More criticism of the FDA

The FDA Law Blog is reporting today that earlier this week, the Government Accountability Office (“GAO”) publicly released its September 2010 Report to the House Committee on Oversight and Government Reform concerning Drug Safety, titled “DRUG SAFETY - FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed (available here).” The report sharply criticizes FDA for persistent shortcomings in its oversight and inspection of foreign drug establishments – functions essential in GAO’s view to “safeguarding the nation’s drug supply in today’s global marketplace.” Go to the FDA Law Blog for the full story. UPDATE Nov 2: For more go to AboutLawsuits.com and Pharmalot.

On the risks of taking generic drugs and the hypocrisy of tort reformers

Last week, Bloomberg News reported (here) that Dr. Janet Woodcock, head of the Food & Drug Administration’s Center for Drug Evaluation and Research has stated publicly she has ongoing concerns about the level of equivalence between generic drugs and name brand drugs on which the generics are based and about whether generics really meet quality standards. This is a serious concern, which again highlights the deficiencies of the FDA as an oversight agency over an industry that affects - and puts at risk - millions of consumers every day. There are many reports out there of consumers of drugs for depression, epilepsy and other common problems who have complained to the FDA about the negative effects of being switched from brand name drugs to their generic "equivalent." Generic drugs account for the vast majority of all prescriptions in the U.S. so it is imperative to determine if we can trust the FDA to protect our safety. That aside, it is interesting to point out the response to the Bloomberg News story by the Washington Legal Foundation, a think tank that supports, among many other things, tort reform. Here is what they had to say: "Generic drugs account for over 70% of all prescriptions written in the U.S. Scores of branded drugs of increasing complexity are soon to lose their patent protection and become subject to generic competition. It is the ideal time for FDA and its overseers to consider whether FDA’s testing sufficiently protects patient safety. In the least, FDA should responded with more urgency to Dr. Woodcock’s caution this year than it did to her “tide of skepticism” statement in 2009. More must be done than simply publishing informational ads and asking that pharmacies display government posters assuring consumers that FDA is protecting them." You can read the full comment here. Stop the presses!!! The WLF and I agree on something?!! Wow! What is going on at the WLF?! I mean, I would have expected them to argue we should trust the FDA. This would have been consistent with the position that the FDA are the experts and that we should oppose allowing litigation in state courts over defective drugs or inadequate warnings as long as the FDA had approved the drug. So how come they are now saying maybe we should not trust the FDA? Oh... wait. I get it. You see, generics create competition for the name brand manufacturers, so "big pharma" does not want generics on the market. I see.... Federal regulation, and, who knows?, maybe even a little litigation, is OK to make sure generics are safe; but totally out of the question when it comes to questioning the safety of products by the big brand name pharmaceutical companies. Makes total sense now.

Prof. Turley's annual collection of halloween stories

Here is the link to Professor Jonathan Turley's Annual Halloween Special of Spooky Torts and Crimes.

Supreme Court will hear oral arguments on seat belt preemption this Wednesday

This coming Wednesday the Supreme Court will hear oral arguments in 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. For my previous posts on this case go here and here. Go here for copies of the briefs and other legal documents. I will post the links to the transcript and audio files on Wednesday night.

West Virginia Supreme Court to decide on the validity of the state's cap on damages for medical malpractice

AboutLawsuits.com is reporting today that the West Virginia Supreme Court has before it a claim challenging the damage cap in medical malpractice cases imposed by the state legislature as an unconstitutional intrusion on the right to a trial by jury. The claim also argues that the statute is invalid because the statute makes an arbitrary legal decision, regardless of evidence and circumstances. The West Virginia cap on pain and suffering was first instituted in 1986, but then the cap was set at $1 million, which would be adequate in most cases and which is much higher than in all other states that have a cap. Since then, however, the cap has been lowered and now limits recovery for pain and suffering to $250,000 in most cases and $500,000 for the most serious injuries but regardless of the number of defendants involved in a case. In the case before the court, the jury awarded the plaintiffs a little over $1.6 million. Applying the statute, the lower court reduced the jury’s award to $500,000. Not suprisingly, lobbyist groups representing doctors and insurance companies have filed a brief in an attempt to ensure the cap remains in place, arguing that it is acceptable for the legislature to interfere with the cases to keep the price of medical insurance low and keep doctors from fleeing the state for fear of being targeted by medical malpractice lawsuits- two arguments that have been thoroughly discredited by all recent studies on the subject. See here. Oral arguments in the case are scheduled for January, with a decision expected later in 2011. State Supreme Courts in Illinois and Georgia have invalidated similar damages caps over the last year. For more on that, go here, here, here and here.

At what age can a child be considered old enough to be sued for negligence? Four is old enough in NY

The Wall Street Journal law blog is reporting today that a trial court judge in Manhattan has held that a 4-year-old girl is old enough to be sued in a personal injury action. The girl allegedly ran into an elderly woman as she raced her bicycle with another child on the sidewalk in front of her house. She was riding her bicycle with her training wheels under the supervision of her mother. Go here for the story in the WSJ, here for the story in the New York Law Journal; here for the NYT article. UPDATE: two more comments on this case here and here.

