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.
To prove substantial equivalency, the device must have:
- The same intended use as the predicate; and
- 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.
Glass Particles Found in Spray Bottle
“The glass particles could block the actuator and impact the functionality of the pump,” the FDA said in a safety alert titled “Fluticasone Propionate Nasal Spray by Apotex Corp: Recall – Due to Potential for Small Glass Particles.” “There is a potential for patients to be exposed to the glass particles and mechanical irritation cannot be ruled out. Local trauma to the nasal mucosa might occur with use of the defective product.”
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.
Precautions Necessary for Fluticasone Use
WebMD describes some of the precautions, as well.
“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.”
Geographic Factors in Opioid Epidemic
The American Enterprise Institute, a public-policy think tank, conducted a study on “The Geographic Variation in the Cost of the Opioid Crisis” and found the costs of the opioid epidemic are disproportionate at state and local levels, as exemplified by the Nebraska / West Virginia comparison.
“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.”
On Tuesday, a jury entered a verdict of $27.8 million against Johnson & Johnson’s Janssen Pharmaceuticals, Inc. and Bayer AG’s Bayer Pharmaceuticals Inc. in the first state court trial out of the Philadelphia County Court of Common Pleas’ mass tort program consolidating Xarelto-related injury lawsuits. Plaintiff, Indiana resident Lynn Hartman, sought damages after she was hospitalized in 2014 with a gastrointestinal bleed. She stated she required four blood transfusions to counter the injury. Ms. Hartman testified she took Xarelto for more than a year – to treat her atrial fibrillation – before her hospitalization. She blamed her Xarelto use for the hospitalization, noting that she subsequently used another blood thinner without incident. The jury agreed with her and awarded $1.8 million in compensatory damages and $26 million in punitive damages.
The plaintiff’s claims were based, in part, on allegation that Janssen and Bayer manipulated the clinical trials for Xarelto and failed to adequately warn patients of the bleeding risks involved with Xarelto use. Former FDA Chief David Kessler testified at trial that, in his opinion, the drug’s warning label did not sufficiently inform doctors or patients of the severity of the potential bleeding risks.
Janssen and Bayer responded to these allegations by arguing the warning label statement that Xarelto “can cause serious and fatal bleeding” was more than sufficient warning of the drug’s bleeding risks. Additionally, the defendants relied upon testimony of Ms. Hartman’s treating physician that she would still have prescribed Xarelto to the plaintiff even with the heightened warning, even though she felt additional information should have been included on the label.
Witness Tampering Allegations
This trial was not without its share of drama. At the beginning of trial, the plaintiff’s attorneys alleged witness-tampering by a Janssen sales representative. The representative had visited one of Ms. Hartman’s treating physicians, Dr. Aldridge, prior to the physician’s deposition. During the deposition, Dr. Aldridge testified that he did not believe the plaintiff’s gastrointestinal bleed had been cause by Xarelto; his testimony seemed to contradict his notes made during Ms. Hartman’s 2014 hospitalization.
Judge Michael Erdos, who presided over the trial, granted the plaintiff’s request to take Dr. Aldridge’s deposition during the trial. Granting a mid-trial deposition is an unusual event, to be sure. However, following the deposition, Judge Erdos denied Ms. Hartman’s request to use the doctor’s testimony during trial. The judge’s denial was grounded in what he determined to be a lack of evidence showing an attempt to influence Dr. Aldridge’s testimony.
Where Does Xarelto Litigation Go from Here
Lynn Hartman’s case was one of approximately 1,500 cases pending in the Philadelphia County Court of Common Pleas. The federal multidistrict litigation currently has around 20,000 cases. Three bellwether trials have concluded from the MDL. All three trials resulted in verdicts in favor of Janssen Pharmaceuticals and Bayer Pharmaceuticals. The next Philadelphia trial is scheduled to begin in January.
Johnson & Johnson and Bayer officials have stated they will appeal the December 5, 2017 Philadelphia verdict.
