$7 Million Settlement Reached in Whistleblower Lawsuit Against All Children’s Hospital

All Children’s Hospital in Florida has agreed to pay a $7 million settlement over a whistleblower lawsuit brought over allegations that the hospital violated anti-kickback laws.

The whistleblower allegations include that All Children’s Hospital paid inflated salaries and bonuses to physicians. In exchange, physicians were to bring in more patients and hospital revenues, according to the Tampa Bay Times.

The whistleblower lawsuit was filed in July 2011; the whistleblower was director of operations for the doctors’ practice at All Children’s for more than 10 years before she left in 2011. She claimed that All Children’s Hospital had overpaid doctors by about $5 million in 2010, a violation of laws that were implemented to regulate the financial relationships between hospitals and the physicians who bring in patients, the Times reported.

A so-called “hiring spree” of physicians meant to ensure increased referrals, including some doctors being promised “significant bonuses based on the number of procedures performed” at the hospital also took place, the lawsuit alleged, according to the Times. Other allegations included that the former hospital CEO, Gary Carnes, and former vice president of strategic business services, William “Bill” Horton, saw a more than doubling of their salaries over physician hiring practices. The hospital denied all claims about executive and physician compensation.

In the mid-2000s, All Children’s Health System “began to feel the sting of lost Medicaid patients and referrals as local competition increased and physicians began referring their patients to other facilities, just as the health system broke ground on a new, $400 million hospital facility,” according to the lawsuit’s allegations. The hospital offered specific physicians “hundreds of thousands of dollars in bonuses and perks, bought out private medical practices, and overpaid new recruits,” the allegations continued, reported the Times. By year three of the effort, “some 80 physicians in 10 specialties” were hired with exclusivity agreements and financial incentives to keep their referrals within All Children’s, the lawsuit also indicated.

In a cited example, one pediatric surgeon was hired at a base salary of $600,000, at a time when the fair market value for a doctor with his experience was about $350,000, according to the lawsuit. Meanwhile, the federal Ethics in Patient Referrals Act—known as the Stark law—bans compensation that benefits physicians for referring patients using Medicare and Medicaid, according to the Times.

All Children’s relies heavily on the state and federal Medicaid program. For example, in 2010, the year the hospital opened its new facility, about 70 percent of its patient care revenues—some $370 million—were received through the Medicaid program, according to an annual report cited in the lawsuit, the Times wrote.

As part of the settlement agreement, All Children’s will pay the federal government $4 million and the state of Florida $3 million. The whistleblower will receive $1.9 million from the state and federal figures according to the Times. In agreeing to the settlement, All Children’s denied any wrongdoing.

The lawsuit was unsealed in 2012.

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Roche Report on Lax Drug Safety Reporting Issued by the European Medicines Agency

The European Medicines Agency (EMA) has announced that it has finalized its probe into the drug maker, Roche, and potentially lax drug safety reporting issues. The EMA report has been sent, for next steps, to the European Commission.

The European Commission will make a decision concerning if the matter should be pursued and if any financial penalties, which may be significant, will be assessed, according to Reuters. Reuters reported that Roche may have breached EU rules; however, due to confidentiality, no further details have been provided.

In November, the EMA indicated that it had not discovered new safety issues associated with Roche drugs over shortcomings in how adverse events are reported. The probe was initiated in 2012 after a routine investigation found that Roche had not appropriately assessed tens of thousands of cases of possible adverse drug reactions. The Roche 19 drugs involved included several that are used to treat cancer, Reuters noted.

Drug makers must evaluate issues concerning their drugs that are reported by physicians and patients; serious cases must be reported to regulators. If Roche is found to have failed to comply with its “pharmacovigilance” obligations under EU rules, it may be subject to up to 5 percent of its yearly EU turnover, some 12.8 billion Swiss francs, or $14.6 billion in United States dollars, according to Reuters. The pharmacovigilance inspection conducted by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) took place in 2012 and identified significant issues in Roche’s pharmacovigilance processes, according to The Pharma Letter.

The inquiry involves Swiss drug maker Roche’s, Roche Registration Ltd., involving, according to the EMA, an infringement procedure against the drug maker, wrote The Pharma Letter. The agency initiated the probe at the European Commission’s request over allegations that Roche did not comply with its pharmacovigilance obligations concerning the 19 centrally authorized Roche medicines.

