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A Win for Consumers in Mandatory Arbitration Cases: Recent Decision in Toyota Hybrid Brake Case Refuses to Follow Concepción When a Party is a Nonsignatory
On January 30, 2013, the U.S. Court of Appeals for the Ninth Circuit affirmed the lower court’s decision in the multidistrict Toyota Motor Corp. Hybrid Brake Marketing Sales Practices and Products Liability Litigation, holding that the plaintiffs’ consumer fraud claims against Toyota, relating to faulty brakes in 2010 Prius models and 2010 Lexus hybrid HS 250h models, were not subject to arbitration.
Citing the U.S. Supreme Court’s decision in AT&T Mobility LLC v. Concepcion—which overturned state laws that categorically preclude enforcement of class action waivers in certain arbitration agreements—Toyota moved to compel arbitration with the plaintiff car-buyers, based on an arbitration clause in the purchase agreements with their dealers. Toyota filed the motion only after failing in its effort to obtain dismissal of the plaintiffs’ lawsuit on the merits. The district court, however, refused to order arbitration because Toyota was not a signatory to the purchase agreements. In other words, the district court said that the arbitration clause was limited to the plaintiffs and the dealerships, not Toyota.
On appeal, Toyota argued that even though it was a nonsignatory, plaintiffs should nevertheless be compelled to arbitrate their consumer fraud claims because the claims are intertwined with the purchase. The U.S. Court of Appeals for the Ninth Circuit rejected this “equitable estoppel” argument, agreeing with the plaintiffs that their consumer fraud claims against Toyota, which relate to the faulty brakes in their vehicles, are not intertwined with the purchase agreements with the dealers, which dealt with matters of financing and insurance.
In particular, the Court of Appeals noted that no court would need to examine the purchase agreements in order to resolve the plaintiffs’ claims. It also rejected Toyota’s argument that a provision in the arbitration clauses required that the issue of whether the claims belong in arbitration be addressed, in the first instance, by an arbitrator rather than the district court, pointing out that Toyota could not rely on that jurisdictional clause because, as a non-signatory to the purchase agreements, it lacked standing to do so. Having rejected Toyota’s contention that the plaintiffs’ claims are intertwined with the agreements, the Court of Appeals saw no need to address the plaintiffs’ alternative argument that, even if their claims were subject to arbitration, Toyota had forfeited any right to seek arbitration by playing a game of “heads-I-win/tails-you-lose” and filing its motion to compel arbitration only after failing in its bid to seek dismissal of the case on the merits.
Toyota marks a significant victory for consumers, especially in cases involving consumer fraud. This decision further signifies that the Supreme Court in Concepcion did not articulate a bright- line rule in deciding cases where mandatory arbitration clauses are in dispute. As we predicted in our previous blog, which examined Concepcion in detail, mandatory arbitration clauses will continue to be a hot-button issue in the courts and hopefully more cases like Toyota will arise giving more protection to consumers.
The case was argued before the Ninth Circuit Court of appeals by Seeger Weiss partner Diogenes P. Kekatos. The court’s decision is published at 705 F.3d
Supreme Court decisions are often puzzling. The Court’s decision in AT&T Mobility v. Concepción is particularly baffling in the world of consumer rights law. In Concepción, Justice Antonin Scalia held that the Federal Arbitration Act (FAA), which favors contractual arbitration clauses, preempts state consumer protection laws. Let’s break down exactly what that means…
Concepción in a Nutshell
In Concepción, customers of AT&T brought a class action suit in a California district court alleging that AT&T’s offer of a free phone for new cell phone customers was fraudulent because the customers actually had to pay sales tax on the “free”phone. AT&T argued that their cellphone contract with their customers contained a clause that provided for arbitration of all disputes and barred any class action lawsuit. Relying on California state law, however, the District Court found the arbitration clause unconscionable because it did not allow for class wide actions. The 9th circuit agreed, and held that the Federal Arbitration Act, which makes arbitration clauses enforceable, did not preempt the California state law. The case went up to the U.S. Supreme Court on appeal.
In a landmark decision, Justice Scalia, overturned the lower court’s decision and held that the FAA preempts California’s law regarding the unconscionability of arbitration waivers. Scalia’s decision is momentous for two reasons. First, it limits a consumer’s rights to take action against a company who breaks the law. Also, Scalia uses Congress’s power and decides that the FAA, which clearly favors companies and disadvantages the consumer, trumps the California law which was enacted to protect consumers.
