South Dakota Natives sue drugmakers over opioids

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

Three Tribes file Opioid Lawsuit

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

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

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

Related:  Opioid Lawsuit Lawyer

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

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

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

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

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

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

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

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

Opioid Lawsuit Lawyer

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

Related

•  Opioid Lawsuit Lawyer

•  Lawsuit Settlements in Opioid Litigation

•  Dangerous Drugs

•  South Dakota Natives sue drugmakers over opioids

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Farmers sue Monsanto over Dicamba

Farmers are suing Monsanto over Dicamba, a so-called herbicide (pesticide poison). Farmers in 10 different states are suing the biotech giant from Missouri for selling Dicamba seeds which the company knew could not be used without illegal spraying.

Related: Monsanto Lawsuit

The farmers’ legal petitions state that Monsanto sold dicamba-tolerant cotton and soybean crops while the company knew the sale would lead to illegal spraying. Dicamba is a highly volatile and drift-prone poison. It consequently presents difficulties for its users as well as for those whose lands are poisoned by its uncontrollable drift.

Imagining that one can apply dicamba (or any other poison) on a field without contaminating nearby lands is akin to posting a no-peeing section in a swimming pool. It is simply not possible, and that is what lawyers for these farmers will argue in the upcoming dicamba cases against Monsanto.

Loraine Chow of EcoWatch reported that Steven W. Landers, et al v. Monsanto Company was filed on Jan. 26, 2018 in the United States District Court for the Eastern District of Missouri, Southeastern Division.  The lawsuit was filed on behalf of Steven and Deloris “Dee” Landers as well as farmers harmed by dicamba in 10 states – Alabama, Arkansas, Illinois, Kentucky, Minnesota, Mississippi, Missouri, North Carolina, Tennessee and Texas.

Negligence, Strict Liability, Failure to Warn, Conspiracy Claims
The farmer plaintiffs seek damages for claims that include negligence, strict liability, failure to warn, conspiracy, disgorgement of profits, punitive damages.

Court documents state that Steven and Dee Landers have operated their family-owned farms in New Madrid County, Missouri, since 1976. The Landers claim their farms have been greatly damaged by the illegal spraying of dicamba on Monsanto’s Roundup Ready Xtend crops. These frankenfood crops are genetically engineered to resist the toxic assaults of dicamba and Monsanto’s Roundup (glyphosate).  The problem is that neighboring farms and fields not genetically modified are also poisoned by dicamba.  Living things not genetically modified to resist these poisons are destroyed.

EcoWatch
EcoWatch reported that the Landers’ 1,550-acre farm primarily grows soybeans and corn.  In 2016, the farm suffered dicamba damage on more than half of its crops and acreage. That damage caused a marked reduction in crop yields.

Farmers in the lawsuit allege Monsanto knowingly marketed its Xtend cotton and soybean seeds to farmers without any safe herbicide being available to use on it. The lawsuit claims Monsanto knew the only option purchasers would have to protect crops grown from those seeds would be to illegally spray dicamba to protect the crops from weeds.

The farmer’s lawyers argue that, “Monsanto chose to sell these seeds before they could be safely cultivated. (Monsanto’s) own advertising repeatedly describes its Xtend seeds and its accompanying herbicide as a ‘system’ intended to be used together. But when Monsanto failed to get approval to sell the herbicide, it recklessly chose to go ahead and sell the seeds regardless.”

As a result, farmers throughout the country used illegal and dangerous herbicides in an attempt to protect the Xtend seeds.

The lawyers have argued that Mosanto knew inappropriate herbicide use would occur, the company even encouraged it, and the result was nationwide destruction of “hundreds of thousands of acres of crops.”

Monsanto’s Roundup
Dicamba is the new formulation of an old Monsanto herbicide (created ca. 1958).  The company seems to have trotted it out largely because its Roundup product has been under attack for some time.  In 2015, the World Health Organization declared glyphosate – Roundup’s main ingredient – to be a probable human carcinogen. Several Roundup cancer lawsuits have been filed against Monsanto since then, as Roundup is suspected of causing non-Hodgkin’s Lymphoma and other leukemia-type cancers. Many American farmers, as well as homeowners, have been diagnosed with leukemia after years of Roundup exposure.

