The “Wyeth discount”: More Preemption Horror in the Offing?

Wyeth v. Levine, No. 06-1249, has been on the U.S. Supreme Court’s docket for a very long time. It took nearly a year for the Court to decide it would take the case. At issue is the Bush administration’s extensive and largely successful efforts to accomplish by bureaucratic fiat what it couldn’t do via the standard legislation route–tort “reform.” Wyeth is back in the news because of SCOTUS’s recent order setting the case for oral argument on November 3, 2008.

I’ve discussed and ranted about the Supremacy Clause and the effects of federal preemption on the availability of state law tort remedies here, here, here and here, among other places. Wyeth probably has more destructive potential than all the cases mentioned in those other entries combined.

Diana Levine received injections of Phenergan, a product of major pharmaceutical manufacturer Wyeth, to treat severe nausea resulting from a migraine headache. The last injection, delivered by a method called an “IV push,” was inadvertently pumped into an artery, a big fat no-no with Phenergan. The resulting gangrene led to the amputation of Levine’s hand and forearm.

Ms. Levine filed suit against the health care center that administered the injections. After that claim settled, she filed a product liability lawsuit in a Vermont state court against Wyeth. The case centered on the adequacy of the warnings Wyeth provided on Phenergan’s label. Levine’s experts said that the warnings should have prohibited IV push use of the drug entirely and mandated use of safer options such as intramuscluar injection or administration via hanging IV bag. Wyeth’s experts said that the existing label, which allowed use of the IV push while warning against accidental arterial injection, was perfectly adequate.

A jury found in Levine’s favor and awarded $7.4 million in compensatory damages ($2.4 million in economic damages, $5 million in noneconomic damages). After adjusting the verdict upward to reflect prejudgment interest and downward to reflect Levine’s settlement with the health care center, the trial court entered judgment for $6,744,000.

Wyeth argued to the trial judge both before and after the verdict that the case should be dismissed outright on federal preemption grounds. Pursuant to the federal Food, Drug and Cosmetics Act (“FDCA”) and implementing regulations adopted by the federal Food and Drug Administration (“FDA”), the FDA approved the existing Phenergan label and declined to approve a more extensive warning label that the company proposed later on. The FDA’s approval of the label, Wyeth claimed, precludes any state law tort claim based on allegedly inadequate warnings.

The trial judge rejected the argument twice, and the Vermont Supreme Court affirmed on October 27, 2006. Levine v. Wyeth. It took quite some time, but SCOTUS finally decided to hear Wyeth’s appeal on January 18, 2008.

Broadly speaking, there are three ways that federal law can trump (preempt) state law. One way is express preemption, in which Congress comes right out and says that a particular federal statute preempts state law. The recently decided Riegel v. Medtronic, Inc., 552 U.S. ____ (2008 ) was such a case. The problem in express preemption cases generally boils down to figuring out what in the goat-blowing hell Congress was babbling about when it passed that horrifically ambiguous preemption clause.

The second type of preemption is “field preemption.” No, that has nothing to do with farming or the Chevy Camaro, which Camaro owners view as a badass muscle car but all right-thinking people view as a “field car.” Field preemption occurs where a federal statutory or regulatory scheme is so broad and pervasive as to support an inference that Congress intended to occupy the entire field and leave the states no room to regulate on the subject at issue, or where the subject of federal legislation is so dominantly a matter of federal concern that Congressional action is presumed to displace state law. Field preemption finds no support whatsoever in the text or history of the Supremacy Clause, so the decisions applying the doctrine tend to be quite clusterfuckish.

Finally we have conflict preemption. The FDCA contains no express preemption provision, and Wyeth stipulated that the federal statute wasn’t intended to “occupy the field” of drug regulation. The dispute in Wyeth was over the applicability of conflict preemption.

As the name implies, conflict preemption involves determining whether there is an actual conflict between federal and state law. A tort defendant can get off the hook by showing that either (1) it’s impossible to comply with both the federal and state regulations, or (2) the state common law tort at issue stands in the way of accomplishing Congress’ full purposes and objectives. Wyeth claimed that both tests mandated a finding of conflict preemption in this case.

