Whistleblower Adviser

In the past two years, 14,663 providers and suppliers have been banned from billing Medicare in response to findings involving fraudulent activity.

The figure, according to USA Today, is about 2.5 times the number from the prior two-year period, and in some states that number reflects a quadrupling of revocations, according to Health and Human Services Statistics.

“We have always been doing some of this,” Peter Budetti, Center for Medicare Services (CMS) deputy administrator for program integrity, told USA Today. “But there has been a special focus under the Affordable Care Act,” Budetti added.

Administration officials were to announce new fraud numbers and note that they are continuing to prompt seniors for more help in fighting fraud. For example, one proposed rule would enable fraud reporters to earn up to $9.9 million in reward money under the new fraud-prevention program, according to USA Today. Previously, beneficiaries were paid up to $10,000 for tips leading to fraud money recovery.

One new element of the anti-fraud campaign, said Budetti, is a new, clearer summary statement that will enable recipients to better understand who may have used their identification numbers to bill Medicare. Budetti told USA Today that he considers this a “landmark change.”

“Our best weapon in fighting fraud is our 50 million Medicare beneficiaries,” he said. The hope is that increasing the reward incentive to a proposed $9.9 million would “attract the kind of attention” the government needs, Budetti said.

The government has recovered $14.9 billion in Medicare fraud money in the past four years, largely due to the 2010 Affordable Care Act in which the government is allowed to review data to find signs of fraud and cease payments to fraudulent providers, USA Today explained. Those providers would then have to reapply to be considered for Medicare participation. Providers unable to meet the requirement, that have incorrect addresses, or that are improperly licensed are not permitted to bill Medicare.

Meanwhile, nursing homes nationwide were previously found to be overcharging the Medicare system about $1.5 billion annually, according to a federal study. In fact, a report from the Department of Health and Human Services found that one in four bills received from nursing homes to the Medicare system contained overcharges for services that were either not performed or deemed unnecessary. Some nursing homes “upcode” the services they provide patients covered by Medicare because they’re confident they’ll receive a full reimbursement.

In many instances, the upgraded, or more intensive care, was never performed and was added to a patient’s bill when the bill was sent to the government for payment. In some cases, the care billed to Medicare for patients was deemed unnecessary and would provide no clinical benefit, according to a prior The Wall Street Journal report. In a single example highlighted by the source, a patient under hospice care had refused a specific treatment, but Medicare was billed by the nursing home anyway.

The Journal previously reported that Medicare spending may be the single largest drain on the national budget, with at least 13.5 percent of all federal spending dedicated to Medicare. Some experts interviewed by the Journal indicated that as much as 30 percent of all government spending on healthcare is wasteful, be it on unnecessary services, unperformed services, or undelivered or unnecessary pharmaceuticals.

Early this week, India’s largest drug maker, Ranbaxy, paid a $500 million fine to settle an eight-year-long battle with the U.S. Food and Drug Administration (FDA).

According to a MoneyControl.com report, whistleblower Dinesh Thakur “single-handedly brought drug maker Ranbaxy to its knees before the U.S. FDA.” Thakur had served as the company’s director and global head of Research Information and Portfolio Management from 2003 to 2005, and went on to unravel “the most high-profile generic drug violation case in the U.S. to date.”

Thakur first reported to management in 2005 that falsified data was coming out of the company’s Ponta Sahib and Dewas plants in India, MoneyControl.com reported. But management took no steps to address his exposure of the fraud, so he brought his concerns to the FDA. This led to the filing of civil and criminal charges against Ranbaxy and some senior directors.

With Ranbaxy pleading guilty to felony charges and agreeing to pay the $500 million fine to settle the civil and criminal cases, Thakur will pocket $48.5 million under the whistleblower provision of the U.S. False Claims Act, MoneyControl.com reported.

“It took us eight years to help government authorities unravel a complicated trail of falsified records and dangerous manufacturing practices that threatened to compromise the quality and safety of Ranbaxy drugs,” Thakur said in a statement. “This case highlights the need for effective regulation that applies to drugs sold in the United States, regardless of where they are manufactured.”

