FDA Alerts Blog

Chantix Lawsuits Settled for $300 Million

December 9th, 2014

All of the nearly 2,900 lawsuits against the smoking cessation drug Chantix have been settled for approximately $300 million, and a federal judge in Alabama ruled earlier this month that the nationwide litigation should be dismissed.

More than 10 million smokers in the U.S. have been prescribed Chantix to help them stop smoking. The drug is highly effective as an aid to smoking cessation, but it has been blamed for triggering suicidal thoughts, behavioral changes, hostility, agitation, depression, and other psychological problems in patients.

In September, the U.S. Food and Drug Administration updated the warnings and precautions section on Chantix to include information from some new studies that have found that the drug’s psychological effects may not be as bad as originally thought, but an FDA advisory panel voted overwhelmingly on October 16 to retain the most serious warnings. Pfizer Inc., the manufacturer of Chantix, had been seeking to have the Black Box warning removed, but only one advisory panel member voted in favor of removal, while 11 voted to maintain the warning, and six voted to strengthen the labeling to include references to sleep disturbances.

The panel also recommended that any further changes to the Black Box warnings should not be considered until after Pfizer completes a post-marketing study anticipated in the third quarter of 2015. Had the Black Box warning been removed, it would have been difficult to have it reinstated later, even if the post-marketing study showed negative findings, what some experts consider to be a motivating factor in the company’s urging to have the warnings removed.

Soon after Chantix was approved for use in 2006, the drug has been associated with reports of suicide and violence. Sales fell to $648 million in 2013 from $846 million in 2008, and Pfizer has spent hundreds of millions of dollars to settle the lawsuits.

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Complications Linked to DePuy Pinnacle Hip Replacement System

December 4th, 2014

If you have experienced problems or complications after receiving a hip replacement utilizing the DePuy Pinnacle metal-on-metal hip implant system, legal recourse may be available to you.

hipThe DePuy Pinnacle is similar in many respects to the recalled DePuy ASR hip system, which was taken off the market in August 2010 because of a higher than anticipated failure rate, which is likely related to the design of the artificial hip.

The Pinnacle system was designed to accommodate younger hip replacement patients by providing more flexibility and range of motion than existing hip replacement products, but the metal-on-metal feature of the system, which was created to help lower failure rates, instead has resulted in more serious problems. 

 

 

Problems with the DePuy Pinnacle System

Some individuals who have received DePuy Hip Replacement systems are reporting debilitating symptoms such as:

  • Unexplained hip pain
  • Problems standing or walking
  • Reduced or lost mobility
  • Dislocation of the hip implant
  • Infection
  • Early hip replacement failure
  • Need for additional hip revision surgery

The metal-on-metal components of the DePuy Pinnacle system has been found to result in metallosis, biologic toxicity and a high failure rate due to microscopic metal particles that are shed when the parts rub against one another. Placement of the system is extremely difficult, even for the most talented surgeons, and without perfect placement, problem results may be intensified.

FDA approval for the DePuy Pinnacle artificial hip system was given to Johnson & Johnson and their DePuy Orthopaedics subsidiary in 2000 under the 510(k) approval process, which does not require rigorous premarket approval testing. Instead, the system was approved as a substantial equivalent to older hip replacement devices.

Doctors who are tracking groups of patients who received the Pinnacle estimate that more than 10 percent of the devices will likely fail in the next two or three years, according to sources.

Contact Us

If you or a loved one received a hip implant and have experienced complications or had to undergo revision surgery as a result, contact our metal-on-metal hip implant lawyers today for a free case evaluation and learn about your legal options. There is no obligation. Our attorneys will work closely with you to seek justice and fight for compensation for your injuries.

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Takata Air Bag Recall-Should It Have Been Done In 2004?

December 3rd, 2014

Former Takata employees have charged that the Japanese airbag manufacturer conducted secret tests in 2004 on 50 airbags retrieved from scrapyards, saying that tests were performed after work hours, on weekends, and holidays during the summer of 2004 at the company’s American headquarters in Auburn Hills, Michigan. Takata denies the allegations.

According to the employees who came forward on the condition of anonymity, when the tests exposed defects in the steel inflators of two of the airbags, instead of alerting federal safety regulators to the potential danger, company executives discounted the results and ordered technicians to delete the testing data from computers and dispose of the faulty airbag inflaters in the trash.