Monsanto EPA Collusion
Meanwhile, the Environmental Protection Agency has recently been shown to have colluded with Monsanto to play down Roundup’s cancerous profile to keep the profits for Monsanto coming.

Xtend System’s Troublesome Rollout
The Monsanto rollout of its Xtend system has been marked by trouble ever since Monsanto sold its Xtend cotton and soybeans several growing seasons before the company received federal approval for the herbicide needed for the system.

Farmers sue Monsanto over Dicamba

Monsanto introduced Bollgard II XtendFlex cotton in 2015 and Roundup Ready 2 Xtend soybeans in 2016. However, the U.S. EPA only approved the corresponding herbicide, XtendiMax with VaporGrip Technology, in late 2016.  The new poison combines dicamba and glyphosate.  It is meant to address the proliferation of “superweeds” that have grown resistant to glyphosate.  The superweeds are another reason farmers have begun to run from Roundup.  Monsanto’s answer is the same as always – to sell more poison, pour more poison on the problem, to kill it, regardless of what gets killed as “collateral damage.”

Dicamba Toxicity

The Cornell University web site says dicamba is moderately toxic by ingestion and slightly toxic by inhalation or dermal exposure.  Symptoms of dicamba poisoning include loss of appetite (anorexia), vomiting, muscle weakness, slowed heart rate, shortness of breath, central nervous system effects (victim may become excited or depressed), benzoic acid in the urine, incontinence, cyanosis (bluing of the skin and gums), and exhaustion following repeated muscle spasms. Inhalation can cause irritation of nasal passages’ linings and the lungs, and voice loss.

Dicamba is very irritating and corrosive. It can cause severe and permanent eye damage.  Dicamba is also a skin sensitizer that may cause skin burns.

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Medical Director Fired for questioning Flu Vaccine

(Feb. 3, 2018) The medical director of the Cleveland Clinic was fired last year for questioning the safety of the flu vaccine. The doctor took the flu shot as instructed; but rather than working as advertised, the shot sickened him instead. He then did what few doctors do. He performed some research into the actual ingredients in the flu shot. He found formaldehyde, which causes cancer, and he alerted the public to it on his twitter page. He apparently missed the memo that questioning the wisdom of any vaccination can be career suicide.

The director of one of the nation’s finest hospitals apparently hadn’t read Dr. Suzanne Humphries’ work. He was likely not familiar with the vaccine investigations of Dr. Jeffrey Bradstreet, Dr. Andrew Moulden, and many others who have been systematically attacked by the mainstream press, neutralized (as the CIA says), discredited, or even murdered for questioning the holy grail of vaccine policy in the “land of the free.”

Vaccine Safety Questions Verboten
The Medical Director and Chief Operating Officer of the Cleveland Clinic Wellness Institute, Dr. Daniel Neides was not fired for being “anti vaccine.”  He was not an “anti-vaxxer.”  He did not imply that all vaccines are dangerous or useless.  Dr. Neides was fired simply for having the temerity to question the lack of disclosure in the flu shot’s ingredients, after he submitted to the flu vaccination himself.

Doctor exposes ‘Preservative-Free Vaccine” Lie
Dr. Neides wrote:
“I, like everyone else, took the advice of the Centers for Disease Control (CDC) – the government – and received a flu shot.  I chose to receive the preservative free vaccine, thinking I did not want any thimerisol (i.e. mercury) that the “regular” flu vaccine contains.

Makes sense, right?  Why would any of us want to be injected with mercury if it can potentially cause harm?  However, what I did not realize is that the preservative-free vaccine contains formaldehyde.

WHAT? How can you call it preservative-free, yet still put a preservative in it?  And worse yet, formaldehyde is a known carcinogen.  Yet, here we are, being lined up like cattle and injected with an unsafe product.  Within 12 hours of receiving the vaccine, I was in bed feeling miserable and missed two days of work with a terrible cough and body aches.”

Despite making it clear that he was not “anti-vaccine,” Dr. Neides was almost instantly branded as an anti-science heretic, promoting “harmful myths and untruths about vaccinations.”

