Sunday, February 28, 2010
Seventh Circuit finds no preemption in suicide case; Levine begins to show its influence
The most important case in the area of products liability last year was undoubtedly Wyeth v. Levine (available here). For a lot of discussion on this case you can go to the labels “FDA” and “pharmaceuticals” on the right panel of this blog.
As you probably know, although the Court found that preemption did not exist in Levine, it held that there could be preemption if the manufacturer showed there was clear evidence the FDA would have rejected the proposed change in the drug’s label. The Supreme Court, however, did not clarify what constitutes “clear evidence.”
As expected, therefore, lower courts now have to address this unanswered question. A few months ago, the Eighth Circuit rejected a preemption argument in In re Prempro Products Liability Litigation, 586 F.3d 547 (8th Cir. 2009).
And now, last week, the Seventh Circuit issued another opinion rejecting a preemption argument in Mason v. SmithKline Beecham Corp (available here). In this case, a 23 year old committed suicide just two days after she started taking Paxil, a popular antidepressant. Her parents sued the manufacturer of the drug claiming it was negligent (among other things) for not warning that taking Paxil increases the risk of suicide, especially among young adults.
In an opinion issued before the Supreme Court decided Levine, the district court granted summary judgment for the defendant concluding that that the plaintiffs’ claims were preempted under federal law because the warnings they said should have been included about Paxil conflicted with the FDAapproved warning labeling for the drug.
In light of the decision in Levine, the Seventh Circuit reversed and remanded concluding that the defendant did not meet its burden of demonstrating by clear evidence that the FDA would have rejected a label change warning about the risk of suicide by young adults.
UPDATE: (3/5/10) For a short article critical of the decision in Mason by the Drug & Device Law Blog go here.
Labels:
FDA,
Pharmaceuticals,
Preemption,
Products liability
Friday, February 26, 2010
No expert = No case
The North Dakota Supreme Court has affirmed a summary judgment for the defendant in a legal malpractice case based on the fact that the plaintiff did not support her claims with the testimony of an expert. For a copy of the opinion go here.
Thanks to the Legal Profession blog for the information.
Med mal reform and health care reform
I did not get a chance to watch the televised "summit" on health care, but according to some reports a lot of it became a forum for Republican lawmakers to press for limits on medical malpractice awards. (See here.) That's unfortunate since med mal reform (at least as it relates to limits on compensation for victims) is largely irrelevant in the larger context of health care reform. See here, here, here and here. Also, go here for all my other posts on medical malpractice.
Here is an article by a Republican Representative making a weak argument that med mal reform is necessary as part of health care reform. Why is the argument weak? Because there very little evidence to support its conclusions. (See the links above.) Read the article first, and then watch this video:
Labels:
Medical malpractice,
Tort reform
Assumption of the risk at the ballpark?
It is often stated that spectators at a baseball game assume the risk of getting hit by foul balls. (Technically speaking, this is not necessarily correct since the issue is those cases is not really a question of assumption of the risk, but that is another story). In any case, a case filed recently now asks whether a spectator also assumes the risk of getting hit by hot dogs thrown into the crowd.
The lawsuit claims that a hot dog thrown by the Kansas City Royal's mascot struck the plaintiff and detached his retina. Go here for the full story in the Wall Street Journal Blog, here for the story in the Kansas City Star and here for a comment in the blog Lowering the Bar.
Labels:
Assumption of the risk,
Baseball,
Sports
More problems for Toyota: claims that it withheld documents in rollover litigation
Just when we thought the Toyota situation couldn’t get any worse comes news that according to the chairman of the House Oversight and Government Reform Committee, documents recently received by the committee show that Toyota deliberately withheld records in “rollover” litigation and other cases and engaged in a “systematic disregard for the law.” Click here and here for the WSJ story.
This Week's Top Stories
Thursday, February 25, 2010
Glaxo denies concealing Avandia caused heart risks
GlaxoSmithKline has released a 30-page rebuttal to the U.S. Senate report that accused the company of intentionally trying to conceal potential heart problems with Avandia. Go here for the full story and helpful links. Check this post later for updates. I will continue to link to new stories throughout the day if I find any new ones.
UPDATES:
Story about Glaxo's rebuttal document in Pharmalot
Labels:
FDA,
Pharmaceuticals,
Products liability
TV report on Avandia
Here is a Bloomberg news report on Avandia from a couple of days ago:
Labels:
FDA,
Pharmaceuticals,
Products liability
Latest report on the hearings on Toyota
Here is the latest report on the Congressional hearings related to the Toyota fiasco: Toyota Grilled Over Lobbying Efforts, Ties to Regulators (Law.com)
Prescription drugs that generated the most adverse event reports
In the third quarter of 2009, the number of serious, disabling and fatal adverse drug events reported to the FDA numbered 29,065, compared to 26,809 in the same quarter a year earlier, an 8.4 percent rise. Not surprisingly, given all the recent news reports, the drug with the most adverse events reported (1218) was diabetes drug Avandia.
