Merck sued by former Vaccine Employees

Two former Merck MMR Vaccinevaccine employees filed a lawsuit against Merck Pharmaceuticals. Virologists Stephen Krahling and Joan Wlochowski filed a lawsuit in 2010 against their former employer over what they say is the company’s falsely reporting the efficacy of the MMR vaccine. The lawsuit,  unsealed in June 2012, claims Merck defrauded the U.S. government and people for more than ten (10) years by overstating the effectiveness of the Merck MMR vaccine.

Merck Inflated Vaccine Efficacy

Merck needed to maintain a certain percentage of effectiveness with its MMR vaccine. When Merck found it could not do so, it simply fudged the numbers, according to the complaint, ratcheting them upward in order to keep their lucrative contract with the U.S. government.

The virologists’ petition claims that they “witnessed firsthand the improper testing and data falsification in which Merck engaged to artificially inflate the vaccine’s efficacy findings.”

Merck sued by former Vaccine Employees

This is not the first time quality control issues have surfaced over Merck vaccines. National Vaccine Information Center (NVIC) President and Co-Founder, Barbara Fisher, noted in an interview with Dr. Mercola that in 2010 Merck’s RotaTeq® vaccine was contaminated with a virus lethal to baby pigs.  Merck is the biggest player in the international vaccine game, taking in some  $20 billion annually in global vaccine sales. The company also makes the controversial shingles vaccine which causes shingles, as well as the ill-fated gardasil vaccine.

Vaccine Safety Compromised by Cozy Relationships

Ms. Fisher discusses the dangerously cozy relationship and conflicts of interest between federal agencies charged with vaccine safety oversight and vaccine makers. NVIC has long called for investigation into federal agency conflicts of interest and the creation of an independent agency to oversee vaccine safety.

Merck Vaccine Safety Questionable

Merck is also maker of the ill-fated Gardasil vaccine and the troubled Shingles Vaccine, which can give someone shingles and also cause eye damage.

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Gunther Tulip IVC Filters Troubling Studies

IVC blood clot IVC Filter Graphicfilters have a troubled history when one looks closely at their safety and efficacy studies. The general safety profile of IVC filters makes them difficult to justify using for the general population.

Gunther Tulip IVC Filter Tilt 91%

Several researchers – including Alan Sag, BS; Joseph M. Stavas, MD; Charles T. Burke, MD; and several others – analyzed a retrospective review of 175 patients with the Gunther Tulip IVC filter implanted from 2003-2007. They reviewed each patient’s medical records and cavagrams, and published their conclusions in the Journal of Vascular and Interventional Radiology in 2008. Ninety-one percent (91%), 159/175 patients had tilt in their filters upon the first retrieval attempt. They found that the tilt “resulted in decreased clot-trapping abilities, increased complications, thrombosis, and difficulty in removing.”

IVC Filters increase DVTs

An American Heart Association study published in March 2005 by the PREPIC Study Group concluded that, at eight years, vena cava filters reduced the risk of PE, but increased the risk of DVT’s, and had no effect on patient survival. The authors’ conclusion was that although IVC filter use “may be beneficial in patients at high risk for pulmonary embolism, systematic use in the general population with venous thrombotic embolism (DVT and PE) is not recommended.” (emphasis ours)

IVC Filter Role Unproven

A clinical investigation by the International Society of Endovascular Specialists in 2007 looked at the retrievability of Cook’s Gunther Tulip Vena Cava Filter after dwell times longer than 180 days for multiple trauma patients. Thirty three (33) of 115 filters could not be retrieved. The investigation concluded that the role of IVC filters is unproven, and that retrieval should be done as soon as clinically indicated.

IVC Filters Difficult Removal

A Journal of Medical Imaging and Radiation Oncology article published in 2008 looked at the retrievable Gunther Tulip inferior vena cava filter in 317 patients. The authors reported that reported retrieval periods for the Gunther Tulip filter have continued to lengthen despite recommendations to remove them at 14 days, which later became at the doctor’s discretion.

