Smith and Nephew SMF and Redapt MDL Update

In April of 2017, multi-district litigation (known as “MDL 2775”) was established in federal court in Baltimore, Maryland before United States District Court Judge Catherine C. Blake against Smith & Nephew, which is based in England and sells its products, which are not limited to hip implants, in 90 countries across the world. The headquarters for Smith & Nephew in the United States are located in Memphis, Tennessee.

An MDL is a “Multi-District Litigation” and these are used to more efficiently speed up the legal process when cases involving many people, such as class actions and mass torts, are filed in the US. Their purpose is to instead of having thousands of cases filed in dozens of jurisdictions is to consolidate these to one court and under one judge.

From 28 to over 600 lawsuits

The Smith and & Nephew MDL began with 28 individual defective hip lawsuits transferred from 19 district courts from across the country. Since then, the coordinated litigation has grown to include more than 600 individual lawsuits. Most of the pending lawsuits relate to cases where patients were implanted with Birmingham resurfacing hip implants (which include a femoral head and acetabular cup but not a femoral stem) and underwent revision surgery due to metallosis, elevated cobalt and chromium ions in the bloodstream and joint fluid, pseudotumor formation, and premature failure of the devices.

There are also a number of individual lawsuits pending and coordinated in the MDL that relate to Smith & Nephew R3 and Birmingham total hip implant devices (which include a femoral stem in addition to the cobalt-chrome femoral head and acetabular cup), which the MDL was expanded to include in 2018. These total hip implant lawsuits also allege that the Smith & Nephew metal-on-metal hip implant products are defective due to an excessive failure rate, the need for revision surgery, and injuries to patients due to heavy metal toxicity and poisoning.

As of May of 2019, more than 1 million pages of documents have been produced from the manufacturer in MDL 2775 with additional discovery continuing through the end of 2019. Most of the discovery so far has focused on the Smith & Nephew Birmingham Resurfacing hip implant. Discovery relating to Smith & Nephew total hip arthroplasty devices, including the Birmingham THA and R3 products, is continuing on a parallel track and expected to be expedited soon, especially in light of the failed mediations and settlement discussions for these particular lawsuits. Dozens of depositions of witnesses in the United States and overseas will also be completed in the coming months in preparation for the first jury trials in the MDL proceedings, which are anticipated to begin in March of 2020. We anticipate that case-specific discovery will be initiated in the latter part of 2019 once Judge Blakes decides which individual patient lawsuits will be included in the pool of cases for these initial MDL bellwether trials in 2020. Judge Blake has encouraged the parties to continue to engage in settlement talks, especially with regard to the THA lawsuits. Smith & Nephew has not been as motivated to discuss settlement on the hundreds of lawsuits involving resurfacing devices, as it contends that those cases are subject to dismissal due to federal medical device preemption laws.

Legal Claims Against Smith & Nephew

The lawsuits that have been filed on behalf of injured patients allege various claims against Smith & Nephew for the metal-on-metal total hip and resurfacing implant products, including that:

  • The devices are defectively designed and generate dangerous metal debris through contact on the articulating surface which causes harm to patients;
  • The warnings that accompanied the products and information that was provided to implanting surgeons and patients were inadequate;
  • The products were not properly approved or cleared by the FDA for implantation in patients;
  • The products have an excessively high failure rate after implantation in patients due to metallosis;
  • The marketing and promotion of the implant system to surgeons was deceptive and misleading;
  • Smith & Nephew failed to properly monitor patients, the published medical information, international device registries, and other sources to identify and address potential safety risks;
  • The hip implants products were not properly tested and studied prior to implantation in patients;
  • The manufacturer violated various federal and state consumer protection requirements relating to design and manufacture of the devices; and
  • Various other allegations relating to defects and negligence in the design, manufacture, marketing, promotion, and safety surveillance and monitoring of the Smith & Nephew hip implant products.

Smith & Nephew has been selling Birmingham resurfacing total hip arthroplasty hip implant products in the United States since 2006. This resurfacing hip implant, often referred to as a “BHR implant” includes a femoral head and a matching acetabular cup, both of which are made from a cobalt-chromium alloy. The R3 Acetabular Hip System incorporates the Birmingham components but has interchangeable liners made of polyethylene, ceramic, or metal. The R3 implant with a metal liner is the product that is included in the MDL litigation, and has been marketed in the United States since 2009.