The Vermont Supreme Court disagreed, relying in large part on the FDA regulation codified at 21 C.F.R. § 314.70(c)(6), which generally allows drug manufacturers to change a drug’s label without going through the usual FDA approval process if the manufacturer determines that existing warnings are inadequate to protect the public, despite FDA approval of the existing warnings. The Vermont court sided with the “nearly unanimous” view of other courts that, given the leeway allowed by § 314.70(c), state law failure to warn claims are not in “conflict” with federal law. There’s nothing in FDCA or the implementing regulations that renders it impossible to comply with both the FDA approval process and state tort law standards regarding adequacy of product warnings.

Before the Bushits took over the federal government, the FDA always took the position that federal law does not preempt state law failure to warn claims. That changed when the Bushits were unable to get Congress to put an express preemption provision in the FDCA. After that, the FDA changed its tune and issued a statement to the effect that the courts have gotten it all wrong up to now and that the availability of state tort law remedies presents a serious risk to the FDA’s ability to enforce labeling requirements.

The Wall Street Journal‘s writeup on the case is here, and Pharmalot’s latest article is here. SCOTUSblog has links to the many briefs filed in the Supreme Court here.

As expected, there has been a veritable shitload of amicus curiae (“friend of the Court”) briefs filed by people and organizations who aren’t parties to the case but have a substantial interest in the outcome. Supporters of Ms. Levine include forty-seven state attorneys general, the entire editorial board of the New England Journal of Medicine and a bunch of constitutional and administrative law scholars. Wyeth’s supporters feature the usual crop of tort “reform” whores, including the Bushit Justice Department and the U.S. Chamber of Commerce.

The WSJ article linked above quotes one prominent plaintiffs’ lawyer as calling this “back door tort reform.” Well, yes and no. It’s “back door” in the sense that it occurs behind the scenes without the illumination that comes through the standard legislative process, but it’s entirely “front door” in terms of brute effectiveness and Bushit administration strategy.

One thing’s for sure: as the WSJ article rightly notes, drug manufacturers and their allies are giddy with girlish glee over the Supreme Court’s decision to take this case. With a clear majority of the Court in favor of using federal preemption as an instrument of tort “reform,” the odds of a decision that will instantly vaporize a vast number of meritorious tort claims are good.

In the meantime, lawyers trying to settle product liability cases against drug manufacturers now, before such cases join the Choir Invisible, are being met with hardball negotiating tactics:

Some drug companies are telling plaintiffs’ lawyers that if they settle their cases now, they won’t pay as much to the plaintiffs as they would have six months ago, before the Supreme Court announced that it would hear the Wyeth case. A lawyer negotiating a settlement with one drug maker said company executives told him it wants “the Wyeth discount.”

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Hit That Fuckin’ Clown Lawyer Still on the Hook

Hit That Fuckin’ Clown is by far the most popular entry in this blog’s history. There we let you in on the story of Aaron Wider, a man whose love for cussing can’t be suppressed, even during a deposition with a court reporter and videographer present.

When we last visited this story, Judge Eduardo Robreno of the U.S. District Court for the Eastern District of Pennsylvania had sanctioned Mr. Wider and his attorney, Joseph Ziccardi, to the tune of over $29,000. Seems that Mr. Wider used The Fuck Word at least seventy-three times during his discovery deposition in a case pending in Judge Robreno’s court. The judge found defense counsel jointly and severally liable for the sanctions because of his failure to reign in his client and persuade him to answer questions without the pottymouthery.

Soon after the sanctions order came down, Mr. Ziccardi withdrew from case and hired his own attorney in an attempt to get the sanctions order vacated as to him. Those efforts have come to naught with Judge Robreno’s recent opinion and order (pdf, 32 pages) denying Ziccardi’s motion for reconsideration.

Of particular dyspepsia-generating import is the portion of the order under which “the stay of enforcement of the Court’s February 29, 2008 order is LIFTED.” Let the collection proceedings begin!

John McCain: Big Fat Liar

So, it turns out that John “Walnuts” McCain’s heartwarming “cross in the dirt” story from Sunday’s Saddleback Forum was stolen in toto from Solzhenitsyn’s The Gulag Archipelago.

But this is actually old news. Ol’ Walnuts has been riding Solzhenitsyn’s coattails for some time, it seems. McCain recounts the same story in his 2005 book Character is Destiny, which received a less than warm reception from the wingers at Free Republic. One freeper readily spotted and called bullshit on the Solzhenitsyn connection back then.

