Friday, February 27, 2009
Pharmaceutical company in trouble for attempts to get doctors to prescribe drug to children
The New York Times reports that the Justice Department has filed a complaint against a pharmaceutical company for violations of FDA regulations. The charges were filed last Wednesday against the drug maker Forest Laboratories for defrauding the government of millions of dollars by illegally marketing the popular antidepressants Celexa and Lexapro for unapproved uses in children and teenagers. The drugs are currently approved by the Food and Drug Administration only for adults.
The complaint alleges that former top executives at Forest concealed for several years a clinical study that showed that the drugs were not effective in children and might even pose risks to them, including causing some to become suicidal. It also alleges that from 2001 to 2004, Forest heavily promoted results from a clinical trial it had financed that showed that the drugs were effective, without disclosing the negative study to those researchers, its own medical advisers or its sales representatives.
Doctors are free to prescribe drugs to patients, including children, for whom those drugs are not approved by federal regulators. But it is illegal for companies to actively promote such uses.
Under the civil charges brought against Forest, the government is seeking to recover up to three times the amount of money spent by federal programs to pay for pediatric prescriptions of Celexa and Lexapro, but did not specify a figure.
Prosecutors also charged that Forest paid kickbacks, in the form of baseball tickets and gift certificates to expensive restaurants, to doctors who prescribed its drugs, and provided some doctors with paid vacations.
Currently, drug makers are required to disclose the results of all their clinical trials. But the issues surrounding Forest’s marketing of Celexa and Lexapro date to before those rules were in place.
For the full story, click here.
Labels:
FDA,
Legislation and regulation,
Pharmaceuticals,
Sports
Lawyer Sues Neighbor over ‘Squealing’ Chihuahuas
"A Manhattan lawyer claims in a lawsuit that two Chihuahuas owned by her neighbor in an apartment building bark so much and so loudly that her chronic back pain is worsening. Lawyer Paulette Taylor says she wakes up several mornings a week because of the “whining, barking, yapping and squealing" by the dogs, the New York Daily News reports. On those days, her back pain “increases exponentially so that she experiences agonizing, acute back pain even before standing and taking her first step of the day and finds herself unable to go back to sleep," the suit says. The suit names the neighbor who owns the dogs and management at Taylor’s apartment building in Central Park West, according to the Daily News account. Taylor claims in the complaint that she has complained to the defendants and police about the dogs, but the animals continue to bark “in a manner that is offensive, constant, continuous and incessant,” the story says."
Thanks to Debra Cassens Weiss at ABA Journal.com
First complaint filed re the Continental plane crash in Buffalo
The first wrongful death lawsuit has been filed involving a passenger of the Continental Connection commuter airplane that crashed on Feb. 12 in upstate New York, killing 50 people. Full story here.
Over in my Professional Responsibility blog I have a couple of posts - and a number of links - on issues related to the solicitation of clients by law firms after the crash. See here and here.
Tobacco industry newest product
This is not a torts issue, but give it some time. I am sure eventually, somehow, we'll be talking about it in this context.
Jonathan Turley's blog reports today that R.J. Reynolds Tobacco Co's latest innovation is chewable tobacco that looks like candy. Orbs Dissolvable Tobacco is being test marketed in Portland and looks like a box of mints but has more nicotine than a cigarette. The American Cancer Society has denounced the product, but R.J. Reynolds insists that it has a warning label to discourage the use by children. In his characteristic style Prof. Turley adds he is "personally looking forward to the Nicotine Jawbreaker and the Tobacco Sucker." For the full story, click here and here.
Here is a photo of the packaging in question. Note the little tablet, which looks like mint:
Top torts stories of the past week
Click here for a list of links to the most interesting stories of the week ending Feb 27, 2009.
Thanks to TortsProf Blog for the information.
Wednesday, February 25, 2009
Tort Reform Bill in Oklahoma
H.B. 1603 passed the Oklahoma House Judiciary Committee and now moves to the full House. The bill would "cap non-economic damages; require an expert witness for pre-certification of a lawsuit; and eliminate joint and several liability, among other reforms." More from Insurance Journal. (Thanks to the TortsProf Blog for this information.)
Like all tort reform bills, the goal is both to make it more difficult for plaintiff to bring claims and to reduce the amount they can get as compensation for their injuries. The provision requiring "pre-certification" will make it more difficult for plaintiffs to bring claims; the partial elimination of the collateral bar rule and the total elimination of joint and several liability will allow a defendant to avoid paying the total value of the damages they caused. A bill with similar provisions was declared unconstitutional in Illinois a long time ago, and a bill with caps on damages in medical malpractice cases was declared unconstitutional in Georgia just a few days ago. See here.
Tuesday, February 24, 2009
Complex litigation plan is set for 9/11 respiratory damages claims
Plaintiffs lawyers and New York City are now ready to follow a road map a federal judge hopes will result in settlements in the complicated process of determining liability for respiratory damage allegedly suffered by thousands of workers who participated in the cleanup of the World Trade Center site. A total of 225 of the most severe cases have been selected by two special masters appointed by Southern District of New York Judge Alvin Hellerstein in the litigation brought by more than 9,000 plaintiffs. Of that group of 225, six cases will soon be selected for what are formally scheduled to be trials but are really a path toward settlement. Two of those sample cases will be selected by New York City, its contractors and other defendants; two more will be selected by attorneys for those who claim injury from the cleanup of toxic materials; and another two will be selected by the judge himself. For the full story go here.
Labels:
Litigation/procedure,
Settlements
Oregon increases damages limits in cases vs the government
About a month ago I reported that Oregon was debating placing a cap on damages in torts cases. Surprisingly, today the TortsProf Blog reports that the Oregon Senate has passed a bill that would substantially increase liability tort limits in cases against the government. According to the report, "[c]urrently, liability against a government agency is capped at $200,000. The new bill raises the cap and sets up a two-tier system depending on whether the suit is against the state or a local government. As LegalNewsline reports, for claims against state government, the bill increases "the liability cap $100,000 a year to a maximum of $1.5 million by 2015 for individual claims against state government. The plan would increase the cap to $3 million for all claims from a single incident." The Oregonian also has more."
Thanks to TortsProf Blog for the information.
