Celgene to Pay $280 Million to Settle Fraud Suit Over Cancer Drugs

The pharmaceutical company Celgene has agreed to pay $280 million to settle claims that it marketed the cancer drugs Thalomid and Revlimid for unapproved uses, the company said on Tuesday.

Under the terms of the settlement, which resulted from a lawsuit filed by a whistle-blower — a former sales representative at Celgene — the company will pay $259.3 million to the United States and $20.7 million to 28 states and the District of Columbia.

. . .

“The company got the idea that it could be fast and loose with what it was saying about its drug because it was selling to cancer patients who might be in need,” Mr. Guttman said. “At the end of the day, what this is about is that even when you’re on life’s edge,” he added, a company “can’t break the law by off-label marketing a drug.”

. . .

The settlement was reached after federal prosecutors declined to intervene in the case, although they continued to monitor it. Under the federal False Claims Act, private citizens like Ms. Brown can bring a suit against companies in the United States and share in any recovery. The amount of her reward has not yet been determined, Mr. Guttman said.

. . .

Read the full story here.

Whistle-blower files suit over alleged double-booked surgeries

By and
The Boston Globe

Orthopedic surgeons at Massachusetts General Hospital repeatedly kept patients waiting under anesthesia longer — sometimes more than an hour longer — than was medically necessary or safe, as they juggled two or even three simultaneous operations, according to a federal lawsuit that alleges frequent billing fraud at the prestigious hospital.

Dr. Lisa Wollman, a former anesthesiologist at Mass. General, alleges in the lawsuit that at least five surgeons endangered patients by regularly performing simultaneous surgeries. Wollman charges that the doctors also defrauded the government by submitting bills for surgeries in which they were not in the operating room for critical portions of procedures, leaving the work to unsupervised trainees.

Wollman said she witnessed surgeons performing simultaneous operations repeatedly from 2010 to 2015, when she left MGH for New England Baptist Hospital. She said hospital policy gave the doctors financial incentives to do more procedures, and they never told patients they would be going back and forth between operating rooms.

“This often meant an unwitting patient was left fully anesthetized — unconscious, paralyzed, intubated, dependent on a ventilator to breathe — for longer than medically necessary, often in the care of trainees, without the backup of a properly qualified surgeon, despite legal requirements,’’ said the suit filed Wednesday in US District Court in Boston.

Mass. General has previously disputed the validity and importance of virtually every complaint about surgeries that overlap, saying there’s no evidence any patients have been harmed. On Wednesday, Mass. General released a statement defending its approach to surgery: “The MGH continues to believe that its practices comply with all applicable laws and regulations, and the hospital will defend the claims accordingly.”

The lawsuit is believed to be the first filed by an MGH physician in the wake of a controversy that roiled Mass. General for years and prompted a national debate over safe surgical practices. Though many surgeons schedule operations to overlap by a few minutes — letting trainees close the surgical wound of the first operation while the surgeon moves on to the second — the debate at Mass. General focused on surgeries that overlapped for much longer.

There’s been relatively little research into the safety of simultaneous surgery, though a University of Virginia researcher found no increase in complications in operations that overlapped by up to 45 minutes. The American College of Surgeons last year issued its first-ever guidelines saying the practice is broadly permissible, within limits, but that “the patient needs to know” whenever a doctor runs more than one operating room at a time.

Wollman listed 16 dates from 2011 to 2013 when five orthopedic surgeons performed at least two operations simultaneously for hours. In every case, the suit said, patients lay under anesthesia longer than was warranted, increasing the risk of complications and inflating anesthesia charges.

Many of the allegations in the 54-page complaint were reported by The Boston Globe Spotlight Team in October 2015 in the first in a series of stories about the double-booking at MGH and other teaching hospitals. Wollman was among several doctors who criticized the practice to hospital leaders in meetings and in e-mails later obtained by the Globe.

The hospital dismissed the orthopedic surgeon who led the opposition to double-booked surgeries, Dr. Dennis Burke, for allegedly violating hospital policy by providing the Globe with internal records. Burke argued that he was fired for blowing the whistle on double-booking.

