Archive for the ‘Whistleblower lawsuits’ Category

Karen Wilson, secretary at a Graham County, N.C. agency, notified state officials of misuse regarding federal aid money intended to be directed toward a flood cleanup operation. Wilson notified officials in 1996, but did not file a False Claims Act suit until 2001 against Graham and Cherokee Counties, as well as other conservation districts and other individual defendants. In between the time Wilson notified officials of the alleged conduct and the time she filed her suit, Graham County hired local accountants to identify the irregular spending. The state followed up and included these findings in its own report.

The False Claims Act does not allow what it calls “parasitic” whistleblower lawsuits that attempt to capitalize on public information. In 2007, federal district court judge Lacy Thornberg found the local audit and state follow-up report to constitute public disclosure under the FCA, thereby barring Wilson’s claim. The question of whether a local or state report constituting public disclosure under the FCA is one that has the federal circuits split almost evenly. The Supreme Court has granted certiorari to Wilson’s case and will address this issue and make a specific determination as to what exactly is meant by public disclosure. For more information on whistleblower lawsuits and the False Claims Act, contact a whistleblower lawyer.

Keith Gordon-Smith, a contractor from Rochester, New York, has been indicted by a federal grand jury on 15 counts of violations to the Clean Air Act, submitting false statements, and obstruction of justice.  The Justice Department claims that Gordon-Smith, who owns Gordon-Smith Contracting, conducted illegal asbestos removal on several occasions and hid the removal from several federal agencies.
 The Clean Air Act requires contractors who remove asbestos to follow certain standards to prevent unsafe exposure.  These standards include reporting to the Environmental Protection Agency (EPA) before beginning the removal, and wetting the asbestos during removal to prevent bystanders from inhaling dangerous asbestos particles.  According to the Justice Department, Gordon-Smith allegedly failed to take both of these precautions.
Gordon-Smith allegedly improperly removed asbestos between June 2006 and August 2008 at Genesee Hospital, Roberts Wesleyan College, and Bloomfield Elementary School.  According to Justice Department officials, anyone present at these locations could have suffered asbestos exposure. 
  Once Gordon-Smith is arraigned, the U.S. Attorney’s Office for the Western District of New York will be providing a public notice in the Rochester Democrat and Chronicle to notify potential victims who may have been directly and proximately harmed as a result of the alleged crimes.  If you or someone you love has been exposed to asbestos illegally, you may be entitled to file an asbestos or mesothelioma lawsuit.  For more information on asbestos lawsuits, contact an asbestos lawyer.

Abbott Laboratories has filed a lawsuit against the Department of Justice (“DOJ”), alleging that the DOJ has abused secrecy provisions in the False Claims Act (“FCA”).  The FCA is a law that governs the filing of whistleblower lawsuits, under which private individuals bring claims on behalf of the federal government to report fraud and misconduct.  Under a qui tam provision of the FCA, whistleblowers are entitled to between 15-30% of the damages awarded to the government by courts.
In a 1995 federal lawsuit ultimately filed in Boston, Ven-A-Care pharmacy in Florida sued multiple pharmaceutical corporations, including Abbott Laboratories, in a whistleblower lawsuit. That lawsuit alleged that Abbott had fraudulently inflated prices.
FCA lawsuits are filed under a seal, meaning that only the whistleblower, the DOJ, and the court have access to information regarding the lawsuit.  As a result, pharmaceutical corporations claim that they are at a disadvantage.  The DOJ can obtain documents without informing the corporation that the documents relate to pending litigation.  Also, although the seal only lasts for 60 days under the FCA, the court can extend the seal if the court deems the extension necessary.
Abbott alleges that the DOJ extended the seal for the Ven-A-Care lawsuit for more than 11 years, and did not preserve the evidence that it obtained under seal.  Because this evidence allegedly was not preserved, there are now evidentiary gaps that could harm the company during trial.  Abbott wants the court to bar damages on claims where there’s missing payment data; order the government to provide state-by-state evidence of fraud; consider missing evidence in Abbott’s favor and order the government to prove that it didn’t knowingly pay claims on terms it now calls false and fraudulent.
Previously, the American Civil Liberties Union (“ACLU”) sued DOJ over the FCA seal.  The ACLU believed that the seal prevents the press and public from learning about the serious fraud allegations that underlie most whistleblower lawsuits.
For more information on the False Claims Act or whistleblower lawsuits, contact a whistleblower lawyer.

