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

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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.

Court Holds Defective Sperm Can't Be Basis for Products Liability Suit; I don't see why not

A little over a year ago, I reported that a federal court interpreted New York law to allow a product liability case for the sale of defective sperm. (For more on that story go here and here.) This week, however, the judge dismissed the claim of the child holding 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." The case is called Donovan v. Idant Laboratories and it is available here. For a report on the case go to Law.com.

The case involved claims by a mother and by her child. The mother's claim was dismissed as time barred by the statute of limitations because she had known that the genetic defect in the sperm was the source of the Fragile X genetic defect in her daughter since 1998, long before she filed the complaint.

The child's claim, however is the one that presents the more interesting questions. First, there is the issue of whether sperm should be considered to be a "product" for product liability purposes. The Restatement (third) of Products Liability excludes from its definition of a product human blood, blood products and human tissue. However, New York's statute apparently only mentions blood and blood products. I am not sure that sperm would be considered "tissue" either, but in any case, the court decided to apply New York law so the sperm would be considered a "product."

Even more interesting, it seems to me, is the holding that to recognize the claim would be equivalent to allowing a "wrongful life" claim. The opinion is very short and it does not explain how the case was argued by the plaintiff which makes it difficult to evaluate the court's conclusion, but from what I can see, it seems to me the court is wrong in one significant respect.

Here is what the court says about the subject in its entirety:

"Guided by the principle that “[w]hether it is better never to have been born at all than to have been born with even gross deficiencies is a mystery more properly to be left to the philosophers and the theologians,” Becker v. Schwartz, 46 N.Y.2d 401, 411 (1978), New York courts have held that “a cause of action may not be maintained on behalf of an infant plaintiff based on a claim of wrongful life . . . ,” Sheppard-Mobley v. King, 830 N.E.2d 301, 305 (N.Y. 2005) (quotations omitted). Wrongful life cases pose particularly thorny problems in the damages context: “Simply put, a cause of action brought on behalf of an infant seeking recovery for wrongful life demands a calculation of damages dependant upon a comparison between the Hobson’s choice of life in an impaired state and nonexistence. This comparison the law is not equipped to make.” Becker, 46 N.Y.2d at 412. Regardless of whether a particular cause of action is denominated as one of contract, products liability, or something else, all of the claims on behalf of B.D. suffer from the same defect: the lack of a cognizable injury. See Paretta v. Med. Offices for Human Reprod., 760 N.Y.S.2d 639, 644 (N.Y. Sup. Ct. 2003) (“[R]egardless of the denomination of the nature of their claims, the infants could not recover because ‘it does not appear that [they] suffered any legally cognizable injury’” by being born with illness (quoting Becker, 46 N.Y.2d at 411).). In arguing that the defective semen left B.D. impaired and in need of costly treatment, D.D. is essentially saying that B.D.’s genetic makeup is her injury. The difficulties that B.D. now faces and will face are surely tragic, but New York law, which controls here, states that she “like any other [child], does not have a protected right to be born free of genetic defects.” See id. at 646. To find the contrary would invite litigation for any number of claimed injuries and, even more problematic, require courts to identify certain traits below some arbitrarily established marker of perfection as “injuries.” Accordingly, we conclude that, applying New York law, the causes of action asserted on B.D.’s behalf fail to identify damages different from those for wrongful life."

Here is where I think the court is wrong. What is typically called a "wrongful life" claim is one where the child claims that "life itself" is the injury, or that the conduct of the defendant prevented an action that would have prevented their birth. The comments and citations the court makes reference to in the first paragraph above refer to that type of claim. I know of no court that has recognized a claim argued that way. But there are a number of jurisdictions that have recognized claims for the economic damages caused by pre-natal conduct that results in increased medical costs after birth.

Assume, for example, that a negligent driver causes an injury to a pregnant woman and that the child is later born with a condition that can be scientifically traced back to the impact suffered by the mother in the accident. Based on those facts, the child-plaintiff could establish all the elements of the prima facie case and courts would allow him or her to support the claim. How is the claim in the defective sperm case any different?