Wisconsin Parents Sue Over "Time-Out" to Middle School Student
Jonathan Turley reports today that the parents of a student at Greenfield Middle School in Brookfield, Wisconsin have filed a $50,000 calim against the school for false imprisonment and battery because the school gave their daughter a “time out.” The full story is available here. Maybe I should be worried. If this claim is recognized, I am going to have to make sure we have "parental immunity"!
Comment on "libel tourism"
The Consumer Law & Policy Blog posted today a long comment on the issue of libel tourism. The first and last paragraphs are reproduced below. For the full story, go here.
"A currently developing situation represents a new low for “libel tourism” – the practice of bringing libel claims against United States defendants in foreign courts where the First Amendment and other provisions of US law that protect free speech are not recognized. The plaintiff's objective is to suppress speech by obtaining a judgment abroad and then claiming that international principles of comity require that the judgment be recognized – subject to a possible defense that enforcing the judgment would violate public policy – or at least to intimidate other speakers that might be tempted to engage in similar criticism.
. . . . The challenge of libel tourism has begun to receive a legislative response, ensuring protection from abusive foreign litigation against speech without having to rely on case-by-case recognition of the significant public policies protecting free speech. In the past year, statutes have been enacted in New York, CPLR 5204(b)(8), and Illinois, 735 ILCS 5/12 621(b)(7) declaring that foreign defamation judgments from jurisdictions that do not uphold American free speech values are unenforceable as against public policy. The House of Representatives also passed such a bill last year, although the Senate took no action on similar legislation proposed by Senators Specter and Lieberman. As Congress begins to consider such bills in the coming year, it should include protection for the immunity of the hosts of allegedly defamatory web sites, because interests abroad that are hostile to free speech can easily suppress opinions they do not like without ever suing the actual speakers, simply by intimidating the companies that host that speech online."
Comment on the recent case re damages for wrongful death of chain smoker
In my recent post about the Florida case that awarded several million dollars for the wrongful death of a chain smoker, I concluded that "obviously, this is not the last we will hear about this case. I am sure the defendant will first ask the lower court to apportion fault, if that fails, to lower the punitive damage award, and then appeal. Stay tuned...." Today, Professor Anthony Sebok has published a column titled: "The Recent, Eight-Million-Dollar Verdict Against Philip Morris and in Favor of A Smoker's Family: Why It Will Likely Be Reversed as Unconstitutional." The title says it all. You can access the article here.
Labels:
Damages,
Products liability,
Punitive damages,
Wrongful death
Monday, February 23, 2009
Merchant's duty to help? ... or policy not to
Today in class we discussed whether a merchant should have a duty to help a customer when the customer is attacked while in (or just after leaving) the establishment.
Right on cue, Jonathan Turley reports a related story from Little Rock, Arkansas. Apparently, a worker at a McDonald's there rushed to help a woman who was struck by a man. The woman's attacker responded by shooting the worker three times.
Based on those facts, the worker was denied worker’s compensation for his injuries (which required three surgeries at a cost of $300,000) because according the the claims person the worker's injuries "did not arise out of, or within, the course of his employment.”
This conclusion was based on the argument that the worker violated an official McDonald’s policy which says that in a robbery situation employees are not to do anything that would put themselves or anyone else in danger.
Sunday, February 22, 2009
Is hunting an adult activity?
In class we discussed whether a child's conduct should be evaluated using the reasonable prudent person standard or a special standard that takes into account the child's age and other characteristics.
Today I read a report on a case from a town in rural Pennsylvania where an 11 year old killed his dad's girlfriend. What I found interesting is that the kid reportedly used "a youth model 20-gauge shotgun — a gun designed to be used by young children."
Take a moment to think about that sentence: "a gun designed to be used by children."
Here is a link to the Orange County NY Shooters with a list of guns for children and take a look at how they make fun of those who claim there is something wrong with giving children a gun. Also, take a look here for a comment on a proposal in South Dakota to lower the legal age for hunting to 10.
If there are guns designed for young children (as there are snowmobiles, ATVs, and motorcycles), and if hunting is an activity that can commonly be done by minors, should we still be talking about "adult activities"? Are there any activities that we can say are exclusively "adult activities"?
Some jurisdictions have abandoned the terminology of "adult activity" and instead refer to "inherently dangerous activities". In those jurisdictions, children engaged in inherently dangerous activities can be held to the standard of care that would apply to an adult. But here is a question: can an activity in which children participate using an instrument specifically designed for children be considered "inherently dangerous"?
If you think that the underlying policy behind the notion of "inherently dangerous" activities is that the activity is somehow "inappropriate" for children then the answer should be No. But I think that inherently dangerous means something else. I think we should think of the underlying policy as one related to the risk involved. If the activity creates a high level of risk when children engage in it, then the child should be held to the standard of care of an adult.
If there are guns designed for young children (as there are snowmobiles, ATVs, and motorcycles), and if hunting is an activity that can commonly be done by minors, should we still be talking about "adult activities"? Are there any activities that we can say are exclusively "adult activities"?
Some jurisdictions have abandoned the terminology of "adult activity" and instead refer to "inherently dangerous activities". In those jurisdictions, children engaged in inherently dangerous activities can be held to the standard of care that would apply to an adult. But here is a question: can an activity in which children participate using an instrument specifically designed for children be considered "inherently dangerous"?
If you think that the underlying policy behind the notion of "inherently dangerous" activities is that the activity is somehow "inappropriate" for children then the answer should be No. But I think that inherently dangerous means something else. I think we should think of the underlying policy as one related to the risk involved. If the activity creates a high level of risk when children engage in it, then the child should be held to the standard of care of an adult.
Labels:
Children,
Prima facie case,
Standard of care
Settlement in case re social host liability
Some time ago, I posted a comment regarding a case that imposed liability on an establishment with no liquor license for the injuries caused by someone who got drunk there. I argued that at some point the same reasoning would be used in a social host type case.
Today I saw a report of another interesting development in this area of the law, although it will not set any kind of legal precedent.
The Chicago Tribune is reporting that a Lake Forest (a suburb of Chicago) woman's homeowners insurance will pay $2.5 million to settle a lawsuit brought by a plaintiff who was paralyzed in a crash that occurred after an underage drinking party in her home.
In this case, some teenage girls invited some friends over to their house (presumably while the parents were away). The girls provided alcohol to their guests. To go home, the plaintiff got a ride from another boy who was drunk. It is not clear from the report whether the plaintiff was drunk too. On the way, the driver lost control of the car and crashed causing the plaintiff's injuries.