These charges in fact have cost Ranbaxy more than $50 million, MoneyControl.com reported. A three-year ban on importing over 30 drugs to the U.S. was imposed on the company. The antibiotics ciprofloxacin, cefaclor and amoxicillin, the acne drug Sotret, and Gabapentin, a compound used to treat epilepsy and certain kinds of nerve pain, are among the drugs cited as failing to meet FDA standards, according to a Bloomberg report.

The company also received no new FDA drug approvals until December 2011, when it signed a Consent Decree. In addition, Ranbaxy forfeited a 180-day window of exclusivity for three of its drugs, which translates into a loss of around $300 million, and surrendered applications on 27 compounds.

The Ranbaxy case has highlighted the fact that drug companies, especially global ones, need to be diligent about data reporting, MoneyControl.com noted.

In separate disclosures, health care products giant, Johnson & Johnson, stated that government investigations are underway concerning two of its medical device products.

Both its hip devices and its surgical mesh are involved in government probes, Bloomberg Businessweek, reports. Hip devices are being investigated over potential false claims accusations and the marketing of surgical mesh is also being probed.

The U.S. Justice Department requested documents concerning if Johnson & Johnson’s DePuy Orthopaedics unit might have provided false claims to federal health care programs over its ASR XL hip devices, Johnson & Johnson stated in a regulatory filing. The filing, noted Bloomberg Businessweek, indicated that the ASR hip devices were recalled in August 2010. Johnson & Johnson also stated that a multi-state investigation is underway in California over the marketing of surgical mesh, according to Bloomberg Businessweek.

Johnson & Johnson stated that it is “fully cooperating” with both the Justice Department’s civil division and the U.S. Attorney’s Office in Massachusetts after it received an informal request this summer over how its hip devices were marketed and used, said Bloomberg Businessweek. “The government is investigating whether any person or entity submitted or caused to be submitted false claims or false statements affecting federal health-care programs in connection with the marketing and use of the ASR XL hip device,” said Johnson & Johnson in the filing. “The government has since made additional informal requests for the production of documents,” the statement continued.

Increasing adverse event report claims of device failure and the ultimate recall of 93,000 ASR hip devices prompted mounting lawsuits. Now, more than 10,000 lawsuits are pending in the United States over the DePuy ASR hip, including that the device maker not only defectively designed the device, but also neglected to warn of its potential risks. At the time of the recall, noted Bloomberg Businessweek, Johnson & Johnson acknowledged that 12 percent of the devices failed in the United Kingdom. Since, reports of much higher failure rates have been reported. The first trial of the 10,000 cases is being heard in California state court.

Meanwhile, the attorney general of California contacted the device maker this past October concerning an investigation into how its mesh products for hernia and urogynecological purposes was marketed, said Bloomberg Businessweek. That probe encompasses 42 states, said Johnson & Johnson.

Transvaginal mesh is used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Complication reports, mounting litigation, and concerns over the lack of clinical testing have raised questions about the devices’ safety, with Johnson & Johnson facing some 1,800 lawsuits over its Gynecare Prolift vaginal mesh implant. The case is being heard in state court in Atlantic City, New Jersey; jury is in the midst of deliberations, said Bloomberg Businessweek.

Last July, the U.S. Food & Drug Administration said that the mesh has no clear advantage over non-mesh methods for treating POP and may actually present additional risks. The FDA went on to say that most POP cases can be successfully treated without the use of transvaginal mesh. In June, Johnson & Johnson told a judge that it will no longer sell four types of transvaginal mesh implants, including the Prolift, Prolift + M, TVT Secur, and Prosima. The company also asked the FDA to postpone post-market safety studies of the devices. Bloomberg Businessweek noted that Johnson & Johnson stated that it was ending worldwide sales of the device because of the products’ lack of commercial viability, and not over any alleged safety or efficacy issues.

Both devices were approved through a fast-track process known as the 510(k), which means that a formal review for safety and efficacy was neither required nor performed. Because the 510(k) route has been used to gain clearance for other controversial products, the process has drawn increasing criticism.

