Unveiling the Dark Side of Medical Devices: Investigating Corporate Ethics and Patient Safety

Medtronic, medical devices, sign.

In recent years, medical device giant Medtronic has come under fire due to allegations involving their business practices and patient safety concerns. Central to this controversy are their medical devices, particularly the GIA 80 surgical stapler, which has led to numerous patient injuries and even deaths due to malfunctions and alleged cover-ups.

Leanne Houston, a former Medtronic sales representative, highlighted Medtronic’s questionable business practices. Taking on the role of a whistleblower, Houston revealed unsettling, unethical conduct by the corporation. She exposed that Medtronic was using kickbacks to secure exclusivity over hospitals and surgeons. This strategy pushed forward the use of their medical devices despite being more expensive and often marketed for off-label uses. Such manipulative actions flagrantly violate the law and indubitably prioritize corporate profits over patient safety.

The allegations made by Houston against Medtronic are grave indeed. The company’s indifference towards patient safety led to the covering up various issues with the surgical staplers and payments to hospitals and physicians solely for the sake of using their products. Houston’s lawsuit accuses Medtronic of engaging in unlawful conduct by leveraging kickbacks to induce hospitals and surgeons to purchase their devices.

This is not the first time Medtronic has been in the hot seat for ethical violations. The company’s history is marred with accusations of fraud, kickbacks, and anti-competitive conduct. In fact, Medtronic’s past settlements total over $60 million on allegations regarding fraud and kickbacks alone. Yet, despite their ongoing controversy, the penalties Medtronic has faced thus far appear to be merely the price of doing business.

This incessant prioritization of profits over patients must invariably cease. It is of utmost urgency that real, substantial barriers and penalties be put in place to deter corporate misdeeds and protect patients’ lives. We must stand against harmful corporate greed exemplified by the likes of Medtronic, ensuring the corporations prioritize their ethical and social responsibilities.

If you or a loved one have been harmed due to a medical device, do not hesitate to seek help and justice. Approach a trustworthy and dedicated lawyer who can help guide you through the legal complexities and ensure you receive the compensation you deserve. Furthermore, if you possess any information about corporate misdeeds, please come forward. Your courage can ensure justice is served and can protect countless others from facing similar harm. Whistleblowers play a vital role in highlighting corporate misconduct and even stand to potentially receive rewards. It’s high time we call out corporate greed and prioritize patient safety.

Source: https://www.icij.org/investigations/implant-files/whistleblower-accuses-medical-tech-giant-medtronic-of-putting-profit-before-patients/

False Claims Act Whistleblowers – Counterclaims

Whistleblower protection lawyers in Beverly Hills - Helmer Friedman LLP.

See U.S. ex rel. Cooley v. ERMI, LLC, et al., C.A. No. 1:20-CV-4181-TWT, 2024 WL 815514, at *1 (N.D. Ga. Feb. 27, 2024)

A recent court ruling has allowed a medical equipment supplier to maintain counterclaims against a former employee who blew the whistle on the company for fraudulent activity. The employee claimed that the supplier provided medical equipment without a valid license. She also alleged that her employer had retaliated against her by stopping her from bringing the company into compliance and by subsequently forcing her out when she threatened to bring an False Claims Act (FCA) suit. The supplier denied these claims and filed counterclaims of its own. These counterclaims alleged that the employee breached her contract and fiduciary duties, and that she misled the company into thinking that a license renewal was forthcoming.

In February 2024, the Court made a decision to uphold the defendant’s counterclaims. The Court clarified that counterclaims for causes of action that are different from the FCA could proceed, even if they came from the same underlying facts as the FCA action. In this case, the Relator’s FCA claim and Defendant’s counterclaims both involved operating without a valid license.

The Court allowed Defendant’s breach of contract counterclaim for the time being. It reasoned that it was too early in the litigation to determine whether Relator fell within the confidentiality agreement’s safe harbor. This safe harbor allows the disclosure of confidential information to a regulator concerning conduct that an employee reasonably believes is illegal or in material noncompliance with applicable laws. If it turns out that Relator retained confidential documents only to support her FCA claim, then this counterclaim could be dismissed on public policy grounds.

The Court agreed with Defendant that Relator’s role in allowing Defendant’s Florida license to expire and misleading it into thinking a renewal was forthcoming was unrelated to the underlying FCA claims. The competitor’s lawsuit against Defendant was brought under the Florida Deceptive and Unfair Trade Practices Act, not the FCA. Therefore, that claim constituted independent damages that did not offset FCA liability.

