Aurora Healthcare Ordered to Disclose Hundreds of Documents!

 

The U.S. Attorney has asked a federal judge to order Aurora Health Care to turn over more than 600 documents sought in a civil investigation of possible fraudulent payment claims made to the government.

Aurora claims that the documents are protected under the state's peer review statute, according to the petition filed last week in Milwaukee.

Peer-review committees review medical errors and other adverse events at hospitals and other health care settings. Their work typically is kept confidential to encourage staff to report errors and to enable the committee to examine the cause of such errors without the risk of their work being subpoenaed in a medical malpractice lawsuit.

The petition seeking the Aurora records is heavily redacted and doesn't provide details about the investigation. But the petition does say the probe is into possible violations of the False Claims Act.
Aurora declined to comment because of the ongoing investigation.

The U.S. Attorney initially requested the documents on Jan. 31. To date, Aurora has produced 1,260 records totaling 61,800 pages. More than 300 of the records, totaling 51,700 pages, were medical records.

Aurora claims that Wisconsin peer-review law bars it from producing the remaining documents and that the documents were "created in order to help improve the quality of health care," according to the petition.

The U.S. Attorney's position is that state law does not apply in a federal matter and federal common law does not recognize a peer review privilege that would prevent documents from being subpoenaed in an investigation.

Wells Fargo Finally Paying Up

 

A New York federal jury ordered Wells Fargo & Co. to pay $54.8 million in damages to resolve a class action lawsuit alleging the late fees charged by two mortgage servicers were improper and excessive.

The mortgage fee class action lawsuit alleged that The Money Store and HomEq, mortgage firms which are now defunct, improperly charged late fees after borrowers’ loans were accelerated and paid off. HomEq had been owned by Wachovia, which Wells Fargo acquired in 2008. The Money Store was owned by First Union, which was later acquired by Wachovia. Wells Fargo never actually owned either mortgage firm.

Plaintiff Joseph Mazzei alleged in the mortgage fee class action lawsuit that he took out a mortgage loan from The Money Store in 1994. Five years later, he fell behind on the loan and defaulted several times. He alleges that The Money Store and others accelerated his loan obligations in 2000, declaring that the full amount of the debt was due immediately.

Subsequently, Mazzei was charged multiple late fees for failing to make monthly payments on the loan, according to the mortgage fee class action lawsuit. He later sold his home and made a payment of approximately $61,000 to the defendants.

The mortgage fee class action lawsuit charged the defendants with breach of contract and violations of the Truth in Lending Act and the California Business & Professional Code. A judge previously dismissed claims under the Fair Debt Collection Practices Act and the Real Estate Settlement Procedures Act.

In January 2013, U.S. District Judge John G. Koeltl certified Classes of borrowers who signed on loans owned or serviced by the defendants and were charged unlawful fees between March 1, 2000 and June 2, 2014. Excluded from the Class are borrowers who signed form loan mortgage agreements after Nov. 1, 2006.

The mortgage late fee class action lawsuit, which was filed in 2001, sought around $629 million for alleged overcharges and interest. The case went to trial earlier this month and lasted 10 days.

“We disagree with the jury’s decision to award damages for some of the claims in this case—all of which are based on allegations dating back 10 years or more at a predecessor company—and we likely will seek review of that portion of the verdict,” a spokesman for Wells Fargo said.

GM Chevy Volt Safety Risk for Drivers!

General Motors LLC (GM) is facing a proposed defective

automotive class action lawsuit over an alleged defect in the

steering system of its Chevrolet Volts which causes the steering

wheel to freeze intermittently while driving. 



 Filed in New Jersey federal court, by plaintiffs Christopher Johnson and Tara Follari-Johnson, the lawsuit claims that GM knew, or should have known, about the alleged defect, but continued to sell the cars. The lawsuit further claims that the alleged defect poses a hazardous safety risk to drivers and that even when GM agrees to fix the steering system, it only replaces the allegedly defective steering rack with the same or similarly defective components.

“When class members present to GM’s authorized dealerships complaining of the steering defect, the dealerships recommend repairs such as replacing the steering rack or steering gear assembly,” the plaintiffs said. “However, these repairs only temporarily mask the problem.”

The lawsuit alleges GM is in violation of the New Jersey Consumer Fraud Act and the Magnuson-Moss Warranty Act, and in breach of implied warranty of merchantability and express warranty and common law fraud.

The plaintiffs propose to represent a nationwide class of owners and lessees of 2011-2014 Chevrolet Volt bought or leased new in New Jersey and a subclass of national class members who live in New Jersey. There are at least 100 members of the proposed class, according to the plaintiffs, and their claims are more than $5 million.

Alstom Hit Hard With Settlement For Bribery

French engineering giant Alstom.  SA agreed to pay $772 million to settle accusations that it paid millions of dollars in bribes to win energy contracts, prosecutors said on Monday.
That amount represents the largest-ever criminal penalty the U.S. Department of Justice has gotten from a company on bribery-related charges.

