Bard G2 IVC Filter Also Unsafe – NBC News Follow-up Report

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If you or a loved one has been injured by a defective blood clot filter, call the IVC filter lawyers at Thornton Law Firm at 1-888-341-1405 for a free, no obligation consultation, or tell us your story using our online contact form.

By: Marilyn McGoldrick, Esq.

In a follow-up to its September report on 27 deaths associated with the C.R. Bard “Recovery” IVC blood clot filter, NBC News reports that Bard knew that its G2 Series IVC filters — intended to replace the company’s Recovery filter — also “had similar and potentially fatal flaws soon after it was put on the market.” NBC obtained internal Bard records showing that Bard was concerned about reported failures of the G2 Series filters just four months after they were approved by the FDA.

But instead of recalling the G2 Series IVC filters, Bard kept them on the market and continued to sell them for implantation in patients with blood clotting disorders for 5 more years, until 2010. More than 160,000 of them were implanted in patients. According to Bard and FDA records, at least 12 patient deaths are linked to the G2 Series IVC filters. There have been hundreds of reports of other device problems.

Like the Recovery IVC filter, the G2 Series IVC filter is a spider-like device with long dangling metal legs meant to catch blood clots and prevent them from entering the heart and lungs, where they can cause death. IVC stands for Inferior Vena Cava, the large vein that carries blood from the lower part of the body to the heart. Unlike other IVC filters, the G2 Series — according to internal C.R. Bard documents — had problems with migration, tilting, and perforation. Bard documents reviewed by NBC showed “the G2 series filters had more fractures, migrations and reported problems than any of its competitors.”

NBC News interviews a interventional radiologist at Stanford, Dr. William Kuo, who specializes in removing failed IVC filters and pieces. Asked whether the G2 is safe for patients, he responds:

“All of the data that we’ve seen in our own studies, as well as other clinician researchers’, is that this device consistently fractures, consistently causes major complications…The number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.”

He believes the G2 should have been recalled. Senator Charles Grassley, the chairman of the Senate Judiciary Committee, has asked the FDA to explain what actions the agency takes when new information emerges about a device that is already approved. At this time, he says the FDA’s response is incomplete. The agency did recommend in 2010 and 2014 safety alerts that doctors consider removing the devices when protection from blood clots is no longer needed. But the FDA has never recalled them despite all the reports of injuries and deaths.

The injuries from a defective IVC filter can be life threatening. Patients have reported filter fracture, filter migration, punctures of the vena cava, heart or lung perforation, hemorrhage, or cardiac tamponade.

If you believe you or a loved one has suffered injury from a defective IVC filter, call the IVC filter lawyers at Thornton Law Firm at 1-888-341-1405 for a free, confidential consultation, or tell us your story using our online contact form. The time limits for filing IVC filter claims are very short. You should seek legal advice as soon as possible.

$12.5 Million Transvaginal Mesh Verdict Against J&J


Call 1-888-341-1405 for a free consultation with a recognized leader in 
personal injury and medical device litigation. You can also contact us online to discuss the details of your case.

By Marilyn McGoldrick, Esq.

An Indiana woman was awarded $12.5 million dollars against Johnson & Johnson’s Ethicon unit in damages for the injuries she suffered from their ProLift transvaginal mesh implant. The Court of Common Pleas jury awarded $5.5 million dollars in compensatory damages and added $7 million dollars in punitive damages to punish Johnson & Johnson for recklessly marketing the device.

Plaintiff Patricia Hammons, age 65, underwent surgery in 2009 for bladder prolapse, and received a ProLift pelvic organ prolapse repair kit to support the area. Shortly after the surgery, she experienced pain, including painful sexual intercourse, and had several corrective surgeries attempting to remove the mesh which had bunched up inside her pelvis.

Plaintiff’s experts testified that completely removing the mesh was exceedingly difficult, if not impossible, describing it as a “surgical train wreck”.  In testimony that may have influenced the jury’s award of punitive damages, J&J’s own product engineer Scott Ciarrocca testified that no one at the company had given any thought as to what to do if the product failed.

Nationwide, there have been 16 verdicts against Johnson & Johnson for defective pelvic mesh implants, totaling $247 million dollars. It is estimated that there are over 100,000 cases pending nationwide against Johnson & Johnson and the other makers of transvaginal mesh products.

