Georgia Stryker Hip Implants Recall Attorneys


March 25, 2014

Stryker Hip Implants Claims For Life Threatening Complications

Aggressive South Georgia Stryker Hip Implant Injury Attorneys

One of the largest medical and orthopedic product manufacturers in the world, Stryker Corporation, created what was originally considered to be a number of revolutionary hip implant component devices. Specifically known as the AB Rejuvenate (Rejuvenate) and ABG II Modular-Neck Hip Stem (ABG II) systems, both of these product lines are comprised of metal and ceramic components, but are specifically made using chromium and cobalt with titanium coated stems. Despite being marketed to the public as a safer and longer-lasting alternative to metal-on-metal hip replacement devices (associated with a number of serious side effects), thousands of its users have nonetheless reported a multitude of adverse health consequences, such as metal corrosion, fretting, metallosis, and severe tissue inflammation and pain surrounding the implanted device (medically referred to as an Adverse Local Tissue Reaction).

In addition to the Rejuvenate and ABG II systems, Stryker released to the public an additional hip implant device known as the Trident Acetubular, (Trident), which unlike its other products, is strictly a ceramic-on-ceramic hip replacement device. Notwithstanding, the Trident has also been associated with causing a number of serious side effects, such as bone fractures, inflammation, pain, and squeaking joints. As a result of the outpouring of public complaints reported to the FDA, all of these systems were ultimately recalled, spurring thousands of lawsuits by those who believe they have been seriously injured by Stryker's hip implant products.

Stryker Hip Replacement Devices & Associated Complications

The AB Rejuvenate and ABG II Modular-Neck Hip Stem Metal-On-Ceramic Systems

In light of the known side effects associated with traditional metal-on-metal implant devices, certain medical product manufacturers started to develop alternative hip implant products containing a mixture of ceramic and metal. One of the largest medical device manufacturers in the world, Stryker Corporation, created several hip implant component products, including the AB Rejuvenate (Rejuvenate) and ABG II Modular-Neck Hip Stem (ABG II) systems, which are comprised of both metal and ceramic components. Specifically, these systems are made of chromium and cobalt with stems coated with titanium. Despite Stryker hip replacement components being marketed as a safer and longer-lasting alternative to metal-on-metal hip replacement devices, thousands of its users have reported serious health consequences, including metal corrosion/fretting, metal poisoning and severe tissue inflammation and pain surrounding the implanted device.

The Trident Acetubular Ceramic-On-Ceramic System

In addition to the Rejuvenate and ABG II, Stryker also created an additional hip implant device known as the Trident Acetubular, (Trident), which is a ceramic-on-ceramic device. While it does not contain metal as with other Stryker hip implant products, the Trident has also been linked to causing a number of serious side effects, such as bone fractures, inflammation, pain, and squeaking joints. Moreover, the company has been reprimanded by the FDA on more than one occasion for serious issues stemming from the manufacture, packaging and storage of the Trident system.

FDA Issues Warning About Stryker's Trident Acetubular System

On March 15, 2007, the FDA issued a warning letter to Stryker Corporation, voicing their concerns over the company's Cork, Ireland facility where certain violations were found pursuant to the U.S. Code of Federal Regulations. Among many of the problems noted, most stemmed from the adulterated manufacture, packaging and storage of the Trident.

Shortly following FDA's first warning, the agency issued a second warning letter to the company on November 28, 2007, targeting certain issues in the company's Mahwah, New Jersey manufacturing facility. Specifically, the FDA discovered dangerous bacterial strains located in clusters throughout the plant, and as such, reprimanded Stryker for failing to contain the contamination and identify its source.

Additionally, the FDA further rebuked the company for failing to address and rectify certain problems directly associated with the Trident, such as poor adherence of the product to bone, delamination of the device's plasma-sprayed coating layer, and faulty implant seating, which has been reported to cause bone wear, fracture and broken devices in several of its users. Specifically, the FDA had been plagued by the high number of adverse health reports associated with the Trident, including squeaking hips, popping, pain and difficulty walking. As a result, the FDA ultimately forced the company on January 28, 2008 to recall the Trident, implicating thousands of hip replacements and revision surgeries throughout the United States.

Stryker Voluntarily Recalls Two of its Metal Component Hip Replacement Devices

In addition to the Trident, on July 6, 2012, Stryker voluntarily recalled both the Rejuvenate and ABG II hip implant systems. Since then, the company has also ceased its global distribution of these two products. What prompted Stryker's recall of the Rejuvenate and ABG II was post-marketing surveillance data which demonstrated that the modular necks on these devices were prone to corrosion and fretting and also were responsible for causing severe inflammation of the tissues surrounding the implanted devices. In fact, shortly before the company's announced its decision recall both the ABG II and Rejuvenate, it issued an Urgent Field Safety Notice to the public, warning about the increate rate of complications such as Adverse Local Tissue Reaction and other adverse health events experienced by users. Specifically, the company's voluntary decision to recall the Rejuvenate and ABG II comes soon after the FDA received thousands of complaints regarding the problems associated with Stryker's hip implant products. Currently, the company has contracted with the third party claims company in order to expedite the handling of product user medical claims and actions for reimbursement.