As long as the plaintiff can scientifically prove that the birth defect was due to the defect in the sperm, and the sperm is a product sold commercially, why not recognize the claim? Even in cases originally filed as "wrongful life" or "wrongful birth" claims, courts have allowed recovery for the costs associated with the child's birth defects.

While denying recovery for general damages for wrongful birth, the Illinois Supreme Court, for example, has allowed recovery for the extraordinary costs of caring for the child during his childhood and just about a year ago, the Illinois Appellate Court held that the parents of a severely disabled child can recover damages for his care after he reaches the age of majority. See here. [UPDATE: that case was later reversed by the Illinois Supreme Court.  See here.]

 I just don't see the claim in the sperm case as a wrongful life claim. The child is not claiming for having lost the chance to avoid being born, but to help cover the costs suffered due to the defect in the defendant's product. The defendant sold a defective product that caused an injury and that injury will cost the plaintiff a lot of money. I don't see why we should not allow the plaintiff to recover the value of that injury.

UPDATE:  Go here to read my second post on this case in which I wonder whether maybe I am wrong about this!

Toyota stops sales of Lexus SUV after negative review in Consumer Reports

Consumer Reports magazine has done something it hadn't done in about 10 years. It rated a car so negatively it actually issued a “Don’t Buy” warning. The car is the 2010 Lexus GX 460 which the magazine found has a trailing throttle problem that could cause it to fishtail, potentially resulting in a rollover or serious accidents for drivers. The warning has led Toyota to halt all sales for the vehicle. For more information go to AboutLawsuits.com.

No insurance coverage for tiger attack

Tomorrow we will start to discuss strict liability. One of the first things we will learn is that strict liability is a theory of liability that applies only in certain types of cases, including cases where the injuries are caused by wild animals. Today, Law.com is reporting on such a case (here). The case itself is nothing out of the ordinary in terms of doctrine, but I thought the timing was so eerie that I would post about it -- if nothing else to be able to tell my students that these thing really do happen in real life. In this case, a 17-year-old high school student wanted to have her "senior picture" taken with a tiger at a farm that was licensed to rescue and shelter exotic animals, including tigers, bears, lions, cougars, monkeys and alligators. The farm had made its animals available for photos in the past. Unfortunately, the 700-pound Siberian tiger attacked the girl and she later died from her injuries. The parents obtained a judgment for wrongful death but the defendant's insurance company denied coverage. It turns out, the defendant's policy was only for "homeowner's insurance" which excluded coverage for business pursuits. For this reason, the court held there was no coverage and the 10th U.S. Circuit Court of Appeals affirmed. The parents still have to right to collect from the defendants themselves but I don't know if the defendants have enough assets to cover the judgment.

Incriminating documents surface regarding Toyota

Toyota’s pattern of dragging its feet over the years on safety issues has drawn recent attention. For example, I previously posted a CNN report on allegations that Toyota has (or had) failed to disclose important documents (see here). Now comes news that documents have been discovered that show Toyota knew of the problems with its cars and purposely delayed a recall. According to a New York Times article new details about the company’s actions — based on government timelines, 70,000 pages of Toyota documents and interviews — show the degree to which the company stalled in fulfilling its recall pledges and treated safety concerns in the United States differently from those in Europe and Canada.

Generic Manufacturer can be liable for inadequate warnings

Last week, a Judge of the US Federal Court for the Central District of California issued an interesting order holding that a generic manufacturer of the antidepressant Prozac could have warned about an increased risk of suicide associated with its prescription medication by changing its labels without approval from the U.S. Food and Drug Administration. The order, Dorsett v Sandoz is available here. The decision echoes similar rulings in the 5th, 4th and 8th circuits, but the it creates a split among district courts in the 9th Circuit. For more on this story go here.

Three Reasons Why Every Tea-Partier Should Oppose Tort Reform

The Tort Deform blog has a short comment called "Three Reasons Why Every Tea-Partier Should Oppose Tort Reform" here. The three reasons are: (1) Tort reform takes power from the people and gives it to politicians, (2) Tort reform will increase the cost of the healthcare reform and (3) Tort reform makes it harder to hold the government accountable. Go read the rest of the comment for the complete explanation.

