First Cook IVC Filter State Trial

(April 18, 2018)  Cook IVC Filter AttorneyThe first Cook IVC filter lawsuit to be tried in state court in the U.S. will begin on May 7, 2017 in Houston, Texas.  The plaintiff is a Texas firefighter who has brought suit against Cook Medical Inc., based in Bloomington, Indiana.  He is represented by David Matthews of Matthews & Associates Law Firm, in Houston, as well as Tim Goss of Freese and Goss in Dallas, Texas.

The lawsuit petition states that the plaintiff was surgically implanted with a Cook Celect inferior vena cava filter at Methodist Hospital. On or about April 23, 2015, surgeons attempted to remove the Celect IVC filter but were “unsuccessful because the filter had tilted and become imbedded in the wall of Plaintiff’s inferior vena cava.”

The vena cava is the blood vessel located beneath the heart which returns blood to the heart from the lower body.

Relevant facts regarding IVC filter removal as stated in the petition show the difficulty of removing the filter from the plaintiff.

Attempts to remove Plaintiff’s Celect IVC Filter
Approximately two months after the Celect filter was implanted, an interventional radiologist  attempted to remove it.  He was unable to remove the filter because it had tilted and the tip was embedded into the wall of Plaintiff’s vena cava.  After multiple unsuccessful attempts to retrieve the filter via access through Plaintiff’s jugular vein, he aborted the procedure.

In June 2015, another jugular removal procedure was attempted by an interventional radiologist. In connection with this attempted removal, imaging revealed that at least two of the filter legs had perforated through the wall of Plaintiff’s vena cava. This retrieval attempt was also unsuccessful.

Finally, on July 20, 2017, Plaintiff had a life-threatening, invasive open surgery to remove the perforated Cook IVC filter. During the open removal surgery, it was determined that Plaintiff had at least three IVC filter legs poking outside of his vena cava: one in his duodenum (bowel); one beginning to perforate his aorta; and one inside his lumbar vein, which had to be resected for the filter leg to be removed. The degree to which Plaintiff will recover from surgery, and the lingering effects of the perforated filter struts, has yet to be determined.

The petition further alleges that the plaintiff is now at risk for future migrations, perforations, and/or fractures from the retained filter.  He also faces numerous other health risks, including increased risk of clots and risk of death.  He will “require ongoing medical care and monitoring for the rest of his life and may ultimately require additional surgery in an attempt to remove the filter.”

The lawsuit petition alleges that the implanting doctor knew or should have known, inter alia, several things, including that:

  • only certain patients were appropriate candidates for an IVC filter.
  • the longer a Celect IVC filter remains in the body, the higher the risk of device fracture or failure.
  • the Celect filter is not effective to prevent clots and/or increases the risks of clots.
  • safer alternatives to the Celect IVC filter existed.
  • IVC filters, such as the Celect filter, should not be used in certain patients, such as the plaintiff.

Cook Celect IVC Filter Problems
The petition alleges that Cook Celect filters frequently tilt, migrate, perforate or fracture and thus, involve a high and increasing degree of risk to a patient who has been implanted with a Celect filter.

The petition further claims that Cook knew or should have known that the Celect device was defective and unreasonably dangerous for several reasons, inter alia, including:

•   Cook failed to conduct any clinical testing, such as animal studies, to see how the device would function once permanently implanted in the human body;

•  The Celect filter had a high rate of fracture, migration, and excessive tilting and perforation of the vena cava wall once implanted. Such failures exposed patients to serious injuries, including: death, hemorrhage; cardiac/pericardial tamponade; cardiac arrhythmia and other symptoms similar to myocardial infarction; severe and persistent pain; perforations of tissue, vessels, and organs; inability to remove the device;

•  Cook knew or should have known that certain conditions or post-implant procedures such as morbid obesity or open abdominal procedures could affect the safety and integrity of the device;

•  Cook knew or should have known these risks for the Celect filter were and are substantially higher than other similar devices;

•  Cook knew or should have known the Celect filter contained conditions which resulted in the device not performing as safely as the ordinary customer would expect;

•  Despite being aware of these risks, Cook misrepresented, omitted, and/or failed to provide adequate warnings of these risks or instructions for safe use;

•  Cook failed to issue a recall of the Celect filter or otherwise notify consumers that a safer device was available.

IVC Filters
IVC filters first hit the medical market in the late 1960s. Several different medical device makers, including C.R. Bard, have introduced several different designs.

IVC filters are allegedly designed to filter or “catch” blood clots (called “Thrombi”) that travel from the lower portions of the body to the heart and lungs. The filters are designed to be implanted either permanently or temporarily within the vena cava.

The inferior vena cava is a vein that returns blood to the heart from the lower portions of the body. In certain people, for various reasons, thrombi travel from the vessels in the legs and pelvis, through the vena cava and into the lungs. These thrombi often develop in the deep leg veins. They are called “deep vein thrombosis” or “DVT.” Once they reach the lungs they are called “pulmonary emboli.” Pulmonary emboli present grave risks to human health, including the risk of death.