The Alliance for Justice Speaks Out
There are many reasons why arbitration agreements are unconscionable, and that’s what makes the Court’s decision so troubling. Alliance for Justice does a masterful job highlighting obvious instances where companies have broken the law, but have relied on Conceptión to escape liability by having their arbitration waivers enforced. The complete line of cases can be found here:http://www.afj.org/connect-with-the-issues/the-corporate-court/att-aftermath-stories.pdf.
Why Mandatory Arbitration Clauses Violate Consumers’ Rights
- Arbitration clauses are often hidden in fine print and contain confusing language which the average consumer has trouble comprehending.
- Arbitration clauses are judicially inefficient. They require each consumer to go through the process of filling out paperwork and completing the necessary calls while foreclosing all class action proceedings. This process is difficult to comprehend (and time consuming!) for a consumer who has no legal training. Whereas, a class action suit allows for multiple consumers to bring a single action against a company and lets the attorney do the legal grunt work, not the consumer.
- Arbitration clauses allow companies to cheat and win. A company who violates the law and strategically adds an arbitration clause to its contract is allowed to settle disputes with individuals “behind closed doors.” But class action suits are public knowledge, and settlements are widely reported in the main stream media. When the public knows companies cheat, companies are more likely to be deterred from continuing to break the law.
- Arbitration clauses create contracts of adhesion which are unreasonable because of the strong bargaining power that large companies possess. These “take it or leave it” deals further weaken the consumer’s position at the time of sale.
What Concepción Means for the Future of Class Action Litigation
Mandatory arbitration clauses should continue to be a hot-button issue for the Supreme Court if articles like these continue to be published. There could be hope for the consumer and the future of class action lawsuits, despite the presence of a contractual arbitration clause, due to of the slim 5-4 ruling in Concepción. Perhaps the Court, in the future, might be swayed by Justice Breyer’s dissent, where he asks this yet to be answered question:“Where does the majority get its contrary idea—that individual, rather than class, arbitration is a ‘fundamental attribut[e]’ of arbitration?” Consumers and class action attorneys, alike,hope that the Court will answer this question sooner than later (if at all).
Companies strive to hire honest employees with strong credentials. In an effort to make informed decisions, employers conduct background checks prior to hiring an employee. These background checks might examine a prospective employee’s employment history, driving record, criminal records, and credit report.
Various laws have been enacted to ensure that the employee is protected throughout this process. The Federal Trade Commission (FTC) enforces the Fair Credit Reporting Act (FCRA), which protects a job applicant’s information found in a credit report and ensures that the information is accurate. The extent to which an employer can legally analyze a job applicant’s criminal history varies on a state-by-state basis. The U.S. Equal Employment Opportunity Commission (EEOC) enforces Title VII of the Civil Rights Act of 1964, which bars employers from using job-screening standards that have a disparate racial impact.
Despite these legal safeguards, job applicants are often treated unfairly during the employment hiring phase. Take, for instance, Green Mountain Coffee Co., who allegedly rejected job applicants after examining unauthorized consumer reports (per FCRA guidelines), which they obtained from a consumer-reporting agency. The Judge agreed to dismiss the suit after the parties resolved the dispute in an undisclosed nature. Another example is Dominoes, who also allegedly violated the FCRA by running employee background reports without proper authorization and by not sharing the reports with applicants and employees before terminating employees or denying job applicants of employment. The case is currently in litigation. LexisNexis agreed to settle their dispute for more than $1.3 million. The company was accused of failing to notify timely thousands of individuals about negative background reports because of a computer glitch. In light of these cases, it is fair to anticipate similar suits being filed in the near future.
When companies violate laws or make errors in the background check process, perfectly eligible candidates are denied jobs. Common mistakes include multiple reports of a single offense, the inclusion of convictions and arrests that were legally expunged, and even the inclusion of another person’s criminal offenses. Job applicants can contest any mistake made by employers, but what happens when employers don’t even share the information (like the alleged behavior of Dominoes)? Worse, even if a prospective applicant contests the mistake, the appeal process usually takes about thirty days. The position is often filled by the time the appeal process ends, and the candidate is left without a job even if the appeal succeeds.
