Update on Trinity Industries

A Texas federal judge tripled a $175 million False Claims Act verdict against Trinity Industries Inc. on June 9 and assessed more than $138 million in penalties. This comes after a jury verdict in October finding that the company defrauded the U.S. government by selling it defective guardrails. U.S. District Judge Rodney Gilstrap entered final judgment of $663.4 million against Trinity, including a $199 million to whistleblower Joshua Harman. Since the U.S. did not participate in the trial and left the defense solely to the whistleblower, he was awarded the 30 percent commission along with more than $16 million in attorneys’ fees, $2.3 million in expenses and $177,830 in taxable costs, for a total award of $218 million. The government was awarded $464.4 million.

We’ve been perplexed by the government’s position from day one in this case. We pursued this case without any help from the government. In fact, we pursued this case in the face of the government’s hostility.

The judgment stems from an October verdict finding Trinity liable for changing the design of the guardrails without getting approval from the U.S. Federal Highway Administration (FHWA), then misrepresenting them as the earlier, approved version even though they were more dangerous. Harman filed his original False Claims Act (FCA) complaint in 2012, alleging that Trinity falsely claimed its modified ET-Plus guardrail was properly crash-tested.

Trinity contended that the government cannot be defrauded because it was fully aware of the facts at the time the representations in question were made. But Harman argued that Trinity intentionally withheld information about the modifications from the government. Trinity says the FHWA has confirmed that the ET-Plus is fully compliant with federal safety regulations, and has always been eligible for reimbursement under the federal aid highway program. It’s certain that, after post-judgement motions, Trinity will appeal to the Fifth Circuit.

Agents from the U.S. Department of Transportation Inspector General’s office and from the FBI’s Boston office have opened a criminal investigation into Trinity and its relationship with the FHWA, according to Bloomberg and ABC News. The original ET-Plus was designed to absorb and dissipate a collision’s impact by flattening the guardrail and pushing it out into a ribbon that is deflected away from the collision, reducing the impact force felt inside a crashing vehicle.

The FHWA approved that device in 2000. But Harman claimed the company changed that design sometime between 2002 and 2005 and that the new design locks up, folds over and protrudes into the crashing vehicle. He says Trinity never disclosed those changes to the FHWA, nor did it test the units according to FHWA protocols. The FHWA partially approved the guardrails after a 2005 crash test, but it’s unclear whether Trinity used the new ET-Plus for the test.

 

Wright's Hip Implant Patient Receives $4.5 Million For Settlement

A California jury has ordered Wright Medical Technology Inc. to pay $4.5 million to Alan Warner, a metal hip implant patient, and his wife after finding that his implant was defective and caused him harm. This was the first trial among 1,200 cases claiming Wright’s hip implants are defective. The jury agreed with the patient’s allegation that the hip implant he received contained a manufacturing defect, and that the implant’s failure injured both him and his wife. Interestingly, the jurors didn’t find that Wright was negligent in designing the Profemur R implant.
The jury didn’t award Mr. Warner any damages for his medical expenses. But they did award him $4 million for his past and future pain and mental suffering. His wife was awarded $500,000 for the losses she’s suffered as the result of his defective hip implant.
The suit was filed in December 2011, alleging that on Oct. 27, 2010, Mr. Warner’s implant failed while he went to the kitchen to get a cup of coffee, throwing him into extreme agony and forcing him to undergo extensive surgery to fix it. Laser guidance marks etched too deeply on the implant allegedly weakened the implant and caused it to fail, according to Mr. Warner. His case is a bit different than most of the others, in that the implant appeared to break in the stem of the implant. Most others appear to have broken in the neck or leeched chromium and cobalt into the bloodstream and hip capsule.
Steven R. Vartazarian, a lawyer for Mr. Warner, told jurors during the trial that the hip implant was supposed to last 15 to 20 years, but that this one failed after less than three years. This case is the first of more than 600 lawsuits in coordinated litigation in California state court and about 600 more in federal multidistrict litigation based in Georgia to go before jurors. All of the cases focus on the alleged metal-on-metal failure of Wright’s Profemur hip implants, though the specific types of failure vary. Wright took the position during the trial that the device failed because it was not installed correctly. It was contended by Wright that this allowed slight movements that eventually caused the fracture.