Someone who undergoes knee or hip joint replacement is at risk for developing DVT/PE. Obese patients are also at risk. So too are those who have vascular diseases, or those who have experienced previous strokes. Several other conditions also predispose some people to DVT/PE.

At-risk people may be prescribed medications like Heparin, Warfarin, or Lovenox to regulate the blood clotting factors. Some at high risk who cannot manage with medications may receive an IVC filter in an effort to prevent thromboembolic events.

Wide Use with no Evidence of Efficacy
IVC filters have been implanted by the hundreds of thousands despite there being no reliable evidence which proves their safety and effectiveness. No evidence proves that IVC filters are worth their risks.

Evidence of harm without evidence of benefit
A 2013 paper published in the Journal of the American Medical Association by Vinay Prasad, MD and others offers a stern critique of IVC filters. The authors declare, “While the benefits of the IVC filter are hard to assess, the complications are evident.”  They conclude their paper with a warning: “Follow current standard of care and place filters where guidelines advise, or do not place filters, after informed consent informs patients that there is evidence of harm without evidence of benefit.”

First Cook IVC Filter State Trial
The Houston trial is expected to last three weeks.

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IVC Filter Controversy Rages

IVC filter lawsuits Cook Blood Clot Filter Lawsuitsare being filed because the preponderance of evidence fails to show that IVC filters are worth their risks.  We are consequently filing IVC filter lawsuits across the country.  Matthews & Associates Law Firm will try the first Cook IVC lawsuit in state court in the country in a trial beginning May 15, 2018 in Houston, Texas.

IVC filter makers such as Cook Medical and C.R. Bard sell fear, first, in order to promote their products.  They always point to the dangers of pulmonary embolism, and claim IVC filters are the only answer to PE when someone is contraindicated for blood-thinning medication.

Pulmonary embolism is undoubtedly a problem, for a reported 422 of 100,000 people in the United States. Left untreated, PE will occur in as many as 40% of all people who develop proximal deep vein thrombosis (DVT).

But identifying a problem doesn’t mean you’ve solved it, or even offered the best solution. Significant controversy surrounds the “appropriate indications” for IVC filter placement. Scientific literature regarding the safety and efficacy of IVC filters is woefully lacking.

Related: IVC Filters risk serious complications

All published guidelines agree IVC filters are indicated in patients who have an acute VTE and cannot receive anticoagulation medications.  Or they are indicated for those whom adequate anticoagulation has clearly failed despite evidence of appropriate use and effect.  Nevertheless, some indications are much more controversial.

Dr. Ido Weinberg and others pointed out in a 2012 IVC filter paper, Cardiovascular Interventions by the American College of Cardiology Foundation, that IVC filters are inserted perioperatively in patients undergoing surgical pulmonary embolectomy. The intent is to reduce the effect of post-surgical PE in this unstable population. In a retrospective analysis of mortality in 520 such patients who were unstable secondary to PE, and who underwent embolectomy – all of whom received an IVC filter – mortality was lower than in 430 patients who received no filter (25% to 58%). The authors wrote that other safety data are conflicting, yet the Society for Interventional Radiology guidelines and ACR appropriateness criteria inexplicably offer that data as a relative indication for placing an IVC filter.

IVC filters are also advocated for high-risk populations without VTE as a prophylactic measure, such as in trauma patients. But several points of controversy apply. First, placing a filter can add complications that include increased morbidity.  Second, patients are at risk for long-term complications if filters are not removed.  Third, studies have shown IVC filters are a poor choice for trauma patients.

IVC filters have also been advocated for people undergoing elective open gastric bypass surgery. Those who received the filters have not been shown to fare any better than those who did not. In fact, studies have shown IVC filter risks outweigh benefits for bariatric patients.

IVC filters are sometimes used in high-risk patients in conjunction with anticoagulation therapy. In a comparison of 251 patients who received both an IVC filter and anticoagulation meds, and 1,377 who received only anticoagulation, there was no difference in PE incidence at 90 days and 5 years, though a trend toward more DVTs in the IVC filter group.

Cochrane Review: compression and anticoagulation effective and safe
Dr. Weinberg and the authors write that, “It is noteworthy that a Cochrane review of combined intermittent compression and anticoagulation for VTE prevention in high-risk patients showed the combination to be effective and safe.”  Which would seem to seriously challenge the notion of IVC filter makers that their filters are the only option in town for high-risk patients.

Do IVC Filters prevent PE?
A population-based study analyzed hospital records from 1991-1995.  It found that the rate of rehospitalization for PE did not decrease with the use of IVC filters. Rehospitalizations for DVT, however, did increase with the increased filter use. Further, Cochrane database investigators could not draw firm conclusion as to whether the filters decreased PE at all.

IVC filter lawsuits filed against Cook and Bard argue that these companies did no relevant long-term studies which randomized patients to find the true effectiveness of their filters. They diligently avoided performing those tests because they knew their IVC filters had no true effectiveness, and that IVC filter benefits are often not worth their risks.

