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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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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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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South Dakota Natives sue drugmakers over opioids

(Feb. 7, 2018)  Three Native American tribes in South Dakota are suing opioid industry players in federal court, the Sioux Falls Argus Leader reported last month. The tribes allege they were sold addictive drugs without being warned of their dangers.

Three Tribes file Opioid Lawsuit

The Rosebud, Flandreau and Sisseton-Wahpeton Sioux tribes filed the lawsuit.  It follows more than 70 similar cases filed around the country.

The tribe’s lawsuit targets drug makers Purdue Pharma, Teva Pharmaceuticals, Allergen PLC, as well as distributors McKesson Corp., Cardinal Health Inc., and AmerisourceBergen Corp.

The tribes’ charges are similar to those made in other opioid industry cases – fraud, deceptive marketing, RICO Act violations.  It is one of the first suits to tie those claims to the impact on Native American populations.

Related:  Opioid Lawsuit Lawyer

The complaint notes that one in 10 Native American youth 12 or older uses opioid pain medications for recreational reasons.  That’s double the rate for Caucasians.  Native Americans also suffer higher rates of overdose.

An attorney for the tribes said, “This epidemic has overwhelmed our public-health and law-enforcement services, drained resources for addiction therapy, and sent the cost of caring for children of opioid-addicted parents skyrocketing.  This is a crisis that affects virtually every Tribal member in the state.”

South Dakota Natives sue drugmakers over opioids
The 106-page petition charges that deceptive opioid marketing included misleading advertisements, paid speakers to sell doctors, and direct-to-doctor marketing.

The tribes charge that they were sold several opioid falsehoods, including that there was a low risk of addiction, that the products carried a low risk of producing a “high,” that there was no maximum dose, and that there were no opioid withdrawal symptoms.

The lawsuit says that because the people pitching the products adhere to a script, “it can be reasonably inferred that most, if not all, of the Pharmaceutical Defendants’ detailers made and continue to make these misrepresentations to the thousands of doctors they have visited and continue to visit.”

RICO Act Charges
The RICO Act violations relate in part to a pharmaceutical group called the “Healthcare Distribution Alliance,” an industry group the lawsuit says was used to inflate opioid sales and supplies.  RICO is an acronym for Racketeer Influence and Corrupt Organizations.  The law behind it allows for both criminal and civil penalties for groups engaged in dishonest financial conduct.

Similar civil and criminal cases have been filed around the country, including a class action lawsuit in Mississippi, and lawsuits in Ohio, Pennsylvania, Washington, and Massachusetts.

The defendant companies have not yet filed a responses to the lawsuit.

Opioid Lawsuit Lawyer

Our law firm is investigating opioid lawsuits.  If you or someone you know was injured by opioid addiction, contact us for a free legal consultation regarding a potential opioid lawsuit.

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Blood Thinners like Xarelto linked with Most Emergency Room visits

Out of more than one million adverse drug events reported to the FDA in 2016, more patients complained of blood thinners than any other drugs. Blood thinners like Xarelto, Pradaxa, Eliquis, Warfarin, and Coumadin are among those most often reported by their users for causing adverse events. Blood thinners, in fact, are responsible for the most emergency room visits compared with all other drugs, including opioids.

Institute for Safe Medication Practices
The Institute for Safe Medication Practices (ISMP) is a nonprofit organization. It provides lists of legal drugs responsible for most injury and adverse event reports. In 2016, ISMP reported that blood thinners – or anticoagulants – were linked to 21,996 adverse events and 3,018 deaths.

Xarelto Bleeding Lawsuits
Xarelto was responsible for most adverse event reports among blood thinning drugs. Xarelto is linked with thousands of blood thinner lawsuits.

Patients who are at risk of developing blood clots are often prescribed anticoagulants or blood thinners.  Each blood thinner targets a particular blood clotting factor to prevent or reduce the formation of blood clots.

Blood Clotting 101
Blood clotting isn’t always bad, of course.  In most cases, blood clotting is vital for preventing small bumps or cuts from becoming severe bleeding events.  Preventing this natural healing process from occurring, especially when a blood thinning drug’s concentration is too strong or improperly balanced, may cause some to suffer uncontrollable bleeding.