Thornton Law Firm’s pelvic mesh team represents women in claims against Johnson & Johnson’s Ethicon unit, as well as  against Boston Scientific, Caldera, Coloplast, Cook Medical, C.R. Bard, Inc., Mentor Worldwide, and Sofradim/Covidien. If you have a transvaginal mesh implant and have experienced any side effects, including infection, pain, bleeding, mesh erosion, mesh contraction, urinary problems, severe pelvic pain, vaginal tightening or shortening, painful sexual intercourse, inability to engage in sexual intercourse, additional surgeries, or organ perforation, and would like a no-obligation, completely confidential evaluation of your legal claim, please call us at our toll free number 1-888-341-1405, or tell us your story using our online contact form. The legal time limits for filing claims are very short, so do not delay seeking legal advice.

$11 Million Verdict in First Wright Conserve Hip Implant Trial

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If you have suffered injury caused by a defective metal-on-metal hip implant, call 888-341-1405 for a 
no-obligation evaluation of your legal rights, or tell us your story using our online contact form.

By: Marilyn McGoldrick, Esq.

A federal jury in Georgia awarded $11 million to plaintiff Robyn Christiansen in the first Wright Conserve metal-on-metal hip implant bellwether trial. After a two-week trial and three days of deliberations, the jury ruled that the Conserve hip implant was defectively designed and unreasonably dangerous, and that manufacturer Wright Medical had mislead the plaintiff as to the product’s safety. The jury found Wright Medical 100% at fault and awarded Christiansen $1 million in compensatory damages and $10 million in punitive damages.

Ms. Christiansen was implanted with a Conserve metal-on-metal hip in April 2006. The hip implant failed in 2012 and she was forced to undergo painful removal and replacement surgery. Evidence presented at the trial showed her surgeon found metallosis, fluid buildup and tissue necrosis.

In June, a plaintiff in California state court was awarded $4.5 million for damages caused by a different Wright Medical metal-on-metal hip implant, the Profemur R. The majority of cases brought to date involve Wright’s Conserve line of metal hip implants.

Wright Medical placed its Conserve, Dynasty, and Profemur hip components on the market by utilizing the FDA’s 501(k) clearance process. Under 501(k) Wright represented to the FDA that the devices were “substantially equivalent” to products already on the market. By using this approval process Wright avoided the time and expense of conducting clinical trials on their new metal on metal hips. The consequences have been severe for patients who received Conserve, Dynasty, and Profemur implants.

Symptoms of a defective metal hip implant include pain or swelling at or near the hip, a change in walking ability, thigh pain radiating to the knee, pain in the groin when going from a sitting to a standing position, or a noise from the hip joint. The FDA lists a variety of symptoms that should be followed up. If you experience any symptom you believe is related to your hip implant, you should see your doctor immediately. You should ask if your doctor if you should have a blood test for the presence of metal ions and fragments in the tissue surrounding the hip joint.

If you received a Wright Conserve, Dynasty, or Profemur metal-on-metal hip implant (or a metal-on-metal hip implant manufactured by any other company including DePuy Orthopaedics, Stryker Orthopaedics, Zimmer Holdings, or Biomet) you may be eligible to file a claim for money damages for the pain, suffering, physical injuries, lost income, medical expenses from replacement, and any other losses you suffered as a result of your injuries.  Contact the Boston law firm of Thornton Law Firm LLP online or at 1-888-341-1405 for a free consultation with a recognized leader in Massachusetts drug and medical device litigation. The consultation is free and completely confidential. We offer a fair and accurate assessment of your case. Like all legal cases, hip implant claims have short, strictly enforced time limits. Do not delay seeking legal advice.

Boston Scientific Recalls Cardiology Guidewire After Patient Death

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If you have suffered injury caused by a defective drug or medical device, call 888-341-1405 for a no-obligation evaluation of your legal rights, or tell us your story using our online contact form.

By: Marilyn McGoldrick, Esq.

Boston Scientific has recalled the RotaWire Elite Guidewire and wireClip Torquer Guidewire components of its Rotablator Rotational Atherectomy System. The company received three reports of wires fracturing, one during preparation of the device, and two during actual surgeries. The fractures during surgery resulted in migration of the wire, puncturing the pericardium surrounding the heart. One patient died during surgery to remove the broken wire.