It is interesting that the parent here did not buy the alcohol for the teens or knew they were drinking in her home. I suppose the insurance policy somehow covers conduct by the children -- otherwise, I am sure the insurance company would have challenged coverage. Also, I wonder if the defendant argued that the plaintiff was negligent himself in deciding to get in the car in the first place -- assuming the driver was visibly intoxicated.
The plaintiff also sued the kid who was driving the car. That defendant has not settled and the trial is scheduled to begin in March.
Labels:
Alcohol,
Children,
Illinois,
Proximate cause,
Settlements,
Social host liability
Saturday, February 21, 2009
The battle over preemption continues
The battle over preemption continues. Yesterday The New York Times published an article (available here) with an overview of the expected fight in Congress to restore people's legal rights against medical device manufactures, which the Supreme Court ruled were preempted by federal law last year. (An earlier article about that case is available here).
The Pop Tort blog has a comment on this here, in which they cite a separate opinion by Wisconsin Supreme Court Justice Ann Walsh Bradley in which she states: “I write separately in order to express my concern that the United States Supreme Court's interpretation of the 1976 Medical Device Amendments does not adequately protect the safety of the citizens of Wisconsin. With one stroke of a pen, it has diminished the states' traditional authority over the development of the common law and substituted instead mandatory adherence to a regulatory standard that may be substandard. I do not believe that such adherence was mandated by the express language of the amendments, although I acknowledge that I am bound by the Supreme Court's interpretation.” This opinion was part of the Court's decision in a case in which it ruled against a man who had a faulty defibrillator.
Labels:
FDA,
Preemption,
Products liability
New case on medical malpractice & medical monitoring
As you know, medical malpractice is a controversial area of the law. Many attempts to "reform" the law of torts concentrate on medical malpractice litigation. Check the list of recommended readings for some very informative materials on the subject (most of them are available for downloading in my documents page).
In any case, today, the Drug & Device Law Blog posted a discussion of an interesting new case that combines medical malpractice, medical monitoring, products liability and civil procedure. It is very interesting. Here is the link.
The facts are long and complicated but they involve an open heart surgery on a newborn baby during which the doctors implanted a device that was not FDA approved - for anything. The court dismissed some of the claims but eventually allowed one for "medical monitoring" which means the defendant will have to pay for the costs the plaintiff incurs in the future due to the need to continue monitoring a condition.
The authors of the blog do not agree with the decision. After a very detailed description of the case and the issues, they conclude: "Thus, in the end, we have to conclude that the pair of Guinan decisions produced a parody of established medical monitoring law. Delaware hasn’t recognized medical monitoring at all, and certainly hasn’t applied it to drug/device product liability cases. A federal court sitting in diversity has no business making that kind of decision for a state. Beyond that, even if Delaware were to recognize this very controversial tort – it’s still a tort. Medical monitoring isn’t free health insurance – the law doesn’t make a product manufacturer pay for somebody’s medical tests simply because it admits that those tests might be a good idea. There has to be a tort – some form of wrongful conduct – and in Guinan there simply wasn’t. The court recognized that, by dismissing every other cause of action that the plaintiffs had, whether based on negligence, strict liability, warranty, or fraud, but decided to let the plaintiffs proceed anyway."
Friday, February 20, 2009
Top torts stories of the past week
Click here for a list of links to the most interesting stories of the week ending Feb 20, 2009.
Thanks to TortsProf Blog for the information.
Thursday, February 19, 2009
Florida Jury Awards $8 million to Family of Chain Smoker
This jury verdict is getting a lot of attention in the blogsphere... and this is certainly NOT the end of it.
The reports I have seen state that the widow and son of a man described as a "chain smoker" who died at age 55 sued Phillip Morris arguing PM showed reckless disregard in concealing the adverse effects of smoking and the addictive nature of cigarettes. The jury awarded $8 million, including $5 million in punitive damages. The plaintiffs had originally asked for $131 million.
A report I saw also stated that the jury found the decedent 58 percent responsible for his own death, and attributed 42 percent of the fault to Philip Morris. But because it also found that the cigarette manufacturer intentionally omitted information that contributed to his death, fault can't be apportioned and the company, at this point, must pay full damages.
Maybe the newspapers got this all wrong, but if the account is accurate, it shows a couple of interesting points: first, note that the decedent's negligence is higher than that of the defendant but the plaintiffs are allowed to recover anyway. This must mean that either the state follows a "pure comparative negligence approach" (according to which a plaintiff can recover regardless of their degree of negligence) or that the state does not take into account the decedent's conduct in determining the right of the plaintiffs to recover. In contrast, most states that apply comparative negligence follow a "modified approach" (according to which the plaintiff's level of negligence must be lower or at least not more than that of the defendant) and most states do take into account the conduct of the decedents in deciding wrongful death cases.
Second, the notion that the judgment will not be apportioned is very strange. Again, if accurate, it suggests that the state follows a very particular rule the effect of which is to impose the duty to pay the full judgment on only one of the tortfeasors when the other one is the plaintiff's decedent. This rule eliminates the effect of the evaluation of the decedent's conduct.
Obviously, this is not the last we will hear about this case. I am sure the defendant will first ask the lower court to apportion fault, if that fails, to lower the punitive damage award, and then appeal.
Stay tuned....
For one of the many stories on this out there, go to the Miami Herald.
Miami Heat Star Dwyane Wade Sues Wife and her Lawyers
Professional basketball player Dwyane Wade (of the Miami Heat) has filed a libel suit against his estranged wife and her lawyers for allegations in a divorce filing that he had an affair and contracted a sexually transmitted disease. The allegations, which allegedly were originally distributed to the media, were later withdrawn. The suit was filed in Chicago and seeks at least $50,000 in damages from each defendant. For more on the story go to the Chicago Sun-Times and the Associated Press.
Interestingly, instead of speaking to the merits of the complaint, the wife's lawyer declared that the libel suit “brings Dwyane Wade’s social life into question.” “If I were Mr. Wade I would not want that. It will be interesting to know what Mr. Wade’s social life has really been all about.”
