In what has become an alarming trend in drug and medical device manufacturing, Smith and Nephew felt compelled to copycat other hip implant manufacturers and market a pair of dual modular hip stems. This trend is alarming because it is yet another example of marketing and fierce competition in the orthopedic manufacturing community driving the innovation bus as opposed to trying to meet a true need. Companies continue to dream up reasons why new products are necessary and then when the products fail, hide behind claims the market demanded them. This behavior consistently gets companies in big trouble, frequently at the expense of injured consumers. The drug and medical device industries are addicted to innovation for innovation’s sake.
The Story Starts With Cremascoli
In this instance, Wright Medical Inc. purchased older technology from an Italian company named Cremascoli. In 1987, Patrizio Cremascoli patented one of the first dual modular femoral stems. Dual modularity refers to the femoral stem being manufactured in two pieces as opposed to one. Dual modular stems have a separate femoral neck component that is inserted into the stem. Traditionally, the femoral stem and neck were, and continue today, to be one piece. Dual modularity was supposed to, in theory, provide surgeons with the ability to more closely reproduce the patient’s native anatomy by supplying different, interchangeable neck options of varying lengths and offsets. This was supposed to improve device performance and patient outcomes. Despite the fact the Cremascoli design met mixed reviews in Europe, Wright purchased the technology and in 2002 introduced its Profemur Z in the United States. It was the first dual modular femoral stem in the U.S. domestic market.
As is par for the course, Zimmer, Stryker and Smith and Nephew all quickly jumped on the band wagon and began developing a copycat dual modular stem. This despite the fact reports began circulating that Wright’s Profemur was prone to neck fracture. Of course, if another company offered a product they didn’t, they would lose precious market share. By 2008, both Stryker and Smith and Nephew had obtained regulatory clearance to market dual modular stems. In Stryker’s case, the Rejuvenate and ABG II were developed and sold. The SMF and Redapt stems were Smith and Nephew’s version of the dual modular stem.
A Material Difference
Unlike Wright Medical, and likely due to reported stem fractures, Stryker and Smith and Nephew manufactured their modular necks out of chromium/cobalt allow where Wright had used titanium. Chrome/cobalt alloys are much stronger than titanium. However, in doing so, both companies ignored years of reported medical literature about the use of mixed metals at critical interfaces between component parts. Since the neck inserts into the stem and obtains fixation through a press-fit Morse taper junction, the mixed metals contact one another at a point of intense stress. Micromotion between the two components is inevitable. With motion comes fretting and with fretting comes corrosion. When corrosion takes place, toxic metal wear byproducts are released into the surrounding tissue. All this was well known and contained in the published literature.
Not surprisingly, by 2012 in Stryker’s case and 2016 in Smith and Nephew’s, their dual modular hips had failed at such alarmingly high rates the companies issued voluntary recalls of the Rejuvenate, ABGII, SMF and Redapt stems. In both instances, patients were being forced to undergo premature, unnecessary revision surgery due to metal wear toxicity.
The irony of the entire dual modular story is the publication of several medical studies concluding after extensive study that dual modular technology does not improve implant performance or patient outcome over traditional one-piece stems. What a shock. The widespread adoption of technology that was never needed in the first place. Will it ever end?
In some sense, justice has been served. Both Stryker and Wright have collectively paid several billion dollars in settlements and judgments because they marketed these devices. Along the way, thousands of victims suffered and continue to suffer disability due to these devices.
The moral of this story is that existing hip implant designs are robust and mature. There are, and have been, perfectly acceptable, well performing devices available for many years. Beware innovation and steer clear of any hip implant design or device that is marketed as being the next greatest thing. Ask your physician questions. Find out what he or she intends to put in your body. Having now represented well over a thousand hip implant patients, my advice is to find a competent surgeon who intends to implant a one-piece titanium stem, ceramic head, highly crosslinked polyethylene liner and one-piece titanium acetabular shell. That is your best bet for a pain free, mobile, happy outcome.
Did you know that 32 million Americans have at least one medical device implant?
