Medical Device Daily Washington Editor
WASHINGTON – The legal process known as discovery offers defendants many tripwires where internal communication is concerned, not just because of the Thompson and McNulty memos released over the past decade by the Department of Justice. One of the executive sessions held on the first day of AdvaMed 2009, sponsored by the Advanced Medical Technology Association (AdvaMed; Washington), dealt with the topic of internal communications, and the underlying message was "think before you press the 'send' button."
Nancy Singer, President of Compliance Alliance (Arlington, Virginia), is a former prosecutor with the Department of Justice who worked on a number of cases for FDA. She offered a little employment humor to start the session. "If you don't win 98% of your cases [as a DoJ prosecutor], you're fired," she wisecracked.
Singer remarked on some of the more commonplace perceptions of attorneys, noting that an attorney "is not allowed to tell a lie," but she acknowledged attorneys are sometimes inclined to "present the facts [so as] to support the client's story." This comes as no surprise to fans of legal dramas on television, but hard evidence is nonetheless the primary driver of legal outcomes.
Defense attorneys have a problem with some clients in that those clients have often inadvertently generated and saved the most problematic evidence against them, namely e-mails and other forms of documentation. "Documents are like diamonds," Singer observed. "They are precious and they last forever."
These documents don't have to address egregious ethical violations in order to create headaches. Documents spell out a company's standard operating procedures and woe to the firm that does not hew to it's own SOPs. As many device makers know, those who fail to follow their SOPs often get hung out to dry in warning letters. Singer reminded attendees that if a failure to observe SOPs comes to light in a patient's lawsuit, the damage can be far greater than that imposed by a letter from FDA.
Management's responsibility for all this is difficult to overstate, Singer noted. "For FDA it's the buck stops here," she said, using the example of Jack Welch, the former CEO of General Electric (GE; Fairfield, Connecticut). She reminded attendees that GE earned a warning letter for lack of a quality system in connection with its acquisition of Marquette Medical (Milwaukee, Wisconsin) in 1998. She said GE had not had time to rewire the firm's compliance systems between the acquisition and the inspection, but that was no matter where FDA is concerned. The irony was not lost on the media, either, she indicated.
"The lay press and the trade press picked it up because Welch was the guru of quality management," Singer said, adding that the press covered the story exhaustively.
Singer posed the question of whether a lawyer would be more peeved by the failure of a client or employer to follow its SOPs, or by a failure to have a procedure covering a function required by regulations. She said that one could make the argument that the answer is a lack of a procedure required by regulations in that it suggests a disregard for regulations, but concluded that most legal counsel would be more frustrated by deviations from existing SOPs. This more effectively conveys that a firm is "not taking the government seriously and you're going through the motions," she said.
On the flip side of the documentation coin, the absence of a document can be damning as well when it comes to the details of good manufacturing practices. "From FDA's perspective ... if you didn't document it, it didn't happen," Singer shrugged.
Singer spent little time dealing with state liability law, but reminded that "product liability is very expensive" because a sympathetic jury gives large awards, another reason to carefully dot and cross the appropriate members of the alphabet.
There is no need to spell out the acronym "CYA" to corporate America, so Singer didn't. She did say, however, that CYA memos typically exacerbate the very headache they are intended to cure because they point directly and loudly to the problem. The process of discovery requires that everything be forwarded to the adversary, so any time the boss writes a CYA memo, "the plaintiff's lawyer is going to see it," she said.
Internal documents of all sorts can create headaches not just because of what they say, but also because of who said it. "It's important to distinguish facts from opinions," Singer observed, and industry ought to emphasize to employees that they should "write facts in e-mails, not opinions" to avoid liability.
Telling a jury that the e-mail contained an overstatement that was intended to highlight a perceived problem usually does not work. "'I didn't mean it' is not a very persuasive defense," Singer said in reference to courtroom denials of such dramatic statements.
Singer also recommended that industry bear in mind that there is a difference between an expert opinion and the opinion of a layperson regarding whether an adverse event qualifies as a medical device report (MDR). She said that in the case of a disagreement over whether an adverse event qualifies, the two non-experts would do well to shelve their differences and consult a medical expert. If "you have a medical officer making that decision," you're on solid ground because "FDA has a tremendous amount of respect for doctors."
Even something as seemingly harmless as an e-mail to one's spouse or significant other that the "company's stock is doing great," could boomerang if your mother-in-law holds shares of your employer's stock. Such a communication may be construed as insider trading, Singer said.
Singer recommended that firms go through these issues with employees regularly, and such sessions might even use samples of e-mails and other documents – submitted anonymously of course – for an exercise as to why something is potentially problematic. She also offered some words of wisdom even when an important regulatory matter is not under consideration. "I should never send an e-mail when angry" and "I should pause before I hit the send button," she said.
Mark McCarty, 703-268-5690