Wisconsin Supreme Court Rules Product Liability Claim Against Device Manufacturer is Preempted
Any time a manufacturer of an FDA approved device modifies that device in a way that affects its safety or effectiveness, the manufacturer must go through a Pre Market Approval (PMA) "supplement". One interesting question is whether the filing of a supplemental PMA is enough to preempt claims against the manufacturer in state court. In Blunt v. Medtronic, Inc., ___ N.W.2d ___, 2009 WL 367768, at *7-11 (Wis. Feb. 17, 2009), the Wisconsin Supreme Court says it is.
Here is a post, in full, from the Products Liability Professors Blog by J. David Prince on this case:
The Wisconsin Supreme Court ruled yesterday that state law tort claims against the manufacturer of an FDA-approved medical device are preempted. In Blunt v. Medtronic, 2009 WL 367768 (Wis., 2-17-09), the Wisconsin court concluded that the U.S. Supreme Court's ruling last year in Riegel v. Medtronic, 128 S.Ct. 999 (2008) governed in this case as well. Joseph Blunt had a Medtronic pacemaker implanted in 2004 to keep his heart from failing. Based on its own laboratory testing, Medtronic warned the following year that the devices' batteries might fail in one out of 10,000 patients. Blunt then chose to have the device removed. Medtronic became aware of the problem two years before it issued the warning. The manufacturer submitted to the FDA a supplemental application reflecting design changes aimed at eliminating the battery problem. The FDA approved these changes but did not order the device with its original design recalled nor did it withdraw its 2002 approval of the original design. During all of this time, Medtronic continued to market and sell the device with its original design. Riegel says that a device-specific pre-market approval of a Class III device by the Food & Drug Administration constitutes a federal requirement that preempts any different or additional state law requirements. The Wisconsin court concluded that the specific device implanted in Mr. Blunt, manufactured according to its original design, had been determined to be safe and effective after a rigourous pre-market review by the FDA. It is in precisely that situation that the federal agency's approval preempts state law, including common law, claims. Two Justices concurred but criticized both Riegel and the FDA's process for assuring the safety of medical devices.
Labels:
FDA,
Preemption,
Products liability
Wednesday, February 18, 2009
Is riding a motorcycle an inherently dangerous activity?
This one is for my students, given what we have been talking about in class the past couple of days....Is riding a motorcycle an inherently dangerous activity? Is it an "adult activity"? Check out this video of a 3 year old:
... and this one:
If you go on YouTube and search for "kids on motorcycles" you will find lots of videos like these, including some of actual motocross competitions for very young kids. Some of the motorcycles do have "training wheels" but not all do.
... and this one:
If you go on YouTube and search for "kids on motorcycles" you will find lots of videos like these, including some of actual motocross competitions for very young kids. Some of the motorcycles do have "training wheels" but not all do.
New York Times calls for replacement of Consumer Safety Commission chair
The New York Times has entered the debate on the effectiveness of the Consumer Safety Commission with an editorial in which it calls for the replacement of the agency's acting chairwoman Nancy Nord. The article is available here.
The editorial concludes by stating: "President Obama must quickly replace the commission’s acting chairwoman, Nancy Nord, who opposed adding new resources and authority to her agency. He should then choose the kind of enlightened leadership that every parent and toy lover needs and that will give consumer safety the priority it deserves."
Attorneys General require Bayer to run a $20 million corrective advertising campaign
Twenty three state Attorneys General, including Illinois Attorney General Lisa Madigan, have reached a settlement with Bayer Corporation based on allegations the company violated a 2007 agreement by using misleading advertising to market its oral contraceptive, Yaz. The new terms, which Madigan helped craft with the Oregon and California Attorneys General and the U.S. Food and Drug Administration’s (FDA), require Bayer to submit all future Yaz television commercials to the FDA for approval prior to airing, to comply with all the FDA’s recommended changes to the advertising, and to clearly and conspicuously disclose the symptoms for which the FDA has approved the advertised medications. The Illinois Attorney General's office press release is available here. The impetus for the AGs actions apparently was an October 2008 FDA Warning Letter to Bayer (available here) concerning two Yaz TV spots.
Tuesday, February 17, 2009
Northwest Airlines to serve peanuts again
Although my son has outgrown his allergy to peanuts, this report really bothers me.
As Jonathan Turley reports today, "[p]eople with allergies are legitimately outraged this week by the decision of Northwest Airlines to re-introduce peanuts to its flights despite the large number of kids and adults with severe allergies to the snack."
Given that there are other snacks available that do not pose such a danger to passengers and that it is widely known that millions of Americans are allergic to peanuts, the decision to continue to serve peanuts is incredible. American Airlines stopped using peanuts years ago (they serve pretzels instead-- although these days I am not sure they serve anything at all anymore, but that is another story). Turley reports that
I could not agree more. One time when my boy was 1 or 2 years old a flight attendant who thought he was cute pinched his ckeeks. In a matter of minutes his face had turned red and developed a terrible rash. By the time the plane landed we had to shoot him full of medicine to prevent him from getting really sick... and his allergy was not even that severe (which is why he eventually outgrew it). It is not a stretch to say that a severely allergic child could have died. Assuming a kid does die under similar circumstances, couldn't the plaintiffs prove the level or risk, the number of people at risk, and the low cost of avoiding it.... Couldn't they build a good negligence case? Assuming they can show that the executives who made the decision knew of the risk and decided to go ahead anyway, could they support a plea for punitives....?
As Jonathan Turley reports today, "[p]eople with allergies are legitimately outraged this week by the decision of Northwest Airlines to re-introduce peanuts to its flights despite the large number of kids and adults with severe allergies to the snack."
Given that there are other snacks available that do not pose such a danger to passengers and that it is widely known that millions of Americans are allergic to peanuts, the decision to continue to serve peanuts is incredible. American Airlines stopped using peanuts years ago (they serve pretzels instead-- although these days I am not sure they serve anything at all anymore, but that is another story). Turley reports that
"[t]he airline insists that “We’ll create a buffer zone of three rows in front of and three rows behind your seat. We’ll also advise cabin service to board additional nonpeanut snacks, which will allow our flight attendants to serve these snack items to everyone within this area.” Forgive me for being doubtful. It is often hard to even get a seat on airplanes. I would be interested to see who the airline will accommodate millions of passengers needing a “buffering zone,” as opposed to saying that they will have to take another flight. More importantly, the risk remains that there will be exposure to peanuts in the bathroom, seat armrests, seat trays etc. I remain surprised that airlines have not been held negligent over the use of this snack, which is clearly preferred because it is a cheap option. For the full story, click here."
