Britax Child Safety is recalling over 207,000 rear-facing infant car seats because part of a clip can break and cause a choking hazard. Britax says in government documents that since February, three customers found broken chest clips in the mouths of children but no choking injuries were reported, according to the Daily Hornet.
The company traced the cause to customers putting pressure on the clips, which help to properly position the harness straps. Britax advises that customers can safely continue using the seats if they remove the chest clip or monitor a center tab for signs of breakage. Britax will notify owners and provide a new chest clip, reports the Seattle Times. Britax has set up a website for owners to determine whether their seats are being recalled and for additional information.
The following model numbers are affected, if they were manufactured between November 1, 2015, or after May 31, 2017:
B-Safe 35 & Travel Systems
E1A183F, E1A185M, E1A185P, E1A186R, E1A203F, E1A205M, E1A205P, E1A206X, E1A206Z, E1A207E, E9LU65V, E9LU66X, E9LU66Z, E9LU67D, E9LU67E, EXA185M, S02063600, S02063700, S03803400, S03803500, S03803700, S03803800, S03803900, S04144400, S04144500, S04144600, S04145000, S04402800, S04884200, S04884300, S04975600, S04978900, S05260200, S06020300, S06020400, S06020500, S06020600, S06020700, S06020800, S06020900, S06147100, S921800, E1A193F, E1A195M, E1A195P, E1A196X, E1A196Z, E9LV16R, E9LV17D, S04144700, S04144800, S04144900, S04183700, S04183800, S04437700, S04884400, S04884500, S06051400, S06051500, S06051600, S06051700, S06051800, E1A233F, E1A235M, E1A235P, E1A236X.
Warranty Replacement Part: S03421600
B-Safe 35 Elite & Travel Systems
E1A215T, E1A215U, E1A216P, E1A221Q, E1A225C, E1A225U, E1A226L, E9LS51Q, E9LS56C, E9LS56L, E9LS57F, E9LS57G, E9LS57H, EXA216L, S01298600, S02063800, S02063900, S02064000, S04281200, S04281300, S04628500, S06018800, S06020000, S06020200, S92370, E9LV21Q, E9LV26C, E9LV26L, E9LV27F, E9LV27G, E9LV2Q8, S01298700, S04184000, S06051300, E9LT15U, E9LT16C, E9LT16L.
BOB B-Safe 35 by Britax
E9LT34A, E9LT34C, E9LT35X, EXLT34A, E9LT54A, E9LT54C, E9LT55X
Britax reported that it began seeing an increase in warranty claims due to chest clip damage in October 2016, one year after the company changed the material it used to make the clips in response that they were too easily opened. “The chest clip is not a required safety device: it is added to the harness system to help position the shoulder straps,” the notice said.
National law firm Parker Waichman LLP has extensive experience and success in representing clients in product liability litigation. Our attorneys are actively reviewing cases on behalf of individuals who are seeking information for those interested in filing a potential lawsuit.
Prior Britax Car Seat Recall
In January 2016, Britax received reports of cracks developing around the carry handle on some infant car seats. This could allow the handle to break and a baby to be injured. This does not affect the crash-worthiness of the car seat. Do not use the carry until you have received and installed the repair kit. Affected car seats were manufactured between October 1, 2014, and July 1, 2015. For a complete list of B-Safe 35, B-Safe35 Elite, and B-Safe 35 Travel System model numbers affected, please visit the Britax website.
Car seat recalls are not very common, but on occasion, companies must recall car seats in order to better protect your baby. You should register your car seats with the manufacturer to receive the fastest notification of any applicable recalls. If your car seat is not yet registered, you can do so easily by calling the manufacturer (there should be a phone number right on one of the car seat labels) or visiting their website.
It is also recommended to check National Highway Safety and Traffic Administration’s (NHTSA’s) extensive recall list if you borrow a car seat from a friend or have to use an older car a seat again after a period of non-use.
Graco My Ride 65
On May 10, 2017, over 25,000 Graco My Ride 65 convertible car seats were recalled because the harness webbing may n adequately restrain a child in a crash. Graco will provide registered owners with a replacement harness.
Baby Trend Hybrid LX 3-in-1 Centennial
December 19, 2016, a small number of Baby Trend Centennial 3-in-1 boosters were recalled because the center adjuster rivet could pull through or break if it is used with a child that weighs more than 40 pounds.