Medtronic Infuse Whistleblower Lawsuit Shady Ties with Doctors
Medtronic has been involved in various controversies over its Infuse® bone growth product and other devices. For example, Medtronic was named in a whistleblower lawsuit alleging it used an editor at a prominent medical journal to generate good press for the Infuse® Bone Graft product. According to the complaint, which was unsealed in the Spring of 2012, during his tenure as editor of the Journal of Spinal Disorders and Techniques, Dr. Thomas Zdeblick published articles “touting the benefits of Infuse® while allowing researchers to conceal their financial relationships with the device maker.” Zdeblick, who was also the inventor of the LT-Cage® delivery system for Infuse®, has received some $25 million in royalties from Medtronic. The Medtronic whistleblower lawsuit alleges that while editing the journal, Zdeblick failed to disclose “that he profited from each and every surgery which used Infuse® through rights in the exclusive delivery vehicle, his LT-Cage®.”
…

It seems that red snapper might be adulterated and labels might not be accurately indicating the actual fish in the packages consumers are purchasing.

The nonprofit ocean protection group, Oceana, conducted a large study of fish purchased and genetically tested in 12 areas of the United States, explained The New York Times. Of the 120 so-called red snapper packages bought for nationwide testing, some 28 different fish species were found. Of these, noted the Times, 17 were not even in the snapper family, citing the study released today.

While grocery stores were the likeliest to honestly sell red snapper and restaurants ranked in the middle, sushi bars—in every city studied—were the likeliest place in which consumers would be misled, said the Times. About one-third of the fish sampled was incorrectly labeled, with a total of 1,215 samples purchased and tested from 2010 to 2012 being mislabeled. The study’s chief author, Kimberly Warner, noted that, given the sheer number of fish in the sea, many look alike. “Even a relatively educated consumer couldn’t look at a whole fish and say, ‘I’m sure that’s a red snapper and not lane snapper,’” Warner told the Times.

Southern California residents were the likeliest, of all of the regions sampled, to be eating a different fish than expected, said the Times. In fact, more than half—52 percent—of the samples purchased and tested—were not what their packages stated. Although Seattle and Boston tested with the lowest deception rates, both areas tested with a 20 percent rate of deception. Some fish deceptions where higher by region, for instance, so-called tuna in New York was actually not tuna in 94 percent of the cases, the Times noted.

The Oceana study did consider a fish mislabeled if the seller followed federal re-naming guidelines. For instance, “orange roughy” is, in fact, “slimehead,” and “Chilean sea bass,” is “Patagonian toothfish,” the Times explained. Yet, after accounting for allowable renaming, the study discovered that mislabeling is quite insidious with retail outlets using names they perceive will make the fish more marketable. One common pattern, Warner told the Times, was that tilapia was often served in restaurants as a substitute for more expensive fish.

The research found that nearly two-thirds of all “wild” salmon sampled was farmed Atlantic salmon, a fish, said the Times, that is considered both less healthy and less environmentally sustainable. Also at issue is that some fish, such as fish that accumulates the toxin, mercury, should be avoided by certain groups. In New York, tilefish, known for high mercury content and listed on federal advisory lists, was sold as red snapper in what the study described as “one of the most egregious swaps,” according to the Times.

The trade group, The National Fisheries Institute, issued a statement indicating that reputable members of the seafood community are fighting such fraud, and that it is up to the federal government to “fulfill its mandate,” of enforcing established food regulations, the Times wrote. The study did not indicate where in the food chain the mislabeling occurred and if the mislabeling was deliberate or by misunderstanding.

Because the intent in the pervasive mislabeling is not known, it is important to note that the False Claims Act allows for private persons to file lawsuits providing the government with information about wrongdoing. Under the Act, if a person is found to have knowingly submitted or caused others to submit false or fraudulent claims to the U.S., the government can recover treble damages and $5,500-$11,000 per statute violation. Should the government be successful in resolving or litigating its claims, the initiating whistle blower can receive 15-25 percent of the amount recovered. Should the government decline to join the case, the lawsuit may proceed privately, and the whistleblower will be entitled to a 25-30 percent recovery reward.