Las Vegas Ponzi Scheme Uncovered

The president and chief executive officer and two former Asia-based executives of a Las Vegas investment company were indicted today for their roles in an alleged $1.5 billion Ponzi scheme. 

“The defendants allegedly preyed on thousands of unsuspecting Japanese victims to enrich themselves by operating a billion-plus dollar Ponzi scheme,” said Assistant Attorney General Caldwell.  “This prosecution shows that the Criminal Division will pursue not only those who victimize American citizens, but also those who use the U.S. as a home base to defraud victims abroad.”

“Investment fraud and other financial fraud cases are a high priority for the U.S. Attorney’s Office in Nevada,” said U.S. Attorney Bogden.  “These defendants are accused of using a Nevada corporation to conduct their $1.5 billion fraud scheme and falsely telling thousands of overseas victims that their investments would be safely held and managed by an independent, third-party escrow agent in Nevada.  Fraudulent ruses and schemes perpetrated by Nevadans using Nevada corporations and entities will continue to be addressed by this office.”

Edwin Fujinaga, 68, of Las Vegas; Junzo Suzuki, 66, of Tokyo; and Paul Suzuki, 36, of Tokyo, were charged in an indictment with eight counts of mail fraud and nine counts of wire fraud.  Fujinaga also is charged with three counts of money laundering.  The indictment seeks from all three defendants forfeiture of the proceeds from the alleged crimes. 

 

Fujinaga was the president and CEO of Las Vegas-based MRI International Inc. (MRI).  Junzo Suzuki previously was MRI’s executive vice president for Asia Pacific, and Paul Suzuki previously was the company’s general manager for Japan operations.  MRI purportedly specialized in “factoring,” whereby the company purchased accounts receivable from medical providers at a discount, and then attempted to recover the entire amount, or at least more than the discounted amount, from the debtor.

 

According to allegations in the indictment, from at least 2009 to 2013, Fujinaga and the Suzukis fraudulently solicited investments from thousands of Japanese residents, and MRI currently owes investors over $1.5 billion.  Specifically, the indictment alleges that Fujinaga and the Suzukis promised investors a series of interest payments that would accrue over the life of the investment and that would be paid out along with the face value of the investment at the conclusion of the investments’ duration.  The defendants allegedly solicited investments by, among other things, promising investors that their investments would be used only for the purchase of medical accounts receivable (MARS) and by representing that investors funds would be managed and safeguarded by an independent third-party escrow company.

 

The indictment further alleges that MRI operated as a Ponzi scheme, wherein the defendants used new investors’ money to pay prior investors’ maturing investments.  According to the indictment, the defendants also allegedly used investors’ funds for purposes other than the purchase of MARS, including paying themselves sales commissions, subsidizing gambling habits, funding personal travel by private jet, and other personal expenses.

 

 

AstraZeneca and Cephalon to Pay $46.5 Million and $7.5 Million

AstraZeneca LP has agreed to pay the United States and participating states a total of $46.5 million, plus interest, to resolve allegations that it knowingly underpaid rebates owed under the Medicaid Drug Rebate Program, the Justice Department announced today.  Of that amount, AstraZeneca will pay roughly $26.7 million, plus interest, to the United States, and the remainder to states participating in the settlement.