No wonder McCain is “reluctant” to talk about his Hanoi Hilton experiences. Every time he tries, he ends up lying about it.

Primary Election Today!

Today’s the day we Coloradans go to the polls ( at least those of us who don’t care much for that newfangled early voting) and decide who’s gonna appear on the ballot in November for a variety of state and federal offices. My fellow City and County of Broomfield residents can get all the necessary information here, including sample ballots and voting center locations.

Republicans in this neck of the woods have no contested races at all. We Democrats have just one, the three-way contest among Joan Fitz-Gerald, Jared Polis and Will Shafroth to become the Democratic nominee for U.S. Congressional District 2. The Democratic nominee for that office is the winner come November. No Republican has a chance in CD2.

The three candidates for the CD2 nomination are a veritable embarrassment of riches. I prefer Fitz-Gerald based on her experience as a legislator at the state level and her fervent hatred of all things Republican, but we really can’t go wrong with any of these people.

I suspect Jared Polis will win. He made a mint in internet commerce awhile back and has been spending a sizeable chunk of his personal fortune saturation-bombing the airwaves with teevee ads for the past several months. Neither of the other candidates has been able to get within hollering distance of keeping up.

Update: As predicted, Polis takes it. With 99% of precincts reporting:

Polis – 42%

Fitz-Gerald – 38%

Shafroth – 20%

Comprehensive election results from across the state are available here.

According to the Denver Post, Polis spent “at least $5.3 million” of his own money on the campaign. That, together with the approximately $1 million in contributions raised by each of the three candidates, made this the most expensive primary in the country.

Polis’ opponents in November are Republican Scott Starin and a couple of random hippies from the Green and Unity Parties. If Polis wins — and it would be the mother of all upsets if he didn’t — he’ll be Colorado’s first openly gay member of Congress.

So yes, you can buy an election in this state. However, you have to be a reasonably decent human being, unlike Pete Coors.

Pigs v. People

Cheye Calvo, the mayor of Berwyn Heights, Maryland, came home on July 29 to find a package addressed to his wife sitting on the front porch. Unbeknownst to the mayor, the package contained thirty-two pounds of marijuana. Turns out that various police agencies had tracked the package across the country when a drug sniffing dog in Arizona first noticed it several days earlier. Pigs decided to let the package complete its journey and bust the addressee, who happened to be the mayor’s wife.

Indeed, it was a pig posing as a deliveryman who left the package on the porch to begin with. When he knocked on the door, the mayor’s mother-in-law answered and refused to sign for the package.

Mayor Calvo, having no idea what the package contained, brought it into the house, set it on a table and headed upstairs to change clothes. Within moments a bunch of sociopathic pigs from the Prince George’s County Sheriff’s Department busted down down the door without knocking and entered with guns blazing. As is standard nowadays for pigs conducting drug raids, their first acts upon entering the home were blowing away the mayor’s two pet dogs, black labs, one of which was running away from the pig who shot him.

Bravo, pigs, bravo. It takes takes a rough, tough, big-nutted, monster-cocked, manly MAN to shoot a housepet that’s scared shitless and running away.

Naturally, the official pig party line is that they “felt threatened” by the dogs and were thus obliged to kill them. The sheer number of cops-shoot-dog stories that arise in similar contexts belie that claim completely. You might as well stop telling that lie, pussies. We all know that it’s SPP (standard pig procedure) to shoot any and all dogs you see upon entering a private residence on a drug raid.

And it gets better. They found the mayor upstairs in his underwear and made him back down the steps with this hands on his head to the first floor. There they handcuffed the mayor and his mother-in-law (the mayor’s wife wasn’t home) and forced them to lie on the floor just a few feet away from one of the slaughtered dogs. You stay classy, ya fucking pig pussies.

Law-and-order types are no doubt asking “Is the wife guilty?”, as if committing a drug offense justifies dog butchery and executing warrants without knocking and announcing. The answer, of course, is no. Yesterday the pigs arrested two guys for running an extensive marijuana smuggling operation that involved mailing the product to unsuspecting recipients. Mayor Calvo’s wife, Trinity Tomsic, was a victim.