Under the False Claims Act, companies are not allowed to retaliate against a whistleblower. An employee who is discharged, demoted, suspended, threatened, or harassed for filing a whistleblower lawsuit can bring an action for re-instatement with his/her seniority restored and is also entitled to recover double back pay with interest and other compensatory damages. Whistleblowers may also initially report fraud anonymously by filing a claim through an attorney. The whistleblower’s identity remains under seal while the Justice Department investigates the case and, should the government choose not to pursue the case, the firm will never know the identity of the whistleblower, unless the claim is privately pursued.

The U.S. Food & Drug Administration (FDA) had not typically targeted cosmetics manufacturers, except in cases that presented serious and significant health risks to consumers. In the past year, however, the federal regulator has been taking a closer look at the cosmetics industry. In fact, last year, the agency sent four warning letters in a matter of two months to Avon Products as part of its crackdown on the marketing of cosmetics products. The cosmetics giant maintains international operations and is based in Manhattan.

For example, one of the warning letters sent to Avon alleged that Avon’s products, “appear to be intended for uses that cause these products to be drugs under the Federal Food, Drug and Cosmetic Act (FD&C Act).” Under the Act, a product cannot be marketed as having effects on the human body’s structures or functioning unless FDA approval was received deeming the product a new drug product, or unless the product meets the standards in place for an over-the-counter (OTC) monograph. The FDA letter claimed that a number of products marketed by Avon violated the Act’s regulations and “appeared to be intended for uses that cause these products to be drugs” under the Act. The FDA went on to say that Avon’s “products are not generally recognized among qualified experts as safe and effective for” the cited uses and, because of this, “are new drugs” under the Act.

At issue is that a number of cosmetics firms have made marketing assertions that involve claims only permitted for approved pharmaceutical products. And, Avon isn’t the only such example. Prior warning letters—notices of intended regulatory action—were previously sent to Lancôme USA, which is a subsidiary of L’Oreal subsidiary; Andes Natural Skin Care, which is based in Nevada; and Janson Beckett, which is located in New Jersey. All of the FDA letters alleged the firms marketed their products using improper claims.

It is believed that these situations do not represent isolated instances and other cosmetics manufacturers and marketers might be making similar, unsubstantiated, and illegal claims.

Cosmetics Industry Whistleblowers

The whistleblower lawyers at Parker Waichman LLP are investigating potential whistleblower lawsuits against cosmetics manufacturers involving violations of the False Claims Act. Current and former cosmetics industry employers and others who qualify as whistleblowers may be entitled to a reward of 15-to-25 percent of any amount the government recovers should a cosmetics industry whistleblower lawsuit be successfully pursued under the federal False Claims Act.

The whistleblower provisions of the False Claims Act contain protections that grant whistleblowers confidentially and bar cosmetics firms from taking any type of retaliatory action against whistleblowers.

If you are aware of a cosmetics manufacturer or marketer that engaged in illegal activities to its marketing practices, the Cosmetics Industry Whistleblower Lawyers at Parker Waichman LLP want to hear from you today. Parker Waichman is offering free legal evaluations to any potential cosmetics industry whistleblower.

False Claims Act Whistleblower Provisions

The False Claims Act allows for private persons to file lawsuits to provide the government information about wrongdoing. Under the statute, if it is established that a person has knowingly submitted or caused others to submit false or fraudulent claims to the United States, the government can recover treble damages and $5,500-to-$11,000 for each statute violation. If the government is successful in resolving or litigating its claims, the whistle blower who initiated the action can receive a share of 15-to-25 percent of the amount recovered. Should the government decline to join the whistleblower case, the lawsuit may proceed privately, and the whistleblower will be entitled to a reward of 25-to-30 percent of the recovery.

The False Claims Act prevents companies from retaliating against a whistleblower. Any employee who is discharged, demoted, suspended, threatened, or harassed for filing a whistleblower lawsuit can bring an action for re-instatement with the same seniority restored. That employee is also entitled to recover double back pay with interest, as well as other compensatory damages.

