Supreme Court rejects appeal by Pfizer in Alien Tort Statute case

Back in January 2009 I reported that the Court of Appeals for the Second Circuit revived a claim filed under the Alien Torts Statute by Nigerian citizens against Pfizer claiming the company subjected their children to medical experimentation without their consent during a 1996 meningitis outbreak. The opinion is available here. Then in November 2009 I noted that case was appealed to the the US Supreme Court and that the Court asked the Justice Department’s Office of the Solicitor General to file a brief in the case. Today, Pharmalot is reporting that the Supreme Court has rejected an appeal by Pfizer after the US Solicitor General filed a brief arguing the Supreme Court should not bother to hear the case. Go here for the full story.

FDA likely to recall Avandia

It appears increasingly likely that an FDA advisory panel will recommend that an Avandia recall be issued next month, as two new studies provide further evidence that GlaxoSmithKline’s diabetes drug increases the risk of heart attack and life-threatening injuries. More on this story here.

Malpractice claim in case that settled

The Chicago Personal Injury Blog is reporting today on an interesting malpractice case filed by Goodyear and Goodyear Dunlop Tires North America Ltd. against two of its former attorneys. The plaintiffs claim that the attorneys' negligence cost them what they believed would be an easy victory in a product liability case. The original case involved a claim by two plaintiffs who suffered injuries when their motorcycle's tire deflated suddenly causing them to crash. According to the story, Goodyear is claiming that the lawyers failed to demand a jury trial; made errors resulting in the judge striking expert witness testimony; and various errors in their cross-examination. Goodyear claims that they should have easily won the case had it not been for the attorney's conduct. But, here is the interesting part: Goodyear didn't lose the case. It agreed to settle that original case. It does not sound like plaintiffs are arguing negligence in inducing it to settle (which would be difficult to prove, I think, given that Goodyear is a sophisticated business client which, I assume, has its own in-house legal resources). So the question is whether the plaintiffs can support a claim for malpractice which requires them to show they would have won the case. In most jurisdictions it would not be enough to show that they would not have settled, or that they would have settled for better terms. Also, does the fact that they decided to settle become now support for a defense? Didn't their decision to settle contribute to their loss in some way?

Debate as to legislative approach to dog attacks and dog breeds continues

Just a few weeks after the city of Elgin (Illinois) adopted a new law regulating "dangerous dogs," the mayor of the city was attacked by a pair of pitbulls while he was out walking his own dog. Injuries caused by dogs is, of course, an important element in the discussion of common law strict liability and whether dogs (or dog ownership) should be regulated is a hotly debated topic. Here is a link to an editorial (and reader comments) published by the Daily Herald (a newspaper of the northwest suburbs of Chicago) discussing the recently approved law in Elgin.

Glaxo settles claims over birth defects allegedly caused by anti-depressant drug Paxil

Last month, GlaxoSmithKline agreed to pay about $60 million to settle 700 lawsuits alleging its Avandia diabetes pill causes heart attacks and strokes (see here, here and here). Now, Glaxo is settling nearly 200 lawsuits that charged its Paxil antidepressant caused birth defects. GSK has settled every case scheduled for trial in the eight months since a Philadelphia jury awarded $2.5 million to the plaintiffs in the first Paxil test case to go to trial. Go here and here for the full story. UPDATE 6/24: AboutLawsuits has more on the story here.

Ninth Circuit may order new trial vs Chevron for aiding and abetting

Back when I first started this blog in late 2008, there were a number of cases in the news related to the Alien Tort Statute (see here). One that gathered a lot of attention was a case by Nigerian citizens who alleged that oil giant Chevron Corp. cooperated with the Nigerian government in human rights abuses of protesters at the company's off-shore Nigerian facilities. That case ended up with a jury verdict in favor of Chevron. For that story (with links to more information) go here, here and here. Now, almost two years later, Law.com is reporting that a Ninth Circuit Court of Appeals panel seemed to be open to the idea of ordering a new trial for the Nigerian villagers. Go here for the full story.

Pharma admits it made false statements on label

Teva Pharmaceuticals has admitted that it made false statements on the label of Gianvi, a generic clone of Bayer’s Yaz birth control pill. For more on this story go to AboutLawsuits.com.