Cancer medications are very strong drugs used to treat very vulnerable patients who suffer from dangerous and life-threatening diseases. Additional or unexpected adverse drug reactions may lead to significant, deadly consequences in people who are diagnosed and who are being treated for cancer. In order for physicians and patients to make informed decisions about drug therapy, it is imperative that full disclosure on drug safety and efficacy be provided.

Parker Waichman LLP has long supported efforts to protect whistleblowers. If you believe that your employer is committing fraudulent activities and would like to maintain your anonymity, or are seeking protection from retaliation by your employer, we encourage you to contact us as, well. Free case evaluations are also available by calling 1-800-LAW-INFO (1-800-529-4636).

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SEC Makes another Payment to First Whistleblower, Possibly More on the Way

The Securities and Exchange Commission’s whistleblower office announced that it will be making another payment to the first-ever whistleblower, Wall Street Journal reports. Furthermore, the whistleblower may be getting even more payouts from the agency in the future. The additional payments are due to the language of the 2010 Dodd-Frank financial reform bill, which helped establish the whistleblower program. Through this program, the SEC awards individuals who give the agency information that leads to legal enforcement action. They anonymous tipster, or “whistleblower”, can receive between 10% and 30% of the money recovered from that action.

Under Dodd-Frank, the payments made to the whistleblower are related to the amount the agency recovers; this can be less than the amount ordered in a case, according to Wall Street Journal.
The initial award was handed out in 2012. It was for 30% of sanctions in relation to an unnamed “multi-million dollar fraud”. The agency collected $150,000 of the $ 1million in ordered penalties, resulting in $50,000 for the whistleblower at the time. Now, the SEC has collected more money in the case and announced on Friday that the tipster will be receiving an additional $150,000. The whistleblower may get $100,000 or more moving forward, the SEC said.

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Stryker and Alliant Pay More than $1 Million to Resolve Whistleblower Lawsuit

The U.S. Attorney’s Office for the Central District of California has announced that Stryker Corporation and Alliant Enterprises have paid the U.S. government a total of $1.05 million to resolve a whistleblower lawsuit. The whistleblower case alleges that the companies avoided heightened government scrutiny by failing to fully disclose information about projected government sales. The case was resolved on March 13th, when a federal judge dismissed and unsealed the case.

According to a press release by the U.S. Attorney’s Office for the Central District of California, “ Stryker and Alliant failed to disclose to government negotiators complete pricing information, which resulted in higher costs to government agencies that purchased medical products from the Federal Supply Schedule contract awarded by the Department of Veterans Affairs to Alliant. As a result of the conduct by Stryker and Alliant, the VA and other government agencies allegedly purchased products at inflated prices.”
Stryker Corporation is a company that has several divisions, including a medical equipment division called Stryker Medical. This unit sold equipment such as critical care hospital beds, medical-surgical hospital beds and stretchers to government purchasers. The contract through which they did this was previously awarded to Alliant. According to the lawsuit, “… because Alliant was used to sell the Stryker-manufactured products, the defendants provided none of Stryker’s commercial pricing history to the VA for price comparison purposes, and that Alliant understated expected sales of the products, which allegedly allowed the defendants to avoid scrutiny and overcharge the VA.”

A former Stryker employee filed the suit in the U.S. District Court in Los Angeles in 2008. The case was filed under the “whistleblower” provisions of the federal False Claims Act; this allows individuals to sue another party on behalf of the government. The whistleblower is entitled to a portion of the money recovered in a settlement or judgment.

The U.S. Attorney’s Office for the Central District of California and the Department of Justice Civil Division’s Commercial Litigation Branch reached the settlements, and the Department of Veterans Affairs’ Office of Inspector General investigated the case. The companies paid the settlements in December; $911,219 was paid by Stryker and $151,215 was paid by Alliant.

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Former LifeLock Executive Files Whistleblower Lawsuit

A former chief information security officer is blowing the whistle on LifeLock, alleging that the company fired him for speaking up when he found out that it turned off or reduced notifications to elderly customers to lower the number of calls to its customer support center. Michael Peters filed the lawsuit in Federal Court against Kim Jones, the chief information security officer for his former employer, Cristy Schaan, the current chief information security officer for LifeLock and LifeLock.

