WHAT ARE THE DETAILS OF THE IVC FILTER LAWSUITS?
Across the country upwards of 100,000 Americans are diagnosed with deep vein thrombosis (DVT) or pulmonary embolism (PE). DVT are blood clots that develop in deep veins and can travel into the lungs. PE is a blockage in one of the pulmonary arteries in the lungs. These medical conditions are dangerous and relatively common in the U.S. population. In fact, the risk for developing PE is so prevalent that the US National Library of Medicine declared the disorder a public health concern in 2010.
According to the Centers for Disease Control, more than 30% of pulmonary embolism patients die within three months of diagnosis. Typically doctors prescribe anti-coagulants, or blood thinners, to treat the condition. However, not all patients respond well to blood thinners. When this happens, a doctor may insert a device called an Inferior Vena Cava (IVC) Filter.
Although IVC filters can be a lifeline for patients with blood clots, some of these devices have their own fatal dangers. In 2014, the U.S. Food and Drug Administration (FDA) issued a safety warning for certain retrievable IVC filters, citing that product may cause serious and life-threatening health conditions.
If you or a loved one has suffered the adverse medical effects of IVC filters, it is time to consider legal action. An experienced attorney can get you the compensation you need to heal from life-threatening injuries, or help you recover from the loss of a family member. Contact the law firm of Pitman, Dutton & Hellums today for a free case evaluation and learn your legal options.
Section 1 What is an IVC Filter?
Section 2 IVC Filter Side Effects
Section 3 Symptoms of IVC Filter Complications
Section 4 IVC Filter Manufacturers Facing Litigation
Section 5 C.R. Bard
Section 6 C.R. Bard IVC Filters
Section 7 Cook Medical
Section 8 Cook Medical IVC Filters
Section 9 Status of the IVC Filter Lawsuits
Section 10 FDA News & Warnings
Section 11 Medical Device Litigation Attorneys
What is an IVC Filter?
IVC filters are small devices with several prongs, designed to prevent a blood clot from traveling into the lungs. Some IVC filters are intended to be retrievable. Once the eminent threat of death has passed and the patient’s health has improved, then the device should be removed. Generally, removal of the IVC filter should occur between the 29th and 54th day after initial implant.
An IVC filter may be inserted after a patient has developed DVT due to surgery, obesity, advanced age, or prolonged immobility such as bed-rest or long plane rides. Injury to the veins, or increased production of the hormone estrogen can also cause deep vein thrombosis. Although the precise number is unknown,
the CDC estimates that as many as 900,000 people may be affected by DVT at some time in their lives.
IVC Filter Side Effects
In 2010, the FDA listed the following side effects from IVC filters:
Filter perforation of the heart or surrounding tissue
Device migration (movement out of set place)
Fracture and break off of the filter’s prongs
Failure to capture an embolism (blood clot) capture
In many cases of IVC, the device may not be removed within the recommended timeframe. In other instances, surgeons may attempt to retrieve the device, but are unsuccessful. A review by the Journal of the American Medical Association found that out of 680 patients, only 8.5% had their IVC filters removed successfully as recommended. The study also found that 13 removal attempts failed due to device migration, perforation of a blood vessel, or device embedment in a venal wall. There were also 74 venous thrombotic events (blood clots) after IVC filters were placed, including 25 pulmonary emboli (blood clots in the lung).
Symptoms of IVC Filter Complications
The longer a retrievable IVC filter device stays implanted in a patient, the greater the chances of adverse effects. Warning signs the IVC filter is failing include:
Shortness of breath
Should you experience any of the above symptoms, seek medical help immediately.
IVC Filter Manufacturers Facing Litigation
Two major medical device manufacturers, C.R. Bard and Cook Medical, are defending their products in multidistrict litigation (MDL) for IVC filter injury. Five IVC device types are the focus of these lawsuits:
Bard Recovery Filter
Bard G2 filter
Bard G2 Express filter
Cook Gunther Tulip filter
Cook Celect filter
After reported complications with defectiveness of different IVC filter devices, the FDA issued a safety update in 2014 stating most devices should be removed between the 29th and 54th day of being implanted.
This alert came two years after the first lawsuits had already been filed.
C.R. Bard is a multinational manufacturer of medical devices for surgical specialties. A NBC News investigation has linked more than 300 injures and 27 deaths to the Bard Recovery filter.
C.R. Bard IVC Filters
A little less than a year after the Recovery filter was put on the market, the company started receiving complaints of device malfunction. In particular, the “legs” or prongs of the device were breaking loose and eventually puncturing tissue in another part of the body. In 2004, Bard hired consultant D. John Lehmann to review the device.
The findings resulted in the Lehmann report, which concluded the Recovery filter was more likely to cause injury or death through migration than other IVC filters on the market at the time. Bard also failed to disclose these adverse effects to the FDA. This report would have remained a secret, had it not been accidentally disclosed to the plaintiff’s lawyer during the trial Ebert v. C.R. Bard, Inc. in 2012.
Cook Medical is one of the world’s largest private medical device manufacturers, and is one of three divisions that form the 42-company conglomerate, Cook Group, Inc. Forbes magazine has listed the Cook Group as one of the largest private companies in the U.S.
Cook Medical IVC Filters
Several of the company’s devices are involved in MDL proceedings, including transvaginal mesh and the Celect and Gunther Tulip IVC filters. As far back as 2009, the Celect filters were found to puncture the walls of the vena cava (large veins carrying blood into the heart).
Status of the IVC Filter Lawsuits
There are class-action lawsuits against Bard in Florida, Pennsylvania and California that have yet to be approved by courts. Also, in October 2014, over 100 lawsuits against Cook from 11 districts around the country were consolidated into an MDL in the Southern District of Indiana.
How these suits may potentially resolve as a settlement to the victims came in early 2015. In February of that year, Bard chose to settle a case with Kevin Phillips, a mere 10 days after trial began. As part of the allegations against the manufacturer, Phillips claims that he was forced to have open heart surgery after one of the Recovery filter’s legs broke off, traveled through his bloodstream and punctured his heart.
Numerous lawsuits remain pending in courts both at the state and federal levels.
FDA News & Warnings
In 2010, the FDA issued its first Safety Alert for retrievable IVC filters after receiving over 900 reports of device fracture, perforation and migration. Broken pieces of IVC filters become a type of embolism, exposing patients to the very risk of sudden death that the filters were intended to prevent.
Soon thereafter, a study published in the Journal of Vascular Surgery found that retrieving the device reduced the risks of adverse events This lead to an FDA alert update in 2014 alert, recommending that physicians provide ongoing care and follow-up removal procedures once immediate danger from pulmonary embolism has passed.
Medical Device Litigation Attorneys
When manufacturers of medical devices push products on the market that are harmful to consumers, they should be held responsible. The attorneys at Pittman, Dutton and Hellums has the legal expertise and experience necessary to stand up to corporations when their products cause more harm than good.
If you or a loved one suffered injury due to C.R. Bard or Cook IVC filters, please call our attorneys to discuss your legal options. We offer free consultations and there is no obligation.
People with ulcers or gastroesophageal reflux disease may be recommended to use proton pump inhibitors (PPIs), which reduce acid production that is necessary to form ulcers. Common brands of PPIs you may have heard of include Nexium, Prevacid, Prilosec and Protonix. While PPIs may reduce acid, prevent ulcers and allow existing ulcers to heal, a 2016 study published in the Journal of American Medicine found using PPIs is associated with an up to 50 percent higher risk of chronic kidney disease. Many patients were unaware of the risks when they started taking PPIs.
A 2017 study published in Kidney International reinforces the findings, adding PPI use is also associated with increased risks of acute kidney injury and end-stage renal disease. The study found more than half of PPI users who develop chronic kidney damage show no signs of acute kidney injury beforehand. Because of the widespread use of proton pump inhibitors that are prescribed unnecessarily two-thirds of the time, including for ailments like heartburn or minor indigestion that do not require them, chronic kidney disease prevalence has risen more quickly than expected.
If you or a loved one has experienced health issues including chronic kidney disease and has used PPI inhibitors, you should be aware that you may be able to secure compensation for your pain and suffering by filing a lawsuit. Contact Pittman, Dutton, Hellums, Bradley & Mann for a free consultation. We work on a contingency basis, so there is absolutely no risk to you to learn more about your options.
Various lawsuits against PPI manufacturers have happened in the past decade due to issues such as improper promotion of how to use products. In 2016, the first lawsuit against a PPI manufacturer in relation to kidney disease was filed. The lawsuit against AstraZeneca Pharmaceutical, which makes Nexium, alleges that the drug is associated with chronic kidney disease and other renal complications.
In 2017, a lawsuit was filed against Takeda, the parent company of PPI Prevacid. The product liability lawsuit alleges Takeda failed to warn doctors and patients about the risk of kidney injury associated with Prevacid.
As of May 2017, there were more than 15 other lawsuits regarding PPI products pending in federal courts, and thousands of potential lawsuit investigations are currently taking place. In August 2017, a U.S. Judicial Panel on Multidistrict Litigation consolidated more than 275 lawsuits from across the country, and the case is currently in the discovery stage.
Because of the studies that have been done and increasing knowledge about the risks of PPIs, more strong lawsuits are expected to reach courts to help get kidney damage victims compensation they deserve due to negligence by drug manufacturers. A 2017 study also found a potential link between PPI usage and dementia, with regular PPI users having at least a 44 percent increased risk of dementia compared with people who don’t use the drugs.
First, if you have ever used a PPI, you should gather materials regarding when you were prescribed PPI medication and advice on how long you should take it for. Often, victims take PPI medication far longer than they should be on it, and sometimes this is due to poor marketing by the drug companies.
Discuss with your physician the risks of the PPI and if your physician has alternatives. Whether or not you decide to stop using PPI medication, you should get a kidney examination and regular follow-up checkups to stay safe. Chronic kidney disease has no cure and can lead to serious long-term problems and complications, including:
- Poor vitamin D and bone health
- Low blood cell count
- High blood pressure
- Bleeding from the stomach or intestines
- Arm and leg nerve damage
- Heart and blood vessel complications
- Liver damage
- End-stage kidney disease and kidney failure, which will require dialysis or a kidney transplant
Signs you may have chronic kidney disease include:
- Swelling in extremities
- Changes in urination
- Skin itching or rashes
- Nausea and vomiting
- Shortness of breath
If you are experiencing any of these symptoms, talk with a physician immediately. Ask about how your use of a PPI may have contributed to chronic kidney disease, and keep all medical records organized and up to date.
If you have already discovered kidney damage and have used PPI medication in the past, contact Pittman, Dutton, Hellums, Bradley & Mann. We have extensive experience working on cases against large corporations that seem too big to take on. Our law firm cares about our clients and helping them to lead happier lives through the obtainment of justice. We don’t get paid unless you win a settlement, so there is no risk to contact us to learn about a potential claim that can be filed. Give us a call at (205) 322-8880 for more information.
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