As stories of companies acting negligently during employment background checks continue to brew, new legislation will continue to pass limiting the employer’s access to job applicants’ personal information. In May 2012, Vermont became the 8th state to restrict the use of credit reports for employment purposes claiming that the results of a credit report have “no correlation to job performance” and do not provide “meaningful insight into a candidate’s character, responsibility, or prospective job performance.” Vermont joined California, Connecticut, Hawaii, Illinois, Maryland, Oregon and Washington to enact such a law. At the federal level, the EEOC is currently investigating the use of credit reports for employment purposes, but has yet to rule on the issue.
Employee Rights When Applying for a Job
It’s become clear that legislative bodies are recognizing the risk of error associated with companies conducting employment background checks. Therefore, it is important that you know your rights when applying for a job.
First, the Fair Credit Reporting Act enables you to get a free copy of your credit report through each of three national credit reporting companies: TransUnion, Equifax and Experian. Each company must provide one free copy of your credit report every twelve months. It might be a good idea to have a current copy of your credit report for your reference before applying for a job.
Second, an employer must get your authorize before obtaining any credit information from third parties. You should probably get this authorization in writing.
Finally, if you have unfortunately been denied employment or had your employment terminated because of a failed background check, an employer must provide you with a written report of the information used to make their decision and a document called “A Summary of Your Rights Under the Fair Credit Reporting Act.” You should carefully analyze the information used in their decision, and you have the right to contest any information you believe to be erroneous.
Background Check Lawsuits
Unfortunately, not all employers will follow the law when conducting employment background checks, and Green Mountain and Dominoes are only a sample of how companies might be acting negligently when making employment decisions. Sometimes it takes a legal proceeding to hold large companies accountable and provide employees with a voice to speak out against the wrongdoings associated with background check errors. As such, we are sure to see class action lawsuits develop against more companies
Consumer and plaintiffs lawyers know that there have been a long string of cases where the Supreme Court has enforced arbitration clauses much to the detriment of consumers. In the course of doing that, though, the Court has always said that enforcing arbitration clauses won’t cause any harm, because arbitration is a forum where anyone with a valid legal claim can be heard fairly. The Supreme Court has also maintained that arbitration is only acceptable where parties can “effectively vindicate their substantive rights.”
In In re American Express Merchants Litigation, we’ll learn if the Court actually MEANT any of those promises. This is the most important and most pro-consumer case involving a challenge to an arbitration clause that has come down in several years. In the case, a number of small business merchants brought a class action in court alleging that Amex is violating the Sherman Act with a Tying Arrangement (using its monopoly power over charge cards to force merchants to take all Amex-branded credit cards — and pay higher fees). AmEx moved to force the case into individual arbitration (with no class action possible). The plaintiffs PROVED, with admissible evidence that was never controverted, that it would be impossible for them to pursue their antitrust claims, in court or arbitration, if they had to go forward on an individual basis. It would cost them hundreds of thousands of dollars to prove their cases in each case, even though their claims are typically only worth about $5,000.
But AmEx, backed by the Chamber of Commerce, wants the Court to abandon the “effective vindication” doctrine, or more likely to re-define it in a way that would make it completely meaningless. They want the Supreme Court to enforce AmEx’s arbitration clause, and class action ban, even though it means that small business plaintiffs will lose all their substantive rights under the antitrust laws.
We support the efforts of organizations such as Public Justice which filed an amicus brief objecting to AmEx’s radical position. The brief explains that if the Court severs the link between arbitration and the opportunity to be heard and obtain justice, then statutes that Congress enacted to protect consumers, small businesses, and workers from more powerful corporations will be gutted. As the brief explains, AmEx’s proposal would change the underlying statute from the Federal Arbitration Act to the Federal Corporate Immunity Act, and would rob it of its legitimacy.”
The brief may be found here.
According to The New York Times, an estimated 500,000 individuals have undergone a surgery involving a metal-on-metal hip implant. A quality hip implant is usually expected to last for approximately 15 to 20 years, depending on the patient’s activity level, fitness level and general health.
Many hip replacement patients, however, find that their implants begin to show signs of failure in a matter of a few short years. These patients have begun pursuing legal action against the manufacturers of these defected implants, but they need to first equip themselves with the necessary information before heading to court.
