I was in Dallas over the weekend for a meeting of the American College of Legal Medicine. Despite being in the Lone Star State (stereotypically associated with hot and dry), Dallas received an icy wallop yesterday and just about all flights at DFW Int’l were cancelled. Luckily, I had flown Southwest Airlines, and they operate out of the smaller, older, Love Field. And for some odd reason, Love stayed open. And flights, while delayed, were still coming and going. I didn’t get home til after 0100 today, but I made it, and I didn’t have to sleep in an airport lounge.

In honor of Southwest’s exemplary performance, this post is dedicated. And fittingly, it’s about Southwest.

SWA

When large companies tangle with each other, lawyers inevitably get involved. And things drag out in court. And the lawyers make a lot of money. And it becomes a war-of-attrition, with the larger corporation with the deeper pockets often prevailing it seems.

But it doesn’t have to be this way. And once, it wasn’t.

Prior to 1978, fares in the domestic airline industry were dictated by the Civil Aeronautics Board, under the commerce clause of the U.S. Constitution, which allows the feds to regulate interstate business transactions. And airlines are almost always interstate, right? They fly from City A in State X to City B in State Y, and the feds were well within their right to regulate same.

But what about a really big state, like Texas? Mightn’t an airline have operated wholly within its borders and not have triggered federal oversight?

When Southwest Airlines was formed by Rollin King and Herb Kelleher, they found that loophole. Operating at first entirely within Texas – Dallas, San Antonio, and Houston – they markedly undercut the fares of their competitors, and there wasn’t anything that the feds, or the competitors, could do, since no ‘interstate commerce’ was involved.

This allowed Southwest to get a toehold in the market, so that when airline deregulation finally occurred in 1978, the company was poised to expand well beyond the home state’s borders.

Southwest carved itself a niche, relying on their zany approach to the business. Stewardesses wearing orange hotpants and go-go boots. Low no-frills fares. And fun ad campaigns; since they are based out of Love Field, many of Southwest’s slogans did, and still do, incorporate mild double-entendres with the word ‘love’: “Love Is Our Field.” “Somebody Up There Loves You.” “You’ll Love Our Low Fares.” “All-Day Love” (for multiple daily flights).

But on 22 October 1990, they tried a new slogan minus love: “Just Plane Smart.” And that’s when the lawyers almost got involved, because Stevens Aviation, based in Greenville SC, had been using “Plane Smart” as their slogan well before Southwest decided to appropriate it. And Stevens let Southwest know this.

However, the chairman of Stevens, Kurt Herwald, aware that he was on sound legal footing but dealing with a much larger entity, and wanting to avoid a Pyrrhic victory after years of litigation, and realizing that Southwest was a bit funky anyway, decided to rein in the lawyers. He instead challenged Southwest CEO Kelleher to an arm-wresting match for the rights to “Plane Smart,” with the loser relinquishing the slogan and donating $15,000 to charity.

Needless to say, in typical Southwest style, Kelleher jumped at this opportunity.

The days leading up to the match were a marketer’s dream. Both companies heavily promoted the match. Kelleher rec’d boxes of Wheaties and cans of spinach from supporters. Herwald was mailed at least one bottle of anabolic steroids from Mexico.

On 20 March 1992, at the Sportatrium in Dallas, the men met for the best-of-three showdown. Limos and cheerleaders were there. Satin boxer robes and shorts with logos were everywhere. The theme from ‘Rocky’ was played. Kelleher, at the last minute, claimed to have ‘injured’ his arm and asked for a stand-in: J.R. Jones, the 1986 Texas state arm-wrestling champion. The score quickly became Southwest 1, Stevens 0.

Not to be outdone, for the second round, Herwald pulled a fast one and substituted a last-minute burly replacement against the now-“healed” Kelleher. Score Southwest 1, Stevens 1.

In round three, the only one in which Kelleher and Herwald actually met, after 35 seconds of intense straining, Herwald pinned Kelleher. Stevens Aviation had prevailed and could keep its slogan!

But realizing that the (almost universally) positive publicity was worth a fortune, Herwald said that Southwest could keep the slogan, his way of thanking Southwest for thinking outside the box and saving years and hundreds of thousands of dollars for both companies.