Dispute Over FDA Approval and Federal Medical Device Preemption Immunity

One of the critical issues in the pending lawsuits across the county is the manner in which the BHR implant components were approved or cleared by the FDA for sale. Smith & Nephew contends that it is immune from liability for any alleged defects in the design of its BHR products on the basis that the Food & Drug Administration approved the product through a Premarket Approval application, commonly known as the “PMA” process (which is a more rigorous review process by the FDA than is often used for other hip implant products). The Defendant also contends that this immunity extends to the Birmingham and R3 total hip implant products as well.

This legal doctrine, approved by the United States Supreme Court, is medical device preemption and is highly controversial and unknown to most patients that assume that a company that produces a medical product that causes an injury should be able to be sued in court by the patient. The Plaintiffs claim in this litigation that the BHR acetabular cup was approved by the PMA process, but that the modular femoral head and femoral stem components used to construct the Smith & Nephew total hip arthroplasty system were not approved by the FDA, such that the Defendant should not be immune from liability for the alleged defects in the design of the product.

10+ Years of Hip Implant Safety Issues

Over the last 10 years, there have been numerous recalls and safety alerts regarding metal-on-metal and modular hip implants. The first recalled devices included the Zimmer Durom Cup and DePuy ASR metal-on-metal hip implant products. These products were noted to have an excessive premature failure rate due to excessive metallic debris emanating from the articulating surface of the implant, where the cobalt-chromium metal femoral head was coming into contact with the cobalt-chromium metal acetabular cup (the part of the implant that replaces the hip socket). This process is known as metallosis and leads to bone and soft tissue damage in the hip joint which undermines support and proper functioning of the hip implant. Ultimately, patients with failed metal-on-metal or modular hip implants require revision surgery and are faced with a number of potential complications including the need for revision surgeries, dislocations, infections, pseudotumor formation, elevated cobalt and chromium metal ions, fluid accumulations around the hip, persistent hip pain, loss of abductor muscles, and inability for the hip to function properly.

Since the first recalls by Zimmer and DePuy in 2008-2010, other metal-on-metal and modular hip arthroplasty devices have been recalled by Biomet, Smith & Nephew, Wright Medical, and Stryker.

The modular hip implant recalls have focused on similar injuries of metallosis leading to premature failure of the devices and the need for revision surgery and medical treatment for various complications, including significant damage to hip muscles, post-operative infections, dislocations, and femur fractures due to the trauma of the revision surgery to remove the well-incorporated femoral stem from the patient’s leg bone. In addition to the device recalls, some of these manufacturers and other, smaller companies decided to stop selling metal-on-metal and modular hip implants due to decreased demand for the products and/or an inability to meet the FDA’s request for enhanced data and studies to substantiate the long-term safety of the implanted devices. There have also been various recalls of these hip implant products in Australia, the United Kingdom, and other parts of the world due to the same concerns.

A worldwide recall of Smith & Nephew’s R3 metal liner was initiated in 2012 after post-surgery surveillance, as documented in international joint registries, noted a 6.3% revision rate within four years of implantation, which was substantially higher than expected based upon published medial data. Post-marketing reports also indicated that female patients, male patients older than 65, and patients that required a femoral head larger than 48 millimeters were at a greater risk of requiring a revision surgery than expected.

The Mass Tort Team at Searcy Denney has nearly two decades of experience in litigating more than 1,000 product liability lawsuits against modular and metal-on-metal hip implant manufacturers. In addition, partners Cal Warriner and Brenda Fulmer have been appointed by state and federal court judges to leadership positions for coordinated litigation involving these defective devices.

