Whistleblower lawsuits in the medtech and pharmaceutical industries are often settled for multiple millions of dollars, but not before they potentially cause harm to patients, caregivers, and quite often, the reputation of manufacturers. How then, can medical device companies better ensure patient safety and avoid costly litigation? Simple communication.

As counter-intuitive as it sounds, manufacturers should strongly encourage their employees to speak up about illicit activity or upon discovering a product could potentially harm a user, or lead to a product recall. One of the best methods to overcome all possible internal concerns and hesitations is through a system that allows employees to report a problem anonymously (e.g., an employee hot line). Institutionalizing employee communication is key to a comprehensive recall readiness plan and also helps create a positive culture that demonstrates a company’s commitment to quality user expectation fulfillment.

U.S. Food and Drug Administration (FDA) regulatory compliance expert Gale Prince contended that whistleblower protections should be an integral part of corporate business ethics and social responsibility policies. “Companies that give employees a safe, anonymous forum to voice concerns or point out potentially dangerous issues opens the lines of communication and could help mitigate any risk to customers or damage to the company’s brand well before the product is in market,” he noted.

To prove his point, Prince cited a “60-Minutes” exposé on a drug company lab worker who warned his supervisor about a steroid pain medication that could possibly cause fungal meningitis. With the warnings ignored, the medication killed 48 Americans and sickened more than 700 others in the worst pharmaceutical mishap in decades. The FDA ultimately shut down the manufacturer’s operation. A company executive receiving such an alarming red flag must fix the problem; failure to do so will only force conscientious employees to disclose their concerns to outside sources like the media or a federal regulatory agency.

Keeping whistleblower communications internal is significantly less damaging for companies than forcing employees to publicly disclose their product safety fears. Last fall, the FDA launched its own whistleblower website to encourage company employees to anonymously alert the agency about product concerns and potential regulatory misconduct inside their respective organizations. The website does not replace the agency’s current MedWatch reporting system, though. MedWatch will continue to collect reports of adverse events, product quality issues, and therapeutic failures from the public.

The FDA inevitably involves itself in all medical device recalls. However, it shouldn’t initiate the corrective action based on an in-house whistleblower lead for several reasons. Perhaps most importantly, FDA-initiated product recalls cause companies to lose control of messaging as well as the type of data revealed. Think about it: Employees who anonymously report alleged misconduct to the FDA must provide a plethora of significant details to help the agency properly assess an allegation. These details might reveal proprietary, unnecessary, or unrelated information that could competitively compromise a company.

Lawsuit-chasing attorneys may also try to court medical device whistleblowers due to the significant monetary rewards offered for medical device fraud reporting.

Fostering Productive Employee Feedback
Companies that want to encourage noncompliance reporting can start by eliminating the overall stigma of workplace informants. The term “whistleblower” itself is often disparaged, conjuring up negative connotations of a disgruntled worker gone rogue.

Incorporating employee feedback as part of a corporate product recall preparedness strategy can address this problem by simply removing “whistleblower” from the corporate lexicon. Include a provision for “product anomaly reporting” or a similarly positive alternative label as part of an early recall readiness plan. Employees will feel more comfortable raising issues if the reporting step is institutionalized.

Training is also essential to ensure that employees’ concerns about product safety are handled properly within a company, according to Prince. “Medical device companies should train employees on what problems to look out for, as well as how to report their concerns privately. Having strong product safety messaging supported by training will provide the mechanism through which everyone feels comfortable in doing the right thing for the company,” he explained.

Prince recommended that companies establish a hotline where employees can file a report without fear of retaliation. This may be a done through a contracted service or employee professional who is trained to gather the appropriate information. It can be executed by phone or electronically, such as a website. Such a vehicle allows anonymous information to be shared with a designated person in the company who “owns” the process and contracts with an outside agency to provide an anonymous 800 number for reporting warnings confidentially. Typical job positions for managing these scenarios could include the chief cultural officer, chief auditing officer, or the head of personnel. 

Employees on a manufacturing line can be the eyes and ears for the executive team, flagging potential issues without fear of retribution, as long as a clear policy is in place. But front-line workers can be intimidated or averse to bypassing their managers for fear of reprisal. It is critical that device manufacturers provide an anonymous reporting mechanism through an online form, phone number, or email so employees can feel confident their identities will be protected.

In the same vein, companies should establish such openness at the executive level by encouraging or incentivizing managers to solicit feedback on problems or irregularities from their direct reports.

It is important to change the corporate culture by providing processes and mechanisms for reporting product problems. It is equally vital that a company’s executive team creates an open culture that puts safety first and encourages speaking up. Employees should be made to understand that reporting a product issue is not about snitching, but rather motivated by a genuine desire to help their company improve and potentially prevent even greater future misfortune. A good business culture policy should clearly convey to all stakeholders the significance of voicing their concerns early, so needed corrections can be implemented to prevent product recalls. 

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Chris Harvey leads a team of recall strategists and works with clients to ensure flawless implementation and customer integration throughout the entire product recall process. He assists in the scoping, plan development, and recall execution for a diverse set of industries, including pharmaceutical, medical device, food and beverage, and consumer products.

Throughout his career, he has managed more than 1,000 recalls, including hundreds of high-profile recalls and withdrawals for the nation’s largest pharmaceutical and CPG companies. With his wide range of experience, Harvey offers Stericycle clients proven and efficient solutions to challenges arising from every aspect of the recall process, from initial planning and preparation to the full-scale execution of a product recall. Additionally, Harvey works with numerous law firms and PR firms across all industries to help their clients mitigate recall related risk. Harvey is recognized as an expert in the recall industry and routinely speaks on best practices for recall planning and execution at trade shows, conventions, and conferences. He is a graduate of Purdue University, where he earned his bachelor’s degree in law and society.