As if the above weren’t sufficient, the pigs originally lied and claimed that a judge had given them a “no-knock” warrant allowing them to enter the residence without warning. A Maryland state law authorizes judges to issue such warrants if the pigs establish to the judge’s satisfaction a reasonable suspicion that knocking and announcing would endanger the officers’ safety or lead to the destruction of evidence. Turns out that the pigs never even requested a no-knock warrant, much less received one.

The pigs’ new story is that they were justified in breaking in without knocking because the mother-in-law saw them approaching and started screaming. That, say the pigs, justified immediate entry because the occupants could have been gathering weapons and/or destroying evidence. The pigs have absolutely no credibility on any issue in this case, so I’m entirely confident in calling this new “justification” a big fat lie.

Disgustingly enough, state statutes authorizing no-knock warrants are all the rage nowadays thanks to the 2006 U.S. Supreme Court decision Hudson v. Michigan, in which a narrow majority concluded that the exclusionary rule didn’t apply to violations of the common law knock-and-announce rule, which the Court long ago incorporated into Fourth Amendment jurisprudence. Justice Scalia assured us that the harsh sanction of excluding illegally obtained evidence was inappropriate in this context because of the “increasing professionalism of police forces[.]”

Professionalism such as that exhibited by the pigs of the Prince George’s County Sheriff’s Department.

The mayor and his spouse gave a press conference today, and footage is available here. I wish this wouldn’t have happened at all, but perhaps the fact that it happened to prominent white couple will draw some much needed attention to the piggish behavior of the pigs and spur us on to start dismantling the police state in which we’ve acquiesced for so long.

So, then, we need some new rules. I suggest that one of them be no snitching. Rat out your fellow man to the pigs in only the most extreme and emergent circumstances. If the situation isn’t life-and-death now, it certainly will be when the heavily armed sociopaths clothed with the state’s imprimatur show up.

On a related note, do not help the pigs. This applies universally, but especially where the pigs are looking for information on a crime. In this lengthy video a law professor explains the dangers of an “I haven’t done anything wrong and thus have nothing to worry about” mindset.

Further, never under any circumstances assume that a pig will treat you or a loved one any way other than brutally and unlawfully. Such behavior is all too common as is, and will only get worse as more and more law enforcement functions are privatized.

A belated Happy Birthday to SCD

This here blog turned one year old on July 30 and even I didn’t notice.

14,246 views, 396 comments, 307 entries, five blocked coronary arteries, one heart attack and a pacemaker later, and still we’re up and running.

My sincere thanks to everyone who’s stopped by. The door’s always open even when there’s no one home. Please feel free to introduce yourself and leave a comment.

My kinda tort “reform”

Fuck caps on recovery and abolishing joint and several liability. Fuck that shit right in the ear. The Babylonians had tort “reform” figured out in 1760 BCE.

The Code of Hammurabi, Law 215 provides that “[i]f a physician make a large incision with an operating knife and cure it, or if he open a tumor (over the eye) with an operating knife, and saves the eye, he shall receive ten shekels in money.” Be careful though, doc. Law 218 states that “[i]f a physician make a large incision with the operating knife, and kill him, or open a tumor with the operating knife, and cut out the eye, his hands shall be cut off.”

And Babylonian tort reform wasn’t limited to med mal. Those boys had construction defect litigation figured out as well. Laws 229 and 230 provide that a builder gets put to death if he fails to construct a house properly, the house falls, and the homeowner or his son is killed.

So I say let’s shitcan the current civil justice system in its entirety and replace it with a Hammurabian system. That solution has something for everyone. For the tort “reform” crowd, the proposal does away with plaintiffs’ PI lawyers entirely. Folks such as myself will like the fact many private insurance companies would simply dry up and blow away.

Personally, I’m particularly fond of the absolute liability imposed in the med mal rule cited above. You don’t have to prove fault (all you need do is show a particular outcome) and there are no defenses. Booya.

H/T – Walking the Berkshires

More on Riegel and FDA preemption

SCD’s coverage of the major preemption case Riegel v. Medtronic, Inc. is available here. The subject of FDA preemption is nearer and dearer to me than ever these days thanks to my receipt of a Medtronic implanted pacemaker on July 2 (my fiftieth birthday).

