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LAWSUIT CLAIMS BREAST IMPLANTS LINKED TO CANCER

May 2, 2018 | Adam Harper

A recently filed lawsuit claims breast implants manufactured by Mentor Worldwide, a Johnson & Johnson subsidiary, caused an Ohio woman to develop a rare form of cancer known as anaplastic large cell lymphoma, or ALCL. Johnson and Johnson purchased Mentor in 2009 for more than $1.1 billion.

According to the complaint, Renee Cashen, 45, of Ashville, Ohio, had breast implant surgery in February 2008. About eight years later, she noticed a lump under her right armpit and a biopsy determined she had anaplastic large cell lymphoma. She had surgery to remove the MemoryGel® SILTEX® implants, made by Mentor, as well as infected lymph nodes. She subsequently underwent chemotherapy for a condition that has become known as Breast Implant-Associated Anaplastic Large Cell Lymphoma, or BIA-ALCL.

Ms. Cashen is one of many women across the country who has experienced health problems related to implants. In March of 2018, the FDA issued a warning to individuals with breast implants alerting them to the potential link to BIA-ALCL. As of September 30, 2017, the FDA had received a total of 414 medical device reports (MDRs) of BIA-ALCL, including the death of nine patients.

Government Study Finds Issues in Oversight of Assisted Living Facilities

February 22, 2018 | Adam Harper

Today, a growing number of Americans live in assisted living facilities. These facilities are intended to be a bridge between living at home and residing in a nursing home. In an assisted living setting, a resident can still live with a high degree of independence, but can receive help managing their medications and performing activities of daily living, like bathing, dressing and eating.

In a shocking report released earlier his month, the Government Accountability Office (GAO) detailed their study that found the federal government lacks even basic information about the quality of assisted living services provided to low-income people on Medicaid. The report titled “Improved Federal Oversight of Beneficiary Health and Welfare is Needed,” was done at the request of a bipartisan group of senators including Orrin G. Hatch (R-Utah), Susan M. Collins (R-Maine), Claire C. McCaskill (D-Missouri), and Elizabeth Warren, (D-Massachusetts). The senators ordered the study in July 2015 to better understand federal and state oversight of these facilities, which increasingly receive federal Medicaid dollars but are not subject to the same federal rules as nursing homes. According to the study, states reported spending more than $10 billion a year in federal and state funds for assisted living services for more than 330,000 Medicaid beneficiaries, an average of more than $30,000 a person. Despite the tremendous amount of federal funds flowing to companies operating assisted living facilities, there is very little government oversight of the industry.

“The GAO report found that 26 states could not report to GAO the number of ‘critical incidents’—serious health and safety problems that could include physical assaults, sexual abuse, unexplained death, unauthorized use of restraints, medication errors and inappropriate discharges or evictions—occurring in assisted living facilities in their state,” a statement from Sen. Warren’s office said. “But the 22 states that did track this information used different definitions of critical incidents, further complicating effective oversight of such facilities.” While all states consider physical, emotional or sexual abuse as a critical incident, some states did not identify other problems. For instance, seven states didn’t indicate potential harm or neglect, such as medication errors, as a critical incident. Three states didn’t consider unexplained death as a critical incident. Of the 22 states that did track critical incidents, the study found that there were more than 22,900 incidents in one year, including the physical, emotional or sexual abuse of residents. In many cases, the report found that when states did identify a significant problem at a facility, that information was not made available to the public.

Whistleblower Lawsuits Yield Big Rewards

October 5, 2016 | John Suthers

Lawsuits brought by so-called “whistleblowers” are also referred to as qui tam lawsuits. The phrase “qui tam” is an abbreviation of a Latin phrase meaning “he who sues in this matter for the king as well as for himself.” In a qui tam lawsuit, an individual, known as the relator, brings a case on the Government’s behalf, alleging that the Government has been defrauded out of money. The Government, not the relator, is considered the real party-in-interest. If the Government succeeds and recovers money from the wrongdoer, the relator receives a percentage of the Government’s recovery. The False Claims Act, codified at 18 U.S.C. § 286, 18 U.S.C. § 287, and 31 U.S.C. § 3279, allows private parties to file qui tam or whistleblower lawsuits. Most states have similar whistleblower laws. Whistleblower lawsuits are an effective and powerful means for whistleblowers to assist the Government in stopping various kinds of fraud, such as Medicare and Medicaid fraud, fraud by defense contractors and other contractors who sell products to the Government, and other types of fraud that have a negative financial impact on the Government. If the lawsuit succeeds, the private party, or relator, who brought the suit initially may receive anywhere from 15% to 30% of the Government’s recovery. Because these cases often involve millions and sometimes, billions of dollars, whistleblower lawsuits can be very lucrative.