WLF comment on the Alien Tort Statute

The right-wing think tank the Washington Legal Foundation has posted a comment on the Order of the Court of Appeals for the Ninth Circuit sending the Rio Tinto case to mediation - about which I wrote yesterday (here). Nor surprisingly, it sides with the dissenting judge in questioning the application of the statute and argues the court should have followed the Court of Appeal for the Second Circuit approach to eliminate plaintiffs' rights under the statute. You can read the WLF's comment here.

More interesting decisions on the Alien Torts Statute

About a month and a half ago, I reported on a decision by the Court of Appeals for the Second Circuit holding for the first time that plaintiffs could not bring claims against corporations under the Alien Tort Statute. This view departs from decades of case law under the ATS. (See here and here.) Now comes news that in a dissenting opinion from an order by the Court of Appeals for the Ninth Circuit a federal judge is suggesting yet another radical departure from accepted doctrine. The Court's order (available here) was surprising too, but for a different reason. Nearly a decade into the litigation of a class action filed on behalf of some 10,000 people who say they suffered from violence, threats of violence and pollution from Rio Tinto's copper mining in Bougainville, Papua New Guinea, the Court has decided to refer the case to a judge to explore the possibility of mediation. In dissent, Judge Kleinfeld argues that the case should not be referred to mediation because he does not think the court has jurisdiction over the case to begin with, stating that "We have not yet decided whether we have jurisdiction over this dispute. I very much doubt that we do. I suspect that we lack jurisdiction both because the case involves a political question and because we lack subject matter jurisdiction on account of extraterritoriality. This case is entirely extraterritorial. The claims are by Papua New Guineans against a British-Australian company for wrongs committed in Papua New Guinea. Although Rio Tinto has operations in many countries, including the United States, and Sarei lived in the United States as a resident alien when the complaint was filed, nothing done by Americans or in America, is at issue." This is a remarkable statement. The notion that the court may not have jurisdiction because the case involves a political question is correct, but the suggestion that the court may not have jurisdiction because the claim is filed by an alien and relates to conduct outside the US departs from the current interpretation given to the statute by the Supreme Court. The ATS exists precisely to provide jurisdiction to aliens to recover for injuries committed outside the US. Most, if not all, the cases decided by the Supreme Court and other federal courts under the ATS involve claims in that context. If the court were to follow the judge's suggestion and hold the court does not have jurisdiction, it would be using a radical interpretation of the statute not based on any previous ATS case. Go here for more on the story. Go here for all my comments on recent developments related to the Alien Tort Statute.

Ct dismisses claim vs brand name pharma in case where the plaintiff had used the generic version

A federal judge in Louisiana has dismissed a lawsuit that was filed by a man who took a generic version of the Reglan heartburn med, but charged that Wyeth and Schwarz Pharma, among others, were liable for failing to warn of serious side effects. The decision continues the trend to dismiss the theory that brand-name drugmakers can be held liable not only for harm caused by their own meds, but also for injuries caused by generic drugmakers selling a copycat version because the law allows generic drugmakers to rely on research and labeling contained in the application for the brand-name med. For more on the story go here. You can read the opinion here. For older stories on the same topic go here, here, here, here and here.

New allegations that Toyota tried to cover up acceleration problems

The Wall Street Journal law blog is reporting today that the plaintiffs in the lawsuit against Toyota for damages caused by the sudden acceleration of some of Toyota's vehicles have amended the complaint to add a few new claims, including the allegation that Toyota investigated sudden-acceleration incidents and then bought back vehicles from the customers who reported problems making them sign confidentiality agreements. Go here for the full story.

Feds finally take action against small pharma company known for its repeated manufacturing problems

Pharmalot is reporting today that earlier this week, the FDA seized prescription and over-the-counter products from a little-known company in New Jersey, Tri-Med Laboratories, for repeated manufacturing deficiencies - a lack of protocols, questionable test results and non-existent cleaning methods, among other things - that caused various products to be considered adulterated. That's bad, but what makes the story worse is the fact that the FDA had known of the problems since 1997! Back in 1997, the FDA issued a warning letter to the company outlining the problems. Seven years later, the same thing happened and again in 2009. The most recent letter also noted that, two years ago, Tri-Med recalled gas relief drops for infants due to microbial contamination. So I guess that after 13 years, someone decided it was time to take action. During those 13 years, however, the company was allowed to put adulterated products in the market placing customers of all ages at risk of injury without oversight. Tort reformers and the pharmeutical industry constantly argue we should not allow state tort claims under the preemption doctrine because we need to trust the federal government agencies who are "the experts" at deciding what is safe for us. We can't trust the litigation system to do this, they say. With stories like this one and many others over the years about the deficiencies of the FDA as an oversight agency (see here and here, for example) , I think this is a difficult argument to make. For more details and links to relevant documents go to Pharmalot.

Glaxo To Pay $750M For Manufacturing Fraud

GlaxoSmithKline has agreed to pay a $750 million fine to settle charges over numerous production problems - contaminated meds, mislabeled packaging and incorrect dosages - at a facility in Cidra, Puerto Rico. For more on the story go to Pharmalot, Law.com, FDA Law Blog, AboutLawsuits.com and the Wall Street Journal Law Blog.

Another reply to Peter Orszag's Bad Medical Malpractice Idea

Last week I posted a link to a reply to Peter Orszag's column in the New York Times in which he complained that the health insurance reform bill did not do enough to federally "reform" state medical malpractice laws. Here is a link to another critical response. In this new reply, Alan H. Crede argues that Orzag's proposal "is both scientifically and legally illiterate" and that "it's not even clear that he understands what he's proposing." Go here to read the full comment.