No one remembers the slogan today. But in the three years after the match, the gross income of Stevens Aviation increased four-fold. Southwest estimated that it gained $6M in publicity, with its stock price doubling in less than 18 months. And Ronald McDonald House charities gained $15,000 from the ‘loser.’

Truly a win-win for everyone. Except the lawyers.

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[Copyright 2013 @ The Alienist’s Compendium]

I was once a big fan of generic medications, seeing them as a way by which to contain healthcare costs and loosen the deathgrip that Big Pharma exerted on the American economy and our individual wallets.

Then I worked briefly for a pharmaceutical contract research organization. And I went to law school.

I’m not so sure any longer.

With that in mind, you know it’s going to be a bad day for constitutional scholars when the high court says that its own ruling from only two years prior “makes little sense.” In this instance, SCOTUS was referring to PLIVA v. Mensing and that decision’s deleterious effect on some of those who have been harmed by prescription medications but now are left with few if any avenues for redress.

Two patients, Gladys Mensing and Julie Demahy, each saw their family physician and rec’d a prescription for Reglan, a medication used to treat nausea/ vomiting and other digestive problems. In both cases, local pharmacists substituted the generic version when filliing the prescriptions – dispensing metoclopramide and not branded Reglan. After each woman had taken the Rx as instructed for several years, both developed tardive dyskinesia (TD), an uncommon but serious and usually irreversible neurological condition more often seen in chronic psychiatric patients taking antipsychotic Rx.

The women filed state tort suits, later joined, claiming that the makers of the generic version of their Rx had failed to provide adequate label warning of this risk.

Metoclopramide was first isolated in the 1960s, when the risk of TD was not fully appreciated. Once approved in the U.S., branded Reglan became very popular, though its use was predictably later supplanted in the marketplace by newer agents. In 1982, Reglan went generic.

And there the story might have ended with Reglan eventually fading to obscurity. But it enjoyed a resurgence in use when one of the newer agents that replaced it was unexpectedly yanked from the market. So before long, millions of American were again taking Reglan (from Schwarz Pharma) and metoclopramide (from twenty-three different generic manufacturers).

Once enough Phase IV data suggested a possible problem, in 2004 a research team published a study that noted a definite TD-metoclopramide association, saying in pertinent part: “given [the Rx’s recent surge in usage], the incidence of TD may increase accordingly. Thus, TD risk factors relative to the intended benefit and duration of use should be considered in metoclopramide prescribing.”

And it was not until several years later that this warning was widely circulated in the medical community.

FDA regulations permit manufacturers of branded drugs to update their labels when new data comes to light, without having to petition first for FDA approval of the changes. However, FDA regulations do not allow makers of generic drugs to change labels on their own; those companies must use exactly the same labels that were originally approved for the branded drug when it was first marketed. Only under an FDA directive mandating such a change can the generic manufacturers update their labels.

Given the clinical findings, Reglan labels were accordingly updated by the brand name manufacturer. But the generic labels were not, as no such FDA directive was then issued.

Had Mensing and Demahy taken brand name Reglan, as their doctors prescribed, their injuries would have been potentially actionable under a failure-to-warn theory (depending on the wording of the added cautionary statement).

But the plaintiffs took generics. The generic labels had no mention of TD as a risk at all, because that informaton was not part of the original Reglan package insert. And the generic manufacturers couldn’t have updated their labels absent an FDA directive to do so.

Thus, held SCOTUS, state tort law was preempted in this instance by (very imperfect) federal generic drug regulations, and the lawsuit of Mensing and Demahy could not go forward.

Little consoluation, but the FDA has since ordered all manufacturers of Reglan/ metoclopramide to include a “black box” warning regarding TD on package inserts.

And as a postscript, I don’t know if the plaintiffs’ theory of failure-to-warn might extend to the pharmacists who substituted? I’ve not been able to ascertain if that’s an option or not.

Either way, the plaintiffs may just be SOL.

[Have an idea for a post topic? Want to be considered for a guest-author slot? Or better, perhaps you’d like to become a day-sponsor of this blog, and reach thousands of subscribers and Facebook fans? If so, please contact the Alienist at vadocdoc@outlook.com]

[Copyright 2013 @ The Alienist’s Compendium]