The secret tests, not previously disclosed, were conducted four years before Takata admitted in regulatory filings that it had conducted tests on the problematic airbags. Later tests led to the first airbag recall four years later, in 2008. Takata blames manufacturing problems and exposure to moisture by cars in humid regions for the defect, which caused the propellant to degrade and burn too strongly when the airbag deployed, rupturing the inflater.

Currently, eleven automakers have recalled more than 14 million vehicles worldwide because of Takata airbag rupture risks. So far there have been four deaths and more than 30 injuries linked to the defect, which causes the airbag’s steel canister to crack and explode into pieces when deployed in a crash, spewing metal debris into the vehicle’s interior, severely injuring drivers and passengers. But complaints have been received by regulators blaming Takata airbags for a minimum of 139 injuries, including 37 individuals who said that the airbags ruptured or spewed out metal fragments or chemicals.

Takata is one of the world’s largest suppliers of airbags, with a global market share of about 20 percent. Although Takata has said the problems with the airbags were corrected in the early 2000s, the National Highway Traffic Safety Administration has reopened an earlier investigation into four deaths in Hondas related to Takata airbags since 2008, and the company is also the subject of a U.S. criminal investigation over the defective airbags.

For more information on the expanded air bag recall click here.

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Wright Medical Profemur Total Hip System Plagued By Design Defects

December 2nd, 2014

The Wright Medical Profemur Total Hip System was approved in the U.S. as a substantial equivalent to existing hip replacement systems, but it is becoming apparent that design defects may make the device prone to early failure.

Signs indicating potential problems with the system include:

  • Inexplicable hip pain
  • Loosening of the implant
  • Inability to stand or walk
  • Hip replacement failure
  • Necessity for additional hip revision surgery

The Wright Profemur femoral neck is designed to be modular so that it can be adjusted according to leg length. It was also intended to be subject to bend, which consequently may lead to faster-than-normal deterioration and an increased risk of hip replacement failure. Numerous consumers who received hip replacements with the Wright Profemur system have reported that the femoral neck broke or fractured during normal use, resulting in severe pain, the need for revision surgery and even permanent injury. 

Wright Profemur Hip Lawsuits 

Allegations made in numerous lawsuits say that the design of the Wright Profemur Total Hip System is unreasonably dangerous, causing the femoral stem to fracture, break, degrade, fret, and ultimately fail. The Wright Medical Group also failed to adequately research the safety of the implant and a recall should be issued after a higher-than-expected number of patients experienced problems within a few years of hip implant surgery, according to court documents.

Wright Medical Group is headquartered in Arlington, Tennessee has been designing, manufacturing, and marketing joint implants since 1950, and about 60 percent of the company’s sales come from its hip and knee products

Although the company has had success with its ceramic-on-ceramic products, the same cannot be said for its metal-on-metal devices, including the Profemur Total Hip System and the Wright Conserve Plus. Like other metal-on-metal systems, the Profemur system is prone to fracture and failure early, and a number of patients have already brought lawsuits against Wright arising from early device failure, pain, excessive metal ions in the blood, and the need for additional revision surgery because of faulty design.

Contact Us

If you or a loved one received a hip implant and have experienced complications or had to undergo revision surgery as a result, contact our metal-on-metal hip implant lawyers today for a free case evaluation and learn about your legal options. There is no obligation. Our attorneys will work closely with you to seek justice and fight for compensation for your injuries.

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Do I have a Recalled Hip Implant?

December 1st, 2014

Our firm is frequently contacted by patients from all over the country to help determine whether their hip implant has been recalled or is defective.  This is currently a very common question following the recent announcement of the proposed settlement of a large number of claims relating to recalled Stryker Rejuvenate and ABGII hip implants for approximately $1.4 Billion.

Trying to determine whether you even have a recalled or defective hip implant can be frustrating, as there is no hip recalldatabase a patient can review to make that determination.  Additionally, it is often difficult to obtain this information from the hospital where the hip replacement surgery took place or from your implanting surgeon.  They are busy and often cannot release that information unless and until you to complete and submit specific forms to obtain your medical records.

