Retrievable IVC Filters Not Retrieved

Retrievable IVCIVC blood clot filter filters are supposed to be temporary, used for the short period of time in which a person – contraindicated for blood thinners – is in danger of developing life-threatening blood clots. After the clotting danger passes, the filters are supposed to be removed. But these temporary filters are seldom removed. The result is that patients – many of them trauma victims who don’t even know they have a filter – often suffer conditions every bit as life-threatening as the clotting danger IVC filters are marketed by their makers to prevent.

Retrievable, “temporary” filters typically remain in the patient’s vena cava far beyond the point where they should have been removed. Retrievable IVC filters are not retrieved at all, in most cases.

Failure to Remove IVC Filters a Problem

A study published in Medscape noted that less than 10% of retrievable IVC filters were removed, even though the blood clotting indication (for which the filter was placed) was no longer present. A Medscape piece published Dec. 13, 2011 noted:

“Less than 10% of retrievable inferior vena cava (IVC) filters are removed from patients at one large US trauma center, despite the fact that the indication for the filter placement is no longer present at discharge. The researchers also observed that one in five patients could not have the filter removed, making this a “common and under recognized problem.”

This under recognized problem of failing to remove a temporary filter can create problems every bit as dangerous as the problems filters are marketed to prevent. Retrievable IVC filters not retrieved in timely fashion can create life-threatening peril for the person implanted.

Patients unaware of IVC Filter Implant

Many people with an IVC filter unfortunately don’t even know they’re in potential peril. Many are never told and consequently don’t even know they’ve been implanted with an IVC filter. In the study cited in Medscape, roughly half of the filters were implanted after trauma, blunt trauma, motor-vehicle collisions, penetrating trauma, and falls. Trauma patients are often never told by a doctor or anyone else that they have been implanted with an IVC filter.

Unretrieved IVC Filters Unsafe for Long-Term

Leaving filters in too long can cause several problems. One clinical study published in 2012 found that as many as “20%-40% of filters cannot be removed by using standard methods because they have become firmly embedded along the vessel wall.” In that study, doctors Kuo, Robertson, Odegaard and Hofmann concluded that, “Our data indicates that the IVCF’s are unsafe for long-term.”

A 2014 study of IVC filter perforations using CT scans found that perforations grew worse over time. The longer IVC filters were left inside a person, the greater the chances that person in the study was likely to suffer perforation. Ohio State Interventional Radiologist & Biomedical Engineer Dr. Joshua D. Dowell and several other researchers found, “Celect Inferior Vena Cava Wall Strut Perforation Begets Additional Strut Perforations.” More and more of the 91 patients who underwent sequenced CT scans suffered strut perforations. (Struts are the ‘legs’ or ‘spokes’ of the filter). the study found:

36% showed strut Perforation at 1st CT
66% showed strut Perforation at 2nd CT
79% showed strut Perforation at 3rd CT

The results of this study strongly suggest that one should have an IVC filter removed as soon as possible. The study clearly shows that the longer an IVC filter is left inside a person, the greater the chances that filter will perforate the vein, which in turn can make the filter more difficult, if not nearly impossible, to then remove.

To be continued. . .

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Washington State sues Johnson & Johnson Mesh Maker

Washington statemesh image is suing Johnson & Johnson mesh maker Ethicon for defective pelvic mesh sold to Washington women.  The state of Washington vs. Johnson & Johnson, et al. petition, filed May 24, 2016, says J&J sold some 12,000 pelvic or transvaginal mesh devices to unsuspecting Washington women from 2005-2015.

The Washington petition alleges that J&J marketed its mesh products as “new and revolutionary,” claimed that they saved time in the operating room, offered superior outcomes to traditional POP or SUI stitch-surgery methods, and had the advantage of faster recovery times.

The complaint reads, “Defendants made these representations without disclosing to doctors the serious complications their mesh can cause women.”

The petition further states that J&J marketed its mesh products as “improvements over traditional repair methods (i.e. native tissue repair) when they knew such claims were inaccurate.”

Severe, Unavoidable Complications

The petition language is clear and forthright, alleging similar problems about which more than 100,000 women across the country have complained and filed suit:

“Defendants knew at all relevant times that the presence of polypropylene [plastic] in the body and the process of implanting mesh through the vagina could cause severe unavoidable complications. (Defendants) knew these complications are caused by the design and placement of the mesh and cannot be avoided by good surgical technique alone.”