How to Find Out if You Have Been Affected by a Defective Hip Implant
The majority of hip implant patients have become accustomed to chronic pain and stiffness over the course of many years. In fact, these two symptoms are the most commonly cited reasons for the decision to have hip implant surgery in the first place. Unfortunately for many hip implant patients, the familiar pain associated with hip problems before the surgery may never actually improve, particularly if the implant used is defective.
Symptoms of a potentially defective or dangerous hip implant include:
- Noticeable swelling that does not respond to anti-inflammatory medications
- Unusual warmth in the area surrounding the implant
- Difficulty when walking, bending, sitting down or getting up
- Pain and stiffness that do not go away with proper medication and rest
Complications that arise from a defective hip implant may grow to be incredibly serious when not addressed in a timely manner. Corrosion of metal-on-metal components in an implant can allow minute particles of metal into the blood stream and into the tissue at the implant site. Severe cases can lead to tissue death around the implant, dangerously high levels of cobalt and chromium in the blood, and substantial bone loss.
List of Recalled Hip Implants
All hip replacement and hip surgery patients are strongly encouraged to consult their surgeons and medical records to determine what type of device was used during their procedure. Though many surgeons are able to reach their patients with relevant recall information relatively quickly after the information has been made available to them, not all patients are made aware of the potential danger they face. The following is a list of some recalled hip implants over recent years:
- DePuy ASR XL Acetabular Hip System
- DePuy ASR Hip Resurfacing System
- Stryker Orthopaedics Rejuvenate Modular Neck Stem
- Stryker Orthopaedics ABG II Modular Neck Stem
- Smith & Nephew R3 Metal-on-Metal Liner
If you or a loved one have undergone hip surgery and have suffered adverse effects because of the type of implant used, you may be entitled to financial compensation. The statute of limitations for filing a lawsuit concerning defective implants varies from state to state, so quick and decisive action is strongly recommended.
A product injury lawyer is a legal professional with experience in pursuing financial compensation for injuries or death caused by faulty products. Your attorney will help you make the important decisions regarding your case from start to finish, as well as make sure that you are awarded a fair amount of money for your pain, suffering and medical expenses. Don’t allow multi-billion dollar businesses to take advantage of you in your time of need. Even if you have not yet begun to experience side effects associated with your hip implant, it is important to obtain a legal consult immediately in order to ensure that you get the compensation you deserve.
Total hip replacements are performed to treat a variety of conditions affecting the hip joint, including degenerative joint disease, arthritis, congenital hip dysplasia, and physical trauma. Hip ailments are more common in elderly people, but younger people can suffer from these conditions as well. Besides various diseases of the joints, physical trauma usually occurs due to falls, auto accidents, or other acute injuries.
The hip is a ball and socket joint. The hip bone itself has a rounded gap, or socket, which the rounded ball of the femur, or thigh bone, fits into. This type of joint has a lot of flexibility as the joint can swivel in any direction. This is why hips can bend in more directions than knees or elbows, for example. It also makes broken hips particularly difficult to heal, which is why surgical intervention is sometimes necessary to promote mobility.
Types of Hip Implants
- Metal on polyethylene implants. This is the most common type of implant. In this method, both the ball and socket portions of the joint are removed and replaced with a metal prosthesis. A polyethylene spacer is then placed between them. The metal used is usually titanium-aluminum, stainless steel or cobalt-chrome. These implants do wear down over time, so subsequent replacements may be necessary in patients who live a long time post-surgery. A relatively new type of polyethylene is quite popular now due to its strength and durability. These new implants rely on a wear-resistant type of plastic that is manufactured to be stronger than regular polyethylene. Because these implants are new, long-term studies have not been completed to determine whether they will truly wear down more slowly than other types of implants
- Metal on metal implants. These work similarly to the above type, but there is no plastic spacer between the metal elements. This reduces the amount of wear that the artificial hip takes, but it does pose a potential risk to patients due to the release of metal ions into the patient’s bloodstream.
- Ceramic on ceramic implants. These implants use ceramic pieces for the ball and socket portions of the joint. Ceramic is much less prone to wear than metal or plastic, but it can be brittle and prone to breaking.
Regardless of the materials used, the implant will generally be held in place with a special type of medical cement. It may also be wedged into place without cement so that the bone can heal over the implant and hold it in place.
