Tuesday, November 30, 2010
The findings of a new study suggest that efforts to decrease the number of medical mistakes in U.S. hospitals have generally failed, reports AboutLawsuits. According to the study, published in the most recent issue of The New England Journal of Medicine, patient safety has not improved since a landmark study ten years ago that put the number of patient deaths due to medical error at 98,000 annually in American hospitals. Alan Crede has more on the story here, including links to more sources.
Monday, November 29, 2010
The September 11 suit concerning 10,000 emergency response and clean-up workers at the World Trade Center settled in June for $712M, with an important provision: At least 95% of the plaintiffs had to agree. And apparently that number has been reached. Go here for more details. Go here for the full story.
About a week ago I reported on another J&J recall (for bottles of Benadryl). Today there are news on yet another recall, this time for Tylenol-cold. Pharmalot has the story here. AboutLawsuits has it here.
The Chicago Bears' victory over the Philadelphia Eagles yesterday was marred by the death of a fan at Soldier Field — the second recent death at a major sporting event this month - reports Prof. Jonathan Turley today. He also comments on the other case - the death of a two year old boy who was able to climb over a glass barrier to plummet to his death at the Staples Center in Los Angeles. Go here to read his comment on the possible torts implications of these events.
Sunday, November 28, 2010
Would it be a good idea to encourage patients to sign "medical malpractice waivers" to give up their rights to sue their doctor for any medical malpractice? In a chapter in his book "Nudge," Professor Cass Sunstein suggests that patients would benefit from such waivers because the cost of health care would be lower (because doctors wouldn't have to pay for medical malpractice insurance or order unnecessary tests to make sure their patients didn't sue them) and doctors could pass on the savings of avoiding those costs to their patients. Alan Crede has recently published a good response to this idea here. He also points out to an article by professors Tom Baker and Timothy Lytton in the Northwestern Law Review entitled, "Allowing Patients To Waive The Right To Sue For Medical Malpractice: A Response to Sunstein and Thaler." You can read the article here. Crede argues that the article is a devastating and complete knockdown of the chapter in "Nudge" in which Sunstein proposes medical malpractice liability waivers. Long time readers of this blog, and my students, may remember Baker as the author of a very good little book called the Medical Malpractice Myth (for an excerpt, go here). For a recent interview with him go here.
The PopTort is commenting on the most recent report from The National Center for State Courts on civil litigation in the United States. The report covers the year 2008 and according to the comment by The PopTort, it concludes that tort caseloads fell by 6 percent from 2007 to 2008 in 13 general jurisdiction courts reporting, whereas contract caseloads rose sharply, increasing by 27 percent in those courts over the same time period. Go here for more on the story. I have not had a chance to look at the report itself, but I will keep it handy so I can take a look at it the next time someone claims we need "tort reform" to deal with the massive numbers of "frivolous lawsuits" our court supposedly have to deal with all the time.
About a month ago, 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. I posted a comment about this here. However, as part of a response to a state senator from New Jersey, the FDA is denying there is a problem. The senator had asked the FDA for its views on a proposed bill in the New Jersey legislature that would prevent pharmacists from switching anti-epilepsy pills over concerns that some patients have reacted poorly to generics that are deemed bioequivalent (read here). In its reply to the senator, the FDA wrote that it has many years of experience reviewing, approving and monitoring of generics and asserted that "we have not seen evidence that demonstrates a problem with therapeutic equivalence for this group of products [generic drugs].” However, it went on to say that the concerns “can not be dismissed lightly” and that out of respect and concern “that patients may lose confidence in their prescribed medications, we have sought to conduct further study.” Go to Pharmalot for the full story. In response to this, the Washington Legal Foundation again reacted with strong criticism of the FDA stating: "Either FDA felt it didn’t owe this state senator any information about impending studies, or nothing in fact is pending. In denying the existence of any problems with any generic drugs and stressing that there is no doubt at the agency, FDA seems to betray its extreme sensitivity to scrutiny of its generic drug approvals. FDA’s own senior leadership has called the Office of Generic Drugs on the carpet for public concern over generic quality, and the agency has been strongly challenged recently over its sudden alterations of bioequivalence criteria for generic versions of complex medicines including extended-release products and locally acting drugs. The bureaucratic hubris FDA exhibits on bioequivalence is irresponsible and unhealthy, given the dire potential consequences of breakthrough seizures if a generic [Anti Epileptic Drug] is ineffective, or if a copycat locally acting anti-bacterial medicine fails to stop an infection. FDA certainly doesn’t feel accountable for any of this to a state senator who represents epilepsy sufferers. Nor is the agency in any hurry to be accountable to Congress on concerns over epilepsy drugs – FDA is almost two months overdue with a report federal elected officials sought on generic AED bioequivalence standards . . ." Go here for the WLF's full comment. For more go to the FDA law blog.