I could not agree more. One time when my boy was 1 or 2 years old a flight attendant who thought he was cute pinched his ckeeks. In a matter of minutes his face had turned red and developed a terrible rash. By the time the plane landed we had to shoot him full of medicine to prevent him from getting really sick... and his allergy was not even that severe (which is why he eventually outgrew it). It is not a stretch to say that a severely allergic child could have died. Assuming a kid does die under similar circumstances, couldn't the plaintiffs prove the level or risk, the number of people at risk, and the low cost of avoiding it.... Couldn't they build a good negligence case? Assuming they can show that the executives who made the decision knew of the risk and decided to go ahead anyway, could they support a plea for punitives....?
Monday, February 16, 2009
More on the proposed ban on prescription drugs direct to consumer advertising
Here is a link to a comment by the folks over at Drug and Device Law Blog on the proposed ban on direct to consumer advertising of prescription drugs. Remember that some legislators want Congress to pass a bill barring direct-to-consumer advertising for the first two years that a new drug is being sold based, at least in part, on the argument that marketing "increases the number of consumers exposed to safety risks of new products long before those risks are truly understood.” As you would expect, drug manufacturers strongly oppose the idea; but perhaps more surprisingly, D&DL Blog reports that, at least, some generic drug manufacturers oppose it too. Their point does make sense: "Generic manufacturers want the innovators [the drug companies that manufacture the original drug] to spend a ton of money on catchy musical jingles and celebrity spokespatients so there's plenty of demand for the product when it goes generic years later. The innovators' advertising expenses redound in part to the generics' benefit."
What is even more surprising, though, is that the D&DL Bloggers admit they have "mixed emotions" about the proposal. See their reaction here.
They start by stating that "On the one hand, the FDA weighs the risks and benefits of new drugs. If a drug is approved, then the FDA has decided that the drug is sufficiently safe and effective to be made available to the public." Then they counter, "On the other hand, . . . [i]f the company sells less of a product, then there are fewer people exposed to the product, and fewer potential plaintiffs. That would make mass torts less massive and all litigation easier to defend."
It is an interesting approach. But I wonder why is there a need to worry so much about people getting exposed to the product if we can be so confident that if the FDA has approved it, it is "sufficiently safe." I think this exposes a weakness in the first premise, upon which the argument for preemption is also based, by the way. I think it is fair to say that history has shown that we don't necessarily want to place so much faith on the FDA's ability to perform (or efficiency in performing) its function.
Saturday, February 14, 2009
Site's new look
Just for fun, from time to time I will change the look of the website. Feel free to post comments or to e-mail me to let me know what you think... Also check the new look of my Professional Responsibility blog. Let me know if you like that one too.
Peanut Corp. of America Files for Bankruptcy
Law.com reports that the peanut processing company at the heart of a national salmonella outbreak has announced it is going out of business. Can't say that I am surprised! The company had considered a Chapter 11 bankruptcy but decided on an outright liquidation under Chapter 7. Companies file Chapter 7 to liquidate their assets and distribute the proceeds to creditors, as opposed to a Chapter 11 filing that gives a company breathing room while it tries to reduce its debts and continue in business. Since more than a dozen civil lawsuits have been filed against the company, if Peanut Corp. doesn't have enough insurance and enough assets to cover the damages, the other defendants King Nut and Kellogg may have to pay up. The Law.com story is avalable here.
Labels:
Bankruptcy,
Litigation/procedure,
Products liability
Friday, February 13, 2009
Georgia med mal damages cap declared unconstitutional
State Court Judge Diane Bessen has ruled that the Georgia statute that capped medical malpractice non-economic damages violates the Georgia Constitution holding that "[a] limit or cap on noneconomic damages ... invades the right to a jury trial by usurping one of the fact-finding responsibilities of the jury... ." The opinion is available here.
Labels:
Damages,
Medical malpractice,
Tort reform
Top torts stories of the past week
Click here for the list of the most interesting stories of the week.
Thanks to TortsProf Blog for the information.
Thursday, February 12, 2009
Videos on Wyeth v Levine and the issue of preemption
Last year I posted a link to a story on Wyeth v. Levine which included a short video with an interview with the plaintiff. Here are two links to more videos on the case and the issue of preemption. The first one is a 22 minute documentary by Alliance for Justice. The second one is a conference (a little over an hour long) held by the Federalist Society.
Labels:
FDA,
Pharmaceuticals,
Preemption,
Products liability
Update on tort reform in Georgia
About a month ago, I posted a couple of notes on the proposed tort reform plan in Georgia. Today the PopTort.com has posted a short comment on this. It states, in part (the links are in the original):
"Senate Bill 101 introduced last week and endorsed by Governor Sonny Purdue would "limit liability for certain drug and medical device manufacturers and sellers." Which is merely a nice way of saying that a company that markets an unsafe drug or device should be given complete immunity for causing deaths or injuries, as long as the FDA approved the product. This law supposes that the FDA is both capable and willing to ensure the safety of all products it regulates – which many including those within the FDA itself doubt. Ah, peanuts anyone?
"Regardless we have seen time and time again how lawsuits have dissuaded companies from continuing to market an unsafe product. And lawsuits have also had a tremendously beneficial role spurring medical research and alerting the public – and ultimately pressuring regulators – to act on larger health risks and problems.
"Unlike what its supporters assume, this legislation would do nothing to create biotechnology jobs in the state. Michigan, the only state in the nation that has such immunity for its pharmaceutical industry have seen thousands of these high-paying jobs leave their state since Governor Engler signed the bill into law in 1995. (See the CJ&D report A Tragic Blunder: Michigan's Drug Industry Immunity Law to learn more about Michigan's unprecedented law that prevents its residents harmed by dangerous drugs from gaining access to the civil justice system.)"
The full comment is available here.
Labels:
Legislation and regulation,
Tort reform
Peanut Corp president takes the Fifth
Peanut Corporation of America owner Stewart Parnell has invoked his privilege against self-incrimination to refuse testimony before Congress. The case against Parnell and his family is building, including emails that reportedly show that Parnell ordered known salmonella tainted products to be sold. Someone should explain to Parnell that his company is history as is his reputation and much of wealth. The only question is his liberty at this point.
