zimmer NexGen® Flex

The Zimmer NexGen CR-Flex is a synthetic knee replacement device used to cap the femur at the point where it connects to the tibia at the knee. Unlike many other knee implants the NexGen CR-Flex Femoral Implant is attached to the femur without cement. Reports have associated certain components of the Zimmer NexGen Flex knee replacement system with failure, painful loosening and the need for revision surgery.

According to medical research findings presented in March 2010 at a conference of the American Academy of Orthopaedic Surgeons, failure rates on certain Zimmer NexGen components could be as high as 9% and other problems may cause significant pain and loosening of the knee. Former investigators working on behalf of Zimmer -including prominent surgeons- have called for the manufacturer to recall the defective product.
In September 2010 a component of the Zimmer NexGen system was recalled due to loosening. Certain Zimmer NexGen MIS components were recalled due to a high number of reports of problems associated with the devices. In addition, some Zimmer NexGen LPS knee components were recalled due to inconsistent geometry and non-conforming designs.
It appears that the manufacturer was aware of the risk of problems with Zimmer NexGen knee replacements, yet failed to take adequate steps to reduce the risk of injury or warn consumers. Zimmer claims on their website that "The FDA has never ordered a recall on any of our Zimmer NexGen knee replacement products... the Zimmer NexGen Knee Replacement System is clinically proven and the most trusted knee replacement system in the world."
However, as early as June 2010 the New York Times reported disputes between Zimmer and two of its top consultants, one of which involved the NexGen CR-Flex knee component. The consultants claimed the components were defective and failed soon after they were implanted, but Zimmer officials blamed the surgeons' techniques for the failure.

  • In September 2010 NexGen Complete Knee Solution MIS Tibial Components, NexGen TM Tibial Trays and MIS Modular Tibial Plates and Keels were recalled.
  • In December 2010 the NexGen LPS-Flex Gender Femoral Component was recalled. According to the recall notice surgeons were notified but no action was to be taken by surgeons.
  • On January 25, 2012 problems with another Zimmer knee device, the Natural-Knee II Durasul All-Poly Patella, prompted the FDA to issue a Class II Recall. The device was recalled because it was prone to fracture, causing device failure and patellar problems. At the time of that recall more than 100,000 devices had already been implanted.

More than 700 lawsuits have been filed against Zimmer for a number of complications resulting from the faulty design of its NexGen Flex devices, including the recalled MIS Tibial Components and the NexGen LPS-Flex GSF Femoral Component. A doctor who authored a study on the knee replacements has called the failure rate of the Zimmer CR-Flex knee implant "horrific" and three surgeons have recommended against the use of certain Zimmer knee replacements due to "unacceptably high" rates of implant failure and loosening.
Those who have received a Zimmer NexGen CR-Flex knee replacement may be at risk for an early failure and should contact their surgeon to follow up and have tests on the knee to make sure it is working well and not loose. Although Zimmer NexGen CR-Flex knee replacements are supposed to last for 15 years, many patients have found that they need their knee replacement revised after only 3 years and others have reported that the Zimmer knee is loose after only 2 years of use.


 

Gynecare Tissue Morcellator  product liability attorney Gynecare Morcellex Tissue Morcellator Morcellex Sigma Tissue Morcellator System Gynecare X-Tract Tissue Morcellator

Power morcellators aid in common types of surgery performed on women, minimizing the invasiveness of procedures that remove fibroids from the uterus. Ethicon, which is owned by Johnson & Johnson, manufactures three of the most popular power morcellator products.

On April 17, 2014, the FDA issued a safety alert to discourage the use of power morcellators in procedures such as hysterectomies and myomectomies. Data has indicated that approximately 1 out of every 350 women who have undergone a hysterectomy or a myomectomy for fibroids was found to have an unsuspected uterine sarcoma, or cancerous mass present. In addition, these cancerous cells were found to exist beyond the uterus and in places such as the abdomen and pelvis. The presence of these dangerous cells in these locations can substantially reduce any patient's chance for long-term survival. Any women who have had this surgical tool used in procedures such as hysterectomies or fibroid removal procedures should seek medical attention.
The FDA plans to convene an advisory panel in order to further investigate the potential link between the use of power morcellators and the development of cancer.


 

Gynecare Tissue Morcellator  product liability attorney Smith and Nephew R3 Acetabular System
Stryker Rejuvenate hip replacement

Smith & Nephew hip replacements have been marketed as parts that would serve as a 'natural' hip joint for patients whose hips no longer functioned properly. These surgeries have become more common in recent years, and according to available estimates more than 7,500 of these products have been implanted in patients.