Sources:
https://www.mdd.uscourts.gov/re-smith-nephew-birmingham-hip-resurfacing-bhr-hip-implant-products-liability-litigation-mdl-no2775

https://www.smithnephew.com/global/assets/pdf/products/surgical/bhr_urgent_field_safety_notice.pdf

https://www.tga.gov.au/alert/metal-liner-components-r3-acetabular-system-used-hip-replacements

Carbon Monoxide – An Often Silent Killer

Carbon monoxide (CO) poisoning causes more than 20,000 emergency room visits and 400 deaths each year in the U.S., according to the Centers for Disease Control and Prevention. It is a colorless, odorless, tasteless gas, making it difficult to detect and therefore difficult to prove as the culprit in countless CO poisoning cases. Many injuries and deaths can be avoided if proper precautions are taken, such as installing CO detectors and designing products to minimize the risk of CO exposure. Despite CO’s deadly effects, it seems the government has done little to recognize the issue as a serious one,  while the automobile and manufacturing industries have barely acted to fix the problem at all.

Sources and Effects of CO Poisoning

The matter of CO poisoning warrants greater attention and awareness, especially after being responsible for so many deaths, like the deaths of Rodney Eric Todd and his seven children. They were all killed from accidental CO poisoning. The carbon monoxide was leaking from a gas generator inside the house that ran out of fuel but was still turned on. While this sounds like an improbable way for eight people to die, CO is known as the silent killer. Perhaps if there were clearer warnings about the dangers of keeping gas generators inside, Todd’s family would still be alive.

Carbon monoxide is a byproduct of many different products such as fuel-burning cars, household appliances, and business operations making CO poisoning possible from many different sources. The estimated annual societal cost of this poisoning is about 1.3 billion dollars based on the medical expenses and lost wages of those affected. Since the compound is commonplace, greater awareness of its effects would decrease the social burden and inadvertent deaths.

Oftentimes it can be difficult to recognize CO poisoning for its flu-like symptoms. Doctors are susceptible to misdiagnosing and improperly treating patients. Symptoms can include headache, dizziness, chest pain, vomiting, and confusion, and even loss of consciousness. One of the most commonly reported conditions is brain damage, caused by the deprivation of oxygen to the tissue and brain as CO binds to hemoglobin in the blood and spreads through the body. There is no cure for CO-related brain injuries, however there are several ways to treat patients. Treatments include cognitive and vocational rehabilitation and hyperbaric oxygen therapy, which is breathing pure oxygen in a chamber with higher-than-normal air pressure. The latter is typically used for severe cases of CO poisoning; it replaces the CO in your bloodstream faster than simply breathing fresh air. The severity of the symptoms depends on the duration of exposure, level of CO, and height and weight of the individual.

CO Poisoning Cases Are Complicated

CO poisoning

Hyperbaric oxygen chambers like this one are sometimes used to treat victims of severe carbon monoxide poisoning.

The wide range of CO sources and the many variables that can affect CO poisoning provides a challenge to the plaintiffs in these cases because they need to prove the source of the CO, establish the cause of harmful exposure, and demonstrate the medical connection between the exposure and injuries. To gather this evidence, many types of expert analyses may be necessary, such as physicians, engineers, medical experts, and a variety of others. A different set of experts are needed to substantiate the effects CO has on the body, including cardiologists, neurologists, toxicologists, and others. Proving damages from CO poisoning is expensive for plaintiffs and results in some difficult obstacles. Another pitfall of these cases are negligence claims based on failure to install a CO detector alarm in the first place. These alarms are an easy way to prevent injury from CO. Unfortunately, CO alarms are only mandated in private domiciles by twenty-seven states via state statute and only five states require them in school buildings. More state laws requiring installation of CO alarms would help to reduce the number of CO poisoning cases.

The type of defendant also changes the way CO poisoning cases are handled. Defendants can range from property owners to hotels and restaurants to appliance repair providers. In the case of property owners, it is vital that they complete preventative maintenance and inspections to determine possible hazards before they occur. If they do not do this, it can constitute a breach of applicable duty of care. There are also various codes that apply in different situations, such as International Fire Codes, International Building Codes, and International Mechanical Codes, as well as standards such as the American National Standards. All of these codes add different layers to defending CO poisoning cases.

Determining the amount of CO in the air that is permissible can also be a contentious issue that often impedes litigation. Governmental agencies and associations have differing opinions. For example, the Occupational Safety Health Administration sets the exposure limit for the workplace at fifty parts per million as a time-weighted-average over an eight-hour period. The recommended exposure limit from the National Institute for Occupational Safety and Health is thirty-five parts per million as a time-weighted average over an eight-hour period. In living spaces, the permissible exposure limit is nine parts per million with the desired level to be zero according to the American Society of Heating, Refrigerating, and Air Conditioning Engineers. These varying numbers suggests that the amount of CO in the air can vary on a case-by-case basis, although the ideal rate is zero parts per million.