One wonders how the doctor rose to the position of “Medical Director and Chief Operating Officer of the Cleveland Clinic Wellness Institute” while being a heretic and anti-science.

The Cleveland Clinic is world-renowned for providing research and thinking “outside the box” when it comes to healthcare. The Cleveland Clinic web site boasts:

“We are a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education.

Cleveland Clinic is one of the largest and most respected hospitals in the country. Our mission is to provide better care of the sick, investigation into their problems, and further education of those who serve.”

The Cleveland Clinic employed Dr. Neides for several years, until he questioned the presence of  cancer-causing chemicals in the flu vaccine.

Was Dr. Neides wrong to tell the truth. Was he wrong to question why a cancer-causing substance like formaldehyde is present in the flu vaccine? Was the doctor wrong to tell the world that the CDC and the flu vaccine maker were lying when they said there was no preservative in the flu vaccine? Is this the world we now live in – that it is wrong to tell the truth if it hurts vaccine policy?

Is it not doing God’s own work to tell the truth? What sort of a country have we become when doctors who tell the truth are silenced, neutralized, or put out of a job?  Make no mistake, that is exactly what happened in this case.  A brave medical doctor simply told the truth, and he was crucified for it.

Confidence in the Flu Shot?

Does the medical monopoly that runs healthcare in the U.S., salong with their CDC partners, imagine that firing honest doctors is going to give us all more confidence in the flu shot, and in the practice of vaccination itself?  If it takes lies to make us all blindly follow some pre-ordained policy, which, given the doctor’s own personal experience, is not good for our health, what sort of a people are we?  What sort of a world have we allowed ourselves to fall into?

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Blood Thinners like Xarelto linked with Most Emergency Room visits

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

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

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

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

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

Blood Thinners like Xarelto linked with Most Emergency Room visits

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Five Reasons to Hire a Railroad Injury Attorney

There are at least five good reasons to hire a railroad injury attorney.  The old adage that anyone who chooses to represent himself has a fool for a client applies to railroad injury cases just as it does with any legal case.  Like it or not, the complications involved in a railroad injury case require experienced handling.  In addition,  railroad injury attorneys typically work on a contingency fee basis, meaning that one never needs to pay them unless they achieve a settlement or a courtroom victory.

Related:  Railroad Cancer Lawsuit

Five Reasons to Hire a Railroad Injury Attorney

1. Railroad Injury Law is Unique –
The Federal Employers’ Liability Act (FELA) was passed by the government in 1908 to protect railroad workers injured on the job. FELA differs from state worker’s compensation laws and state automobile injury laws. Railroad employees injured in workplace accidents may recover damages based on their losses, which can include past, present and future wages; pain and suffering; and loss of enjoyment of life.

FELA gives engineers, brakemen, switchmen and other railroad employees the right to sue for on-the-job injuries in state or federal courts. The railroad law has been strengthened by both Congress and the U.S. Supreme Court over the years to provide good protection to injured railroad employees.

To recover damages under FELA, however, a plaintiff must show some that negligence by the railroad caused the plaintiff’s injury. It takes an experienced railroad injury attorney to gather the evidence needed to put such a negligence case together.

2. Experience is Everything
Whether the injury claim is something as simple (relatively speaking) as carpal tunnel syndrome, or as complicated as trauma injuries, it is critical to have an attorney who knows FELA and has experience in railroad law. The FELA provides every railroad worker with the right to sue in state or federal court, and the choice of venue is something an injured person would be wise to discuss with an experienced railroad injury attorney.

3. Accept a settlement offer, propose another, or go to trial?
Whether to accept a settlement offer, propose a different settlement, or go to trial is a decision best discussed with experienced railroad counsel. There are so many factors to consider, including a long history of legal precedents and other crucial information which most laymen will not know or fully understand. An experienced railroad injury attorney can help an injured party separate wheat from chaff, and choose the individual’s best option for success.

4. Railroad Attorneys win more Compensation than Attorneyless Plaintiffs
Statistical evidence compiled by the Transportation Research Board, National Research Counsel Special Report 241 concluded: “Statistical evidence has established that of all injured railroad workers, the 20% of injured railroad workers who hire attorneys receive 70% of the money paid out by the railroads. The remaining 80% of the injured railroad workers who don’t hire attorneys split only 30% of the money paid out on FELA claims.”