The record criminal penalty in part reflects what prosecutors saw as an initial failure of the company to fully cooperate, according to people familiar with the matter.

U.S. authorities have ramped up overseas bribery enforcement in recent years, often investigating foreign companies that have a subsidiary located within the U.S. The Foreign Corrupt Practices Act makes it a crime to bribe a government official in exchange for business.

“This investigation spanned years and crossed continents, as agents from the FBI Washington and New Haven field offices conducted interviews and collected evidence in every corner of the globe,” said FBI Executive Assistant Director Anderson.  “The record dollar amount of the fine is a clear deterrent to companies who would engage in foreign bribery, but an even better deterrent is that we are sending executives who commit these crimes to prison.”

Alstom pleaded guilty to a two-count criminal information filed today in the U.S. District Court for the District of Connecticut, charging the company with violating the Foreign Corrupt Practices Act (FCPA) by falsifying its books and records and failing to implement adequate internal controls.  Alstom admitted its criminal conduct and agreed to pay a criminal penalty of $772,290,000.  U.S. District Judge Janet B. Arterton of the District of Connecticut scheduled a sentencing hearing for June 23, 2015 at 3pm.

In addition, Alstom Network Schweiz AG, formerly Alstom Prom (Alstom Prom), Alstom’s Swiss subsidiary, pleaded guilty to a criminal information charging the company with conspiracy to violate the anti-bribery provisions of the FCPA.  Alstom Power Inc. (Alstom Power) and Alstom Grid Inc. (Alstom Grid), two U.S. subsidiaries, both entered into deferred prosecution agreements, admitting that they conspired to violate the anti-bribery provisions of the FCPA.  Alstom Power is headquartered in Windsor, Connecticut, and Alstom Grid, formerly Alstom T&D, was headquartered in New Jersey. 

According to the companies’ admissions, Alstom, Alstom Prom, Alstom Power and Alstom Grid, through various executives and employees, paid bribes to government officials and falsified books and records in connection with power, grid and transportation projects for state-owned entities around the world, including in Indonesia, Egypt, Saudi Arabia, the Bahamas and Taiwan.  In Indonesia, for example, Alstom, Alstom Prom, and Alstom Power paid bribes to government officials – including a high-ranking member of the Indonesian Parliament and high-ranking members of Perusahaan Listrik Negara, the state-owned electricity company in Indonesia – in exchange for assistance in securing several contracts to provide power-related services valued at approximately $375 million.  In total, Alstom paid more than $75 million to secure $4 billion in projects around the world, with a profit to the company of approximately $300 million.   

Alstom and its subsidiaries also attempted to conceal the bribery scheme by retaining consultants purportedly to provide consulting services on behalf of the companies, but who actually served as conduits for corrupt payments to the government officials.  Internal Alstom documents refer to some of the consultants in code, including “Mr. Geneva,” “Mr. Paris,” “London,” “Quiet Man” and “Old Friend.”

Xarelto Safe or Deadly??

 

The use of the medicine Xarelto, while originally believed to help prevent the formation of blood clots, has reportedly led to serious bleeding issues and, ultimately, adverse medical events or even death to numerous patients. Legal remedies may be available to residents who have been injured or lost a loved one due to the use of dangerous and defective drugs, such as Xarelto.

Xarelto was released for consumption back in 2011. It, like many other drugs of its type, was created to reduce a patient's risk of developing deep vein thrombosis, stroke and a variety of other blood-clot-related injuries. The manufacturers of this product promoted it as a superior medication compared to others of its kind. Since its release, millions of consumers have been prescribed this medication, but, unfortunately, numerous patients have also come forward claiming the use of this drug has caused severe medical issues -- or worse.

Some of the common issues blamed on this drug include internal bleeding and brain hemorrhages, among others such as

• bleeding that is severe or can't be controlled

• unexpected bleeding, or bleeding that lasts a long time

• menstrual bleeding that is heavier than normal

• vaginal bleeding

• bleeding from the gums

• black stools (that look like tar)

• bright red stools (have blood in them)

• coughing up blood and/or blood clots

• feeling dizzy or weak

• frequent nose bleeds

• headaches

• pain, swelling, or new drainage at wound sites

• red, pink, or brown urine

• vomit that looks like coffee grounds

• vomiting blood

• bruising easily

 Stay tuned for more information about the allegations raised against manufacturers Johnson & Johnson and Bayer, the developers of Xarelto.

NCAA Concussion Case Was Enough Money Awarded?

 

Plaintiffs in the NCAA’s concussion case submitted

documents earlier this week arguing that the $75 million

settlement funds were sufficient to fund a 50-year

medical monitoring program. Those documents were

submitted at the request of US District Judge John Lee,

 who is presiding over the case.