Blood Thinners like Xarelto linked with Most Emergency Room visits

In 2016, internal hemorrhages made up most blood thinner injuries reported to the FDA:

•  17,218 anticoagulant-related hemorrhages
•  8,495 gastrointestinal hemorrhages
•  1,019 cerebral hemorrhages

Some of these adverse events were serious enough to require an emergency room visit. The ISMP authors warned that 6.3% of patients on blood thinners will require an E.R. visit, and half those visits will require hospitalizations. Patients on blood thinners, were, in fact, 2.4 times more likely to need an E.R. visit than patients prescribed opioids, which are prominently in today’s news due  to a nationwide epidemic.

Anticoagulants were responsible for 17.6% of all FDA-reported hospitalizations, more than opioids or any other type of drug.

Xarelto Lawsuits over Unacceptably High Safety Risk
Drug injury attorneys filing Xarelto blood thinning lawsuits believe that Xarelto’s maker and marketer, Bayer and Janssen (part of Johnson & Johnson) have created an unacceptably high safety risk for many patients placed on the blood thinner.  Thousands of claims have now been filed in the Xarelto multidistrict litigation (MDL) set in the federal Eastern District of Louisiana.

Xarelto’s Dosage Problem
Monitoring blood thinner concentration level is important because Xarelto can create “peaks and troughs” in the drug’s severity for some patients.  This creates a particular problem for Xarelto’s once-daily dosing.  Bayer and J&J have used the once-daily routine to market Xarelto as a more convenient alternative to its cheaper generic competition – Warfarin – which requires a dosing twice daily.

A once-daily dosing may seem more convenient, but it may leave a patient more vulnerable to strokes or bleeding events.  A once-daily schedule can create inconsistencies in the drug’s concentration.  It may be too weak at times and hence present a stroke risk; or it may be too strong at other times and present an uncontrollable bleeding risk.

Xarelto also poses potentially greater health risks than Warfarin because it does not require regular patient monitoring. Regular medical visits, by contrast, could help patients receive an accurate dosage, and prevent dangerous fluctuations in the blood thinner’s concentration. According to a 2017 Mayo Clinic study, one in six patients on newer blood thinners may be prescribed the wrong dosage.

Xarelto Still Lacks an Antidote
Of the more than 17,000 patients who suffered a blood thinner-related hemorrhage in 2017, those on Xarelto (rivaroxaban) had no access to an antidote to help stop the bleeding.  Without a reversal agent to stop bleeding, these events could quickly become life-threatening.

Pradaxa allegedly caused 1,000 deaths
An antidote for Pradaxa (dabigatran) was not approved until 2015; that was not soon enough to prevent more than 1,000 casualties allegedly caused by the blood thinner.

An antidote, ISMP researchers said, could significantly reduce the number of fatalities and serious injuries.  Warfarin has had a simple vitamin K antidote available for years, but despite this major difference, Xarelto and Pradaxa were marketed as superior alternatives.

Xarelto, Pradaxa Lawsuits Nationwide
This dangerous risk of bleeding, combined with misleading advertising, inadequate warnings and a lack of antidote, has resulted in thousands of lawsuits against Xarelto and Pradaxa makers.

New Orleands MDL: 14,000 Xarelto Lawsuits
Some 14,000 Xarelto lawsuits are consolidated in New Orleans.  Thousands more have been filed in state courts against Bayer and Janssen, the Johnson & Johnson subsidiary that markets Xarelto in the U.S.

Pradaxa Lawsuit Settlement
In 2014, Boehringer Ingelheim (Pradaxa’s manufacturer) settled 4,000 of its lawsuits for $650 million. This was before an antidote was available, however, so some patients were still suffering from Pradaxa-related injuries. Therefore, Pradaxa litigation is likely far from finished for Boehringer Ingelheim.

Blood Thinner Injury Lawsuit Help
Our experienced drug injury attorneys are handling lawsuits against the makers of Xarelto and other blood thinner drugs.  If you or someone you love was injured by Xarelto, email us for a free legal consultation or call 888-520-520.  You may be entitled to significant compensation.