Saturday, November 27, 2010
Tuesday, November 23, 2010
Monday, November 22, 2010
A federal judge has ruled tentatively that he would reject most of Toyota’s legal challenge to the hundreds of suits filed in the wake of claims that the company’s vehicles were mysteriously accelerating. Go here for the full story.
Friday, November 19, 2010
A couple of days ago, I reported that the magazine Corporate Counsel was going to publish a long article about a former lawyer for Toyota who has accused the company of hiding important and relevant documents in product liability cases. Here is the link to the article. (Note it is six pages long; you have to keep hitting "next" at the bottom of each page to keep reading.)
Thursday, November 18, 2010
Long time readers of this blog will remember that I have criticized New York courts on more than one occasion for their sloppy analysis when it comes to the concept of assumption of the risk. See here and here, for example. The first of these cases, about which I reported on back in April of 2009 is back in the news because the Court of Appeals just heard oral arguments. I am hoping the Court corrects the mistake.The case is called Anand v. Kapoor and it is available here. My original comment about it is availble here. This is the case in which the New York state Appellate Division, Second Department, discussed the issue of whether a golfer can be liable for his conduct on the golf course if this conduct creates an unreasonable risk of harm to others. In the end, the court held that the voluntary decision to participate in the game means that golfers assume the risk of injury regardless of how the injury occurs. As I said last year in my original post on this case, I disagree with this holding as a torts professor and as a golfer! Sports activities do present risks to participants but that does not mean that other participants do not have a duty to act like reasonable people. Even if there is an inherent risk of getting hit by a ball on the golf course -- something I am not sure I agree with -- I don't think that means a golfer assumes the risk of getting injuried because of another golfer's negligence ... unless what the court is trying to say is that golfers simply have no duty to exercise due care when playing the game, which, in my opinion, would be contrary to public policy. For my full comment on the case go here. For more on the case go to the Wall Street Journal law blog.
Tuesday, November 16, 2010
Following up on my post from two days ago on this topic, the PopTort is offering today a short comment (with links to more) on the "“not so well thought out” ideas of the Co-Chairs of the deficit reduction commission" to enact a national cap on damages. Such a measure would disproportionately hurt seniors and other injured victims like women who work inside the home, children and the poor, who are more likely to receive a greater percentage of their compensation in the form of non-economic damages if they are injured. Go here for the full story.
Sunday, November 14, 2010
The New York Times' Room for Debate - a page dedicated to publish short opinion pieces on interesting timely topics - has just published a series of entries on the topic of "ways to cut the deficit." (Available here). Not to be missed among the 16 different short pieces is one by Michelle Mello, a professor of law and public health at the Harvard School of Public Health in which she tries to (very weakly) advance the myth that tort reform is worth pursuing as a way to reduce the deficit (here). Because, I guess, eliminating or obstructing the rights of victims of medical malpractice to recover is a good way to help the economy! To her credit, Prof Mello admits to the weaknesses of her position and to the lack of support for her conclusions. Unfortunately for her argument, though, what she is left with is a position with no support. She starts by pointing out that medical liability costs amount to about 2.4 percent of total health care spending and that, as a result, the potential for reducing our health care bill through liability reform is modest. "Modest" is an understatement. As has been demonstrated by a number of reports (including one authored by Prof. Mello herself) tort reform would not reduce the costs of health care. Go here for previous posts on this issue. Prof. Mello even admits that the Congressional Budget Office estimates that nationwide implementation of a package of five traditional tort reforms, including caps on noneconomic damages, would save 0.5 percent of health care spending. But, of course, the myth persists, because despite the evidence and the reports available, as she puts it, "it is difficult to precisely estimate the savings . . . especially if the particular reforms that Congress adopts prove more effective than the traditional reforms . . ." In other words, maybe we'll save more if Congress comes up with better alternatives than the ones that don't work. Can't argue with that logic! Prof. Mello suggests better alternatives include reforms that encourage early settlement of disputes, alternatives to litigation, and “safe harbors” for doctors who practice according to well-accepted practice guidelines. Yet, these alternatives have also been discredited. See here, here, here, here, here, here, here, here, here, here and here for just some examples. I am all for alternatives to litigation but not for alternatives that eliminate the right of victims to recover for their injuries or that make it more difficult for them to have access