5. The Railroad Hires its own Attorneys
The railroad’s own attorneys will question any injured railroad worker following any accident or compensation claim. Those questions are designed to find ways to minimize or negate any railroad liability. A railroad’s attorneys favor the railroad, period. An injured worker without his own counsel is at a severe disadvantage. Anything the injured worker says to a railroad attorney may be used against him. A good railroad injury attorney working for an injured man helps protect him against saying anything that might unfairly affect his case.  Knowing what not to say can be as important as knowing what to say.

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Second trial to test J&J Baby Powder Mesothelioma Link

A Middlesex County courtroom heard the opening statements Jan. 29, 2018 in a lawsuit against Johnson & Johnson. The petition alleges that J&J’s talc products caused an Essex County man’s cancer.

Stephen Lanzo, III, 46, of Verona, says the Johnson’s Baby Powder he used throughout his life exposed him to asbestos. His lawsuit petition says that powder led to his developing mesothelioma, a deadly cancer that affects lungs and abdomen tissue.

Related:  FDA on Talc

"Cosmetic companies have a legal responsibility for the safety and labeling of their products and ingredients, but the law does not require them to share their safety information with FDA."

The lawsuit petition filed in 2016 reads that Mr. Lanzo and his wife Kendra seek monetary damages after “Lanzo regularly and frequently used and was exposed to asbestos-containing Johnson & Johnson talc powder products.”

Mr. Lanzo’s is the first case to be tried at the Middlesex County Courthouse, which is less than a mile from Johnson & Johnson headquarters in New Brunswick. He is the second person to allege that J&J’s talc products have caused a user to develop mesothelioma cancer.

Related:  California Jury awards $22 Million in Talc Asbestos Trial

Hundreds of J&J Talc Cancer Cases
Several other cases filed across the country have claimed J&J’s talc powder products have caused women’s ovarian cancer. Hundreds of plaintiffs in other suits claim Johnson’s talc powder caused their cancer.

Opening Statements

The Lanzos’ lawsuit claims J&J knew its products contained asbestos, but failed to properly warn its consumers.  In opening statement, Mr. Lanzo’s lawyer said, “It’s true, we don’t know how many Johnson & Johnson users have mesothelioma.  (The) fact is that the defendants have never studied that.”

J&J’s lawyers argued in opening statement that the company’s talc products never contained asbestos, and that the plaintiffs used faulty test methods to prove otherwise.

Second trial to test J&J Baby Powder Mesothelioma Link

Defendants in the case also include Imerys Talc America and Cyprus Amax Minerals Co.
The case is being presided over by Judge Ana Viscomi. It is expected to last through February 2018.

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FBI, DOD Investigate USA’s Largest Psychiatric Hospital Chain

The FBI and Department of Defense (DOD) are investigating the USA’s largest psychiatric hospital chain.  Universal Health Services is suspected of systematically holding patients to maximize profits.  Two nurses at one of the company’s facilities raised the serious allegations after a protest at company headquarters in Pennsylvania last spring. Our law firm is investigating these reports and others for potential healthcare fraud lawsuits. 

Universal Health Services Investigated
According to three sources with direct knowledge of the investigation, officials are examining whether Universal Health Services (UHS) directs its hospitals to hold patients for as long as their insurer will pay, regardless of medical need.  BuzzFeed News reported that the probe has been ongoing since at least 2013.  That year, the Department of Health and Human Services issued subpoenas to ten UHS psychiatric hospitals.

BuzzFeed News learned last spring (2017) that the latest investigation has been broadened to include the FBI and DOD, which is scrutinizing UHS’s billings to Tricare, the insurance plan for active military members and their families.  A $12 billion company, UHS made nearly one-third of its 2016 revenues from U.S. government insurance providers like Medicare and Medicaid.

Search for Witnesses
Officials working on the investigation continue to seek witnesses to any potentially fraudulent activity.  According to BuzzFeed, an agent on the case said, “Putting together a successful prosecution will require the testimony of patients, intake coordinators, nurses, social workers, providers, and executives.”