The authors concluded: “Our data suggest (that) the extended filter dwell times may compromise successful retrieval.”

IVC Filters Not Retrieved

A Journal of Vascular and Interventional Radiology article published in 2008 examined 188 patients with attempted filter removal, with a mean dwell time of 63 days. Even at just two months, 12% were retrieval failures. The authors concluded that 90 percent of filters not retrieved perforated the IVC, the connection between perforation and inability to remove. Just as disconcerting, they concluded that increased dwell time was a significant factor in determining retrieval success.

Gunther Tulip worsens over time

Another Journal of Vascular and Interventional Radiology article, this one published in 2013, found the Gunther Tulip Filter troubling when left in a person over time. The authors concluded: “Although the Gunther Tulip and Option filters exhibit caval penetration on CT imaging, only the GTF (Cook) exhibits progressive penetration over time.

Gunther Tulip IVC Filters Troubling Studies

A 2007 study published in The Journal of Trauma and Acute Care Surgery found that despite IVC filters being generally accepted to reduce the risk of fatal PE, “this has not been proven, particularly when used for prophylactic indications.”

Further troubling, the study found that most IVC filters are not retrieved when placed for trauma patients. That information comes in addition to the fact that IVC filters have not been proven to increase trauma patients mortality.

 

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IVC Filters Risk Serious Complications – Health Canada

IVC filters riskHealtha Canada serious complications, said Health Canada this week. Serious IVC filter complications, including death, have been reported in patients implanted with an IVC filter.  IVC filters can result in caval perforation, caval thrombosis, filter fracture and fragment embolization, intracardiac migration, cardiac perforation, and/or cardiac tamponade. Many of these serious complications occurred with long-term filter implantation – greater than 30 days. Health Canada said these complications have also been reported internationally.

Dear Doctor Letter for IVC Filter Use

On July 25, 2016, Health Canada sent a “Dear Healthcare Professional Letter” (a ‘Dear Doctor letter’ in American parlance) to warn doctors and other medical professionals about the dangers of IVC filters. The IVC Filters named in the letter include those made by Bard, Cook Medical, B. Braun and Cordis.

The letter said its intended audience was physicians who request or implant Inferior Vena Cava (IVC) filters and clinicians responsible for follow-up care:  radiologists, cardiologists, vascular surgeons, thrombosis specialists, internists, emergency physicians, bariatric surgeons, orthopaedic surgeons, primary care physicians.

It also asked these professionals to distribute the letter to “relevant departments and appropriate personnel who use IVC filters.”

Limited Indications for IVC Filters

Healthcare professionals were cautioned in the letter that they should carefully consider the indications for IVC filters. Health Canada said the IVC filter should be considered only for patients with acute proximal deep vein thrombosis (DVT) of the leg, and those with acute pulmonary embolism (PE) IF those patients also have a contraindication to anticoagulation (blood thinner medication such as cumadin).

Retrievable IVC Filters short-term only

The letter further cautioned that retrievable IVC filters are intended only for short-term placement. When possible, they should be removed when anticoagulation therapy can be started or if a patient’s PE risk subsides.

Health Canada encourages each hospital to identify all patients who have a retrievable IVC filter placed and to develop a formal strategy to assess these patients for filter removal.
Health Canada said it had received 121 reports of serious complications associated with IVC filters as of June 6, 2016. Serious complications such as caval perforation, caval thrombosis, filter fracture and fragment embolization, intracardiac migration, cardiac perforation, cardiac tamponade, and death have been reported in patients who have been implanted with IVC filters. Many of these complications occurred with long-term (greater than 30 days) filter implantation. These complications have also been reported internationally.