Permanent Disability, Egregious Suffering

The petition alleges that some women become “permanently disabled” from mesh complications, from mesh that can erode and migrate into internal organs, becoming nearly impossible to remove:

“The suffering by these women is even more egregious considering that the underlying condition the mesh is meant to treat is not life threatening. Further, women have a non-mesh surgical alternative [with native tissue] that has been used for decades. Native tissue repair does not pose the same risks as mesh and can be just as effective for treating pelvic floor conditions.”

Mesh misrepresented, adds Risks

The main problem with plastic mesh for women’s pelvic floor repairs is tidily summed up in the complaint section which says J&J misrepresented the safety of its products by failing to disclose risks and complications associated with pelvic floor surgery: “Defendants failed to disclose that their mesh devices carry similar risks as other pelvic floor surgeries and additional risks caused by the mesh.”

All mesh makers have always had a fundamental problem with the very idea of selling a medical device designed to be implanted in an open-contaminated area such as the vagina, which cannot be sterilized, ever. Such a procedure violates the first rule of surgery, that one needs a clean, sterile field of operation.

Contaminated Surgical Procedure

The petition reads: “Although all of Defendants’ products were used in contaminated areas – the vagina, Defendants misrepresented that ‘if the mesh implant is to be used in contaminated areas, it must be only with the understanding that subsequent infection may require its removal.’”

The petition further states that Defendants misrepresented plastic mesh’s risk in other ways, including that mesh causes infection in a cavity that can never be completely sterilized; mesh is not inert as claimed by Defendants, on the contrary, it causes a foreign body reaction; the mesh hardens, contracts, erodes into other body organs, becomes so rigid and distorted that complete mesh removal is extremely difficult or impossible.

The petition details several complications that can result:

• chronic infection
• chronic foreign body reaction
• chronic inflammation
• mesh hardening
• mesh contracture, erosion into other body organs
• mesh exposure (migration of mesh into the vagina)
• mesh extrusion
• mesh degradation (breakdown of mesh particles)
• permanent dyspareunia (inability to have sex)
• chronic pain
• vaginal shortening, stiffness, distortion
• sexual dysfunction
• injury to sexual partners
• urinary and bowel dysfunction
• other lifelong problems

The petition reads: “Mesh removal is the only treatment option for most continuing mesh complications. Removal often requires multiple surgeries, which may or may not resolve complications, and may in fact result in new problems. (Yet) Defendants failed to disclose the lack of a safe and effective means for removal.”

Mesh not FDA Approved

The petition also alleges that J&J and its subsidiaries misrepresented in their informational and marketing materials that their Polypropylene Mesh Products were FDA Approved.  Mesh was never approved. It was only cleared by the FDA 510(k) equivalency process, which fails to verify safety or efficacy of the product in question and does not usually require clinical trials.

J&J and its subsidiaries also stand accused by the petition of failing to disclose adverse events reported by women who had been implanted with transvaginal or pelvic mesh

Washington State sues Johnson & Johnson Mesh Maker

Mr. Bob Ferguson first launched an investigation into J&J’s pelvic or transvaginal mesh implants when a Washington state woman wrote the DA a letter detailing the problems she had with mesh and complaining that she had not been warned of the risks.

Mr. Ferguson filed the petition, which was also signed by Washington State Senior Counsel Elizabeth J. Erwin, Asst. AG Andrea M. Alegrett,  Asst. AG Leilani N. Fisher.

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States sue J&J Transvaginal Mesh Maker

J&J hit with State Lawsuits over Pelvic Mesh

The states of Ethicon_Transvaginal_MeshCalifornia and Washington have filed lawsuits against Johnson & Johnson for false advertising and deceptive marketing of surgical mesh for women. The lawsuits say J&J failed to properly inform patients and doctors of the potential severity of mesh complications.

Washington Woman Blows Whistle

According to Mesh News Desk, the Washington state lawsuit has its roots in 2012 when a Washington woman wrote her attorney general to report that women were not warned about the dangers of mesh, that there was no informed consent, and thousands of women like her were duped into believing that what J&J called a  “minimally invasive” procedure could not end in a lifetime of pain. (Washington Mesh Complaint.)

J&J Concealed Mesh Risks

Attorneys general Kamala D. Harris of California and Bob Ferguson of Washington say Johnson & Johnson knowingly concealed the risks associated with their pelvic mesh products. The mesh in question is designed to treat common conditions in women such as stress urinary incontinence (SUI) and pelvic organ prolapse (POP). The plastic mesh material can cause serious complications including loss of sexual function, chronic pain, infection, permanent urinary or defecatory dysfunction, a devastating impact on quality of life.

