Morcellator Device Violates Standard of Care

A California surgeon Hysterectomy Sarcoma Attorneyhas said the morcellation device violates the standard of care.  V.G. Hufnagel, MD, said that she warned Johnson & Johnson back in 1993 that the morcellator would spread disease. The doctor said she told J&J and German morcellator maker Karl Stortz that morcellation would trigger infection, endometriosis, adonomyosis, and fibroids.  The doctor also says she told J&J and Karl Stortz that their morcellation devices would kill women with sarcoma.

Morcellator Design Flawed
Dr. Hufnagel, who said she was the first California surgeon to remove a fibroid with a laparascope, has also reported that she told J&J the morcellator was not properly designed.  She says she told J&J that tissue cannot be chopped up and then spread all throughout the pelvic cavity.

The “Unexpected Cancer” Lie: How Morcellator violates Standard of Care
Dr. Hufnagel, a self-described whistleblower, said that the morcellator device violates the standard of care.  She said the standard of care is simple:  “All tissues need to be evaluated for cancer and other conditions before operating on any woman.”

The problem is that no reliable test can now evaluate whether or not a woman’s uterine fibroids are cancerous.  Consequently, any surgeon morcellating a woman’s fibroids is taking a chance that they are not cancerous.   One wrong guess can kill the patient.

Surgical Oncology – Unambiguous Rules
Dr. Hufnagel says that surgeons and morcellator makers try to explain the unfortunate results as “unexpected cancer.”  Dr. H. Cries foul on that explanation.  She says that surgeons and device makers have “fabricated the concept of ‘unexpected tumor’ and ‘unexpected cancer’.  She says they use those marketing and false medical finding/diagnostic terms to “take away [or cover up] the full knowledge that all have had.”

The surgeon says that during any operation, “all tissues must be treated as if they are cancer.”  The doctor wrote:  “In the morcellaton process all of the science used to develop oncological protocol to give the best outcome for the patient was and is totally ignored.  It is truly madness.  A chopper is racing about chopping up tissue emulsifying it into small particles and with it speeds spreading tissue about the body.”

Morcellator Device Violates Standard of Care
Dr. Hufnagel also explains that without full knowledge of the dangers of morcellation, women cannot give their informed consent to a procedure that involves the use of a morcellator.

Surgeon Files Formal Legal Complaint
Dr. Hufnagel filed a formal legal complaint against morcellator makers on Dec. 31, 2015.  Her petition includes the claim that she redesigned the device in 1995, which she says she showed and explained to the medical device committee of the FDA.

Dr. Hufnagel’s petition also includes the claims that she wears several hats. She is:

•  a gynecological surgical ethics specialist

•  creator of a new surgical branch of gynecology called Female Reconstructive Surgery before 1985

•  a student of Kurt Semm ( Germany) and Viktor Bonney (UK)

•  the first physician to write law to protect patients in the USA, Calif., Texas, New York with informed consent for hysterectomy

•  an internationally known women’s health care expert and whistle-blower on abuses.

Dr. Hufnagel, however, is not the first physician to announce that morcellation violates the standard of care.  Dr. Amy Reid and her husband, Dr. Hoonan Noorchashm, have also spoken out about the problems of morcellating cancer tissue.  Dr. Reid, a mother of five, died of cancer this past Spring after a morcellator was used on her.

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Seven Deaths Follow Weight Loss Balloon Treatment

Seven Deaths Follow Weight Loss Balloon Treatment

Seven people have died following weight loss balloon treatment since 2016, according to the FDA.  The obesity balloons were placed inside the people’s stomachs.

FDA Issues Alert
The FDA issued a letter August 10, 2017 to an audience of surgeons, gastroenterologists, and other health care professionals. The agency said the deceased had all received “liquid-filled intragastric balloon systems to treat obesity.”

Deaths within a Month
The agency reported that five deaths occurred within a month or less of balloon placement. Death occurred in three cases within 1-3 days after a balloon was placed.

Orbera & ReShape Intragastric Balloon Systems
The agency said it also received two additional reports of balloon deaths in the same time frame. One was a gastric perforation with the Orbera Intragastric Balloon System and the other an esophageal perforation with the ReShape Integrated Dual Balloon System.

Four death reports involve the ReShape Integrated Dual Balloon System made by Apollo Endo Surgery; one involves the ReShape Integrated Dual Balloon System made by ReShape Medical, Inc.

Root Cause of Death Unknown
The FDA wrote in its August 2017 alert: “We do not know the root cause or incidence rate of patient death, no have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices (e.g., gastric and esophageal perforation, or intestinal obstruction).”