Originally posted by Jonathan Turley.
Update on lawsuit vs Roberto Alomar
Yesterday I commented that I was not sure I understood what the plaintiff's claim was for. Today, CNN reports that she "claims in the lawsuit that Alomar's negligence caused her severe "emotional distress" over the health of her children. Court papers say that because the couple lived with the children, they may have been exposed to Alomar's saliva or blood in the bathroom, through things like toothbrushes and other items. [She] claims to suffer from "permanent emotional distress" even after repeatedly testing negative for HIV. The lawsuit claims her fear of contracting the disease is known as "AIDS phobia" and that she suffers from permanent post-traumatic stress disorder." The new CNN story is available here.
Wednesday, February 11, 2009
FDA finds some "natural" dietary supplements are, in fact, not
The New York Times reports today that, in a continuing investigation that has prompted consumer warnings and recalls by some distributors, the FDA has determined that dozens of weight-loss supplements contain hidden and potentially harmful drugs. For example, the agency found that the "StarCaps" weight-loss capsules, promoted as natural dietary supplements using papaya, contain a potent pharmaceutical drug called bumetanide which can have serious side effects. According to the article, the agency plans to issue a longer list of brands that are spiked with drugs. Michael Levy, the director of the F.D.A.’s division of New Drugs and Labeling Compliance is quoted as saying “A large percentage of these products either contain dangerous undeclared ingredients or they might be outright fraudulent on the ingredients and have no effect at all,” said “We don’t think consumers should be using these products.” The article is available here.
Thanks to Drug and Device Law Blog for the cite.
Claim vs baseball star for exposure to HIV
An ex-girlfriend of former major league baseball player Roberto Alomar has filed a lawsuit alleging Alomar insisted on unprotected sex for four years despite showing obvious signs of HIV. She is seeking at least $15 million in punitive damages. Alomar's lawyer has told the New York Daily News the allegations are "frivolous and baseless." The plaintiff claims she started to date Alomar in 2002 and had unprotected sex for the next four years. She says that Alomar refused to get tested for HIV, despite what she claims were signs associated with AIDS. She says that Alomar finally tested positive for HIV in February 2006 and that follow-up exams determined that he had full-blown AIDS. The plaintiff, however has tested negative.
These claims raise a couple of interesting questions. First of all, it is not clear to me what is the basis of the claim. Is it battery, intentional infliction of emotional distress, negligent infliction of emotional distress? Also, assuming all the allegations are true, given that the plaintiff has not tested positive for HIV, what is the injury? Without more information, it seems that the result of the claim will hinge on whether she can recover merely for the emotional distress at finding out that she had been exposed to HIV rather than having to show that she was infected with HIV. Jurisdictions are split on that question. Also, if she knew of the problem back in 2002, why did she continue to have unprotected sex with the defendant for four years? Should the court find that her own conduct, at some point, gives rise to a defense based on assumption of the risk?
The full story is available here.
Thanks to Alexandros Stamatoglou for the information
Labels:
Baseball,
Emotional distress,
HIV/AIDS,
Sports
More disturbing news on the peanut butter salmonella case
If you like peanut butter, stop reading this right now! I am warning you...
The PopTort Blog just posted an update on the story surrounding the peanut butter salmonella outbreak - available here.
Two interesting items to note:
1. A former plant employee has come forward saying that he once opened a container of peanuts and discovered several baby mice. He also said he witnessed coworkers put “new” stickers on buckets of old peanut paste, and seeing bags of nuts with holes in them, apparently caused by burrowing rats. Even worse, said the former employee, “they would put tape on them or sew them up and send them out.”
2. The U.S. House Energy and Commerce Committee is holding hearings today and asked the president of Peanut Corporation of America, Stewart Parnell, to appear. He said he would not go unless he was subpoenaed (which the committee did on Tuesday).
Family members of Navy personnel sue for wrongful death
Family members of four Navy personnel who were killed in a helicopter crash two years ago are suing the helicopter’s manufacturer for wrongful death. The story is available here.
This is an interesting story because these types of laswsuits are rarely successful. Manufacturers who design and manufacture products for the military according to specific requests (i.e. according to the military's own specificications) are protected by the same immunity that protects the military itself -- unless the plaintiff can show that the manufacturer knew the dangers posed by the product (and that the government did not).
One famous case was made into a movie called "Afterburn" in which Laura Dern plays the widow of a military pilot who dies in a crash. She sued the plane's manufacturer and won at trial. The movie ends there which is a fairly satisfying "hollywood ending." Unfortunately, the reality is that the real case was later reversed and the claim dismissed. You can find that opinion here.
Cheerleading as contact sport
The Wisconsin Supreme Court has ruled that cheerleading is a contact sport and therefore participants cannot be sued for accidentally causing injuries. The opinion is available here.
The plaintiff in the case case was a "flyer" (the cheerleader who is tossed up in the air) who fell while practicing without mats. She sued the cheerleader who was supposed to catch her for failure to spot her, the school district for failing to provide a second spotter and appropriate surfacing/mats. The claim against the "spotter" was dismissed under a Wisconsin statute that provides immunity from liability for injuries caused by negligent conduct to participants in contact sports. On appeal, the Wisconsin Supreme Court found cheerleading to fit within the plain language of the statute ("physical contact between persons in a sport . . .").
For the full story, including many links to further comments, click here, here and here.
Tuesday, February 10, 2009
Health care reform and medical malpractice
"Once President Obama turns his attention to health care reform, what role, if any, will medical malpractice liability reform play?" This is the question Professor Anthony Sebok addresses in his most recent column, available here. In the introduction, he explains his approach: "In order to understand the choices that will really face Obama and his health care czar, we have to clear away a few misconceptions about the relationship between the medical malpractice system and health care costs. In this column, I’ll debunk several leading myths in this area."
Monday, February 9, 2009
Home-invasion death suit settled
This item is not particularly remarkable other than the fact that it deals exactly with what we were talking about in class today.
A few days ago, it was reported that a federal civil lawsuit filed against a homeowner who shot and killed two home invaders in 2005 has been settled. The wrongful-death lawsuit was filed by the parents of two young men who were shot and killed as they fled the home of the defendant. For more details on this story (although there aren't that many) go here.