The Court upheld Defendant’s breach of fiduciary duty claims, as they were not violative of public policy. The Court determined that there was a clear distinction between the facts supporting liability for each claim, even though both the Relator’s FCA claim and Defendant’s counterclaims involved operating without a valid license. The Court held that overlap is what makes Defendant’s counterclaims compulsory.

The court allowed the supplier’s breach of contract counterclaim to proceed for the time being, stating that it was too early in the litigation to determine whether the employee’s actions fell within the confidentiality agreement’s safe harbor provision. If it is later determined that the employee retained confidential documents only to support her fraudulent activity claim, then the counterclaim could be dismissed on public policy grounds.

This ruling provides a roadmap for companies facing fraudulent activity claims to pursue remedies against whistleblowers, even if these counterclaims stem from the same underlying facts as the fraudulent activity claim. Companies should evaluate potential injuries imposed by the whistleblower’s actions during and after their tenure, and determine whether counterclaims may be appropriate.

Pasadena Officer’s Case Highlights Importance of Whistleblower and Anti-Discrimination Protections

Constitutional rights lawyers of Helmer Friedman LLP.

In an age where increased scrutiny is being directed toward police conduct, we must remind ourselves of the protections officers who blow the whistle on inappropriate behavior within their departments can count on. A recent case involving Officer Taisyn Crutchfield from the Pasadena Police Department exemplifies this.

Officer Taisyn Crutchfield, a Black officer, has lodged a claim against the City of Pasadena, alleging retaliation, discrimination, and harassment. This claim came after Crutchfield attempted to de-escalate a tense situation involving another officer and the son of a man killed by Sheriff deputies. Such a case invariably highlights the robust protections for individuals in such situations.

“She’s doing the right thing, she doesn’t believe in a code of silence. She doesn’t believe in circling the wagons,” attorney Bradley Gage said. “She believes in integrity, honesty and safety.”

Attorneys Bradley C. Gage and Ben Crump cite laws protecting law enforcement officers like Officer Crutchfield from retaliation and discriminatory treatment. These include the Fair Employment and Housing Act (FEHA), the Peace Officer Bill of Rights, the Bane Act, and the Ralph Act.

The Fair Employment and Housing Act (FEHA) protects employees from discrimination, harassment, and retaliation in employment because of race, color, ancestry, national origin, and other characteristics. Officer Crutchfield’s experience, if proven accurate, represents a clear violation of this Act.

The Peace Officer Bill of Rights Act (POBAR) ensures that officers are afforded their constitutional right to fair treatment. Officer Crutchfield’s allegation raises questions about whether her rights under POBAR were violated when she was placed on administrative leave following her intervention in the incident above.

Crutchfield was placed on paid administrative leave for six months after being sent back to the department, claiming that she was never given any reason for her punishment.

The Bane Act, also known as The Tom Bane Civil Rights Act, protects from threats, intimidation, coercion, or attempts to interfere with someone’s state or federal statutory or constitutional rights. The Ralph Act also protects individuals from violence or threats of violence based on their race or ethnicity.

It’s crucial to remember that these laws work in combination to provide comprehensive protection to law enforcement officers. They allow officers to carry out their duties without fear of reprisal while also demanding an environment free from harassment and discrimination.

While the City of Pasadena has characterized the claim as inaccurate and pledged to contest the allegations, the incident serves as a potent reminder of the importance of these protective laws. Regardless of the outcome, it underscores how essential it is for law enforcement agencies to uphold these protections and ensure a fair, safe, and tolerant working environment for their officers.

Only through an unwavering commitment to these protections can we continue to build trust and integrity within our police forces and their relationships with the communities they serve.

Whistleblower Case Against City of Florence Moves Forward: Judge Denies Dismissal

Sex discrimination is not only illegal, but it has been proven to negatively affect public safety.

Is your city safe? The question might seem straightforward, but for the people of Florence, the answer might be more complex than it seems. Sex discrimination is not only illegal but it has been proven to negatively affect public safety. Sarah Glenn, a city employee, alleges that the City of Florence has been systematically violating state and federal civil rights laws, even retaliating for exercising her First Amendment rights.

Glenn’s allegations include being treated less favorably than her male counterparts, being assigned menial tasks, and expressing genuine safety concerns that were ignored. The city attempted to dismiss Glenn’s First Amendment claim, arguing that her disclosures were not of public concern and could disrupt the workplace. However, a statement from US District Court Chief Judge Philip A. Brimmer suggests otherwise. He denied this motion, emphasizing that Glenn’s claims can’t simply be bulldozed as personal grievances.

The City is now seeking a summary judgment to resolve the First Amendment claim in their favor and is hoping to avoid a trial. However, it’s worth noting that this isn’t the first litigation against the City of Florence, as there’ve been multiple lawsuits, including allegations of misconduct by the former city manager.