The attorneys general launched the lawsuits against J&J and its subsidiary Ethicon Inc. in California and Washington state courts. California alleges violations of the state’s unfair competition and false advertising laws. Washington state charges “tens of thousands of violations” of the state’s consumer protection laws.

Deceptive Practice Charges

California and Washington are both seeking injunctive relief and monetary penalties potentially in the millions of dollars. Harris wrote that her action is meant, “to ensure that J&J stops its deceptive practices.”

Ms. Harris said, “Johnson & Johnson put millions of women at risk of severe health problems by failing to provide critical information to doctors and patients about its surgical mesh products. Johnson & Johnson’s deception denied women the ability to make informed decisions about their health and well-being.”

Mr. Ferguson said in a statement May 24, 2016 that complications can crop up years after surgery and are in many cases irreversible, while mesh removal mesh can be nearly impossible.

Horrific Injuries, Doctors duped

Mr. Ferguson said, “It’s difficult to put into words the horrific injuries and pain many women are still suffering as a result of Johnson & Johnson’s deception. They believed they were making informed medical decisions, but that was impossible when Johnson & Johnson was spreading inaccurate information about its products’ risks, essentially duping doctors into using their own patients as clinical trials.”

J&J Responds

A J&J spokeswoman told Law360 this week that J&J plans to “vigorously defend itself against the allegations.” J&J said in the statement that both states’ lawsuits were “unjustified.”

The J&J statement further said, “The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products. The use of implantable mesh is often the preferred option to treat certain female pelvic conditions, including pelvic organ prolapse and stress urinary incontinence, and is backed by years of clinical research.”

J&J Lawsuit Verdicts Upheld

The states’ lawsuits continue a long series of litigation against J&J over its pelvic mesh products.

In some of the latest developments, in March 2016 a New Jersey appeals court upheld a $11.1 million jury award for a woman who claimed Ethicon’s pelvic mesh caused debilitating nerve pain. The appeals court ruled that ample evidence presented at trial showed that better warnings of the product’s risks might have prevented her injuries.

In April 2016, a Philadelphia jury returned a $13.5 million verdict against J&J and Ethicon in another case brought by a woman who claimed J&J’s mesh implant was defective and that it reduced her to nearly constant pain, discomfort, and sexual dysfunction. J&J appealed that verdict, as it has appealed every pelvic mesh verdict  rendered against it.

States sue J&J Transvaginal Mesh Maker

Both Ms. Harris and Mr. Ferguson said May 24 that in addition to false advertising and deceptive marketing, J&J misrepresented the severity and frequency of common complications, and failed to disclose that its surgical meshes “presented risks not present in alternative treatment options.”

Ms. Harris said that J&J had sold more than 42,000 pelvic mesh devices in California from 2008- 2014. She said the company faces more than 35,000 personal injury lawsuits across the country..

Mr. Ferguson said J&J had sold 12,000 mesh products in Washington state during roughly that same time period. He said he would seek the maximum $2,000 penalty for each violation of Washington’s consumer protection laws.

Law360

Law360 reports the state of California is represented by Kamala D. Harris, Judith A. Fiorentini, Jinsook Ohta, Sanna Singer and Michelle Burkart of the state Attorney General’s Office.

Washington state is represented by Robert W. Ferguson, Elizabeth J. Erwin, Andrea M. Alegrett and Leilani N. Fisher of the state Attorney General’s Office.

The cases are California v. Johnson & Johnson et al., in the Superior Court of the State of California, County of San Diego, and Washington v. Johnson & Johnson et al., in the King County Superior Court in the State of Washington.

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Boston Scientific, Cook IVC Filter Lawsuits Filed

Boston Scientific IVC Filters fail to improve Anticoagulant Therapyand Cook Medical were tagged on May 6, 2016 with IVC filter lawsuits in Kentucky federal court. The suits accuse them of making faulty inferior vena cava filters. The petitions charge that the filters shifted or caused blockages in patients with deep vein thrombosis.

The suits say the companies negligently designed and made Boston Scientific Greenfield Vena Cava Filters and Cook Celect Vena Cava Filters. The IVC filter devices were implanted in women to treat or control pulmonary embolisms.

Boston Scientific IVC Filter Case

In her suit against Boston Scientific, Katherine Milan says that after being implanted with a Boston Scientific inferior vena cava filter, she not only suffered pain in her thigh and lower abdomen, but also extensive clotting. Her complaint says that a CAT scan showed her IVC filter had become occluded.