More criticism of the Obama administration
Here is a report by the Center for Progressive Reform on President's Obama's choice of Cass Sunstein as a "regulatory czar." The introduction explains: "President Obama’s presumptive selection of Cass Sunstein to serve as the “regulatory czar” for his administration surprised most observers. The business community has generally greeted the announcement with satisfaction. Progressives have expressed concern because Professor Sunstein’s long track record on regulatory issues is decidedly conservative. As longtime colleagues of Professor Sunstein who have debated him numerous times in a variety of settings, we write this paper to explain those concerns, in the hope that if and when he is confirmed, we will be able to continue this debate and work with Professor Sunstein . . . in practical ways during the Obama Administration."
The report is available here.
Article on the peanut butter case
Here is a link to a new article on the issues raised by the recent news regarding the the role of the FDA in the peanut butter case. Click here for the article.
Thanks to TortsProf Blog for the information.
More comments on Obama's administration and the future of tort law
The Pop Tort Blog has posted a note critical of the Obama Administration as "business as usual." Here is an excerpt (the links are from the original post):
"When word emerged that the U.S. Chamber of Commerce’s top lobbyist had visited the Obama transition office 16 times, and then “pronounced himself satisfied that the incoming administration will consider the needs of corporate America,” we were left thinking, WTF did that mean? Well, here we go. Obama has chosen Mark Gitenstein to head his Justice Department’s Office of Legal Policy, office overseeing legal policy and judicial nominations. And as the Los Angeles Times reports, Gitenstein faces ethics problems because he was a lobbyist for the U.S. Chamber of Commerce’s Institute for Legal Reform, a group dedicated to eviscerating the civil justice system, using front groups to funnel dirty corporate money into local judicial and Attorney General campaigns, and using the deplorable practice of funding negative attack ads against pro-consumer judges and AG’s."
Suicides in the military part 2
Last week I posted a note on a recent report on the rates of suicides among the armed forces. See here. Today, Prof. Jonathan Turley comments on one specific case:
"As Congress struggles to understand the shocking report of a massive increase in suicides in the Army, they might want to study the case of Army Pvt. Adam Lieberman to see how some officers treat soldiers in mental distress. Lieberman was experiencing severe mental problems after a year in Iraq . . . When he tried to kill himself, he wrote his suicide note on the wall in his room. The Army reportedly responded to the suicide attempt by charging him criminally and cut a deal with this mom. If she re-painted the wall, his charges would not include defacing of government property. After she painted the wall with the help of her handicapped sister, they charged him anyway with the crime. . . . . Under this logic, if a soldier jumps from a window and splatters over a bench or crushes a car’s roof, they would be guilty of the same offense if they survive. The military continues to enjoy immunity from tort lawsuits under the infamous Feres Doctrine [which prohibits military personnel from suing the government for injuries that occur in service.] In the case of private employers ignoring the signs of mental illness and self-medication that the mother has described, there would be a serious threat of liability. Ultimately, most suicide attempts are not treated as a matter for liability for an employer. However, Feres has been blamed for decades in producing a lack of response or concern in many cases."
Note to my students: we will discuss the Feres Doctrine in class as part of our discussion of the Federal Torts Claims Act -- the act that recognizes a limited right to sue the Federal Government arguing tort liability.
Religious rights or torts liability?
Last month I posted a comment on whether there should be a cause of action for injuries to a child when parents refuse medical services for religious reasons (available here). Last week, FindLaw.com published two interesting related articles.
In the first one, Cornell University Prof. Sherry Colb discusses a recent case in Wisconsin where prosecutors charged the parents of an 11 year old child with second-degree reckless homicide for failing to prevent her death. She died of untreated diabetes while her parents prayed for her recovery and chose not to consult a medical professional.
The facts of the case are very similar to those in Lundman v. McKwon, 530 NW2d 807 (MinnApp 1995) in which the court discussed whether to impose tort liability for the same conduct. Although Prof. Colb's article is not about torts liability, the issues discussed are essentially the same. She concludes that whether there should be liability is not as easy as it looks at first glance:
In the second article, Benjamin N. Cardozo School of Law Prof. Marci A. Hamilton discusses the grand jury investigation by a Los Angeles US Attorney into allegations of a child sex abuse coverup by the Catholic Church's Los Angeles Archdiocese. In it, she discusses the claim that the investigation is unnecessary given that the Church has settled torts claims with the victims. In response to this argument, Prof. Hamilton states:
As you can probably guess from this excerpt, Prof. Hamilton supports the grand jury investigation. Her article is available here.
Also recall the recent decision by the Sixth Circuit Court of Appeals recognizing a possible claim against The Vatican for similar conduct. See here.
The facts of the case are very similar to those in Lundman v. McKwon, 530 NW2d 807 (MinnApp 1995) in which the court discussed whether to impose tort liability for the same conduct. Although Prof. Colb's article is not about torts liability, the issues discussed are essentially the same. She concludes that whether there should be liability is not as easy as it looks at first glance:
"Perhaps the most striking fact about the Neumanns, viewed in this way, is that they apparently did not mean for any harm to befall their daughter. They were not trying to discipline her, teach her a lesson, or deprive her of what she needed. They loved her and had, until this tragic episode, apparently taken good care of her. They thought that God would protect Kara, if only they prayed hard enough. By comparison to other, more aggressive zealots, their tragically misguided conduct might seem, in relative terms, far less malevolent."Prof. Colb's full article is available here.
In the second article, Benjamin N. Cardozo School of Law Prof. Marci A. Hamilton discusses the grand jury investigation by a Los Angeles US Attorney into allegations of a child sex abuse coverup by the Catholic Church's Los Angeles Archdiocese. In it, she discusses the claim that the investigation is unnecessary given that the Church has settled torts claims with the victims. In response to this argument, Prof. Hamilton states:
"The apparent reasons behind the settlement are very pertinent: First, early on, the church hierarchy succeeded in getting many claims consolidated . . ., so as to avoid individual litigation. Many survivors wanted their day in court and opposed consolidation, but this procedural move by the hierarchy meant that large collections of cases were treated as though they were single cases with judges overseeing many at one time. That way, the hierarchy could argue to reduce per-person claims, because the size of the total award would be large no matter what and the hierarchy could more effectively and efficiently control what information about the coverup would be released. Second, the Archdiocese settled essentially on the eve of trial, when it appeared that the Cardinal would have to testify regarding his obvious knowledge of a great deal of abuse. In other words, the settlement was a tactic to keep a further lid on damaging information. Thus, despite the settlement, relatively little information, especially given the amount that is still under the sole control of the Archdiocese, has reached the public."
