Zimmer Hip Lawsuit Settlement Funding
Pre Settlement Funding on Recalled Zimmer Hip Litigation
Zimmer Inc., one of the leading manufacturers of metal-to-metal hip components, constructed a one-piece metal socket device with plasma material and called it the Durom® Acetabular Component or “Durom Cup”. Zimmer later recalled the product after numerous complaints and liability lawsuits were filed against the company.
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Zimmer Holdings, Inc. is a manufacturer known for its joint and skeletal replacement systems. Zimmer Holdings, Inc. recently acquired Biomet. Once the sale is finalized in 2015, Zimmer will become the second largest orthopedics company in the United States. The company has developed numerous technologies to further develop and innovate its product lines including the Kinectiv Modular-Neck Technology and the Trabecular Metal Technology.
Zimmer, like its competitors, is familiar with various lawsuits and litigations regarding its products. In this case, however, the scrutiny is for the product called Durom Acetabular Component or more commonly known as the Durom Cup. Lawsuits have claimed that Zimmer not only practiced negligence on several counts, but also sold and marketed a defective product, release of inaccurate claims regarding safety and effectiveness, and failed to warn patients and surgeons regarding the safety risks, even when the company was aware of them.
The Durom Cup is prone to various risks associated with metal-on-metal hip replacement systems. However, many claims also suggest that the device has additional risks and complications such as dislocation or loosening of the implant within the hip joint. The product was intended to solve durability and range of motion issues. But studies have shown that the Durom Cup has higher failure rates and cannot be seated properly in the join, causing many patients insufferable pain because the device has a tendency to slip from its original positioning.
Zimmer has paid claims totaling over $400 million. Experts expect that the number of lawsuits and amount of payouts will continue to grow over the years. Zimmer has not discontinued the product, nor have there been reports of the product not being out in the market anymore. However, the Durom Acetabular Component is missing from the list of products in the Zimmer website.
Zimmer Lawsuits and Litigation
MDL No. 2158 was created on June 2010 when the Judicial Panel on Multidistrict Litigation ordered to transfer federal cases to the United States District Court for the District of New Jersey for lawsuits regarding the Zimmer Durom Cup. The cases are still separate but were consolidated together for pretrial proceedings.
It was in 2008 when Zimmer Holdings made a $69 million fund to pay claims that met exact requirements. The company has currently settled cases totaling up to $400 million to those who were injured by the Durom Cup. Zimmer is expected to cough up more than $200 million to settle other pending lawsuits. One complaint has stated that the Durom Cup failure rate is as high as 30 percent and that the company continued to sell and market the product all while knowing of this information.
240 cases were grouped together in the federal litigation and is overseen by Judge Susan D. Wigenton. Approximately 100 of the 240 cases were resolved, either through trial or through settlements. A chunk of lawsuits against Zimmer have also been filed in state levels, in conjunction with those filed in New Jersey state courts.
Claims against Zimmer include several counts of negligence, selling and marketing of a defective product, Zimmer’s failure to warn of the risks, failure to properly test the Durom Cup prior to selling, improper marketing, release of inaccurate statements regarding safety and effectiveness, and unfair profiting from the sales of the product.
Plaintiffs against Zimmer Holdings regarding injuries from the Durom implants are able to get compensation for medical bills, pain and suffering, lost income, loss of consortium and punitive damages.
Background on Zimmer Holdings
Zimmer Holdings, Inc. manufactures joint and skeletal replacement systems, as well as surgical tools, and biologics to aid in joint replacement surgeries. The Indiana-based orthopedics company, through its Kinectiv Modular-Neck Technology, has developed its devices in such a way that surgeons have more flexibility in terms of options to better customize an implant for a patient.
The Kinectiv Modular-Neck Technology has four components instead of three so that surgeons are able to choose which components of the prosthesis, which alters the size and shape of the device in order to match the actual hip of the patient.
Traditional hip implants use cast metal; a number of Zimmer hip products are different in the sense that it uses Metasul Metal-on-Metal articulation, a forged metal. The forged metal is supposedly a material that would help make the devices harder and smoother, thus making it more durable.
Other Zimmer products, on the other hand, use Trabecular Metal Technology. This technology is a three dimensional material. It is intended to mimic the spongy bone of the body, which administers a high level of friction. The high level friction allows the hip joint to stabilize instantly after its implantation. The material is also intended to allow bone growth into the hip implant.
Zimmer announced its acquisition of Biomet in April 2014 for $13.35 billion. The sale of the competitor will be completed by 2015, making Zimmer Holdings the second highest orthopedics manufacturer and maker in the United States.