NJ court holds plaintiff is required to file a "certificate of merit" in order to file a legal malpractice action.... Bad idea

Last week the New Jersey Appellate Division held that a plaintiff in a legal malpractice action is obligated to serve a timely affidavit of merit on attorneys as part of the process in a legal malpractice claim. New Jersey has a statute that requires filing such a certificate in cases against a number of professions but it defines "attorney" as a person licensed to practice law in the state of New Jersey. In this case, at least some of the defendants had provided legal services from offices outside the state and were not admitted in New Jersey. The case is called Lacrosse v. Klehr, Harrison, Harvey, Ranzburg, Ellers, LLP, and is is available here. The court only imposed the requirement prospectively, however, because prior state case law was unsettled and federal decisions on the subject attempting to apply New Jersey law had taken arguably different approaches. My problem with this is not the holding in this case in particular but with the notion that a plaintiff should be required to file a certicate to begin with. The court here was simply deciding whether the terms of a particular statute applied to the facts of the case. I just don't like the statute. I think the requirement of a certifcate of merit is a bad idea for the same reason I think requiring certificates of merit in medical malpractice cases is a bad idea. In fact, I have stated before that if forced to choose between caps for damages and certificates of merit requirements I would have to support caps. Both caps and certificates of merit requirements are popular "tort reform" measures, which, as all such measures, are looking to do one of two things: either to make it more difficult for victims to get compensation (by making it more difficult for them to get to court) or, if they can get compensation, to reduce the amount of money they can recover. Caps on damages are examples of the latter approach to reform; requiring a certificate of merit is an example of the former. It is, admittedly, a close call as to which would be worse for victims, but I am leaning towards saying that the certficate requirements are worse. With the cap, at least the victim does get some compensation and, as long as the cap is generous, many plaintiffs may not be affected. Of course, those who would be affected would be precisely those who need the compensation the most - those who suffer catastrophic injuries - but I as I said, I am being forced to choose between bad choices and with this one at least the victims get a chance to get something. In contrast, the approaches to reform that seek to make it more difficult for victims to find representation, to find expert witnesses willing to certify their claims, and to make it more difficult to file claims to begin with, if successful, leave the victims with no recourse and no recovery at all. Thanks to the Legal Profession Blog for the information. For more on the case go to Law.com.

Consumer product safety commission product liability database

The Consumer Product Safety Commission has established a publicly available, searchable online database containing consumer product safety information. The database is required by Section 212 of the Consumer Product Safety Improvement Act of 2008, which created a new §6A of the Consumer Product Safety Act entitled "Publicly Available Consumer Product Safety Information Database." The database can be accessed already at SaferProducts.gov. For an article (originally published in the New York Law Journal) expressing some concerns over the database go here. It concludes, among other things that the database "is potentially a worthwhile tool, providing both consumers and manufacturers with information that might be valuable. But it also portends significant product liability concerns for companies, including for those that are falsely accused."

Lead paint, market share liability and due process

As you probably know, "market share liability" is a concept created to help a plaintiff establish the element of cause in fact when the plaintiff can't truly identify the specific person or entity who caused the injury. Originally, it was created to allow plaintiffs to recover in cases where the plaintiff joined as defendants the manufacturers of products that were chemically identical. For many years, the concept was used only in cases involving the drug "DES." That changed in Thomas v. Mallett, 701 N.W.2d 523 (Wis. 2005), one of only a couple of cases to recognize liability for injuries related to lead paint. Now, a new decision by the Federal District Court for the Eastern District of Wisconsin challenges the use of the market share liability doctrine in cases other than those for which it was originally created holding that the expansion of state common-law tort liability can be so overreaching and so contrary to settled legal expectations as to violate a defendant's right to due process. See Gibson v. American Cyanamid, Inc., (E.D. Wisc. June 15, 2010) (available here). In other words, Gibson declares unconstitutional the expansion of market share liability to non-fungible products. For a long comment on this case, go here.