Types of Hip Replacement Procedures
Surgeons utilize a variety of surgical options to address pain experienced by patients suffering from diseases of the hip joints. These options include total hip replacements where an artificial ball, socket, and stem is implanted into the joint to replace the existing diseased or damaged bone. Surgeons may also perform a total hip resurfacing where an artificial ball and socket is implanted, but the stem is very short in length and does not penetrate deep into the femoral bone. A resurfacing procedure is generally less invasive than a total hip replacement. Surgeons may also perform a partial hip replacement, also known as a hemi-arthroplasty, in which only the ball is replaced with an artificial implant. For physical trauma, depending on the extent of an injury, a broken hip can sometimes be healed naturally by limiting a patient’s movement. More serious injuries may require surgical intervention.
A traditional hip replacement surgery requires an incision through either upper thigh or buttocks of the patient. Less-invasive techniques use smaller incisions and specialized instruments to complete the procedure. Regardless of the procedure completed or the materials used, a hip replacement surgery takes time and therapy to recover from. Some complications can arise if the new hip does not form a strong attachment to the existing bone. The patient may also continue to experience pain in the joint long after recovery is over. Fortunately, as technology improves, hip replacement surgeries become more effective.
Stryker is a prominent medical device and orthopedic product manufacturer that supplies hip implants, knee implants and surgical equipment used at major medical centers. Over the past several years, some of Stryker’s products have been recalled due to defects in their design or construction which have resulted in devastating injuries. These defects can make medical products unsafe for their intended use. Under product liability law, a manufacturer is responsible for ensuring that its products meet safety standards and do not pose a threat to consumers. Manufacturers are also responsible for warning patients of the risks associated with their products.
Here are a few of the major lawsuits and recalls that have affected Stryker and unsuspecting consumers across the country.
The Stryker Neptune Waste Management System
Stryker issued an urgent Class I recall for its Neptune series of waste management systems. This recall was issued on June 8, 2012, after the company received reports of serious and fatal injuries. These systems collect fluids during surgery by using a vacuum-like apparatus. When operated at high-pressure, the device can cause serious tissue damage, organ damage and fatal complications. This recall covered all six waste management models in the Neptune series. Stryker is facing a growing number of product liability lawsuits for injuries caused by these dangerous devices. Investigations show that these systems were not approved by the FDA and were not labeled properly.
Stryker Ceramic Hip Recall
In January 2008, Stryker voluntarily recalled its ceramic Trident Acetabular PSL Cup and Trident Hemispherical Cup implants. Stryker’s Trident hip implants were recalled due to contamination at a manufacturing plant. These particular ceramic hip implants were prone to premature failure. A number of patients reported embarrassing squeaking and popping noises during normal activities. These issues are related to ceramic fragments, hip fractures and the loosening of components. Patients who were affected by faulty Trident hip implants are still coming forward, and more lawsuits are being filed.
Stryker Metal-on-Metal Hip Implants
On July 6, 2012, Stryker voluntarily recalled its ABG II and Rejuvenate modular neck stems that are used in hip replacement surgeries. The first product liability lawsuit alleging problems with the ABG II and Rejuvenate neck stems was filed on August 7, 2012. An increased risk of corrosion and metal poisoning were cited as the reasons for the recall. Stryker admitted that the systems were prone to wear and tear near the neck junction. These problems may cause pain, swelling and adverse local tissue reactions. If left untreated, these conditions can lead to aseptic loosening and sepsis.
More than 50,000 defective implants were sold before the recall, and people have begun to file suit. These plaintiffs are requesting a case consolidation that would allow patients from Arizona, Florida, Minnesota and New Jersey to move their cases to New Jersey’s Bergen County Superior Court where they will receive individual trials and settlements. This venue was requested due to the proximity to the Stryker headquarters.
Since 2007, Stryker has received several urgent warnings and complaints from the FDA and the U.S. Department of Health and Human Services. These citations were for failing to test problematic devices and for failing to fix the defects. The company also received multiple contamination warnings. Sterile medical implants were allegedly cleaned and packed in unsanitary areas where microbes exceeded allowable levels.
Between 2007 and 2008, Stryker, DePuy, Zimmer, Smith & Nephew and a host of high-profile orthopedic manufacturers were sued by the Department of Health for engaging in unfair sales strategies and offering unlawful kickbacks to surgeons who directed hospitals to purchase their orthopedic implants and other devices. The FDA has noted several serious design flaws and sterilization issues associated with Stryker’s surgical implements and orthopedic implants. Problems with Stryker’s Duracon, Scorpio and EIUS Unicompartmental Knee Implants have lead to more recalls and lawsuits.
