The LA Times ran an article today (Legal fight over drug liability law) on Wyeth v. Levine, the case being heard by the U.S. Supreme Court this fall that could very easily slam the Courthouse doors on consumers who have been injured by drug companies’ failing to warn them of risks from prescription drugs.

There has been extensive reporting about the case, including another article in the LA Times, on September 7, 2008 (Drug makers seek shield from lawsuits)

As we reported recently (PAL joins “friend of the Court” brief in Supreme Court preemption case), Prescription Access Litigation joined a “friend of the Court” (amicus curiae) brief, arguing that the Supreme Court should find in favor of Diana Levine, and hold that state court lawsuits arguing that drug companies failed to warn consumers about prescription drug risks should not be barred on the grounds that the FDA’s authority “preempts” them. To see other posts from this blog on preemption, go here.

The LA Times article starts out by saying it’s going to answer this question:

If you experience a serious reaction that you suspect may be linked to a medication you took, what can you do now, and how would a ruling in favor of the drug companies change that? We asked some consumer healthcare advocates.

After describing how patients and their doctors can file a report to the FDA about a serious reaction that they believe was caused by a prescription drug (at www.fda.gov/medwatch, it begins to describe what’s at stake in the case before the Supreme Court.

But rather than focus on how this would really impact patients, much of the balance of the article focuses on how a change in the law in favor of drug companies would affect lawyers’ willingness to bring cases against them. Of course, whether or not a lawyer would bring such a case determines whether or not the consumer can seek redress for their injuries. But the article places way too much emphasis on this, such as in this section:

Because plaintiffs’ lawyers foot the bills on product-liability cases — working for a slice of the award — they take cases they think they can win.

“If you take the most likely cause of action away, the calculations for the plaintiff’s lawyer become much more dire,” says Gary Marchant, professor of emerging technologies, law and ethics at Arizona State University. “It will change the dynamics of which cases are brought. Only the much stronger, the real sure-win kind of cases will be brought. The iffy ones will become financially unviable.”

Personal-injury lawyers hope the ruling goes toward the plaintiff. “Pharmaceutical drugs right now are probably the hottest area of liability,” Marchant says. The pharmaceutical industry and the Bush administration believe the excess of product liability cases must be reined in, Wolfman says.

While much of this true, it’s not the point. If Wyeth is successful in this case, consumers will have no ability to hold drug companies accountable in court when they are injured by a prescription drug and when the drug company failed to warn them about a risk that was known, but not disclosed. Given how much the FDA has demonstrated its inability and unwillingness to really monitor the activities of the drugs and drug companies they regulate, this should frighten every one who ever puts a pill in their mouth.

In addition to compensating consumers who’ve been injured or even killed by inadequate warnings on drugs, lawsuits against drug companies for “failure to warn” act as a deterrent – the threat of someday being held accountable in court discourages a drug company from keeping a risk secret. The FDA’s powers are limited — yes, it can force a drug off the market, but it can do next to nothing for the people who’ve been injured while the drug was on the market — such as the tens of thousands of people whose heart attacks were caused by Vioxx.

And lawsuits such as these often bring critical and previously hidden information to light. A great article in the Journal of the American Medical Association, The Role of Litigation in Defining Drug Risks, discusses this, and gives examples in which previously unknown information about drugs came to light only as a result of litigation, including cases on the drugs Vioxx, Zyprexa, Paxil, Bextra, Baycol, Rezulin, and others.

In sum, press reports on the Wyeth v. Levine case need to focus on the very serious impacts that a ruling in favor of drug companies would have on patients and consumers. In an environment in which the FDA is reluctant to use its already limited powers to police drug companies and hold them accountable, litigation plays an essential role. If state court lawsuits on failure to warn are preempted by the Supreme Court, the public will suffer, and the public’s confidence in the safety of drugs will suffer as well.

Wyeth v. Levine, a case being heard by the Supreme Court in November, has been in the news a lot lately. The case concerns the injuries suffered by Diana Levine, a professional musician in Vermont who Wyeth [NYSE:WYE] nausea medication called Phenergan in a visit to the emergency room. The drug was given incorrectly, causing her to lose her right arm below the elbow. She sued Wyeth, arguing that Wyeth’s warning in its FDA-approved labelling for the drug was insufficient.

A Vermont state court jury awarded her $6 million, and Wyeth appealed, all the way to the Vermont State Supreme Court, which sided with Levine. Wyeth argued that Levine’s state law personal injury and failure-to-warn claims should be “preempted” by the FDA’s authority to regulate the labels of prescription drugs. Since their argument is based on federal law, on which the U.S. Supreme Court is the ultimate authority, they were able to appeal the decision to the Supreme Court.

We frequently get on our soapbox here at the PAL blog on the topic of preemption – to see our previous posts on this subject, go here.