The FDA’s adverse report system is broad and not designed to immediately prove a device or drug caused a complication.  It is designed to gather information about anything that happens to anyone using a drug or device (or soon after); so that investigators can determine cause and effect.

FDA Letter of Feb. 2017 Re: Intestinal Balloon Labeling
In Feb. 2017, FDA issued a previous letter to health care providers recommending close monitoring of obese patients treated with liquid-filled intragastric balloon systems.  The FDA alerted providers to the potential risks of acute pancreatitis and spontaneous over-inflation.  Both companies then revised their patient labeling to address these risks.

FDA continues to recommend health care providers closely monitor anyone implanted with an obesity balloon.  It also urges professionals to promptly report any adverse events related to intragastric balloon systems through MedWatch., the FDA Safety Information and Adverse Event Reporting Program.

Law Firm Investigating Obesity Balloon Deaths
Matthews & Associates Law Firm is investigating obesity balloon death cases for potential litigation.  Contact our law firm for a free legal consultation if you or someone you love was injured by an intestinal balloon used to treat obesity.  We have been handling medical devices litigation for more than a decade.

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Acthar linked with Hospitalizations, Deaths

Acthar has been linked with hospitalizations and deaths at a rising rate. Adverse events from Acthar spiked in 2016. FDA data shows that hospitalizations tripled, while “other serious” Acthar side effects quadrupled. Those injuries and a hardball sales push for off-label use have triggered a whistleblower lawsuit against Acthar’s maker, Mallinckrodt Pharmaceuticals.

Acthat Whistleblower Lawsuit
A former Mallinckrodt sales rep has filed a whistleblower lawsuit against the company. The former employee says he was pushed to promote Acthar for off-label uses. Meanwhile, a neurologist who has studied Acthar says the spike in hospitalizations could indicate that it is being overused.

Acthar Blockbuster Drug
Acthar may be the primary reason that Mallinckrodt Pharmaceuticals has triggered a big run of short selling on Wall Street. Word on the street is that Acthar is oversold, and it doesn’t work in off-label uses for which the whistleblower says it was pushed by the company. Off-label Acthar use may be killing elderly people.

Acthar Off-label Use Under Fire
Stock traders who are profiting from Mallinckrodt’s stock decline have questioned Acthar’s efficacy. They also question Mallinckrodt’s dependence on deals with pharmaceutical middlemen for expanding Acthar use. They question why a drug primarily indicated as a treatment for infants has morphed into a massive expense for Medicare, a program for the elderly.

FDA: Acthar linked with Hospitalizations, Deaths
BusinessInsider.com reports that Acthar critics now have a new line of attack. U.S. FDA data shows adverse event reports for Acthar users have recently spiked. Acthar has triggered everything from hospitalizations to death. That increase has far outpaced prescription rates.

Andrew Left of Citron Research jumped on the data. Mr. Left released a report June 22, 2017 that said Citron “believes the reason for the increase in adverse events is the company’s expansion of Acthar into new indications where it has not conducted clinical trials in order to test its safety in new indications.”

Mr. Left is not the only short seller targeting Mallinckrodt. Company shares tumbled in early trading on June 22 before regaining their losses.

9,000 Acthar Users
Roughly 9,000 people now take Acthar, according to Mallinckrodt.

Acthar Deaths Rising
Eighty-two deaths were reported in 2016, 69 in 2015. Hospitalizations nearly doubled to 427. Other serious side effects quadrupled to 436.

Mallinckrodt Response
Mallinckrodt released a statement saying that side effects linked to Acthar were often relatively minor. The company said that correlation of Acthar side effects didn’t necessarily mean causation.

Acthar Problems – Uses Not FDA Approved
The data does show Mallinckrodt’s strategy of taking an old drug that never went through the rigors of FDA approval and trying to expand its use could be causing the company problems. Mallinckrodt has turned Acthar into a drug with over $1 billion in annual sales. It has done so by persuading doctors to prescribe it even to the sickest patients, even when there are much cheaper alternatives.

Acthar Overuse Triggering Side Effects
Dr. Dennis Bourdette, the chair of neurology at the Oregon Health & Science University, said the spike in adverse events could be a sign the drug is being overused in a way that is triggering side effects.

“Some doctors are using Acthar like an ongoing, monthly, or weekly therapy over long periods of time, and when you do that there are all sorts of side effects that can occur because of the steroid effects that can occur,” said Dr. Bourdette.

Acthar Acts Like Steroid
Acthar’s website shows the company claiming Acthar is not a steroid, even though its effects are similar. The site says Acthar “works by helping your body produce its own natural steroid hormones.” Dr. Bourdette says the explanation doesn’t matter, because Acthar still acts like a steroid. ” said Dr. ACTH is having all these effects on the immune system apart from releasing cortisol,” Bourdette, referring to the adrenocorticotropic hormone in Acthar.