IVC Filter Risks
IVC filters can become embedded in the vena cava. They can also break apart, and their various pieces can travel to the heart, lungs, nearly anywhere the blood can take them in the human body. They have not been proven efficacious. They are decidedly dangerous, and that is why you see so many IVC filter lawsuits filed in state courts and in federal multi district litigation courts across the country.

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IVC Filter Makers Liability over FDA Process

Lawyers for bothBard IVC Filter Lawsuit | Blood Clot Filter Lawyer IVC filter plaintiffs and IVC filter manufacturers continue to tussle in court over the FDA’s role in allowing different IVC filters to be sold on the market. Defense lawyers would like juries to believe that IVC filters were approved by the FDA for implanting in people’s inferior vena cava. Plaintiff’s lawyers want juries to know that IVC filters were never approved by the FDA for use in people. Can both sides be right? What gives?  IVC filter makers face liability over a little-known but common FDA process.

Federal Preemption for Medical Devices
The makers of medical devices which have been approved by the FDA through its regular Pre-market Approval (PMA) process typically avoid lawsuits against those products. That vanishing liability is a a direct result of a 1970s act that changed the nation’s long-established tort law.  Federal regulatory preemption of medical devices began with the 1976 Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act of 1938 (FDCA). 21 U.S.C. §§ 360c-1; 21 U.S.C. §§ 301 et seq.

Related:  IVC Filter Lawsuit | Lawyer

In a nutshell, the 1976 Act means that any medical device approved by the FDA through its PMA process immunizes its maker against legal liability. Whether or not the device turns out to hurt more people than it helps doesn’t matter. If the FDA approved it, people injured by such a device are out of luck. They had, and still have, little to no chance to remedy their grievances in court.

IVC Filters Not Approved by FDA
IVC filters, by contrast, have not been approved by the FDA.  They never went through the agency’s PMA process.  Instead, IVC filters have been “cleared” by the FDA under the auspices of the agency’s 510(k) clearance process. This process greatly abbreviates the PMA path. It allows the agency to “clear” devices for the market without putting them through the rigorous testing required of devices which seek full FDA approval.

The FDA web site explains, “A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.”  The term “substantially equivalent” can, of course, be very subjective.

Because devices “cleared” through 510(k) are not subject to the same rigorous testing as products put through the PMA process, the companies that make them can still be subject to civil liability.

In the first IVC filter trial in the Phoenix MDL court against C.R. Bard last month, the plaintiff’s attorneys sought to keep misleading characterizations of the FDA’s device approval processes from coming before the jury. They felt that any mention of the FDA allowing the filter on the market could prejudice the jury. The Arizona federal judge overseeing the case denied the plaintiff’s motion to preclude evidence about the devices’ 510(k) clearance.  But the judge also moved to clarify for the jury the FDA’s role in the IVC filter’s market presence.

IVC Filter Makers Liability over FDA Process

The judge said that he would allow the FDA evidence “in context” and would not allow the 510(k) clearance to be used as evidence that the devices are approved by the FDA. (In Re: Bard IVC Filters Products Liability Litigation, MDL Docket No. 2641, No. 15-2641, Sherr-Una Booker v. C.R. Bard, Inc., et al., No. 16-474, D. Ariz., 2018 U.S. Dist.).

Bard loses $4.6 Million Verdict in First IVC Filter Trial
Having learned that the FDA had not approved the IVC filter but had only allowed it under the auspices of its 510(k) program may have helped sway the jury into seeing the problems caused by the product.  The jury awarded the plaintiff $4 million, $3.6 million of which was assigned to C.R. Bard, maker of the IVC filter.

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Warming Blanket Recall

More bad news came recently for a 3M warming blanket used for hip and knee replacement surgeries that may cause serious infection.  FDA issued a Class 2 recall of 165,000 Bair Hugger Forced Air Warming Blankets on Feb. 12, 2018. The blankets were recalled for a design problem that may prevent them from warming up people during surgery, which is the blanket’s sole intent.

3M’s recall notice said health care providers should identify and discard any Bair Hugger underbody blankets affected by the recall. Recalled lot numbers are R10359, R10360, R10361, R10362, R10363, R10364, R10365 and R10366. They represent some 33,108 cases of five units each distributed worldwide.

The Bair Hugger is a single-use blanket that keeps patients warm before surgery. Four out of five hospitals use the single-use device today. The blankets are used in approximately 90 percent of all hip and knee surgeries.

Warming Blanket Lawsuits
3M Co. faces warming blanket lawsuits from more than 4,200 people who claim the company’s popular “Bair Hugger” surgical warming blankets circulate contaminants and cause debilitating deep-joint infections.

The Bair Hugger forced-air warming blanket has been used in more than 200 million surgeries since 1987.  Lawyers for the Minnesota-based 3M company say no study has proved the blanket causes surgical infections.

3M company spokeswoman Donna Fleming Runyon told the Star Tribune:  “3M will vigorously defend the product and the science against these unwarranted lawsuits. (We) think (plaintiffs’) attorneys are using bad science to blame their clients’ infections on a device that has helped so many people.”