to the courts. I am also intrigued by this notion of "safe harbors" for doctors, which as she describes it does not need to be legislated. This "reform" already exists and works well. It is called the burden of proof that all plaintiffs need to prove when it comes to duty and breach of duty. Her comment seems to be based, again, on the myth that plaintiffs can just go to court and accuse a doctor of negligence without having to support the argument with actual evidence that they deviated from the standard of care - which anyone who knows anything about tort law knows has to be supported with expert evidence too and which is not an easy burden to meet. In the end, having spent more words weakening her own argument than supporting it, Prof. Mello concludes that "[g]iven the abysmal performance of the liability system in serving the needs of injured patients . . . reform is well worth pursuing even if it does not prove to be the next big deficit buster." I wonder what evidence there is about this claimed abysmal performance. What is it so bad about the liability system? Is it that plaintiffs don't get compesated fairly? Hm, could that be because of the many states that limit liability arbitrarily by imposing caps on damages? Or is it that victims don't have easy access to justice? Well, let's see, could that maybe be because of the many states that require plaintiffs to provide certificates of merit even before they have access to the evidence they need to prove their claims? It seems to me that, if the litigation system has resulted in an abysmal performance, maybe the reason is tort reform and not the litigation system itself. All that aside, the question remains, is medical malpractice reform really something to consider in the debate over the deficit? Even assuming it could save some money, what would be the real cost? Do we really want to go tell the victims of medical malpractice that they should give up their rights in order to save a minimal amount of money to help reduce the deficit?
As you know, Toyota has been in the news recently because of claims of defects in its cars that cause sudden acceleration problems. A side story to that on-going litigation is the litigation against one of its former lawyers who has accused the company of hiding important and relevant documents in product liability cases. I reported on this back in March (here). A couple of days ago, Law.com posted a video previewing an upcoming story in Corporate Lawyer on the lawyer who has accused Toyota of discovery fraud. The video of a conversation with the lawyer is available here.
Friday, November 12, 2010
Whether the Accutane acne medication (now off the market) was capable of causing someone to attempt suicide has been a long-standing debate. Pharmalot is reporting today that a new study suggests Accutane may be linked to suicide risk. Go here for the full story. UPDATE 11/17/10: AboutLawsuits.com has the story (including a link to the study itself) here.
This is not really a torts story but since I have posted so many stories on the Avandia debacle, I am posting the headline and you can go read the full version here. The gist of it is that the Utah Attorney General has filed a lawsuit arguing that GlaxoSmithKline illegally marketed its Avandia diabetes pill and should repay the state $7.8 million, which is the amount Utah spent to purchase Avandia between Jan. 1, 2001 and June 30, 2010 for its Medicaid program. UPDATE 11/17/10: AboutLawsuits.com has the story here.
Thursday, November 11, 2010
As we observe Veterans day today, I would like to invite you to take a look at this page where I have stories about torts that affect veterans and people in the military. Scroll down and read the headlines as you go up to see them in chronological order. There are a number of very interesting stories there.
Tuesday, November 9, 2010
AboutLawsuits.com is reporting today on yet another new report criticizing the FDA's shortcomings in its oversight and inspection functions. According to the story, this new report, published last week in the British Medical Journal, indicates that the FDA is currently unable to protect the public from harmful medical devices because it lacks the manpower, the budget and the authority to do so. Go here for the full story and more links. This is just the latest in a series of reports criticizing the FDA. For more information on some of the other reports that have found the FDA is not an efficient or reliable agency go here, here, here, here, here and here.
Saturday, November 6, 2010
Friday, November 5, 2010
Thursday, November 4, 2010
Go here for a recap of the oral argument in Williamson v Mazda in the Supreme Court blog. According to the Wall Street Journal, the Court appeared divided on whether to allow state product liability lawsuits against car makers for installing lap-only seat belts. Click here for Brent Kendall’s story in the WSJ and here for more from the Wall Street Journal law blog.
Wednesday, November 3, 2010
Here is the link to the transcript of the oral argument in Williamson v Mazda. For the background on this case, go here, here and here. Go here for copies of the briefs and other legal documents.
A few days ago I reported (here) that plaintiffs in the lawsuit against Toyota for damages caused by sudden acceleration have alleged that Toyota investigated sudden-acceleration incidents and then bought back vehicles from the customers who reported problems making them sign confidentiality agreements. AboutLawsuits has picked up the story today here.