The Mass Tort Unit of Searcy Denney Scarola Barnhart & Shipley, led by veteran pharmaceutical and medical device lawyers Brenda Fulmer and C. Calvin Warriner, III, recently filed several more lawsuits against the manufacturers of Xarelto. The law firm has filed dozens of personal injury and wrongful death lawsuits against Bayer and Janssen Pharmaceuticals alleging that Xarelto is defective and has caused numerous serious and some fatal bleeding injuries to patients.
Searcy Denney Files Xarelto Lawsuits
One of the newly-filed lawsuits involves a Dade County, Florida resident who began taking Xarelto after being diagnosed with atrial fibrillation after failing aspirin therapy. The patient was placed on Xarelto in 2014. One of the allegations in the national Xarelto litigation effort is that prescribing doctors should have been warned by Xarelto’s manufacturers that this particular blood thinner should not be considered as first-line therapy in light of the reported increased incidence of bleeding injuries, the lack of an antidote to reverse the anti-clotting effects of Xarelto (which is available for Coumadin and Pradaxa), and the inability to determine which patients might be particularly susceptible to a bleeding episode while on Xarelto. This patient developed an acute upper GI bleed, the most common injury associated with Xarelto, after taking the drug for about a year. The patient developed significant hematuria (blood in urine), severe abdominal pain, and coffee-ground stool (a classic sign of bleeding in the gastrointestinal tract). The patient developed severe anemia which led to respiratory failure and significant abdominal bleeding which caused the bladder to rupture.
Searcy Denney’s pharmaceutical lawyers also filed a recent lawsuit on behalf of a Delray Beach, Florida patient who developed a GI bleed and bleeding in his brain after taking Xarelto for three years. This patient was prescribed Xarelto in 2012, shortly after this drug was approved by the FDA. At the time, there was a lot of hype over Xarelto and its ease of use over Coumadin, which requires regular blood monitoring of INR levels and dietary and medication restrictions. Patients were assured that Xarelto had the same safety profile as Coumadin, yet it would be easier to use and be less of a hassle, which was very compelling to young patients with busy lives. Unfortunately, since then, Xarelto has become one of the drugs with the highest number of adverse events reported to the FDA. In the pending Xarelto MDL litigation, the plaintiffs contend that Xarelto patients face a far greater risk of developing bleeding injuries than patients who ingest Coumadin and that representations in Xarelto’s warning label and marketing materials to the contrary were false.
The third recent lawsuit filing by our Mass Tort Unit involves a wrongful death claim on behalf of the surviving family members of a Pompano, Florida man who died in Broward County earlier this year due to an intracranial hemorrhage after ingesting Xarelto for a few months. Prior to starting Xarelto in 2016, the patient had taken Plavix and aspirin for several years for his atrial fibrillation. The primary use of Xarelto is in patients with this common heart arrhythmia who are at risk of developing blood clots and ischemic strokes from pooling of blood in the heart. Anticoagulant drugs (like Coumadin, warfarin, Xarelto, Pradaxa, and Eliquis) thin the blood and make patients less likely to develop blood clot-related injuries, including ischemic strokes where a clot blocks blood flow in the brain. Xarelto, however, has a propensity to cause hemorrhagic strokes, where there is bleeding in the brain (rather than a blockage).
Xarelto Lawsuits Consolidated into MDL
These individual lawsuits will become a part of MDL No. 2592, which are coordinated legal proceedings for Xarelto pending in New Orleans. Currently, there are more 18,000 individual lawsuits pending in these multi-district litigation proceedings. These cases include both personal injury and wrongful death claims, and most involve allegations that use of Xarelto led to the development of bleeding injuries in the GI tract or brain. Bleeding injuries have been reported after just a single dose of Xarelto. Judge Eldon Fallon is presiding over the national litigation and has extensive experience with supervising complex pharmaceutical cases. There are also nearly 1,500 cases pending in state court in Pennsylvania.