Dept of Justice to investigate Glaxo over issues with Avandia

Amid ongoing accusations that the pharmaceutical giant GlaxoSmithKline knew their diabetes drug Avandia increased the risk of heart attacks and tried to suppress that information, the Department of Justice (DOJ) has subpoenaed the drug maker to gain access to clinical data and marketing information. For more on this story go here.

Problems in the auto industry

The Pop Tort has a short comment on safety issues in the auto industry here. Among other things, it reminds us that about 10 million Toyota cars and trucks have been recalled worldwide this year (for faulty gas pedals and floor mats, braking problems,stalling engines). Toyota had to pay a $16.4-million fine as a result of what the National Highway Traffic Safety Administration argued was a failure to report the problems to government regulators in a timely manner. Meanwhile, Honda has recalled an unspecified number of Acura RL sedans and Odyssey minivans. Chrysler recently recalled over 26,000 vehicles with power steering problems. Volvo recalled almost 10,000 cars for problems with airbags. GM and Nissan had seven recalls while BMW, Chrysler and Ford had five each. In all, the auto industry has had 56 safety recalls for passenger vehicles in the last six months, according to government data.

Peter Orszag's Truly Bad Medical Malpractice Prescription

Yesterday's New York Times published a column by Peter Orszag in which he complains that the health insurance reform bill did not do enough to federally "reform" state medical malpractice laws. He argues that Congress should "shield from malpractice liability any doctors who followed evidence-based guidelines in treating their patients" and "provide safe harbor for doctors who follow evidence-based guidelines." He says, "[A]nyone who could demonstrate that he has followed the recommended course for treating a specific illness or condition could not be held liable." In response, Joanne Doroshow replies "This is a horrendous idea." I agree. Go here to read her full response.

Comment on unsafe baby products

In my class we are getting ready to discuss Ayers v. Johnson & Johnson, 818 P.2d 1337 (Wash. 1992), a case that many of my students find very scary, in which the court discusses the dangers of baby oil. As if on cue, the PopTort blog has just published a short comment on unsafe baby products here.

Short documentary on BMW v. Gore

As I am sure most of the readers of this blog already know, BMW v. Gore, was the first case where the Supreme Court developed an analysis to determine if the amount of punitive damages imposed on a defendant was excessive. It openned the door to other cases in which the Court then continued to develop its approach to the constitutionality of punitive damages. As part of its “Voices of American Law” series, Duke University has produced a 14 minute documentary on this case. The video, as well as links to many relevant documents is available here.

Federal Court finds South Dakota would adopt learned intermediary doctrine because another federal court had found North Dakota would

The Federal District Court for the district of South Dakota has issued an interesting opinion in which it dismisses a claim against a prescription drug manufacturer by applying the learned intermediary doctrine even though the state courts in South Dakota have not yet decided whether to adopt that doctrine. The case is called Schilf v. Eli Lilly & Co., and it is available here. In this case, the plaintiffs’ 16-year-old son committed suicide while on Cymbalta, an Eli Lilly antidepressant. The parents sued, claiming that the drug's warnings were inadequate because they did not warn about an increased risk of suicidal thoughts and behaviors in children and adolescents on antidepressants. After discovery, Eli Lilly moved for summary judgment based on the learned intermediary doctrine (which allows a manufacturer to avoid liability as long as it adequately warns the physician who then has to duty to warn the patient). One interesting thing about the case is that the courts in South Dakota had not decided whether to adopt the learned intermediary doctrine, so the federal court had to predict whether it was likely that the South Dakota Supreme Court would adopt the learned intermediary doctrine. In deciding that it would be likely, the court cited Ehlis v. Shire Richwood, Inc., 367 F.3d 1013 (8th Cir. 2004), in which the Eighth Circuit predicted that the Supreme Court of North Dakota would adopt the doctrine. I have not idea whether this will be well received in South Dakota. Does South Dakota always follow what North Dakota does? Do South Dakotans resent being compared to North Dakotans? I just don't know. Why what North Dakota does in terms of tort would be relevant to what South Dakota would be likely to do is a mystery, but there you have it. I think the court could have reached the same result (and avoided this potentially politically incorrect approach) by simply basing its decision on an analysis of South Dakota law and tort policy. The fact of the matter is that the learned intermediary doctrine is still applied in most jurisdictions and that there are policy reasons to support it in most cases. (I say "most cases" because I think the argument is weaker in cases that involve direct to consumer advertising, but that does not seem to have been an issue in this case.) Adopting the learned intermediary doctrine does not, by itself, absolve the manufacturer of liability, though. The court still has to determine that the manufacturer provided warnings to the doctor and that the warnings were adequate. Having done that, then the court addressed cause in fact: would the doctor have prescribed the drug anyway? In a comment about the case, the folks from the Drug and Device Law Blog describe this part of the case this way: The prescriber also was asked whether he still believed that the decision to prescribe Cymbalta was correct. That question is often a key moment in a prescriber’s deposition. The deposition room goes quiet; many people subconsciously hold their breath, as they know that the entire case could hinge on this one answer. Experienced defense counsel will act nonchalant, trying to communicate nonverbally to the prescriber that the answer is a given rather than communicating that the answer is a really big deal. Then the prescriber answers, and everyone exhales. Here, the prescriber said yes. Based on that testimony, the court held there was not sufficient evidence of causation to allow the question to be submitted to the jury.