“When your body produces too much cortisol you’re going to have chronic steroid side effects we’ve known about for decades, and every doctor is trained in those side effects.”

Acthar Designed for Infants, not Geriatrics
Acthar is supposed to be taken for about five to 15 days to treat infantile spasms and multiple sclerosis. At the same time, there’s no specification on dosage for the 17 other conditions that Mallinckrodt says can be treated with Acthar.

Acthar was grandfathered into FDA approval because it dates back to the 1950s before clinical testing was required. Consequently, some have questioned its efficacy.

Mallinckrodt Defense?
Mallinckrodt has said repeatedly that only the most desperate patients should take Acthar. Publically, the company suggests it’s not the primary treatment for many of the ailments it is used against. Thee company says Acthar is used only after other drugs don’t work. But is that what they tell their drug salesmen, and the doctors to whom they’ve marketed the drug off label?

Mallinckrodt’s web site admits the company doesn’t know “the exact way that Acthar works in the body” and says “further studies are being conducted.” It also says that some information on the website “is based on laboratory data, and how it relates to patient benefit is unknown.”

Acthar Whistleblower Lawsuit
Why would doctors prescribe too much Acthar for the wrong ailments? We may find out from a whistleblower lawsuit. In December 2016, a former Acthar sales rep, Barry Franks, filed a whistle-blower lawsuit against Mallinckrodt.

Mr. Franks’ lawsuit accuses the company of pushing him to promote Acthar’s use for off-label indications. He said his bonus depended on off-label promotions. He says that he was fired because he wouldn’t do things Mallinckrodt’s way.

The complaints states that Mr. Franks, “alleges that there were illegal sales practices being committed in other regions, and that Mallinckrodt used these regions as the gold standard or basis Incentive Bonus Plans for which all regions were compared and asked to duplicate. Franks was expected to deliver sales that were not supported by lawful practices.

“Franks was also aware of other compliance related issues at Mallinckrodt, which Franks … alleges that these issues include but were not limited to: potential insurance/Medicare fraud … HIPPA violations where four or eight week prescriptions were provided where there was no patient visit and violations where Mallinckrodt permitted, for a certain period of time, certain employees to manipulate the compensation plan by having physicians wrote shorter prescriptions that were refilled, to earn a bonus on the patient at the shortest prescription interval.

“(Shorter prescriptions did not allow sufficient time to see if a patient responded to the drug. In some cases the drug was shipped the same day as the referral was received. This was done to ‘game the system’ and potentially commit insurance/Medicare fraud.)”

Acthar linked with Hospitalizations, Deaths

Mallinckrodt did not respond to a journalist’s request for comment on Franks’ claims.

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Doctor Who Denounced Morcellator Dies

A medical doctor who denounced morcellators has died, likely because of a morcellator that was used on her.  Dr. Amy Reed, a mother of six children, died from cancer May 23, 2017, after fibroid removal surgery spread cancer cells throughout her body. Surgeons had used a morcellator on her to remove precancerous uterine fibroids. Dr. Reed died at her Yardley, Pa., home. She was 44.  Dr. Reed is survived by her husband and six children.

Morcellator Lawsuit
The doctor and her physician husband filed a morcellator lawsuit against Johnson & Johnson, makers of the morcellator that was used on her. Dr. Reed and her husband denounced the morcellator device which hastened the spread of her cancer. She and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, had held teaching posts at Brigham and Women’s Hospital in Boston, which is affiliated with Harvard Medical School. There, both Dr. Reed and Dr. Noorchashm had teaching positions. A post operation biopsy found Dr. Reed had a hidden leiomyosarcoma. Dr. Noorchashm later called the morcellator a threat to national security. As a surgeon himself, Dr. Noorchashm was incensed at the notion of shredding potentially cancerous tissue inside a body cavity. He had been trained to cut around tumors, not through them, precisely because slicing into them could spread cancer cells.

Leiomyosarcoma Death
Dr. Reed’s cause of death was listed as a type of cancer called leiomyosarcoma. This uterine cancer was greatly accelerated by a botched operation in 2013, when the doctor first went under the knife for the removal of precancerous fibroids. Dr. Reed was told that it was safe to surgically remove the fibroids with the high-powered tool called a morcellator.

Morcellator Device
The morcellator device works by slicing up tissue and vacuuming up cancerous cells piece by piece. The morcellator was approved by the U.S. FDA in 1995. The device has a spinning blade that slices up tissue so that it can be extracted through small incisions. Many surgeons regard it as a great boon to minimally invasive surgery, but if a patient has cancer, as Dr. Reed did, morcellation can worsen and spread the disease. The problem is that fibroids can’t be reliably distinguished from leiomyosarcoma.