The Rotabator Rotational Atherectomy System is used to surgically remove atherosclerosis from arteries. The device uses a tiny burr rotating at high speed to remove plaque and improve blood flow to the heart. The tip of the device rotates at 190,000 rotations per minute during the procedure.

The recall covers 955 devices distributed in the following states: Arizona (AZ), California (CA), Delaware (DE), Florida (FL), Georgia (GA), Illinois (IL), Louisiana (LA), Maryland (MD), Mississippi (MI), Minnesota (MN), Nebraska (NE), New York (NY), Pennsylvania (PY), South Carolina (SC), Texas (TX), Washington (WA), and Wisconsin (WI). The recalled devices were manufactured from June 26, 2015 to Sept. 10, 2015 and distributed from July 9, 2015 to Oct. 1, 2015.

Boston Scientific sent hospitals an Urgent Medical Device Recall letter in October of 2015 asking them to stop using the device immediately. The FDA announced the Class 1 recall of the device in November.

If you believe you suffered injuries as a result of a faulty Boston Scientific guidewire, contact the Boston law firm of Thornton Law Firm LLP online or at 1-888-341-1405 for a free consultation with a recognized leader in Massachusetts drug and medical device litigation. You have nothing to risk. We offer a fair and accurate assessment of your case.

Duodenoscopes and Superbug Infections Scrutinized by FDA

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Patients who have acquired a superbug CRE infection after undergoing an ERCP endoscopy can call 1-888-341-1405 for a no-obligation evaluation of your legal rights, or tell us your story using our online contact form.

By: Marilyn McGoldrick, Esq.

Antibiotic-resistant superbug infections caused by duodenoscopes have become more and more common. In an effort to prevent future infections, the FDA has ordered the three manufacturers of duodenoscopes to perform postmarket surveillance on how the devices are being cleaned and sterilized (reprocessed) in clinical settings.

Duodenoscopes are a specialized endoscope used for one medical procedure: the ERCP, which stands for endoscopic retrograde cholangiopancreatography. The ERCP is the least invasive way to examine and treat pancreas and bile ducts blocked by cancerous tumors, gallstones, or other conditions. Like all endoscopes, the duodenoscope consists of a tube fitted at the end with a tiny camera and a light that allows the gastroenterologist to see the area being treated. They also contain a tiny moving part known as an elevator which allows a tube or a stent to be inserted into the ducts. The devices are reusable and the elevator part is extremely difficult to clean properly between uses.

The FDA has ordered the three manufacturers of duodenoscopes — Olympus America, Fujifilm Medical Systems, USA, and Hoya Corp. (Pentax Life Care Division) — to submit plans for the surveillance studies within 30 days. The manufacturers must study how the devices are actually being used and whether hospital personnel are following the manufacturer’s recommendations for reprocessing.

The order follows several deadly outbreaks of CRE — carbapenem-resistant Enterobacteriaceae — in hospitals across the country, and the world, over the past two years. In February the FDA noted 135 possible infections from duodenoscopes had been reported from January of 2013 to December of 2014. The most recent reported outbreaks were at UCLA’s Ronald Reagan Medical Center and Cedars-Sinai Medical Center in Los Angeles.

For now, the FDA has decided to allow the devices to stay on the market, finding that the benefits of diagnosis and treatment via ERCP outweigh the risk of infection. Patients are advised to discuss risks and benefits of the procedure with their doctors, and after undergoing ERCP be aware of these potentially dangerous complications:

Call your doctor if, following your procedure, you have a fever or chills, or other symptoms that may be a sign of a more serious problem (such as chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting, or black or tarry stools)

If you or someone you love has been injured by a superbug infection after an endoscopy procedure, call the duodenoscope lawyers at Thornton Law Firm at 1-888-341-1405 for a free, no-obligation consultation, or tell us your story here. Like all legal claims, superbug infection claims have short, strictly enforced time limits, so seek legal advice at your earliest opportunity.

NBC News Investigates 27 Deaths Associated With Bard Blood Clot Filter

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By: Marilyn McGoldrick, Esq.

