Proton Pump Inhibitor – Kidney Injury Lawsuits Consolidated

The U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized all federally-filed proton pump inhibitor (PPI) – kidney injury lawsuits on August 2, 2017. All the suits involve kidney failure, chronic kidney disease, and other kidney injuries. U.S. District Court, District of New Jersey will host the JPML.

The JPML’s Transfer Order affected 166 lawsuits filed against the makers of Nexium, Prilosec, PrevAcid, Protonix, and Dexilant. Any similar PPI lawsuits filed in federal courts in future will be eligible for transfer to the District of New Jersey.

Creating a multidistrict litigation court can help both plaintiffs and defendants. This one will allow all federal proton pump inhibitor – kidney injury claims to follow coordinated pretrial proceedings, including discovery and motion practice. The JPML process is designed to improve judicial efficiency, prevent inconsistent court rulings and duplicative discovery. It is also meant to preserve court resources and lighten loads on witnesses and others in the litigation.

Individual Cases Must Stand on Own Merits
Though pretrial proceedings will be coordinated, each proton pump inhibitor lawsuit in the multidistrict litigation will maintain its own identity and be decided on its own merits. All plaintiffs will continue to maintain control over important decisions affecting their own individual claims. That control includes whether or not to accept any future settlement offers.

Proton Pump Inhibitor – Kidney Injury Claim
The nationwide law firm of Matthews & Associates is handling lawsuits for people who took a proton pump inhibitor and then developed kidney problems. Chronic kidney disease, kidney failure, acute interstitial nephritis, or acute kidney injury have all been linked with popular PPI drugs: Nexium, Prilosec, Protonix, PrevAcid, Dexilant.

PPPI-Lawsuit | Lawyer

If you or a loved one has been diagnosed with any kidney issues that could be related to proton pump inhibitors, contact our office today. Protect your legal rights.  Email us for a free legal case review, fill out our short form or call us at (888) 520-5202.

What are proton pump inhibitors?
Proton pump inhibitors are a class of heartburn medications that include the prescription drugs Nexium, Prilosec, Protonix, and PrevAcid, as well as various over-the-counter (OTC) brands and generics. Those sold via prescription are approved to treat symptoms associated with GERD, ulcers and other problems linked with the overproduction of stomach acid. OTC proton pump inhibitors are often recommended for people who suffer from frequent heartburn (two or more episodes per week.)

An estimated 15 million Americans used proton pump inhibitors in 2013. Research suggests these drugs are often overused, and that many people use them far too long. Proton pump inhibitors are thought to be generally safe for short-term use, but long-term use has been linked to several serious side effects, including C. diff infections, certain bone fractures, low magnesium levels, B12 deficiency, and more. Research also suggests extended PPI use may increase one’s risk for dementia, heart attacks, chronic kidney disease, acute kidney injury, kidney failure.

What causes kidney failure?
Kidney failure is the final stage of chronic kidney disease. Also known as end stage renal disease, the condition occurs when the kidneys no longer function in a way that would allow a patient to survive, resulting in the need for dialysis or kidney transplantation.

Diabetes and high blood pressure are the leading causes of kidney failure. Other causes include:

•  Toxic exposure
•  Certain acute and chronic diseases
•  Severe dehydration
•  Kidney trauma

Other recent studies also suggest proton pump inhibitors may harm kidneys.

•  April 2015: A study published by Canadian researchers found older people who used PPIs were more likely to suffer acute kidney injury, a form of sudden renal failure.
•  April 2016: A paper appearing in the Journal of the American Society of Nephrology linked extended use of proton pump inhibitors to a 96% increased risk of renal failure compared to alternative medications.
•  January 2016: Research that appeared in JAMA Internal Medicine reported that proton pump inhibitors might increase the risk of chronic kidney disease by as much as 50%. The Journal of the American Society of Nephrology study also suggested PPI use was associated with a 28% increase in the risk for chronic kidney disease , compared to another class of heartburn drugs.

