Bill to make Drugmakers “Justify” Price Hikes

Democrat and epipensRepublican Senate and House representatives introduced a bill last week to make drugmakers “justify” price hikes greater than 10 percent. USA Today reported that the bill was proposed due to the firestorm surrounding Mylan’s recent EpiPen price hikes. The lawmakers were also careful to point out that this move was not “regulation,” per se, so as not to offend any  Reagananomics worshippers.

Related: How Deregulation Destroyed U.S. Dominance

Facing public outrage over recent exorbitant EpiPen price hikes, Mylan recently announced it was taking the unprecedented step of offering a generic version of EpiPen at roughly half the price of the brand item. Drugmakers typically milk the profits from a brand name of a drug as long as possible before federal drug pricing guidelines force them to introduce or allow generic versions to hit the market.

The Fair Accountability and Innovative Research (FAIR) Drug Pricing Act is co-sponsored by Sen. Tammy Baldwin (D-Wis.); Sen. John McCain (R-Ariz.); Rep. Jan Schakowsky (D-Ill.).

Drug Company Disclosure Demands

At least 30 days before raising the price of a particular drug by more than ten (10) percent, the bill would require a drugmaker to disclose to HHS – the U.S Department of Health and Human Services – the company’s spending on advertising, development, manufacturing, and research for the drug. The drugmaker would also need to report net profits from the sale of the drug.

Transparency Buzzword Sounds Good

Mr. McCain, with his heavy constituency of retirees using prescription drugs in his state of Arizona, said the bill “would bring much-needed transparency to prescription drug prices. Transparency leads to accountability, and it is past time that mantra applied to the skyrocketing cost of prescription medication.”

Ms. Schakowsky also echoed the transparency theme: “Prescription drug corporations should not be allowed to hide behind a curtain, refusing to disclose information on drug prices, and price gouging with impunity.”

Tammy Baldwin, (Rep. Wis.)
According to Ms. Baldwin, the bill is not likely to pass this year because it was introduced so late in the session. She said the main effort is “intended to create momentum” for 2017 when the lawmakers plan to reintroduce the measure.

Campaign for Sustainable Rx

Executive director for the Campaign for Sustainable Rx Pricing, John Rother, called the lawmakers’ effort a first step in repairing the “broken prescription drug market.” If it is a first step, it certainly seems to be a very small one.*

USPSTF Listing
Consumer advocates, as well as Mylan, seek to add EpiPen to USPSTF’s list of preventive medical services. Under the Affordable Care Act, insurers must cover services with that exclusive status at no cost to patients.

Mylan Profits Secure Either Way

The New York Times noted that while that designation could limit out-of-pocket costs for insured patients, it would also allow Mylan to raise prices further, because insured patients wouldn’t bear any of the treatment’s cost. Moreover, consumers could still be strapped with higher costs through higher premiums or copays for other drugs, if their insurers seek to mitigate the costs of covering the EpiPen at no cost.

Bill to make Drugmakers “Justify” Price Hikes

According to the Times, the USPSTF list does not include any other prescription drugs for diagnosed conditions, so it could be tough to get EpiPen listed. USPSTF has recommended at least one over-the-counter drug, aspirin. It usually lists treatments for patients only if there are “no signs or symptoms of the specific disease or condition” (O’Donnell, USA Today, 9/15; Flom, Roll Call, 9/15; Lipton/Abrams, New York Times, 9/16; Abrams, New York Times, 9/16).

Meanwhile, as more and more people are becoming aware of just how little power they have in deciding drug prices, more and more are turning to alternative healthcare, which is really a contradiction in terms. Whatever care one chooses is an “alternative.” The important thing is to choose yours wisely.

*As for the drug pricing flap, what difference could it make if companies had to disclose these things whenever they want to raise a price more than ten percent? They will likely be able to find a workaround even if only to save the “shame” of broadcasting their profits. Maybe just raising the prices by 9.9% over different periods of time will easily defeat the purpose of this bill, even if the bill ever reaches the point of being put into law in the distant future. This bill would appear to have no teeth to really control drug prices. Real action would require “regulation,” which most Washington D.C. politicians and most of the people of the U.S. have been brainwashed to believe would signal the death knell for Capitalism.

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Law Firm Filing IVC Filter Lawsuits

Matthews & Associates Law FirmIVC Filter is handling IVC filter lawsuits nationwide against all the major makers of IVC – Inferior Vena Cava – blood clot filters. The firm, with offices in Houston and New York, is engaged in litigation against Bard, Cook, Cordis, and Rex, the major IVC filter manufacturers.

IVC Filter Injury Research

Matthews & Associates attorneys have reviewed thousands of internal documents and dozens of published medical studies. They have also consulted with several leading experts in the field. These reviews and consultations have found, unfortunately, that mounting evidence indicates most IVC filters will eventually fail. In addition, many temporary filters are not being retrieved in a timely fashion, and many IVC filter implantees are unaware they have a filter implanted.

Several different injuries may constitute a potential IVC filter case. The firm is investigating cases in which one of the following IVC filter injuries obtain:

1) any part of the IVC filter fractured or broke off;
2) the IVC filter or a part of the IVC filter moved or migrated from its original location;
3) the filter perforated the inferior vena cava or other organ;
4) the filter is embedded or tilted;
5) a doctor tried to remove the filter without success;
6) a doctor recommended removal but felt the procedure was too risky;
7) a doctor diagnosed someone, AFTER the filter was implanted, with one of the following medical conditions, which could be associated with the IVC filter:
a. caval thrombosis;
b. pulmonary embolism;
c. DVT /post-thrombotic syndrome; or
d. thrombosis/embolism.