On April June 1, 2012, the FDA issued a recall for the Smith and Nephew R3 Acetabular System, which had had only been used in the United States since 2009. The metal cup liner of the hip replacement implant was the specific area of concern in the unusually high level of problems suffered by R3 Acetabular System patients, including implant loosening or dislocation, metallosis or accumulation of metallic debris in the blood, infection and bone fracture.
Also in 2012 the FDA issued a recall for Stryker Rejuvenate Hip Stems. The Rejuvenate product had attempted to moved away from a metal-on-metal joint, however, it did still contain components that generated the presence of metal shavings. Additionally, the simple failure of many Rejuvenate units before they were supposed to be replaced contributed to the decision to initiate the Stryker hip replacement recall.

A number of metal-on-metal hip implants have reportedly been linked to metallosis, a type of poisoning caused by the release of metal debris into the body. A spokeswoman for Smith and Nephew claimed that metallosis was not among the problems which necessitated the recall of the metal liner. It has been alleged that the company may have been too quick to discount metallosis as the cause of the patients' injuries. Metallosis is of particular concern because such damage can compromise revision surgery.


 

surgical mesh  product liability attorney Anterior Elevate®, Apical Prolapse Repair System, Pelvicol® Tissue, Gynemesh®, the Advantage Sling System, Avaulta Plus® BioSynthetic Support System and Pelvitex Polypropylene Transvaginal Surgical Mesh Products

Transvaginal (also known as Urogynecological or simply "Pelvic") surgical mesh implants are used to support and repair a weakened bladder or urethra, or to reinforce and improve function in the vaginal wall. More than 100,000 women a year are fitted with surgical mesh to offer additional support for conditions of pelvic organ prolapsed (POP). Since 2005 the FDA has been notified of over 1,500 instances of complication and adverse side effects from patients after being implanted with surgical mesh products.

The most commonly used synthetic mesh slings are manufactured by Johnson & Johnson, C.R. Bard, American Medical Systems and Boston Scientific Corporation. Popular brand names include the Elevate Anterior and Apical Prolapse Repair System, Pelvicol Tissue, Gynemesh, the Advantage Sling System, and Avaulta Plus BioSynthetic Support System and Pelvitex Polypropylene Mesh. Due to the increased number of complaints, the FDA has instructed doctors to exercise caution when performing this procedure and advised them to warn their patients. Despite these measures, the number of complaints continued to rise and on July 13, 2011, the FDA announced that patients undergoing pelvic organ prolapse repair with a surgical mesh may be at a greater risk for mesh complications than women pursuing other surgical treatments. The agency's investigation into the matter is ongoing.

Pelvic organ prolapse (POP) repair surgery can be performed through the abdomen or the vagina using either stitches or a surgical mesh to reinforce the repair and to support the pelvic organs. According to the FDA, the transvaginal placement of surgical mesh may put women at a greater risk for complications than other surgical options. The agency also claims that there is no indication of greater clinical benefit for women electing to undergo pelvic organ prolapse repair surgery transvaginally.

In a study reported by the New England Journal of Medicine comparing the trans vaginal placement of mesh with colporrhaphy, a surgical procedure that involves stitching connective tissue together to strengthen pelvic muscles, multiple side effects were found to be caused by the placement of synthetic mesh slings. The study also highlighted the high risk of product defect, reporting that women who undergo the procedure are seven times as likely to suffer from bladder perforations and nearly twice as likely to suffer from loss of bladder control. The report also stated that 3.2 percent of women ultimately need corrective surgery following the procedure.

Symptoms and adverse side effects documented by the FDA as being connected to the use of transvaginal surgical mesh include infection, continued issues with prolapse or incontinence, bladder, blood vessel and bowel perforation, dyspareunia and vaginal scarring.

You have a limited time to take action after being injured by a medical device, so do not hesitate to seek legal help in protecting your rights.

Medical devices often require an operation to be implanted in the patient; if a device does not work properly or has unintended and dangerous side effects this could necessitate one or more "revision surgeries" to remove or otherwise address the implant problem. But many problems with defective medical devices only become apparent well after the initial surgery; if the device is implanted a patient can suffer a variety of serious symptoms during the time it takes for the revision surgery to occur. Even then, revision surgery does not always solve the problem.

If you have become the victim of personal injury in the state of Texas it is important that you seek advice from a legal professional; you may be entitled to claim compensation if you have suffered physical or mental injury that has stemmed from the use of a defective medical device. If you are experiencing serious side effects from a procedure involving a medical device implant or an injury from any defective product, or if you have been using a device or medication subject to a FDA recall contact Brent M. Cordell for a free initial consultation and case evaluation. We also represent family members of those who have suffered a wrongful death due to dangerous drugs or defective products.

If you believe that you or a loved one has suffered serious personal injury from a defective medical device, you may be eligible to seek compensation for your medical expenses, pain and suffering, loss of income, diminished earning capacity and more. Under product liability laws the manufacturer, distributor and seller can all be held liable for your injuries.

 

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