As you can probably guess from this excerpt, Prof. Hamilton supports the grand jury investigation. Her article is available here.
Also recall the recent decision by the Sixth Circuit Court of Appeals recognizing a possible claim against The Vatican for similar conduct. See here.
Friday, February 6, 2009
Ban on direct to consumer advertising?
Almost two months ago, I reported that Rep. Henry Waxman (Calif), the new chairman of the House of Representatives Energy and Commerce Committee, stated he would like to pursue the idea of giving regulators the power to ban advertisements to consumers when a new medicine first reaches the market and risks are not fully known. (Full story here.)
Today, Time/CNN.com has published a story, available here, arguing that "with a new President who has vowed to fight Big Pharma to lower drug costs and a Democratic Congress with several anti-DTC advocates, drug and media companies are justifiably jittery" about a possible ban on direct to consumer advertising.
As the story points out, direct-to-consumer "advertising by pharmaceutical companies has always been somewhat controversial. The U.S. is one of only two countries that permit it (New Zealand is the other). Critics claim that these advertisements encourage consumers to seek out overly expensive brand-name drugs from doctors. Their symptoms might not require such medications, and when they do, cheaper generic drugs may be available. Such marketing probably drives up overall health-care costs. More important, new drugs that are aggressively marketed can pose a safety risk. Merck's heavy promotion of pain reliever Vioxx . . . is a prime example of advertising gone awry. The drug was later taken off the market after it was found to increase risk for heart attacks."
Two items related to claims against the government for injuries to vets
Newsday.com is reporting today that the parents of a 21-year-old ex-Marine who died of a heroin overdose are suing the Department of Veterans Affairs, saying admissions personnel at a VA hospital in Pennsylvania incorrectly advised their son that he was ineligible for medical coverage assistance when he sought treatment there the day before he died. The story is available here. The suit alleges that VA officials told Robert Cafici he was ineligible because of his less than honorable discharge. Cafici had gone to a VA hospital in Lebanon, Pa., on Dec. 13, 2007, complaining of symptoms of jaundice, according to his parents, Vincent and Concetta Cafici. The lawsuit claims that a routine check of VA medical records would have shown VA personnel in Pennsylvania that Cafici was being treated for post-traumatic stress disorder and other unspecified ailments at the Veterans Administration Medical Center at Northport. Doctors there considered him a suicide risk because of a similar overdose six months earlier, according to the records.The lawsuit, which was drafted last year, comes amid allegations by veterans groups that Washington has been incompetent in addressing the psychological needs of U.S. troops and veterans stressed by more than seven years of war. Last month, both the Army and the Marines released figures showing sharp increases in suicides among uniformed personnel.
In a related story, the US Army just released a report that concludes that more soldiers killed themselves than died in combat last month. A CNN story on the report, which an Army official is quoted as calling "terrifying:, is available here. Jonathan Turley also reports that the Marines are also reporting an increase in suicides: 41 in 2008, up from 33 in 2007 and 25 in 2006, according to a Marines report.
The situation of the men and women in the armed forces is a huge political topic that goes beyond issues of tort law and that we don't have time to discuss here, although in our class we will discuss some aspects of it. Click here for other posts on torts stories and claims related to the military.
Top torts stories of the past week
Here is the link to this week's "Roundup" of the most interesting stories from the past week. Click here. Thanks to TortsProf Blog for the iformation.
Thursday, February 5, 2009
Court invalidates Consumer Product Safety Improvement Act advisory opinion
The ongoing saga related to the Consumer Product Safety Improvement Act continues. Here is the latest: A federal judge issued a ruling today setting aside a CPSC advisory opinion issued last November 17, which stated that products violative of the ACt may continue to be sold and distributed in commerce as long as these products were manufactured prior to February 10, 2009. The court's decision, holding that the phthalate prohibitions unambiguously apply to existing inventory, is available here.
Thanks to Products Liability Prof Blog for the update.
FTC files suit vs pharmacetical company
The Federal Trade Commission has filed suit in federal court in an attempt to block a deal in which a manufacturer of a brand-name testosterone-replacement drug paid three competitors to delay rolling out cheaper generic versions. The FTC said the "pay-for-delay" agreement violates antitrust laws, robs consumers of less-expensive alternatives and allows the brand-name drugmaker an unfair monopoly. The state of California joined the federal agency in its complaint, which was filed last week in U.S. District Court in the Central District of California.
FTC officials are hoping the case will ultimately reach the U.S. Supreme Court. "We want to stop these unconscionable pay-for-delay deals that force consumers to overpay for much-needed drugs," said Jon Leibowitz, an FTC commissioner. More on the story here, here and here.
Commenting on this development, the blog "Tort Deform" has posted the following comment:
"The tort “reform” movement often argues that personal injury lawyers and lawsuits keep needed drugs from reaching the marketplace. It turns out they’re half right. Lawyers are keeping drugs from the market, but it’s the pharmaceutical industry’s lawyers – and not personal injury attorneys - that are doing it . . . When I hear a “reformer” argue in favor of FDA preemptionbecause lawsuits might be keeping drugs off the market, I have an easy litmus test to see if he or she is concerned for public safety or is merely a corporate lackey who is paid to parrot the party line: I ask how he or she feels about “pay to delay” deals. . . . The fact that pharmaceutical companies enter into agreements with competitors to keep drugs off the market shows that those companies care far more about profits than they do about patient safety. And it’s disingenuous to the extreme for those same companies to argue in favor of preemption on the grounds that lawsuits keep needed drugs off the market."
What do you think?
Labels:
FDA,
Preemption,
Products liability,
Tort reform
Criticism of Consumer Product Safety Commission Chair
"What’s it going to take to finally remove the disastrous Nancy Nord as acting head of the Consumer Product Safety Commission, and replace her with a new Chair who is competent, fair and honest and actually cares about consumers - you know, the people the agency is charged with protecting?" That is the question the Blog "The Pop-Tort" is asking today in a short comment calling for President Obama to replace Nord, available here.
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