Shareholders without a Voice
The latest allegations against UHS were raised during its shareholders meeting in the spring of 2017, by nurses who protested outside the event, along with an investor in the room.  The New York City Comptroller’s office represents pension funds that own more than $25 million in UHS stock; the NYC office referenced the government investigations into UHS as it called for the company to abandon its shareholders voting system, which fails to favor majority owners.

Two Nurses Blow Whistle on UHS
Two nurses from one UHS facility, Brooke Glen Behavioral Hospital, told BuzzFeed that they had direct experience with UHS holding patients longer than necessary to collect higher insurance payments.  The nurses recalled telling doctors that patients were safe to be discharged, but that the doctors would ask when their “last covered day” was, meaning the last day Medicare, Medicaid, or other insurance would pay for and discharge the patients, regardless of their condition.

The nurses said the doctors would sometimes have to come up with new notes to explain the extended times, such as a change in medication.

Milking Medicare & Medicaid
“If they’re on Medicare or Medicaid, they’ll (the doctors will) milk it,” said Valerie Riling, who has worked at Brooke Glen for nearly two years. “We’re not doing right by our patients.”

“They’ll admit people just to fill a bed,” said nurse Brandi George.

Last year, a BuzzFeed News investigation into UHS reported that staff in at least 14 of its hospitals said they were directed not to release patients until they had run through all available insurance funds.  Employees said that the instruction would often come in the form of the coded phrase, “Don’t leave days on the table.”

Physicians at a UHS facility in Oklahoma also told BuzzFeed News they were pushed not to release patients until their insurance days were up, especially when the hospital was operating below capacity.  That hospital has also been plagued by riots and safety issues, the investigation reported.

Because psychiatric hospitals are reimbursed for each day that a patient stays, extending patients’ stays can drive up a hospital’s profits. But billing for treatment that is not medically necessary can constitute fraud.  And patients needlessly held in locked-up places can be traumatized.

UHS Denies Any Wrongdoingl

UHS has said it “absolutely rejects” BuzzFeed News’s reporting and that it does not manipulate a patient’s stay for financial gain.  UHS said its record of quality care “speaks for itself,” and that it has consistently received high-satisfaction marks from patients.

FBI Investigates

An FBI spokesperson declined to confirm or deny the investigation into UHS, but said the bureau actively pursues allegations that hospitals admit or hold patients who do not need treatment.

FBI spokesman John Althen said that in such instances, a hospital will “ignore the recommendations of its own clinicians to discharge patients, pressure the clinicians to keep patients in a hospital as long a patient’s insurance policy will pay for treatment, or employ clinicians who are complicit in the scheme.”

At least one in ten of UHS’s psychiatric facilities nationwide is now under government scrutiny. Part of the investigation has been referred to the criminal frauds section of the Department of Justice.  In 2015, the probe was expanded to UHS as a corporate entity.

UHS has described the civil investigation in filings to investors as a “False Claims Act investigation focused on billings submitted to government payers in relation to services provided at those facilities.”  UHS has not provided any details about the criminal investigation, nor has it disclosed that the DOD is among the agencies investigating.

In a response to BuzzFeed, UHS said that it “takes these matters very seriously and is cooperating with all agencies involved.”  It added, “Investigations such as these are an unfortunate but common reality facing the healthcare industry.”

UHS Settled Lawsuit with Government
In 2012, UHS settled a lawsuit that the government filed against one of the company’s youth facilities in Virginia.  A federal petition alleged that the hospital was delaying the release of patients who no longer needed care in order to increase Medicaid payments.  It charged that UHS deliberately provoked patients so that their reactions would warrant longer stays, and even altered therapists’ records to justify longer stays.

High Anxiety

Given the 2012 settlement against UHS and some of these latest allegations of forcing a patient to stay in the hospital for profit, Mel Brooks’ comedy “High Anxiety” may not have been so far from the truth.  In that film, a therapist (played by Harvey Korman) provokes a patient into remaining “disturbed” in order to keep him imprisoned in a psychiatric hospital.

Matthews & Associates Law Firm is investigating potential cases involving psychiatric patients held against their will, beyond the therapeutic point.  If you believe that you or or someone you love has been held in a hospital beyond the therapeutic point, solely for profit, contact us for a free legal consultation.