In a separate settlement arising out of the same case, Cephalon Inc. has agreed to pay the United States and participating states a total of $7.5 million, plus interest, to resolve similar allegations.  Of that amount, Cephalon will pay roughly $4.3 million, plus interest, to the United States, and the remainder to states participating in the settlement.
Pursuant to the Medicaid Drug Rebate Program, drug manufacturers are required to pay quarterly rebates to state Medicaid programs in exchange for Medicaid’s coverage of the manufacturers’ drugs.  The quarterly rebates are based, in part, on the Average Manufacturer Prices (AMPs) that the manufacturers report to the government for each of their covered drugs.  Generally, the higher the reported AMP for a drug, the greater the rebate the manufacturer pays to state Medicaid programs for the drug.  These settlements resolve allegations that AstraZeneca and Cephalon underreported AMPs for a number of their drugs by improperly reducing the reported AMPs for service fees they paid to wholesalers.  As a result, the government contends that AstraZeneca and Cephalon underpaid quarterly rebates owed to the states and caused the United States to be overcharged for its payments to the states for the Medicaid program.
The two settlements partially resolve a lawsuit 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.  The amounts to be received by the whistleblower in this suit, Ronald J. Streck, a pharmacist, have not yet been determined.

Pfizer Agrees to $325 Million Settlement for Fraudulant Marketing of Neurontin

Pfizer Inc. and Warner-Lambert Co. LLC have agreed to pay $325 million in settlement of a lawsuit brought by a class of third-party payers. It was alleged that the drug Neurontin had been fraudulently marketed by Pfizer and Warner-Lambert. All of the claims brought by class members arising out of the sale and marketing of Neurontin will be resolved. The Plaintiffs’ motion for preliminary approval of the settlement came just more than a month after Pfizer agreed to settle the remaining claims for attorneys’ fees in Kaiser Foundation Health Plan Inc.’s suit against the drug manufacturer in the multidistrict litigation (MDL).
The class Plaintiffs, which include Harden Manufacturing Corp., Louisiana Blue Cross/Blue Shield and others, were ready to bring the litigation to an end. The members of the class Plaintiffs’ steering committee (PSC) wrote in a memorandum in support of the settlement:
This settlement, which provides significant and long-awaited benefits to class members, exceeds the standard for preliminary approval of a class action settlement.
The settlement came less than a month after Pfizer agreed to settle another suit in the MDL. Pfizer agreed in that settlement to pay Kaiser, a health maintenance organization, an undisclosed amount of attorneys’ fees. Since 2004, payers of Neurontin have accused the Defendants in several suits of fraudulently marketing the drug and causing them economic harm. Those suits were ultimately centralized before the United States District Court for the District of Massachusetts for MDL proceedings.
In the newly settled suit, class Plaintiffs alleged a fraudulent scheme to market and sell Neurontin for a variety of uses not approved by the U.S. Food and Drug Administration (FDA). The defendants sought to market the drug for several off-label uses in a variety of ways, including through false or misleading statements to physicians, according to the suit. The third-party payers involved in the action include insurance companies, health care benefit providers, union health and welfare plans and others. The class Plaintiffs have sought preliminary approval of the settlement and certification of the class for settlement purposes. They have asked for date for a final approval hearing.

Novartis To Pay Billions for Kickback Scheme

The U.S. Department of Justice says that Novartis should pay up to $3.35 billion in damages and civil fines for using kickbacks to boost sales of two drugs that caused federal health care programs to overpay for medicines, according to documents filed in federal court in New York.

 

The feds argue that Novartis violated the False Claims Act by using different plans, including rebates, to induce specialty pharmacies to boost prescriptions for two drugs: the Myfortic treatment for kidney transplants and Exjade, a medicine used for reducing excess iron in patients who undergo blood transfusions.

In its filing, the Justice Department is seeking up to $1.52 billion in damages, which represents triple the amount of money that Medicare and Medicaid paid for the drugs as a result of kickbacks between 2004 and 2013. The feds are also seeking up to $1.83 billion in fines – or $5,500 to $11,000 – for each of more than 166,000 allegedly false claims that were submitted for reimbursement to the health care sales manager.

Two years ago, the Justice Department and about a dozen states joined the litigation and a trial date for the lawsuit brought by the feds is set to begin in November. We should note that the feds also joined a separate whistleblower lawsuit filed by another former Novartis employee. In that suit, court document allege that Novartis paid for lavish trips and that speaker dinners given for doctors were purportedly kickbacks that used to induce them to prescribe Novartis drugs, according to court documents.