 

        CBS Sports  reports that Lee denied

preliminary approval for the settlement on Wednesday,

citing several concerns he wants to see addressed. Lee

was concerned the settlement won’t fully fund the

medical monitoring program because of the inclusion of

student-athletes from non-contact sports. Lee asked for

a more specific framework of a medical monitoring

committee that will evaluate student-athlete

questionnaires, because if the “method used to

 determine who receives a medical evaluation” it

wrongfully limits those who are eligible, “the health of

individual who should be receiving treatment could be

endangered.” He also raised concerns over the ability for

the plaintiffs and NCAA to notify class members since

many have been out of school for more than ten years.

Attorney Jay Edelson, representing plaintiff Anthony

Nichols, said the settlement is dead and indicated that

he will instead “aggressively” pursue a series of class-

action lawsuits against individual universities.

 

        The Chicago Tribune states that Lee’s concern over

the ability of the settlement to fund the program depends

on participation rates calculated by experts for the

plaintiffs, which Lee said “are not reliable.”

 

        The AP adds that Lee also questioned

whether the NCAA has jurisdiction to implement

concussion policies and wonders how they would

enforce them in the event of non-compliance.

      

  The New York Times notes that though Lee had several

concerns, he called the proposal “a significant step in

trying to arrive at a resolution.” Furthermore the Times

says that a rejection of a preliminary settlement isn’t

unusual. 

       

False Claim Act Helps Hold Trinity Accountable For Cutting Corners!

 

Virginia is suing the guardrail maker Trinity Industries, saying that it sold the state thousands of pieces of potentially dangerous, improperly tested and unapproved products.

We first reported on this a couple of months ago when it was first discovered they have been cutting corners to save money in manufacturing.

 

The suit makes Virginia the first governmental entity to participate in whistle-blower suits against Trinity, which is based in Dallas. The suits were brought on behalf of state and federal governments, but none of those entities, until now, have been plaintiffs.
 

In October, a jury found that Trinity had defrauded the federal government when it did not inform the Federal Highway Administration of changes it made to the guardrail, the ET-Plus, in 2005. The company sold the guardrails to state governments, which, in turn, received federal reimbursement.

 

The jury returned with a verdict for $175 million, which will, by law, be tripled, to $525 million. The highway agency did not participate in the federal case.

 

It is shocking that a company would think they could secretly modify a safety device in a way that may actually pose a threat to Virginia motorists,” he said. “Trinity had an obligation to test and seek approval for its equipment, but instead, they sold the commonwealth thousands of unapproved products that had not been properly tested to ensure they would keep motorists safe.”

Trinity said it would defend itself against Virginia’s lawsuit. “Trinity did not commit fraud against the Commonwealth of Virginia,” said Jeff Eller, a spokesman for Trinity. He said it was “conducting the eight tests requested by the F.H.W.A., which includes the two tests specifically requested by Virginia,” and had “given them all the data they have requested.

 

In addition to the Virginia case, a separate lawsuit was filed by counties in Illinois. Prosecutors in Hamilton and Macon counties sued Trinity in federal court on Nov. 26 on behalf of all Illinois counties, accusing the company of a “fraudulent cover up” and deceptive trade practices, court records show.

 

 

Virginia and more than 30 other states have banned the guardrail products, which are suspected of having a defect that could make them jam. When that happens, the rail can pierce a vehicle. More than a dozen other private lawsuits blame the guardrails for five deaths and more injuries.

 

In October, after the federal jury verdict, Virginia’s Transportation Department threatened to remove the guardrails if Trinity did not do more tests. Soon after, the federal highway agency required further testing.

FDA Getting Kickbacks For Favorable Evaluations?

“Pharmalot” blog reports on an analysis conducted by the

Journal that revealed that many of the physicians and

other professionals who sit on FDA advisory panels to review

medical devices have financial ties to manufacturers,

although the agency has refrained from disclosing the

relationships. The analysis reviewed panels from 2012

through 2014, and found that of the 122 people who sat on

the panels evaluating devices, one-third received some form

of compensation, including money, research grants or travel

and food from companies. Additionally, almost 10% of FDA

advisers received compensation directly from the specific

company whose product was up for evaluation. The

regulatory agency only disclosed 1% of the connections. FDA

Associate Commissioner Jill Hartzler Warner explained to the

Journal, “If you have a financial interest with a sponsor or a

related firm, but it’s not related to the product at the meeting,

it’s not disqualifying.”

-How Common Are Kickbacks Between Medical Professionals and Medical Device Producers?-

• 

Reports from New York state that the medical device maker Stryker “will pay about $80 million to end a federal investigation into its acquisition of a company that the U.S. said was marketing a product that hadn’t been approved by regulators.” Stryker said that the Justice Department “acknowledged that the sales occurred before Stryker bought OtisMed in 2009, and that it was unaware of those sales.” Stryker “first revealed the federal investigation in 2010 and set aside $80 million to cover any future settlement.” 
        Bloomberg News reports that OtisMed “will pay a fine of $34.4 million and forfeit $5.16 million in a criminal case, while paying a civil fine of $41.2 million.” 