Time limits apply to filing lawsuits, so we urge anyone with a potential case to call us immediately for a free, no obligation consultation.

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Blood Pumps Can Kill Patients

Blood pumps can kill patients in their homes when they try to change the controller. At least 26 advanced heart failure patients have died and 19 have been injured trying to change the controller on Abbott Laboratories’ HeartMate II blood pumps.

70 Reports of Malfunction
After 70 reports of malfunctions, Abbott released new software and alarm guides concerning nearly 29,000 devices to doctors on March 30, 2017. The malfunctions were reported following unsuccessful controller replacement.

HeartMate II Left Ventricular Assist Device
The HeartMate II Left Ventricular Assist Device (AVLAD) blood pump is an implantable medical device which Abbott acquired from St Jude Medical in January 2017.  Implanted inside a patient, it works to pump blood around the body when a heart is too weak to work alone.  (There’s poetry in there.)  One must replace an external Pocket System Controller needed to operate the device. Abbott has advised that replacements be conducted only by clinical professionals.

Because of user dangers, the FDA in March 2017 issued a Class 1 recall – its most serious – which urged users not to change controllers themselves.

The recall notice said: “Patients may sometimes need to change to their backup system controller during the course of ventricular assist therapy. (The) change should be done quickly and in the hospital, because it can present a significant challenge to patients that are elderly and/or untrained. For these patients, a slow or improper…changeover places them at risk of serious injury or death.”

The expensive HeartMate II device was designed to keep people alive until they could receive a heart transplant; however, the FDA approved its use as a “destination therapy” in those who do not qualify for such a transplant.

Abbott’s Response
Abbott responded to the FDA’s decision by noting that it is currently engaged in continuing practices to ensure the device’s safety. Abbott spokesman Justin Paquette said: “We are updating its alert guides, conducting a software upgrade and adding controller alignment markings for the HeartMate II System Controller as part of a continued effort to ensure patients are successfully able to exchange their pocket controller in emergency situations. Despite past efforts to improve training and education, we are aware of patients experiencing a very low level of adverse events as a result of unnecessary patient controller exchanges.”

Mr. Paquette added that this Class I recall was not about recalling products, but “communication to physicians so they can ensure their patients have their controller exchange completed in a clinical setting.”

Blood Pumps Can Kill Patients

Therein would seem to lie the problem. What if someone needs it changed NOW? Anticipating that problem of urgency, Mr. Paquette said, “We have also updated our software and controller alerts to help guide patients to talk to their physician when the time is approaching to have their controller exchanged.”

Medical Device Injury Lawyers
Matthews & Associates Law Firm, a longtime leader in medical device litigation, is investigating Heartmate II Blood Pump problems. Contact the law firm for a free legal consultation.

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Drug Industry, Congress fuel Opioid Epidemic

A DEA whistleblower told CBS News that Congress derailed the DEA’s attempt to keep addictive opioids off U.S. streets.  Joe Rannazzisi ran the DEA’s office of Diversion Control during the worst drug epidemic in American history.  His division regulates and investigates the drug industry.  In a joint investigation by 60 Minutes and The Washington Post, Mr. Rannazzisi revealed how the opioid crisis was allowed to spread.  It was aided by Congress, lobbyists, and a drug distribution industry that shipped hundreds of millions of pills to rogue pharmacies and pain clinics.  Those loads fueled the opioid crisis that has killed some 200,000 people in the last 20 years.

People Die for Drug Profits

“This is an industry that’s out of control,” Mr. Rannazzisi told CBS’ 60 Minutes.  “What they wanna’ do, is do what they wanna’ do, and not worry about what the law is. And if they don’t follow the law in drug supply, people die.  That’s just it.  People die.”

Mr. Rannazzisi said drug distributors turned a blind eye and “allowed millions and millions of drugs to go into bad pharmacies and doctors’ offices, that distributed them out to people who had no legitimate need for those drugs.”

A former DEA deputy assistant administrator armed with law and pharmacy degrees, Mr. Rannazzisi seemed most upset with the distributors, some of them multibillion dollar, Fortune 500 companies.  These blue-blood middlemen ship the pills from makers like Purdue Pharma and Johnson & Johnson to drug stores countrywide.  Mr. Rannazzisi accuses the distributors of fueling the opioid epidemic by pretending not to see pills being diverted for illicit use.