As the main regulatory agency charged with ensuring the safety and efficacy of drugs and medical devices, the Food and Drug Administration (FDA) is entrusted with the safety and well-being of countless Americans every day. Their mission statement describes the agency as being “responsible for protecting the public health by ensuring the safety” of products, such as medical devices and pharmaceutical drugs.
However, the reality is that many people are hurt by medical devices that have slipped through loopholes in the FDA’s regulatory framework. This includes the 510(k) Fast Track program.
What is the 510(k) Fast Track Program?
Americans want solutions, and they want them fast. In an effort to reduce the time it takes for a medical device to become available to the public, many manufacturers often use a fast-track premarket approval process known as the 510(k) Fast Track program when submitting their devices to the FDA for marketing approval.
Through this process, the manufacturer must demonstrate the device is safe and effective enough to be marketed without further testing. Thus, the length of the approval period is significantly shortened.
How Products Are Approved Under the 510(k) Program
For a device to be approved under 510(k), manufacturers must first file a Premarket Notification (PMN). The FDA will review the PMN within 90 days to determine which class the device falls into.
Devices are put into one of three categories:
Class I: This class is considered “low risk” and involves devices not intended to treat potentially fatal conditions, or that won’t cause life-threatening harm if misused. Class I devices are available over-the-counter and not governed by the FDA.
Class II: This class is for “medium risk” devices that are not typically intended to treat potentially fatal conditions but can cause harm if misused. Class II devices are eligible for 510(k).
Class III: This class is for “high risk” devices that are intended to support or sustain life and present high risk of injury or death if misused. Class III devices are not eligible for 510(k).
In addition to this three-tiered system, the FDA allows what is known as substantial equivalency through the 510(k) program. This means that a new device can be approved if the manufacturer can demonstrate that it is as safe and effective as a similar, previously approved medical device, known as the primary predicate.
The same technological characteristics as the predicate;
The same intended use as the predicate; and
Different technological characteristics, yet does not raise different questions of safety and effectiveness; and
The information submitted to FDA demonstrates that the device is at least as safe and effective as a similar, the legally marketed previously approved device.
Proving a device is similar enough to another device already on the market bypasses specific testing. Because of this, almost two out of three 510(k) applications are cleared within six months.
Why the 510(k) Program is Faulty
The FDA’s 510(k) fast-track program often causes more problems than it solves.
Thousands of unsuspecting consumers might imagine that our medical device industry only delivers quality, life-saving products to Americans in need. However, the reality is that our medical device industry actually willingly bypasses important testing by expediting the approval process, skipping vital steps that could save lives.
Fast-tracking puts devices on the market with little to no specific testing. Because many products do not undergo important clinical trials, consumers end up being the true test subjects for manufacturers. New side effects and dangers are only discovered over the life of the device – and without clinical trials – unsuspecting patients can be injured.
To complicate matters, it is difficult to remove a device from the market once it has been approved, even if it has injured multiple consumers. If a device’s primary predicate is recalled, there is a significant chance that the substantially equivalent 510(k) device is also dangerous. However, the two products are treated separately, meaning the 510(k) device may remain on the market even if its predecessor was later proven dangerous.
Popular Medical Devices Recalled After 510(k) Program Approval
Many products fast-tracked through the 510(k) Fast Track Program have caused untold damage to countless Americans. Notorious devices include metal-on-metal implants and transvaginal mesh.
Certain hip replacements released to the public were made of titanium parts, which corroded when the joints rubbed together. This released metallic debris into the bloodstream, leading to a dangerous condition known as metallosis, or blood poisoning. These metal-on-metal implants received 510(k) clearance without additional clinical testing after proving substantial equivalence to earlier devices.
Another example, transvaginal mesh, received nationwide attention after the FDA received more than 3,000 reports of adverse reactions in just two years. Two such products – ProteGen bladder sling and Mentor ObTape – have been removed from the market. However, Avaulta’s vaginal mesh sling remains on the market, despite numerous side effects and lawsuits filed by recipients.
The FDA has since concluded that transvaginal mesh, originally labeled as having “moderate risk,” was linked with serious complications such as organ perforation, chronic infections, mesh erosions and other permanent damage.