AstraZeneca's antipsychotic Seroquel came in second (977 reported cases). I also recognized two other drugs on the list because they advertise a lot on TV: Cymbalta and Boniva which came in 12th (266 reported cases) and 13th place respectively (249 cases reported). Cymbalta's ad campaign uses the catch phrase "depression hurts" and Boniva's uses actress Sally Field as a celebrity spokesperson.
Go here for the full story and a link to the source of the study.
Also, just out of curiosity, I went to YouTube and searched "cymbalta." I was looking for a video of a tv commercial but what I found was a bunch of videos of people complaining about the drug and its side effects. In contrast I found lots of videos with Sallie Field advertising Boniva and only one of a consumer complaining about it.
UPDATE: (2/26/10) AboutLawsuits.com
Labels:
FDA,
Pharmaceuticals,
Products liability
More on Avandia
Pharmalot is reporting today that, according to a study presented at the American College of Preventive Medicine annual meeting, a study of the reports on GlaxoSmithKline’s Avandia diabetes pill shows that reports authored with ties to the pharmaceutical industry were more likely to conclude the drug did not increase the risk of myocardial infarction compared with authors with no industry ties. Go here for the full story. Thanks to Pharmalot for the information.
Labels:
FDA,
Pharmaceuticals,
Products liability
Wednesday, February 24, 2010
More on the controversy over Avandia: what did the company know, and when?
I have been posting updated links related to the controversy over the diabetes drug Avandia here, but this story, published in the New York Times a few days ago is so interesting it deserves its own post. Here are the leading paragraphs...
Three years ago, Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic, conducted a landmark study that suggested that the best-selling diabetes drug Avandia raised the risk of heart attacks. The study led to a Congressional inquiry, stringent safety warnings, a sharp drop in the drug’s sales and a plunge in the share price of GlaxoSmithKline, Avandia’s maker.
The battle between Dr. Nissen and GlaxoSmithKline was waged from afar in news releases and published papers. But on May 10, 2007, 11 days before Dr. Nissen’s study was published in The New England Journal of Medicine, he and four company executives met face to face in a private meeting whose details have not been disclosed until now.
Fearing he would face pressure and criticism from executives, Dr. Nissen secretly recorded the meeting — which is legal in Ohio as long as one party to the conversation is aware of the taping. On a recent day in his sunny office at the Cleveland Clinic, Dr. Nissen shared the contents of the recording with The Times.
What was said at the 2007 meeting raises questions about science and ethics that have suddenly become keenly relevant.
Continue reading the full story here.
Thanks to Pharmalot for the link to the NYT Story.
Labels:
FDA,
Pharmaceuticals,
Products liability
A very negative consequence of the Illinois Supreme Ct's decision invalidating the cap on med mal damages
Here is a link to a short story (and not of the fiction genre, unfortunately) posted in the PopTort blog that spells bad news for Illinois. When Illinois lawmakers passed their unconstitutional cap on compensation for medical malpractice victims, they also enacted a very good med mal insurance regulatory law which includes strong oversight over rates and new transparency requirements. Unfortunately, they added a “non-severability” clause to the law which means that if the cap were struck down, all of the great medical malpractice insurance regulatory laws would be thrown out as well. This would leave Illinois medical malpractice insurers virtually free to go back to their old practices. In the few years this regulatory law has been in place, its positive impact has been tremendous, but that may be about to change.
Update on controversy over diabetes drug Avandia
There are lots of reports and comments coming out regarding the controversy over diabetes drug Avandia. Check this post for updates. I will post links as they become available...
Go here and here for my more recent posts on the controversy over Avandia.
From a story in AboutLawsuits.com: Following the release of a scathing Senate report, which revealed that some federal health officials have been calling for a recall of Avandia since at least 2007, the FDA announced Monday that the agency is still reviewing safety data on the diabetes drug and conclusions will likely not be released until a public meeting scheduled for July 2010. Go here for the full story.
Go here for an update in the Drug Recall Lawyer blog.
Should Vandia be withdrawn from the market: a reader poll in Pharmalot blog
Labels:
FDA,
Pharmaceuticals,
Products liability
Reports from Congressional hearings on Toyota
Reports are starting to come in regarding the Congressional hearings on Toyota. Make sure you come back to check this post as I will be updating it with more links as they become available.
Here is the first one: Law.com reports that James Lentz, president of the automaker's U.S. distribution unit, testified yesterday before Congress that two factors contributed to the unexpected acceleration that consumers say has caused accidents: lack of communication within the company about prior recalls, and pressure to increase production at the expense of safety.