“This is an industry that allowed millions and millions of drugs to go into bad pharmacies and doctors’ offices,” said Mr. Rannazzisi, “that distributed them out to people who had no legitimate need for those drugs.”

The Perps – Cardinal Health, McKesson, AmerisourceBergen

Mr. Rannazzisi said the three largest distributors are Cardinal Health, McKesson, and AmerisourceBergen.  They control some 85-90 percent of the drugs flowing downstream.  Mr. Rannazzisi said these companies knew they were pumping drugs into American communities and killing people.

Opioids Oxycodone, Hydrocodone

Opioids like oxycodone and hydrocodone became a routine medical treatment for chronic pain by the late 1990s.  Drug companies assured doctors and congressional investigators that the pain pills were effective and safe.  A Purdue Executive told Congress in 2001 that addiction was rare in the pain patient properly managed.

Many doctors were apparently convinced the opioids posed few risks (or apparently knew nothing about the long sordid history of opioid abuse); so prescriptions skyrocketed along with addiction.

Many who had become addicted to painkillers turned to what CBS news called “pill mills” – pain clinics featuring rogue doctors who would write fraudulent prescriptions and complicit pharmacists to fill them, one stop shops for legal drugs.

Drug Dealers in Lab Coats

Mr. Rannazzisi said many pain clinics popped up overnight.  The whole fiasco “made the crack epidemic look like nothing.”  He said, “They were just drug dealers in lab coats.”  But despite several arrests, opioids kept flooding the black market while the death toll kept rising.

Mr. Rannazzisi said that prosecuting crooked doctors and pharmacists failed to slow the epidemic, so he moved up the food chain.  He said the DEA saw hundreds of bad orders involving millions of tablets, so the agency started going after the distributors.

Distributors Required to Monitor Suspicious Orders

A distributor’s representative told CBS that doctors who overprescribe pain medication were the problem.  However, the distributors know exactly how many pills go to every drug store they supply.  The Controlled Substances Act requires distributors to report and stop what the DEA calls “suspicious orders.”  These include unusually large or frequent shipments of opioids.  DEA investigators said many distributors simply ignored that requirement.  (The better to profit, my dear.)

Former DEA man Jim Geldhof told CBS, “Their plan was to sell a lotta pills and make a lot of money. And they did both of those very well.  All we were looking for is a good-faith effort by these companies to do the right thing. And there was no good-faith effort. Greed always trumped compliance. It did every time.”

9 Million Pills for 392 People?

A 40-year DEA veteran, Mr. Geldhof ran pharmaceutical investigations from the Detroit field office.  Frank Younker supervised the DEA’s operations in Cincinnati.  Joe Rannazzisi was their supervisor. They saw distributors shipping thousands of suspicious orders. In one example, a pharmacy in tiny Kermit, West Virginia (Pop. 392) ordered nine million hydrocodone pills over two years.

With such obvious signs, Mr. Geldhof finds it ludicrous that the distributors now claim they didn’t see suspicious orders. He says the companies are culpable in the epidemic: “I can tell you with 100 percent accuracy that we were in there on multiple occasions trying to get them to change their behavior. And they just flat out ignored us.”

McKesson, Cardinal Health Fined Millions

In 2008, the DEA slapped McKesson, the country’s largest drug distributor, with a $13.2 million dollar fine. That same year, Cardinal Health paid a $34 million fine.  Both companies were penalized by the DEA for filling hundreds of suspicious orders – millions of pills.

Distributors fines have totaled more than $341 million over the last seven years. The companies complained to Congress that DEA regulations were vague and said the agency was treating them like a foreign drug cartel.  In a letter, the healthcare distribution alliance, which represents distributors, said they wanted to work with the DEA.  Effective enforcement, they wrote, “must be a two-way street.”

Drug Distributors flex Political Muscle

More than 17,000 Americans died from opioid prescription overdoses in 2011, the year Cardinal Health started pushing back at Joe Rannazzisi.  Cardinal’s attorneys called his bosses at the Justice Department, who called in Mr. Rannazzisi to explain his tactics.