The morcellator operation exacerbated Dr. Reed’s condition. The tool had spread harmful cancer cells inside her body. In just minutes, the slicing and dicing elevated her disease status from stage I to stage IV cancer. Days after her initial operation, biopsy reports revealed Dr. Reed had hidden leiomyosarcoma, a rare and aggressive cancerous soft tissue tumor.

Doctor Who Denounced Morcellator Dies
Dr. Reed then embarked on an extensive treatment plan that included chemotherapy radiation, immunotherapy, and experimental treatments. She also underwent several major operations. Meanwhile, the cancer kept spreading, to her lungs, spine, abdomen. Following the first surgery, both Dr. Reed and Dr. Noorchashm pushed for FDA to ban power morcellators. They sent thousands of emails to the FDA and several sectors across the country. They also emailed device makers, hospitals, legislators, professional societies, individual doctors, and news outlets.

One in 350 Women Affected
The devastated pair attained a major victory in 2014, a year after Dr. Reed’s surgery. They got the FDA to examine published and unpublished data on morcellation. Earlier estimates showed that between one in 10,000 to in one in 500 women with fibroids could have undiagnosed leiomyosarcomas or other uterine sarcomas. In April 2014, the FDA reevaluated. The agency concluded that hidden sarcomas were more common, affecting one in 350 fibroid cases. Soon afterwards, Johnson & Johnson pulled its morcellators from the market.

In November of 2014, the doctor pair gained another victory, as FDA released recommendations against using morcellators in a majority of women with uterine fibroids. The agency said that using the power morcellator on fibroid patients with hidden sarcoma could spread the cancer and reduce the patients’ mortality. The FDA also stressed that the statement should be treated as a “safety communication.” It did not issue any new regulation for morcellators.

Sadly, any victories the couple gained for morcellator safety came too late to help Dr. Reed.  But heroically, she successfully turned a personal tragedy into a crusade to save other women from the procedure that had so harmed her.

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Humans not engineered to withstand Glyphosate

Dead or leukemia-strickened farmers have thrown a wrench into Monsanto’s dream to monopolize the world’s food supply. Monsanto has, unfortunately for the chemical giant, not yet learned how to genetically engineer humans to withstand  Roundup and glyphosate. Until robots can be made to drive tractors, milk cows, shovel manure, throw hay, poison fields with glyphosate, write checks to Monsanto, etc., the human farmer will remain a weak link in Monsanto’s otherwise perfect corporate process. Humans not engineered to withstand Glyphosate are threatening Monsanto’s bottom line.

Glyphosate Poisoning for All
Since it is now well known that most Americans have some cancer-causing glyphosate in their bodies, this is a subject that few, if any, can escape. Carcinogenic Glyphosate has been found in many popular foods and in all California wines. It has even been found in all vaccines.  Yes, it is now being injected directly into people’s bloodstream.  Even those not personally sickened, suffering from non-Hodgkins Lymphoma, Leukemia, stomach rot, obesity, diabetes or liver disease from glyphosate, can be deeply affected. Health insurance and medical costs rise for all when so much of the population is unhealthy from eating nutrition-stripped, glyphosated food. We all live and die by nutrients. In addition to its killing properties, glyphosate is a chelator which strips foods of their vital nutrients.

Dead Farmer Failed to Tolerate Glyphosate

California farmer Anthony “Jack” McCall was a healthy man who didn’t even use Roundup on his crops. He just used it on his property to kill weeds, right up until he was diagnosed with non-Hodgkin’s lymphoma. He died three months later, on the day after Christmas in 2015. His family thinks Roundup also killed him. The tragic irony, if it’s true that Roundup did kill Mr. McCall, is that he was so pleased with the product that he recommended it to friends and fellow farmers. Like many other farmers who have suffered non-Hodgkins lymphoma and other leukemia cancers, Mr. McCall did not realize that he needed to be genetically engineered to withstand glyphosate.

People Are Plants

Mr. McCall did not realize that the human body shares a vital number of important traits with plants. Recent science has shown that people are a whole lot more like plants than previous “wisdom” revealed.  In fact, we now now that People Are Plants. But Monsanto still does not know it, apparently. Monsanto apparently does not recognize its own lies on its own Roundup label.  More likely Monsanto scientists do know it, and either don’t care to reveal it, or know that doing so would put them out of a job. The company has recently been shown to manipulate or collude with the EPA and doctor its own studies on glyphosate safety.