Wollman’s lead attorney, Reuben Guttman of Washington, D.C., argues that the doctors violated rules for two government health insurance programs, Medicare and Medicaid, which require surgeons to be present for all “critical portions” of an operation in order to get paid. If surgeons weren’t present and billed the insurers without making their role clear, it could constitute billing fraud, though the rule has seldom been enforced.

Wollman initially filed the lawsuit under seal in May 2015. It was recently unsealed after Carmen M. Ortiz, who was US attorney at the time, and state Attorney General Maura Healey declined to join the suit as plaintiffs. Wollman filed a revised version of the suit Wednesday, telling the Globe in a statement released by her lawyer that she decided to pursue it without government help because she wants to end a practice “based on deception and driven by economic benefit.”

“I am pursuing this case because my ethical obligation is to patients — past, current, and future — who are unknowingly scheduled for concurrent surgeries,” said Wollman, who worked at Mass. General, Harvard’s largest teaching hospital, for more than 20 years.

Both the US attorney’s office and Healey’s office declined to comment on Wollman’s suit.

The lawsuit, which names MGH and its parent company, Partners HealthCare System, as defendants, uses pseudonyms for five orthopedic surgeons who allegedly supervised simultaneous surgeries and, in Wollman’s view, defrauded the federal and state governments in the Medicare and Medicaid programs. But the Globe was able to identify several of the surgeons based on earlier reporting.

One of the surgeons appears to be Dr. Jon J.P. Warner, chief of MGH’s shoulder service and the highest compensated employee at the hospital about a decade ago, earning just over $2.1 million one year, according to financial documents filed by the hospital. Wollman’s suit said Warner, identified only as “Surgeon A” in the lawsuit, regularly booked two simultaneous operations in the morning and two in the afternoon.

One morning in October 2011, the suit said, a 65-year-old patient on blood pressure medication waited under anesthesia for a full 90 minutes before Surgeon A arrived from another operating room to start the patient’s surgery. The suit said Surgeon A had scheduled the two long shoulder operations to start within 15 minutes of each other.

Yet, the suit said, Warner wrote on the patient’s operative note that he participated in the entire surgery. Wollman complained to hospital officials at the time, the suit said, and Warner corrected his report.

On another occasion, one of Warner’s patients lay waiting for him anesthetized when a second surgical patient asked Wollman if she could see Warner, the suit said. It turned out that Warner was in another building on the MGH campus seeing other patients, the suit alleges.

Warner, described by the hospital as one of the nation’s foremost shoulder surgeons, could not be reached, but in the past has declined to discuss specific cases to protect patient privacy.

In general, Warner wrote in a 2015 statement to the Globe, “The suggestion that I am not managing all my patients’ care while they are in the operating room is both untrue and malicious.”

Warner noted he always performs the key components of surgery and that fellows occasionally do “noncritical activities,” such as positioning and making the initial incision.

Wollman said another doctor, identified as Surgeon B, “never appeared in the room” for an April 2013 operation when he was supposed to be the attending physician and she provided the anesthesia. Based on e-mails cited in the lawsuit that are identical to ones obtained by the Globe, Surgeon B appears to be Dr. Malcolm Smith.

Wollman said the patient suffered a serious and sudden constriction of the airways while Surgeon B was not present, though a senior trainee was. The lawsuit said that Wollman complained to the operating room director about Surgeon B’s absence, writing, “Isn’t he obligated to be there?”

But Wollman said senior medical officials at Mass. General did not follow up on her concerns “except to threaten her by saying that she had violated patient privacy and could face legal action.”

Smith could not be reached for comment, but he has previously said he did nothing improper and declined to comment on individual cases. In 2015, he told the Globe in a statement that allegations that he did not take proper care of his patients were based on “innuendo, incomplete and inaccurate data.”

But Wollman claims that incidents like the one involving Surgeon B both were frequent and continued long after the hospital placed more limits on overlapping surgeries in 2012.