Health Canada named six IVC filter manufacturers and twelve (12) different IVC blood clot filter products in the letter:

Filter & Maker:

ALN:

•  ALN Vena Cava Filter   (Retrievable)

Bard:   

•  Denali Vena Cava Filter (Retrievable)

•  G2 Filter System            (Retrievable)

•  Simon Nitinol Vena Cava Filter  (Permanent)

B. Braun Medical:

•  VenaTech LP Vena Cava Filter (Permanent)

Cordis Cashel:

•  Optease Vena Cava Filter       (Retrievable)

•  Trapease Permanent Vena Cava Filter

William Cook, Europe APS And Cook, Inc.:

•  Cook Celect Platinum Vena Cava Filter (Retrievable)

•  Cook Celect Vena Cava Filter (Retrievable)

•  Gianturco-Roehm Birds Nest Vena Cava Filter (Permanent)

•  Gunther Tulip Vena Cava MREye Filter Set (Retrievable)

 REX Medical, LP

•  Option Retrievable Vena Cava Filter System  (Retrievable)

Randomized Control Trials show IVC Filters fail efficacy

Randomized control trials are the gold standard for testing medical device safety. Health Canada said there have been several clinical studies of IVC filters, but only two randomized controlled trials (RCTs). Results from those two RCTs fail to support IVC filter use in patients who can be treated with anticoagulation. In addition, those RCTs failed to show reductions in VTE and mortality.

IVC Filters Risk Serious Complications – Health Canada

Health Canada also noted that it is working with IVC filter makers to monitor post-market safety and effectiveness of IVC filters in Canada and worldwide. Health Canada has required IVC filter makers to put post-market evaluations in place that could include Canadian registries. The agency said it wants to “further understand appropriate patient populations that should be treated with IVC filters.” Health Canada said it is also sharing this important IVC filter safety information with healthcare professionals via fax, in addition to publication on Healthy Canadians Web site, as well as MedEffect.

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Whistleblower says Big Pharma Execs need Prison Time

The Department of melayna-two-300x298Justice announced July 20, 2016 that two former Big Pharma executives were convicted by a jury on 10 counts of introducing adulterated and misbranded medical devices into interstate commerce. William Facteau, 47, of Atherton, Cal., and Patrick Fabian, 49, of Lake Elmo, Minn., were convicted after a six week trial.

As part of the deal, Johnson & Johnson subsidiary Acclarent must pay the U.S. government $18 million to settle a whistleblower lawsuit under False Claims Act violations.

Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division, said, “The FDA approval process serves an important role in ensuring that federal health care participants receive devices that are safe, effective and medically appropriate. (We) will not permit companies to circumvent that process and put profits over patient safety.”

 

Medical Device Illegally Marketed

Acclarent made the RElieva Stratus Microflow Spacer – also known as Stratus – meant to be used with saline solution to maintain sinus openings after surgery.

Acclarent, however – at the behest of Mr. Facteau (CEO) and Mr. Fabian (VP of Sales) – marketed Stratus as a drug delivery device for corticosteroids, even after FDA rejected Acclarent’s request to include that indication (for approved uses) in 2007. Acclarent went so far as to produce a video that demonstrated Stratus being used with the corticosteroid Kenalog-40.

Trial evidence demonstrated Mr. Facteau and Mr. Fabian moved to develop and market products, including the Stratus, as a drug delivery device, to create a projected revenue stream to make the company an attractive business for either an initial public offering or an acquisition.

Facteau and Fabian were acquitted by the jury on 14 felony counts of fraud, but convicted on ten misdemeanor counts related to the same conduct.

A charge of violating the Food, Drug and Cosmetics Act can bring a sentence of no more than one year in prison on each count, one year of supervised release, and a fine of $100,000, or twice the gross gain or loss. Actual sentences for federal crimes are usually lower than the maximum penalties. A federal district court judge imposes sentences based on U.S. Sentencing Guidelines and other statutory factors.

False Medicare Claims

As a consequence of the illegal marketing of Facteau and Fabian, health care providers who submitted claims to Medicare and other federal health programs for that illegal use did so under false pretenses.

 

Whistleblower says Big Pharma Execs need Prison Time

Melayna Lokosky, a former Acclarent sales rep who blew the whistle on the two executives, believes they should be held accountable and deserve to serve prison time. Ms. Lokosky has initiated a petition at Change.org. She wants them to serve the stiffest penalties possible under law.