Product liability issues are particularly dangerous when medical devices are involved. Due to the implications of defective medical devices, patients can often sue to recover medical expenses and punitive damages. Victims might also be eligible to request compensatory damages for pain, suffering and loss of consortium.
Stryker Orthopaedics Corporation has issued a voluntary recall on its Rejuvenate Modular and ABG II Modular Neck Stems after post-distribution reports were issued stating that these implants are susceptible to corrosion and/or fretting, which can lead to metallosis, adverse local tissue reactions, and pseudotumors.
Arthroplasty, also known as a hip replacement, is the replacement of the diseased or deteriorated hip joints with a prosthesis to relieve pain and increase mobility and function in the hip. The Stryker Rejuvenate system is a device with a stem and neck designed to replace the patient’s hip by providing a mechanism that allows the joint to pivot as it would naturally. The Stryker ABG II Modular Neck Stem is a product designed to reconstruct the hip joint area by attaching inside the femur and coming out to connect with the hip.
Hip Replacement Risk
Standard risk to patients who receive hip replacements include decrease of bone mass or bone loss, nerve damage, uneven leg length, stiffness, and decrease in immune system function. Revision surgery is usually warranted in cases where the patient is experiencing post-surgical issues such as metal sensitivity, loosening of the implant, audible sounds from the area during movement and general wear over time.
When metal pieces in hip implants constantly rub against each other, corrosion occurs. Unlike true metal-on-metal devices where the ball and socket are both made of metal components, both the AGB II and Rejuvenate products had metal stems and metal necks that rub together in a way similar to how the ball and socket devices do.
When corrosion or fretting occurs in metal hip implants made with cobalt and chromium metals, such as the Stryker Rejuvenate Modular and ABG II Modular Neck Stems, the patient can develop metallosis, a condition where metal debris collects in the soft tissues. This can cause inflammation and swelling, as well as destroy the otherwise healthy tissue surrounding the implant site. With deterioration of the tissue, the implant may become misaligned, causing severe pain, infection, swelling, and dislocations These complications can eventually necessitate a revision surgery.
While hip replacements are designed to withstand up to fifteen years of use, both the ABG II and Rejuvenate replacements began showing signs of failure after several months. This caused excessive post-surgical pain that required revision surgery in some patients.
If metallosis exists, inflammation and swelling of the area around the implant could occur, with some cases of pseudotumors and fluid in the joint. Tissue damage from metallosis can present as a rash in the affected area. An often overlooked sign of metallosis is extreme pain, which many patients dismiss as after-effects of the replacement. Metallosis can also cause the levels of cobalt and chromium metals in your blood to elevate. In some cases, this elevation of metal levels can be toxic and cause many systemic illnesses.
Further side-effects of metallosis include the following:
- Recurring infections
- Gastrointestinal issues
- Emotional imbalance
Patients who have either the Rejuvenate Modular or ABG II Modular Neck Stems should contact their doctor immediately. While not every patient who received Stryker’s ABG II or Rejuvenate products have experienced symptoms of metallosis or product failure, all ABG II or Rejuvenate recipients should contact their doctor.
Fresenius Medical Care, the German-based company responsible for treating over one third of American dialysis patients, is under scrutiny after information came to light linking their dialysis products GranuFlo and NaturaLyte to an increased risk of cardiac arrest. More troubling than the up to six-fold increase in risk of cardiac arrest over competing products is that Fresenius appears to have hid the information from the public, as evidenced by an internal memo that was released in November 2011. The memo, titled “Dialysate Bicarbonate, Alkalosis and Patient Safety,” was distributed to doctors operating in Fresenius-owned medical care centers in the United States, and warned that their products could be linked to an increased risk of patients dying through sudden cardiac arrest. It wasn’t until the memo was anonymously leaked in March of 2012 that the problem became public knowledge.
Of particular import in a case such as this are the dates in which the situation unfolded, e.g., there was over a four months between the date of the initial memo and the release of the leaked version. Therefore, to help make the case clearer, we have outlined the most crucial developments in the case in the timeline below.