Contact the Defective Drug Attorneys at Searcy Denney
Unfortunately, the FDA’s 510(k) program has caused many Americans to be unwillingly used as guinea pigs for uncovering dangerous side effects of medical devices that should have been properly tested beforehand. If you were harmed by a dangerous medical device, you are not alone. Thousands of injured individuals have taken legal action to stand up against Big Pharma.
Our team of experts understands the pain and heartache caused by dangerous medical devices. With our experience, we can help answer any of your questions so that you feel confident in your choice to seek legal remedy.
At Searcy Denney, we stand upon 40 years of experience helping our clients return to their normal lives after they are injured from the negligent and careless acts of others. We can help you, too. Find out how in a free, private consultation today by calling (800) 388-3905.
Small particles of glass are to blame for the recall of a widely used fluticasone nasal spray that treats symptoms of hay fever in children.
The nasal spray, known by its brand name Fluticasone Propionate Nasal Spray USP and manufactured by Apotex Corp., of Weston, Fla., was pulled voluntarily from the market by the company, which said the glass particles could clog the bottle and cause it to malfunction and, more importantly, abrade the inside of the nose. The U.S. Food & Drug Administration (FDA) said the issue was detected via a complaint.
With the exception of the complaint, Apotex Corp. has not been made aware of any other adverse events as a result of the recall.
“Patients, wholesalers, retailers, hospitals or institutions with Lot# NJ4501 and an expiration date of July 2020, should stop use and distribution of the remaining units and quarantine immediately,” according to the safety alert. “Healthcare Professionals in your organization should be informed of this recall.”
Fluticasone Widely Used for Allergies
Fluticasone Propionate Nasal Spray USP is for patients between the ages of 4 and 17 who suffer from seasonal allergies, sinus pain, sneezing and a stuffy nose. The drug also helps with itchy, watery eyes. It is a corticosteroid. WebMD explains its uses:
“The dosage is based on your age, medical condition, and response to treatment. Do not increase your dose or use this drug more often or for longer than directed. Your condition will not improve any faster, and your risk of side effects will increase. You may be directed to start with a higher dose of this drug for the first several days until you have begun to feel better, then decrease your dose. Children may need to use this drug for a shorter amount of time to lower the risk of side effects. If a child is using the over-the-counter product, read the package information to see how long he / she should use it and when you should check with the doctor.”
WebMD notes that the drug does not relieve symptoms immediately.
“You may feel an effect as soon as 12 hours after starting treatment, but it may take several days before you get the full benefit. If your condition does not improve after 1 week, or if it worsens, stop using this medication and consult your doctor or pharmacist. If you think you may have a serious medical problem, get medical help right away.
“Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness / injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months. Though it is unlikely, this medication may slow down a child’s growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child’s height can be checked. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.”
Anyone who has experienced problems with Fluticasone Propionate Nasal Spray USP should contact his or her physician immediately. The affected product’s label reads “50 mcg per spray 120 Metered Sprays.” It was distributed to wholesalers, including Sam’s Club and Walmart, nationwide.
“When inhaling nasal spray, glass probably tops the list of things you hope aren’t accidently in the bottle,” Healthcare Packaging states in an article on its Web site titled “Nasal Spray Recalled After Packaging Found to Contain Glass Particles.” “According to a recent FDA news release, Apotex Corp. has voluntarily recalled one lot of Fluticasone Propionate Nasal Spray for just that reason.”
Consumers who have questions about the recall are encouraged to reach out to Apotex Corp. at (800) 706-5575 or at email@example.com. Healthcare professionals are encouraged report adverse events to the FDA MedWatch program at fda.gov/medwatch A form also can be obtained by calling (800) 332-1088.
In an age where data is widely available and almost everything is stored online, data breaches are becoming more common, and the outcomes of cases involving data breaches are unpredictable. Data involved in a breach can range from financial data, such as credit card numbers, to health data, such as treatments and medical history. Based on previous settlements reached, stolen health data typically has the most extensive damages due to the incredibly personal nature of the data, while stolen credit card data has the least damages. It is a lot easier to cancel and replace a credit card than it is to replace identifying information such as a Social Security number. When there is a breach of identifying information, continued alertness is necessary to prevent identity theft, adding to the costs.