What is acute interstitial nephritis (AIN)?
Acute interstitial nephritis is a sudden inflammation of the kidney tubules often caused by a hypersensitivity reaction to a medication. AIN symptoms include:

•  Fever
•  Blood in the urine
•  Exhaustion, fatigue
•  Confusion
•  Nausea, vomiting
•  Rash
•  Water retention and weight gain
•  Swelling
•  Feeling bloated
•  Elevated blood pressure

When acute interstitial nephritis is caused by a drug, most doctors would cease treatment of that medication. If not recognized swiftly, the condition can progress to chronic kidney disease and renal failure.

FDA Label Warning Update
In 2014, the U.S. Food & Drug Administration ordered the makers of all prescription proton pump inhibitors to add information about acute interstitial nephritis to their product labels.

Proton Pump Inhibitor Settlements
Parties involved in the proton pump inhibitor litigation have not announced any settlements in kidney-related cases. The first such lawsuits were just filed in 2016. Pharmaceutical drug cases can take several years to come to fruition for plaintiffs, if they ever do. Anfyone suffering kidney injury after taking a protom pump inhibitor is encouraged to call our offices to discuss a potential case against the PPI maker.

Free Legal Consultation
Matthews & Associated drug injury lawyers offer free legal reviews to people who may have suffered chronic kidney disease, kidney failure, or other renal complications linked with Nexium, Prilosec, Protonix, or Prevacid.  Email for a free legal consultation or call us at (888) 520–5202.

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Hernia Mesh vs. Suture Repair

Most people considering surgery for hernia repair will find themselves facing a difficult choice.  Of course, one can always “wait and see” in the event of a hernia (more on that below).  And it is sometimes possible to use belts or trusses to help manage or simply live with a hernia.  Most people suffering from a hernia, however, will likely face a choice of surgical options.  Most will decide whether it is best to choose a plastic hernia mesh to repair a hernia, or to find a surgeon who can perform a more traditional hernia repair using sutures and/or natural tissues.

What is a Hernia?
A hernia occurs when an organ, intestine or fatty tissue breaches a weak spot or a hole in muscle or connective tissue.  Hernias often occur at the abdominal wall.  Sometimes a hernia can be visible as an external bulge, particularly when one strains or bears down.  There are many types of hernias, but inguinal hernias – in the groin area – are by far the most common.

Hernia Types
•  Inguinal: inner groin
•  Femoral: upper thigh/outer groin
•  Incisional: incision or scar breach in the abdomen
•  Ventral: general abdominal/ventral wall
•  Umbilical: belly button
•  Hiatal: inner abdominal, along the upper stomach/diaphragm

Hernia Causes
Most hernias are caused by a combination of pressure and an opening or weakness of muscle or connective tissue.  Pressure pushes an organ or tissue through the opening or weak spot.  The muscle weakness can be present at birth, but it usually occurs later in life.  Anything that increases abdominal pressure can cause a hernia.  Risk factors include obesity, heavy lifting, diarrhea, constipation, persistent coughing, sneezing.  The FDA web site notes that poor nutrition, smoking, and overexertion can also weaken muscles and contribute to hernia risk.

Hernia Treatment Options
The FDA reports that more than one million hernia repairs are performed each year in the U.S. About 80% involve inguinal hernias.  Treatment options are myriad.

1. Non-Surgical
Watchful Waiting – One can watch a hernia to see that it is not getting larger or causing problems. Though surgery is the only treatment that can repair hernias, many surgical procedures are elective for adult inguinal hernias.  Watchful waiting is an option for people who do not have complications or symptoms with their hernias, and if recommended by their surgeon.

2. Surgical
a. Laparoscopic – A surgeon makes several small incisions in the abdomen that allow surgical tools in for repair.  Laparoscopic surgery can be performed with or without surgical mesh.

b. Open Repair – A surgeon incises near the hernia and repairs the weak muscle area. Open repair can be done with or without mesh. Open repair using sutures without mesh is referred to as primary closure.  Primary closure, says FDA, is used primarily to repair inguinal hernias in infants, small hernias, strangulated or infected hernias.  But one can use primary closure for other reasons, as well (such as fear of hernia mesh and its “side effects”), though the FDA does not say so.