Kiddy World Plus
Nearly 1,500 Kiddy World Plus combination car seats were recalled on April 29, 2016, because the buckle may only partially engage, and may not sufficiently protect a child in case of a crash.
Evenflo Transitions 3-in-1
Transition car seats manufactured before January 29, 2016, were recalled because a child could reach the center front harness adjuster and loosen the harness. This could allow a child to be improperly restrained, which might lead to injury in a crash. Evenflo provides a remedy kit to prevent a child from reaching the harness adjuster.
Information on Filing a Product Liability Lawsuit
If you or someone you know has been injured by a defective or recalled product, you may have valuable legal rights. Attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information contact us at 1-800-YOURLAWYER (1-800-968-7529).
On September 11, Medtronic announced that it has begun to inform patients worldwide of a voluntary recall of certain lots of infusion sets used with all models of Medtronic insulin pumps. Infusion sets help connect an insulin pump device to the body. The recall involves a certain discontinued component in these infusion sets and does not include glucose sensors or insulin pumps.
Insulin Over-Delivery Risk
Medtronic determined that a component, the vent membrane, in the recalled infusion sets may be prone to being blocked by fluid during the process of priming, or the removal of air bubbles. This may lead to potential over-delivery of insulin shortly after an infusion set change, which may bring on hypoglycemia (low blood sugar). The Dublin-based company received reports of hypoglycemia requiring medical intervention, potentially linked to this issue, Medtronic said.
Now manufactured infusion sets, available since April 2017, include a design update of this component which Medtronic believes reduces the risk of insulin over-delivery after an infusion set change.
National law firm Parker Waichman LLP has extensive experience and success in representing clients in defective medical device litigation. Attorneys at the firm are available to answer questions for any individuals seeking legal information for a potential lawsuit.
“Our priority is to work with our patients to mitigate risk to patient safety. While we have shipped a significant number of the new and enhanced sets since April, we are committed to replacing recalled infusion sets for all patients,” said Francine Kaufman, M.D., chief medical officer of the Diabetes Group at Medtronic. “Our Medtronic Diabetes team will work as quickly as possible to complete all exchanges to the new and enhanced set and fully support our customers throughout this process.”
Pump Malfunction and Severe Hypoglycemia Case
In July 2015, a product liability lawsuit was filed by a New York man who alleged that a Medtronic MiniMed Paradigm insulin pump caused him to suffer severe hypoglycemia due to a pump malfunction. The complaint was filed in the Southern District of New York alleging that the Medtronic MiniMed pump had a faulty design, resulting in a failure to deliver the appropriate amounts of insulin to control his diabetes.
The plaintiff indicated that he began using the MiniMed Paradigm insulin pump in 2010, in an effort to manage and control his type 2 diabetes. In June 2012, the complaint indicates that the plaintiff lost consciousness in his bathroom, falling and injuring his face and hip. He was diagnosed with hypoglycemia, which the lawsuit maintained was due to the malfunctioning insulin pump.
The plaintiff accused Medtronic of failure to warn, designing and manufacturing a defective product, negligence, and breach of warranty, seeking both punitive and compensatory damages.
During the Medtronic MiniMed pump lawsuit, allegations were raised that there have been known issues with the device for years, but Medtronic neglected to take appropriate actions to prevent consumers from suffering serious injuries.
Prior Medtronic Complaints and Recalls
In 2009, the FDA accused Medtronic of dragging its feet on addressing customer complaints in a warning letter that revealed that the company waited 18 months before reporting a MiniMed Paradigm Insulin Pump device malfunction. The company is required to report an incident within 30 days.
In September 2014, Medtronic issued a MiniMed Paradigm insulin pump recall for over half a million units following reports that programming errors led to patients receiving an incorrect dose of insulin. At least one report of hypoglycemia was associated with the problem, which caused some users to inadvertently give themselves the maximum insulin dose.
Medtronic issued a MiniMed Paradigm infusion set recall in June 2013, because fluid could get into vents, preventing the pump from priming properly, which could cause severe or even fatal health problems for diabetics. It was one of four recalls or urgent device notifications regarding Medtronic’s insulin pumps that year alone.