January 1st – December 31st, 2010 – First Information Concerning Risks Emerges
Research carried out by Fresenius Medical Care (FMC) discovers that 941 patients from 667 facilities suffered from cardiopulmonary arrest. This figure is over six times higher than that of competing products.
September 15th, 2011 – FDA Sends Warning Letter to Fresenius
The FDA sends a warning letter to the Fresenius CEO after their investigation reveals FMC is inadequately addressing complaints filed by patients using the company’s products. The letter addresses five major areas of fault, including “Failure to establish procedures for investigating the cause of nonconformities stemming from incidents pertaining to NaturaLyte Acid Concentrate” and “Failure to establish and maintain an adequate preventative action to ensure identification of actions needed to corrects and prevent problems.”
November 4th, 2011 – Internal Memo Circulated
The internal memo, “Dialysate Bicarbonate, Alkalosis and Patient Safety,” is sent out to Fresenius doctors warning of the risks associated with their GranuFlo and NaturaLyte products. In the document it is written that “[the] issue needs to be addressed urgently.”
March, 2012 – Memo is Leaked to the FDA
Over four months after the original internal memo was circulated, the memo is anonymously leaked to the Food and Drug Administration (FDA).
March 29th, 2012 – Fresenius Issues Warning to Doctors
On March 29th, 2012, Fresenius releases a modified update to the original memo, warning doctors of the dangers associated with its products. The same day, the FDA issues a statement informing the public of the notice. In the statement, the FDA writes, “The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ Naturalyte Liquid and Granuflo Dry Acid Concentrate…This product may cause serious adverse health consequences, including death.” The recall is listed as “voluntary.”
May 25th, 2012 – FDA Issues Update Warning Doctors of Dosing Dangers
The FDA releases an update warning doctors of “alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate.” The press release recommends that doctors exercise more caution when prescribing these products to patients and urges doctors to “be aware that metabolic alkalosis (pre-dialysis serum bicarbonate levels greater than or equal to 27 mEq/L) has been associated with a higher risk of death in hemodialysis patients.
June 14th, 2012 – New York Times Reports that FDA is Investigating Fresenius Medical Care
An article released on June 14th raises the public profile of the Fresenius case by reporting that the FDA is investigating the company to determine if Fresenius “violated federal regulations by failing to inform customers of a potentially lethal risk connected to one of its products.” The report gives a brief summary of the case until that date, and includes a statement from Steven Silverman, the director of compliance for the FDA’s medical device division, in which he states, “Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern.”
June 27thth, 2012 – FDA Issues a Class I Recall of GranuFlo and NaturaLyte Products
FDA releases a statement announcing a Class I recall of GranuFlo and NaturaLyte, citing that “Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis.” Class I recalls are the most serious recalls of their kind and the move is considered one of the most important developments in the ongoing case against Fresenius.
For more information, visit www.seegerweiss.com/granuflo-lawsuit.
For some patients, the recent hip implant recall by Stryker Orthopaedics will lead to revision hip surgery. Hip revision surgery will unfortunately be needed to replace their faulty Rejuvenate or ABG II module implants. This is truly unfortunate because the typical lifespan of a well-functioning artificial hip joint is 10-15 years and revision surgery brings a lengthier and riskier procedure, as well as greater uncertainty of its outcome.
Few Options Available for Patients
The most pressing and problematic issues with the Stryker recall devices center on its fretting and corrosion, which may lead to metallosis, a serious condition from metal debris leaking into a patient’s bloodstream, the loosening of the implant causing grave pain and discomfort, and the inflammation and damage to surrounding bone and tissue. All of these conditions may warrant a hip revision surgery and bring forth new complications that the patient and surgeon need to consider, for example:
- Quality of patient’s bone and the ability to securely fit revision hip replacement into position
- Higher chance of hip dislocation after surgery due to weaker tissue surrounding the bone as well as more fragile bone
- Lengthier surgery by having to remove old implant and securely placing new one
- Longer rehabilitation timeframe
- Possibility of smaller range of motion
- New prosthesis won’t last as long (eight to 10 years vs. 10-15 years)
If your physician is recommending hip revision surgery because of the Stryker recall and its inherent problems, contact us as soon as possible. Legal options may be available.
For more information about the Stryker hip implant recall and your legal options, visit www.seegerweiss.com/stryker-hip-recall.