She was fired from her position at Acclarent after objecting to the illegal marketing. She started a Facebook page, Killing My Career to help publicize the Acclarent story.  She has also become something of an advocate for women involved in transvaginal mesh lawsuits, for which upwards of 100,000 women who have filed lawsuits have witnessed an almost complete major media blackout.

Ms. Lokosky states on her petition: “If you were injured by a medical device then you’ll want to pay attention to this story. Don’t miss your opportunity to weigh in on sending convicted white collar medical device executives to jail. Especially if your injury stems from a company first funded by NEA – New Enterprise Associates (like Gynecare or Essure because they also funded Acclarent.”

“We cannot allow the courts to encourage, replicate and reward unethical and illegal behavior that a jury of peers already CONVICTED on, by going soft on medical device executives during their sentencing.”

Accountability for Medical Device Executives

The case is unusual for holding executives of a major corporation accountable rather than simply imposing civil fines.

U.S. Deputy Attorney General Sally Yates issued a memo published in fall 2015, which stated: “One of the most effective ways to combat corporate misconduct is by seeking accountability. (Such) accountability (deters) future illegal activity, it incentivizes changes in corporate behavior, it ensures that the proper parties are held responsible for their actions, and it promotes the public’s confidence in our justice system.”

Medicare, Medicaid Fraud Team

The whistleblower lawsuit was filed under the Health Care Fraud Prevention and Enforcement Action Team, created by Health and Human Services in May 2009 to reduce and prevent financial fraud in Medicare and Medicaid. The False Claims Act allows whistleblowers to alert lawmakers to financial crimes and share in a portion of the recovery. The DOJ has reportedly recovered more than $30 billion since January 2009.

The civil lawsuit was filed in the District of Massachusetts United States ex rel. Melayna Lokosky v. Acclarent, Inc.

Stratus was taken off the market in May 2013 and marketing for the device was discontinued. According to the DOJ, it is no longer commercial available in the U.S.

Johnson & Johnson acquired Acclarent in 2010, which, according to J&J, was before the executives broke federal laws.

Attorneys for Mr. Facteau & Mr. Fabian said they will appeal the misdemeanor convictions.

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Myomectomy Fibroids can trigger Morcellator Lawsuit

Myomectomy is the Morcellator Surgery Risksurgical removal of fibroids from the uterus. Myomectomy saves the uterus, and it can save a woman from undergoing a complete hysterectomy. Myomectomy is the preferred fibroid treatment for women who wish for pregnancy, because it can improve the chances of it.

Fibroids – according to womenshealth.gov – are muscular tumors that grow in the wall of the uterus (womb). Another term for fibroids is “leiomyoma”, or simply “myoma.” Fibroids may grow as a single tumor in the uterus, or they can grow in bunches, individually as small as a seed, or as big as a grapefruit. In rare cases they can grow even larger.

Cancerous Uterine Fibroids

Fibroids are usually benign, non cancerous. But when they are cancerous and that cancer is not detected, problems can result. When a power morcellator slices and dices cancerous fibroids and simultaneously vacuums them out of the uterus, the morcellator can spread the cancer with tragic results, leading to uterine cancer and perhaps other types of soft tissue cancer. When that happens, Morcellator Lawsuits are being filed across the country.

Surgical methods for Myomectomy (Web MD):

  • Hysteroscopy – a lighted viewing instrument inserted through the vagina and into the uterus.
  • Laparoscopy – a lighted viewing instrument used for one or more small abdomen incisions.
  • Laparotomy – a larger incision in the abdomen.

Myomectomy Method of choice depends on several factors:

• Fibroid size, location, numbers.
• Hysteroscopy to remove inner wall fibroids that haven’t grown deep into the uterine wall.
• Laparoscopy to remove fibroids, up to 2 in. (5.1 cm) across, growing on the outside of the uterus.
• Laparotomy to remove large or many fibroids, or fibroids grown deep into the uterine wall.
• To correct urinary or bowel problems without causing organ damage, laparotomy usually best.