LifeLock sells identity theft protection. According to Courthouse News, it has been sued more than 80 times in recent years. Among these cases is a securities fraud class action lawsuit filed on behalf of shareholders who allege that the company did not comply with an order from the Federal Trade Commission in 2010. LifeLock deceived its customers into thinking they were getting services that they were not, according to the FTC settlement statement.

Peters alleges in his whistleblower case that there were “many instances of illegal and incompetent practices that constituted fraud against LifeLock’s shareholders”, which he discovered while starting an initial risk assessment. In his lawsuit he says he discovered that “LifeLock would turn off or reduce the services alerting elderly customers to reduce the call volume received by LifeLock’s customer support center,” He alleges that this is fraudulent because the company “sold its services to the general public without any disclosure that alert services would be limited for certain segments of the population.”

He also found that the company was in the process of finalizing a new product called PassLock, which “would be identified by most service providers as intrusive, illegal, illegitimate, and then blacklist the source address”.
According to Peters, he met separately with LifeLock’s chief financial officer Chris Power and chief information officer Rich Stebbins to disclose his findings and was fired. He alleges that the company directed its in-house special counsel for labor and employment to find a reason to fire him.
Peters’ allegations are similar to what customers are saying on Consumer Affairs. Brenda, a consumer in California, said she noticed she wasn’t getting as many notifications as she expected starting last August. When she applied for a loan, she thought that this would immediately trigger an alert, but she wasn’t notified until the next day. “I thought they would alert you right away the same day that your credit was being pulled and put a stop to it until they get a response back.” she said to Consumer Affairs. Other users say they get even less than that. Jeffrey, a consumer In Tennessee, said to Consumer Affairs last July “We got Lifelock three months ago, thought we might need it. So we called and they told us all the good things that they do …. [they said] anytime we applied for any kind of credit, within 5 minutes we would be texted to see if it was us or someone trying to use our credit. In the last 3 months we have opened up a credit account and have been using it. They haven’t texted or called us to let us know. This week we bought a $10,000 ATV and there have been no texts to our phone or no emails. That could have been anyone doing that. We canceled our membership today.”

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Hospital System To Pay $85 Million Over Alleged False Claims Act Violations

Halifax Health of Daytona Beach, Florida, announced an $85 million settlement just moments before the start of jury selection in a case involving conflict-of-interest regulations.

The settlement may resolve the first half of a trial involving Halifax Health’s physician compensation deals and determining if those deals violate laws over conflicts of interest, according to Modern Healthcare.

Halifax Health had been readying for the trial, which involved the largest potential civil whistle blower case damages against a single hospital. According to Modern Healthcare, about one billion dollars was at stake and Halifax Health was preparing to become one of just a few hospitals to ever reach trial in this type of a case. The case followed a similar 2013 case in which a $237 million judgment was found against a hospital in South Carolina over allegations of doctors being overpaid.

Halifax Health opted to settle the first half of the case out of court. That portion of the allegations included that hospital administration illegally compensated nine neurologists and medical oncologists for their referrals of Medicare patients to the hospital, Modern Healthcare reported. The parties agreed to a settlement-in-principle for $85 million, which must be approved or dismissed by U.S. District Judge Gregory Presnell. If this case is approved, the whistleblower will receive $20.8 million of the settlement.

Spokeswoman for Halifax Health, Berit Hallberg, said the settlement would not include admission of wrongdoing noting, “We still believe that we acted responsibly in our efforts to comply with the highly complex Stark law, but it is our fiduciary responsibility to avoid the risk associated with going to trial and the appeals.” She added, “We will not increase taxes to pay this settlement. The settlement will be paid over several years through belt-tightening and the potential delay of some capital expenses.” Coming to a settlement will also remove a large possible liability from Halifax Health’s ledgers, according to Modern Healthcare.