The Problems of Surgical Mesh for Hernia Repair
The FDA on its web site seems solidly in favor of surgical mesh for hernia repair.  At the same time, it is worth noting that the agency also backed – at least in the beginning – the use of plastic mesh on women suffering from pelvic organ prolapse (POP) or stress urinary incontinence (SUI). The agency’s confidence in mesh appears to have been misplaced for many women.  More than 100,000 have filed lawsuits alleging they were injured by the plastic mesh used on them.  Many thousands of those lawsuits were settled, while many of them remain in the courts.  Just a few weeks ago, a jury awarded a woman several million dollars for a Johnson & Johnson mesh product that she testified badly injured her.  Several mesh trials resulted in large jury verdicts, including a recent $73 million award in Dallas.  The material used in the mesh on that injured Texas woman – along with thousands of others for POP or SUI – is the same material used in hernia meshes.

The FDA reports on its web site that mesh-based hernia repairs have increased since the 1980s.  By 2000, non-mesh repairs made up less than 10% of groin hernia repair techniques.  Does that mean that hernia mesh is safe?  Not according to at least one surgeon, who says that 10-20% of hernia mesh patients suffer complications.

FDA also says “the use of surgical mesh may also improve patient outcomes through decreased operative time and minimized recovery time.”  But FDA also cautions that recovery time depends on the type of hernia, the surgical approach, the patient’s condition before and after surgery.

The agency also says that the medical literature has “consistently demonstrated a reduced hernia recurrence rate when surgical mesh is used to repair the hernia compared to hernia repair without surgical mesh.  For example, inguinal hernia recurrence is higher with open repair using sutures (primary closure) than with mesh repair.”  But does that mean hernia mesh is safer than suturing, or superior to suturing?

FDA Cautions on Hernia Mesh
The FDA also admits that despite reduced rates of recurrence with hernia mesh vs. suture repairs, situations arise in which surgical mesh for hernia repair “may not be recommended. Patients should talk to their surgeons about their specific circumstances and their best options and alternatives for hernia repair.”

Hernia Mesh vs. Suture Repair

While the literature may indicate that using mesh for hernia repairs does have its advantages, the FDA categorically fails to state one glaring fact for those whom the mesh fails.  At least one prominent hernia surgeon says that the complication rate for hernia mesh surgery is a shocking 10-20%.   The FDA also fails to state, in its hernia mesh literature, what we saw with plastic mesh used on women for POP or SUI.  Namely, if the mesh fails the patient, for whatever reason, it can be difficult or impossible to remove it.  That unfortunate situation can lead to permanent pain for the person meshed.  This is one more instance, among an endless list of examples, where the FDA tends to err on the side of industry rather than on the side of the consumer, and safety.  In this instance and in many, many others, the FDA downplays the serious risks of a medical device (or drug), while promoting its alleged benefits.  Buyer beware!

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Hernia Mesh 10-20% Complication Rate, says Surgeon

Hernia mesh has a 10-20% complication rate, says a surgeon who has performed dozens of hernia mesh removals.  That’s much higher than the 1-2% complication rate that has been reported by mainstream doctors who parrot mesh makers’ claims.

Doctor will speak to UK Parliament

On Oct. 18, 2017, Dr. Robert Bendavid will tell the UK Parliament just how troublesome plastic mesh can be for hernia repair.  Dr. Bendavid works out of Shouldice Hospital in Toronto, Canada.  Jane Akre of Mesh News Desk reports that the surgeon is frustrated with the way plastic hernia mesh makers have downplayed the number of catastrophic events triggered by hernia repair that inserts plastic mesh into the human abdomen.