Palsgraf v Long Island RR revisited (with Legos)

Thanks to Brian Bendoff and Leigh Harmon for the link

Indiana OSHA says there is no evidence of negligence in accident during Transformers movie

The Chicago Personal Injury Blog is reporting that although the lawsuit filed against the producers of the film "Transformers 3" on behalf of an extra who was severely injured during the filming of a stunt is still moving ahead, the Indiana Occupational Safety and Health Administration has called the accident "unforeseeable" and cleared the producers of violating workplace safety rules. For more on the story go here and here. I am not sure the use of the term "unforseeable" is accurate here since what the Agency concluded was that those in charge of the film were not negligent. In other words, to the extent that the Agency's ruling relates to the elements of a tort action, the ruling is really that there was no breach, not that there is no foreseeability, a term that is usually used to refer to proximate cause or duty.

Interesting trivia I learned today

Here is a little bit of interesting trivia I learned today: William Marston (the “father” of the modern day polygraph), is credited as the creator of the systolic blood pressure test used in an attempt to detect deception, which became one component of the modern polygraph. Under the pseudonym Charles Moulton, he created “Wonder Woman” whose magic lasso requires those bound by it to tell the truth. For more information on comic books and law go to the Abnormal Use Law Blog. Most Fridays, they feature a classic comic book cover with a law related theme.

Jury finds Johnson & Johnson liable and orders it to pay $258 Million for misleading marketing of a drug

A Louisiana jury has issued a $257.7 million verdict against Johnson & Johnson for misleading Louisiana doctors about the possible side effects of one of its anti-psychotic medications. For more on this story go to AboutLawsuits.com or Law.com.

Thousands of complaints vs Bayer claim injuries caused by Yaz, Yasmin and Ocella

About 4,200 people have filed lawsuits claiming they suffered severe, and sometimes fatal, injuries due to side effects of the birth control pills Yaz, Yasmin and Ocella. Go here for the full story.

Risk still present even after Meridia is taken off the market

A few days ago, I posted a note asking whether the FDA had waited too long try to get Meridia off the market. See here. Now, AboutLawsuits.com is reporting the question might actually be moot since many unregulated dietary supplements appear to use bibutramine, the active ingredient in Meridia, including in some that do not list it as an ingredient. Go here for the full story.

New study concludes ATV accidents are more likely to be fatal than motorcycle accidents

I often use hypos involving ATVs and motorcycles in my torts class. So, my students may find it interestint to know that a new report announced at an annual meeting of the American College of Surgeons this month found that victims of an ATV accident were 50 percent more likely to die than victims of a motorcycle accident, even when the severity of the injuries appeared to be the same. Go here for the full story.

Report rates the USA last in "access to justice"

The World Justice Project issued a new report today ranking the “rule of law” in 35 countries, including the United States. Go here for a copy of the full report. One of the four “universal principles” WJP examined was “access to justice,” defined as “access to legal representation and access to the courts,” calling these principles a “critical cornerstone for the implementation of policies and rights that empower the poor.” The US civil justice system was found to have less access to justice than in countries in Western Europe and North America as a whole, and other “high income” nations throughout the world. In fact, overall, the U.S. ranks last (7 out of 7) in the region, and last (11 out of 11) among high-income nations. "Tort reform" is one important cause of the poor U.S. ranking, of course, but not the only one. Lack of adequate funding for legal service programs is certainly a huge part of it too. Thanks to the PopTort for the information and links. For its full comment go here.

Recent case to illustrate issues on the traditional rule on (no) duty to help

Here are some links to a recently reported story about a CVS pharmacist who refused to sell an asthma inhaler to a customer even though she was having an attack at the moment because the customer was just over a dollar short. Could CVS be liable for it under the common law? No. (There may be some special statute that applies to a situation like that but I don't know of any.) What about other customers? Assume other people were around and did not offer to help. Could they be liable?  The Boston Personal Injury Lawyer Blog has a good comment about the case here, and there is more on the story here and here.

TV segment on Bruesewitz v. Wyeth

Go here for the argument recap by the SCtUS blog on Bruesewitz v. Wyeth. Here is a video of a segment from PBS News Hour commenting on the case:

Listen to oral argument in Bruesewitz v. Wyeth here

Go here to listen to the oral argument on Bruesewitz v. Wyeth. It is available in several different formats including windows media and MP3.

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.

More on the hypocrisy of the Chamber of Commerce

Following on the comment on the hypocrisy of the Chamber of Commerce I posted a few days ago, here is a short comment from the blog Tort Deform on the same subject. In it they point out that the head of the Chamber has "bragged that the Chamber has sued the EPA “six times” this year. What would Tom [the head of Chamber] say about someone who bragged about suing Wyeth six times in a single year? Tom would probably brand the plaintiff a “serial litigant” and accuse him of “clogging the courts with frivolous lawsuits.” Don’t get me wrong. Tom and the Chamber of Commerce have the right to sue the EPA six times a day if they believe the EPA has wronged them. But the flip side is that we American citizens also have the right to sue Chamber members when they wrong us. If Tom doesn’t want his right to sue to be limited, then he shouldn’t ask us to limit our right to sue."