Toyota Steering Problems Uncovered in Lawsuit Lead to NHTSA Probe

AboutLawsuits.coom is reporting that a wrongful death lawsuit over a fatal Toyota pick-up truck accident has brought documents to the surface that once again have federal investigators questioning whether Toyota dragged its feet on issuing an earlier recall over steering problems. For the full story and links to more information go here.

This Week's Top Stories

The editors of the TortsProf Blog weekly round-up of top stories are taking a well deserved break for the summer. My own selection of top news stories is available here, though.

"Female Viagra" pill update: FDA says NO

It's a "no go" for the so-called female viagra pill discussed in my previous post (see below this one). Here is the story (edited) as reported in Pharmalot: After weeks of anticipation and debate, an FDA advisory committee decided a Boehringer Ingelhim pill that was tested for treating Hypoactive Sexual Desire Disorder in women was neither safe nor effective. The voting was rather stark - all 11 panelists decided the side effects were unacceptable, and 10 ruled the pill, known as flibanserin, is not effective. The outcome is hardly surprising, given concerns outlined by FDA reviewers in briefing documents that were released prior to the meeting. . . . . . . . .The run up to the meeting was characterized by a full-scale promotional push and heated debate over the validity of using medication to treat HSDD, which some refer to as Female Sexual Dysfunction. Some critics even question the extent to which HSDD has been legitimatized in the Diagnostic and Statistical Manual of Mental Disorders . . . In any event, the FDA panel vote leaves US women without what some like to call a female equivalent to Viagra, at least for now. For the full story (including links to more information), go here.

(In)direct to consumer advertising?

I am sure you have heard of "direct to consumer advertising" -- the marketing of prescription drugs directly to consumers (on TV, radio, printed media and the internet, etc) even though the products can only be obtained by prescription. But how about "indirect advertising"? And how about promotion of a product which has not even been approved by the FDA yet?

Pharmalot is reporting that for the past month, The Discovery Channel has been running on its web site a four-part series called ‘Understanding Female Sexual Desire,’ the sponsor of which just happens to be Boehringer Ingelheim, which is trying to convince the FDA to approve a pill to treat a disorder related to female sexual desire it calls female sexual dysfunction. The program is careful to not mention any drugs or to suggest that the problem should be treated with drugs, particularly since there is no drug approved to treat the condition, but it seems to be designed to suggest that there is a need for such a drug. And since the sponsor of the program happens to be the company trying to get such a drug approved by the FDA.... well, you can draw your own conclusions.

Maybe it is a great company, seeking to help a great deal of women by providing a product that they truly need ... Or maybe not....

There is an ongoing debate as to whether the so-called dysfunction is really a medical condition/disorder or something the pharmaceutical industry came up with in order to convince women to buy a product they don't need.

In fact, there is a new documentary in limited release around the country called Orgasm, Inc. (go here for more information, including screening schedules) that apparently argues that a pharmaceutical company, along with a cadre of other medical companies, are trying to take advantage of women (and potentially endanger their health) in pursuit of billion dollar profits. Here are two trailers for the movie:

 

 


UPDATE: Two days before of the controversial FDA advisory committee meeting to discuss what is now being referred to as the "female Viagra pill", a team of agency reviewers found the Boehringer Ingelheim pill, which was tested to treat Hypoactive Sexual Desire Disorder, failed to meet agreed-upon criteria to establish effectiveness in two company studies. According to Pharmalot, there was no statistically significant improvement on the co-primary endpoint of sexual desire, although the pill did show a statistical difference in generating sexually satisfying experiences when compared to a placebo (read the report here). The FDA meeting is TODAY (Friday June 18). I will continue to update this post with more reports as I see them....

FDA Draft Study Concludes Avandia Side Effects May Have Hurt or Killed 100,000 People

A draft study by an FDA scientist (available here) has linked side effects of Avandia to tens of thousands of heart problems among elderly users, and suggests that more than 100,000 Americans may have suffered heart attacks, strokes or other problems from Avandia since the drug was introduced. Go here for the full story.

Radiation Exposure Concerns Lead To New Industry Standards

AboutLawsuits.com is reporting that radiation therapy equipment manufacturers have launched an initiative to implement new industry-wide safety standards in the face of FDA scrutiny and growing concern over the radiation risks of CT scans and radiation-emitting medical devices. Go here for the full story.