Zimmer hip replacement products basically have three categories. One category is the femoral components which include the M/L Taper with Kinectiv Technology, M/L Taper Hip Prosthesis, Fitmore Hip Stem, Trabecular Metal Primary Hip Prosthesis, and the VerSys Epoch FullCoat Hip.
Another category is the acetabular (cup) components with devices such as Continuum Acetabular System, Trabecular Metal Modular Acetabular System, Trilogy Acetabular System, and the Durom Acetabular Component. The last category of the Zimmer hip replacement products are designed for revision surgery, the products listed in this category are: Trabecular Metal Acetabular Revision, ZMR Hip System, ZMR Taper Distal Stem, ZMR Porous Distal Stem, and Wagner SL Revision Hip.
Zimmer Durom Cup
Also known as the Durom Acetabular Component, the Durom Cup is made with a single sheet of cobalt chromium alloy metal. Designed to be used without the cement technique, the device was designed with a porous coating to promote bone growth as well as better fusion with the hip socket to keep the implant in place.
The synthetic replacement for natural acetabulums was designed to resolve the implicit problems that were found in hip replacement devices of the past, which are durability and range of motion. These two problems are predominant in patients with hip implants with active lifestyles, and patients that were in a younger age group.
While Zimmer was under the impression that the Durom Cup was able to address these two problems, product use showed otherwise. Because the Durom Cup can easily slip off from its original place, patients are also easily prone to intense pain when this dilemma occurs. The Durom Cup was also intended to be used with the Metasul Metal-on-Metal Tribological Solution LDH so that the products are able to contribute a durable hip replacement system that also gave a wider range of motion for patients.
Larger device heads were supposedly going to allow patients to have better range of motion than smaller sized heads. However, larger implant heads have more wear and tear on the devices.
Reports from the lawsuits claim that contrary to the company’s claims, the Durom Cup failed to properly bond or fuse with the bone and fit in the hip socket, therefore placing patients in danger of severe pain, dislocation, nerve damage, and the need for revision surgery to correct the complications that resulted from the use of the device. In 2008, Zimmer estimated that their hip replacement side effects, which were caused by the Durom Cup, were 5.7 percent in all of the hip surgeries it was used in.
A year after its FDA approval in 2006, dilemmas with the Durom Cup started to arise. Nationally recognized orthopedic surgeon Lawrence Dorr, M.D., was a paid consultant of Zimmer Holdings. In 2007, he reported problems that came about from the use of the Durom Cup in patients. He stated that the prosthesis failed and caused excruciating pain after just a few months of the initial implantation. He also said that he performed revision surgeries in patients to replace the hip replacement system and accused the product of poor construction.
In 2008, Dorr also informed colleagues at the American Association of Hip and Knee Surgeons regarding his encounters with the Durom Cup. He precisely identified 10 revision surgeries out of 165 Durom Cup surgeries in his letter and presented three important points: revision surgeries were needed by patients within the first year of the primary surgery due to loose implants; the fixation surface was inadequate; and the circular cutting surface at the edge of the implant actually kept the device from being seated properly in the joint. Zimmer allegedly accused these problems on Dorr’s technique, even after Dorr found out that other surgeons had also encountered similar problems with the Durom Cup.
FDA Recalls, Warnings and Reports
The Durom Cup, like most of the hip replacement devices, was approved through the 510(k) premarket approval system of the FDA. The premarket approval system approves a product that is pending approval as long as it is substantially equivalent to another product that was already approved by the FDA and is being sold in the market. The 510(k) system does not require the need for clinical tests or human testing.
The Durom Cup was approved by the FDA in 2006 and it was being sold and used until July 2008 when the company initiated a Class II recall of the device. The FDA stated that the recall was due to the fact that the instructions regarding uses and surgical techniques were not adequate.
After the recall, Zimmer holdings sent out letters to surgeons to explain the cause of the recall. Also included in the letters were Zimmer’s urgencies to halt the use of the device in implantations until additional training was received. In spite of its problems, the Durom Cup was back in the market after the company had updated its labels and made a surgical training program on the Zimmer website.
The University of Wisconsin had a recent study which compared the progress of patients a year after their initial hip replacement surgery, encompassing different devices from different companies. The Durom Cup, as reported by the study, had an 11 percent failure rate. Recipients of the product also noted that the pain and discomfort they felt were not any better after receiving the hip replacement surgery.
Senator Charles E. Grassley, in July 2010, asked Zimmer Holdings to provide information regarding the company’s way of handling complaints about product problems from medical consultants, as well as how it keeps surveillance on long-term performances of the company’s devices. The Senator asked the company for this information after The New York Times released an article about disputes between Zimmer consultants and the company.
Zimmer was one of the manufacturers included in the FDA advisory panel in 2012 which was created to discuss metal-on-metal hip replacements and its adverse effects.
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