NYU lawprof Catherine Sharkey has written an essay on Riegel and its likely effects on the future of preemption law. The essay is available online in two parts here and here.

Recall that we’re talking not about FDA regulations trumping some state administrative agency’s conflicting regs. No sir. We’re talking about FDA regs wiping out state tort law in toto with respect to defective medical devices. That’s created a worst-of-all-worlds scenario in which the FDA provides grossly inadequate safeguards on the front end while at the same goddamn time taking away the innocent victim’s chance at redress on the back end. It’s fast becoming a libertopian/personal responsibility nightmare up in here.

Manufactured Christian free speech lawsuit dismissed

Here we brought you the story of Erica Corder, one of fifteen valedictorians for the Class of 2006 at Lewis Palmer High School near Colorado Springs, Colorado. The school required that valedictorians have their graduation day speeches vetted by school officials in advance. Corder submitted a prepared speech to the school principal in advance of the ceremony and got approval. Trouble is, she gave a substantially different speech at the ceremony itself, waxing starry-eyed about the Lord Jesus Christ and how He could do wonderful things for those assembled as well. Erica got in a bit of trouble over that. Given the state of Establishment Clause jurisprudence, public schools understandably tend to be a little skittish about overt proselytizing at school events.

Erica filed suit in August 2007 in the U.S. District Court for the District of Colorado. The lawsuit was manufactured all the way. Corder’s father was a director of the uberfundamentalist, extreme right wing Christian political action group Focus on the Family. Although daddy denies any knowledge of what his daughter was planning, a more transparent lie is difficult to imagine. As if to emphasize the abject bullshittiness of the cover story, the Corders hired Bullshittin’ Mat Staver of the Christian right “Liberty Counsel” to pursue the case.

(I don’t have anything against manufactured lawsuits per se. I have little doubt that some of the biggest civil rights decisions of all time were dreamed up in a law firm’s conference room. What honks me off here is the outright dissembling.)

On Wednesday, Judge Walker Miller granted the school district’s motion for judgment on the pleadings and tossed the case in toto. The opinion is available here (pdf, 18 pages). The judge meticulously analyzes one by one the five causes of action Staver alleged in his complaint, concluding that each one failed as a matter of law.

The opinion is pretty much self-explanatory and readily comprehensible, so I’ll refrain from a detailed discussion. I only want to highlight a few points that illustrate what dirtball Staver and his cohorts at Liberty Counsel truly are.

The school board moved to dismiss Corder’s claims for declaratory and injunctive relief on mootness grounds. Corder graduated and received her diploma, the argument goes, so there’s no longer a live controversy between the parties. Liberty Counsel responded by claiming that their client was not seeking injunctive relief even thought the Staver-drafted complaint included a demand that the court “issue a permanent injunction” to prevent the school board from enforcing its “unwritten policy” of excising religious statements from student graduation speeches.

Equal Protection Clause claims regularly receive ten or more pages of analysis in cases such as this. The applicable law is complex and the calls can get quite close. Here, the court was able to shitcan the EP claim with near-record brevity:

Defendant argues that Plaintiff’s equal protection claim should be dismissed because she was not treated differently than anyone similarly situated to her; since Plaintiff was the only one who deviated from her rehearsed speech, she cannot show that Defendant treated her differently without a legally justified basis. In response, Plaintiff’s argument is that she did not do anything wrong, she only “rehearsed a speech before Mr. Brewer and then offered a speech referencing Jesus,” which should not be considered a misrepresentation. Response at 18. Plaintiff’s argument is unavailing. Although Plaintiff disagrees that her conduct should be considered “deceitful,” there is no indication that any other student engaged in the same conduct she did and, therefore, she was not treated differently from any similarly situated person. Therefore, this claim also must fail.

My, oh my. Keep pleading those frivolous claims, Mat. Someday you’ll dethrone Roy Pearson as the poster boy for tort “reform.”

In another argument, discussed on Page 11 of the opinion, Liberty Counsel seems to be suggesting that a Colorado state statute trumps federal Free Speech Clause jurisprudence. Dissemblin’ Mat and the other lawyers at Liberty Counsel went to law school, so I assume they were exposed to the Supremacy Clause at some point in their lives. Oh, how soon they forget.

H/T – Religion Clause