FDA issues warning against Pfizer for failure to report side effects

In response to a six week long audit of Pfizer’s New York headquarters last summer, the FDA has recently issued what has been decribed as a "stinging" 12-page letter scolding Pfizer for failing to meet regulatory deadlines for reporting serious side effects with many of its drugs, including Lipitor, Selzentry, Lyrica, Camptosar and Viagra. Go here for the full story. Go here for a copy of the letter.

Three new TV shows (with trailers)

With the recent demise of the original "Law & Order" and "Raising the Bar," the major networks are apparently feeling the need to introduce new law related shows. Here are the trailers. One is called "Outlaw" about a Supreme Court Justice who decides to retire and go into private practice. Another is called "The Defenders" and is about a pair of criminal defense lawyers. The third one is "Harry's Law" about people brought together by fate to form a law firm. I enjoy watching law related shows and movies and reading "legal thrillers" as much as anyone, but I often wish they were much better than what they usually are. I will give all of these a chance but from what I can see in these trailers at least two of them appear to be based on tired old stereotypes: either every client is innocent (Outlaw) or criminal defense lawyers are sleazy (The Defenders), aside from the fact that apparently all lawyers are young, beautiful, fit, sexy and have lots of sex in the office and law libraries. Outlaw also seems to have the stereotypical "team" of characters (common to so many "heist" type movies): the outlaw, the rebel, the intellectual, the smartass, the computer genius, etc. If they add a demolitions expert maybe they could compete with the A-team. The Defenders looks like it might be more of a comedy "detective" show; more about trying to figure out "who did it" than about legal issues. Harry's Law seems to escape the mold - or at least part of it. This one is produced by David E. Kelley, producer of three relatively successful law related shows. The trailer has some pretty funny lines and Kathy Bates is always entertaining. But, given that I didn't like any of the three previous David E. Kelley shows, I will have to wait and see... But I am getting way ahead of myself. Let's give them all a chance.... Maybe they will last longer than the last few attempts ... Does anybody remember "Shark" or "Eli Stone"?

Will a criminal investigation of the oil spill affect civil cases?

Law.com is reporting that the U.S. Justice Department's decision to open a criminal investigation into the Gulf Coast oil spill is threatening to complicate scores of lawsuits brought by people seeking compensation for the disaster. Read the full story here. I think, though, that what is going to affect the civil claims the most is BP itself. I am very pessimistic about this. I fear BP will find a way to avoid paying compensation for the damages caused. It will claim caps, delay payments or make it difficult for people to access their payments (there are reports of this already) or, when all else fails, file for bankruptcy. I hope I am wrong.

After second try, judge approves 9/11 settlement

Almost three months after sending the lawyers back to the bargaining table because he said that their original $657 million settlement agreement paid too little to injured rescue and cleanup workers, Southern District of New York Judge Alvin K. Hellerstein has given his stamp of approval to a renegotiated settlement of suits filed by 10,000 plaintiffs who suffered respiratory and other illnesses in the wake of the 9/11 terror attacks. The new settlement has a minimum value of $625M with 95% participation by the claimants, and as much as $712.5M if other conditions are met. The original settlement was for $575M to $657M. For more on the story, go here and here.

Congress to investigate Wyeth's alleged illegal promotion of drug to African-Americans

About a week ago, I posted a note (here) about a lawsuit that alleges that Wyeth encouraged its sales force to promote Rapamune to doctors practicing heart, lung, liver, pancreas, and islet cell transplants even though the drug was never approved for patients receiving transplants of these organs. Today, Pharmalot is reporting that the House Committee on Oversight & Government Reform has launched an investigation to determine if Wyeth promoted its kidney transplant drug for unaproved uses and, specifically, targeting African-Americans, even though this is a high-risk patient group. For the full story, go here.

Duty to inform lover's husband of STD?