The False Claims Act also allows whistleblowers to initially report fraud anonymously by filing a claim through an attorney. The whistleblower’s identity remains under seal while the Justice Department investigates the case. Should the government chooses not to pursue the case, the firm will never know the identity of the whistleblower, unless the claim is privately pursued.

Legal Help For Whistleblowers

If you have knowledge that a cosmetics firm illegally marketed cosmetics you may have valuable legal rights as a cosmetics industry whistleblower. For a confidential, no obligation evaluation of your potential cosmetics industry whistleblower lawsuit, please fill out our online form, or call 1 800 LAW INFO (1-800-529-4626) today.

Certain Type 2 diabetes medications continue to be associated with risks for pancreatic side effects that include pancreatic cancer. Drugs such as Victoza (liraglutidefrom), which are used along with diet and exercise to lower blood sugar in adults with Type 2 diabetes, are known as icretin mimetics and are being evaluated by the U.S. Food and Drug Administration (FDA).

Icretin mimetics, including Victoza, have been the subject of research, specifically unpublished findings under evaluation by the FDA. This emerging research was conducted by a group of academic researchers whose findings suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes—pancreatic duct metaplasia—in Type 2 diabetic patients treated with incretin mimetics. Pancreatitis is a known risk cancer for pancreatic cancer.

The findings were based on a review of a small number of pancreatic tissue specimens taken from patients who died from a number of causes. The agency has requested the researchers to provide the methodology they used to collect and study these specimens, and have also requested the tissue samples utilized so that the agency may continue investigating possible pancreatic toxicity associated with Victoza and other incretin mimetics. These drugs imitate the body’s incretin hormones, which are meant to stimulate insulin release following a meal.

Victoza Whistleblower Protection Under the False Claims Act

In recent years, many pharmaceutical employees have come forward to report fraudulent billing, illegal marketing techniques and undisclosed drug side effects.

Although the FDA said it has not reached new conclusions on the safety risks associated with Victoza and other drugs in its class, the FDA did inform the public and the health care community that it intends to secure and evaluate the new information that reveals links between Victoza and similar Type 2 mediations and increased risks for diseases of the pancreas, such as pancreatic cancer.

The FDA previously issued a warning concerning post-marketing reports of acute pancreatitis—fatal and nonfatal—associated with Victoza and other drugs in its class, but has not advised the public about the pre-cancerous cell changes seen with these drugs, The Associated Press (AP) noted. On the FDA website, the FDA did indicate that this is the first time the agency has communicated a possible pre-cancerous link to incretin mimetics, said Reuters.

Watchdog group, Public Citizen, petitioned the FDA to remove diabetes injection drug, Victoza, from the market because it likely increases the risk a patient will suffer thyroid cancer or pancreas and kidney failure. The group told the FDA that Victoza’s risks outweigh its benefits and the agency’s own review panel had reservations before Victoza was ultimately approved for use in 2010. Three scientists on an FDA advisory panel reviewing Victoza for approval made recommendations against its approval over reports the agency had collected concerning Victoza’s link to thyroid tumors. The FDA acted against that advice, voting to approve the drug. Public Citizen also cited evidence that Victoza was also associated with other side effects in addition to its likelihood to cause thyroid tumors. Currently, the FDA only warns people with a family history of thyroid diseases to avoid taking Victoza.

The False Claims Act allows for private persons to file lawsuits that provide the government with information about wrongdoing. If a person is found to have knowingly submitted or caused others to submit false or fraudulent claims to the U.S., the government may recover treble damages and $5,500-$11,000 per statute violation under the Act. If the claim is successfully resolved or litigated, the whistleblower can receive 15-25 percent of the monies recovered. Should the government decline to join the case, the lawsuit may proceed privately; the whistleblower will be entitled to a 25-30 percent recovery reward in this case.