In a statement, a Novartis spokeswoman writes us that the document filed by the feds is a pre-trial order,which is a standard procedural step in which all parties submit an overview of their case and a list of the documents and witnesses they plan to utilize at trial. Novartis continues to dispute the allegations and is continuing to defend itself in this litigation.”

Last month, by the way, Express Scripts agreed to pay $60 million to resolve allegations by the feds that one of its business units participated in the kickback scheme. Last year, another specialty pharmacy, BioScrip, agreed to pay $15 million to settle allegations as part of the same litigation.

 

DaVita To Pay $450 Million For Violating False Claims Act

DaVita Healthcare Partners, Inc., the largest provider of dialysis services in the United States, has agreed to pay $450 million to resolve claims that it violated the False Claims Act by knowingly creating unnecessary waste in administering the drugs Zemplar and Venofer to dialysis patients, and then billing the federal government for such avoidable waste.  Davita is headquartered in Denver, Colorado, and has dialysis clinics in 46 states and the District of Columbia.

“This settlement is an example of what can be accomplished as a result of the successful cooperation between the government and whistleblowers in protecting our vital federal health care programs,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division.

This civil settlement resolves allegations brought in a whistleblower action that DaVita devised and employed dosing grids and/or protocols specifically designed to create unnecessary waste of the drugs Venofer and Zemplar.  These drugs are packaged in single-use vials, which are intended for one-time use. Sometimes, the amount of the drug in the vials does not match the dosage specified by the physician, resulting in the remainder of the drug in the vial being discarded.

At the time of the alleged scheme, Medicare would reimburse a dialysis provider for certain waste if the dialysis provider – acting in good faith – discarded the remainder of the drug contained in a single-use vial after administering the requisite dose and/or quantity of the drug to a Medicare patient.

The whistleblowers’ complaint alleged that, to create unnecessary Zemplar waste, DaVita required its employees to provide Zemplar to dialysis patients pursuant to mandatory and wasteful “dosing grids.”  Zemplar, a Vitamin D supplement usually administered at every dialysis session, is packaged in single-use vial sizes of 2 mcg, 5 mcg, and 10 mcg. Davita allegedly created unnecessary waste by requiring its employees to provide Zemplar to dialysis patients pursuant to mandatory “dosing grids,” which were designed to maximize the amount of Zemplar administered to patients.  DaVita then allegedly billed the government not only for the amount of Zemplar administered to patients, but also for the amount “wasted.”
With regard to Venofer, an iron supplement packaged only in a single-use vial size of 100 mg during the relevant time period, DaVita allegedly enacted protocols that required nurses to administer this drug in small amounts, and at frequent intervals, to maximize wastage. For instance, in certain instances, DaVita’s protocol called for a patient to receive 25 mg of Venofer per week, which resulted in 300 mg of waste per month that was billed to the Government.  In contrast, if the order had been filled by giving the patient the entirety of a single 100 mg vial, once per month, no waste would have resulted.

In 2011, the Centers for Medicare and Medicaid Services changed the manner by which it reimbursed dialysis providers for such drugs.  As a consequence, wastage derived from single-use vials was no longer profitable, and, as a result, DaVita allegedly changed its practices and reduced its drug wastage dramatically.

“Through personal sacrifice and courage, two whistleblowers exposed knowingly wasteful dosing practices designed simply to increase profits and improperly drain the government’s resources,” said Acting U.S. Attorney John Horn of the Northern District of Georgia.  “This settlement returns hundreds of millions of dollars to the treasury that had been improperly obtained by DaVita through these wasteful practices.”

The allegations resolved today arose from a lawsuit filed and ultimately litigated to this succesful resolution by two whistleblowers, Dr. Alon Vanier and nurse Daniel Barbir, under the qui tam provisions of the False Claims Act.  Under the Act, private citizens can bring suit on behalf of the government for false claims and share in any recovery.  The United States may intervene in the action or, as in this case, the whistleblower may pursue the matter.