Inventor says Device Creates Infection Risk
Attorneys representing the injured people say research shows the device can spread airborne contaminants while warming up surgical patients.  Dr. Scott Augustine, the inventor of the device developed in the 1980s, is expected to testify that it creates infection risk, especially for joint-surgery patients.

“There is no question that it’s a true phenomenon. It’s happening. And it’s easy to show,” said Dr. Augustine, a Minnesota Twin Cities anesthesiologist and entrepreneur who now opposes Bair Hugger use. “With regard to orthopedic infections, a scare is what’s needed. This product should never be [used] on another orthopedic patient.”

Dr. Augustine would be a witness with some baggage. He pleaded guilty to a health care-related misdemeanor in 2004, paid a $2 million fine, and denied any wrongdoing.  Today he is chief executive of Eden Prairie’s Augustine Temperature Management, which sells a competing patient-warming device called the HotDog, which uses conductive heat similar to an electric blanket.  The Bair Hugger uses forced air.

Dr. Augustine said he regularly lectures to health care professionals about his concerns regarding the Bair Hugger device.

3M sells various disposable Bair Hugger patient-warming blankets that retail from $6 to $24 each. The blankets include rows of inflatable tubes that fill with hot air to warm patients.  The goal is to improve surgical outcomes by preventing heat loss from the body’s core and reduce hypothermia risk from anesthesia.

A separate warming unit, connected by a hose, pumps air into the Bair Hugger blanket.

Dr. Augustine says that Arizant “stumbled onto” the discovery that the warming unit can disrupt the carefully designed flow of sterile air inside an operating room. He said waste heat from the unit builds up under the operating table and creates convection currents that can stir up contaminants from the floor and embed them on the surface of a knee or hip implant.

“We studied this extensively for about 18 months. I can tell you with 100 percent certainty that the waste heat rises every single time. This was reported before 3M even bought the company,”said Dr. Augustine. “3M can say that it doesn’t happen. … But when you are going against a basic law of physics, it’s kind of an absurd thing to say.”

Bone and Joint Journal Backs Plaintiff’s Theory
In November 2011, the Bone and Joint Journal in the United Kingdom published a paper from a study of experiments with mannequins and research on past patient records that found the Bair Hugger created a “significant” increased risk for deep-joint infection compared with patients who used the HotDog. The study used statistical regression to report an infection rate of 3.1 percent with forced air, compared with 0.8 percent with the HotDog.

Defense Evidence
A medical-evidence entity, ECRI Institute, evaluated the Bair Hugger and HotDog data. ECRI concluded in 2014 that there wasn’t sufficient evidence to determine whether one system was better at reducing surgery-related infections.

A systematic review of past studies published in the Journal of Bone and Joint Surgery in Massachusetts last year concluded, “forced air warming can impact [air] flow under certain very specific conditions, but any actual clinical impact on surgical site infections must be considered unproven at this time.”

3M claims the Bair Hugger’s safety is supported by 60 randomized controlled clinical trials since its development in 1987.

One plaintiff’s attorney who represents some people suing 3M said the cases could be tough to prove because no direct evidence shows the Bair Hugger stirring up contaminants, then placing them into any particular patient’s surgical wound.

The burden of proof is on the plaintiffs to prove that the blankets are more likely than not causing infections.  The attorney noted that similar indirect evidence on relative risks was the basis for tens of thousands of lawsuits filed against Merck & Co. over its $4 aspirin Vioxx. Merck eventually agreed to pay $4.85 billion to resolve those cases.

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IVC Filter Verdict: $4 Million

(March 30, 2018)  The first Bard IVC filter verdict in the U.S. District Court for the District of Arizona yielded a $4 million jury award for a woman injured by one of the blood clot filter devices. The jury ordered C.R. Bard to pay plaintiff Sherr-Una Booker $1.6 million for failing to warn her surgeon about problems linked with the filter, and an additional $2 million in punitive damages.  The jury found Bard 80% responsible, a radiologist 20% responsible.

The woman’s C.R. Bard blood filter broke inside her body, causing her to suffer open heart surgery. The jury found that Bard had negligently failed to warn the plaintiff and doctors of the device’s problems despite numerous reports of IVC filter complications.

The jury found 20% of fault attributable to radiology errors.  Law 360 reported that a radiologist “failed to flag a visibly separated filter piece on an X-ray in 2009, before Booker’s injuries developed to the point where she needed open-heart surgery.”  Bard’s share of the total damages amounts to $3.6 million.  Despite Bard’s arguments blaming the surgeon, the jury found the surgeon was only partially able to remove pieces of the broken IVC filter from the plaintiff’s body, and was not a cause of her injuries.

IVC Filters show no proof of efficacy but proof of harm

“We expect to see many more of these verdicts,” said attorney David Matthews, who deposed Ms. Booker’s interventions radiologist in the case.  “IVC filters show no proof of efficacy with proof of harm.”

Ms. Booker’s federal case is one of nearly 3,500 claims consolidated in the Ariz. MDL, where U.S. District Court Judge David Campbell is presiding. Ms. Booker filed the case after her IVC filter broke apart in her body. The judge limited the legal claims to defective design, failure to warn, and punitive damages. The plaintiff won all but defective design.