Companies are prohibited from retaliating against a whistleblower under the False Claims Act. In fact, an employee who is discharged, demoted, suspended, threatened, or harassed for filing a whistleblower lawsuit can bring an action for re-instatement with his/her seniority restored, recovery of double back pay with interest, and other compensatory damages. Whistleblowers may initially and anonymously report fraud by filing a claim through an attorney and the whistleblower’s identity remains under seal while the Justice Department is conducting its investigation. Should the government choose not to pursue the case, the firm will never know the whistleblower’s identity, unless the claim is privately pursued.

Approved in 2006 by the U.S. Food & Drug Administration (FDA), the Type 2 diabetes medication, Januvia, continues to be associated with risks for pancreatic side effects that include pancreatic cancer.

In 2009, the agency required a label update warning of the risk of acute pancreatitis, a painful, potentially fatal disorder and a known risk factor for pancreatic cancer.

Icretin mimetics, drugs such as Januvia (sitagliptin), have been the subject of research, including unpublished new findings that are being evaluated by the U.S. Food and Drug Administration (FDA). This research was conducted by a group of academic researchers whose findings suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes—pancreatic duct metaplasia—in Type 2 diabetic patients treated with incretin mimetics.

Findings were based on a review of a small number of pancreatic tissue specimens taken from patients who died from a number of causes. The agency has since asked the researchers to provide the methodology used to collect and study these specimens, as well as with the tissue samples utilized so that it may continue investigating potential pancreatic toxicity associated with Januvia and other incretin mimetics.

Other drugs in the incretin mimetic class that are made with the same active ingredient as Januvia include Janumet, Janumet XR, and Juvisync. Incretin mimetics imitate the body’s incretin hormones, which are meant to stimulate insulin release following a meal.

Januvia Whistleblower Protection Under the False Claims Act

In recent years, many pharmaceutical employees have come forward to report fraudulent billing, illegal marketing techniques and undisclosed drug side effects.

Although the FDA said it has not reached any new conclusions about the safety risks associated with Januvia and similar drugs, the agency informed the public and the health care community that it intends to secure and evaluate the new information that reveals links between these Type 2 mediations and increased risks for pancreatic diseases, including cancer of the pancreas. The FDA previously issued a warning concerning post-marketing reports of acute pancreatitis—fatal and nonfatal—associated with sitagliptin, known by its brand name, Januvia, and exenatide. The agency has not advised the public about the pre-cancerous cell changes seen with these drugs, The Associated Press (AP) noted; however, in a notice on its website, said Reuters, the FDA indicated that this is the first time it has communicated a possible pre-cancerous link to incretin mimetics.

Prior research revealed that Januvia (sitagliptin) has been associated with reports of increased risks for pancreatic and thyroid cancers. In fact, researchers at the University of California, Los Angeles looked at Type 2 diabetes drugs, including Januvia, in comparison to other therapies and all of the drugs’ risks for pancreatic and thyroid cancers and pancreatitis. The study revealed that Januvia patients experienced a nearly three-fold risk of developing pancreatic cancer.

The False Claims Act allows for private persons to file lawsuits providing the government with information about wrongdoing. Under the Act, if a person is found to have knowingly submitted or caused others to submit false or fraudulent claims to the U.S., the government may recover treble damages and $5,500-$11,000 per statute violation. Should the government be successful in resolving or litigating its claims, the whistleblower can receive 15-25 percent of recovered recovered. Should the government decline to join the case, the lawsuit may proceed privately; the whistleblower will be entitled to a 25-30 percent recovery reward in this case.

Companies are prohibited from retaliating against a whistleblower, under the False Claims Act. In fact, an employee who is discharged, demoted, suspended, threatened, or harassed for filing a whistleblower lawsuit can bring an action for re-instatement with his/her seniority restored, recovery of double back pay with interest, and other compensatory damages. Whistleblowers may initially and anonymously report fraud by filing a claim through an attorney. The whistleblower’s identity remains under seal while the Justice Department investigates the case. Should the government choose not to pursue the case, the firm will never know the whistleblower’s identity, unless the claim is privately pursued.

Research has revealed that Byetta (exenatide), which is prescribed for the treatment of Type 2 diabetes, has been associated with increased risk reports for pancreatic and thyroid cancers.