 

Myomectomy Overview

Hysteroscopy is an outpatient procedure, while Laparoscopy may be an outpatient procedure or may require a one-day stay. Laparotomy requires an average stay of 1-4 days.

Recovery time depends on the myomectomy method. It can take from a few days to six weeks or more. :

Fibroid Recurrence

Fibroids return after surgery in 10 to 50 out of 100 women (according to Web MD), depending on the original fibroid problem. Larger and more numerous fibroids are most likely to recur.

Hysterectomy for Fibroids

In rare cases, a hysterectomy is needed when the surgery reveals that the uterus is too overgrown with fibroids for a safe myomectomy.

Related

•  WomensHealth.Gov: Uterine Fibroids Fact Sheet

•  Uterine Fibroids Health Center (Web MD)

•  Morcellator Lawsuit

•  Uterine Cancer Lawsuit

•  Morcellator Lawsuit Update

•  Morcellator a National Security Threat from FDA

•  American College of Obstetricians and Gynecologists (2008, reaffirmed 2012). Alternatives to hysterectomy in the management of leiomyomas. ACOG Practice Bulletin No. 96. Obstetrics and Gynecology, 112(2, Part 1): 387-399.

•  Parker WH (2012). Uterine fibroids. In JS Berek, ed., Berek and Novak’s Gynecology, 15th ed., pp. 438-469. Philadelphia: Lippincott Williams and Wilkins.

•  Practice Committee of the American Society for Reproductive Medicine, Society of Reproductive Surgeons (2008). Myomas and reproductive function. Fertility and Sterility, 90(3): S125

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Transvaginal Mesh Media Blackout

Anyone who doesn’tJustice Peaking Blog think news content is controlled by corporations needs to take a hard look at the national media coverage of transvaginal mesh – or rather, the lack of coverage. Transvaginal mesh verdicts as large as $73 million on a single case have not been reported in the New York Times, Wall Street Journal, Washington Post; nor have they been reported on CBS, NBC, ABC or any other major television news channel.

Some 100,000 American women have filed lawsuits against pelvic or transvaginal mesh makers Johnson & Johnson (Ethicon), Boston Scientific, Bard, American Medical Systems (AMS) and other mesh makers. The sheer numbers of women who claim mesh injuries clearly indicate that this IS a news item, or should be. But you’d never know it by the roar of silence from mainstream media.

Transvaginal Mesh Media Blackout

So why the mainstreammesh image media blackout?  One word: Advertising.  Johnson & Johnson spends hundreds of millions of dollars in advertising with mainstream publications and television outlets. Do those “news” organizations want to bite the hand that feeds them?

The issue of the media blackout is not about taking a side in the litigation. The issue is that people deserve to have news reported to them when it concerns them. Transvaginal mesh concerns them, or it concerns someone they love or know.  Mainstream media, instead of giving people information they need to make informed decisions regarding their health or the health of their loved ones, takes the advertising money from J&J and others, and then fails to report in timely and fair fashion, anything that could be construed as negative press against those corporations. On the rare occasions they do report, you won’t find it on page one where it belongs.  You’ll find such stories buried where most people will never see them.

U.S. Press partners with Corporations

Because U.S. media is so thoroughly corrupted by corporate money, more and more intelligent people turn to the web for their news. Those people understand that the mainstream media, the press, which is supposed to be the 4th estate – a watchdog for corporate corruption, malfeasance, negligence and the like – is instead in partnership with the very corporations they are supposed to investigate. It’s not a conspiracy. Anyone with a job and a brain knows that you work to make the paymaster happy. That’s simply how the world works, or doesn’t.

Just as the Democratic National Committee partnered with the Hillary Clinton campaign to marginalize and disenfranchise Bernie Sanders and the issues he brought to the fore, the mainstream media partners with corporations to marginalize victims of transvaginal mesh.