In addition to the $1.6 million award for failure to warn, the jury added another $2 million in punitive damages.

IVC Filter Verdict: $4 Million

First filed in February 2016, Ms. Booker’s lawsuit claimed that her injuries included IVC filter tilting, fracture and perforation. The case is 2:15-md-02641-DGC)

C.R. Bard faces an additional several thousand IVC filter lawsuits filed in state courts across the country.

IVC Filter History
IVC filters were first introduced in 1979. Since then, hundreds of thousands of IVC filters have been implanted in people.

IVC Filter Lawsuits
In August 2010, the FDA issued a safety communication that stated IVC filters “are not always removed.” The agency indicated then that known long-term IVC filter risks included lower limb deep vein thrombosis, filter fracture, filter migration, filter embolization, IVC perforation. More than 7,000 IVC filter lawsuits have been filed in state and federal courts against C.R. Bard, Cook Medical, Johnson & Johnson, Cordis Corporation, B. Braun, Rex Medical, and other filter makers.

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FDA Medical Device Proposal Threatens Public Safety

(March 29, 2018)  A new FDA medical device proposal threatens public safety, according to attorney David Matthews, who is preparing to try the first Cook IVC filter lawsuit in state court in the country.

The FDA now wants to work with medical device manufacturers to make it easier to get new devices to the market.  What could go wrong?  Plenty has gone wrong in the past.  Some FDA-cleared medical devices have been recalled by FDA; many have been “voluntarily” recalled by the device makers themselves.

For medical devices such as IVC filters, said Mr. Matthews, “the FDA follows the 510(k) ‘substantially similar’ mandate and does not do a safety and efficacy analysis which would be required under a PMA approval process.   Their hands are tied to a certain extent.    We all have to rely on the device manufacturers, and that is an inherently flawed process.”

“The history of the IVC filter provides valuable insight into the shortcomings of medical device approval in the United States,” said a JAMA article published online March 18, 2013.  The doctor authors noted that as the device approval or clearance process currently stands, “there is little incentive for IVC filter makers to embark on [testing] trials that can only eliminate their products’ market share.”

Thousands of Medical Device Problems

Thousands of people have had trouble with medical devices that include transvaginal mesh, metal-on-metal hip implants, knee replacements, IVC filters, hernia mesh, and many other medical devices.  It’s troubling, to say the least, that the FDA now wants to move devices through its review processes even faster.

Device makers argue that they can’t get their useful devices out to people fast enough, that they’re being held back by too much regulation.

Deregulation rules the Day in D.C.

As the Trump administration continues to assert that almost any regulations are bad for the economy, Mr. Trump’s FDA personnel appointments are working to create a new fast-track path to the market for medical devices.  Legal experts, however, say such a move may exceed the FDA’s authority and require some creative reasoning to justify to judges.

FDA Commissioner Scott Gottlieb proposed in December 2017 the creation of a quick route to market for certain products that may not meet the criteria for clearance under the agency’s existing fast-track pathway, known as 510(k).  Mr. Gottlieb said such fast-tracking would foster innovation, though it’s hard to follow his logic, if any logic applies – or matters anymore where corporate profits are concerned.

The fast-track proposal is part of a broader effort by the agency to reduce the amount of clinical evidence required for medical device approvals.  Medical device companies could save millions of dollars and years of development time, if the plan is made law.

510(k) Approval Process
A product cleared under the auspices of 510(k) in current law must show substantial equivalence in materials and intended use to an existing legally marketed device, which is known as a predicate product.  Some 3,000 devices are cleared this way each year, making 510(k) the most common pathway for a medical device to reach the market.

The new FDA proposal would eliminate the need to test a new product against a specific predicate product.  Instead, 510(k) would be replaced by a set of technical standards that would serve as a kind of proxy for the predicate.  The FDA said it would release further details in “non-binding guidance” for industry players early this year.

Mr. Matthews said the agency appears to be changing the law to make it easier for device makers, at the expense of consumers, who need and have a right to expect safe and effective products.

Reuters reported that an expert in medical technology and public health law at the University of Florida, Lars Noah, doubts the FDA plan can hold up under legal scrutiny.

Mr. Noah said, “If somebody with standing wanted to challenge the FDA’s decision in court, a judge is going to say: ‘Show me the predicate.’  I don’t see how the court would side with the agency.”

Abbreviated 510(k)?
The head of the FDA’s medical device division, Dr. Jeffrey Shuren, said in an interview that the move would simply expand on something the agency is already doing with its rarely-used “abbreviated” 510(k) pathway.

The abbreviated route allows companies to show their device meets certain product standards but does not eliminate the need for a specific predicate.  Dr. Shuren said companies in future could show substantial equivalence “to a technology” rather than a product.

In some ways the FDA’s new proposal mimics a frowned-upon practice known as “predicate stacking” in which companies include multiple predicates in their application.  The new product might contain characteristics substantially equivalent to a conglomeration of predicates but not be substantially similar to a single product.