Stryker Hip Replacement Device Recall Timeline & Overview

As a result of the numerous side effects reported to the FDA by users of Stryker hip replacement products, several of its product lines were recalled, the timeline of which is as follows:

• March 15, 2007. FDA issues warning to Stryker Corporation regarding conditions at its Cork, Ireland manufacturing facility
• January 28, 2008. Following a number of safety warnings issued to Stryker Corporation, the FDA ultimately recalls the Trident ceramic-on-ceramic hip replacement system due to serious side effects reported by users as well as substandard plant manufacture, packaging and storage of the device.
• July 6, 2012: Stryker Corporation voluntarily recalls its Rejuvenate and ABG II hip implant systems due to post-marketing surveillance data which demonstrated that the modular necks on these devices were prone to corrosion and fretting and also were responsible for causing severe inflammation of the tissues surrounding the implanted devices.

Stryker Class Action Lawsuits & Multidistrict Litigation Cases: What's the Difference?

Many prospective litigants contact our office with the hopes of finding a qualified Georgia Stryker class action lawyer. However, it is important to understand that Stryker lawsuits are not class action lawsuits but rather, multidistrict litigation suits, or MDLs. The following are some facts to help you understand the difference:
MDLs

For large-scale civil cases that involve a number of different yet injuries related to a specific type of product, an MDL is a much more preferable cause of action to a class action suit. Specifically, MDLs allow several plaintiffs with all types of related injuries to join together for the initial phases of a court proceeding. Although these cases are consolidated during the pretrial phase, during trial, each case is individually heard before a judge and jury. Regarding the formation of a Stryker MDL, a judicial panel reviews these types of product liability cases being filed in federal courts located throughout the U.S. Only one judge is assigned to oversee the entire MDL during all pretrial proceedings.

Class Action Lawsuits

Stryker lawsuits that have been filed are not class action lawsuits. Specifically, a class action lawsuit is a civil proceeding that is typical to product liability lawsuits involving multiple plaintiffs who all have a shared interest in the case. Class action lawsuits are more appropriate for cases involving a number of victims with similar injuries who are suing one product manufacturer or individual person. While these cases are efficient since they consolidate all complaints into one single lawsuit, they unfortunately do not account for individual injuries sustained by each plaintiff. Class action lawsuits also involve plaintiffs who must share the financial settlement or monetary damages award, regardless of the nature and severity of their injuries.

Stryker Lawsuits & Noteworthy Plaintiffs

A number of state and federal lawsuits have been filed against Stryker Corporation due to the thousands of adverse health effects experienced by users of its ABG II, Trident and Rejuvenate Hip Implant systems. The following are the most noteworthy cases that are currently pending in a number of courts across the United States:

• As of January 31, 2013, the New Jersey Supreme Court approved the centralization of all Stryker hip lawsuits filed within the state in the Superior Court in Bergen County. Currently, about 553 lawsuits have been filed in New Jersey related to severe heath complications associated with the Stryker Rejuvenate and ABG II modular-neck stems (In Re: Stryker Rejuvenate Hip Stem and the ABG II Modular Hip Stem Litigation, No. 296).
• On February 19, 2013, a petition was filed by plaintiff Robert Davis with the U.S. Judicial Panel on Multidistrict Litigation requesting that that all federally-filed Stryker hip replacement lawsuits be transferred to the U.S. District Court, District of Minnesota. The Petition states that several claims have been filed against Stryker in a number of federal district courts, and provides that many more will likely be filed in the near future. (In Re: Stryker Rejuvenate and ABG II Hip Implant Products Liability Litigation, MDL 2441). Currently, there are approximately 462 pending cases before the district court.
• On May 16, 2012, Miles Minkler filed a lawsuit in the Circuit Court of the State of Oregon against Stryker Corporation, which was later removed to the U.S. District Court, District of Oregon on June 15, 2012. Specifically, Mr. Minkler seeks about $5 million in damages against Stryker for complications that he experienced following his Trident Stryker hip replacement surgery. In his complaint, Mr. Minkler claims that following his hip replacement surgery, he suffered from severe pain and discomfort in his right hip and groin area as well as regularly heard a "popping" and "grinding" sound coming from his right hip. The plaintiff also alleges to have difficulty walking, moving around and also, constantly feels like his right leg will "give out" at a moment's notice. Mr. Minkler sought $4.5 million in non-economic damages and another $400,000 in economic damages, costs and disbursements. The case has since been terminated however, Minkler continues to face several challenges associated with his hip implant surgery.
• Dianne Pingel of Boca Raton, Fla., filed a lawsuit against Stryker Corporation due to having received two defective hip implant devices in 2011. Instead of being able to retire, Ms. Pingel spent more than a year in out and of hospitals due to complications she experienced as a result of her defective Stryker hip implant devices, which include metal poisoning, tissue death, bone fractures and revision surgeries.