The third bellwether trial against Janssen Pharmaceuticals (a division of Johnson & Johnson) and Bayer Corporation began on August 7, 2017, at a federal courthouse in the Southern District of Mississippi in Jackson. This case involves Dora Mingo, a 69-year-old retired schoolteacher from Summit, Mississippi who developed deep vein thrombosis (a “DVT”) in January of 2015, after undergoing hip implant surgery earlier that month. She developed by the DVT while she was on the blood thinner Lovenox following her hip surgery, so a hospital doctor prescribed Xarelto 15 mg to be taken twice a day for 21 days and then a 20-mg dose to be taken daily after that. After taking Xarelto for only a few weeks, Ms. Mingo’s blood work showed significant abnormalities in her hemoglobin and hematocrit levels, and she was instructed to go to the ER immediately. At the hospital, she was diagnosed with severe anemia and testing showed that she had an acute upper GI bleed for which she received blood transfusions and underwent a procedure to clip a bleeding ulcer. She was hospitalized for two days for the Xarelto-induced bleed and associated anemia.
The Xarelto defendants sought to dismiss her lawsuit and prevent the jury trial from proceeding in July and contended that Ms. Mingo was unable to prove that Xarelto was defective under Mississippi’s product liability law which requires that the plaintiff prove that the product was unreasonably dangerous to consumer and that she was injured by the drug. Further, Bayer and Janssen contended that Ms. Mingo’s case should be dismissed as they do not believe that she can fulfill her burden to prove that the Xarelto that she ingested failed to function as expected and that there was a feasible alternative medication available that she could have taken and avoided the risk of developing the upper GI bleed and anemia. In the Xarelto MDL litigation, the plaintiffs contend that there are safer alternative blood thinners available, including Coumadin or warfarin (which have been prescribed for decades) as well as other modern blood thinners, including Eliquis (which has a different dosing regimen) and Pradaxa (which reportedly now has an antidote available). The plaintiffs have also argued that manufacturers should warn that patients be given a blood test (known as an anti-Factor Xa assay, which is being used in Europe to identify high-risk patients) prior to use of the newer blood thinners to confirm that the patient will tolerate the drug.
The biggest challenge in meeting the plaintiff’s burden of proof is that the FDA has not determined that Xarelto is unreasonably dangerous (and, in fact, has promoted the safety of the drug). The plaintiff also has a burden in proving that the risk of a GI bleed is higher with Xarelto than with the other blood thinners, as the studies on this issue are conflicting and all blood thinners can cause GI bleeding events. The FDA originally approved Xarelto (also known as rivaroxaban) in 2011 for blood clot and stroke prevention in patients with atrial fibrillation and those who have undergone orthopedic surgeries.
Request for Summary Judgment from Defendants Denied
On July 21, 2017, Judge Fallon denied the defendants’ request for a summary judgment dismissing the lawsuit under Mississippi’s product liability statute, finding that there were disputed fact issues that prevented the claims from being dismissed prior to trial. It is likely that these same issues will be raised during the course of the trial after evidence and testimony on the existence of a product defect is presented to the Mississippi federal court jury. Additional motions to dismiss the case on the basis of federal court preemption and claims that federal law prevented Xarelto’s manufacturers from enhancing the safety warnings for the blood thinner have also been denied by the MDL judge. Judge Fallon also considered and rejected motions from both parties to exclude their opponents’ expert opinions on the risks associated with other anti-coagulants, unapproved dosing and monitoring regimens, and whether Ms. Mingo’s injuries were caused by her short-term use of Xarelto.
Judge Fallon is expected to preside over a fourth Xarelto bellwether trial, the Henry case, in Texas federal court later this year. The first two MDL bellwether trials were tried before juries in New Orleans and both resulted in verdicts in favor of the drug’s manufacturers. Appeals are pending regarding these trial losses by the plaintiffs.
The law firm of Searcy Denney, with offices in West Palm Beach and Tallahassee, represents more than 50 clients in their mass tort product liability lawsuits against the manufacturers of Xarelto. The firm has a dedicated Mass Tort Unit that focuses solely on drug and medical device claims. The timeframe for filing of lawsuit over a defective drug can be short, so please do not delay in contacting a lawyer if you or a loved one have suffered a gastrointestinal bleed, bleeding in the brain, or other injury associated with the use of Xarelto.