Product Liability claims for off label marketing

After agreeing to pay $520 million to settle civil charges for off-label marketing of its Seroquel antipsychotic, AstraZeneca still faces an estimated 26,000 product liability lawsuits brought by individuals who claim that the risk of developing diabetes was hidden from patients and physicians. However, as Ed Silverman reports in Pharmalot, it is unlikely, for now, that AstraZeneca will be motivated to reach a settlement with these plaintiffs. Why? The drugmaker has so far succeeded in fending off the initial rush of challenges, partly by arguing plaintiffs already suffer from health problems that can cause diabetes.

More on "off label marketing"

Here is a link to an editorial in St. Louis Today that argues that off-label marketing should remain illegal.

Thoughts on the "learned intermediary doctrine"

In a comment on whether the ban on "off label marketing should be eliminated (available here), the blog Tort Deform makes the case for abolishing the "learned intermediary doctrine:"

 . . . I would . . . end the learned intermediary doctrine. The learned intermediary doctrine traditionally prevents consumers from suing pharmaceutical companies for failing to warn consumers of the dangers of a prescription drug. Instead, a consumer has to sue the pharmaceutical company for failing to warn doctors of the dangers of a specific drug. Because consumers can’t just buy a prescription drug on their own, they have to get a prescription from a doctor[, the] doctor acts as an intermediary between the consumer and the pharmaceutical company. And it is the doctor’s responsibility to ensure that the patient is a proper candidate for the drug. I believe if we abolished the learned intermediary doctrine, pharmaceuticals would be more forthcoming in their disclosures about specific drugs. Warning consumers about the dangers of a drug is different than warning doctors. Pharmaceutical companies would have to do more to educate the public than release a study in a medical journal, for example. More importantly, abolishing the learned intermediary doctrine would take into account how drugs are actually prescribed. In reality, many patients see a drug on TV and then decide they want that drug. They then get an appointment with their doctor, ask the doctor for a prescription, and the doctor writes the prescription with few if any questions. Instead of acting like a “learned intermediary,” many doctors act like nothing more than a middleman, happy to collect an office visit fee in exchange for a prescription for just about any drug a patient wants. Abolishing the learned intermediary doctrine would force pharmaceuticals to actively attempt to warn consumers about the dangers of specific drugs. This can only improve patient safety. 

 I agree.

This Week's Top Stories

Go here for the list of last week's most interesting Tort Law stories as selected by the TortsProf Blog. In addition, go here and scroll down for my own selection of top news stories.

DOJ continues to fine pharmaceutical companies for "off label marketing"

At the end of last year I predicted that the issue of "off label marketing" would become the "hot" topic in 2010 (here and here). I may turn out to be right. Although issues of "off label marketing" have not generated a lot of attention in terms of product liability litigation, the practice has generated a lot of attention in other ways. This week the Justice Department announced three agreements with pharmaceutical companies to resolve charges the companies with marketing drugs illegally. Ortho-McNeil Pharmaceutical and Ortho-McNeil-Janssen Pharmaceuticals subsidiaries are ponying up $81 million for their illegal marketing of Topamax, an epilepsy drug. Schwarz Pharma will pay $22 million for failing to tell the Centers for Medicare and Medicaid Services that two unapproved drugs didn’t qualify for coverage under federal health care programs. And earlier this week, AstraZeneca agreed to pay $520 million for its illegal off-label promotion of the Seroquel antipsychotic. For more details on these stories go to Pharmalot, Law.com, The Blog of the Legal Times. For more on the story on AstraZeneca go here. UPDATE 5/3/10: for more on the story go to AboutLawsuits.com

New York court adds to the confusion re assumption of the risk

Long time readers of this blog will remember that I have criticized New York courts on more than one occasion for their sloppy analysis when it comes to the concept of assumption of the risk. See here and here. Now comes news of yet another case from New York that adds to the confusion. In a case called Ballou v. Ravena-Coeymans-Selkirk School District (available here), the court held that although a cheerleader assumes some risk when practicing stunts with her squad, her participation in the potentially dangerous activity is not a complete defense by her school district for liability for the serious injuries she suffered and that "[s]chools are required to exercise reasonable care to protect student athletes from unassumed, concealed or unreasonable increased risks." The decision on this case may be irrelevant now that, just a few days ago, NY's highest court held that assumption of the risk was not a valid defense if the plaintiff is a minor. See here. But to the extent that it adds to the debate on the issue of assumption of the risk, it follows the wrong type of analysis I have criticized in the past. What I have argued in the past is that courts in NY use the "primary assumption of the risk" analysis to support the conclusion that a plaintiff is unable to satisfy the prima facie element of duty. This has nothing to do with assumption of the risk, which is a an affirmative defense based on an evaluation of the plaintiff's conduct. Using the phrase "primary assumption of the risk" to refer to cases in which the issue is whether there is a duty is confusing (at least). The Ballou case reported today follows this line of reasoning when it holds, as quoted above, that "[s]chools are required to exercise reasonable care to protect student athletes from unassumed, concealed or unreasonable increased risks." Note what this statement actually says. It says that under the circumstances of the case the plaintiff can support a claim that the defendant has a duty to exercise reasonable care. In other words, once again, the court is using the language of assumption of the risk (supposedly an affirmative defense) to reach a conclusion related to an element of the prima facie case. The issue in the case was whether the defendant had a duty, not whether the plaintiff assumed the risk. Until NY courts gets this distinction straight, they will continue to make the same mistake. For more on the story, go to Law.com.