This case reveals the dark side of sex discrimination. It obstructs justice, inhibits the free flow of information, and potentially risks public safety. It’s time to recognize these issues. Stand with Sarah Glenn. Stand up for equal rights and public safety.

Unveiling Illegal Discrimination, Harassment, Donations for Scholarships, and Whistleblower Retaliation

Workplace violations, discrimination, whistleblower retaliation lawyers Helmer Friedman LLP.

Not Just a Game: Former Cal State University Northridge coach files lawsuit against the school, claiming wrongful termination following exposé on dubious recruiting tactics!

In recent news, an alarming case has surfaced involving the former women’s soccer coach at Cal State University Northridge, Keith Andrew West, who is now taking legal action against the school. The case highlights some of the endemic issues that are often overlooked in higher education, such as illegal discrimination, harassment, unethical donations for scholarships, and whistleblower retaliation.

Athletic Director, Brandon Martin instructed West to terminate one of his male assistant coaches to make room for a female assistant coach, the suit alleges.

The crux of West’s lawsuit lies in whistleblower retaliation, a serious violation of employee rights that often go unreported due to fear of reprisals. In this situation, West claims to have fallen victim to retaliation following his exposure of alleged impropriety within the university’s department.

In addition to this, West reports incidents of discrimination and harassment. He points out the university’s resistance to renewing his contract, expressing an intention to replace him with a female. This seeming gender-bias raises questions about illegal discrimination within hiring and contracting practices.

“The president wants a female in your position.”

Further adding to the university’s list of alleged violations, West reveals he was pressured to use his recruitment abilities to target a potential student athlete based on their potential financial contributions to the school. This brings to light the questionable practice of procuring donations for scholarships, a practice that deeply undermines the merit-based principle that should ideally govern academic scholarships.

In the wake of these accusations, West was subjected to an investigation and subsequent termination, causing him considerable losses, both financial and emotional. His case illuminating potential gross abuses of power and violations of both employment and educational law that should not be dismissed or ignored.

As this case unfolds, it serves as an important reminder of the dire need for transparency, fairness, and ethical practices in higher institutions. We must ensure that illegal discrimination, harassment, and whistleblower retaliation are not swept under the rug, and we must question practices like donations for scholarships that compromise the integrity of higher education.

Worker Terminated after Reporting Injury, Employeer Ordered to Pay $225K


Oct. 15, 2014

Burlington Northern Santa Fe LLC ordered to pay more than $225K to worker terminated after reporting injury at Kansas City, Kansas, rail yard

KANSAS CITY, Kan. – Burlington Northern Santa Fe LLC wrongfully terminated an employee in Kansas City after he reported an injury to his left shoulder, according to the U.S. Department of Labor’s Occupational Safety and Health Administration. The company has been found in violation of the Federal Railroad Safety Act*, and OSHA ordered the company to pay the apprentice electrician $225,385 in back wages and damages, remove disciplinary information from the employee’s personnel record and provide whistleblower rights information to all its employees.

“The resolution of this case will restore the employee’s dignity and ability to support his family,” said Marcia P. Drumm, OSHA’s acting regional administrator in Kansas City, Missouri. “It is illegal to discipline an employee for reporting workplace injuries and illnesses. Whistleblower protections play an important role in keeping workplaces safe because they protect people from choosing between their health and disciplinary action.”

OSHA’s investigation upheld the allegation that the railroad company terminated the employee following an injury that required the employee to be transported to an emergency room and medically restricted from returning to work. The company’s investigation into the injury, reported on Aug. 27, 2013, concluded that the employee had been dishonest on his employment record about former, minor workplace injuries unrelated to the left shoulder. These conclusions led the company to terminate the employee on Nov. 18, 2013.

OSHA found this termination to be retaliation for reporting the injury and in direct violation of the FRSA. BNSF has been ordered to pay $50,000 in compensatory damages, $150,000 in punitive damages, more than $22,305 in back wages and interest and reasonable attorney’s fees.
Any of the parties in this case can file an appeal with the department’s Office of Administrative Law Judges.

OSHA enforces the whistleblower provisions of the FRSA and 21 other statutes protecting employees who report violations of various airline, commercial motor carrier, consumer product, environmental, financial reform, food safety, health care reform, nuclear, pipeline, worker safety, public transportation agency, railroad, maritime and securities laws.

Employers are prohibited from retaliating against employees who raise various protected concerns or provide protected information to the employer or to the government. Employees who believe that they have been retaliated against for engaging in protected conduct may file a complaint with the secretary of labor to request an investigation by OSHA’s Whistleblower Protection Program. Detailed information on employee whistleblower rights, including fact sheets, is available at http://www.whistleblowers.gov.