Money and Influence

Joe Rannazzisi told CBS he was infuriated at having to explain his motives for going after corporations.  He told his staff they were in a war: “We’re going after these people and we’re not going to stop.”  But he was hamstrung by his own agency.

He said the drug industry used its money and influence to pressure top DEA lawyers to take a softer approach.  Former DEA attorney Jonathan Novak said it divided the litigation office. He said in 2013 that he noticed a sea change in the way prosecutions of big distributors were handled. Cases his supervisors once would have easily approved were no longer good enough.

Mr. Novak told CBS that they had achieved “incredible success in an almost unstoppable wave,” but suddenly his caseload dramatically slowed as his bosses began to scuttle the whole system, demanding unreasonable amounts of evidence.

Big Pharma minions in Congress then moved to further defang the DEA and save corporate profits at the expense of U.S. Citizens.  See the whole story at CBS News.

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FDA Recalls Johnson & Johnson Heart Device

The FDA has recalled a Johnson & Johnson heart device. The U.S. Food & Drug Agency announced Jan. 2, 2018 its strictest form of recall for a cardiac device made by Sterilmed.  A faulty valve in the device poses the risk of seriously injuring or killing a patient.

FDA Class I Recall: Its Most Serious
The FDA said the recall of Agilis Steerable Introducer Sheath devices – made by Sterilmed Inc. – is a Class I recall. That’s the agency’s most serious type of recall. This sheath device is used to insert and position cardiovascular catheters. It is sometimes used on the heart’s left side through the wall of tissue separating the heart’s right and left chambers.

Improper Seal
The FDA said the sheath’s hemostatic valve is at risk of failing because of an improper seal on the sheath’s hub. The valve is designed to keep blood from flowing back through the valve.

The FDA said, “Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure or can create a difference in pressure that allows air into the circulatory system (air embolism).”

The improper seal happens when there isn’t enough glue used to reattach the sheath’s cap after use. But too much glue can also block the valve and make the device unusable, according to the FDA.

Fatal Flaw
FDA said, “The use of affected products may cause serious health consequences for patients, including death.”

Some 112 affected devices are included in the recall, which covers sheaths made between Jan. 1, 2017, and May 5, 2017, according to the FDA.

In addition, patients with a lower body mass index may be more at risk if there is blood loss, said the FDA. Smaller patients and those with a pre-existing lower lung capacity may also be more susceptible to air embolisms.
The FDA advised health care facilities and providers to search their inventories for the sheath and return any unused sheaths to Sterilmed. The agency said providers should also continue to monitor patients treated with the sheath, just as they would normally do.

FDA Recalls Johnson & Johnson Heart Device

A Sterilmed representative said that the company initiated the recall in June and that it has not received any reports of adverse events related to the devices.

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Failed Medical Procedures Proliferate

In November Cook Blood Clot Filter Lawsuits2017, new studies revealed that stents put into heart disease patients to keep arteries open work no better than a placebo. Hundreds of thousands of US patients receive expensive stents each year for the relief of chest pain. Americans pay anywhere from $11,000 to $41,000 for a stent procedure that, it turns out, is useless for most.  The wasteful and dangerous stent is just the latest in a long string of expensive and unnecessary medical treatments foisted on us all in recent years. Failed medical procedures proliferate in our profit-driven medical culture.

IVC Filters, Power Morcellators, Hernia Mesh Failures
To name just three others in recent memory, IVC filters have also been found to be almost completely unnecessary.  They are rarely, if ever, worth the risk of their implantation.  Power morcellators used for hysterectomy or uterine fibroid removal are another dangerous “improvement”; they can be lethal when used on women with undiagnosed cancer.  And finally, hernia mesh (plastic) is another unnecessary and dangerous “improvement” recently unmasked.  Lawsuits have been filed against the promoters and makers of all three of these “improvements,” because risk-benefit analysis shows that each is not worth the risk of its potential failure.