Byetta, a twice-daily injection, was approved in 2005 for use with other diabetes treatments; the drug was later approved as a stand-alone Type 2 diabetes therapy. In a class of drugs called glucagon-like peptide-1 (GLP-1), Byetta increase some natural substances that lower raised blood sugar levels. Typically, diabetics either do not efficiently utilize insulin or have abnormally low insulin levels.

Studies have linked Byetta to some significant adverse reactions. Up until now those links have been specifically with pancreatitis. Of note, pancreatitis is a known risk factor for pancreatic cancer. Other serious side effects have been linked to Type 2 diabetes drugs like Byetta such as low blood sugar; anaphylaxis and other allergic reactions such as hives, rash, swelling of face, lips, tongue, and/or throat; and death.

Byetta’s pancreatic cancer risks are being seen more-and-more in recent research. In fact, a study on Byetta and drugs like it, conducted by researchers at the University of California, Los Angeles found that Byetta patients experienced a nearly three-fold risk of developing pancreatic cancer. Evidence also suggests an increased incidence of thyroid cancer among patients taking Byetta.

Most recently, a March 14 Drug Safety Communication issued by the U.S. Food and Drug Administration (FDA) stated that pancreatic tissue samples taken as part of a study revealed inflammation and cellular changes that are often precursors to cancer. The samples came from a small group of diabetes patients who had taken the new medications, said the Associated Press (AP). The samples were secured post-mortem and the deaths were due to an array of causes.

Although it has issued alerts about pancreatic risks associated Byetta and drugs like it, the FDA has not advised consumers about the pre-cancerous cell changes seen with these drugs, said the AP.

Byetta Whistleblower Protection Under the False Claims Act

In recent years, many pharmaceutical employees have come forward to report fraudulent billing, illegal marketing techniques and undisclosed drug side effects.

The False Claims Act allows for private persons to file lawsuits providing the government with information about wrongdoing. If a person is found to have knowingly submitted or caused others to submit false or fraudulent claims to the U.S., the government can recover treble damages and $5,500-$11,000 per statute violation. Should the government successfully resolve or litigate its claims, the person who brought the whistleblower complaint may receive 15-25 percent of the recovered amount. If the government declines to join the case, the lawsuit may proceed privately, with the whistleblower entitled to a 25-30 percent recovery reward.

This is important given that, Amylin Pharmaceuticals, the maker of Byetta, was criticized for allegedly hiding a study that revealed serious heart risks associated with Byetta. In fact, the FDA alleged that Amylin concealed the Byetta heart study from the agency and tried to keep the agency from accessing key study data when the FDA learned of its existence. Byetta and Bydureon (exenatide) are both made with the same active ingredient.

Last year, the division director of the FDA unit responsible for the regulation of kidney drugs wrote that approval of Amylin’s longer-acting Bydureon was a “long and complicated process,” in part because of “Amylin’s withholding of information on Byetta that FDA deemed to be important to its evaluation of the safety and effectiveness of Bydureon.” The memo stated that the agency only learned of the disturbing cardiac findings associated with Byetta when Canadian regulators alerted the FDA. The FDA asked that data be included in Amylin’s Bydureon resubmission. When the application was resubmitted, the data were missing, and were, instead, submitted separately and as an addendum to the original Byetta regulatory file.

The FDA eventually did approve Bydureon; however, noted TheStreet, Amylin hid the truth about the Byetta heart study from its investors and FDA records indicate that Amylin neglected to disclose that the Byetta heart-safety study played a significant role in the FDA’s rejection of the drug.

Bloomberg
By John Hechinger – Mar 15, 2012 4:54 PM ET

Education Management Corp. (EDMC), the second-largest U.S. for-profit college chain, defrauded U.S. taxpayers by paying illegal bonuses to recruiters who cited falsified job-placement data to lure students, a former employee claimed in a lawsuit.

Education Management used “boiler-room” tactics to receive millions of dollars in federally backed student loans and grants, Jason Sobek, a former recruiter for the company’s South University, said in a complaint unsealed yesterday in Pittsburgh federal court. The company targeted “troubled” students, including the homeless and mentally ill, according to the lawsuit.