Earlier this year, the Supreme Court ruled in Riegel v. Medtronic that state law claims concerning medical devices are preempted, by the federal Medical Device Amendments. However, that decision does not mean that the Court will necessarily rule the same way in the Wyeth case, since they concern two different federal laws — and the Medical Device Amendments specifically address preemption, while the Food Drug and Cosmetics Act (FDCA) does not. (PAL joined an amicus brief in that case too, arguing against preemption).

The issue is hardly academic. If Wyeth prevails, injured consumers will be all but precluded from suing drug companies when they are injured by unsafe drugs. The FDA’s authority to approve prescription drugs and their labels will stand as a shield to liability — and therefore to accountability. Given that the drug safety scandals of the past four years have underscored the FDA’s inability and unwillingness to do its job, this should scare the daylights anyone who ever takes a pill. It is part of a larger attack on consumers’ access to the Courts by industries that seek to avoid responsibility when they harm, deceive, injure and even kill consumers through carelessness and greed. Preemption, as some like to say, is the new tort reform.

Prescription Access Litigation has joined an amicus curiae (“friend of the Court”) brief in the case, supporting Diana Levine and arguing against preemption. The brief was written by AARP, and is also joined by the National Women’s Health Network, a member of the PAL coalition.

To read the AARP/PAL/NWHN amicus brief, go here.

And Ed Silverman, of Pharmalot, has helpfully compiled most of the other amicus briefs that have been filed:

“Here are the briefs filed by the 47 state attorneys general; the former FDA commissioners; constitutional scholars; Senior Citizens League; National Conference of State Legislatures; New England Journal of Medicine editors; the California Medical Association; AARP; consumer activists; trial lawyers’ association; members of Congress; various unions; various economists and various tort law professors.

And if this isn’t enough, you can sift through Levine’s brief, an interview with Levine, the Wyeth brief and the brief filed by the US Solicitor General. And if you look here, you can read friend-of-the-court briefs filed earlier by PhRMA, BIO, the General Pharmaceutical Association, the US Chamber of Commerce, the American Enterprise Institute and the Washington Legal Foundation in support of preemption.”

Consumers and third party payors in California who paid for Premarin, used to relieve the symptoms associated with menopause and to prevent osteoporosis in postmenopausal women, may be eligible to receive payments from a $5.2 million settlement fund. For more details, go to premarinclassaction.com

Claims must be filed by October 1, 2007. Objections to the settlement must be filed by August 15, 2007.

Trivia tidbit: Premarin is made from the urine of pregnant horses — Premarin = PREgnant MARes uRINe.

Excerpted from www.premarinclassaction.com/premarin/california.htm

A Proposed Settlement has been reached in a class action, Elizabeth Blevins, et al. v. Wyeth-Ayerst Laboratories, Inc., et al., Case No. 324380, filed in the Superior Court of California, County of San Francisco.

The Superior Court of the State of California for the County of San Francisco entered an Order Granting Preliminary Approval of Settlement, Directing Notice to the Class, and Scheduling Fairness Hearing. The Court has scheduled a Fairness Hearing on final settlement approval on September 10, 2007.

Description of the Lawsuit
Premarin® is a conjugated estrogens product prescribed by doctors to relieve the symptoms associated with menopause and to prevent osteoporosis in postmenopausal women. Plaintiff alleges that the manufactures Wyeth Pharmaceuticals (formerly Wyeth-Ayerst Laboratories, Inc.) and Wyeth (formerly American Home Products Corporation) violated California’s antitrust and unfair competition laws by engaging in anti-competitive and exclusionary conduct that blocked consumer access to Cenestin®, which was an alternative to Premarin®. Plaintiff does not challenge the safety or effectiveness of Premarin®.

The lawsuit claims that the Defendants violated California antitrust, unfair competition, unfair trade practices, and unjust enrichment laws by entering into exclusive rebate contracts with managed care organizations such as HMOs, insurance companies, and pharmacy benefit managers (“Third-Party Payors”). Defendants deny that they committed any violation of law or any wrongdoing or that they have any liability with respect to Plaintiff or the Class. However, the parties have agreed to this Proposed Settlement to avoid the risks and expense of continuing the case.

The Class includes all persons or entities who purchased or reimbursed others for the purchase of Premarin® from March 24, 1999 through April 3, 2007 in California for consumption by themselves, family members or covered individuals, and not for resale.

The Defendants have agreed to pay $5.2 million to settle this case. After deductions of Court-approved costs and expenses, the remaining amount will be divided between consumers and Third-Party Payors in the Class, subject to available funds based on the actual claims received.

“Class Member” Description
The proposed “Class” includes:

All persons or entities who, during the period from March 24, 1999 to April 3, 2007, purchased, paid for, or reimbursed for Premarin® purchased in the State of California for consumption by themselves, family members or covered individuals (including members, beneficiaries, employees and insureds) and who suffered economic loss thereby as a result of allegedly anticompetitive conduct by Defendants.

Excluded from the Class are Defendants and their respective subsidiaries and affiliates, all governmental entities, and all persons or entities that purchased Premarin®: (i) for purposes of resale, or (ii) directly from any of the Defendants. The Class also excludes those Class Members who have properly opted out of the Class.