What do the Stryker Lawsuits Generally Allege the Company?

For the most part, the lawsuits that have been filed against Stryker Corporation generally allege the following:

• Failure to adequately test its hip implant devices before released them to the public.
• Used of deceptive marketing and sales tactics.
• Failure to properly design hip implant devices to insure that they do not corrode, fret or deteriorate.
• Falsely claimed that the hip implant devices were safe alternatives to traditional metal-on-metal devices.
• Marketed its implant devices as a "perfect fit" for younger patients, yet recalled the devices within 3 years due to poor design and improper testing.
• Failure to respond to reports of early failure of the implant devices.
• Continued to market and sell its hip implant devices despite the knowledge that its titanium alloy did not properly perform when fitted with chrome components.
• Failure to warn patients and medical professionals regarding the risk of metal poisoning.
• Designed the ABG II and Rejuvenate hip implant systems based upon another device that has been the subject of litigation due to poor design and associated complications.


Grounds for Filing a Stryker Hip Replacement Lawsuit

Finding out that your hip replacement device is the subject of a recall, or if you have already experienced serious side effects associated with these devices, it is likely that you may be considering filing a lawsuit. Accordingly, the following is a list of factors that are important for you to consider in determining whether you have a plausible case:

1. Stryker Hip Implant Recall. Find out whether you have a recalled Stryker hip replacement device, you need to contact the doctor that performed your hip replacement surgery. He or she will have a record of the type of implant you received, which will be important for you to provide to your attorney in order to proceed with filing a lawsuit.

2. Damages. It is important to understand that you do not necessarily have to experience symptoms in order to have a credible claim for damages against Stryker Corporation. Known as presumed damages, these involve the reimbursement for out-of-pocket costs associated with medical monitoring and other associated costs should you have a recalled hip device that has not caused any current symptoms to manifest. In the event that you have experienced certain symptoms/complications associated with your recalled hip implant, you will want to discuss this with your attorney in order to determine the scope of your legal options. The most common signs and symptoms are:

• Pain when walking
• A clicking noise at the site of the implant
• Difficulty walking, getting up from a seated position, or moving around
• Metal poisoning
• Bone fractures
• Inflammation and pain in the implant area
• A revision surgery to replace a defective/recalled hip implant device

For more information, it is highly recommended that you contact a qualified products liability attorney to maximize your chances of recovering damages for your injuries.

Your Legal Options: Why Montlick & Associates?

If you were the recipient of a Stryker hip replacement product that has been recalled, it is important to understand where to turn next and also, that you have legal options. First and foremost, it is highly recommended that you speak with one of the experienced and highly seasoned attorneys at Montlick & Associates. Specifically, our qualified team of personal injury attorneys can guide you as to the appropriate steps necessary for you to take in order to maximize your chances of recovering for your injuries. We can also help you protect yourself and your legal interests during the process of filing a product liability claim against your implant manufacturer. For example, many patients who received Stryker's hip implant products have been ill advised by the company to call its third party claims company, Broadspire, in order to seek reimbursement for their medical costs and other associated out-of-pocket expenses. As a result, several of these individuals' communications with Broadspire can be used against them in court, potentially jeopardizing their ability to recover damages. Don't wait until your time has run out to file your case. Contact Montlick & Associates today to learn more about your legal options!

If You Developed Complications after Receiving a Hip Implant Device, Contact Montlick & Associates Today!

If you or a loved one experienced any of the above-listed complications after receiving a hip replacement implant device, contact the Georgia personal injury attorneys at Montlick & Associates for your free consultation. Our team of seasoned Georgia personal injury lawyers have been representing victims for over thirty years throughout all the State of Georgia and the Southeast, including but not limited to all smaller cities and rural areas in the state. No matter where you are located, our attorneys are just a phone call away, and we will even come to you. Call us 24 hours a day/7 days a week for your Free Consultation at 1-800-LAW-NEED (1-800-529-6333). You can also visit us online at www.montlick.com and use our Free Case Evaluation Form or 24-hour Live Online Chat.

Category: Personal Injury

Please Note:
Many of our blog articles discuss the law. All information provided about the law is very general in nature and should not be relied upon as legal advice. Every situation is different, and should be analyzed by a lawyer who can provide individualized advice based on the facts involved in your unique situation, and a consideration of all of the nuances of the statutes and case law that apply at the time.