Ms. Milan’s suit says that she was admitted to a hospital in Paducah, Kentucky, with a diagnosis of deep vein thrombosis in her right leg in May 2005. After she had undergone a clot extraction, surgeons implanted a Boston Scientific Greenfield Vena Cava Filter in her inferior vena cava.

The very next month, Ms. Milan was taken to the emergency room with pain in her left thigh and lower abdomen. She was then admitted to a hospital with extensive clots in her right leg and acute deep vein thrombosis in her left leg. According to her lawsuit, a CAT scan showed occlusion of her IVC filter. Consequently, her suit says, she must take blood thinners the rest of her life.

Cook Medical IVC Filter Case

In her lawsuit against Cook Medical, Olenda Homes says that she had chronic back and lower extremity pain after being implanted with a Cook IVC filter. Ms. Homes says an angiogram showed a lot of clotting.

Ms. Homes’ complaint says she was admitted to a hospital February 2013, diagnosed with deep vein thrombosis in her right leg. After then being implanted with an IVC filter, she experienced progressively worsening lower back pain. Ms. Homes made an emergency room visit in July 2015 for chronic back and lower extremity pain. According to her lawsuit, an angiogram showed what appeared to be fresh thrombus in her pulmonary vasculature.

An angiogram showed her IVC filter had tilted, causing acute deep vein thrombosis in the left lower extremity. A doctor then placed another inferior vena cava filter above the Cook one, and Ms. Homes also received right and left vein catheter placements. She says in her suit that she will now need to take long-term anticoagulation medication.

Negligent, Reckless, Wanton Charges

The lawsuits both say that, “Defendants negligently, recklessly, wantonly, and carelessly failed to properly design and manufacture the [IVC filters]”.

IVC Filter Warning from FDA

The FDA (which cleared but never approved IVC Filters) advised health care professionals in 2010 to be vigilant of the risks associated with the long-term use of IVC filters. At that time, according to Law 360, the agency had received more than 900 adverse event reports involving the devices since 2005.

Product Liability

Both of the women’s lawsuits exonerate the doctors who inserted the IVC filters, arguing that they properly followed the defendants’ instructions, guidelines and directives.

Each of the lawsuits makes product liability, warranty, strict liability, negligence, gross negligence claims against the device manufacturer, and then seeks unspecified damages and further relief.

Boston Scientific, Cook IVC Filter Lawsuits Filed

The cases are Katherine Milan et al. v. Boston Scientific Corp., case number 5:16-cv-00065, and Olenda Homes et al. v. Cook Medical Inc. et al., case number 5:16-cv-00066. Both were filed in U.S. District Court for the Western District of Kentucky.

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Morcellator Lawsuit Settlements

Johnson & Johnson Hysterectomy Sarcoma Attorneyis moving to settle lawsuits filed by women who say J&J’s power morcellators spread undetected uterine cancer, according to The Wall Street Journal. J&J and its Ethicon division pulled the devices in 2014 following reports which said power morcellators spread uterine cancer when used for hysterectomy or fibroid removal.

100 Morcellator Cases

An estimated 100 cases have either been filed or prepared for lawsuits against J&J and Ethicon, which enjoyed the lion’s share of laparoscopic power morcellator sales. Power morcellator cases have been consolidated in Kansas City, Kan., federal court, before Judge Kathryn H. Vratil. Of the roughly 100 claims, J&J has settled nearly 70 over the past few months, according to the Wall Street Journal.

WSJ estimated that settlements so far have ranged from $100,000 to roughly $1 million, according to a WSJ source who claimed knowledge of resolved cases.

Morcellator Lawyer

David Matthews, a plaintiff’s lawyer handling power morcellator cases, said the range of settlement amounts reported by WSJ seems low considering the seriousness of the injuries.

“If the amounts reported are right, many of the cases that have settled must have had significant issues. You would tend to think that women who have died or are dying from morcellator injuries would not settle for the small amounts we have seen reported. But it’s always awfully hard to make any generalizations regarding settlement amounts. We don’t know what problems or issues such and such a case may have had to settle for whatever amount is reported. They call these mass torts, but there is never anything ‘en mass’ about them. Every case is always unique.”