It's funny that is just about the same amount as they had saved up!!

The firm pleaded guilty in a Newark, NJ Federal court “where former Chief Executive Officer Charlie Chi also pleaded guilty.” The company “admitted it never obtained U.S.
Food and Drug Administration approval to sell 18,000 custom-built devices used by surgeons, from 2006 to 2009 to make accurate bone cuts to implant prosthetic knees.” OtisMed “applied for FDA approval in October 2008, and the agency said 13 months later the company hadn’t shown it was safe and effective.” Chi “then shipped 218 devices to surgeons, overruling his advisers and board and with disregard of consumer safety."

Pharmaceutical- and device-makers paid doctors roughly $380 million in speaking and consulting fees, with some doctors reaping more than half a million dollars each, during a five-month period in 2013,according to an analysis of federal data released. Other doctors made millions of dollars in royalties from products they helped develop.

This is a real example of why, we as consumers


really need to follow our instincts if we feel something is


wrong the medical field is trained, but they also love to get


kickbacks.

Maricopa College District Settles Whistleblower Claim!

 

 

Reports from Phoenix that the Maricopa

County Community College District “has agreed to pay

more than $4 million to settle claims that it submitted

false information for education awards.” Justice

 Department officials said on Monday that the settlement

will ensure that money from the Corporation for

National and Community Service is given only to eligible

 individuals.” A whistleblower suit “alleged that the

college district lied about the number of service hours

students had to complete to be eligible for education

awards,” and that “the college district improperly

received grant funding to administer the project.”

 

        The Arizona Republic reports the district’s

governing board “approved the fine Nov. 25

and it was agreed to by the U.S. Department of Justice.”

The case “dates back to 2011, when the federal

government began investigating student work from 2007

 through 2010 with Project Ayuda, which was

administered at Paradise Valley Community College.”

The Republic notes that Christine Hunt, a district

employee, “had filed a whistleblower lawsuit over the

matter and she will receive $775,827 of the $4 million.”

The settlement did not determine liability. 

 

The really scary thing about it, is if you do a

 

search for Maricopa College and lawsuit they are

 

no stranger to the courtroom.

Apple E Book Settlement Finalized

 

Final approval of a $450 settlement has been granted ending an antitrust class action lawsuit against Apple Inc. The lawsuit alleged that Apple conspired publishers to raise e-book prices. While all the publishers settled their claims, only Apple went to trial.

The lawsuit was brought by the US Department of Justice and 33 states and claimed that in 2010 Apple signed distribution deals with five top publishers, namely Simon & Schuster Inc., Penguin Group USA, Macmillan Publishers USA, Hachette Book Group Inc. and HarperCollins Publishers LLC, that raised the prices for digital books from $9.99 to as much as $14.99. This resulted in consumers paying hundreds of millions of dollars. In July 2013, Judge Denise Cote ruled that Apple had “played a central role in facilitating and executing” the conspiracy. The company has since appealed that decision to the Second Circuit.

Under the terms of the settlement, consumers will receive $400 million. According to court documents, a claims administrator and e-book retailers have sent emails or postcards to almost 23 million addresses of people eligible to receive compensation.

The settlement contains a provision allowing Apple to pay $50 million to consumers and $10 million each to the states and class counsel if Judge Cote’s 2013 decision finding Apple liable is vacated and remanded on appeal or reversed and remanded with instructions for reconsideration or a new trial.

Effoxor Recalled For a 2nd Time This Year

 

Sun Pharmaceutical Industries Ltd. has recalled 68,000 bottles of the antidepressant Effexor (venlafaxine), in the second recall of the drug this year, the Food and Drug Administration (FDA) said.

In both instances, the recalled drug was manufactured at the Indian generic drug maker’s plant in Halol in the state of Gujarat. The drugs were recalled after they failed to dissolve properly in quality tests. The earlier recall, in June, was for 252,000 bottles of Effexor.

Sun Pharma is attempting a $3.2 billion purchase of Ranbaxy Laboratories, an Indian drug manufacturer that has been under scrutiny for manufacturing problems. Ranbaxy has been under export restrictions on its facilities in India, leaving it with only one plant able to manufacture drugs that can be shipped to the U.S. market. The plant in Halol has come under scrutiny from the FDA after a series of recalls of drugs manufactured there, including the diabetes drugs metformin. The FDA inspected Sun Pharma’s plant in September and the agency criticized the company for having “no formalized corrective action plan” to prevent future recalls. If the FDA is not satisfied with Sun Pharma’s plans to resolve the problems found at the plant, it can issue a warning letter, and impose an export ban on the factory.

U.S. regulators are increasing scrutiny of generic drugs made in India, after a series of recalls of prescription and over-the-counter medicines made by Indian drug companies. The FDA is concerned that the drugs fail to meet U.S. standards. Dr. Margaret Hamburg, the FDA commissioner, made a nine-day visit to India in February to meet with pharmaceutical makers to discuss quality and safety issues. Indian companies supply about one quarter of the medicines used in the U.S. In 2013, the FDA banned imports from four plants belonging to Ranbaxy Laboratories Ltd. and Wockhardt Ltd.