The Latest Technology Prejudice
The Western medical establishment, run on the sick-model-profit-motive, is decidedly prejudicial when it comes to using the “latest” technology. Most of us have also been unwittingly conditioned to embrace the latest gadget or device.  If it’s new, we almost instantly imagine that it must be better.  We are, at the least, encouraged to think so by television advertisements, the shiny new brochures that litter doctors’ offices, our own doctor’s own glowing recommendation that this is the “new great thing.”  New being the operative word, and sadly, if our doctor doesn’t know what “the latest” device, drug, or procedure is, we are conditioned to think she has failed to keep up with the times, and are apt to look for another, more “up to date” doctor model.

Money Prejudice

There is also a money prejudice at work.   Conditioned to pursue and worship money and to listen to those who have it, we sacrifice or denigrate our own skills and aptitude, as we genuflect to the money.  If some computer, phone, or medical device company spent millions developing this latest thing, it must be good, we imagine, because why else would they have spent all that money?  (Our money prejudice is a non sequitur we ignore at our peril.)  At the very least, we want to benefit from this great new thing, this new peachy pinnacle of money power.

We’re All Sales People Now
In our personal lives we act as (unwitting) sales people as we show one another the slickest features on the “new” cell phone, the bells and whistles on the latest model car, television, or “Smart” (Read: stupid) appliance.  Most of us embrace so-called Smart meters without a whimper of protest (or a single minute of research), even though they don’t save us anything and actually cost us all more for power in the long haul.  (But thousands of citizens have complained to Calif. PG&E; so some people are, fortunately, paying attention.)

Stents Unnecessary (for most), Expensive, Dangerous
As for stents, “Several randomized trials have clearly shown that stents and angioplasties don’t prolong life or prevent heart attacks in stable patients. Now, we know that they don’t reduce angina either,” wrote Dean Ornish, MD, clinical professor of medicine at the University of California of San Francisco.

IVC Filter Problems
No study has proven IVC filters are necessary or more effective than the treatment which preceded them – blood-thinning drugs and dietary and lifestyle changes. No study has demonstrated the efficacy of IVC filters. They have been shown by thousands of people, however, to be quite dangerous. They can be impossible to remove. They have likely killed thousands of people whose deaths were not attributed to the filters. They can break apart and migrate and perforate the heart and lungs, causing life-threatening conditions. IVC filter lawsuits have, consequently, been filed by the thousands against Cook Medical, Bard, Boston Scientific, Cordis, and other IVC filter makers. Even the AMA, virtually always friendly with medical device makers, has admitted these devices have proliferated despite any evidence of efficacy.

Power Morcellator Problems
Power morcellators have been used for performing hysterectomies and removing uterine fibroids. They’ve been marketed as a more convenient method for surgeons and as a less invasive method for women to undergo certain surgeries. The problem is that when they are used on women with undiagnosed uterine cancer (not entirely uncommon), they can spread that cancer throughout the body, and weaponize it so that it becomes lethal. As a result, power morcellator lawsuits have been filed against Johnson & Johnson (Ethicon) and other morcellator makers.

Hernia Mesh Problems
Hernias were fixed for at least 100 years with simple suturing, until some medical device maker got the bright idea to insert plastic mesh into the human body. The procedure is easier for surgeons or doctors who don’t have the chops to perform a good old fashioned suturing job, and it promises the patient a “less invasive” procedure with faster recovery times. The problem, however, is that once that mesh goes in, it “meshes” with the body’s tissues, grows into them in ways which can make it all but impossible to remove. When infection follows, as it often does in the body’s natural foreign body reaction, the mesh often needs to be removed; but it can be all but impossible to remove. The unlucky mesh implantee can then be doomed to a lifetime of pain. In the “old” method of simple suturing, any complications could be much more easily corrected or revised. The doctor could even remove all the stitching, if necessary, and begin again.  Not so with mesh.

Failed Medical Procedures Proliferate
Given all these failed or at best dubious devices and procedures, people would be wise to do their research before submitting to the latest, greatest procedure, pill or medical device. Discerning patients might be wise to start by looking very closely at their own ingrained prejudices concerning the latest, greatest anything.  Advertising dollars run what we call “the news,” which is often little more than the promotion of corporate products and corporate values, which is no values at all beyond the blind worship of profits.

Patient, beware.

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