The new fast-track plan makes it appear FDA could now be encouraging stacking, which is hardly ideal, as several devices could be offered as predicates for various features, despite the fact that none may be a true predicate.  It appears the FDA is merely stacking the deck to allow companies to get devices to the market faster, despite a dearth of safety testing and a clear predicate.

The agency is already at work helping companies market digital health products for which the FDA is not requiring approval at all.  Nine companies, including Apple Inc., Roche Holding AG, and Johnson & Johnson will be “pre-certified” based on certain quality and technical metrics to release new digital health products without filing a 510(k) for each.

FDA Medical Device Proposal Threatens Public Safety

“Why is the FDA working with companies to help them waive the statutory obligation to file a 510(k)?” asks Mr. Matthews.  “The 510(k) clearance problems themselves are well documented, and now the FDA is working to help companies sidestep even that clearance altogether? It’s fair to ask whether that agency is working for companies or for people.  It’s fair to ask, for whom does the FDA work, and what are its priorities?”

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Decline in IVC filter use fails to affect VTE hospitalization rates

Cook Medical, C.R BardCook IVC Filter Attorney and other IVC filter makers claim their devices lower rates of venous thromboembolism.  But a sharp decline in IVC filter use has failed to affect VTE hospitalization rates.

A letter published in the Journal of the American Medical Association reported in July 2017 that after the FDA issued a safety warning in 2010 about adverse events associated with IVC filters, their use decreased. However, that warning failed to impact VTE hospitalization rates.  If the filters were working as advertised, one would have thought that reducing their use would have raised VTE hospitalizations.

Researchers analyzed U.S. rates of IVC filter placement to determine any differences before and after the FDA’s August 2010 advisory. They analyzed VTE hospitalization rates to find whether changes in IVC filter use caused changes in VTE-related hospitalizations.

More than 1 Million Patients Analyzed
Satyajit Reddy, an internal medicine MD at Philadelphia’s Temple University Hospital, and some colleagues analyzed 1,131,274 patients in the National Inpatient Sample database.  All had IVC filters placed from 2005 to 2014.

The researchers found IVC filter placement increased 22.2% between 2005 (45.2 per 100,000 U.S. residents) and 2010, the year of the FDA advisory (55.1 per 100,000 U.S. residents).

Placement of the blood-clot filter devices then declined between 2010 and 2014 (39.1 per 100,000 U.S. residents).  That is when the statistics became interesting, strongly suggesting that the filters were doing nothing to stop or lower VTE.

Dr. Reddy and his colleagues wrote that the rate of VTE-related hospitalizations did not significantly change between 2010 (211.6 per 100,000 U.S. residents) and 2014 (211.3 per 100,000 U.S. residents).

Research Rebuttals
Although Cardiology Today reported speculation which claimed the decline in IVC filter placements was related to decreased reimbursement due to changes in the bundling of associated Current Procedural Terminology codes that went into effect in 2012, the decline actually began two years earlier, after the FDA advisory, wrote Dr. Reddy and his colleagues.

Dr. Reddy and fellow researchers also speculated that another possible factor was the introduction of nonvitamin K antagonist oral anticoagulants for treatment of VTE, but they also said its impact (if any) on IVC filter placements was not clear.

Decline in IVC filter use fails to affect VTE hospitalization rates

“Given the short- and long-term complications associated with [inferior vena cava filter] placement, the use of these devices should mostly be reserved for patients with an absolute indication like active bleeding,” Dr. Reddy and his colleagues wrote. They also noted that IVC filter placement remains much higher in the U.S. than in Europe, where the rate is less than 3 per 100,000 people.

IVC Filter Lawsuits’

Because IVC filters were never approved by the FDA, and because thousands of people have reported problems with their IVC filters tilting, breaking, and/or migrating, IVC filter lawsuits have been filed across the U.S.  Our law firm is handling and filing many of these lawsuits, including several against some of the largest IVC filter makers such as C.R. Bard and Cook Medical.  Contact us now for a free legal consultation if you have experienced any problems with an IVC filter.

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•  Decline in IVC filter use fails to affect VTE hospitalization rates

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Medical Devices May Harm more than Help

(March 12, 2018) There’s a decided prejudice in our “modern” society which tends to embrace with little question any new technology that comes along. Like private investigators, we tend to follow the money. Because we know corporations spend millions on R&D, we tend to think they get what they pay for and so will we, if we use their latest device. But the plain fact is that corporations don’t always get what they pay for and neither do we.

Techno “Values” (not so fast)

Technology has of course helped many of us for many reasons; but there comes a time when it is necessary to ask whether a new technology or device is always the best choice.  The law of diminishing returns can apply to any technology as well as to economics.

Related: Thousands get Stents that May Do More Harm than Good

Consider the leafblower, for example. It may be faster than the beautifully simple (and beautifully quiet) rake, but does that mean it’s always superior?  Whether or not you want to fire up its ear-shattering engine to blow your leaves and allergens onto the neighbor’s property or street – in order to have them blown back next day by an equally obnoxious noisemaker – is one technology choice that likely won’t threaten your health or your life.  When it comes to choosing (or not choosing) a medical device, however, your choice could dramatically alter your life, or even end it.