In 2009, a former compliance officer, who is still employed at Halifax in a different role, filed a whistleblower lawsuit that accused Halifax administrators of paying physicians increased rates and also paid bonuses for the most active physicians who used the hospital’s share of funds meant for Medicare. If the arrangement allegations are proven true, the arrangements would be a violation of the so-called Stark law and might also be a violation of the False Claims Act if they were found to have been done intentionally and with a reckless disregard for the law, according to Modern Healthcare. This could increase damages three-fold, costing hundreds of millions of dollars.

The Stark Law bans doctors from referring Medicare and Medicaid patients to those business entities with which they share a financial relationship. This includes a compensation arrangement.

When doctors are compensated in ways that differ from Medicare service volume or value, this may lead to a situation in which those physicians become incentivized to give unnecessary care or to make decisions that are not always in the best interests of the patient and which lead to increased profits. This is illegal. There are exceptions to the law, which Halifax claimed protected it from liability. A jury was being put together to decide that, Modern Healthcare explained, when the settlement for the first portion of the matter was announced. The Justice Department joined in those qui tam allegations against the hospital in 2011 and alleged violations of the False Claims Act, the Stark Law, and the federal Anti-Kickback Statute.

Even if this settlement is approved, Halifax must litigate the separate whistleblower allegations in July; the Justice Department did not join in this related case. In this second matter, the whistleblower alleged that Halifax ignored obvious signs that it billed Medicare for inpatient hospital care in cases in which medical need had not been documented. Halifax officials denied the allegations, according to Modern Healthcare.

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Medtronic’s Spine Business Soft Compared to Other Units

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Device maker, Medtronic Inc., just announced company-wide increased net income; however, its spine division is seeing some sagging business

Medtronic, which manufactures implantable heart devices, insulin pumps, and spine surgery products posted overall net income of $902 million for second-quarter, fiscal year 2014, ended October 25th, according to The Memphis Daily News. This translates into a 40 percent increase year over year. Second-quarter revenue was recorded as a total of $4.2 billion, which is a 2 percent increase over the prior year’s $4.1 billion.

“Our Q2 revenue growth was in line with our outlook for the year, and we’re performing at or better than the market in almost every one of our business lines,” said Omar Ishrak, Medtronic chairman and chief executive officer, according to The Memphis Daily News. “Q2 also represents another quarter where our organization delivered balanced growth, with strong performances in some areas offsetting challenges in other parts of our business,” Ishrak added.

In fact, the device maker enjoyed quarterly revenue growth in three of its key business units—its Diabetes Group, its Restorative Therapies Group, and its Cardiac & Vascular Group. Each group, noted The Memphis Daily News, saw between 2-4 percent growth for the quarter.  “Looking ahead we are confident that our three primary strategies: therapy, innovation, and globalization in economic value will position us well to thrive in the transforming health care environment,” Ishrak said.

Medtronic’s Infuse Bone Graft sales have taken hits following revelations over the way in which it handled the product’s studies and marketing, according to The Memphis Daily News. That product area is in the company’s Restorative Therapies Group.

The controversial bone graft product is a synthetic, or genetically engineered, recombinant human Bone Morphogenetic Protein (rhBMP-2) that was approved by the U.S. Food and Drug Administration (FDA) in 2002 for specific uses. Infuse was designed to stimulate spine growth in patients suffering from lower spinal degenerative disease. Infuse was approved for use in one type of spinal surgery and some dental procedures; the product is not approved for use on the upper, or cervical spine, although Infuse is widely used in off label procedures.

On July 1, 2008 the FDA issued a notification warning about Infuse’s ties to serious complications when used in cervical spinal fusions.

Infuse has been the focus of growing controversy and there are concerns over the way in which Infuse research was conducted, including that the research was Medtronic-funded. Medtronic has been accused of promoting Infuse off label, of downplaying the device’s risks, and of overstating Infuse benefits. These accusations have led to a Senate probe, the FDA warning, and independent studies.

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Research Concerning Victoza Cancer Risks Under FDA Review

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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.

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FDA Further Researching Type 2 Diabetes Drug, Januvia, Pancreatic Cancer Links

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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.

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Undisclosed Drug Side Effects? Type 2 Diabetes Drug, Byetta Linked to Increased Cancer Risks

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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.

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Education Management Preys on Students, Ex-Recruiter Claims

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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

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New Food Safety Law Protects Whistleblowers

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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).

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