Chaotic Labz Bodybuilding Medications Dangerous and Recalled!

A popular bodybuilding supplement, which is available over-the-counter across the country, was recently recalled due to issues with its chemical makeup. According to a recent report, the Mayhem bodybuilding supplement may contain prescription level drugs which are not included on the product label. The use of these drugs could cause harm to consumers.

Chaotic Labz is the manufacturer of Mayhem dietary supplements. Products by this manufacturer can be found both in-store nationwide and online at various retailers. The product that has been recalled is packaged in a clear container with yellow capsules and have an expiration date of June 2016.

According to the FDA, these supplements may contain dexamethasone and cyproheptadine. Dexamethasone is a corticosteroid which can reduce the body's ability to fight off infections, increase blood sugar levels and can suppress adrenal gland function, among many other known side effects. Cyproheptadine is an antihistamine which can cause drowsiness. These products, if unknowingly digested by consumers, could cause serious side effects if combined with other medications.

At this time, no reports of any adverse medical events have been recorded in relation to using this supplement. Connecticut residents who feel they or a loved one have suffered any injury or harm as a result of using this particular drug may be entitled to legal recourse. Product liability claims can be filed against Chaotic Labz and others in the chain of commerce deemed responsible for this product.

Are Generic Medications Always Cheaper--Find Out The New Answer!

 as “prices for some generic medicines have skyrocketed in the last 18 months,” governments are investigating. “A federal grand jury in Philadelphia and the Connecticut Attorney General are looking into possible antitrust violations by generic drugmakers,” and the Senate Subcommittee on Primary Care and Aging is holding a hearing on Thursday “in hopes of getting some answers.” Adam J. Fein, who “follows the pharmaceutical supply chain as president of Pembroke Consulting,” wrote in an analysis released in August “that one out of 11 generic drugs more than doubled in cost in the prior 12 months, with some increases exceeding 1,000 percent.”

Consumers are encountering substantial increases for some drugs. One notable example is a heart drug known as digoxin, which used to sell for pennies a pill, but a month’s supply can now fetch up to $1,200—although the average cost is closer to $50, according to GoodRx.com, a website that tracks prices.

Some insurers are responding by changing reimbursement coverage so that consumers must pay a larger share of the cost, says Adam Fein of Pembroke Consulting, who follows pharmacy distribution. Meanwhile, he calculates that in this year’s third quarter, pharmacies paid more for 37% of all generics than they did in the previous quarter, and 3% of 2,535 generics more than doubled in cost.

This last point underscores that not every generic has skyrocketed in price and the Generic Pharmaceutical Industry Association argues that assuming there are across-the-board price increases is a mischaracterization. What’s more, consumers whose insurance coverage hasn't changed do not feel the higher prices paid by pharmacies.

The FDA has a policy to expedite reviews to combat shortage, but there is a backlog of applications for generic approvals. As of early last month, agency data shows there were 3,552 applications waiting to be processed, compared with 1,359 in October 2012, when legislation passed to create fees for speeding reviews.

So can the logjam be broken? Mr. Fein believes selective generic inflation will continue for another 12 to 18 months, but new supplies should emerge and reduce prices. And while some insurers may want consumers to pay more, insurers are also “a little nervous, because they’ve spent so many years telling consumers to switch to generics and don’t want to go back on that story.”

Avis Takes Away Your Right To Due Process

Avis Budget Rental Car Group LLC is facing an unfair business practices class action lawsuit alleging the car rental agency charged drivers for traffic tickets they incurred while renting Avis vehicles, without providing the consumer an opportunity to protest them.

Filed in federal court in New Jersey, the lawsuit claims that Avis paid traffic tickets that it received in the mail without giving any notice of the charges to the people who rented the vehicles that were ticketed. By so doing, Avis denied the renters, its customers, of their right to due process. 

 ATS Processing Services LLC, a ticket-paying service Avis uses that allegedly charges drivers steep handling fees for the payment of these possibly warrantless tickets is also a named defendant in the lawsuit.

According to the complaint, “Avis Budget chooses to pay such fines on behalf of class members ... very often, if not always, without notice to the class member, and without making any effort to contest the alleged fine on behalf of the class member. Although Avis Budget has no knowledge as to whether the class member actually committed the purported infraction.

The lawsuit goes on to allege that while the Avis rental agreement signed by plaintiffs clearly states that renters will be responsible for any fines incurred, as well as processing fees, it does not include a waiver of renters’ rights to contest an infraction, and does not specify the cost of processing fees.

According to the lawsuit, lead plaintiff Dawn Valli was automatically charged $180 for an alleged speeding violation after she rented a car from Avis Budget, $150 of which covered the fine, and the remaining $30 of which represents an “unreasonable and excessive” handling fee.