Filter Failure more likely over time

Virtually all of the medical evidence that our attorneys have reviewed indicates that the longer an IVC filter remains in the body, the more likely it is to fail. In addition, the medical literature we have reviewed indicates that damage caused by the filter tends to be progressive.

For these reasons, people with an IVC filter in place might be wise to get screened even if they have had a prior test which showed that the filter was intact and in place.

Statutes of Limitations Issues

If upon testing and screening by a doctor, someone is diagnosed with one of the seven conditions listed above, that person might may want to contact an attorney to consider an IVC filter lawsuit. Anyone who has had complications arising from the removal or attempted removal of an IVC filter, or has been diagnosed by a doctor with any of the conditions above, or who has experienced a failed attempted removal of the filter, could trigger a deadline to file a lawsuit in court. That person might be wise to contact an attorney if they do not already have legal representation. Lawsuits have strict time limits for filing, and IVC filter lawsuits are no different.

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Epi Pen Scandal takes Generic Turn

Mylan has jacked epipensup the price of EpiPens – a lifesaving allergy treatment – 15 times since 2009. EpiPens now give a list price of $609 for a two pack, a 400% increase since 2009. The obscene price gouging has inflamed social media. To mollify the steaming public, Mylan has this week taken the almost unprecedented step of offering EpiPen in a generic turn years before the company would have been forced to do so by FDA and Congressional regulations.

Brand name drugs typically enjoy a long run at high prices – sometimes for as long as 20 years – before they must be offered in cheaper generic forms. (Sometimes brand names makers cheat a little bit, with pay-to-delay schemes, keeping generics off the market a little longer in order to make more profits, but that’s another story.)

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Expensive at Half the Price

Mylan Pharmaceuticals and its now infamous CEO Heather Bresch knew they needed to respond to a relentless social media campaign that took umbrage at Mylan’s taking advantage of sick people. The company response was to announce the launching of a generic version of EpiPen, at 50% off its current price. The company also announced that it would work to make EpiPen treatment more affordable.

Congress Investigates EpiPen

Where social media goes, votes go, especially in an election year; so now Congress has announced that it is investigating Mylan. The House Oversight Committee sent a letter to Ms. Bresch Monday, August 29, 2016 to request a briefing as well as company documents regarding EpiPen.

Mylan has sought to pin the blame for its price gouging on a shadowy health care system and supply chain. Ms. Bresch has responded to criticism by calling the system “broken.” She has said it is in “crisis,” comparing it to the 2008 financial crisis. She took no blame (or credit, for that matter – depending on your viewpoint and stock portfolio) for her company’s wildly jacking up prices because they can.

Critics say Mylan lacks Empathy

Ms. Bresch’s arguments don’t wash with many.

Wells Fargo analyst David Maris said Mylan doesn’t understand the “very emotional, very stressful situation” parents are going through when their children need this drug.

“No one’s expecting Mylan to give away their products,” said Mr. Maris. But empathy is the most human emotion. And when you raise prices year after year, by a lot, for a drug that’s lifesaving, it shows a complete lack of empathy.”

No one forced Mylan to dramatically raise EpiPen prices, Mr. Maris pointed out: “It’s outrageous. People shouldn’t be fooled by the idea that the system made them do it. Mylan is to blame for the high prices of EpiPen.”

Broken System or Opportunistic?

The most recent round of price hikes looks more opportunistic rather than a result of health care system problems. In November 2015, Mylan raised EpiPen prices by 15% (the 14th price raise since 2009), just one month after EpiGen’s main rival Auvi-Q was pulled from the market. Six months later, Mylan again raised prices, by another 15%.

Bernstein analysts wrote in a recent report that Mylan was in a position to raise prices because competitors were out of the market; so Mylan raised prices.

EpiPen CEO made $19 million last year

Ms. Bresch made a cool $19 million as Mylan CEO last year. Maybe the outrageous EpiPen price hikes were needed to help pay her outrageous salary. The daughter of a U.S. Senator (Joe Manchin), Ms. Bresch is nobody’s fool. She has shown that she knows how to fire back with a good sound bite as well as her daddy or any other Washington D.C. politician.

Do Good and Do Well?

Ms. Bresch said to the nation’s paper of record, The New York Times: “You can do good and do well, and I think we strike that balance around the globe.”

She did also add, perhaps for the benefit of her shareholders and the American way: “I am running a business. I am a for-profit business. I am not hiding from that.”

Some people, however, no doubt wish they could hide from her company’s prices.

$1,260 out of pocket expenses

A New York Post story of August 26, 2016 details the lives of Tom and Samantha Marino trying to keep up with their son’s EpiPen meds. While Ms. Bresch also told the Times that most of EpiPen’s costs for people are paid by insurance, that doesn’t appear to be the case with the Marinos.

Mrs. Marino told the Post that earlier this year, the couple paid $1,260 out of pocket for three EpiPens that will expire in February 2017. That was before the latest price increases.

The Marinos said they need three EpiPen Jr 2-Paks for their young son, who has a severe reaction to peanuts that can be life threatening They keep one at home, one in Mrs. Marino’s pocket, and one at school.

Epi Pen Scandal takes Generic Turn

This might be an easy story to ignore for those of us who don’t need EpiGen, but there for the grace of God go we. How many more drugs will Big Pharma be able to gouge people for before some sort of reasonable regulation is put into place to protect us from the unreasonable booty taken by a $19 million per year CEO and her rapacious company?

Perhaps her senator father will get the job done and protect us all from future gougings?  You think?

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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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