On June 9, 2009, the NAACP and nine class representatives filed a motion for class certification in the United States District Court for the Southern District of Indiana, Indianapolis Division, on behalf of an estimated 2,000 current and former employees of the Eli Lilly Company, one of the world’s largest pharmaceutical companies.  The plaintiffs also filed an amended complaint alleging that pervasive discriminatory practices by the company affected African-American employees in pay, promotion and promotion-related opportunities, thus denying these employees an equal opportunity to advance within the company. 

Additionally, more than 100 members of the class filed certified declarations describing their experiences with discrimination while at the company.  The plaintiffs are seeking declaratory and injunctive relief, back pay, front pay, attorneys’ fees, and other costs and expenses.   Plaintiffs’ spokesperson Cassandra Welch, who worked at Lilly from 1992 until she was let go in 2004, stated that she was subjected to years of racist comments and threats – including having a dark-colored doll with a noose around its neck left on her desk.  The other class representatives and the declarations all have similar stories, and claim that complaints to supervisors were never properly investigated.  According to co-lead class counsel for plaintiffs, “Lilly discriminates against its African-American employees by advancing the company’s white employees more quickly, and by denying African-American employees equal job assignments, promotional opportunities, training, compensation and other benefits of employment.”

Whether or not these allegations have merit is yet to be seen, but the number of similar declarations filed and potential class members nationwide cannot be ignored.  Discriminatory employment practices should not be tolerated, and praise must go out to those who are stepping forward to bring light to the situation, particularly those who are still currently employed by Lilly and have to deal with the pressures of going against the employer.  If you have experienced or observed questionable and illegal business practices at your company, you may want to speak to one of our whistleblower attorneys to determine if there are any legal options.

The U.S. Attorney’s Office in the Eastern District of Pennsylvania announced yesterday that a grand jury incited Norian Corporation, Synthes, Inc. and four top Synthes executives, including Michael Huggins, Thomas Higgins, Richard Bhner and John Walsh with conducting medical device clinical trials without FDA approval.  Norian is charged in 52 felony counts of the indictment and the parent company, Synthes, is charged in 44 misdemeanor counts.  Each of the executives are charged with misdemeanors. 

The allegations center around obstructing an FDA investigation of adulterated and misbranded Norian XR and Norian SRS bone cements used in treating fractures.  The defendants allegedly prevented “the FDA from carrying out its role of supervising clinical trials of significant risk devices, and deprived patients of the safeguards provied by FDDA oversight of clinical trials.”

Synthes is a Delaware Corporation based in West Chester, Pennsylvania.  It is the U.S. branch of a large multinational medical device manufaturer that specializes in trauma products to treat damaged human bone.  Norian is a subsidiary of Synthes that specializes in the manufactuer of osteobiologic medical devices. 

The medical devices at issue, Norian XR and Norian SRS were used to treat “vertebral compression fractures of the spine (”VCFs”), a painful condition commonly suffered by elderly individuals.”  The surgeries were allegedly done despite the FDA-cleared label for the Norian XR specifically exclusing the device for this use and “in the face of serious medical concerns about the safety of the devices when used in the spine.”  Early studies in animals and by other means showed that the bone cement reacted chemcally with blood to cause clots.  Despite knowledge of this problem, the company allegedly prceeded to market the device for VCFs without putting it through FDA required testing. 

The company allegedly did not stop marketing the Norian XR until a third patient had died on the operating table in January 2004.  Indeed, even after the third patient died, the indictment allegeds that Synthes did not recall the Norian XR from the market because doign so would have required the company to disclose details of the three deaths to the FDA.  The defendants allegedly compounded their crimes by carrying out a coverup in which they lied to the FDA during official inspections in 2004. 

One of Synthes’s own surgeron consultants that conducted a “test market” of the device pleaded with the company that doing such tests would “amount to human experimentation whose only defense seems to be that it will be a small study.”  If the surgeron consultant had simply retained a whistleblower lawyer and reported the potential crime to the government, perhaps deaths could have been avoided.

On June 9, 2009, the Minnesota Appeals Court dismissed a lawsuit from former Minnesota Occupational Safety and Health Administration (“MOSHA”) investigators who alleged that they were transferred from their position and dismissed contrary to federal anti-retaliation statutes.  The investigators had complained about their supervisors’ failure to pursue citations against a concrete plant that the investigators believed was conducting business contrary to MOSHA regulations.  The complaining investigators were subsequently denied raises.  MOSHA claimed that the transfers were done to centralize staff, and that the denial of raises was an appropriate management decisions.