In 2009, Medtronic Inc., issued a similar recall for approximately three million Quick-set infusion sets used with its MiniMed Paradigm insulin pumps, due to a manufacturing defect that could result in the delivery of incorrect doses of insulin and cause injury or death for diabetics using the Medtronic insulin pumps.
After that recall, a number of Medtronic infusion set lawsuits were filed on behalf of patients who suffered serious injury or death when they received too little or too much insulin.
Legal Help for Diabetes Medication Issues
If you or someone you know has been affected by defective diabetes devices or medications, you may have valuable legal rights. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact our personal injury attorneys at 1-800-YOURLAWYER (1-800-968-7529).
from Parker Waichman http://www.yourlawyer.com/blog/medtronic-recalls-insulin-sets-due-hypoglycemia-risk/
A complaint by a South Carolina woman involving a Cook IVC filter joins a multidistrict litigation (MDL) against the medical device manufacturer. The plaintiff alleges that the Cook Celect Vena Cava (IVC) Filter she had implanted in July 2010 has caused her serious injury. She claims that Cook was aware of the problems associated with the devices and intentionally failed to warn patients and the medical community of the dangers and disadvantages of its IVC filters.
IVC filters are small, spider-like medical devices implanted into the vena cava, and have been used since the 1960s. By 2012, about 259,000 filters had been inserted as a temporary measure to impede blood clots before they have an opportunity to travel from the legs and pelvic region to the lungs or heart. The inferior vena cava is a major vein that returns blood to the heart from the lower part of the body. The IVC is used as an alternative for those patients for whom anticoagulants or blood thinners are not an option, according to the Mayo Clinic.
Cook IVC Filter Complications
The Cook Celect IVC filter has four struts to anchor the device and eight independent secondary struts to center the mechanism and trap potential blood clots. Plaintiffs in the Cook IVC MDL allege the company was aware the struts could break off as they were not affixed strongly enough to withstand normal anatomical and physiological movement within the body. Despite knowing this, the IVC filters were widely promoted as a safe and effective treatment for the prevention of pulmonary embolisms by way of placement in the vena cava.
The Cook filters were designed as a temporary measure and to be retrievable, but a study revealed that of 130 retrieval efforts made between July 2006 and February 2008, 33 failed. Either the struts had penetrated the vena cava wall, or tissue grew around the small hooks of the IVC filters.
The product liability lawyers and personal injury attorneys at Parker Waichman are closely monitoring events in IVC filter litigation. Associates at the firm are available to answer any questions for individuals seeking information about filing a potential lawsuit.
Vena Caval Penetration
Between August 2007 and June 2008, a study of 73 patients implanted with the Celect filter found a “high incidence of caval filter leg penetration.” Caval penetration is a frequent, but clinically underrecognized complication of IVC filter placement, according to PubMed. Immediately after placement of a fluoroscopy-guided filter in 61 patients, four filters (6.5 percent) showed significant tilt. A subsequent abdominal CT (computed tomography) scan in 18 patients demonstrated filter related issues in seven (39 percent), which included penetration of filter legs in four and fracture/migration of filter components in one.
A story published in the March 30, 2011 journal Cardiovascular Interventional Radiology revealed that one hundred percent of Cook Celect and Guther Tulip IVC filters imaged after 71 days of implantation “caused some degree of filter perforation of the vena caval wall.” The filters that were studied had been implanted in 2009 between July and May. The same study showed that 40 percent of the filters had tilted, and that all the tilted filters had vena caval wall penetration.
Based on studies such as these, the Cook filter MDL says that Cook knew or should have known that their IVC filters were probably going to perforate the vena cava wall. An MDL is a type of mass tort that transfers lawsuits with common questions of fact to one court before one judge. This type of consolidation makes the legal process faster and more efficient because it eliminates duplicate discovery and streamlines proceedings. The Cook IVC Filter MDL case will take place in the U.S. District Court for the Southern District of Indiana, Indianapolis Division.
FDA’s Controversial 510(k) Approval
Plaintiffs in the Cook litigation point out that IVC filters were approved through 510(k), meaning manufacturers did not have to submit clinical test data proving that devices were safe and effective prior to obtaining approval. This contrasts to the FDA’s normally strict premarket approval process which does mandate clinical testing. The 510(k) process is a fast-track route that only requires products to be “substantially equivalent” to a previously approved device, even if that device had safety issues of its own.
Substantial equivalence means that a product is at least as safe as its predicate. However, safety advocates have argued that 510(k) is not appropriate for certain medical products. The route was never intended for high-risk devices. Due to a regulatory loophole, however, some high-risk devices have been cleared through 510(k).
Have You been Injured by a Cook IVC Filter?
If you or someone you know has sustained injury associated with a Cook IVC filter, you may be eligible for valuable compensation. Parker Waichman personal injury law firm offers free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).
from Parker Waichman http://www.yourlawyer.com/blog/cook-ivc-filter-complications-lead-massive-mdl/
On September 7, 2017, a Philadelphia jury awarded $57.1 million in damages to a Pennsylvania woman who was injured by pelvic mesh implants made by Johnson & Johnson’s Ethicon division.
The 51-year-old woman suffers constant pain and incontinence because the mesh migrated from the insertion site and damaged her urethra, Philly.com reports. Doctors operated three times to remove two devices.
This verdict is the largest awarded in a pelvic mesh suit. The award includes $50 million in punitive damages. In December 2015, an Indiana woman was awarded $12.5 million; a New Jersey woman received $13.5 million in February 2016. In April 2017, another New Jersey woman received $20, and a Pennsylvania woman received $2.1 million in June.
National law firm Parker Waichman notes that Ethicon is not the only mesh manufacturer facing legal action. Boston Scientific, C.R. Bard, Cook Medical, Coloplast, and American Medical Systems also face substantial numbers of lawsuits over their mesh products.
Pelvic Mesh Devices
Pelvic mesh—transvaginal mesh—is used to treat women’s pelvic organ prolapse (POP) and stress urinary incontinence (SUI). SUI and POP occur when the pelvic structures that support a woman’s uterus, bladder and intestines weaken due to childbirth, surgery, or aging. The organs drop (prolapse) into the vagina, causing incontinence and bowel and sexual problems.
The mesh device is implanted to provide support for the organs and relieve pain and other symptoms. Before transvaginal mesh came to market, surgery for POP and SUI involved creating support for the organs using the woman’s own tissues. Surgeons began using surgical mesh in the 1950s for hernia repair. Several decades later mesh products gained U.S. Food and Drug Administration (FDA) approval for POP and SUI surgeries.
Injuries and Complications
Women who have filed transvaginal mesh lawsuits allege they have suffered complications including
- mesh protrusion into the vagina
- nerve damage
- scar tissue
- organ perforation
- painful intercourse
- urinary and bowel incontinence
Many women who have experienced transvaginal mesh complications have needed additional surgery to attempt to remove the mesh and to repair organ damage. Often, however, these surgeries are not successful. Some women are caught in a cycle of repeated episodes of mesh erosion and surgery to remove protruding mesh. In other cases, the mesh has become embedded in the woman’s organs and cannot be removed. In legal documents, women have said they felt they were worse off after the surgery.
J&J Withheld Information about Complications and Injuries
Evidence introduced during the trial indicated that J&J manipulated the literature about problems with its pelvic mesh products and withheld information about complications and injuries from doctors, Philly.com reports.
Many of the lawsuits allege that Ethicon failed to warn the women and the medical community about potential complications. With adequate warnings about pelvic mesh complications, women say they would have chosen the older surgical technique.
In a 2011 safety communication for women and health care providers, the FDA said serious complications associated with transvaginal mesh “are not rare.” Further, the agency said, it is “not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”
In January 2016, in response to thousands of lawsuits and reports of mesh failure and complications, the FDA issued two orders for transvaginal mesh devices. The first order reclassifies vaginal mesh devices from Class II, the moderate-risk device category to Class III, the high-risk category. The categories are assigned depending on how likely it is that a particular device will cause serious and permanent health consequences or even death. The second FDA order requires vaginal mesh manufacturers to submit premarket approval (PMA) applications to support the safety and effectiveness of their vaginal mesh devices.
Carl Tobias, who teaches product liability law at the University of Richmond in Virginia, believes Johnson & Johnson should consider a comprehensive settlement for all the pending pelvic mesh cases. “There’s no sense in continuing to shell out for the defense costs and suffer the reputation damage that comes with each win by the plaintiffs.” Tobias explains.
Help for Women Who Have Suffered Transvaginal Mesh Injuries
If you or someone you know has suffered injuries or complications from a transvaginal mesh device or have undergone additional surgery to remove the mesh or repair organ damage, the attorneys at Parker Waichman LLP can evaluate your legal options. For a free, no-obligation consultation, fill out the online contact form or call 1-800-YOURLAWYER (1-800-968-7529).
A recall has been issued for CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps made before June 30, 2017 due to the risk of a valve failure which prevents the balloon from inflating and deflating. The U.S. Food and Drug Administration (FDA) has categorized this as a Class 1 recall. This is “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
Datascope Corp. and MAQUET expanded a recall issued earlier in the year to include 12,319 units of the CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps that were made from July 1, 2003 through June 16, 2017. The FDA warns that “device failure may result in immediate and serious adverse health consequences, including death” for patients who need circulatory support to survive. Electrical failure of the pump is linked to the death of one patient, reports the Daily Hornet.
According to the manufacturer, “The device failed to pump due to an electrical test failure, which has been associated to a patient death due to the failure of the device to initiate therapy.” The problem with the devices is a “false blood-detection alarm and ingress of fluid” into the Intra-Aortic Balloon Pump, said the FDA when it initiated the Class 1 designation, its highest level of safety recall.
The FDA warns that the balloon should not remain inactive in the patient (not inflating or deflating), for more than 30 minutes due to the potential for thrombus (blood clot) formation.
National law firm Parker Waichman LLP has extensive and successful experience representing clients in defective medical device litigation. Attorneys at the firm are available to answer any legal questions for individuals seeking to file a potential lawsuit.
Preventative Design Change
Datascope Corp./MAQUET initiated a design change in June 2013 to prevent the electrical failure that stops the balloon from inflating or deflating. The problem is that not all devices that were manufactured before June 13, 2013, were upgraded or serviced, the Daily Hornet reports.
In March 2011, the FDA announced a defective fan in the power supply could cause overheating and shut down the Intra-Aortic Balloon Catheter Pump without visible or audible alarms. The recall was designated as Class 1.
Function of an Intra-Aortic Balloon Pump
An intra-aortic balloon pump (IABP) is a mechanical device that helps the heart pump blood. The balloon pump is inserted into the aorta, the body’s biggest artery. It is a thin, long tube called a catheter with a balloon on the end of it. Done typically in a hospital setting, the doctor will insert an IABP. The area of the leg should be numbed by the physician who would then thread the IABP through the femoral artery in the leg, into the aorta. The IABP will then be positioned at the center of the aorta, below the heart. An X-ray machine used during this procedure will help to accurately position the IABP, according to WebMD.
An IABP is normally used for a short period of time, such as hours or days. A long-term treatment will likely be needed, such as valve surgery or the insertion of a left ventricular assist device (LVAD).
How an Intra-Aortic Balloon Pump Works
The IABP reduces the workload on the heart, which allows the heart to pump more blood. The IABP is inserted into the aorta, the artery that takes blood from the heart to the rest of the body. The balloon on the end of the catheter inflates and deflates with the rhythm of the heart.
The IABP improves the function of only the left ventricle, as this is the chamber that pumps blood into the aorta. After the left ventricle has contracted, the balloon inflates. This inflation helps increase blood flow to the heart and the entire body. As the left ventricle is about to pump out blood, the balloon deflates. This deflation creates extra space in the aorta, allowing the heart to pump out more blood.
IABPs may have some adverse side effects. An IABP may cause an infection in the bloodstream if it is used for too long. The balloon may overinflate and tear the aorta. The IABP is also somewhat uncomfortable. When this device is in place, the patient must lie extremely still, according to WebMD.
Legal Information and Advice Regarding IABPs
If you or someone you know has been involved in an incident involving medical negligence or complications with a medical device, such as an Intra-Aortic Balloon Pump, you may have valuable legal rights. Parker Waichman law firm offers free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).
from Parker Waichman http://www.yourlawyer.com/blog/class-1-recall-datascope-intra-aortic-balloon-pumps/
Children who lived in lower Manhattan and were exposed to toxic clouds of debris from the terrorist attacks of September 11th are already showing signs of increased risk of future heart disease. It has been almost 16 years since the attacks, but a new analysis published in the journal Environment International studied blood tests of 308 children, half of whom were in contact with the toxic dust, the New York Post reports.