The lawsuit targets complaints that are recorded by automated devices, such as speeding and failure to pay toll tickets. In these cases, the driver is not immediately aware that he or she has been ticketed and is powerless to act until being notified. However, Avis applies a blanket policy to these types of tickets, of immediate payment, which is equal to an admission of guilt the lawsuit alleges.

Avis sent Valli a demand for payment a full 45 days before the deadline to contest her ticket, at which point Avis had already paid on her behalf, according to the complaint.

The class is suing under the New Jersey Consumer Fraud Act, under which it is seeking treble damages. The class also asserts claims for unjust enrichment against both defendants and breach of the implied covenant of good faith and fair dealing against Avis.

Have You Taken Bystolic? High Blood Pressure Medication Causing Problems For Many!

 

 

In a previous post, we discussed several medications that were recalled on a national level due to dissolution issues. Drugs that are improperly designed, are likely to be ineffective and can have temporary to severe adverse health consequences to consumers. Forest Laboratories, the manufacturer of Bystolic -- one of the many drugs included in our previous post -- recently issued another recall for the same drug. This is the second recall of this medication in the last three months and, as the company ships nationwide, consumers in Connecticut may be affected.

Forest Laboratories which is now a unit of Actavis, issued an expanded recall of Bystolic. This is, again, due to dissolution issues with the products in question. The first recall issued a few months ago affected approximately 90,000 sample bottles, and this recall is much the same. More than 94,000 cartons of 20-mg tablet sample bottles are included in this recent recall.

Bystolic is a fairly popular blood pressure medication. Last year alone, consumers spent over $455 million dollars buying this product. This amount is an increase of almost 24 percent compared to the amount sold in 2012.

Patients who require medication to control blood pressure may experience serious health consequences should their medication fail. Pharmaceutical liability claims seek to hold drug manufacturers accountable for the safety and effectiveness of their products and grant victims of improperly designed medications compensation for any damages sustained.

LeanSpa Admits to False Marketing to Consumers

 

The Federal Trade Commission (FTC) and the State of Connecticut have reached a settlement with LeanSpa for allegedly engaging in consumer fraud by using fake news websites to promote acai berry and "colon cleanse" weight-loss products, making deceptive weight-loss claims, and telling consumers they could receive free trial products by paying a nominal fee for shipping and handling.

In addition to allegations of creating fake new websites, the deceptive marketing class action also claimed that the marketers of the weight loss supplement LeanSpa falsely informed consumers that they could receive a free trial of the weight loss products if they paid a small shipping and handling fee.

However, the lawsuit contends that consumers in fact paid nearly $80 for the “free” trial and were signed up for monthly subscriptions that were difficult to cancel. Consumers reportedly paid more than $25 million to the defendants.

The FTC and the state of Connecticut shut down the alleged LeanSpa scam operation and charged the defendants with violating portions of the FTC Act, the Electronic Funds Transfer Act and the Connecticut Unfair Trade Practices Act, in 2011. Then, in January, 2014 an agreement was reached between the parties in which the marketers of LeanSpa supplements have agreed to pay up to $7 million in consumer refunds.

Eligible consumers include people who bought LeanSpa weight loss or other LeanSpa health supplements such as LeanSpa; LeanSpa with Acai; LeanSpa with HCA; LeanSpa Cleanse; NutraSlim; NutraSlim with HCA; QuickDetox; and SlimFuel.

Hertz Rental Commits Fraud!



 A settlement has been reached in a consumer fraud class action lawsuit pending against Hertz Corp, and two Nevada airports brought by plaintiffs who alleged they were unlawfully charged undisclosed fees.

The $53 million settlement received final approval on October 30th, and contains $43.2 million restitution for Hertz customers who were billed for “airport concession recovery fees” at airports in Reno or Las Vegas between October 2003 and September 2009.

Brought by plaintiffs Janet Sobel and Daniel Dugan, the suit alleged that Hertz violated a Nevada Revised Statute that requires car rental firms to include all charges in the rates they advertise in order to make rate comparisons reliable for those looking for the best deal. Specifically, Hertz allegedly tacked on a recovery fee separately from the rate it quoted its customers. The complaint stated that Hertz used that extra fee to pass along to consumers an assessment imposed on the company by the airports, which charge Hertz and other rental car firms a percentage of their gross revenues for the right to operate on site.

Careall Commits Fraud With Medicare and Medicaid Over Charges

 

 

Careall Companies Agree to Pay $25 Million to Settle False Claims Act Allegations

CareAll Management LLC and its affiliated entities (collectively have agreed to pay $25 million, plus interest, to the United States and the state of Tennessee to resolve allegations that CareAll violated the False Claims Act by submitting false and upcoded home healthcare billings to the Medicare and Medicaid programs.  CareAll is based in Nashville, Tennessee, and is one of Tennessee’s largest home health providers. 