1984

In George Orwell’s classic novel, 1984, newspapers and all news is tightly controlled by the state. In our not very brave new world, the “news” is tightly controlled by corporations. In many cases, corporations which are most in need of having light shined on them have the least light shined.

Can’t Get Fooled Again

As George W. Bush famously (or infamously, depending on your point of view) said: “Fool me once, shame on you. Fool me twice. . . can’t get fooled again.”  Let’s not get fooled again. Dig out the news and the truth yourself, because you’re not going to get it watching television, or reading mainstream rags which refuse to print the larger truths which concern us all.

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IVC Filter Risks outweigh Benefits in Bariatric Surgery

Bariatric patients IVC Filter Graphic(Lap band surgery) implanted with an IVC filter had a higher death rate than those who received no filter during their surgery.

Bariatric surgical procedures (according to the American Society for Metabolic and Bariatric Surgery) are designed to trigger weight loss by restricting the amount of food the stomach can hold, causing malabsorption of nutrients, or by a combination of both gastric restriction and malabsorption.

“In bariatric surgery, the risks of IVC filter insertion exceed the benefits and their use should be discouraged,” said Jonathan D. Finks, M.D., of the University of Michigan in Ann Arbor.

The most popular bariatric surgery procedures are gastric bypass; sleeve gastrectomy; adjustable gastric band; biliopancreatic diversion with duodenal switch. According to a study published as an abstract in 2011 and presented at a conference, anyone who underwent any of these procedures and was simultaneously implanted with an IVC filter had a higher death rate than bariatric surgery recipients not implanted with IVC filters.

IVC Filter Recipients’ Higher Death Rate

VTE, according to a story in Medpage Today, occurred in 1.8% of 1,045 filtered patients versus 0.4% of a propensity-matched cohort. The 30-day mortality was 0.07% with a filter and 0.02% in a matched cohort of unfiltered patients. Dr. Finks reported the findings in an American Society for Metabolic and Bariatric Surgery meeting.

Analysis of 29,000 unmatched registry patients without filters showed similar disparities in VTE, mortality, and other adverse outcomes in IVC filter recipients compared with unfiltered people.

FDA IVC Filter Safety Alert

Concern about potential risks associated with IVC filters led FDA to issue a safety alert in 2010. The agency said that since 2005 it had received nearly 1,000 adverse event reports related to IVC filters, most involving device migration (328); embolization (146); perforation (70); IVC filter fracture (56).

The FDA recommended medical professionals consider removing retrievable IVC filters and encouraged close follow-up of all filtered patients.

Dr. Finks said investigators in the Michigan Bariatric Surgery Collaborative took notice of IVC-related complications a year or two before the FDA alert. About 8% of Michigan hospitals reported routine use of IVC filters during bariatric surgery. More recent data shows IVC filter use lowered to less than 1%.

No Benefit for PE Risk and Greater Risk of Complications

Previous analysis of the collaborative’s data showed IVC filters did not reduce the risk of pulmonary embolism and trended toward an increased risk of complications (Ann Surg 2010; 252: 313-318).

In further efforts to assess the risk-benefit analysis of IVC filters for bariatric surgery patients, Dr. Finks and colleagues examined the collaborative database for patients who had undergone bariatric procedures from 2006-2011. They found that 1,045 of 31,499 patients received prophylactic IVC filters.

From the patients who did not receive filters, investigators produced a propensity-matched cohort of 1,045 patients for comparison with the filter group.

IVC Filter Risks outweigh Benefits in Bariatric Surgery

Dr. Finks reported that 39% of patients in the filter group had a history of VTE, as did 36% of the matched cohort, both substantially higher than in the 29,409 unmatched patients who did not receive filters.

Dr. Finks disclosed a relationship with Ethicon EndoSurgery.

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Morcellator Hazards must be reported if Bill passes

Morcellator hazards morcellator uterine cancermust be reported if a new bill passes. Today, morcellator problems for women with undetected uterine cancer are rarely reported by doctors. Likewise for other dangerous medical devices such as transvaginal mesh or metal-on-metal hip or knee replacements. Sadly, medical professionals just don’t take the time, or don’t have the time, to report adverse medical device events as they occur. A new bill proposed last month may, however, change the whole game.