Recent Research Findings
The researchers from NYU Langone Health found that children whose blood contained chemicals known to have been in the debris had raised levels of artery-hardening fats in their blood. If left unchecked, higher levels of fat in their blood may lead to blood-vessel hardening, blockage, and heart attacks.
Chemicals that came from the particles of pulverized building materials, electronics, and the fires that incinerated the debris, released any number of disease-causing chemicals into the air. Children who lived near the World Trade Center were exposed to massive amounts of chemicals when compared with children who were not in the city on the day of the attack, according to the Post.
“Since 9/11, we have focused a lot of attention on the psychological and mental fallout from witnessing the tragedy, but only now are the potential physical consequences of being within the disaster zone itself becoming clear,” says lead study investigator and health epidemiologist Leonardo Trasande, an associate professor at NYU School of Medicine.
Study Advocates Early Intervention
However, the damage is not necessarily irreparable. According to Trasande, these risk factors can be addressed through diet and exercise. “[Our study] offers hope that early intervention can alleviate some of the dangers to health posed by disaster.”
Parker Waichman is a national law firm that has spent many years fighting to ensure that heroes and survivors of the September 11th terrorist attacks are never forgotten. The firm is committed to helping anyone seeking legal information concerning a potential lawsuit.
Previous Studies Involving Toxic Dust
Researchers have determined that dust and debris that hovered over lower Manhattan contained a toxic mix of compounds, including asbestos, pulverized cement, polychlorinated biphenyls (PCBs), benzene, dioxin, glass fibers, gypsum, fiberglass, jet fuel, heavy metals (including lead), irritants, toxins, and carcinogens. More than 90 health conditions, including 60 types of cancer, are believed to be a direct result of toxic exposure.
When the World Trade Center (WTC) towers collapsed on September 11, 2001, a massive cloud of toxic dust was produced. The dust, debris, and smoke from the burning rubble suspended over downtown Manhattan, exposed first responders, rescue and recovery workers and people who lived and worked in the area to toxins, irritants, and carcinogens. Particularly in the early days after the attacks, many rescue and recovery workers worked without proper protective equipment.
Many people exposed to 9/11 toxins became ill shortly after 9/11, but for others, illnesses emerged over time. Toxic 9/11 exposures frequently contributed to the worsening of previously existing health problems.
World Trade Center Health Program
As of June 30, 2016, 5,441 people enrolled in the World Trade Center Health Program had been diagnosed with 6,378 separate cancers, with some people suffering from more than one kind of cancer. Researchers say the 9/11 community is experiencing prostate and thyroid cancers, leukemia, lymphoma and multiple myeloma at a significantly higher rate than expected in the general population. Health experts expect 9/11 cancers as well as other serious health conditions to continue to emerge for years to come.
Zadroga Act and Victim Compensation Fund
The James L. Zadroga 9/11 Health & Compensation Act, became law in 2010 in order to provide aid to sick responders and survivors. It provides compensation, as well as medical treatment and monitoring. The Act was named to honor an NYPD officer who died of respiratory disease that developed as a result of his work at Ground Zero.
The 2015 Zadroga reauthorization extended health benefits for 75 years, until 2090, to ensure that all those who become ill because of September 11 would have the monitoring and care they deserve.
The Zadroga Act reopened the September 11th Victim Compensation Fund (VCF), which provides compensation to individuals who became ill and their families, as well as to the families of rescue workers who died due to a 9/11-related illness.
Legal Help for Those with WTC-Related Health Conditions
If you or someone you know has developed cancer or another illness that may be linked to 9/11 toxic exposure, the attorneys at Parker Waichman LLP can offer a free, no-obligation consultation on your right to compensation. For more information contact us at 1-800-YOURLAWYER (1-800-968-7529).
An Alabama man was prescribed the anticoagulant Xarelto to treat his pulmonary embolism (blood clot in the lungs), but in a lawsuit the man claims the drug caused him to develop potentially fatal internal bleeding. Bayer HealthCare and Johnson & Johnson (J&J), the manufacturers of the medication, are facing a growing multidistrict litigation (MDL) as Xarelto lawsuits continue to increase in number.