“Home health agencies may only bill Medicare and Medicaid for care that is necessary and covered by the programs,” said Acting Assistant Attorney General Joyce R. Branda for the Justice Department’s Civil Division.  “This settlement is another example of the department’s commitment to ensuring that home health care dollars – which are so vital to ensure the care of homebound patients – are spent for their intended purposes.”

This settlement resolves allegations that between 2006 and 2013, CareAll overstated the severity of patients’ conditions to increase billings and billed for services that were not medically necessary and rendered to patients who were not homebound.      

This is CareAll’s second settlement of alleged False Claims Act violations within the last two years.  In 2012, CareAll paid nearly $9.38 million for allegedly submitting false cost reports to Medicare.  As part of the settlement announced today, the companies agreed to be bound by the terms of an enhanced and extended corporate integrity agreement with the Department of Health and Human Services-Office of Inspector General in an effort to avoid future fraud and compliance failures.

“Fraudulent home-based services are surging across the country,” said Special Agent in Charge Derrick L. Jackson of HHS-OIG in Atlanta.  “We will continue to protect both Medicare and taxpayers, and ensure that funds are not siphoned off by companies more concerned with the bottom line than patient care.”

Under the False Claims Act, private citizens, known as relators, can bring suit on behalf of the United States and share in any recovery.  The relator in this case, Toney Gonzales, will receive more than $3.9 million as his share of the recovery.

 

Verizon Fraud Uncovered!! Will You Be Part Of The Settlement?

Verizon Communications Inc. has agreed to pay $64.2 million to settle a class action claiming it improperly billed Family SharePlan participants for overtime minutes and in-network and in-family calls. U.S. District Judge Jose L. Linares, a New Jersey federal judge, is being asked to approve the settlement. Payments pursuant to the settlement include a $36.7 million cash payment from Verizon. Also that will be $27.5 million in “calling units” that will be accessible via personal identification number. The proposed settlement — which was reached after multiple mediation sessions facilitated by retired U.S. District Judge Layn Phillips — calls for the certification of over 2 million settlement class members. Class members can obtain PINs allowing them to make free phone calls in an amount to be determined by a court-appointed claims administrator.

Pursuant to the notice plan, potential settlement class members will be notified by way of Facebook, Internet banner ads and an ad in People Magazine. The litigation goes all the way back to 2006 and involves Verizon’s alleged undisclosed billing practice of charging Family SharePlan customers for overtime minutes resulting from calls made on the primary line at a higher rate applicable to calls made on the secondary line. It also involves the company’s allegedly improper practice of charging customers for in-network or in-family calls it had promised would be free.

It was alleged in the suit that Verizon initiated a nationwide marketing plan in 2001 to promote its Family SharePlan, which advertised a monthly allotment of minutes that could be shared among up to four phones for a single fixed monthly charge. But the suit claimed the company failed to disclose that it would charge overtime minutes at a higher rate associated with the plan’s secondary phones, as opposed to the additional minute rate associated with the primary phones, even if the overtime minutes were made on the primary and not on a secondary phone.

It was alleged that Verizon was aware that its overtime minutes billing practice was inadequately disclosed to and that the customers didn’t understand the practice. Family SharePlan customers. A deadline of Feb. 27, 2015, was requested for objections to be filed to the proposed settlement. A final approval hearing was requested to be held on March 20, 2015.

 

Biotronik Inc. to Pay $4.9 Million to Resolve Claims that Company Paid Kickbacks to Physicians

Biotronik Inc. of Lake Oswego, Oregon, has agreed to pay the United States $4.9 million to resolve allegations made under the False Claims Act that the company made various improper payments to induce physicians to use devices that it manufactured and sold, the Justice Department announced today.  
“When medical device manufacturers make improper payments to physicians, they encourage medical decision-making based on financial gain rather than the best interests of patients,” said Acting Assistant Attorney General Joyce R. Branda for the Justice Department’s Civil Division.  “Today’s resolution demonstrates the Department of Justice’s continuing commitment to ensuring that consumers of federal health care programs receive appropriate medical care.”
The settlement resolves allegations that Biotronik, through the payment of kickbacks to physicians, caused hospitals and ambulatory surgery centers to submit false claims to Medicare and Medicaid for the implantation of Biotronik pacemakers, defibrillators and cardiac resynchronization therapy devices.  Biotronik allegedly induced electrophysiologists and cardiologists practicing in Nevada and Arizona to continue using Biotronik devices, or to convert to Biotronik devices, by paying the implanting physician in the form of repeated meals at expensive restaurants and inflated payments for membership on a physician advisory board.
“Today’s resolution of claims underscores one of the key purposes of the Anti-Kickback law – to ensure that the judgment exercised by health care providers in treating Medicare and Medicaid patients is not influenced by illegal payments,” said U.S. Attorney Benjamin Wagner for the Eastern District of California.
The settlement announced today stems from a whistleblower complaint filed by a former Biotronik employee, Brian Sant, pursuant to the qui tam provisions of the False Claims Act, which permit private persons to bring a lawsuit on behalf of the United States and to share in the proceeds of the suit.  The act permits the United States to intervene and take over the lawsuit, as it did in this case as to some of Sant’s allegations.  Sant will receive approximately $840,000 of the federal settlement.
This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by the Attorney General and the Secretary of Health and Human Services.  The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.  One of the most powerful tools in this effort is the False Claims Act.  Since January 2009, the Justice Department has recovered a total of more than $23 billion through False Claims Act cases, with more than $14.8 billion of that amount recovered in cases involving fraud against federal health care programs.
 