If the new bill becomes law, doctors would be required to report to the FDA potentially serious problems with medical devices they use.

The “Medical Device Guardian’s Act,” is being pushed by some members of Congress to help raise awareness of the risks of power morcellators and other hazardous medical devices.  Morcellator uterine cancer problems inspired the bill’s sponsors to change the law. A long warnings delay kept thousands of women from making informed decisions about whether or not to allow power morcellators to be used on them. Laparoscopic power morcellator alre often used for cyst removal or hysterectomy.

In 2014, the FDA belatedly called for a “black box warning” for power morcellators. The agency then announced that morcellators can spread a hard-to-detect uterine cancer during surgery.

 

FDA receives Delayed Reports

Though medical studies and literature had highlighted the risk of power morcellators since they were first used in the 1990s, the FDA didn’t receive any report of an adverse event until late 2013.  It took a medical professional, Dr. Amy Reed, to bring dangers of the morcellator to the agency, after a morcellator was used on her personally during a hysterectomy at a Boston hospital.

Dr. Amy Reed, Morcellator Cancer Victim

The Wall Street Journal reported that U.S. Reps. Mike Fitzpatrick (R., Pa.) and Louise Slaughter (D.,N.Y.) wrote in a letter to colleagues introducing the bill: “After that initial report from Amy, hundreds of other safety reports began to flow into the FDA.”

“In retrospect, it should not have fallen on patients to get the FDA’s attention,” the representatives said.  “[E]veryone in the chain of care” should be responsible for informing the FDA of medical device hazards.

The FDA now requires hospitals and device manufacturers to report deaths and serious injuries linked to medical devices to the agency’s database of adverse events. However, doctors are not legally mandated to inform the FDA of adverse events, though the agency encourages them to report and even accepts doctors’ reports by smartphone.

The medical device legislation proposed would add doctors and doctors’ offices to the list of mandated reporters. Bill sponsors also said the bill would protect doctors from having reports they file to the FDA used against them in civil cases. Doctors’ understandable aversion to litigation, has, of course, left some or most of them reluctant to file such reports; but it seems this caveat of the bill could open the door for a potentially troubling conundrum. Would any doctor who reports his or her involvement in an adverse medical device event then be categorically immune from any responsibility related to using the device?

Power Morcellator Problems

Doctors use power morcellators in tens of thousands of minimally invasive procedures yearly to remove benign growths known as fibroids; however, uterine cancers called sarcomas can also appear as benign fibroids that can’t be detected before surgery.  A morcellator used in such cases can spread malignancies – and other diseased tissues – inside the body, spread cancer and lead to worse outcomes.

In most cases, doctors and patients have learned only after the morcellator was used that a benign “fibroid” was in reality cancerous, after pathologists then tested the tissue.

The Government Accountability Office has since launched an investigation, and dozens of morcellator lawsuits have been filed.

J&J Morcellator Lawsuits Settled

Johnson & Johnson and Ethicon suspended sales of their power morcellators in April 2014, then withdrew them from the market in July 2014. The company has settled more than 100 legal claims and lawsuits tied to the morcellator’s cancer-spreading risk, according to attorney David Matthews, a plaintiff’s lawyer who handles medical device and pharmaceutical drug lawsuits.

A spokeswoman for J&J’s Ethicon division was quick to point out: “The resolution of these cases is not an admission of liability. (We) believe that Ethicon acted appropriately and responsibly at all times in relation to its morcellation devices. We will defend ourselves in remaining lawsuits.” The woman refused to give amounts on settled claims or to discuss their terms.

Morcellator Litigation Nationwide

Separate morcellation cases are pending against other morcellator makers nationwide, including more than 40 filed in a Los Angeles court against Karl Storz GmbH. That company has denied wrongdoing in court filings and did not respond to a request for a comment from the Wall Street Journal in June 2016.