The good news is – we can help.  Our hip implant recall lawyers at Childers, Schlueter & Smith have been working on these cases for several years, and we know the right questions to ask and how to get the information quickly.  With approaching settlement deadlines and statutes of limitation, it is critical that you figure out what type of hip implant you received, and whether your hip device has been recalled.

Please call us at 1-800-641-0098 or email us intake@cssfirm.com for an immediate and free initial review.

Our hip recall lawyers, led by firm founder Richard Schlueter, have spoken with and assisted thousands of patients all over the country, including patients implanted with the following hip implant devices:

Stryker Rejuvenate

Stryker ABG II Modular-Neck

Stryker Accolade TMZF

DePuy ASR

DePuy Pinnacle with Ultamet liners

Biomet Magnum M2a and Magnum M2a Taper

Zimmer Durom Cup

Wright Profemur Modular Neck

Wright Conserve Hip Implants

Wright Dynasty Acetabular Cup

If you know the date of your hip replacement surgery, the hospital where the surgery took place, and the name of your implanting surgeon, we can quickly help you determine if you received a recalled implant or a device with a known defect.Hip Implant X-Ray

Other limited forms of information can also help us determine what type of hip implant device you have. Some patients only have a portion of their records, and do not have the have the “implant stickers” that identify the specific make and model of their implanted device. We frequently receive records via e-mail, fax, or text message, and can review them immediately.  We also can review photos or x-rays to narrow down or definitively determine the specific hip implant involved.  With the large number of hip implants that have been recalled over the past several years, it is important that you know what type of implant you have.  Without this information, a patient may not appreciate the need to follow up with their doctor, and may not discover their injuries until they have progressed to the point of causing long-term and/or permanent health problems.

If you have questions or think you may have a defective or recall hip implant device, call or e-mail us now to get answers: 1-800-641-0098 or intake@cssfirm.com

There is no obligation and all initial reviews are free of charge.

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Update: Stryker Rejuvenate and ABGII Hip Global Settlement Announced

November 3rd, 2014

Just over two years since the Stryker Rejuvenate and ABGII hip implant products were recalled from the market in June 2012, national leadership in the multi-district litigation (MDL) today announced a global settlement proposal for all Stryker Rejuvenate and ABGII hip implant victims who have undergone revision surgery to remove and replace their recalled Stryker hip implant on or before November 2, 2014.  The settlement proposal includes a base award amount of $300,000.00 to each claimant who has undergone revision surgery on or before to November 2, 2014, and otherwise qualifies for the settlement. There are certain limited potential reductions to the base award for age, prior hip revisions, and other relevant factors.  Claimants may also receive additional compensation, referred to in the proposed settlement as “Enhancements,” at a later date if they can demonstrate that they meet the eligibility requirements for the categories set forth in the settlement agreement.

Stryker-Rejuvenate-Hip-Replacement-Recall-Although participation is voluntary, it is expected that many of those that qualify (those who have had their recalled Stryker hip removed and replaced on or before November 2, 2014) will benefit from the settlement program, and may ultimately decide to participate in the settlement.  Any such decision should be made on an individual, case-by-case basis.

The following is a basic summary highlighting key aspects of the Master Settlement Agreement:

The settlement program applies to patients who are U.S. citizens and residents who had either an ABG II Modular Neck System or a Rejuvenate Modular Neck System implanted in their bodies in the United States, and who had a qualified surgery to remove and replace the recalled device on or before November 2, 2014.  The settlement program is also open to certain patients who have been deemed to be too sick or medically unstable to undergo a necessary revision surgery.

At Childers, Schlueter & Smith, our attorneys will immediately undertake to determine how the proposed settlement will affect each of our clients, and will work with each client individually to carefully consider the benefits of the proposed settlement so that they can make an informed personal decision on whether or not to participate.  As a nationally appointed leader in this litigation, founding partner Richard R. Schlueter will ensure each and every one of our clients has all of the information he/she needs to make the best choice for his/her unique situation.   Richard Schlueter has been involved in the various hip implant litigations (including DePuy ASR/Pinnacle, Zimmer Durom Cups, Biomet M2a Magnum and Wright Conserve Plus among many others) for several years, and has unique knowledge relating to hip implant failures and the injuries caused by those failures. Our current and future clients will be continue to be very well represented and informed during the entire process.