As an example, take the case in which Tenet Healthcare, which owns hospitals across the U.S., including Tenet subsidiaries that operated hospitals in Georgia and South Carolina, agreed recently to pay more than $516 million to the Government in settlement of a whistleblower lawsuit. Tenet Healthcare was accused of conspiring to pay kickbacks and bribes to several clinics that were operating in Georgia that targeted Hispanic, expectant mothers and directed them to Tenet hospitals for their deliveries. Tenet made claims to Medicaid for the services that were provided to these undocumented foreigners. It was also alleged that Tenet’s hospitals used contracts that were shams to try to cover up the payments of kickbacks to the clinics for the referrals of thousands of undocumented, pregnant patients. Medicare and Medicaid laws, as well as anti-kickback laws, bar hospitals from paying clinics, doctors or others for steering patients to them for treatment. The whistleblower who brought the lawsuit using private attorneys was the former Chief Financial Officer at a Tenet hospital in Georgia. He will receive approximately $84 million from the recovered funds for his role in bringing the case.

Other examples of significant recoveries by whistleblowers include a former sales executive for pharmaceutical giant GlaxoSmithKline who filed a qui tam lawsuit alleging off-label or unapproved marketing of several of the manufacturer’s drugs. That case was part of several whistleblower lawsuits against the manufacturer which resulted in a then record settlement of $3 billion in 2012. In another similar case involving a drug manufacturer, a former sales representative of Pfizer, Inc., brought a qui tam lawsuit, alleging the manufacturer engaged in off-label marketing of its painkiller, Bextra. The claims involved Pfizer’s marketing of the drug for unsafe and potentially dangerous uses. In that case, Pfizer paid $1.8 billion as part of a settlement with the Government for Medicare fraud. Whistleblower lawsuits have been filed against large nursing home chains, alleging that the nursing homes billed Medicare and Medicaid for services that were not provided to residents. These cases resulted in large recoveries by the Government and large rewards to the relators. In a case involving a defense contractor that was allegedly defrauding the Pentagon, the Government recovered $88 million as a result of the whistleblower lawsuit. The whistleblower in that case was a former manager for the defense contractor. His reward for being the whistleblower was 21.5% of the Government’s recovery, which totaled almost $19 million.

False Claims Act Cases Result in $Billions Recovered

October 25, 2013 | John Suthers

The United States Department of Justice announced that it recovered $4.9 billion in settlements and judgments in civil cases that involved fraud against the Government during fiscal year 2012. It was also reported that since January 2009, total recoveries under the False Claims Act totaled $13.3 billion, the largest four year total in the Justice Department’s history. Why should private citizens care about cases involving fraud against the Government? The answer is money.

Under the federal law known as the False Claims Act, private citizens can sue individuals or businesses that are committing fraud against the Government and recover money on behalf of the Government. Most states have similar laws, allowing private citizens to bring cases involving fraud against state agencies. These lawsuits are known as whistleblower, or qui tam, lawsuits. They allow the whistleblowers, known as the relators, to be rewarded for the risk they take in pursuing the case and exposing the fraud against the Government. If the Government prevails and recovers money, the whistleblower can receive anywhere from 15% to 30% of the amount recovered. Consider this fact in the context of the $4.9 billion in recoveries that the U.S. Government secured for fiscal year 2012. The private citizens, who obtained evidence of fraud against the Government and took the risk of pursuing qui tam lawsuits, were rewarded amounts totaling between $735 million and $1.47 billion.

Qui tam lawsuits have become a very powerful tool for private citizens to aid the Government in stopping various types of fraud, such as Medicare or Medicaid fraud perpetrated by healthcare providers, defense contractor fraud perpetrated by military suppliers, and other types of fraud that have a significant financial impact on the Government. The following list of qui tam lawsuits were brought by the whistleblower employees of companies who were defrauding the Government: