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
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.
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.
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.
While 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.
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
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
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.
The U.S. Food and Drug Administration has issued a Class 1 recall for a handheld instrument used during hip-replacement surgery. The device failed sterility tests.
Greatbatch Medical Recalls The Affected Instrument
Greatbatch Medical recalled the instrument, a Standard Offset Cup Impactor. The instrument enables doctors to implant cups and balls in the joint area after the removal of their orthopedic counterparts – the acetabulum and the femoral head. The directions on how to decontaminate the instrument in its accompanying case were inadequate.
“Non-sterile surgical devices can lead to infections, and other serious adverse health consequences, including death,” the FDA states on its Web site, noting the company has since updated the sterilization process to meet federal standards.
Greatbatch Medical, in July of 2016, initiated corrective action on the recalled instrument. They determined the device must be individually wrapped for sterilization to be successful. The company says no adverse events have been reported.
“Greatbatch Medical has notified its distributors and customers via overnight mail that Standard Offset Cup Impactor with POM-C Handle grip should be individually wrapped during sterilization processing,” according to a corporate press release.
Urgent Field Safety Notice Contact Information
The instruments in question were made between 2004 and 2013 and distributed through 2015. Consumers can call (619) 498-9487 or email firstname.lastname@example.org with any questions or concerns.
“Torque limiting devices are supplied non-sterile and require cleaning and steam sterilization prior to use and subsequent re-use,” states an Urgent Field Safety Notice released by Greatbatch Medical. “This issue carries with it the possibility of patient infection. We deeply regret this inconvenience, but we greatly appreciate your understanding as we take actions to ensure patient and customer satisfaction.”