Proliferation of Keyless Ignitions in Automobile Industry Presents New Challenges

There are separate challenges presented by keyless ignition cases, which are an excellent example of the automobile industry’s lack of recognition on the issue of CO poisoning. While push-to-start features and smart keys are a technological advantage, they can lead to cars being unintentionally left on after the driver leaves the vehicle. The longer the car is left on, the more harmful exhaust full of CO is released, which can then travel from the garage into the house and harm unsuspecting families, especially if the car is left on overnight. These cars are designed to start when the key fob is nearby, however the fob can be taken away and the car will remain on. While this is a safety problem, automakers have failed to publicize this problem and will continue to promote these cars because the National Highway Traffic Safety Administration is not acting.

All of the above-mentioned complications of CO poisoning result in costly and complex litigation. Each case entails a unique set of requirements and must be approached with individual manner. More accidental deaths will continue to happen, and they will require more persistent advocates to get the attention and care their cases require unless awareness of CO poisoning is more widely spread.

Surgeons are Finally Tuning in to Stryker Trunnion Failure Cases

We have been investigating Stryker trunnion failure cases since 2012. During our involvement in Stryker Rejuvenate and ABG II stem failures and subsequent recall we began receiving inquiries into Stryker monoblock stem trunnion failures. At first glance it appeared that most of these failures were associated with Stryker TMZF stems (Accolade, Meridian and Citation). This made sense to us since the Rejuvenate and ABG II were also TMZF titanium alloy stems. We filed the first Accolade failure case in 2013. We’ve filed over 100 such cases since.

The monoblock TMZF stem failures looked exactly like the Rejuvenate and ABG II failures. Patients suffered from high levels of cobalt and chromium in their blood, the development of large fluid collections and pseudotumors and frequently pain, disability, bone and tissue destruction. Upon deeper investigation it became clear that corrosion, fretting and the release of metal wear debris was occurring at the connection between the stems and metal femoral heads. This was exactly the same failure mode as the dual modular Rejuvenate and ABG II just at a different metal on metal connection. The problem is frequently referred to as “metallosis.”

Stryker Trunnion Failure – Redesign?

In 2011, with little or no explanation, Stryker “redesigned” its best-selling Accolade stem. The changes were very subtle but, the most glaring change was barely mentioned. Stryker eliminated TMZF titanium and instead replaced it with Ti6 titanium. No coincidence there yet a change that was seriously downplayed by Stryker and thus, completely lost on the orthopedic community. The timing is eerily similar to the recall of the TMZF Rejuvenate and ABG II stems.

So, for years patients with painful hips returned to their surgeons only to be told that their x-rays looked fine and their implant was not on the recall list. Patients were sent to more rehab, injected with steroids and some referred to their back doctors to see if it was their backs causing the problem. One of my clients was told it was all in their head and referred to a mental health professional! At the same time Rejuvenate and ABG II patients were being quickly and appropriately worked up and their recalled devices removed and replaced.

Another Massive Stryker Recall

Now, news of the recall is starting to filter out into the orthopedic surgical community. In addition, medical literature is starting to raise awareness of the problem. So, instead of scratching their heads, orthopedic surgeons are starting to do the right testing and voila, they are getting answers. Patients are now getting appropriate care as opposed to receiving the run around. Some doctors, sick over yet another recall (some have implanted hundreds of these devices as well as hundreds of Rejuvenate and ABG II’s) are reaching out to their patients and asking them to return for appropriate follow up. I personally know of surgeons in Pennsylvania, Wisconsin, Georgia, Texas and Florida who have done so.

Stryker Trunnion Failure Cases – Ticking Time Bombs Across the Country

In fact, numerous doctors have published reports of catastrophic failure of Stryker stems when combined with metal heads. In those cases, wear at the connection between stem and head is so severe that the head moves until it grinds the stem to a point and eventually the head falls off of the stem. This means every person implanted with a TMZF Stryker stem and metal head is a, “potential ticking time bomb” as one surgeon has put it.