20% Hernia Mesh Failure Rate
Dr. Bendavid says 20% is likely a closer complication rate for the meshes used in hernia repair. He laments that, for about 20 years, synthetic meshes have become the mainstay of hernia surgery. The reason, he says, is not for efficacy.  Like plastic mesh put into women for pelvic organ prolapse (POP) or stress urinary incontinence (SUI), hernia mesh surgery has exploded in popularity primarily because mesh makers have so assiduously promoted it.  Mesh makers have doled out millions promoting mesh conferences, societies, and free surgical training sessions.  Those promotions have even formed a whole new generation of surgeons who were taught to favor mesh over traditional suture repair for hernias.  Meanwhile, the drawbacks of meshes, says Dr. Bendavid, “were always vague and nebulous.”

Today, mesh-based repairs are touted as the ideal in the guidelines of the European, Danish and Swedish Hernia Societies.  The American Hernia Society has gone right along with the mesh program.  Dr. Bendavid has not.

Shouldice Repair for failed Plastic Mesh Repair
The doctor notes: “Shouldice repair, a pure tissue repair, rated a mention only when infected mesh was removed!”  He adds that Shouldice repair was considered the “gold standard” 20 years ago, but today no one performs or knows how to perform it outside Thornhill. (editor’s note: We believe there are some American doctors and others in other countries who do perform Shouldice repair.)

Plastic Mesh spawns New Injury
Dr. Bendavid further notes that, “The world literature is now replete with publications on chronic postherniorrhaphy inguinodynia, a condition unknown before the introduction of mesh.  In 1964, in Nyhus’ classic hernia, postherniorrhaphy pain did not rate a mention in its index.  In Ponka’s equally excellent book, pain is mentioned in half a column as ‘uncommon’ and due to ‘scar tissue’ (1980).”

Hernia Mesh Complications
Many publications are now providing more up-to-date statistics on postoperative complications of mesh. Dr. Bendavid says that 11% of patients will have a “history of severe chronic postoperative inguinodynia severe enough to be detrimental to their quality of life.”

Mesh Pain Irreversible
Another group of patients (3%–4%) will suffer irreversible dysejaculation, which 20 years ago, sans mesh, had an incidence of 1 in 2500 cases and was reversible.  That is a hundred-fold (or 10,000%) increase.  Another 10% of patients will suffer severe testicular pain secondary to mesh erosion of the vas. This in some cases requires an orchidectomy. Additionally, transmigration of mesh into adjacent organs is commonly reported but not systematically quantified with any accuracy through industrial surveillance. Dr. Bendavid asks: “With such evidence, would a ‘duly informed’ patient consent to mesh-based surgery?

Mesh is now used in 90-97% of hernia surgeries around the world, but in just 3% of the cases at the Shouldice Hospital.

Professor Volcker Schumpelick, Editor in Chief of the Hernia, in his address to the American Hernia Society (2005) stated: “[D]espite the introduction of mesh and laparoscopy, there has been no reduction in the incidence of hernia recurrences in the last 30 years. That incidence worldwide is 14%.”  So Dr. Bendavid fairly asks: “Why are the European guidelines rushing to be launched as World guidelines?”

Dr. Bendavid has helped launch a study to pin down the percentages of complications resulting from hernia meshes used in hernia surgery.  He says the current hernia mesh surgery complication rate, “estimated at 10-20%, could be brought to a mere 5% with simple emphasis of anatomy. The Shouldice Hospital already demonstrated, 20 years ago, that 1%–5% is the magic number depending on the type of hernia.”

The doctor also notes that it takes surgeons 4-6 years to learn the necessary skills to safely and successfully perform hernia mesh surgery, while plastic mesh industry representatives, who are not always doctors, train doctors to perform plastic mesh surgery in minutes.  How many hernia sufferers would rather their hernia surgeon have trained for 4-6 years rather than for just a few minutes?

