Friday, June 24, 2016

The Road to Hell?

I believe it was Stephen King who once said: “The road to hell is paved with adverbs.” In legal writing, the same can be said for adjectives. I—like every other legal writing “expert” I know—caution against the use of adjectives and adverbs. The most effective legal writers don’t tell the reader: “This was a terrible accident”; they show the reader what made the accident terrible (The investigating officer described the accident as “the worse [he’d] seen in [his] 15 years of accident investigation.”). 

Paul Clement
But Paul Clement, former Solicitor General, one of the nation’s best Supreme Court advocates, and an excellent writer, uses adjectives and adverbs effectively for emphasis. Take the following from his brief on behalf of Allergan in Allergan v. United States, an important First Amendment case involving a dispute over drug companies’ ability to speak to physicians about off-label uses of their drugs:

When the Government starts picking favored speakers, First Amendment values are in grave danger.

The inclusion of the modifier “grave” takes the sentence up a notch—First Amendment free speech rights aren’t just in danger (which is bad enough)—they’re in grave danger (even worse!).

Clement uses other descriptors strategically throughout the Allergan brief with similar results:

“It is perfectly lawful for physicians to prescribe Botox® for [spasticity] and other off-label uses.”

The Government opens its brief by ominously warning that Allergan has launched a “sweeping assault” on the framework for new drug approval that the Kefauver-Harris Amendments to the FDCA established in 1962.

The Government also has studiously avoided taking a litigation position here that might bind either FDA or DOJ in the future. The Government never squarely states an official position that FDA’s regulations do not prohibit non-promotional speech...

The overbreadth problem posed by the Government’s expansive conception of “promotional” speech is particularly problematic because it infringes upon fully-protected speech.

First, the FDCA’s “new drug” and misbranding rules trigger First Amendment scrutiny because they are irretrievably content-based....

The Government has not come close to proving that FDA’s blanket suppression of off-label speech survives First Amendment scrutiny.

FDA’s indiscriminate prohibitions of off-label speech manifestly fail this test.

There is “no hint,” however, “that the Government even considered these or any other alternatives” before enacting its draconian regulations suppressing virtually all off-label speech.

It is thus not clear whether FDA ever had a coherent reason for suppressing virtually all off-label speech, or if this approach was less a conscious choice than an inadvertent byproduct of regulations aimed at mitigating other harms.

This is why FDA’s approval process is extremely rigorous.

The staggering breadth of the “intended use” regulations is also irrational in light of the legal and practical reality that off-label use is lawful and often necessary to appropriate patient care.

FDA has nonetheless chosen the route of censorship, completely prohibiting all forms of off-label advertisement, even where the advertised use is medically accepted and the advertisement is truthful and directed at physicians rather than consumers.

Clement is a master of this technique, employing it selectively and strategically for his most important points. If you’re interested in testing it out, follow that lead.

While the road to hell may be paved with adverbs (and adjectives), as Clement demonstrates, the road to a good brief may be paved with a few of them as well! 

Happy Friday!

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