Thank goodness this information is starting to motivate well-intentioned surgeons to reach out to unknowing patients, many of whom have been living with painful hips for years. In this instance more information is a good thing. Had it come out earlier a lot of pain and suffering could have been avoided.

New Jersey Stryker LFit V40 Lawsuits Receive Consolidation

On August 29, 2016, Stryker issued a voluntary recall of certain lots of Stryker LFit Anatomic Cobalt Chromium V40 femoral heads, a prosthetic hip replacement device, manufactured before March 2011. This recall included over 40,000 defective hips. Stryker cited to “higher than expected” complaints about the failure of the femoral head to fully lock onto the stem at the stem-head taper junction, also referred to as “taper lock failure.” Additionally, patients have experienced issues with fretting and corrosion where the femoral head connects to the femoral stem, which has led to the systematic release of metal particles into surrounding tissue and bone. The systematic release of these metal particles has placed patients at risk for certain medical conditions and has required some patients to undergo revision surgery. The issues may not only be due to the femoral head design, but also due to its intersection with the Stryker Accolade, Meridian and Citation titanium alloy femoral stems.

Due to the defects in the Stryker devices, multiple federal and state courts lawsuits arose all over the country against Stryker Orthopaedics and its New-Jersey-based subsidiary, Howmedica Osteonics Corporation (“HOC”). In the last year, plaintiffs with lawsuits in both federal and state courts have requested to consolidate their cases into multi-district litigation (“MDL”) and multi-county litigation (“MCL”), respectively.

Why Would Plaintiffs Want to Consolidate Their Stryker LFit Cases?

There are many strategic explanations for why plaintiffs may decide to consolidate their cases. The “centralization” of multiple actions promotes just and efficient conduct of the actions, serves the convenience of all parties and witnesses, promotes the interest of justices and conserves judicial resources. The plaintiffs can pool their resources and coordinate legal strategies while reducing costs, avoiding potentially inconsistent rulings by the courts and eliminating unnecessary duplicative discovery. Cases consolidated into multi-district or county litigation get a lot of attention; the more plaintiffs involved in the litigation, the higher the cost to the defendant, which the plaintiffs can use as leverage during settlement negotiations. And, for HOC, the MDL and MCL litigation will attract extra negative attention.

Consolidation of Federal and State Court Lawsuits

In April of 2017, the U.S. Judicial Panel on Multidistrict Litigation (also known as “JPML” or “Judicial Panel”) considered a request by plaintiffs to consolidate federal court lawsuits against HOC over the femoral heads in Massachusetts federal court. Defendant HOC opposed centralization but, as an alternative, suggested the selection of the District of New Jersey or Southern District of New York as the transferee district. But, all responding plaintiffs supported centralization in the District of Massachusetts. After considering all arguments, the Judicial Panel signed off on the plaintiffs’ request to centralize the lawsuits. The Judicial Panel decided that the actions in this litigation involved common questions of fact. Centralization in the District of Massachusetts would serve the convenience of the parties and witnesses and would promote the just and efficient conduct of the litigation.

stryker lfitWhile it was decided that the federal cases would be transferred to the District of Massachusetts, plaintiffs with pending cases across the state of New Jersey patiently awaited a decision from the New Jersey Supreme Court on whether their statewide cases would be consolidated under a multi-county litigation. In seeking MCL status, the plaintiffs argued that the litigation involved recurrent legal issues of design defect, failure to warn, breach of warranty, and possibly manufacturing defect. Defendants argued that the designation was unnecessary because the pending lawsuits were already assigned to Judge Harz and steps had been taken to effectively coordinate the matters. Defendants argued that if the Supreme Court did grant the plaintiffs’ request for MCL, the MCL should be limited to only those devices that were specifically recalled. Plaintiffs disagreed, arguing that such a limit would preclude the numerous device failures of non-recalled femoral heads from being included in the MCL.

On May 16, 2017, the New Jersey Supreme Court approved the bid from plaintiffs to consolidate the state court lawsuits, therefore designating all pending and future actions against HOC, in connection with the Stryker LFit V40 femoral heads, as multicounty litigation. The MCL was assigned to Bergen County for centralized case management by Superior Court Judge Rachelle L. Harz. And, the Supreme Court chose not to limit the MCL to specifically recalled lot numbers of the Stryker devices, again finding in favor of the plaintiffs.