$95,000 in sanctions for filing a lawsuit knowing it was time-barred

The 2nd U.S. Circuit Court of Appeals has affirmed a nearly $95,000 sanction that Eastern District of New York Judge Denis R. Hurley imposed on a Long Island attorney and his client for knowingly filing a time-barred securities fraud lawsuit. Go here for the full story.

Comments on Snyder v Phelps

The big news this week continues to be the new cases before the Supreme Court. Here is a link to a couple of comments on Snyder v. Phelps.

Comment on Connick v Thompson

Sherrilyn Ifill, Professor of Law, University of Maryland School of Law, has published an article called Why We Ignored the Supreme Court’s Review of Connick v. Thompson in the American Constitution Blog (available here). In it, she concludes that "How the Court resolves the Connick case will have a powerful effect on public confidence in the justice system - especially for African Americans. It is one thing to know that some prosecutors will violate their oath of office and violate the constitutional rights of criminal defendants. It's quite another for the highest court in the land to suggest that prosecutors can do so with impunity."

Articles on Bruesewitz v. Wyeth

As reported yesterday, the Supreme Court heard arguments on Bruesewitz v. Wyeth – in which the Court is considering whether the National Childhood Vaccine Injury Act preempts all vaccine design-defect claims. Here is a list of articles on the case as reported in ScotUS blog: NPR, New York Times, Washington Post, Los Angeles Times, Wall Street Journal, WSJ Law Blog, CNN, National Law Journal, Christian Science Monitor, Bloomberg, USA Today, C-SPAN, PBS NewsHour, Nature, and Courthouse News Service. Also, here is a link to a long analysis of the oral argument by the Drug & Device Law Blog.

Transcript of the oral argument in Bruesewitz v. Wyeth

Here is a the transcript of the oral argument in Bruesewitz v. Wyeth.

Did the FDA wait too long to take Meridia off the market?

As I reported a couple of days ago, the FDA asked Abbot Labs to take its weight-loss drug Meridia off the market. The FDA's request (not an order) came more than eight months after the drug had been taken off the market in Europe. Did the FDA take too long to make its decision? The prominent consumer advocacy group Public Citizen is arguing it did. Here is a link to PC's press release, in which it concludes that "[t]he FDA’s decision today to ask pharmaceutical maker Abbott to withdraw the drug is commendable, but dangerously too late for all of the victims of its unacceptable risks." For more on this story go to AboutLawsuits.com.

Radio podcast on medical malpractice risk management

Here is a link to a radio podcast on medical malpractice risk management. If that link does not work, try this one.

Oral arguments in Bruesewitz v. Wyeth at the Supreme Court

The US Supreme Court heard oral arguments in Bruesewitz v. Wyeth. As you may recall, this is the case where the Court will decide whether Section 22(b)(1) of the National Childhood Vaccine Injury Act of 1986 — which expressly preempts certain design defect claims against vaccine manufacturers “if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warning” — preempts all vaccine design defect claims, regardless whether the vaccine’s side effects were unavoidable. As I have mentioned elsewhere, the case is being closely watched because of the enormous health and legal implications for drugmakers and parents. As AboutLawsuits.com states, the case "could potentially mean the end of virtual immunity for vaccine makers and may open the door for hundreds of vaccine injury lawsuits." See AboutLawsuits.com's comment on the case here. I am sure there will be a lot of commentary on this case over the next few days. For now here are a few links with more information about the case. I will keep adding links as I see them, so keep checking .... ScotUS Blog has an argument preview here. The Wall Street Journal law blog The PopTort For all the briefs, court opinions, transcripts and other legal documents, go here. UPDATE: here is the transcript of the oral argument Here is a story from Law.com

The Defenders

I have been following the new "lawyer shows" on TV for the past three weeks (see here) and, at the risk of getting laughed at, I have say that the one I like the most is "The Defenders"! Go here to see why.

On the implications of the FDA's request to withdraw Meridia

The decision late last week by the FDA to encourage Abbott Laboratories to withdraw its Meridia diet pill has obvious implications for other drugmakers seeking approval for obesity drugs. Pharmalot has a comment on the subject here.

Comments on Connick v Thompson's oral argument

Here is a link to a comment on the oral argument in Connick v Thompson published as part as the continuing coverage of the case by the Supreme Court of the US blog (SCOTUSblog).

Meridia drug is finally ordered off the market.

After a very long debate - and many entries in this blog about the subject - Federal regulators have finally decided that the weight-loss drug Meridia is too dangerous to stay on the market due to the risk of heart attack and stroke. The drug was withdrawn in Europe eight months ago, but less than a month ago an FDA panel issued a split vote (8-to-8) on whether to recall it. Two days ago, however, the FDA announced that Abbott Laboratories has agreed to pull the drug from the market at the FDA's request. Go here for the official FDA announcement. Go here for the full story.

Chicago Tribune on medical malpractice

The PopTort has a short comment on a recent series of article on the Chicago Tribune on medical malpractice. According to the comment, the Tribune's past editorials have repeatedly endorsed draconian caps on compensation for patients, criticized Illinois courts for striking down caps as unconstitutional and given comfortable platforms to business-backed tort reform groups. But the more recent articles suggest a different view. Go here for the full story.