Absent Cardiologists Get Better Results
A recent USA Today  story puts the medical device choice in perspective.  A Harvard study published Friday, March 9, 2018 in the Journal of the American Heart Association found that patients nationwide who had a heart attack during the biggest interventional cardiology conference of the year fared better than those who got sick in the weeks before or after the conference.

The paper reported that the results are either a statistical fluke, or that interventional cardiologists – who insert stents to open arteries – sometimes do their patients more harm than good.

Researchers examined 30-day survival rates of Medicare patients who suffered heart attacks during their cardiologists’ five-day conventions.  They found that an extra 1.5% survived heart attacks which happened during the convention, as opposed to those who had heart attacks before or after it.

The difference means that thousands of lives were saved when cardiologists were at a five-day convention when their patients suffered heart attacks. The differences couldn’t be explained by the number of emergency stents implanted in patients, according to study leader Anupam Jena, an associate professor at Harvard medical School and Massachusetts General Hospital in Boston.

This research raises important questions about the safety and efficacy of placing stents in patients. The data suggest that stents should be placed only in those who are suffering a heart attack caused by a blocked artery. Where the cause of a heart attack is less clear, the disease may be managed by medication, which is usually overseen by general cardiologists, according to Robert Yeh, an interventional cardiologist and co-author of the study.

IVC Filters
IVC Filters, inferior vana cava filters placed in the vein returning blood to the heart, with the advertised purpose of trapping blood clots, are another questionable device. Though they’ve been used extensively by many doctors for some ten years or so, their safety and efficacy is very much in question.  There is virtually no evidence blood clot filters help.  As a result,  IVC filter lawsuits have  been filed throughout the country.  Lawsuit petitions in these cases argue that some IVC filters even cause more problems than they solve.

Hernia Mesh
For at least 100 years, surgeons used simple suturing for hernia repairs, where surgery was deemed necessary.  Then someone got the bright idea of using plastic mesh instead.  The results have been catastrophic for many people, who, if given the choice again, would gladly choose the “old method” rather than the latest new plastic technology.  Hundreds hurt by hernia mesh have filed hernia mesh lawsuits throughout the country.

Transvaginal Mesh
Tens of thousands of lawsuits have been settled over transvaginal mesh made by Johnson & Johnson, Boston Scientific, C.R. Bard and others.  Thousands of women who suffered stress urinary incontinence or pelvic organ prolapse sued mesh makers and had their lawsuits settled.

Medical Devices May Harm more than Help
Medical device makers like C.R. Bard and Cook Medical will continue to develop and promote all manner of the latest technology in IVC filters, surgical mesh, and other medical devices of dubious value.  Whether or not one chooses to use that latest medical device is a potentially life-changing choice.  It is a decision not to be taken lightly.  Attractive medical device models who sell doctors and shiny brochures do not a magic product make. One would be wise to perform a lot of research to see if any medical device is worth the risk of being implanted with it.

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Diabetes Drug Raises Risk of Foot, Leg Amputations

The diabetes drug Invokana raises the risk of foot and leg amputations. As a result, the FDA required Johnson & Johnson to add new warnings to the Invokana drug label in 2017.

The agency required the warnings after two clinical trials showed leg and foot amputations occurred about twice as often in patients with type 2 diabetes treated with Invokana (canagliflozin), as those given a placebo. The FDA announcement came May 17, 2017, along with a posting on its website.

FDA Boxed Warning
The FDA said the warnings include a boxed warning, which is reserved for the most serious possible adverse events.

Diabetes Drug Invokana
Invokana is part of a newer class of type 2 diabetes drugs called SGLT-2 inhibitors. These drugs are promoted to help remove excess blood sugar through urine. Other drugs in the class include AstraZeneca’s Farxiga and Eli Lilly’s Jardiance.

Amputation Risk Doubles for Invokana – Study
The FDA noted that results of one clinical trial showed the risk of amputation in patients treated with Invokana was equivalent to 5.9 out of 1,000 in a year’s time, compared with 2.8 out of 1,000 for patients given a placebo drug.

A second trial showed the risk of amputation was equivalent to 7.5 out of every 1,000 patients treated with Invokana compared with 4.2 out of every 1,000 patients given a placebo.

Diabetes Drug Raises Risk of Foot, Leg Amputations
The FDA said amputations of the toe and middle of the foot were the most common, but that partial leg amputations also occurred below and above the knee.

The National Diabetes Statistics Report from 2017 said that some 23.1 million people – or 7.2% of the U.S. population – had diagnosed diabetes. The total included 132,000 children and adolescents younger than 18; 193,000 children and adolescents younger than 20. About 5% of people with diabetes are estimated to have type 1 diabetes.

Among U.S. adults 18 or older, data for 2013–2015 indicated American Indians/Alaska Natives had the highest prevalence of diagnosed diabetes for both men (14.9%) and women
(15.3%) Prevalence varied by region, from 6.0% among Alaska Natives to 22.2% among American Indians in certain areas of the Southwest.