AboutLawsuits.com is reporting that Forest Laboratories is beginning to settle lawsuits that allege that its antidepressants Celexa and Lexapro caused teenagers to attempt suicide or take their own lives. The Celexa and Lexapro settlements come about a month after the company pled guilty to illegally marketing of the drugs to children. There are 54 lawsuits pending against the company, which were consolidated and centralized in federal court in St. Louis. The defendant agreed to settle four of the cases last week, two others in the weeks before that and more settlements are expected in the coming months. Go here for the full story.
Here is the perfect follow up to my most recent post! As I reported back in June (here), 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. This morning, the FDA law blog is reporting that the U.S. Solicitor General of the United States has filed its highly anticipated amicus brief. The Solicitor General’s recommendation is that the Supreme Court deny review given the current lack of a split of authority among the Circuit Courts on the issue of preemption and state law failure-to-warn claims against generic drug manufacturers, as well as several uncertainties in Mensing that “further counsel against review at this time.” For the quick background to understand this story go here. Go here to read the story in the FDA law blog. Go here for a copy of the brief itself. For my previous posts on this topic go here, here, here, here, here, here and here. Here is the bottom line of the Solicitor General's brief: "The court of appeals correctly held that respondent’s failure-to-warn claims are not categorically preempted, because a generic pharmaceutical manufacturer, like a brand-name manufacturer, can (and indeed, must) inform FDA of new information about risks that may require a change in the labeling of its drug." UPDATES: 9:45am: More on the story at SCOTUS blog here. 10:15am: Pharmalot has the story here. Nov 4: Drug & Device law blog has a comment here. Nov. 5: AboutLawsuits.com has a comment here.
Tuesday, November 2, 2010
Here is a short video, courtesy of the Washington Legal Foundation, on some intereting issues related to preemption and generic drug manufacturers. The whole topic is very interesting, but I want to hightlight one related issue. Note how the speaker argues in favor of preemption by arguing that generic manufacturers are obligated by law to provide the exact same warning that brand name manufacturers provide and that generic manufacturers are not allowed to change or update the warning unless the brand name manufacturers do so first. Brand name 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. Here is what I find intersting about that argument: there has been a lot of discussion (see here) about whether a brand name manufacturer should be held liable for injuries suffered by the user of a generic equivalent. I understand that sounds unfair, and I think it would be unfair if the drugs are not really "equivalent" (for more on that issue go here). But what if the claim is for lack of adequate warnings? If the warnings in the generic drug are essentially controlled by the brand name manufacturer and they are inadequate, can't you say that the brand name manufacturer contributed to the injury and should be partly responsible? I don't see why not. For my previous posts on this topic go here, here, here, here, here and here.
I have mentioned several times that tomorrow the Supreme Court will hear oral arguments in Williamson v. Mazda Motor, which asks the Court to determine the preemptive effect of the National Highway Transportation Safety Administration regulations on seat belts and which will allow the court to review its 2000 decision in Geier v. American Honda Motor Co. Here is a link to an article on the case, via the SCotUS blog. The PopTort also has a preview here.
A few days ago I reported (here) that the Government Accountability Office (“GAO”) recently published a report that sharply criticizes FDA for persistent shortcomings in its oversight and inspection of foreign drug establishments. Two other blogs have picked up the story. For more go to AboutLawsuits.com and Pharmalot.
Monday, November 1, 2010
Jay Feinman, Distinguished Professor of Law, Rutgers-Camden, has posted a very good short comment on the TortsProf Blog titled "Tort Law and the New Economics of Insurance." Here are the first two paragraphs: There is widespread acceptance of the idea that tort law and insurance are intimately related. The growth of liability insurance permitted the expansion of tort liability through the twentieth century, and the expansion of tort law in turn spurred the further development of liability insurance. The compensation objective of tort would not be served without the presence of insurance. First-party insurance obviates the need for tort in some circumstances and, through the collateral source rule, effectively funds contingent fees in other circumstances. And so on. All of these ideas are based on the assumption that insurance works—that companies assess risks, insureds purchase policies against those risks, and the companies pay claims that are within coverage. Unfortunately, the facts about insurance are increasingly at odds with this assumption. Most companies pay out most claims most of the time, of course. But more and more, insurance companies deny valid claims in whole or part and force policyholders and tort victims to litigation to obtain the benefits to which they are entitled. Go here to continue reading the full comment.