Attorneys representing those interested in participating in the Stryker hip implant settlement will have to register their clients in the program on or before the initial reporting deadline of December 14, 2014.  After that, the next deadline will be the formal enrollment of each individual patient who chooses to participate into the Settlement Program.  Those qualified claimants who would like to participate in the settlement program must enroll by March 2, 2015.  If less than 95% of the qualified claimants elect to participate in the settlement, Stryker has the ability to walk away and cancel the settlement program.  Stryker must make that decision on or before June 15, 2015.  Assuming the participation threshold is met and the settlement continues after June 15, 2015, the deadline to file claims for Enhanced benefits is September 30, 2015.  Additional compensation through the Enhanced benefits portion of the settlement will relate to damage to the femur, soft tissue damage, additional procedures and infection.  There is a cap on the Enhanced damages so that most total claims (Base award and Enhanced benefits) will be no more than $550,000.00 per claimant.

Patients-Suing-Over-Recalled-Stryker-Hip-ImplantBased on the timing of the deadlines in the proposed settlement, it is unlikely that any settlement payments will be made prior to late summer or early fall 2015.

For patients who are not eligible for the settlement program, Stryker’s existing program for reimbursement of eligible out of pocket costs, administered by Broadspire, remains available.  The decision to undergo a revision surgery is a medical decision, not a legal decision, and should be made only by patients in consultation with their surgeons.  If you were implanted with a recalled Stryker Rejuvenate or ABGII hip implant product but are not eligible for the settlement program, all of your legal rights and claims are preserved and you will not be affected so long as you have a filed legal claim with the Court.  Patients who have been implanted with a recalled Stryker hip in both hips (referred to as “bilateral” hip implants), in whom only one hip has been revised, will retain all of their claims and legal rights in regard to the unrevised hip, even if they participate in the settlement for their revised hip.

Childers, Schlueter & Smith is committed to continue litigating all claims for our clients who don’t qualify, who are arbitrarily penalized so as to not receive an offer under this proposal, who have not had revision surgery by today’s date, and those who choose not to participate in the proposed settlement.  If you have a recalled Stryker Rejuvenate or ABGII, please call us for a free consultation regarding your legal options.

For those looking for answers and guidance on these and/or any other Stryker hip implant related issues, we welcome you to contact our office for more information.

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FDA Regulates Approval of Drugs, Not How they are Prescribed

October 27th, 2014

People generally understand that the U.S. Food and Drug Administration regulates drug approval, but many would be surprised to learn that the FDA does not control how approved drugs are really prescribed.

Doctors are given great latitude to prescribe any drug for any reason that they deem medically appropriate, and are not required to tell the patient that the medication is being used for something other than the condition it was approved for. The process, commonly known as “off-label prescribing,” is legal and extremely common. Pharmaceutical companies are not permitted to market medications for off-label uses, however, and this practice has led to several large legal settlements.

What is “Off-Label?”

Off-label generally means that a medication is not being prescribed for a use specified in the FDA’s approved packaging label or insert included with the drug. The label is a written document that gives detailed information about approval uses and dosages, based on the results of clinical studies that the drug maker provided to the FDA to gain approval. According to WebMD, more than one-fifth of the outpatient prescriptions written in the U.S. are for off-label uses.

Doctors who choose to prescribe medications for a use other than what they were approved for have many significant responsibilities, including:

  • To be well informed about all medications they prescribe
  • Base their use on scientific rationale and sound medical evidence
  • Weigh the pros and cons of off-label prescribing
  • Consider the best interest interests of their patients at all times

There are some risks and benefits to off-label prescribing, and it is often helpful when patients have exhausted all other approved medication options. Cancer treatment often includes the use of off-label drugs for chemotherapy, since a drug approval for one specific type of cancer may also target many kinds of tumors. In these circumstances, off-label use of a drug represents the standard of care. Other common off-label uses of prescription medications include:

  • Beta-blockers that are FDA-approved to treat high blood pressure but are widely prescribed by cardiologists to treat heart failure
  • Tricyclic antidepressants used to control chronic pain
  • Antipsychotics prescribed for those suffering from attention deficit hyperactivity disorder (ADHD)
  • Selective serotonin reuptake inhibitors, FDA approved to treat depression, are also routinely prescribed for a wide variety of off-label uses, including borderline personality disorder, stuttering, alcoholism, and premature ejaculation

Because the FDA makes it clear that it does not regulate the practice of medicine, off-label drug use has become common, and occurs in virtually every medical specialty, particularly those in which the patient population is less likely to be included in clinical trials – pregnant women, children, or the elderly. Off-label prescription drug use can be a polarizing term because it is associated with both great benefit as well as great harm to patients, and health care professionals must continually education themselves about OLDU and its risks and benefits to patients.