Pharmaceutical halts development of so called "female viagra" pill

Last summer I reported on the ongoing debate as to whether the so-called Hypoactive Sexual Desire Disorder in women 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. See here. The drugmaker (Boehringer Ingelheim) geared up an enormous publicity effort to promote the pill, but the FDA was not impressed and decided the pill was neither safe nor effective. See here. Now, three months after the vote against approving the drug, the manufacturer has decided to discontinue development entirely. For more on the story go here.

Dora sues Nickelodeon

Caitlin Sanchez, 14, the voice actor for Dora the Explorer, has filed a lawsuit against Nickelodeon alleging that the network denied her full compensation as the voice of the cartoon character. The claim alleges that she (and her parents) were taken advantage of by network lawyers who convinced them to sign an unfair and ambiguous contract. Go here for the full story.

Story about a sponge left in patient after surgery pt 2

A few weeks ago I posted a note about the case of a judge who suffered injuries because of a sponge left in his abdomen after surgery. (See here). Now here is a comment from the Boston Personal Injury Lawyer Blog on the same case. It argues how the judge's case illustrates why caps on damages are a bad idea.

Another story on guilty plea to charges of off label marketing

As I reported not too long ago, Novartis Pharmaceuticals Corporation has agreed to plea guilty to charges of off-label marketing and bribing doctors to prescribe the anti-epileptic drug Trileptal, as well as other drugs, and has agreed to pay nearly half a billion dollars to settle a whistleblower lawsuit and federal charges. AboutLawsuits has more on the story here.

Attorney sanctioned for comments and attitude during trial; but Ct does not declare a mistrial

Pharmalot has a story (here) about Gary Douglas, a plaintiff's attorney who represented a client who claimed Fosamax caused her to develop osteonecrosis. A few days ago, the judge in the case hit Douglas with a $2,500 sanction due to what has been described elsewhere as his manic and outrageous conduct during trial. According to the story, Douglas referred to another trial when he should not have done so, attacked the FDA during his summation over the way the agency is funded, characterized the FDA and the pharmaceutical industry for having an “incestuous relationship,” compared the FDA’s ability to monitor drug safety with the federal government’s response to Hurricane Katrina, improperly injected his own opinion concerning evidence into his summation, improperly referred to adverse event reports, accused Merck and its attorneys of hypocrisy, repeatedly disparaged defense witnesses and acted rudely, using sarcasm, gestures, imitations, mockery, singing, derogatory tones, laughing and what the judge called "fooling around’ and making fun.” The judge's order is available here. Although I have not looked at the record, it does sound like the totality of the circumstances justify imposing sanctions, but I have to say that I don't have that much of a problem with the part about the comments during the closing argument. After all, the FDA is underfunded and its relationship with the pharmaceutical companies is questionable. Was it relevant in the case? Was it evidence in the case to support the claim? I don't know... but assuming there was some relevance and some reference to it, I would have let this go as examples of acceptable rhetoric. The defendant would have its turn to counter the statements. They were not so damaging.... Go here for the full story. But the story does not end there. Once the jury came back with an $8 million verdict for the plaintiff, the defendants (and their supporters) are complaining that the plaintiff's lawyer's antics should have resulted in a mistrial and that they should be granted a new trial. See here. The court, however, found no need for a new trial because the lawyer's conduct did not touch on the key evidence of the case. Instead, the judge reduced the judgment from the $8 million awarded by the jury to $1.5 million - which is half of what the plaintiff wanted. Supporters of the defendant's position have argued (here) that the fact the plaintiff’s told the jury that his client needed $3 million as full compensation for her injuries and the jury awarded $8 million is "a big, flashing, incontrovertible sign that counsel’s advocacy improperly influenced the jury." "What else could possibly explain that verdict?" Well, since I have not seen the record, I really don't know. But I can say this: no, the verdict, by itself, is not an incotrovertible sign of anything other than the fact that the jury thought $8 million would be a better result than the one the lawyer asked for. And why could that be the case? Maybe the jury thought the lawyer was incompetent and that the evidence showed the client should be better compensated; maybe the jury wanted to impose punitive damages to punish the defendant but couldn't so they added more zeros to the compensatories; maybe the jury wanted to "nullify"; maybe the jury was incompetent... who knows? As even the defendant's supporters have argued, "attempts to ascertain the prejudicial effect of conduct are necessarily based on speculation about the effect of that conduct on a jury." Thus, at least from what I have seen so far, I think the judge was justified in denying the request for a new trial. Since I am as intolerant of improper conduct as the next guy, I am certainly willing to be convinced otherwise, but that's what I am saying now.... The judge should deal with the conduct by imposing sanctions or contempt, not by giving the defendant a new trial. Law.com has more on the story here. AboutLawsuits has the story here.

On the hypocrisy of the Chamber of Commerce

Eric Turkewitz, of the popular NY Personal Injury Law Blog, attacks the Chamber of Commerce's hipocrisy in a short comment here. It appears that chamber CEO and President Thomas Donohue issued a statement that says “Litigation is one of our most powerful tools for making sure that federal agencies follow the law and are held accountable,” while it is about to pump $10 million into advertising for the coming election to get tort “reformers” elected in an effort to make it more difficult for victims of accidents to have access to litigation to get compensation for their injuries. It’s the single largest expenditure by any group other than the Democratic and Republican parties. So, as Turkewitz argues, “Litigation is one of our most powerful tools" for making sure that government is accountable -- that's ok. But to say that litigation is a powerful tool to make tortfeasors accountable.... well, that's not ok. Read Turkewitz comment here.