This designation came rather quickly—not even a year has passed since Stryker issued the previously discussed recall of certain lots of the Stryker LFit V40 femoral head devices. Just 7 days after the Supreme Court’s Order designating the MCL, Judge Harz issued the first comprehensive Case Management Order, which discussed both proper procedure and the Court’s expectations of the parties throughout litigation in the MCL. Judge Harz has already scheduled a Case Management Conference for June 21, 2017.

The dedicated Mass Tort Unit of Searcy Denney Scarola Barnhart & Shipley represents plaintiffs who have been injured by defective medical devices and drugs. The firm filed the first Stryker Accolade/LFit case in New Jersey in 2013, and had already filed the first Stryker Rejuvenate case in New jersey by 2012. Over the past several years, I have devoted much of my time and effort to representing patients who have developed medical conditions due to the defects in the Stryker LFit V40 femoral head
devices. Presently, our firm has the largest number of cases filed in the Stryker Accolade litigation and we are currently accepting new cases, as sadly, patients are continuing to develop medical conditions due to the defects in the Stryker LFit V40 femoral head devices.

Finally – Victims of Stryker’s Latest Recall Receiving Notice

Lawsuits have been filed against Stryker since 2013 alleging that its line of TMZF hip replacement stems are a danger when combined with metal femoral heads. However, patients who have received this potentially dangerous combination of products are just now being notified. Oddly enough, Stryker is not the one doing the notifying. Despite recalling approximately 44,000 metal heads in 2016, Stryker has left it up to surgeons to notify patients. Some doctors have now taken it upon themselves to write to their patients explaining their concern over the product’s safety.

To compound the danger, Stryker’s instruction in its recall is for patients to “continue to follow up with their doctor at their normal scheduled appointment.” Most patients are released from the doctor’s care after one year of follow-up. So, if a patient’s implant has been in for a few years, then they are not scheduled for any follow-up appointments.

Dangerous Situation for TMZF Stem Hip Recipients with Metal Heads

This is a very dangerous situation for patients. All patients who received these implants should see their doctor to obtain baseline testing to see if, in fact, their device is already failing despite a lack of symptoms. However, since only a small handful of patients are even being told their implants are subject to a recall, thousands are left in the dark and have no idea they may be in danger.

These devices fail in much the same way tens of thousands of metal implants have failed over the past 10 years. At the connection between the TMZF titanium stem and the chrome/cobalt metal head motion leads to corrosion. This, in turn, leads to material loss. The process leads to toxic metal debris getting into the patient’s tissue and bloodstream. The metal debris can result in the death of both muscle and bone, as well as an inflammatory response leading to large fluid collections. Not all patients who suffer from this problem feel symptoms. Left untreated, the process can cause muscle and bone loss substantial enough to leave the patient with serious disabilities even after the bad device is removed and replaced.

Letter Sent from Local Surgeon

LFIT V40 recall

Read the letter here. Click on the image.

The latest letter that has come to my attention is from a surgeon at Holy Cross Hospital in Fort Lauderdale, Florida. The letter was sent to one of my existing clients who has already undergone revision surgery because of the above problems. He forwarded the letter to me.

Potentially thousands of these devices were implanted in Florida because of its large retirement population. Any patient implanted with a Stryker hip after 2006 should contact their surgeon and ask for their specific implant model. If the patient has any combination of a TMZF stem (Accolade, Meridian or Citation) and a metal head, they should insist on having a baseline blood chromium and cobalt study even if they are not having problems. Obviously, if the patient is having problems, he or she should consult with their surgeon as soon as possible. Finally, if the blood study shows elevated cobalt or chromium in their blood, they should insist on having a MARS protocol MRI scan of the affected hip.

One last comment about the recall. Stryker is only recalling a small subset of the metal heads it manufactured from 2002 – 2011. I have personally seen numerous failures in patients who received metal heads that are not on the recall list either because of their size or because they were manufactured after 2011. If it were me, I would not be satisfied if my surgeon told me I had nothing to worry about just because the metal head I have is not on the recall list.