We encourage all our patients to ask their doctor about the medication they are prescribing. Ask if the medication prescribed is FDA approved for the condition being treated. Ask why they think this medication would be better than another type or some other treatment. Ask what are the material risks of the medication and have they heard of any adverse side effects from it.

Asking these important questions will make you a more informed patient and hopefully keep you and your family safe from a prescription error or injury.

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DePuy Pinnacle Hip Implant Jury Trial Underway

September 4th, 2014

The first bellwether jury trial began yesterday over the controversial DePuy Pinnacle hip implant that has caused thousands of patients to needlessly suffer as a result of the product’s defective design and questionable marketing practices.

depuy-recallKathleen Herlihy-Paoli, claims the metal hips made by J&J, the world’s largest health-care company, leaked cobalt and chromium material into her bloodstream, causing an infection and other complications that ultimately required the devices to be surgically removed.

This marks the first jury trial over the DePuy Pinnacle Hip Implant device that was first brought to market by Johnson & Johnson and its subsidiary DePuy Orthopaedics in 2005. With more than 6,000 cases now pending in the Pinnacle MDL consolidated before the Honorable U.S. District Judge Ed Kinkeade, allegations of inadequate testing, failure to warn and defective design of the hip implant device will all be discussed and debated. The Pinnacle jury trial is expected to last 6-8 weeks.

J&J’s DePuy unit ignored signs the Pinnacle hips suffered from design flaws and assured doctors the metal devices worked “99.9 percent of the time,” Mark Lanier, a lawyer for a Montana woman who sued after complications forced her to have the device removed, told jurors today in Dallas federal court on the first day of trial of her lawsuit.

Although not recalled like the DePuy ASR hip implants, Bloomberg.com reports that:

J&J stopped selling the metal-on-metal version of the Pinnacle hip in August 2013 after the U.S. Food and Drug Administration said it would require device makers to submit new versions of the artificial hips for pre-market approval.

J&J touted the metal-on-metal implants, first sold in the U.S. in 2005, as a design that would last 20 years and offer greater range of motion.

pinnaclePatents all over the world, and doctors alike, now know these claims are simply inaccurate and completely misleading. It is yet another prime example of Big Pharma putting profits over people.

The case is Herlihy-Paoli v. DePuy Orthopaedics Inc., 12-cv-3590, U.S. District Court, Northern District of Texas (Dallas).

As more develops in this trial it will be updated here.

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Childers, Schlueter & Smith Files 25 More Stryker Hip Lawsuits

September 4th, 2014

Atlanta, Georgia based law firm Childers, Schlueter & Smith, LLC recently filed another 25 Stryker hip replacement lawsuits, joining nearly 1,800 other Stryker lawsuits pending in U.S. District Court. Stryker lawsuits have been consolidated into multicounty litigation (MCL) in the Superior Court in Bergen County, New Jersey, and into multidistrict litigation (MDL) in the U. S. District Court of Minnesota. The MDL is being overseen by U.S. District Judge Donovan W. Frank, and is expected to grow by hundreds of new hip implant recall cases in the next few months alone.

Many of the new plaintiffs in the MDL proceedings have undergone surgery to have their hip stems removed, but some are still in the medical monitoring phase to determine if a hip implant revision surgery will be necessary in the future. These lawsuits, like the others, claim that Stryker did not adequately test the artificial hip stems to ascertain that they would not fret, corrode, or otherwise deteriorate and lead to severe metal toxicity in those receiving the implants. The lawsuits also allege that:

  • Stryker’s representation that the hips stems would not fret or corrode were misleading to both physicians and consumers
  • Stryker marketed the device as a perfect fit for younger patients, leading doctors and patients to believe that it was superior to other hip implants available
  • The hip stems contain design and manufacturing defects that can cause serious or even permanent damage to patients
  • Stryker aggressively marketed the hip implants without informing consumers about the risks when safer alternatives were available

Stryker Recall

The Rejuvenate and ABG II hip stems were voluntarily recalled by Stryker in June 2012 after reports of corrosion and fretting at the modular neck-junction were received. At the time of the recall, Stryker issued a report stating that the neck components of Rejuvenate and ABG II are made of chromium and cobalt, the stems are coated with titanium, and the two parts wearing against each other will generate metallic debris released into the patient’s bloodstream or surrounding body tissue.