What to watch for during oral argument in Bruesewitz v. Wyeth

The Drug and Device Law Blog offers some thoughts on what to watch for here.

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. In my opinion, though, the most interesting story this week is the beginning of the Supreme Court's term which has before it four very important cases related to torts issues including the constitutional limits to an intentional infliction of emotional distress claim, the reach of prosecutorial immunity and issues related to preemption in products liability claims. For more on those stories go here.

Bruesewitz v. Wyeth: the fourth torts case to watch in the Supreme Court

Next Tuesday, the US Supreme Court will hear oral arguments in Bruesewitz v. Wyeth, a fourth very important torts case before the court this term. In the case, the Court is asked to decide whether Section 22(b)(1) of the National Childhood Vaccine Injury Act of 1986 — which expressly preempts certain design defect claims against vaccine manufacturers “if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warning” — preempts all vaccine design defect claims, regardless whether the vaccine’s side effects were unavoidable. As Pharmalot explains, the case is being closely watched because of the enormous health and legal implications for drugmakers and parents. For more information on this case go to Pharmalot. For all the briefs, the opinion of the lower court and other legal documents go here. Next Tuesday afternoon/evening or Wednesday morning you will be able to find a copy of the transcript of the oral argument and at the end of the week you will also be able to find the recording of the argument here also.

Listen to oral argument in Snyder v Phelps here

Go here to listen to the oral argument on Snyder v Phelps. It is available in several different formats including windows media and MP3.

Listen to the oral argument in Connick v Thompson here

At the end of each week the Supreme Court releases audio recordings of the week’s oral arguments. Go here to listen to the oral argument on Connick v Thompson. It is available in several different formats including windows media and MP3.

Article on Snyder v. Phelps

In Snyder v. Phelps, the United States Supreme Court will decide to what extent state tort law may impose liability for “intentional infliction of emotional distress through outrageous conduct” without running afoul of the First Amendment’s guarantee of freedom of speech. Ben Zipursky (Fordham) has a forthcoming article on the case in which he puts forward the reasons for rejecting the outrageousness argument. You can download a copy of Zipursky's paper here. Thanks to TortsProf blog for the link.

Williamson v. Mazda Motor of America, Inc: a third torts case to watch before the Supreme Court

Ten years after the Supreme Court decided Geier v. American Honda Motor Co., the issue of preemption under National Highway Traffic Safety Administration’s safety regulations is back before the Court. In Geier, the Court held (5 to 4) that a state claim against Honda was impliedly preempted by the federal law/regulations that gave automobile manufacturers the choice to use either seat belts or air bags in their cars. Now, in Williamson v. Mazda Motor of America, Inc., which will be argued in November, the Court has been asked to decide whether a federal safety standard allowing vehicle manufacturers to install either lap-only or lap/shoulder seatbelts in certain seating positions preempts a state common-law claim alleging that the manufacturer should have installed a lap/shoulder belt in one of those seating positions. 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 all the briefs, lower court opinions and other legal documents go here.

Connick v. Thompson: another important torts case at the Supreme Court yesterday

Snyder v. Phelps was the center of attention yesterday at the Supreme Court, but it was not the only important case the Court heard. The other important case before the court was Connick v. Thompson, a case in which the U.S. Court of Appeals for the 5th Circuit had affirmed a $14 million award for the wrongful conviction and death sentence of the defendant in a murder case. The basis of the claim is that the defendant district attorney's office failed to train its lawyers on their legal and ethical duty to disclose exculpatory evidence, which resulted in the wrongful conviction of the then-defendant-now plaintiff. The opinion of the Court of Appeals is available here. When originally reported in the Blog of the Legal Times, District Attorney Leon Cannizaro Jr. was said to have appealed the ruling to the Supreme Court, "asserting that upholding the 5th Circuit's decision "exposes district attorney's offices to vicarious liability for a wide range of prosecutorial misconduct."" This is a strange argument since the original claim was not based on vicarious liability at all but on the conduct of the district attorney's office itself. According to a story in Slate magazine, at one point, when questioned under oath the then-district attorney Harry Connick, Sr. could not articulate the Brady rule and after listening to two days of testimony about how Connick ran his DA's office, with the acting prosecutors blaming each other and fumbling over conflicting and inaccurate explanations of what Brady requires, a federal court jury in New Orleans awarded Thompson a $14 million verdict in 2007. The jury found that his 18 years behind bars (14 of which he spent in solitary confinement on death row) were caused by Connick's deliberate failure to train his prosecutors on their obligations to turn over exculpatory evidence. According to the Innocence Project, a national organization that represents incarcerated criminals claiming innocence, 36 men convicted in Orleans Parish during Connick's tenure as DA have made allegations of prosecutorial misconduct, and 19 have had their sentences overturned or reduced as a result. The petitioners' response has been to argue that prosecutors should have absolute immunity from suit— because the plaintiff did not show there was a "pattern" of violations of the duty under Brady. They argued repeatedly that the case was the result of a single violation and in response to some questions during the oral argument appeared to argue that, even if there was a pattern of conduct, there could never be liability for the first offense. The misunderstanding about whether the case is about vicarious or direct liability aside, the case will have important implications for the concept of prosecutorial immunity and the reach of possible civil liability in tort and of the ethical responsibilities of the DA's office and its prosecutors. The case also has another interesting connection to another issue of professional responsibility: the original case against the defendant was the underlying case in In Re Riehlmann (La 2005) often discussed in connection with the duty to disclose attorney misconduct under Rule 8.3. This was the case in which a former prosecutor, upon learning he was dying of cancer, finally decided to unburden himself and confess to a friend (Riehlmann) that he (the prosecutor) had intentionally withheld exculpatory evidence in a case that resulted in the imposition of the death penalty. That case was the case against Thompson, the then defendant-now plaintiff who eventually got the $14 million for the wrongful conviction. So, let's recap. In 1985, a prosecutor withholds exculpatory evidence intentionally in a case against a man named Thompson, who is then convicted and sentenced to death. In 1994, the prosecutor confesses what he did to his friend Riehlmann. Riehlmann does nothing about this for 5 years. After the exculpatory evidence is discovered in 1999, Riehlmann reveals what the former DA had told him. (Years later, Riehlmann is disciplined for his own misconduct in failing to disclose the prosecutor's misconduct). Eventually, after spending almost 20 years in death row for a crime he did not commit, Thompson's conviction is vacated, he is re-tried and found not guilty. Thompson then sued for damages arguing a violation of this rights under 42 USC Sec 1983 and was awarded $14 million. The Court of Appeals affirmed and now the Supreme Court will review the case. Interpreting the questioning by the justices during yesterday's oral argument, Law.com concludes that the "Supreme Court justices on Wednesday appeared ready to give the green light to efforts by a New Orleans man to win compensation for prosecutorial misconduct that put him behind bars for more than two decades for a murder he did not commit." For a detailed account of the story behind the case go to Slate. For more on the case go to the Legal Ethics Forum, USA Today, the Washington Times, the Boston Herald, the Law.com, Main Justice, and the the Washington Post. (Thanks to Scotus Blog for these links). For the actual transcript of the oral argument go here. For all the briefs, the opinion of the Court of Appeals and other legal documents go here.

