Dangerous Documents: How Good Writing Can Help Medtech Firms Avoid Painful Litigation

“Let’s meet on Tuesday to destroy the documents.”

That statement may sound suspect, but it could easily be a completely innocent email to an employee referencing a standard, run of the mill practice of getting rid of old memo drafts. However, if a company employee wrote that email with no other context and the company faced litigation years hence, that statement could be used against them effectively.

“Let’s meet on Tuesday to implement our document retention policy and discard draft minutes, memos and other documents that are cluttering up the files.”

That, Nancy Singer told Medical Product Outsourcing, would be the correct way to write the email. Just the facts—but make be sure to include all the facts.

Nancy Singer, J.D., LL.M, founder and president of pharmaceutical and medtech consultancy company Compliance-Alliance LLC, has implemented a program to help companies communicate better and avoid writing “dangerous documents,” as she calls them.

From conception to inventions to manufacture to marketing, every step of medical technology innovation presents its own unique challenges. One of the last steps before a medical device hits the market is for it to gain approval or clearance from the relevant regulatory bodies, which in the United States is the U.S. Food and Drug Administration (FDA). The costly process is of course hoped to result in approval/clearance and then a commercial launch, and a not-approvable letter can be devastating.

The process of gearing up for a device approval has many moving parts. Many documents change hands, and today most of those documents are electronic. Emails between OEMs and their CMOs; emails between the FDA and the OEM; inter-company emails; all of these have the potential to contain “landmines,” words and phrases that, if exposed or taken out of context, could seem unethical. For instance, software giant Microsoft got into a lot of hot water in the late 1990s for bribing companies to damage its competitor, Netscape. “How much do we have to pay you to screw Netscape?” Microsoft CEO Bill Gates wrote in an internal document that was ultimately exposed. These landmines can cause endless legal headaches even if, which was not the case with Gates, the words are written with innocent intent.

“Drug and device companies manufacture inherently risky products,” Singer explained in a 2009 issue of Regulatory Affairs Journal. “They cannot insulate themselves from being sued for products liability. However, if companies implement the six-step program … their employees should be proud to take responsibility for what they write. They will also be accountable for their actual behavior, instead of hypothetical actions that could be inferred from incomplete or cryptically written statements.”

Singer breaks these landmines into five main categories. First is an unrealistic expectation of privacy. No electronic communication is inherently secure, and it should never be assumed to be private. If a company is sued, lawyers have the right to access all “relevant” written communication, and that word is applied broadly.

The second category is including one’s opinion in an email. According to Singer, employees should not send emails detailing their regulatory opinion if they do not have responsibility and authority for the issue. If the employee were subpoenaed, a prosecutor could argue that when the employee wrote the email, he/she had spoken on behalf of the company, and if that employee voiced an inaccurate or ill-informed opinion, that could spell trouble for the company.

The third landmine, surprisingly, is extremely detailed minutes of meetings in which the minutes state who said what. Although this might seem contradictory, such notes could serve as ammunition in a product liability case.

Fourth is the belief that headings such as “confidential” can and will prevent disclosure. On the contrary, this designation does nothing to protect a document from being obtained  by a lawyer during the discovery process in a  law suit.

Finally, companies should, according to Singer, give up the notion that merely documenting a product concern that he/she raised internally in a memo will protect them if a public health issue arises. If an actionable incident occurs, neither the government nor the public will accept the employee’s memo as a sufficient and blameless course of action.

“It’s really about training,” Singer told MPO, explaining how device companies can easily avoid document landmines. “When writing any company document, employees need to look beyond the fact that they are really just employees doing the right thing, and consider how a third party who might be trying to attack them will view their writing. They should consider how something they write could be taken out of context. What I say is write the facts. Don’t embellish. Don’t use unnecessary adjectives or inflammatory words. Understand that you’re operating in a state of control and you’re doing everything right, but you’re also writing a compliance story. You do comply with the law. You do have a quality policy. And you want to tell the whole story.”

A former attorney for the United States Department of Justice, and a former instructor at Catholic University Law School, George Washington University Law School and University of Southern California, Singer is one of the only professionals providing a training service to help medtech companies avoid litigation fodder. Because medtech companies are on the cutting edge of innovation, the field is highly competitive, dynamic—and ripe for attack from third parties both with good intentions (consumer advocates) and less-than-good- intentions (competitors).

“When I teach I always start by saying say congratulations, you’re a device company, you’re protecting public health, you’re very visible and making the world a better place,” Singer said. “Your visibility sells products but you’re under a magnifying glass, and not everyone’s a cheerleader.”

Singer went on to describe the array of entities that could want to use a company’s own words against it. Competitors have an obvious vested interest in a company failing, and could use a company’s responses to an FDA 483 observation or other such public statements to discredit a company. The way a competitor could do that is to use media outlets looking for a negative, expository story as it attracts readers. Drawing from her legal expertise, Singer also explained that if federal prosecutors believe they can make an example out of a company, they will. State prosecutors, too, could go after a fine to fill a budget shortfall. And all of these third parties—outsiders to a company’s operations—can and will use company documents to create their version of a story. That is why it is vital for a company to write its own compliance story, leaving as little room as possible for misunderstanding or manipulation.

Nancy Singer’s career began as an attorney with the United States Department of Justice where, during a three year period, she successfully prosecuted seven firms for violations of various criminal statutes. Subsequently she was a partner at the law firm of Kleinfeld, Kaplan and Becker. Singer received her B.S. from Cornell University, and J.D. and LL.M. degrees from New York University Law School. During her career she was an instructor at Catholic University Law School, George Washington University Law School, University of Southern California, and at compliance symposia at Harvard University. She received Vice President Gore’s Reinventing Government Hammer Award, the FDA Commissioner’s Special Citation, and the Food and Drug Law Institute’ s Distinguished Service and Leadership Award. Singer is a retired Commander in the United States Naval Reserve.