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Limbrel Capsules withdrawn from the Market

Limbrel capsules were withdrawn from the market in Jan. 2018.  Primus Pharmaceuticals Inc., Scottsdale, AZ withdrew its osteoarthritis capsule Limbrel this month following a strong recommendation from the FDA.  The agency said in Nov. 2017 that Limbrel may cause drug-induced liver injury, as well as a lung condition called hypersensitivity pneumonitis.

The FDA sent a letter to James D. Weir, president and chief executive officer of Primus in Scottsdale, AZ.  The letter demanded that Primus cease distribution and immediately recall specific Limbrel lots, which include:

•  Limbrel (flavocoxid) 250 mg capsules
•  Limbrel250 (250 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules
•  Limbrel (flavocoxid) 500 mg capsules
•  Limbrel500 (500 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules

FDA Letter to Primus
The agency wrote in its letter to Mr. Weir at Primus: “The FDA has determined that these Limbrel products are unapproved new drugs and represent a serious health hazard.  Between January 1, 2007, and November 9, 2017, FDA received 194 adverse event reports associated with the use of Limbrel products.”

Primus Liver Injury & Hypersentsitivity Pneumonitis (HP)
The FDA letter further stated that adverse event reports it had received “identified a close relationship between the use of Limbrel and adverse events involving the development of drug-induced liver injury (DILI), pancreatitis, and hypersensitivity pneumonitis (HP).” Those health problems can present varying degrees of severity, ranging from mild to life-threatening.

FDA: Limbrel Products Unapproved
The FDA further wrote: “In addition, your Limbrel products are unapproved new drugs distributed in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 331(d) and 355(a)].”  The agency letter added that the claims on the product labeling establish that the Limbrel products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.   FDA said the label claims establish that the product is a drug because of such language as “clinical dietary management of the metabolic processes of osteoarthritis.”

Primus Response
On its Limbrel website, Primus pushed back at the FDA, appearing to blame the agency for the withdrawal.  Primus said the action to withdraw the Limbrel products from the market was “in response to repeated aggressive press releases from the FDA” and the letter it received from the FDA on December 19.

Unwarranted Pressure from FDA?
The Primus statement on its web site read in part: “Primus Pharmaceuticals, in response to unwarranted pressure from the FDA, has voluntarily suspended promotion and sale of Limbrel, an important and in many cases the only medical option for people suffering from osteoarthritis, pending Primus receiving requested safety data held by the FDA and meeting with the FDA as requested.”

Limbrel: Medical Food or Drug?
The company further questioned the FDA’s determination that Primus had marketed Limbrel as a drug, rather than a food.  Through its Washington law firm, Primus’ formal response to FDA included this statement: “For nearly 14 years, Limbrel has been marketed as a medical food dispensed by prescription and under physician supervision, with over 2 million packages sold and sampled in that time to an estimated 450,000 patients.”

In their response dated Dec. 20, Primus’ lawyers claimed Limbrel does meet the statutory definition of a medical food as set forth in the Orphan Drug Act.  “In fact, Limbrel has been referenced as such in many peer-reviewed nutritional, regulatory, clinical, and scientific peer-reviewed articles.”

Primus’ response also countered FDA’s adverse-event claim.  Primus said that historically, “both FDA and Primus have received very low numbers of reports of acute hypersensitivity pneumonitis (AHP) and elevated liver function tests (LFTs).”  The company added that the reactions have been temporary and medically reversible.

Primus has reportedly requested further meetings with FDA to lobby that Limbrel is safe and should be considered a medical food.  If that effort fails, Primus indicated it might pursue a reclassification of the product as a nutritional supplement, according to a Jan. 2018 report in The Arizona Republic.

The newspaper quoted Mr. Weir as saying, “We don’t understand why this product has been on the market for so long with such consistent feedback and use, and now is an issue.”

FDA Recommends ceasing Limbrel Use
In its Nov. 2017 warning, the FDA also advised health care providers who are aware that their patients are taking Limbrel to tell them to stop using it.

