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.