Stryker Reaches Settlement Deal for Problematic Hip Implants!



Stryker Corp. will pay at least $1.43 billion to settle thousands of lawsuits from patients who had to have surgery to remove problematic hip implants, under a deal announced Monday.
The agreement, brokered by a New Jersey Superior Court judge, resolves state and federal lawsuits against the maker of orthopedics. It was announced Monday in U.S. District Court in St. Paul, Minnesota.

Stryker said the $1.43 billion figure represents the "low end of the range of probable loss to resolve these matters."

The lawsuits stem from two hip implants that Stryker recalled due to corrosion and other problems in 2012. One year ago Johnson & Johnson paid $2.5 billion to settle 8,000 lawsuits from patients who had to have the company's metal ball-and-socket hip implant removed or replaced.

Plaintiffs in 39 states alleged Kalamazoo-based Stryker sold defective hips that corroded while in patients' bodies and caused illness, including pain and swelling in the tissue around the implant.

"The settlement represents one of the largest medical device settlements with an unlimited compensation fund," said Minneapolis lawyer Charles Zimmerman, who helped negotiate the deal as part of the lead-counsel committee for the case. "We are pleased that we were able to reach a settlement with such meaningful relief."

Stryker Corp. expects to make most of the payments by the end of 2015.

Thousands of cases from patients across the country have been consolidated under a single federal judge in Minnesota in a "multi-district litigation," a common type of mass lawsuit filed against health care companies, the Star Tribune of Minneapolis reported.

EBI Not Upholding Original Claims Of Bone Growth Stimulators!

 

EBI LLC, doing business as Biomet Spine and Bone Healing Technologies and Biomet Inc. have agreed to pay $6.07 million to resolve allegations that EBI violated the False Claims Act by paying kickbacks to induce use of its bone growth stimulators and billing federal health care programs for refurbished stimulators.

 EBI is a medical device company located in Parsippany, New Jersey, that sells bone growth stimulators, which are used to repair fractures that are slow to heal.  It is a subsidiary of Biomet, which is based in Warsaw, Indiana.    

“Medical device companies must not use improper financial incentives to influence the decision to use their products,” said Acting Deputy Assistant Attorney General August Flentje of the Justice Department’s Civil Division.  “This settlement demonstrates the department’s commitment to protect patients, and the taxpayers who fund their care, by ensuring that medical decisions are based on the patients’ medical needs rather than the financial interests of others.”

The United States alleged that, from 2001 to 2008, EBI paid staff at doctors’ offices to influence doctors to order its bone growth stimulators.  These payments were allegedly provided pursuant to personal service agreements with staff members. The United States concluded that these payments violated the Anti-Kickback Act and resulted in false billings to various federal health care programs, including Medicare.  The settlement also resolves EBI’s disclosure that it received federal reimbursements for bone growth stimulators that had been refurbished.     

“This settlement demonstrates our resolve in ensuring that patients receive, and the government pays for, health care that is based on sound medical judgment, and not compromised by kickbacks,” said U.S. Attorney Carmen M. Ortiz of the District of Massachusetts. 
“Kickbacks taint medical decision-making, cause overutilization of services, and lead to increased taxpayer and patient costs,” said Special Agent in Charge Phillip Coyne of the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG).  “These improper inducements have no place in government health programs relied on by millions of Americans.”

The settlement resolves in part an allegation filed in a lawsuit by Yu Yue, a former product manager for EBI, in federal court in New Jersey.  The lawsuit was filed under the qui tam, or whistleblower, provisions of the False Claims Act, which permit private individuals to sue on behalf of the government for false claims and to share in any recovery.  Yu’s share has not yet been determined.

This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by the Attorney General and the Secretary of Health and Human Services.  The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.  One of the most powerful tools in this effort is the False Claims Act.  Since January 2009, the Justice Department has recovered a total of more than $23 billion through False Claims Act cases, with more than $14.8 billion of that amount recovered in cases involving fraud against federal health care programs.

The settlement was the result of a coordinated effort by the Commercial Litigation Branch of the Civil Division; the U.S. Attorney’s Office for the District of Massachusetts; HHS-OIG; the U.S. Postal Service Office of Inspector General; the Defense Criminal Investigative Service; the U.S. Department of Veterans Affairs, Office of Inspector General and the U.S. Food and Drug Administration, Office of Criminal Investigations.