Overall, prevalence was higher among American Indians/Alaska Natives (15.1%), non-Hispanic blacks (12.7%), and people of Hispanic ethnicity (12.1%) than among non-Hispanic whites (7.4%) and Asians (8.0%). Among Hispanics, Mexicans had the highest prevalence (13.8%), followed by Puerto Ricans (12.0%), Cubans (9.0%), and Central/South Americans (8.5%).

Among Asians, Asian Indians had the highest prevalence (11.2%), followed by Filipinos (8.9%), and Chinese (4.3%). Other Asian groups had a prevalence of 8.5%. Prevalence varied sharply by education level, which is an indicator of socioeconomic status. Specifically, 12.6% of adults with less than a high school education had diagnosed diabetes versus 9.5% of those with a high
school education and 7.2% of those with more than a high school education.

Untreated type 2 diabetes can cause blindness, nerve and kidney damage and heart disease.

Invokana Lawsuit Help

Anyone who has taken Invokana and suffered an amputation could be eligible for financial compensation for pain and suffering, loss of income and quality of life.  Contact an experienced drug injury attorney now for a free legal consultation.

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First Bard IVC Filter Trial Scheduled

(Feb. 21, 2018) The Bard Recovery Blood Clot Filter Flawedfirst Bard IVC trial has been scheduled to be heard next month. The first jury trial against medical device maker C.R. Bard is set for March 14, 2018 in Phoenix, Arizona.

Lawsuits filed over Bard IVC filters claim the blood clot filter device can migrate, perforate, and break up into fragments which can travel to vital organs and lead to catastrophic injuries.

3,500 Bard IVC Filter Lawsuits

More than 3,500 plaintiffs have had their Bard IVC filter lawsuits consolidated in the C.R. Bard MDL litigation venue established in Phoenix. Since August 2015, all personal injury and product liability lawsuits filed against Bard in the federal court system have been centralized. U.S. District Judge David Campbell presides in the District of Arizona as part of the multidistrict litigation.

Bellwether Trials

The first scheduled trial in any mass tort litigation is informally considered by legal scholars to be a bellwether trial. These first trials generally set the tone for a given litigation. They can often help determine the merits of not just one plaintiff’s case but all plaintiffs’ cases.  The defense goal in these cases is to have them dismissed outright, if possible, while plaintiffs work to prove to a jury that the product in question is defective and fails to pass muster in any fair basic cost-benefit analysis.

Defendants in these cases will usually attempt to extol the virtues of their beleaguered device and will further attempt to show it as not only necessary but superior to other available options at the time of implant.  The Plaintiffs side, by contrast, will work to show the device is perhaps entirely unnecessary and/or unreasonably dangerous. They will also try to prove to the jury that alternative treatments were available which were both safer and better than the device which was used.

In the first Bard IVC filter lawsuit scheduled for next month, a woman was implanted with a C.R. Bard G2 IVC filter in June 2007.  She alleges that she suffered personal injuries as a result.

C.R. Bard, Cook Medical, and Cordis are the main IVC makers facing IVC filter lawsuits.  Cook Medical is exposed to 3,750 IVC filter lawsuits in a separate MDL based in Indiana.

What is an IVC filter?
IVC filters, or inferior vena cava filters, are made to trap or filter blood clots. They are tiny, umbrella-like devices placed in the inferior vena cava – the vein returning blood to the heart – to prevent blood clots in the leg from traveling to the heart, lungs, or even the brain.

Blood Thinners vs. IVC Filters
Blood thinners or anticoagulants are usually the first, best treatment option for blood clots in the leg.  Blood thinners, however, are contra-indicated for some people. A person with a pre-existing bleeding problem may not be able to take a blood thinner.  That unlucky person might be implanted with an IVC filter.

IVC Filters Meant for Temporary Use
IVC filters are meant to be implanted only for temporary use.  Once the threat of a clot has passed, they are supposed to be removed. In reality, however, most retrievable IVC filters are never retrieved, or they are not retrieved until after the safe removal window recommended by the FDA has passed.

IVC Filter Retrieval Problems
Some IVC filters cannot be retrieved at all. Sometimes the filter embeds in the vein wall, causing severe risk of injury. In several cases, the IVC filter has been found to embed and perforate the wall of the inferior vena cava. The filter can also tilt or break free from the insertion point and migrate to the heart and lungs. The brittle spider-legged struts of the IVC filter have been found to snap off and embolize or migrate into vital organs.

First Bard IVC Lawsuit Trial
Judge Campbell has ordered that the first Bard IVC filter bellwether trial will be conducted in two phases. The first will be a determination of liability, compensatory damages, and possible punitive damages. The second phase will determine the amount of any possible punitive damages.

IVC Filter Injury Lawsuits
If you have been implanted with a troublesome IVC filter (a Bard Recovery, G2, Cook Celect, Gunther Tulip, Cordis Optease, or Trapease) and you have suffered IVC filter failure or injuries by embedment, migration or embolization requiring emergency care or surgery, contact an IVC filter attorney today. Call 713-522-5250 or email Matthews & Associates Law Firm for a free legal consultation.  We are handling IVC filter lawsuits in all 50 states and Puerto Rico.

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