On March 4, 2009, the Supreme Court of the United States (SCOTUS, to those “in the know” and Tom Clancy fans) issued a landmark ruling in Wyeth v. Levine. The issue was “Preemption,” the doctrine that (according to Wyeth) mandates that when the federal government (acting through that bastion of patient safety, the Food & Drug Administration) says a product is safe, mere mortals in the state courts are powerless to say otherwise. Drug companies, and many other industries regulated by the federal government, have been asserting the preemption defense for years. The Bush Administration loved preemption, and its lawyers were cheerleaders (and often brief-writers) in support of big industry against individuals maimed by dangerous products.
In a 6-3 decision that pleasantly stunned many of us who represent victims, SCOTUS held that FDA approval of a product’s labeling did not preempt a “failure to warn” claim against Wyeth regarding its anti-nausea drug Phenergan (“Promethazine” to those in the generic world). You could hear the consumer advocates and trial lawyers shout and holler praise at this decision. We finally won one before SCOTUS! Even Clarence Thomas voted for us!
Those of us in Texas, however, could only manage a muted “Hip Hip” but not a “Hooray,” for this decision did nothing to undo a nasty bit of legislation, passed by the Tort Reformers of the Texas Legislature in 2003 (“TROTSK3” to those reading this blog), that enshrined in Texas statutory law the very idea of FDA preemption that SCOTUS just rejected. Section 82.007 of the Civil Practice & Remedies Code (“CPRC” to those in the law biz) creates a “rebuttable presumption” that any warning blessed by the FDA is adequate under Texas law and cannot be the subject of a lawsuit based upon the manufacturer failing to warn a health care provider (doctor or nurse) or a consumer of a danger inherent in the drug. The full text of the section is reprinted below. The CRPC, by the way, is the place where Texas lawmakers write laws that affect lawsuits. In other words, it is a breeding ground for mischief by those folks who have the money to get (I did not say buy) the votes in Austin to advance their political-economic interests. Yes, I’m talking about TROTSK3s. Read the whole CPRC and you will need a large dose of Phenergan.
But, with apologies to the late, great Paul Harvey, we should review the rest of the story.
Wyeth, a big pharmaceutical company that has recently been acquired by Pfizer (the Viagra® folks), manufactured, marketed and sold Phenergan. Many of us have taken Phenergan, and it has probably helped a few of us overcome that sickening feeling we get from anesthesia, a bout of the flu, or reading stock quotes. Phenergan can be administered in a number of ways, including by injection, pill or suppository. When injected, it is commonly injected into an IV line in a manner where it mixes with the saline solution that constantly flows into the vein. The patient receives all the medication, but not in a concentrated dose.
Ms. Levine, who suffered from migraines that often are accompanied by nausea, was treated with Phenergan injected by “IV push,” which means she was given a big shot of Phenergan through her IV line. Phenergan, like many other drugs, can cause a reaction when it is injected directly into a vein, particularly if it is injected too quickly. Another risk of IV push administration is that the nurse will miss the vein and hit an artery, which is even more dangerous. This is what happened to Ms. Levine. She suffered a severe reaction to the Phenergan, developed gangrene and had her forearm amputated. She sued Wyeth in Vermont state court. Wyeth claimed a “preemption” defense, and neither the jury, the trial court, nor the Vermont Supreme Court agreed Wyeth should get away with failing to properly warn health care providers of the dangers of IV-push administration of Phenergan.
Wyeth appealed to SCOTUS, and a great deal of money (not just in this case) was riding on the expectation that the August Justices on SCOTUS would toss Ms. Levine and her case out on preemption grounds. SCOTUS had recently decided a different preemption case in favor of a medical device manufacturer. One can just imagine the cases of champagne chilled and ready to serve at Wyeth – or shall I say Pfizer – headquarters.
When the decision in favor of Ms. Levine was announced, the legal world stopped rotating on its axis (I did not say “of evil”). This was the equivalent of Casey hitting the home run instead of striking out. There was a brief moment of silence and then a huge upwelling of cheers from the American Association for Justice (www.justice.org), and other pro-consumer and victims’ rights organizations. At the same time, Forbes, the Wall Street Journal and other folks who only like lawyers when they need one (and when they need one, they don’t want any silly little laws interfering with their right to hire counsel), began wringing their hands. As if there were not enough other issues in the world for them to wring their hands over.
Truthfully, CPRC §82.007 might not have prevented Ms. Levine from winning a lawsuit in Texas. Her lawyers may have been able to overcome the rebuttable presumption by showing that Wyeth hid evidence or misrepresented the results of its research to the FDA. Drug companies are legendary for their secrecy and the extreme measures they take to lock down their research. One of their big, nasty secrets – that they have had numerous doctors on their payroll for promoting their drugs and doing “unbiased research” into the effects of their products – is presently being unraveled. Perhaps Ms. Levine’s lawyers were good enough to dig behind the veil of secrecy and uncover some gem of hidden evidence or misrepresentation and show that the FDA’s approval was based upon “lies, damn lies and statistics.”
From where I sit, Ms. Levine was a very unfortunate woman. She has migraine headaches, an unfortunate condition that is difficult to treat. She needed medicine, and she unfortunately received Phenergan. Her nurse injected the Phenergan into her IV line, and instead of allowing it to mix with the saline solution, she unfortunately used the “IV push” method. Ms. Levine suffered an unfortunate reaction that led to gangrene and the tragically unfortunate amputation of her forearm.
About the only thing that happened to Ms. Levine that was not unfortunate is that she did not live in Texas.
Steve Waldman – swaldman@gwlawyers.com
CPRC § 82.007. Medicines
(a) In a products liability action alleging that an injury was caused by a failure to provide adequate warnings or information with regard to a pharmaceutical product, there is a rebuttable presumption that the defendant or defendants, including a health care provider, manufacturer, distributor, and prescriber, are not liable with respect to the allegations involving failure to provide adequate warnings or information if:
(1) the warnings or information that accompanied the product in its distribution were those approved by the United States Food and Drug Administration for a product approved under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), as amended, or Section 351, Public Health Service Act (42 U.S.C. Section 262), as amended; or
(2) the warnings provided were those stated in monographs developed by the United States Food and Drug Administration for pharmaceutical products that may be distributed without an approved new drug application.
(b) The claimant may rebut the presumption in Subsection (a) as to each defendant by establishing that:
(1) the defendant, before or after pre-market approval or licensing of the product, withheld from or misrepresented to the United States Food and Drug Administration required information that was material and relevant to the performance of the product and was causally related to the claimant’s injury;
(2) the pharmaceutical product was sold or prescribed in the United States by the defendant after the effective date of an order of the United States Food and Drug Administration to remove the product from the market or to withdraw its approval of the product;
(3) (A) the defendant recommended, promoted, or advertised the pharmaceutical product for an indication not approved by the United States Food and Drug Administration;
(B) the product was used as recommended, promoted, or advertised; and
(C) the claimant’s injury was causally related to the recommended, promoted, or advertised use of the product;
(4) (A) the defendant prescribed the pharmaceutical product for an indication not approved by the United States Food and Drug Administration;
(B) the product was used as prescribed; and
(C) the claimant’s injury was causally related to the prescribed use of the product; or
(5) the defendant, before or after pre-market approval or licensing of the product, engaged in conduct that would constitute a violation of 18 U.S.C. Section 201 and that conduct caused the warnings or instructions approved for the product by the United States Food and Drug Administration to be inadequate.