Failure to Warn

Women suing J&J underwent hysterectomies or uterine fibroid removal in which surgeons used power morcellators. The women say J&J and Ethicon failed to warn them about the risk that the devices could antagonize and spread undiagnosed uterine cancer, making it more difficult to treat. Several plaintiffs have died before or after the lawsuits were filed; hence, morcellator attorneys are trying to accelerate the litigation to allow clients their chance to air their case in court.

Power Morcellators

Power morcellators are electric-powered devices with blades that allow surgeons to slice up large pieces of tissue like the uterus or fibroids in order to remove them through small incisions in the abdomen. This “minimally invasive” surgery is supposed to allow for quicker healing time, less blood loss, fewer complications.

Morcellators pulled by J&J

Laparoscopic power morcellators made by Ethicon and several other companies became controversial in 2014 after the FDA released a warning which said 1/350 women had undiagnosed uterine cancer that could be spread by morcellation. One type of cancer, leiomyosarcoma, is especially deadly when morcellated.

After the 2014 FDA warning, J&J, which had the largest percentage of the market, pulled its morcellator devices.

Morcellator Lawsuits

Morcellator lawsuits against J&J and Ethicon claim the devices are defective and that the company knew about the chance of spreading cancer yet failed to warn the public. J&J previously told the Wall Street Journal that its morcellators “have always included cautions in their instructions for use about the potential spread of malignant (or suspected malignant) tissue.”

Morcellator Lawsuit Settlements

Regardless of J&J’s pronouncement that it has always warned of morcellators’ spreading potentially malignant cancer, according to Mr. Matthews, J&J is already in talks to settle more of its morcellator lawsuits, including those it faces in state courts throughout the country.

Free Legal Consultation

If you or a loved one has been diagnosed with uterine cancer or  leiomyosarcoma after undergoing hysterectomy or fibroid removal with a laparoscopic power morcellator, contact  an experienced Morcellator Lawyer for a free legal consultation regarding a potential Morcellator Lawsuit.

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IVC Filters not FDA approved

IVC Filters are notIVC Filter FDA approved. They were only cleared for use through the FDA’s 510(k) process. Were IVC blood clot filters formally approved by FDA through the agency’s regular device approval process, the people injured by them would have little to no legal recourse to pursue claims against IVC filter makers C.R. Bard, Cook Medical, Boston Scientific and others.

The 510(k) Approval Process

The popularity of 510(k) clearance among device makers stems from its relative lack of rigor – devices reach the market much more quickly and less expensively under this process than under other FDA avenues of review.

The traditional premarket approval process for a medical device typically involves some 1,200 review hours, as opposed to the 510(k) process, which is completed in an average of 20 hours.

The 510(k) process was not designed to evaluate the safety and effectiveness of a device. A finding of ‘substantial equivalence’ signifies only that the device is similar in certain respects to a previous predicate device. No determination about risks to safety or effectiveness comes as a result of clearance through the 510(k) process.

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IVC Filter Controversy

IVC filters stir ivc_filtercontroversy despite being implanted in millions of people in the last 30 years or so. Increasingly, learned professionals in the medical community question the safety and efficacy of IVC blood clot filters. As IVC filter lawsuits are being continuously filed across the country, more and more people seem to be paying attention to the IVC Filter Controversy.

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DePuy Hip Verdict $498 Million

Johnson & Johnson DePuy was hit with a DePuy Hip Verdict of $498 Million Thursday, March 16, 2016, in Dallas, Texas, in the second bellwether trial in the multidistrict litigation over Pinnacle hip prosthesis  made by DePuy Orthopaedics Inc. Plaintiffs had presented the consolidated claims of five patients who testified that the Pinnacle hip replacement devices were defective and gave them problems.

Law 360 announced that after a two-month trial and several days of deliberations, a Dallas jury found in favor of all five plaintiffs, delivering a verdict that included $360 million in punitive damages.

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Cook IVC Filter Consolidated Complaint Filed

Matthews & Associates hasLogo Box 2012 downsized filed a Cook IVC Filter Consolidated complaint. The firm filed a “Master Consolidated Complaint for Individual Claims”  in the Cook Medical federal multi-district litigation (MDL) court in Indianapolis, Indiana. The Master Complaint serves the administrative functions of efficiency and economy and presents certain common claims and questions of fact and law in the MDL Court.

The master complaint consolidates charges that are shared by all of the cases filed against Cook Medical. The master saves money and time for the courts, plaintiffs, their attorneys and the defense. Though each case presented to a jury will eventually be decided by its own individual facts and merits, any cases filed with the consolidated complaint also shares basic charges brought forth by plaintiffs.

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