The Type of Data in a Data Breach Matters
There are two cases that illustrate the disparity between settlements involving different types of data. An infamous hacker who goes by the name “Cumbajohnny” was responsible for hacking both T.J Maxx and Heartland Payment Systems. Data for approximately 130 million credit and debit cards was stolen from Heartland, and more than 45 million credit card5s were affected from the T.J Maxx breach. However, the Heartland settlement was $500,000, despite involving the breach of three times the amount of data. The T.J Maxx settlement was valued at $6.1 million. The court’s value was based on the type of data breached; Cumbajohnny and his cohort stole identification information from at least 450,000 customers of T.J Maxx, including Social Security and driver’s license numbers. Although the nominal value of credit card information was larger for Heartland, considering the threat of identity theft, the real value of the 455,000 people affected from T.J Maxx was much greater. In fact, eighty-six percent of the T.J Maxx settlement was from the much smaller number of identifying information stolen, and the other fourteen percent is attributed to the 45 million stolen card records.
Although identifying information is valuable in settlements, medical records often add the most value to a data breach settlement because they contain deeply personal information. For example, the breach of Advocate Health Care included unencrypted medical records, affecting 4.03 million patients. The case settled for $5.55 million, remaining the largest HIPAA settlement to date. This case exemplifies the need to keep up with the swiftly-evolving digital landscape to protect clients’ information. It may also demonstrate legislative attention to particularly personal and sensitive data. Due to the variation and uniqueness of each data breach case, it is important to evaluate the types of compromised data.
Identify Theft Also Important Factor
Generally, cases with elements identity theft will be stronger because it is difficult to prove standing without it. Some jurisdictions require the plaintiff to have suffered from identity theft to have standing. It can be difficult to prove that the hacker had malicious intention and/or sold the data they stole, and until they do sell it, some jurisdictions will not give the class standing. For large data breach cases, such as the T.J Maxx settlement, the plaintiff’s attorneys must be prepared to litigate the case under the standing rules of the federal court in any district because many cases filed all over the country can be consolidated into one federal district court for multidistrict litigation.
The value of data breach cases does not only include the monetary value of the breach. Protection against future losses, such as improved digital security and credit monitoring, are important to preventing identity theft and ensuring the affected company isn’t breached again. It can be beneficial to the plaintiff if the company at fault had a previous breach and did not take proper measures to increase their security.
What Happened After the Breach?
Before initiating a case, it is valuable to research what a company has already done after experiencing a breach. Oftentimes, the company will offer one-year free credit-monitoring for customers who experience ongoing credit risk. While credit-monitoring is helpful for preventing a breach, some companies may only monitor one of the three credit bureaus (Equifax, Experian, and TransUnion) to keep costs low, leaving customers vulnerable to fraudulent activity that shows up on other bureau’s credit reports.
Researching if the company bulked up its security after a breach is also useful. It can be difficult to find exactly what the company did in the aftermath because the discovery may not be accessible. Cybersecurity blogs can come in handy to get technical details of how the hacker was able to get into the company’s system in the first place and learn what, if anything, the company did to improve security. If there is a lot of room for security or credit-monitoring improvement, the value of the settlement may be greater, however the court can enforce this by either raising the dollar value of the settlement or mandating the company increases security. For example, after the Target data breach, which affected 41 million customers, the settlement required Target to employ a chief officer who manages security, to actively monitor its systems for security events, provide security training to its employees for five years, and perform routine security assessments. The case settled for $18.5 million, but the injunctive relief was much greater.
Third Party Vendors Can Play Role
Determining if the company or a third-party vendor is at fault for the breach can be challenging. The company experiencing the data breach often claims they have the most up-to-date security systems, however discovery usually reveals gaps that the hackers used to get in and out with the data. If a third-party could be responsible, it would be best to establish the relationship between the company and the vendor as soon as possible and determine if the vendor is primarily responsible for the breach.