The metallic debris can cause patients to experience negative side effects, including local tissue reactions, swelling, anddepuy-recall pain. It can also require the removal of the lower portion of the modular stem due to design failures in the human body. Stryker advised that hip implant recipients should have their blood tested for metal ions and imaging screening, even if they are not experiencing any problems with their hips.

CSS is experienced in handling the legal matters faced by claimants that have recalled Stryker hip device(s) and ensures its clients are well informed on the monitoring process of their claims. In addition to these services, the challenges of reimbursement for past and future medical expenses, mileage and lost wages through the Broadspire process are handled for free to CSS clients while the Firm pursues the product liability claim on a contingent fee basis. (no fee until your claim is settled or tried to verdict in favor of a client).

For more information of the Top 10 Things All Stryker Hip Implant Patients Need To Know check out our previous blog on the hip implant recall.

news_CBS_SchlueterChilders Schlueter & Smith, LLC is taking a leading role in the National litigation by appointment of its partner, Richard Schlueter, by Federal Judge Donovan Frank to the Plaintiff Steering Committee ( PSC)  in MDL  13-2441 IN Re: Stryker Rejuvenate and ABG II hip implants products liability litigation.

If you have questions about your potential Stryker hip implant recall case and want answers, please contact us today. Our hip implant lawyers are standing by to help and will discuss your claim with you in detail. All inquiries are kept completely confidential.

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3 More Stryker Hip Lawsuits Settled After Mediation

September 2nd, 2014

Three Stryker lawsuits filed on behalf of those who suffered serious complications caused by the Rejuvenate Hip Stem and the ABG II Modular Hip Stem have completed mediation and two have been settled, according to the Long Island News. This brings the number of New Jersey Multicounty Litigation (MCL) cases mediated up to 21 and the number of mediated cases resolved to 19. Others are still pending in the Stryker Hip Implant MDL and have been set for trial in the Summer of 2015. It is expected these cases will help expose the inadequate pre-marketing testing and derive top dollar for those affected by these defective implants.

The lawsuits allege that Stryker’s metal on metal hip implant products cause serious side effects including metal toxicity and device failure, according to court documents. In December 2013, Stryker agreed to settle four other hip lawsuits filed in New Jersey state court for undisclosed sums. Stryker has reportedly set aside between &700 million and $1.1 billion for litigation expenses, according to the Wall Street Journal.

Stryker Hip Implant Recallstryker

Stryker decided to voluntarily recall its Rejuvenate and ABG II hip stems in June 2012 due to prospective fretting and corrosion at the modular-neck junction that could potentially result in adverse local tissue reactions (ALTR) as well as pain and/or swelling at or around the hip.

After the recall, Stryker recommended that surgeons consider performing blood work and cross section imaging on all patients who received a Rejuvenate or ABG II modular-neck hip stem, even in the presence of normal findings and regardless of whether the patient is experiencing pain and/or swelling.

Costs to Stryker

According to Stryker, the ultimate total cost to resolve the entire matter is still uncertain and will depend on the number of and actual costs of patients seeking testing and treatment services, the number of and actual costs of patients requiring revision surgeries, the number of and actual costs to settle lawsuits, and the amount of third-party insurance recoveries. Stryker is reimbursing patients for testing, treatment, revision surgery if necessary, and other costs related to the recall via a company called Broadspire. Read our previous post on Broadspire before you reach out to them as there are some important things you need to know about them.

Patients-Suing-Over-Recalled-Stryker-Hip-Implant Approximately 20,000 of the Stryker devices have been implanted in the U.S., and more than 3,000 lawsuits have been filed over damages caused by the hip implants. Stryker hip implant recall lawsuits continue to be filed by those affected by these dangerous products and the law firm of Childers, Schlueter & Smith continue to review and file the same. If you have questions about your potential hip implant claim, give us a call to learn how we can help.

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