From a story in Law.com: A man who says he contracted a sexually transmitted disease after his wife had an affair with her allegedly infected psychiatrist can bring a negligence action against the doctor, a state judge has ruled. The man, [...] claimed that Dr. [...] had a duty to warn him that he had herpes simplex before having unprotected sex with Levine's wife. I have no problem imposing liability, but doesn't this sound just a little odd? So the plaintiff is saying that his cheating wife's lover should give him a call before he sleeps with the wife to let him know....? I wonder how that call is going to go... "Hello, Mr. Doe. This is your wife's doctor. I am pretty sure I am going to have sex with her tonight. Just thought I'd let you know... Oh and by the way, I have an STD. Have a good day now....." Also, given the quoted language, I have another question. Suppose the good doctor had used protection. Would that have elimanted the duty to make the call?

NJ Supreme Court recognizes a malpractice claim based on dissatisfaction with a settlement

Last week, the New Jersey Supreme Court allowed a legal malpractice suit to go forward, in a ruling that clarified the circumstances in which clients who become disenchanted with settlements can sue their attorneys for negligence. The case is called Guido v. Duane Morris. Holding that "the existence of a prior settlement is not a bar to the prosecution of a legal malpractice claim" arising from the settlement. The court attempts to resolve the tension between the two leading precedents on the subject: Ziegelheim v. Apollo, 128 N.J. 250 (1992), which allowed a malpractice suit, and Puder v. Buechel, 183 N.J. 428 (2005), which did not. For more on this story go to Law.com.

Preemption debate regarding generic drugs

In what promises to be a very important upcoming case, the U.S. Supreme Court has asked the U.S. Department of Justice to "express the view of the United States" on whether the FDCA preempts failure to warn claims against generic drug manufacturers. The drugmakers claim federal law preempts state lawsuits because otherwise they would be required to write labels that are different from what appears on the label of the brand-name medication. Here is a quick background information to put the issue in its proper context. Federal law or regulations require manufacturers of generic drugs to use exactly the same warnings used by the manufacturers of the original drugs. The original manufacturers, on the other hand, are permitted to update the warnings when newer information becomes available to them that suggests the warning should be improved or strengthened. But generic manufacturers can't do this; they can't change the warnings unilateraly. Based on this, in 2008, a Court of Appeals in California ruled in Conte v. Wyeth that a brand-name drug manufacturer could be held liable for harm to individuals who take the generic version of their name-brand product for alleged deficiencies in the generic drug’s labeling. The decision was based on the notion that if the federal law requires generic drug labeling to be the same as brand-name labeling, then injured plaintiffs should be allowed to recover against brand-name drug manufacturers who could change their labeling to provide stronger warnings without violating the Act. Liability in such case would encourage original manufacturers to improve warnings which would be the only way to get generic manufacturers to improve theirs. Since that decision, not one other reported case has followed its reasoning and there are several that explicitly reject it. Then, late in 2009, the U.S. Court of Appeals for the Eighth Circuit decided a case called Mensing v. Wyeth, Inc (available here) in which the court rejected arguments that failure to warn claims against generic manufacturers are preempted by the FDC Act. The Court also rejected the reasoning set forth by the California Court of Appeal in Conte v. Wyeth and held that brand-name drug manufacturers were not liable for harm caused by a plaintiffs’ use of a generic version of the pioneer’s brand-name drug. Shortly after the Eighth Circuit issued its decision in Mensing, the U.S. Court of Appeals for the Fifth Circuit came to a similar conclusion in Demahy v. Actavis. The Supreme Court's request for comment came as part of the cert petition process in the Mensing case. The Petitions for Writ of Certiorari in Mensing are available here and here. Apparently, the other case has not been appealed yet. This promises to be a very hot topic in product liability this year. Stay tuned... Fore more information (with lots of comments and links) on the subject go to these posts in: Pharmalot, the FDA Law Blog, AboutLawsuits.com, the Drug and Device Law Blog and the Washington Legal Foundation. UPDATE 7/9/2010: In the consolidated appeal of the Smith v. Wyeth, Wilson v. Pliva, and Morris v. Wyeth cases, the Sixth Circuit has formally requested the FDA's views on this subject, and has given the FDA until July 29, 2010 to file its brief. UPDATE: 11-03-10. The Solicitor General has filed its brief. Go here for details.