Hernia Mesh 10-20% Complication Rate, says Surgeon

How many people would rather have hernia surgery with a product (pure tissue) that can be safely and fully removed, rather than with a product that may be impossible to fully remove (plastic hernia mesh) and that could cause permanent, debilitating pain?

Ralph Nader, for one – who tends to do his research – chose to forego plastic mesh for his own hernia repair.  Mr. Nader chose Dr. Bendavid to perform his recent hernia surgery.  The man who started Consumer Reports may know a thing or two when it comes to safe products.

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Cook IVC Filter Lawyers can depose ex-Cook President, says Judge

Cook IVC filterCook Blood Clot Filter Lawsuits lawyers can depose an ex-Cook president, a judge ruled on September 13, 2017.  Cook defense lawyers had moved to block the deposition.  Attorney David Matthews of Matthews & Associates Law Firm will handle the deposition for the plaintiff in the case.  Mr. Matthews represents the plaintiff in the first Cook IVC filter case scheduled for trial this fall.

U.S. District Judge Richard L. Young issued an order that overruled Cook’s appeal from the denial of a Motion for Protective Order Barring Proposed Deposition of former Cook Group, Inc. president Kem Hawkins.  The Court ordered that Cook must produce its former executive for a deposition by September 27, 2017.

In early 2017, Matthews & Associates requested the deposition of Kem Hawkins to question him over IVC filter documents that included emails from his personal email account.  Plaintiffs contend those documents reveal Mr. Hawkins was intimately involved in the decision-making process and strategy regarding critical issues in the case.  The issues included decisions regarding the testing, design, marketing, and production of the Gunther Tulip and Celect IVC filters.

Defendants had filed a Motion April 27, 2017 for a Protective Order to prevent the Plaintiffs from deposing Mr. Hawkins.  However, on June 30, 2017, the Magistrate Judge denied Cook’s request. He stated: “Hawkins was involved in the decision-making process and strategy regarding the testing, design, marketing, and production of the [Gunther Tulip and Celect] filters.”

The judge rejected Cook’s attempt to thwart potentially damaging discovery:
“… Hawkins is the better source for information related to this litigation because he was the president of Cook during the time the Gunther Tulip and Celect IVC filters were manufactured and sold in the United States. Moreover, Hawkins regularly communicated on a personal email account, which Plaintiffs suspect the Cook Defendants did not search when producing responsive documents to their discovery requests. This all suggests that Hawkins has relevant knowledge that is not already available to Plaintiffs.”

The District judge agreed, adding that a review of the sealed documents shows Mr. Hawkins was involved in “strategic decisions regarding the enhancement of the Tulip filter and the development of the Celect filter to increase market share. He was aware of the timetable for the Celect clinical trials and sought to speed up the process to get Celect on the market. Most importantly, the documents reflect that he was aware of the risk that both IVC filters could perforate the wall of the vena cava.”

Cook IVC Filter Lawyers can depose ex-Cook President, says Judge
The Cook Defendants in the case must produce Mr. Hawkins for deposition within two weeks of the Court’s September 13, 2017 Order.  The ruling means Plaintiffs are entitled to seek relevant documents from Mr. Hawkins and ask him questions about his personal email account.

The first Cook IVC Filter trial is scheduled for an Indiana courtroom in November, 2017.

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Illinois Man files Bard IVC Filter Lawsuit

An Illinois man filed a Bard IVC filter lawsuit August 25, 2017, in the multi-district litigation (MDL) court set in Arizona.  The man was implanted with the Meridian® Inferior Vena Cava Filter (IVC Filter) made by C.R. Bard Inc. and Bard Peripheral Vascular Inc.

Related:  Bard IVC Filter Lawsuit

Bard Meridian® IVC Filter
The IVC Filter was surgically implanted in the man on March 19, 2014 at an Illinois  hospital. The blood clot filter was supposed to prevent a pulmonary embolism (blood clot in the lungs), but instead caused the man severe side effects.