Published on September 9, 2015

NBC News has released the results of a year-long investigation into medical device manufacturer C.R. Bard and their “Recovery” blood clot filter.  Part 1 of their report details the defects in the product; perhaps more shocking, Part 2 of their report asserts that C.R. Bard may have submitted the forged signature of a prominent regulatory scientist in order to get the defective product approved.

The NBC News investigation found at least 27 deaths associated with the Bard “Recovery” retrievable IVC filter, and at least 300 non-fatal problems were also reported. A confidential scientific study, obtained by NBC, showed that the “Recovery” blood clot filter had higher rates of  relative risk for death, filter fracture, and movement than any competing device. NBC outlines cases in which pieces of the Recovery device broke off and migrated in the patient’s body. One patient experienced the entire device being pushed into the heart by a blood clot, puncturing her heart. Bard sold about 34,000 Recovery IVC filters until 2005 when it was replaced by the very similar G2 filter, which remains on the market today.

In 2002 C.R. Bard obtained FDA approval to sell the “Recovery” retrievable IVC filter. Permanent IVC filters have been used for decades to prevent blood clots. The filters, cone-shaped, porous little cages, are surgically placed in the inferior vena cava — the largest vein in the body — to catch and stop blood clots before they can reach the heart and lungs.

Retrievable filters are used in patients who cannot use blood thinners for a temporary medical reason. The “Recovery” device is far different in design than other IVC filters. It looks like a long-legged spider with 12 thin separate metal legs dangling from the top piece. The FDA rejected Bard’s first application to sell the device. Bard then hired regulatory specialist Kim Fuller to help them get FDA clearance.

Fuller told NBC News that she had serious safety concerns about the device, and complained to Bard that it was withholding important safety studies from her. She was told, in essence, that is she continued to question safety, she could leave the team. Fuller reported her concerns to the FDA and resigned from Bard.

NBC showed Fuller the Bard FDA application which contained her signature. She stated that she did not sign the application, and that it was not her signature. The FDA and C.R. Bard declined to be interviewed for the NBC News story, but Bard issued a statement calling any suggestion that Bard submitted forged documents to the FDA “flatly untrue”.

If you or someone you love has been injured by a defective blood clot filter, call the IVC filter lawyers at Thornton Law Firm at 1-888-341-1405 for a free, no obligation consultation, or tell us your story using our online contact form. Like all legal claims, IVC filter claims have short, strictly enforced time limits, so do not delay seeking legal advice.

FDA Warns Invokana May Lead To Ketoacidosis

By: Marilyn McGoldrick, Esq.

The Food and Drug Administration recently issued a Drug Safety Communication warning doctors and patients that taking the new class of diabetes drugs known as SGLT2 inhibitors — including Invokana — may lead to high levels of blood acids called ketones, a serious medical condition called ketoacidosis. Diabetic ketoacidosis can cause a host of medical problems, and in the most severe cases can lead to a diabetic coma and death.  Contact the Boston law firm of Thornton Law Firm LLP online or call us toll-free 888-491-9726 for a free Invokana consultation with a recognized leader in drug and medical device litigation.

Invokana and other sodium-glucose-cotransporter-2 drugs (SGLT2 inhibitors) work by causing excessive blood sugar to leave the body through the urine, lowering the body’s blood glucose levels. SGLT2s are prescribed to Type 2 diabetes patients and are popular because they also can lower blood pressure and make it easier for the patient to lose weight. SGLT2 inhibitors on the market include:

Brand Name Active Ingredients Manufacturer
Invokana Canagliflozin Johnson & Johnson
Invokamet Canagliflozin & Metformin Johnson & Johnson
Farxiga Dapagliflozin AstraZenica
XigduoXR Dapagliflozin & Metformin extended release AstraZenica
Jardiance Empagliflozin Lilly & Boehringer-Ingelheim
Glyxambi Empagliflozin & Linagliptin Lilly & Boehringer-Ingelheim

Johnson & Johnson’s Invokana, marketed in the U.S. by Janssen Pharmaceuticals, was the first SGLT2 approved by the FDA; it went on the market in March of 2013. In the first year that SGLT2 drugs were prescribed to diabetes patients, the Institute for Safe Medication Practices identified hundreds of complaints about users suffering serious side effects, including renal (kidney) failure or impairment; kidney stones, fluid/electrolyte issues, primarily dehydration; urinary tract infections, weight loss, hypotension (low blood pressure); and hypersensitivity.