However, the Appeals Court determined that the plaintiff in this case, Douglas Crosby, was unable to prove that his transfer and denied raise were connected to his previous complaints about his employer’s behavior.  If this connection had been proven, Crosby would be eligible to receive payment under the federal False Claims Act (“FCA”), which contains a qui tam provision allowing whistleblowers to collect 15-30% of damages awarded by federal courts.  It is unclear whether Crosby will appeal the Appeals Court’s decision.

Another similar lawsuit brought by MOSHA investigator Terrell Swanson is still ongoing.  Swanson’s allegations are similar; he was also denied a raise and transferred following his complaints about his supervisors’ behavior.

If you are aware of ongoing fraud against the government, you could have a whistleblower lawsuit. Contact an experienced whistleblower lawyer for a claim evaluation.

Pharmaceutical companies pay $995 a pop to send employees to a course to help their employees avoid the attention of Food and Drug Administration (FDA) investigators, prosecutors, and products liabilities attorneys.  The course, entitled “Dangerous Documents: Avoiding Land Mines in your FDA Records and Emails,” is apparently offered by the Medical Technology Learning Institute and Compliance Alliance, and has been attended by Allegan, Inc., Sepracor, Inc., Varian Medical Systems, Inc., Siemens AG, and Medtronic, Inc., the manufacturer of the InFuse Bone Graft, which has been the subject of off-labeling marketing inquiries.

Nancy Singer of the Compliance Alliance developed the course while working as counsel for a device firm. “I noticed that employees at the firm did not understand how a plaintiff’s lawyer could use their emails and other documents to the firm’s detriment if the firm was ever sued in a products liability action,” she said.  The “Dangerous Documents” seminar teaches companies to avoid any written communications whenever possible, and to use vague language that cannot be connected to any potentially illegal activity that the company is conducting.  The seminar also teaches what FDA investigators search when reviewing documents, words that attract the attention of prosecutors, the kind of information that should never be included in written documents, and practices that are likely to alert the attention of investigators.  By attending the seminar, corporate drug manufacturers learn how to placate government officials, and in the process, avoid lawsuits.

One example of such a lawsuit resulting from careless documentation is the Microsoft antitrust lawsuit of 1996.  Government lawyers found a memo from an AOL executive recounting a meeting in which Bill Gates said, “How much do we need to pay you to screw Netscape.”  The memo was used in the antitrust case against the company, which Microsoft eventually lost. 

As companies become aware of the tactics of prosecutors and plaintiff’s attorneys, whistleblowers will become invaluable to uncovering corporate fraud.  If you have knowledge of corporate activity that violates an FDA policy or any governmental regulation, you could bring a civil lawsuit on behalf of the government and collect a portion of the damages.  These are called whistleblower lawsuits, and are authorized by the False Claims Act (“FCA”).  FCA whistleblower lawsuits could lead to a reward for the whistleblower of up to 15-30% of the damages awarded by a judge.

Controversy is building over a lucrative side job for many university doctors and medical professions: giving speeches at events funded by prescription drug manufacturers. Across the country, university doctors are receiving over 20,000 dollars per promotional talk to “educate” other doctors on proper use of drugs. But some watchdogs are concerned that these promotional talks could pressure doctors into prescribing particular drugs, negatively affecting patient care in the process. Moreover, as the university doctors often work at publicly-funded institutions, these critics believe that taxpayer dollars are being used to aid doctors in promoting drug firms.

Although the Senate has considered a bill to track and publish payments made by pharmaceutical companies to doctors, intermediary entities called “medical education and communication companies” complicate the investigatory process. These middleman firms, funded by prescription corporations, organize training events at restaurants and lecture halls and pay doctors to give speeches. Because the go-between firms directly pay university doctors, the doctors do not have to disclose that the money may have ultimately come from prescription drug manufacturers. University doctors never report these top-dollar deals as a conflict of interest.

Other medical professionals are beginning to criticize these promotional and educational events. Some academic doctors who are veterans of the promotional-talk circuit claim that lecturers use slides provided by pharmaceutical companies. These talking points are intended to persuade doctors to begin prescribing certain drugs in order to boost sales. Because of the risks associated with inaccurately prescribed pharmaceuticals, medical school administrators are beginning to ban doctors from giving promotional talks, or from using the university’s name or logo during speeches. This policy is aimed at ending any unseemly relationship between state medical schools and private drug corporations.

Anyone with knowledge of fraud committed against the United States government, specifically the Food and Drug Administration (“FDA”), could have a whistleblower lawsuit. Contact us for more information about pharmaceutical corporations, whistleblower lawsuits, or to file a claim.