Lawsuit claims Wyeth targeted African Americans illegally for off label use of drug

Pharmalot is reporting that two former hospital sales reps have filed a whistleblower suit alleging Wyeth, which is now owned by Pfizer, illegally promoted its Rapamune kidney transplant drug for use with other organs and targeted African-Americans, even though this is a high-risk patient group. Go here for the full story.

Supreme Court agrees to hear case on seat belt preemption

In November 2010, the United States Supreme Court will listen to oral arguments in a case called Williamson v. Mazda Motor of America, Inc., which asks the Court to decide whether a claim for damages in state court caused by a car manufacturer's failure to install a three point seat belt in a 1993 car is preempted by federal regulations that allow vehicle manufacturers to install either lap-only or lap/shoulder seatbelts in certain seating positions. The main question in the case has been summarized like this: "Where Congress has provided that compliance with a federal motor vehicle safety standard “does not exempt a person from liability at common law,” 49 U.S.C. § 30103(e), does a federal minimum safety standard allowing vehicle manufacturers to install either lap-only or lap/shoulder seatbelts in certain seating positions preempt a state common-law claim alleging that the manufacturer should have installed a lap/shoulder belt in one of those seating positions?" Stated this way, it seems to me the case will allow the Court to reconsider its decision in Geier v Honda (2000) (available here), in which a divided court (5 to 4) found that the federal regulation conflicted with the notion of recognizing a claim in state court and, thus, the claim was preempted. In that case, the federal regulation gave manufacturers the choice to install either seat belts or airbags. Given that the regulation allowed the manufacturer to make a choice, the Court found recognizing a claim for damages based on the lack of the system the manufacturer failed to choose was incompatible with federal law and, thus, preempted. It will be very interesting to see if, in the wake of Wyeth v. Levine, the Court changes its view. It will also be an interesting element of the legacy of retiring justice Stevens who wrote the dissenting opinion in Geier and the majority in Levine. Williamson v. Mazda Motor Corp comes from the Court of Appeals of California which decided against the plaintiff holding the claim was preempted under federal law. Here is a link to a copy of the California opinion. For more on the case go to TortsProf, where guest blogger Catherine M. Sharkey, Professor of Law at New York University School of Law, has posted a very informative comment on the case. She concludes that "Williamson will narrow the reach of Geier implied obstacle preemption, but will not sound the death knell entirely..." For up to date information and for all the relevant opinions, petitions and other documents go (and periodically continue to check) here.

Update on the settlement on claims for Avandia

Yesterday I reported on the settlement of certain claims related to damages caused by the drug Avandia. Here is a link to another account and update on the news, courtesy of the Drug Recall Lawyer Blog.settl

When a doctor wants to file for medical malpractice

Here is a link to a very interesting story describing the experience of a practicing plaintiffs' lawyer during an interview with a doctor who wanted to file a claim for medical malpractice. You should read the full story, but the key to the story is that the doctor's expectations about the case were unreasonable and that his understanding of the legal system was faulty. The author concludes: "He [the doctor] was mis-informed. For years and years and years he has been told that all it takes to win a malpractice lawsuit is to claim an injury, file a lawsuit, and a bunch of nincompoops on the jury will give you a check for millions of dollars. He was told that lawyers are greedy bastards, that they will file any lawsuit regardless of merit, and that they can extort money out of people who had done nothing wrong. He believed that because this was so, his case - his meritorious case, the case to right the wrong done to his beloved father - was thus worth millions, because if all those money-grabbing, deadbeat plaintiffs on public assistance can get money for nothing he should get more money for a real loss. He had been mis-informed for so many decades that it was part of his being. I understand his frustration. He doesn't have the time to look at the real data about malpractice cases. He only knows what he is told. And what he has been told is wrong."

Glaxo settles more cases on Avandia

AboutLawsuits.com is reporting today that "GlaxoSmithKline has reached additional Avandia settlements in an estimated 5,000 lawsuits over the side effects of their diabetes drug, which has been linked to an increased risk of heart attacks and other potentailly life-threatening injuries." This second batch of cases inolved claims scheduled for trial to begin later this month in Pennsylvania. The first Avandia trial is now expected to begin in October 2010, unless additional settlements are reached. Go here for more details on the story.