In May 2015 the FDA warned that patients should be alert to the symptoms of ketoacidosis, and seek medical attention immediately if they experience “difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness” while taking SGLT2 diabetes drugs such as Invokana. The FDA has received over 20 complaints of ketoacidosis from patients taking SGLT2s:

“A search of the FDA Adverse Event Reporting System (FAERS) database identified 20 cases of acidosis reported as diabetic ketoacidosis (DKA), ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors from March 2013 to June 6, 2014 (see Data Summary). All patients required emergency room visits or hospitalization to treat the ketoacidosis. Since June 2014, we have continued to receive additional FAERS reports for DKA and ketoacidosis in patients treated with SGLT2 inhibitors.”

If you have taken Invokana or one of the other SGLT2 diabetes drugs and have experienced side effects, you should contact your physician immediately for diagnosis and treatment. If you have been diagnosed with ketoacidosis or any other serious side effects after taking Invokana or the other SGLT2 diabetes drugs, you may have a legal claim. Call the Invokana lawyers at Thornton Law Firm at our toll free number 888-491-9726 or contact us online for a free, no-obligation review of your case. Like all legal claims, there are strict time limits for taking legal action, so do not delay seeking legal advice.

$9.2 Million Hip Implant Verdict Against Zimmer

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By: Marilyn McGoldrick, Esq.

 

UPDATE: The trial judge later granted a remittitur to Zimmer, ruling that the jury verdict was excessive. The plaintiff declined the trial judge’s remittitur award of $828,153 and elected to appeal. In 2018 a California appeals court panel, while upholding the jury’s liability verdict against Zimmer, granted a new trial on appeal, ruling that the jury’s damages award excessive.

Published on July 28, 2015

A California state court jury has awarded $9.2 million dollars to a man who received Zimmer’s Durom Cup metal-on-metal hip implant in 2007 and was forced to have it surgically removed 15 months later. Gary Kline, age 59, presented evidence that his doctors performed two traumatic surgeries in 15 months in an attempt to repair the scar tissue and nerve damage caused by the Durom Cup implant, but ultimately it had to be removed. Thornton Law Firm is accepting Zimmer hip implant cases nationwide. If you had a defective metal-on-metal hip implant call the Thornton Law Firm hip implant team at 888-341-1405 or tell us your story using our online contact form.

Zimmer’s Durom Cup, also known as Durom Acetabular Component, was marketed to younger hip implant recipients with claims that the metal cup would last longer than older ceramic hip implants. The Durom Cup is a monoblock cup made from a single piece of cobalt chromium alloy metal. Once implanted, it was supposed to become fixed to the hip joint by the bone growing onto the back of the cup. When bone growth does not occur, the cup rubs against the bone, causing both excruciating pain and the very scar tissue and nerve damage that Mr. Kline endured. Unfortunately, like other metal-on-metal implants, the Durom Cup can generate high levels of metal in the body, leading to metallosis, tissue damage, and damage to the bone.

Zimmer’s Durom Cup was approved by the FDA for use in total hip implants in 2006. But problems surfaced soon thereafter, and Zimmer actually withdrew the hip implant from the market in 2008. The July 2008 recall was brief as Zimmer said it was recalling the devices “because the instructions for use/surgical technique instructions were inadequate.” The FDA also initiated a Class 2 recall of 19,014 products in September of that year; that recall was terminated in October of 2009. Zimmer resumed selling the Durom Cup hip implant after updating the product label and instituting a training program for surgeons.

Zimmer Durom Cups and all other metal-on-metal hip implants can cause a host of complications including allergic reactions, pain, scarring, metallosis, infections, revision surgery, or even death. If you or a loved one suffered any complications after receiving a metal hip implant, call the medical device team at Thornton Law Firm which specializes in helping patients nationwide who have been injured by defective medical devices. For a free, confidential evaluation of your legal rights, contact us at 888-341-1405 or tell us your story here. All legal claims have short, strictly enforced time limits for filing a claim; do not delay seeking legal advice.

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