Bard Filter not FDA Approved

The Meridian IVC Filter is one of the newer IVC Filters on the U.S.  market.  It was not approved by the FDA through normal channels.  It was, rather, “cleared” by the agency in 2011 under the auspices of its controversial 510(k) process.  An accepted 510(k) application allows a medical device maker to put a product on the market if it is judged by FDA to be “substantially equivalent” to other, similar medical devices.  This market route, however, also leaves a given device maker vulnerable to potential civil litigation.  By contrast, devices approved under regular channels are given “pre-emption” (via the Draconian 1976 Medical Device Act), which allows a given device maker to injure people at will without fear of civil liability. (See Wyeth v. Levine)

Defective Medical Device
The Illinois man’s lawyers accuse C.R. Bard of selling a defective medical device and inadequately testing the Meridian IVC Filter for safety.

C.R. Bard faces 13 charges in the lawsuit:

1.  strict products liability – manufacturing defect
2.  strict products liability – information defect (failure to warn)
3.  strict products liability – design defect
4.  negligence – design
5.  negligence – manufacture
6.  negligence – failure to warn
7.  negligence per se
8.  breach of express warranty
9.  breach of implied warranty
10. fraudulent misrepresentation
11. fraudulent concealment
12. violations of applicable law prohibiting consumer fraud, unfair & deceptive trade practices
13. punitive damages

Illinois Man files Bard IVC Filter Lawsuit
The lawsuit was filed on August 25, 2017 in the U.S. District Court for the District of Arizona — Case No. 2:17-cv-02875-DGC.

This lawsuit will be centralized with more than 2,200 other IVC filter lawsuits now pending against C.R. Bard in Multi-District Litigation (MDL No. 2641) – In Re: Bard IVC Filters Products Liability Litigation.

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Alabama Man files IVC Filter Lawsuit

An Alabama man who required open-heart surgery when an IVC Filter migrated to his heart six days after being implanted has filed a lawsuit against Cordis Corporation and Johnson & Johnson. The IVC filter makers stand accused of selling a defective medical device and failing to adequately warn of its dangers.  Cordis is a subsidiary of J&J.

Related:  IVC Filter Lawsuit | Lawyer

The lawsuit was filed by an Alabama man injured by the OptEase® Retrievable Inferior Vena Cava Filter (“IVC Filter”) made by Cordis and J&J.

The man was implanted with the Cordis IVC Filter on April 20, 2016 in LaGrange, Georgia by Dr. William E. Behm at West Georgia Medical Center. He was discharged from the hospital in good health.

Cordis OptEase® Retrievable IVC Filter
Six days later, the man was readmitted to the hospital after feeling severe chest pains. An emergency cardiac catheterization revealed that the Cordis IVC Filter had migrated to his heart. The wayward filter was obstructing his right ventricle and right atrium.

The man was then transferred to Piedmont Atlanta Hospital in Atlanta, Georgia. On April 29, 2016, he underwent emergency open-heart surgery. Doctors removed the OptEase IVC Filter and repaired damage which the filter had caused to his heart’s atrium, ventricle, and tricuspid valve.

The man’s physicians said, “Surgery was necessary to treat and prevent imminent death or life-threatening deterioration and failure of his circulatory system.”

One-Month Recovery from Surgery
Following open-heart surgery, the man spent one month recovering in hospital. On May 23, 2016, he was transferred to an inpatient rehabilitation facility.  There he spent nearly four months recovering from his life-threatening injuries.

Cordis Corporation and Johnson & Johnson stand accused, in the lawsuit petition, of selling defective medical devices and failing to warn the man about dangerous risks.

The lawsuit is Case No. 60565803.  It was filed August 17, 2017 in the Circuit Court of the 11th Judicial Circuit in Miami-Dade County, Florida.

4,000 IVC Filter Lawsuits Pending

Roughly 4,000 other IVC filter lawsuits are now pending against B. Braun, Cook Medical, C.R. Bard, Johnson & Johnson, Rex Medical, and other medical device makers in state and federal courtrooms nationwide.

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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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