Morcellator Hazards must be reported if Bill passes

Power morcellator problems have additionally revealed gaps in the U.S. system for tracking serious device risks.  In the congressional representatives’ letter that introduced the legislation, they noted the hospital that treated Dr. Reed also saw a patient “harmed by a morcellator one year earlier”, yet failed to inform the FDA.

The Wall Street Journal reported that Brigham and Women’s Hospital in Boston had confirmed two cases – Dr. Reed’s in 2013 and another woman’s in 2012 – in which a power morcellator spread cancer. Hospital officials, however, according to a Brigham spokeswoman, had determined these two cases weren’t reportable because the “device functioned as expected and was used in the way it was intended, although with unintended and tragic consequence.” The woman added that Brigham has since fully reported both cases.

FDA admits Limitations

Still, the bill wouldn’t be a cure-all, the FDA intimated in a statement in June 2016 that the bill would not solve device reporting problems. The agency would not comment on pending legislation, but did say the medical device reporting system has “important limitations.”

The agency is now planning a national evaluation system that would use data generated during patient care to identify safety issues more quickly. The FDA said it needs congressional and industry support to “build this system.”

 

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IVC Filter Patients Unaware of Implants

Many IVC filter IVC Filterpatients are unaware of the implants in their own bodies. Many people implanted with the strange umbrella-skein like device in their inferior vena cava (vein beneath the heart) have it implanted without their knowledge or consent when they enter a hospital as trauma patients. Trauma patients comprise some 30% of the IVC filter market, and studies show that implanting them with IVC filters is a highly questionable practice.

No Survival Benefit for Trauma Patients

One study examined 803 patients who received an IVC filter after a traumatic event that occurred from 2010 to 2014. The results were surprising and unsettling. Not only did patients who received IVC filters fail to receive any survival benefit, they also suffered an increased rate of deep-vein thrombosis. Deep-vein thrombosis can be as life threatening as a loose blood clot the filters are promoted to prevent.

IVC Filters Deep Vein Thrombosis Risk

Deep vein thrombosis refers to a blood clot formed deep in the body, usually in the legs. The authors of the study concluded that, “High rates of (preventative) IVC filter placement have no effect on reducing trauma patient mortality and are associated with an increase in DVT events.”

IVC Filter Patients Unaware of Implants

Patients who are unaware of their filter implants are especially at risk, because unknown temporary implants left inside a person past the indication (when blood clot risk has passed) become increasingly difficult to remove.

Unretrieved Filters carry Long-term Risks

A 2013 paper published in the Journal of the American Medical Association (JAMA) notes that unretrieved removable filters may carry significant long-term risks. The paper (from Dr. Shayna Sarosiek and others) cites data from a review of 37 studies that confirm the increased rate of complications when filters are left in place for longer than 30 days and indicate a retrieval rate of some 34%.

Authors of the paper – Indications, Complications, and Management of Inferior Vena Cava Filters – said that the risks “seem to increase with the length of time that the filter is in place.”

FDA: Remove Filters when PE Risk Subsides

The Food and Drug Administration recommends that IVC filters should be removed just as soon as the risk of PE has subsided. Study evidence, however, shows that is not what is happening. And how can people have their filters removed when they don’t even know they have one implanted?  You know medical device implantation, the entire train of the medical system has run off the tracks, when people can be implanted with a dangerous device without their knowledge or consent.  A device that shows no proof of safety or efficacy.

 

Free Legal Consultation

Matthews & Associates is handling IVC filter cases nationwide. If you or someone you love was implanted with a Bard IVC Filter, Cook IVC Filter, or some other blood clot filter, contact us now for a free legal consultation regarding a potential IVC Filter Lawsuit.

 

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Retrievable IVC Filters Not Retrieved

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

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

Failure to Remove IVC Filters a Problem

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

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

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

Patients unaware of IVC Filter Implant

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

Unretrieved IVC Filters Unsafe for Long-Term

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

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

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

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

To be continued. . .

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