Pharmaceutical company goes after defeated plaintiff

Back in 2007, 7-year-old Kristen Spears, who suffered from cerebral palsy, was administered a series of therapeutic Botox shots to relax the girl’s clenched limbs. She died. Her mother sued Allergan, the drug's manufacturer arguing that it had concealed information about the dangers of the drug. But a jury in Santa Ana, California, decided last month Allergan wasn’t responsible for the girl’s death in 2007 death. And now Allergan wants to recover $460,000 in legal costs from the mother. Given that the Spears case was the first to come to trial of 15 plaintiff lawsuits accusing Allergan of hiding the dangers of Botox, it is pretty clear the drugmaker is trying to send a message to other plaintiffs to back off. “I’ve been a lawyer for 25 years, and I’ve never seen anything more outrageous than a corporation pursuing this lady for $460,000,” Spears’ attorney, Ray Chester, tells The Orange County Register. “It’s the worst case of corporate bullying I’ve ever seen.” Go to Pharmalot for more on this story.

This Week's Top Stories

Go here for the list of last week's most interesting Tort Law stories as selected by the TortsProf Blog. In addition, go here for my own selection of top news stories.

FDA considers halting Avandia safety study; taking the drug off the market next?

Back in February I reported that an FDA report concluded that diabetes prescription drug Avandia should be withdrawn from the market because it was allegedly causing many users to suffer heart attacks. See here. Since then many other stories, reports and studies have been published and debated. See my posts on this here, here, here, here, here, here, here, here, here, here, here and here. Today, The Wall Street Journal reports that the FDA is considering whether to stop a diabetes drug safety study involving patients taking Avandia due to concerns over heart risks and Pharmalot adds that halting the study could also determine whether the drug stays on the market. For more on the story go to AboutLawsuits.com.

Further thoughts on sperm case

A few days ago, I wrote about Donovan v. Idant Laboratories, in which the court held that genetic defects in sperm from a sperm bank cannot form the basis for a products liability suit because allowing such a claim would be tantamount to recognizing a claim of "wrongful life." I have thought more about the case and I want to clarify my position a bit. There is more to it than I had originally thought.

I now understand the court's position. And I have to concede that there is support for it. At first, I thought that we could analogize the case to one where a fetus suffers an injury because of a product used by the mother during pregnancy. In such a case, the child could recover for his/her injuries after birth, assuming, of course, that the connection can be made between the injury and the product used by the mother. Such a case is not a "wrongful life" case because the child is not claiming that he/she would not have been born had it not been for the product; the child is arguing he/she would have been born without a birth defect. In other words, the use of the product caused the birth defect, not the birth itself. If the mother had not used the product, or if the product had not been defective, the child would have been born healthy.

However, there is an importnat distinction between that type of case and the case of the "defective sperm." Since that sperm contains the genetic material that makes a child who she is, what the use of the defective sperm caused was the birth of that particular child who is now the plaintiff in the case. If the sperm had not been defective, its use would have resulted, not in the birth of the plaintiff without birth defects, but rather, in the birth of a different child.

The point can be even better illustrated if the case had been argued as a negligence claim. Assume that the plaintiff had claimed that the defendant was negligent in not testing or screening the sperm, etc. If the defendant had not been negligent, the defective sperm would not have been provided to the mother. She would have been provided different sperm - with a different genetic code - and the child that would have been born would have been a different child than the one who was, in fact, born. The child who was born - who is now the plaintiff in the case - would not have been born at all.

Looking at it that way, the child's claim does resemble a wrongful life claim.

Having said that, however, what I said about the approach to damages in wrongful birth/life cases still stands. Many jurisdictions reject the general damages claim for wrongful birth/life while recognizing a specific claim for extraordinary medical expenses. In a jurisdiction that has adopted this compromise position, the court could allow recovery for expenses in the sperm case even while rejecting the wrongful life claim.