Under the Occupational Safety and Health Act of 1970, employers are responsible for providing safe and healthful workplaces for their employees. OSHA’s role is to ensure these conditions for America’s working men and women by setting and enforcing standards, and providing training, education and assistance. For more information, visit http://www.osha.gov.

Whistleblower Case: First Federal Supreme Court Broad Reaching

Robert MacLean, a former air marshal, was fired because of his federal whistleblower actions. (Courtesy of House Committee on Oversight and Government Reform)

Robert MacLean didn’t realize that by trying to protect America’s flying public, his employer — his government — would treat him almost like a traitor.

Soon, the Supreme Court will have a chance to decide if MacLean, a whistleblower and former air marshal, was treated justly, or at least legally. It is the first case the high court will hear directly concerning a federal whistleblower.

The implications of the case go well beyond MacLean. If he loses, Uncle Sam will have greater power to bully whistleblowers. Fewer federal employees might be willing to disclose waste, fraud, abuse and dumb decisions.

Oral arguments are scheduled for Nov. 4. The Obama administration is appealing a lower court decision that MacLean’s disclosures were covered by the Whistleblower Protection Act. If the justices rule against MacLean, federal agencies could have broad power to weaken that law by using the government’s power to make secret more information than Congress intended.

Here is MacLean’s story:
In July 2003, air marshals, including MacLean, were summoned for mandatory training to prevent suicidal airline hijacking plots by al-Qaeda. Days later, the Transportation Security Administration sent an unsecured, unclassified text message to air marshals informing them that all long-distance assignments requiring an overnight stay would be canceled.

Knowing that could hamper efforts to thwart hijackers, MacLean said he complained about this shortsighted, money-saving plan to an agency supervisor and to the Department of Homeland Security’s inspector general’s office. MacLean also leaked information to MSNBC, which he admitted to during a leak investigation two years later. He was placed on administrative leave in September 2005 and fired in April 2006.

This is the incredible part: It wasn’t until August 2006 that the government retroactively labeled as sensitive the information MacLean was fired for leaking — three years after the text message was sent.

The question before the court: Was MacLean’s disclosure “specifically prohibited by law?”

DHS and the Justice Department say it was
.
But noteworthy to MacLean’s defense is thata key bipartisan group of members of Congress say his disclosures are, or at least should have been, protected from agency reprisal by the whistleblower law.

They should know
.
The administration argues that “by law” includes statutes and “substantive regulations that have the force and effect of law.”

The lower court’s decision “is wrong, dangerous, and warrants reversal,” say the government’s lawyers. The earlier ruling “imperils public safety,” they added, “by dramatically reducing the effectiveness of Congress’s scheme for keeping sensitive security information from falling into the wrong hands.”

But members of Congress who were instrumental in passing the legislation say that’s not so. In fact, “Congress deliberately crafted” legislation “to exclude agency rules and regulations,” says a brief filed by Sens. Charles E. Grassley (R-Iowa), Ron Wyden (D-Ore.), Reps. Darrell Issa (R-Calif.), Elijah E. Cummings (D-Md.), Blake Farenthold (R-Tex.) and Stephen F. Lynch (D-Mass).

“If agencies could decide which disclosures receive whistleblower protections, they would inevitably abuse that power,” the members said. “The result would be to deter whistleblowers and restrict the flow of information to Congress.”

Sadly, the message here is that agency officials can’t always be trusted to do the right thing. When employees expose bad policies, too often the reaction of their bosses is to cover managerial behinds. Whistleblowers should be congratulated, praised for serving the public. Instead, many are harassed, punished and pushed from government service.

“After all,” said a brief filed by the U.S. Office of Special Counsel, “whistleblower protection laws exist because government officials do not always act in the nation’s best interests.”

Agencies can be creative in their reprisals, even belatedly declaring information sensitive, as TSA did, in order to better take revenge against whistleblowers.

“[I]n fear that such retroactive designations are possible, whistleblowers may refrain from alerting the public to dangers that could have been averted or mitigated,” said the brief by OSC, which works to protect whistleblowers. This is the first Supreme Court friend-of-the-court brief filed by OSC.

This wariness of the way agency managers treat whistleblowers is shared by the Republicans and Democrats who filed the congressional brief.

“Time and time again,” they said, “agencies have found ways to suppress inconvenient information.” An administration victory over MacLean, the elected officials warned, “will deter untold numbers of whistleblowers.”

If that happens, it’s not only MacLean who will lose. The American people will, too.

By Joe Davidson October 9, 2014