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Steve Thomas
Steve Thomas
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Failed metal hip replacements the horses out of the barn

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Conducting a regulatory review process designed to “assure that patients had timely access to safe and effective medical devices,” the U.S. Food and Drug Administration’s Center for Devices and Radiological Health, according to the center’s 2013 Strategic Priorities, has been developing ways to “strike the right balance between pre-market and post-market evidentiary requirements” for medical devices.

In this regard, the FDA staff will rely on expertise from academia and from medical device manufacturing, venture capital, and medical device testing and research industries. Expect participants in this Entrepreneurs-in-Residence Program to announce recommendations later this spring.

The program is also “focused on streamlining clinical trials” and on “reducing the length of time between FDA approval of devices and their reimbursement by insurers,” according to a November 2012 report titled “Improvements in Device Review,” which was written jointly by the FDA and by the U.S. Department of Health and Human Services, of which the FDA is a division.

The FDA’s list of medical devices includes metal-on-metal hip implants, the increased failure rates of which have resulted in serious patient injuries and thus have triggered the filing of product liability lawsuits.

When it comes to metal-on-metal hip replacements and other medical devices, review processes can help to ensure device safety but also can decelerate the introduction of products that patients need; hence, theoretically, one reason for evidentiary “balance.”

Nevertheless, as we await the panel’s findings, it is apparent that a lot of those metal-on-metal hip implant designs squeaked into the market with preventable defects about which the manufacturer should have known and should have disclosed and corrected either pre-market or early in post-market, claim many of the plaintiffs in metal-on-metal hip replacement lawsuits.

Injured victims of device failure could pull out extensive medical-treatment records, including those that pertain to revision surgeries, or they could show the extent to which their general health has worsened, and then make a cogent case that there has been an imbalance between public health and commercial expediency in the metal-on-metal hip replacement market.

Anyone who believes the injured metal-on-metal hip replacement patients are whiners ought to contemplate an hour in their shoes. Medical device attorneys have represented clients who have suffered adverse reactions, including the following complications that the FDA has reported:

• “Loss or reduction of joint function. Improper design or inadequate mechanical properties of the device, such as its lack of strength and resistance to wear, may result in the loss or reduction of joint function due to excessive wear, fracture, deformation of the device components, or loosening of the device in the surgical cavity.”

• “Adverse tissue reaction. Inadequate biological or mechanical properties of the device or its breakdown products, such as its lack of biocompatibility, may result in an adverse tissue reaction due to dissolution or wearing away of the articulating surfaces of the device and the release of materials from the device to the surrounding tissues and the systemic circulation.”

• “Increased risk of premature device failure. Elevated adverse event rates for these devices may lead to an increased risk of premature revision.”

• “Infection. The presence of the prosthesis within the body may lead to an increased risk of infection. The distinctive risks associated with metal/metal total hip replacements in comparison to other types of bearing surfaces are the wear particles generated and release of metal ions. These wear particles and metal ions may cause adverse tissue reactions in addition to the standard osteolysis seen with different bearings for total hip replacements and may lead to an increased risk of premature device revision. These adverse tissue reactions include metallosis, hypersensitivity/allergy, tumor (pseudo) or aseptic lymphocyte dominated vasculitis associated lesion (ALVAL).”

The horse, representing every balky metallic hip, basically ran over thousands of patients after it was let out of the regulatory barn. After the stampede, the FDA put on what one might consider somewhat of a re-balancing act, proposing a rule that would require the manufacturer of each new metal-on-metal hip replacement to show scientific evidence that the device is safe before it would be “placed in commercial distribution.”

At the that time the proposal was introduced in January, and up to 90 days after the rule’s effective date, the device merely must have been “found to be substantially equivalent to any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that [already is] in commercial distribution.”

Robert J. Binstock, founding partner of the law firm Reich & Binstock, issued the following statement Jan. 18 in response to the FDA’s proposed rule:

“The U.S. Food and Drug Administration’s quest to bring safe, effective and cost-saving medical devices to market for the benefit of patients is a laudable pursuit which reflects the agency’s abiding regulatory purpose. The FDA’s proposal to require manufacturers to perform clinical trials on all new metal-on-metal hip implant designs is a key component. The FDA’s move hopefully would help to ensure that a sector of the medical device industry no longer serves as its own regulator and that product safety does not acquiesce to market influences alone.

“In the meantime, the judicial process is thankfully there to deal with the entitlement to just compensation for victims of failed metal-on-metal hip implants who suffered metallosis and other sources of agony.”

Anyone who has suffered metallosis or other complications related to the failure of any of the following metal-on-metal hip implants may want to contact one of the experienced personal injury attorneys at Reich & Binstock for a free consultation:

• Biomet M2a Hip Implants
• Biomet M2a-Magnum
• Biomet Regenerex
• Birmingham Hip Replacement
• Birmingham Hip Resurfacing (BHR) system
• DePuy ASR XL Acetabular System
• DePuy ASR Hip Resurfacing System
• DePuy Pinnacle Acetabular Cup System
• DePuy PINNACLE ULTAMET Metal Liner
• Portland Orthopaedics Ltd. M-COR Modular Hip System
• RingLoc + Modular Acetabular System
• Stryker Hip Implants
• Wright CONSERVE Total Resurfacing Hip System
• Wright PROFEMUR Hip Implant
• Zimmer Durom Cup
• Zimmer Continuum Acetabular System

Reich & Binstock operates in every state and may be reached either toll-free at 1-866-LAW-2400 or through the electronic case evaluation form that is posted on the law firm’s Web site, www.reichandbinstock.com.