Farmer vs. Monsanto
McCall vs. Monsanto is one of hundreds of Roundup lawsuits filed so far against the chemical giant from Missouri. The lawsuits have been filed by plaintiffs in California, Florida, Missouri, Delaware, Hawaii, and in other states. All the suits accuse Monsanto of hiding evidence and manipulating regulators (like the EPA) and the public into believing glyphosate is safe.

Monsanto Defends Glyphosate to the Death
Monsanto’s glyphosate brings the company some $5 billion yearly, about a third of Monsanto’s total sales. Consequently, Monsanto would appear to have little choice but to defend its most popular poison to the death. It owes it to its stockholders to continue the Big Lie. The company’s very existence could depend on success in defeating these lawsuits.

Glyphosate – Monsanto Cornerstone
Glyphosate poison is the cornerstone of Monsanto’s entire business gambit. Roundup (with glyphosate as its main active ingredient listed) is designed to kill everything which has not been engineered to withstand it. Roundup works great at killing. It kills everything with which it comes into contact. That includes monarch butterflies and bees, which Monsanto has yet to genetically engineer (so far as we know), and we can now add humans to the list. The experiment has now gone on for more than 20 years, and the results are in.

Humans not engineered to Withstand Glyphosate

Since people are also not genetically engineered (at least not by Monsanto), it hardly seems a stretch to suggest that they also could be sickened or killed by Roundup.

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Xarelto Makers win First Trial

A jury in the first Xarelto Lawsuit trial found that Johnson & Johnson and Bayer AG are not responsible for a Xarelto user’s internal bleeding. Some 18,000 additional lawsuits have been filed by others who took Xarelto or by family members of Xarelto users who died after taking the blood-thinning drug. Lawsuit petitions claim Xarelto can cause irreversible bleeding and lead to a higher risk of strokes.

The jury in this trial, set in federal court in New Orleans, ruled that J&J and Bayer did not mislead a Louisiana man — Joseph Boudreaux — and his doctors about Xarelto’s health risks. Therefore, the jury found the companies not liable for his injuries and subsequent medical problems.

Related: Xarelto Lawsuit

The May 3, 2017 ruling concluded the first of more than 18,000 patient lawsuits against J&J and Bayer, which jointly developed Xarelto. The companies face separate trials this summer over three other Xarelto users’ complaints. Some users claim Bayer and J&J downplayed Xarelto’s bleeding risks.

Xarelto Top Selling Drug for Bayer

Xarelto, Bayer’s top-selling product, generated 3 billion euros ($3.24 billion) in sales last year and 2.3 billion euros in 2015 for the Leverkusen, Germany-based pharmaceutical company. Xarelto is J&J’s third-largest seller. It generated $2.29 billion in revenue in 2016.

Bayer officials said the jury’s finding affirms the safety of the blood thinner.

Xarelto Marketing Questioned

Xarelto belongs to a new class of drugs aimed at replacing Bristol-Myers Squibb Co.’s Coumadin, first used in the 1950s. Some Xarelto users accuse J&J and Bayer of falsely marketing Xarelto as better than Coumadin because the companies said Xarelto patients didn’t need frequent blood tests.

Misleading Label, say Plaintiffs

Lawyers for the NOLA plaintiff in the first trial and other former Xarelto patients, stress that the drug has no antidote. This can be fatal for some users at high risk for bleeding out if they suffer an injury. By contrast, coumadin’s blood-thinning effects can be arrested. Plaintiffs argue that J&J and Bayer officials should have warned consumers that  they could be tested to gauge their Xarelto bleed-out risk.

“They only accept science they like, and decide to ignore science they don’t like,” said one of Mr. Boudreaux’s lawyers in closing arguments. “They know if they require blood testing, they’re terrified that doctors will just use another drug.”

FDA Approval for Xarelto

J&J and Bayer attorneys argued that the FDA found Xarelto “safe and effective” for patients; the drug makers should be cleared of any liability. The lawyers also argued that millions of users have taken Xarelto without suffering bleeding side effects.

Xarelto defense attorneys also dispute the validity of the safety test designed to gauge Xarelto users’ bleeding risks. They say in court filings that the test didn’t provide useful information to doctors.

The cases are Boudreaux v. Janssen, 14-cv-2720 and In RE Xarelto Products Liability Litigation, 14-MD-2592, U.S. District Court, Eastern District of Louisiana (New Orleans).

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IVC Filter Lawsuit filed in Dallas

A Cook IVC filter lawsuit has been filed in Dallas by the law firms of Matthews & Associates and Freese & Goss. The two firms jointly represent the plaintiff, a Texas resident.

The plaintiff was implanted with the Cook Gunther Tulip IVC filter April 19, 2016, according to his lawsuit petition. Just three days later, on April 22, the implanting surgeon attempted to remove the temporary filter. The surgeon attempted removal through the jugular vein and also the right common femoral vein.