Limbrel Injury Symptoms
Of the 194 adverse event reports regarding Limbrel that the FDA received, 30 gave sufficient information for FDA medical experts to determine that Limbrel was likely associated with these adverse events.  The agency has recently seen a spike in the number of serious, potentially life- threatening health problems associated with Limbrel, including drug-induced liver injury and hypersensitivity pneumonitis.

Various symptoms of drug-induced liver injury may include jaundice, nausea, fatigue, and gastrointestinal discomfort.  Anyone experiencing any of these symptoms is advised to contact a health care provider right away.  Symptoms of hypersensitivity pneumonitis may include fever, chills, headache, cough, chronic bronchitis, shortness of breath or trouble breathing, weight loss, fatigue.  Anyone experiencing any of these symptoms, is also advised to contact a health care provider right away.

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First Self-Driving Car Lawsuit Filed after Crash

General Motors is involved in the first self-driving car lawsuit filed after a crash. GM is now being sued over an accident involving a self-driving car.  Thankfully, this was a low-speed crash without a fatality.  A motorcyclist said he suffered neck and shoulder injuries after one of GM’s self-driving cars swerved into his lane and knocked him down.

Oscar Willhelm Nilsson said on Jan. 22, 2018 that the accident occurred when he tried to pass a Cruise Automation 2016 Chevrolet Bolt.  The Bolt began to switch lanes, but then suddenly swung back into its original lane and hit Mr. Nilsson.  His lawsuit said that he has had to take disability leave from his job due to his injuries.

His lawsuit petition reads: “As a result of such negligent driving, Mr. Nilsson sustained serious injuries of body and mind and incurred expenses for medical care and attendance, all to the great detriment of Mr. Nilsson for past, present, and future damages.”

The accident occurred Dec. 7, 2017 in San Francisco. Calif., while the GM car was in self-driving mode, according to the complaint.  Mr. Nilsson said the car indicated it was merging left, so he drove straight ahead once the car had cleared lanes.  Then, however, the Bolt swerved back into the original lane, knocking him over and causing neck and shoulder injuries that require “lengthy treatment.”

Mr. Nilsson is seeking damages, costs and attorneys’ fees for the alleged negligence.

GM Disputes Lawsuit Claim
GM reported a different version of events to the California DMV.  GM said its car was driving in the middle of three one-way lanes when it started to merge into the left lane. The minivan ahead of the car then slowed down, and the Bolt abandoned its attempt to merge, said GM.

While the GM car was “re-centering” itself in the middle lane, a motorcycle that had passed between two vehicles in the center and right lanes hit the side of the car and fell over, scuffing the  vehicle’s side, said the report.

The GM report said the self-driving car had been keeping pace with surrounding traffic at 12 mph while the motorcycle was traveling 17 mph.

GM Statement
A GM representative said by email: “Safety is our primary focus when it comes to developing and testing our self-driving technology.  In this matter, the [San Francisco Police Department] collision report stated that the motorcyclist merged into our lane before it was safe to do so.”

Mr. Nilsson’s lawyer reached on Jan. 24 by The Mercury News (former paper of the courageous Pulitzer Prize Winner Gary Webb) said again that they believe GM’s self-driving vehicle was at fault in the accident.

First Self-Driving Car Lawsuit Filed after Crash
The case is Oscar Willhelm Nilsson vs. General Motors LLC, case number 3:18-cv-00471 in the U.S. District Court for the Northern District of California.

This may not turn out to be a particularly strong case, if the GM defense position has merit, but it may well turn out to be an historic case. Millions of self-driving vehicles may one day soon be on the nation’s roads.  Uber is already wildly enthusiastic about the possibility, as self-driving cars could cut out the middle man and make it a lot cheaper for the company to run people to their destinations.

Self-driving Car Lawsuit

Matthews & Associates Law Firm is investigating self-driving car lawsuits.  If you or someone you love was injured by a self-driving car, contact our law offices for a free legal consultation.

 

Related

•  GM Recall Lawsuit

•  Houston Car Accident Attorney

•  Houston Truck Accident Lawyer

•  First Self-Driving Car Lawsuit Filed after Crash

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Blood Pumps Can Kill Patients

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

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

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

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

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

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

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

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

Blood Pumps Can Kill Patients

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

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

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