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.