IVC Filter stuck in Patient
The surgeon, who is named a party in the lawsuit, was unable to remove the Cook Gunther Tulip filter. In his first attempts, he noted that it had migrated from the inferior vena cava and was lodged in the right ventricle of  the man’s heart.

The petition reads: “During the numerous attempts to retrieve (the filter), Plaintiff’s heart rate slowed on a number of occasions and Plaintiff suffered from severe episodes of bradycardia, pericardial effusion, and symptomatic pericardial tamponade requiring urgent pericardiocentesis and pericardial catheter placement.”

The filter could not be retrieved intravascularly; it was stuck . This situation led to emergency bypass surgery. There was no other way to remove the filter from the right ventricle of the man’s heart, according to the petition. The surgery required the opening of his sternum and pericardium and led to his cardiopulmonary bypass. Surgeons found the filter in the right ventricle of the heart “with the tip pointed toward the right ventricular apex and the legs of the filter entwined with the chordae tendinae of the tricuspid valve preventing the closure of the tricuspid leaflets.”

Cook IVC Filter Lawsuit Petition

The plaintiff’s lawyers allege in the petition that because of the open heart surgery caused by the filter’s migration and embedment in his heart ventricle, the man “suffered injury and pain and suffering, and currently suffers from and will continue to suffer from numerous health risks for the remainder of his lifetime, including increase risk of heart failure, kidney damage, and increased risk of death.” They also allege that he will also require ongoing medical care and monitoring for the rest of his life and may ultimately require additional surgeries.

The petition further charges that the surgeon knew or should have known that only certain patients were proper candidates for an IVC Filter, that the Cook Gunther Tulip had a high rate of device migration and failure, that it is not effective to prevent clots and/or increases the risks of clots, that safer alternatives existed, that IVC filters such as the Cook Gunther Tulip frequently tilt, migrate, perforate or fracture, and thus involve an increasing degree of risk to a patient implanted with one.

The plaintiff’s petition also charges that the Cook Defendants knew or should have known that the device was defective and unreasonably dangerous for six reasons. Cook defendants::

* failed to conduct any clinical testing, such as animal studies

* knew or should have known that the Gunther Tulip had a high rate of fracture, migration, excessive tilting, perforation of the vena cava. Such failures exposed patients to serious injuries including death, hemorrhage, cardiac/pericardial tamponade, cardiac arrhythmia, severe and persistent pain, perforations of tissue, vessels, organs such as the heart, inability to remove the device, and/or extensive surgeries to remove it.

* knew or should have known these risks were substantially higher than other similar devices

* knew or should have known that the Gunther Tulip contained conditions that resulted in the device not performing as safely as the customer would expect

* misprepresented , omitted, and/or failed to provide adequate warnings of these risks or instructions for safe use

* failed to issue a recall or otherwise notify people that a safer device was available

IVC Filter Lawsuit filed in Dallas

The case has been filed in Dallas County. The plaintiff has requested a trial by jury and submitted the appropriate fee.

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Texas IVC Filter Lawsuit Filed

A Texas man hasCook IVC Filter Attorney filed an IVC Filter Lawsuit in Houston’s Harris County courthouse.  The man has filed a case naming the implanting doctor and Cook Incorporated, a/k/a Cook Medical, LLC.

State Jurisdiction

Cook Medical is headquartered in Indiana, but the implanting doctor practices in Texas; so the plaintiff has exercised his right to demand a jury trial in Harris County. The plaintiff’s claims in the action were also brought solely under state law. The petition states that the “Plaintiff does not herein bring, assert, or allege, either expressly or impliedly, any causes of action arising under any federal law, statute, regulation, or provision.  Thus,” it argues, “there is no federal jurisdiction in this action on the basis of a federal question under 28 U.S.C. section 1331.”

The plaintiff was surgically implanted with an IVC filter in 2015, by Dr. Adrian A. Wong, a specialist in Interventional Radiology. Dr. Wong implanted a Cook Celect Inferior Vena Cava Filter in the plaintiff.

Failed Removal Attempts
Seven weeks later, on or about April 23, 2015, surgeons attempted to remove the Celect IVC filter but were unable to remove it. According to the petition, the filter had tilted and imbedded into the wall of the plaintiff’s vena cava.  Another removal attempt was made June 2015, but was also unsuccessful. A leg or strut of the IVC filter had protruded through the man’s vena cava wall and lodged in a position adjacent to his aorta, according to the petition.