“The practice of billing for unreasonable and unnecessary anesthesia was not a remote occurrence” among orthopedic surgeons, the suit says. “Rather, it was commonplace and a direct outgrowth of the concurrent surgery practice which, to succeed, required patients to be put under general anesthesia waiting for their surgeon to arrive.”

Guttman, Wollman’s attorney, said it was premature to talk about the damages if Mass. General is found to have improperly billed Medicaid and Medicare, but the costs could be considerable. The law calls for treble damages and Mass. General could face an additional penalty of at least $5,000 for each instance of improper billing, Guttman said. If Wollman prevails, he added, she could potentially receive 25 percent to 30 percent of any money recovered under the False Claims Act.

cf  www.bostonglobe.com

Democracy Misconceived

By William Nettles and Reuben Guttman

There is a misconception among many that democracy and freedom are synonymous and that freedom, in turn, equates to the right to do and say anything.

The White House recently issued an Executive Order and a Memorandum setting a course toward deregulation; this misconception may explain why initiation of plans for the scrapping of rules – actually promulgated pursuant to laws passed by Congress — may seem as American as the Boston Tea Party. Yet, merely having the optics of consistency with American values does not mean that the President’s plans are – in truth – consistent with our sacred rule of law.

Read the full article here.

Marijuana, Immigration And Private Prisons

On August 18, 2016, then Deputy Attorney General, Sally Yates, issued a memorandum directing the Bureau of Prisons (BOP) to begin to reduce – with an eye toward eliminating – the use of private prisons. Yates directed “that, as each contract reaches the end of its term, the Bureau should either decline to renew the contract or substantially reduce its scope in a manner consistent with law and the overall declines in the Bureau’s inmate population.”

Of course, when the Deputy Attorney General wrote that memo, DOJ was not in the mode of targeting enforcement of Marijuana laws or rounding up “illegal immigrants.”

Read the entire article here.


Recommended Reading: United States ex rel. Rodriguez v. Hughes, et al., Relators Version

US ex rel Rodriguez v Hughes et alby Paul J. Zwier, Reuben Guttman, Matthew J. McCoyd, Alexander G. Barney

The three case files of United States ex rel. Rodriguez v. Hughes, et al.… explore the suit brought by Juan Rodriguez, a prominent engineer, who acted as a whistleblower against his employer, Hughes Aircraft, for violations of the False Claims Act.

Richard Hughes (CEO of Hughes Aircraft) learned that the United States Department of Defense (DOD) was looking for a new helicopter to provide to the Mexican government as part of the United States’ Mérida Initiative, which provided Mexico resources to help it fight its war against the drug cartels. Hughes, on behalf of Hughes Aircraft, entered into a sole source contract with the DOD. Hughes was favorably positioned to do so as it was the sole manufacturer of the Screaming Eagle helicopter S-70, the model the DOD was seeking to purchase.

Rodriguez’s employment background put him in a position to ascertain whether his employer, Hughes Aircraft, was making false claims to the DOD. Initially, Rodriguez had been employed at Sikorsky Aircraft Inc., a predecessor of Hughes, working in the design and manufacture of the first Screaming Eagle helicopters. Later Sikorsky Aircraft was bought by Hughes Aircraft. During his tenure at Hughes, Rodriguez had designed and retrofitted early versions of the Screaming Eagle helicopter. When retrofitted with heavy missiles, one of the first versions, the UH-A, suffered cracks on landing. Accordingly, metals intended to help crash-proof the helicopter were added to the design. Hughes also started to employ Magnaflux testing to ensure that later versions of the Screaming Eagle did not have subsurface cracks.

Rodriguez claims that he saw cracks in the cabin of one of the Screaming Eagles Mexico helicopters, and that he also saw workers welding over the cracks. Rodriguez claimed that he considered the welding over of cracks in the cabin of the Screaming Eagle a “cover up” of the failure to conduct testing and thus an act of fraud—passing on defective helicopters to the governments of the United States and Mexico.

Available on line at Barnes & Noble.