BARD IVC FILTER INJURIES
A recent NBC new story raised serious questions about the safety of Bard IVC filters. The NBC story reports on two compelling and tragic stories of Bard IVC filters fracturing or dislodging and traveling into the patient’s heart. In one case the Bard IVC filter filter fractured, traveled to the heart, and forced the patient to undergo emergency open heart surgery. In another case a blood clot dislodged the Bard IVC filter which led to a puncture of the heart and death. Blood clots are exactly what the Bard IVC filter is implanted to capture and protect the patient from. More troubling, the report points to sources and documents that show that rather than fix the Barc IVC filter or remove the Bard IVC filter from market, CD Bard brought in outside consultants such as a “high powered public relations firm.”
BARD IVC FILTER CASES CONSOLIDATED
Recently 22 Bard IVC filter cases filed in various federal courts across the country were transferred to the United States District Court in Arizona for multi-district litigation (MDL). The presiding judge is the Honorable David Campbell. An MDL is not the same as a class action, but it is similar in that it combines similar Bard IVC filter cases for discovery purposes because most cases have similar legal questions that need to be answered. These include: Were IVC Bard filters defectively designed? Were the Bard IVC filters appropriately tested before they were put on the market? Were physicians appropriately warned of the risks and benefits of Bard IVC filter implantation? How did the company respond to reported adverse events such as Bard IVC filter fractures and migrations such as were discussed in the NBC new story? The Arizona MDL will allow discovery on these issues and will likely oversee a number of cases tried before an Arizona jury to assess the company’s liability and damages to injured plaintiffs. These trials are known as “bellwether trials.”
Perdue & Kidd has successfully litigated, tried, and won cases against pharmaceutical and medical device companies both within MDLs and on an individual basis. If you or a family member have been injured by a Bard IVC filter call the medical device attorneys at Perdue & Kidd for a fee and confidential case evaluation.
A recently published study in The Journal of the American Medical Association (JAMA) highlights the potential public health dangers posed by medical devices that undergo limited testing to determine their safety and effectiveness. In 2010 and 2011 there were 28 medical devices that received Premarket Approval (PMA). PMA is considered the Food and Drug Administration’s (FDA) most rigorous approval process for medical devices before they are allowed to be sold on the market. These devices require PMA because they are considered high risk and are not substantially similar to other medical devices already on the market. Once approved, these devices are generally considered Class III medical devices, and it is very difficult for individuals injured by Class III medical devices to bring suit against the manufacturer. This is because courts, including the United States Supreme Court in Riegel v. Medtronic, have held that individual claims are largely preempted by federal law. Our firm has been unable to represent many clients who have been injury by Class III medical devices because potential claims are considered preempted.
The recent JAMA study brings into question how rigorous the PMA process really is. Of the 28 medical devices that received PMA by the Food and Drug Administration (FDA) in 2010 and 2011, most averaged two premarket clinical studies. Only one of those two studies generally focused on the long-term safety and efficacy of the medical device in question (pivotal studies). Equally disturbing is that as a condition for PMA, the FDA required that these 28 medical devices undergo a total of 33 post market studies. The JAMA study found that only 6 of these 33 post market studies had been completed. The rigorous PMA process does not appear to be nearly as rigorous as advertised. This study brings into question the preemption arguments made for Class III medical devices that undergo PMA.
As we have previously blogged, approximately 99% of medical devices that are on the market do not even undergo PMA. The other 99% of medical devices are cleared through the 510K process that require zero premarket clinical studies. All medical devices that Perdue & Kidd is currently litigating underwent the 510K clearance process, including transvaginal mesh, metal on metal hip implants, and Zimmer knee implants.
If you or a loved one has suffered a medical device failure please contact the medical device litigation attorneys at Perdue & Kidd for a free consultation.
On March 12, 2015 the Food & Drug Administration (FDA) website posted a Class II recall for Zimmer, Inc.’s Persona Trabecular Metal Tibial implant following an increase in reported adverse event complaints of radiolucent lines and loosening. Radiolucent lines are lines that are seen on x-rays, appearing dark on the exposed film. They are risk-factors for knee replacement failure, associated with early loosening of the acetabular component of a knee replacement. All sizes and lots of the Persona device were being removed from distribution. This recall includes roughly 11,500 knee implant devices. Specifically, the recall included all lots and sizes C-J of the implant that were sold from November 2012 until early 2015 throughout the United States, including Arkansas, Alaska, Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin.
Urgent Medical Device Recall notices were issued to affected distributors, hospitals, and surgeons on February 16, 2015 via mail. Customers were asked to review the notification and ensure that affected personnel were aware of the contents. All affected product were to be located and quarantined immediately.
The Zimmer Persona Knee
According to Zimmer, whose headquarters are located in Warsaw, Indiana, the Persona knee is “redefining knee arthroplasty and ushering in a new era of personalization.” The Persona Product Brochure describes the implant as being more personalized in that it offers improved tibia rotation, more precise ligament balancing, and replicates a more natural femoral design.
While there has been a current trend in the knee device industry to manufacture and sell personalized or customized knee implants as opposed to off-the-shelf implants, these implants lead to their own set of potential complications. Zimmer NexGen knee implants are currently the subject of nationwide litigation due to high rates of loosening.
If you or a loved one has suffered loosening or device failure of a Zimmer Persona knee implant please contact the defective knee implant attorneys at Perdue & Kidd for a free consultation.