The man is now at risk for future migrations, perforations, and/or fractures from the irremovable filter, charges the petition. He also faces numerous health risks from the retained filter, including increased risk of blood clots and the risk of death. He will require ongoing medical care and monitoring for the rest of his life and may ultimately require more surgery in further attempts to remove the filter.

The Doctor’s Responsibility Alleged
The petition further alleges that the doctor knew or should have known, inter alia, that only certain patients were proper candidates for an IVC filter, and the doctor also should have known that:

  • the longer a Celect IVC remains in the body, the higher the risk of device fracture or failure
  • the Celect IVC filter is not effective to prevent clots and/or increases the risks of clots
  • safer alternatives to the Celect IVC filter existed
  • Celect filters frequently tilt, migrate, perforate, fracture, and thus involve a high increasing degree of risk to a patient implanted

Lack of Clinical Testing, Contraindications

The petition further claims Cook failed to conduct any clinical testing, such as animal studies; that Cook knew or should have known the Celect filter had a high rate of fracture, migration, and excessive tilting and perforation of the vena cava wall once implanted. It further claims that Cook knew or should have known such failures exposed patients to serious injuries that include death, hemorrhage, cardiac/pericardial tamponade, cardiac arrhythmia, and other symptoms similar to myocardial infarction – severe and persistent pain, perforations of tissue, vessels, and organs; and inability to remove the device. Cook also knew or should have known certain conditions or post-implant procedures such as morbid obesity or open abdominal procedure could affect the safety and integrity of the Celect IVC Filter.

The petition also claims Cook should have known these risks for the Celect were and are substantially higher than other similar devices. The petition also alleges that Cook failed to issue a recall of the Celect Filter and failed to notify customers that a safer device was available.

Texas IVC Filter Case Filed

The case is No. 201703885 in Harris County District Court. Defendants are Adrian A. Wong, M.D.; Cook Incorporated; a/k/a Cook Medical, (LLC).  Attorney David Matthews of Matthews & Associates Law Firm represents the plaintiff.

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Women not warned of Permanent Hair Loss – Cancer Drug

American women were taxotere-lawsuitnot warned about the increased risk of permanent hair loss that can result from the cancer drug Taxotere, while doctors and their patients in France and Europe were warned about the added risk of Alopecia several years earlier. The drug’s maker consequently faces Taxotere Lawsuits.

U.S. Women Warned a Decade Late
French drug maker Sanofi-Aventis waited until December 2015 to warn U.S. cancer patients and their doctors about the risk of permanent alopecia from the company’s cancer drug Taxotere. And even at that late date, the company added the warning only after the U.S. Food and Drug Administration ordered it to do so.

Taxotere Warnings
Sanofi-Aventis began to warn patients in Europe and Canada back in 2005 about permanent hair loss from Taxotere. U.S. doctors and their patients, meanwhile, were at least for a decade unaware that Taxotere raised the risk of permanent alopecia. Americans were also unaware of an alternative chemotherapy drug that is just as effective, and is safer and less expensive – Taxol, made by Bristol-Myers Squibb.  Taxol also comes without Taxotere’s “side effect” of permanent hair loss or complete baldness, which can hardly be called a mere side effect when it represents a permanent condition.

Sanofi-Aventis fined $109 Million in Qui Tam Lawsuit
Sanofi-Aventis’ deceitful, duplicitous marketing of Taxotere comes on the heels of criminal behavior for which the company has been held accountable in the past. Sanofi-Aventis was ordered in 2012 to pay an enormous fine stemming from criminal behavior used to hoodwink the public and boost profits.

Sanofi Agrees to Pay $109 Million Fine for False Claims, Kickbacks
The U.S. Justice Department web site stated Dec.19, 2012 that Sanofi-Aventis U.S. Inc. agreed to pay $109 million to resolve allegations that Sanofi US violated the False Claims Act. The company paid for a scheme in which it used physicians to file false reports which were used to set reimbursement rates that caused government programs to pay inflated amounts for Sanofi products.

The United States alopecia-2contended that Sanofi faced pressure from a lower-priced competitor, so the company trained its sales representatives to manipulate the market. The U.S. Justice Department said, “Sanofi US sales representatives often entered into illegal sampling arrangements with physicians, using the free units as kickbacks and promising to provide negotiated numbers of them in order to lower Hyalgan’s effective price. The government contends that there were numerous such arrangements.”

Taxol, The Safer Alternative
Taxotere Lawsuits brought by women suffering permanent hair loss will all point out that a safer, better, alternative drug was available when the victims were prescribed Taxotere by unwitting medical personnel. Taxol is derived from more natural means than Taxotere, which is twice the strength of Taxol. It is too strong, in fact, as its strength seems to be the mechanism that permanently kills hair follicles, leading to permanent baldness.