Commentary on tort reform

The blog "Tort Burger" posted two posts today with links to articles on tort reform. The first one is an article in the Detroit Free Press by Jim Marcinkowski titled “Tort Reform Made Simple” that Tort Burger states "does a good job of breaking down the workings of the legal system and what it is that tort reform seeks to do. Marcinkowski explains the concept of tort law and the reform movement as follows: 1. Accident happens; 2. Injury does not go away; 3. The injury costs money (medical, lost wage, etc.); 4. Compensation – either the responsible party pays or the government pays; 5. Tort reform seeks to lower the costs of doing business by shifting the burden of these costs on to the public. He summarizes the analysis by making the statement, “Tort reform is.. just another mechanism to increase private profit by socializing any cost or loss.”" The second one is about an editorial in the Oklahoman about a tort reform bill passed last year in Oklahoma.

New York court holds assumption of the risk does not apply against children

Last Tuesday, in a case called Trupia v. Lake George Central School District, New York's highest court refused to recognize the doctrine of primary assumption of risk as a defense against liability for injuries suffered by a 12 year old. The court rejected the attempt of the Lake George Central School District to amend its answer to a negligent supervision suit to assert assumption of risk in a case where a 12-year-old student was injured when he fell while sliding down a bannister, as he had on earlier occasions. According to a report in Law.com, the court wrote that allowing the amendment would edge the state back toward a time when plaintiffs' contributory negligence was widely invoked by defendants to bar liability for injuries. This being so, the court should have abandoned assumption of the risk as a defense entirely as so other jurisdictions have done. But wait! Assumption of the risk had been abandoned in NY. In fact, the state legislature abolished contributory negligence and assumption of risk as absolute defenses and adopted an approach under which awards are apportioned according to the culpable conduct of the parties. However, assumption of risk survived as a bar to recovery for organized sports and recreational activities, such as skiing or horseback riding, where participants freely assume a known risk, negating the duty of defendants to safeguard them. I have criticized that aspect of the application of the assumption of the risk doctrine by NY courts here and here. In Trupia, the court reaffirms its approach to allow assumption of the risk as a defense in certain cases while denying its use to the facts of that specific case.

Toyota is fined $16.4 million for hiding known dangers from US regulators

The U.S. government says Toyota Motor Corp. “knowingly hid a dangerous defect” by trying to cover up the Toyota gas pedal problems that have caused some vehicles to unexpectedly accelerate out-of-control. For this reason, the U.S. Department of Transportation has imposed a civil penalty of $16.4 million. Transportation Secretary Ra LaHood said that “We now have proof that Toyota failed to live up to its legal obligations . . . Worse yet, they knowingly hid a dangerous defect for months from U.S. officials and did not take action to protect millions of drivers and their families. For those reasons, we are seeking the maximum penalty possible under current laws.” For the full story and links to more useful information go here.

FDA proposes new rule on direct to consumer ads

The FDA has proposed a new rule to amend its direct-to-consumer regulations covering broadcast ads and would require info about side effects and contraindications to be presented in a “clear, conspicuous and neutral manner.” Go here for the story. UPDATE 4/13: Mass Tort Defense blog has more on the story here.

Another prescription drug for people who don't need it?

Pharmalot is reporting that AstraZeneca recently received FDA approval to market its Crestor cholesterol fighter as a preventive pill for millions of folks who don’t have high cholesterol. Not surprisingly, this has prompted some to wonder whether this is a good idea. For more on this go to a story in the The New York Times. The skeptics point to concern that cholesterol meds may not be as safe as a preventive drug as previously believed for people who are at low risk of heart attacks or strokes. Others suggest the benefits may not outweigh side effects. Go here for the full story.

Did the FDA ignore risks of CT scans?

Some FDA scientists are indicating that their warnings about the risks of radiation exposure from CT scans were ignored by FDA managers, leading to unnecessary health problems and dangers for patients. For the full story go to Pharmalot and AboutLawsuits.com.

16th Annual DePaul Univ Law School Symposium

Every spring, the law school at De Paul University in Chicago hosts a symposium on issues related to tort law. Go here for more information and a registration form. This year's program will be on April 8 and 9.

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.