An example where the vendor was unmistakably at fault is the case of the Stanford Hospital data breach. The hospital’s business associate (BA), Multi-Specialty Collection Services, LLC, posted 20,000 patients’ emergency room records, including hospital account numbers, billing charges, and emergency room admission and discharge dates, to a student homework website asking how to graph the patients’ data. Stanford Hospital properly encrypted the records before sending them to the vendor, but they were still responsible for paying the administration costs of the $4 million settlement. The hospital also agreed to train its vendors on how to most effectively protect patient data. Since vendors are typically smaller entities, they likely have fewer resources, and this could affect the settlement amount.
One trillion dollars. That’s how much the country spent on the opioid epidemic between 2001 and 2017, according to a report released by the nonprofit institute Altarum, a consulting group focused on improving public health.
The cost of the crisis trickles both up and down and impacts corporations, governments and insurance companies, as well as families, local businesses and neighborhoods.
“The greatest cost comes from lost earnings and productivity from overdose deaths – estimated at $800,000 per person based on an average age of 41 among overdose victims,” the report states. “This figure is largely made up of lost wages of workers and productivity losses of employers, but it also weighs on government in the form of lost tax revenue. It has increased in recent years as the epidemic has transitioned away from older people to younger ones and from prescription opioids to illicit drugs.”
Opioid Epidemic Results in High Costs to Society
More than 42,000 deaths were caused by opioid overdoses in 2016, according to the U.S. surgeon general’s office. In 2010, the death toll was 21,000. The startling spike spurred the office to take action, with Dr. Jerome Adams issuing an advisory: “Be prepared. Get naloxone. Save a life.” Naloxone is an easily administered nasal spray that quickly reverses the deadly symptoms of an overdose.
“Health care costs related to the opioid crisis reached $215.7 billion from 2001 to 2017,” the report states. “This stemmed largely from emergency room visits to treat and stabilize patients after an overdose, any associated ambulance and Naloxone use required, and related indirect health care costs associated with the increased risk of other diseases or complications.”
And the costs have nowhere to go but up.
“An additional $500 billion is estimated through 2020 if current conditions persist,” the report states.
Governing magazine, a nonpartisan news outfit, reports that Middletown, Ohio, spent $1 million-plus on ambulance dispatches for overdoses between October 2016 and October 2017. It also reports that Pennsylvania will spend $5 million this year on naloxone alone. In Nebraska, the epidemic costs $465 per resident. In West Virginia, it costs $4,793 per resident. The state has one of the highest rates of opioid overdoses in the country.
“The costs build up slowly over time, so you almost don’t even notice it,” Nashville lawyer Mark Chalos told the magazine in an article titled “How Much Is the Opioid Crisis Costing Governments?” “But when our people really started to dig into the budgets, they realized the costs are more significant.”
“The types of costs attributable to opioid abuse – health care costs, criminal justice costs, and lost productivity, for example – are fairly well understood, as is the economic impact of the crisis at the national level,” the study states. “However, the economic burden of the opioid epidemic is unevenly distributed across the country, with many communities especially hard hit. As federal, state, and local policymakers and stakeholders seek to curb the epidemic, it is vitally important that they know how these costs are distributed.”
VSL – Value of a Statistical Life – A New Way to Measure Cost of Opioid Epidemic
Enter the White House’s Council of Economic Advisers, or CEA. The federal agency compiled a paper in November 2017 that used a metric called the Value of a Statistical Life, or VSL, to gain insight into the costs of the opioid epidemic. The VSL essentially puts a price tag on one’s willingness to lower his or her death risk. It is helpful for shaping policies and programs that reduce fatalities.
“CEA finds that previous estimates of the economic cost of the opioid crisis greatly understate it by undervaluing the most important component of the loss – fatalities resulting from overdoses,” states the executive summary of the paper, titled “The Underestimated Cost of the Opioid Crisis.” “CEA estimates that in 2015, the economic cost of the opioid crisis was $504.0 billion, or 2.8 percent of GDP that year. This is over six times larger than the most recently estimated economic cost of the epidemic.”
The paper states that though this is the first of its kind to be published, it will not be the last.
“A better understanding of the economic causes contributing to the crisis is crucial for evaluating the success of various interventions to combat it,” it concludes. “CEA will conduct further economic analysis of actual and proposed demand- and supply-side interventions; consider the impact of public programs such as Medicare and Medicaid; and explore the important role of medical innovation in combatting the crisis.”
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.