The plaintiff had used the drug as prescribed, for its intended purpose only, had taken the medication according to prescription instructions, and followed medical advice. According to his Xarelto gastrointestinal bleeding lawsuit, he had only been taking the medication between April 2, 2016 and April 13, 2016.
Plaintiff’s Bleeding Complications
Despite following all instructions for use of Xarelto, the plaintiff reportedly suffered a number of internal bleeding complications including gastrointestinal bleeding, secondary gastrointestinal bleeding, acute anemia, and melena. Melena is the passage of dark, tarry stools containing decomposing blood that is typically an indication of bleeding in the upper part of the digestive tract.
The plaintiff had to undergo a number of blood transfusions and prolonged hospitalization due to these complications. The plaintiff’s doctor immediately stopped his Xarelto prescription and the plaintiff decided to file the Xarelto gastrointestinal bleeding lawsuit against the pharmaceutical giants after he found out other patients had suffered severe internal bleeding injuries.
National law firm Parker Waichman has extensive and successful experience representing clients in pharmaceutical litigation. Attorneys at the firm are available to answer any questions for individuals seeking information about filing a potential lawsuit.
The U.S. Food and Drug Administration (FDA) approved Xarelto in 2011. It was made available to patients as a joint effort between Bayer HealthCare and J&J to come into the established anticoagulant market. The approval of Xarelto came one year after Pradaxa, the first medication to be released since warfarin (brand name Coumadin) over 60 years ago. Xarelto, Pradaxa, Eliquis, and other more recently released blood thinners, are called the new generation anticoagulants.
The new generation blood thinners became popular rapidly as the tried and true warfarin requires regular monitoring and dietary restrictions, so the newer drugs were more convenient. However, plaintiffs remark that warfarin has a reversal agent to stop excessive bleeding, while, at this point, the newer blood thinners, other than Pradaxa, do not have a reversal agent to stop bleeding. Lawsuits allege that Xarelto manufacturers promoted the benefits of the drug while neglecting to warn about the lack of an antidote.
Praxbind was released in 2015 as Pradaxa’s bleeding antidote, five years after Pradaxa was approved and brought to market.
How Anticoagulants Work
Most often, Xarelto is prescribed to treat atrial fibrillation (an abnormal heart rhythm that increases the risk of a blood clot), for stroke prevention, deep vein thrombosis (DVT) and other blood clot risks. Xarelto is also used to prevent blood clots in patients undergoing a hip or knee replacement surgery.
Anticoagulants, including Xarelto, work by impairing the blood’s ability to clot. This is necessary to prevent serious, potentially fatal complications in some patients. However, there are situations where physicians may need to counteract the drug’s blood thinning effects, such as during an uncontrollable brain or GI (gastrointestinal) bleed, or emergency surgery in case of an accident. However, this also prevents the body from recovering from internal bleeding injuries which could result in fatalities.
Failure to Disclose Potential Risks
At the time of Xarelto’s release, Pradaxa was dealing with intense criticism for internal bleeding issues. Patients maintain that J&J and Bayer were absolutely aware of potential problems and they knew or should have known about the potential Xarelto internal bleeding issues.
Purpose of MDL
The Alabama man’s Xarelto gastrointestinal bleeding lawsuit is joining an MDL where it will stand with other claims alleging similar complaints. By joining the MDL, the Xarelto gastrointestinal bleeding lawsuit will be streamlined through the court process consolidating cases and proceeding in one court before one judge. This lowers court costs, avoids duplicate evidence, allows a faster outcome, and is typically more efficient.
In this case, the plaintiff is seeking compensation for medical costs and is alleging multiple counts of negligence and failure to warn. The trial will take place in the U.S. District Court for the Eastern District of Louisiana. The plaintiff says he would never have used Xarelto if he had been aware of the risks of potentially fatal Xarelto internal bleeding occurrences.
Legal Help for Xarelto Users
If you or someone you know suffered adverse side effects, such as uncontrollable bleeding due to the use of Xarelto, you may have valuable legal rights. The attorneys at Parker Waichman offer free, no-obligation case evaluations. For more information, contact our personal injury lawyers at 1-800-YOURLAWYER (1-800-968-7529).