Snyder v Phelps, on protests at funerals: one of two torts cases that dominate the discussion at the Supreme Court

Two torts cases were the center of attention yesterday at the Supreme Court. The Court heard oral arguments on Snyder v. Phelps and Connick v. Thompson. Snyder captured most of the attention, but I think Connick is just as interesting. I will post a separate comment on Connick shortly. Snyder asks whether the First Amendment allows the family of an American soldier, killed in Iraq in 2006, to recover damages for intrusion upon seclusion and intentional infliction of emotional distress from members of the Westboro Baptist Church who routinely demonstrate at funerals and other events to promote their message that God is punishing the United States for its acceptance of homosexuality using their now well known slogan "Thank God for Dead Soldiers." Putting aside the irrational and incoherent logic of the argument that there is some connection between war, soldiers' death and homosexuality, the case presents a serious legal issue. According to several accounts, Justice Ruth Bader Ginsburg at one point asked "This is a case about exploiting a private family's grief and the question is: Why should the First Amendment tolerate exploiting this Marine's family?" The answer, of course, is that the First Amendment exists precisely to protect the right to express unpopular views. If we only protected ideas everyone agreed with, freedom of expression would have no meaning. But the case is not that simple. Another key issue is whether the plaintiffs are to be considered "public figures." If so, they have to meet a much higher standard to meet in order to support their claim. For a debate on the case featuring Vikram Amar, law professor, U.C. Davis, Christina E. Wells, law professor, University of Missouri and William Rich, law professor, Washburn University go to The New York Times' Room for Debate. For coverage of the case go to Law.com, The Wall Street Journal law blog, and SCOTUS Blog which also has a more recent "round-up" of links on the case here and a thoughtful comment here. For all materials, briefs, and other legal documents on the case go to SCOTUS Blog. For the actual transcrips of the oral argument go here. These are only a few of many more links to more information about the case you can find out there! Finally, here are two videos on the case. The first one is the report from PBS' NewsHour. The scond is an interview with a journalist from the National Law Journal who was present at the oral argument:

Federal Judge Rules that Punitives Can Only Exceed Compensatories by 9-1 Ratio; I don't see why

Slashing a jury's punitive award of $500,000 down to $270,000, a federal judge has ruled that the constitutional maximum for punitive awards is ordinarily no more than nine times the compensatory award -- even in cases where the defendant is a repeat violator. Go here for the full story. I have never really understood this line of reasoning. There is no reason why punitive damages need to have any ratio/relationship to compensatory damages at all. Punitive damages are assessed to punish, not to compensate, and they are imposed to deter conduct on the part of the defendant that is particularly irresponsible, reprehensible, dangerous, offensive, etc. To justify placing a hard limit on punitives based on the ratio of compensatories to punitives one has to say that the evaluation of how bad the conduct is depends only on the amount of compensatory damages it causes. Evidently, this is inconsistent with the goals of tort law and of the use of punitive damages in the first place. There are many other factors that should be used to determine how bad a person's conduct really is.

Dog Bite Lawsuits Account for a Third of Homeowner Insurance Liability Claims

A report issued last month by the Insurance Information Institute found that more than one-third of all homeowner insurance liability claims paid out in 2009 were due to dog bites. The report indicates that liability costs associated with dog bite lawsuits were $412 million in 2009, a 6.4 percent increase from the previous year and that the cost of such claims increased for the fifth year in a row. You can read the report here. For more on the story go to AboutLawsuits.com.

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.