Taxotere’s Misleading Promotion 

Taxotere (docetaxel) has been vastly promoted by Sanofi-Aventis as a newer, more effective alternative to Taxol (paclitaxel).  Since its 1992 approval, the older chemotherapy drug Taxol (made by Bristol-Myers Squibb) has been one of the most widely used drugs in the adjuvant treatment of breast cancer. Taxol has been supported by high-quality evidence in the scientific literature that prove its safety and effectiveness. Comparison between the two medications proved them to be nearly equivalent; however, Sanofi kept claiming docetaxel superior to paclitaxel in early advertising campaigns. The advertising blitz apparently paid off, as Taxol use has progressively fallen in the last ten years, while Taxotere has gained substantial market share, despite its higher price.

Women not warned of Permanent Hair Loss – Cancer Drug

In April 2009, the FDA accused Sanofi of overstating the efficacy of Taxotere by giving the doctors and patients misleading promotional material that included unsubstantiated superiority claims. In its warning letter, FDA highlighted that no clinical experience ever provided substantial evidence about the fact that docetaxel was safer, better or more effective than paclitaxel. Sanofi falsely claimed that Taxotere was associated with significantly higher response rates, longer duration of response, longer median overall survival compared to its competitor, Taxol. Sanofi cited a study in support of these claims that FDA deemed insufficient, ruling that the study failed to demonstrate statistical significance and was never replicated.

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Contaminated Devices threaten Heart Surgery Patients

The Centers for sorin-3tDisease Control has acknowledged that contaminated heater-cooler devices used for open chest surgeries threaten heart surgery patients. The CDC is warning healthcare providers and patients about the potential risk of infection from  devices used for open heart surgery. The agency recommends hospitals take action, and it advises patients who suspect infection to seek care.

Infection Symptoms: Sweats, Aches, Weight Loss, Fatigue, Fever
CDC announced on Oct. 13, 2016 that people who had open heart surgery should see a doctor if they experience infection symptoms such as night sweats, muscle aches, weight loss, fatigue, fever.

Stöckert 3T heater-cooler devices
The CDC advice follows reports that some LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T heater-cooler devices, which are used during open heart surgeries, might have been contaminated during their manufacture. That contamination could put patients at risk for life-threatening infections.

250,000 Heart Bypasses Yearly
More than 250,000 heart bypass procedures using heater-cooler devices are performed in the U.S. yearly, some 60 percent of total bypasses in the country. Heater-cooler units are used during surgery to help keep a patient’s circulating blood and organs at a specific temperature. CDC estimates that in affected hospitals, the risk of a patient getting an infection from the bacteria was between 1/100 and 1/1,000. CDC admits these infections can be severe and that some patients have died, but says it is unclear whether the infection caused death.

Valve and Prosthetics Patients at Higher Risk
The CDC has also cautioned that patients with implanted valves or prosthetics are at higher risk of these potentially deadly infections.

October 2016 CDC Health Alert Network Advisory
“It’s important for clinicians and their patients to be aware of this risk so that patients can be evaluated and treated quickly,” said Michael Bell, M.D., deputy director of CDC’s Division of Healthcare Quality Promotion. “Hospitals should check to see which type of heater-coolers are in use, ensure that they’re maintained according to the latest manufacturer instructions, and alert affected patients and the clinicians who care for them.”

CDC and the FDA initially published information and alerts about Stockert 3T heater-cooler device problems in 2015. Then in October 2016, CDC’s Morbidity and Mortality Weekly Report covered recent laboratory tests by CDC and National Jewish Health which show bacteria from 3T heater-cooler devices match bacteria found in patients in several states.

German Manufacturing Problems Revealed
Results of the latest tests add to previous evidence from Europe that suggests bacteria which contaminated these devices came from the device’s manufacturing process in Germany.

Mycobacterium chimaera Bacteria
The bacteria, Mycobacterium chimaera, is a species of nontuberculous mycobacterium (NTM) often found in soil and water. M. chimaera rarely makes healthy people sick in normal circumstances, but patients who have been exposed to it through open-heart surgery can develop general and nonspecific symptoms which can often take months to manifest. Diagnosis of these infections can consequently be missed or delayed for months or years, which adds to treatment difficulties. No test yet exists to determine whether a person has been exposed to the bacteria. Laboratory culture is needed to diagnose infections. The slow growth of the bacteria means it can take months for infection to be ruled out.

Contaminated Devices threaten Heart Surgery Patients

CDC says it will continue to work with the FDA and the clinical community to further evaluate and reduce the risk associated with these devices. The agency recommends that open-heart surgery survivors concerned with any symptoms  contact their healthcare providers.

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