For more info read : http://www.bloomberg.com/news/2012-03-15/education-management-preys-on-students-former-recruiter-claims.html

A significant component to the newly enacted Food Safety and Modernization Act provides protection for workers who blow the whistle on companies that violate food safety standards. However, officials are concerned that workers with information that help prevent foodborne illness are not aware of the corporate whistleblower protection provision.

NewsInferno.com reports that under the newly enforced provision that encourage whistleblowers to step forward with information about food safety violations, food industry workers employed by Food & Drug Administration (FDA)-regulated companies are protected against employer retaliation when stepping forward to expose company fraud. Workers are protected from being fired, demoted, unfair treatment and denied promotions if they decide to speak against employer violations.

The food safety law, signed by President Barack Obama, is geared to allow the FDA to implement recalls and hopes to ease the process of how contaminated food is traced back to its starting point. Food must pass a government approved spot check, but if the system fails to recognize a violation, officials hope workers will step forward if they realize that the food they are working with is a threat to public health.

Much is happening to increase worker awareness. At a recent conference in Washington, Kenneth Kendrick, former plant manager and whistleblower, spoke about the awful conditions at the Peanut Corporation of America (PCA) plant in Texas. At the time, Kendrick sent anonymous emails about rat infestations and bird droppings that contaminated PCA products. It wasn’t until he was employed at another FDA-regulated company that he publicly disclosed the information which resulted in job termination and long-term inability to find another position.

In the end, PCA was held accountable for the 2008-2009 Salmonella Outbreak that sickened hundreds, killed nine, and stemmed in thousands of recalls.

If you know of wrongdoing on the part of a business or government organization and you want to reveal these acts, it is important to have an experienced whistleblower lawyer on your side to protect your rights. The whistleblower lawyers at our firm can make sure you are compensated for the risk you take. Please contact us by filling out our online form or by calling 1-800-LAW-INFO (1-800-529-4636).

Whistleblowers are key components of our society and in recent years the role of the whistleblower has begun to play an increasingly more important role in the corporate world due to the improvements in U.S whistleblower protection law and organizations that provide corporate whistleblower protection. Nowadays there are numerous forms of corporate whistleblower protection and opportunities for individuals to discuss the consequences of whistleblowing with experienced attorneys at a whistleblower law firm.

Whistleblower Protection

Before improvements were made to whistleblower protection law there were no set whistleblower statutes so individuals who wanted to blow the whistle would have to face the unfavourable consequences of whistleblowing, which usually included loss of job and in many cases discrimination.

In order to protect whistleblowers and encourage more individuals to disclose information of wrongdoing or illegal activity in the workplace the U.S government introduced the Whistleblowers Protection Act which protects the whistleblower in a number of areas. This act particularly protects whistleblowers from retaliation as there is a whistleblower protection law that states that assistance will be provided to any whistleblower that cannot defend his or herself.

Corporate Whistleblower Protection

The Sarbanes-Oxley Act of 2002 deals with corporate governance and provides significant corporate whistleblowing protection. This act contains diverse civil, criminal and administrative provisions which contribute towards making this statute an extremely important whistleblower protection law. Unlike other whistleblowers laws the Sarbanne Oxley Act provides provisions that are not limited to providing a remedy for wrongfully discharged employees. This act contains another four provisions designed to provide corporate whistleblower protection. These provisions include audit committees, new ethical standards for attorneys who practice before the SEC, amendments to the federal obstruction of justice statute and also grants jurisdiction to the SEC to enforce all aspects of the act; including various whistleblower provisions. These provisions make the Sarbanne Oxley Act a unique federal framework which enforces comprehensive corporate whistleblower protection.

Whistleblower protection laws are an important part of today’s society as they allow individuals to do the right thing without having to fear the consequences of whistleblowing. If you know someone that is involved in corporate fraud or wrongdoing in the workplace but are unsure about blowing the whistle, then an experienced attorney at our personal injury law firm can offer their legal help. Please fill out an online form and find out more about the consequences of filing suit, your legal rights and corporate whistleblower protection.