I guess it is interesting, if it wasn't so insulting, to hear an automotive industry executive admitting that his company is more interesting in making profits even if it comes at the expense of the safety of the consumer. Obviously, this is nothing new; anyone who has followed the automotive industry over the years knows this is true, but you don't hear the company CEOs (and certainly not the marketing departments) admitting to it publicly very often.
UPDATES:
AboutLawsuits.com reports that Toyota Motor Corp. is now the target of a federal criminal investigation.
Wall Street Journal Law Blog
NPR's show "All Things Considered" (you can read the story or listen to the broadcast) (thanks to TortsProf blog for this link)
Tuesday, February 23, 2010
Toyota memo, other infamous memos and a video
As I reported over the weekend, now there are reports that there is a document out there that shows Toyota knew of the problems with its cars long before it did anything about it and that it hailed as a "win" its success in lobbying federal safety officials to limit a recall tied to sudden acceleration complaints to just 55,000 vehicles, saving the company $100 million. This piece of news prompted The PopTort blog to post a short comment reminding us of other similar "profits over safety" documents including the infamous "Pinto memo" where someone at Ford made calculations that concluded it would be cheaper for the company to do nothing to fix the defects in the Pinto even though it created the risks of death to consumers. The post also comments (and links to a copy of) a similar memo from GM in another case.
Here is a video discussing some of the questions raised by the recently discovered document. It is short and doesn't really add much to the discussion but for whatever it is worth, here it is:
More and more on Toyota
As Toyota executives head to Capitol Hill today for the first of three hearings on the automaker's product safety record, here is a link to a story in The New York Times states that government watchdog groups are raising questions about whether deep financial and personal connections between lawmakers and Toyota could taint the Congressional investigation. The car company had 31 lobbyists working in Washington last year and has spent nearly $25 million on federal regulatory and legislative lobbying matters in the last five years, far more than any other foreign automaker. A number of lawmakers have personal financial ties to Toyota as well. For more comments on the significance of the Congressional hearings go here.
Meanwhile, Federal prosecutors have also launched a criminal investigation into Toyota's safety problems. For the AP story on this go here, which also includes a short video news story.
Monday, February 22, 2010
More bad news for Toyota
On Saturday, I noted that a growing number of complaints over steering problems with Toyota Corolla vehicles has sparked a federal investigation. Today the Wall Street Journal Blog has published two separate stories on this.
The first one states that the U.S. House Oversight and Government Reform Committee has obtained a document from a Toyota executive which notes that Toytoa saved money by lobbying federal officials to limit recalls tied to sudden-acceleration complaints, characterizing the lobbying effort as a key company achievement in 2009. That story is available here.
The second one states that Toyota has received subpoenas from a U.S. federal grand jury and the Securities and Exchange Commission requesting documents related to sudden unintended acceleration and the braking system of its Prius hybrid. That story is available here.
Labels:
Auto industry,
Products liability
Possible claim against Blackwater for wrongful death of member of the army
UPDATED 11/11/10
Yesterday's 60 Minutes show featured a segment on a claim filed by an army widow against Blackwater alleging negligence in managing and piloting a flight in which her husband was killed in Afghanistan. The military contractor argued it was covered by government immunity before eventually settling. The segment was available in full in the CBS website (and there are links to it) but it appears that it was removed and the links are not working.
However, you can still read the full story (4 pages) which summarizes the 60 Minutes program and access more information by going here.
Update on the story re diabetes drug Avandia
As I reported during the weekend, according to a Senate report, some FDA officials have been calling for a recall of the diabetes drug Avandia since at least 2007. AboutLawsuits.com is reporting today (here) that the report also accuses GlaxoSmithKline, the manufacture of the drug, of intimidating doctors and failing to adequately warn patients about the risk of a heart attack from side effects of Avandia and that about 500 heart attacks and 300 cases of heart failure may be avoided each month if Avandia were recalled. The Senate report is available here.
Meanwhile, GlaxoSmithKline has issued a strongly worded rejection of the US Senate Finance Committee report (available here). Glaxo complained the report drew inconsistent conclusions, cherry picked information from documents and mischaracterized “efforts to research Avandia and communicate those findings to regulators, physicians and patients.” Glaxo also claims that it has consistently shared data with regulators around the world and updated safety information as new data became available.
However, as reported today in Pharmalot (here), there is evidence that the FDA has in the past chastised the drugmaker for failing to report multiple postmarketing studies involving Avandia as required by law. Pharmalot's article includes at least one link to an FDA letter that supports this conclusion.
Labels:
FDA,
Pharmaceuticals,
Products liability
Saturday, February 20, 2010
Possible health hazards for soldiers
Here is a link to a story on possible health hazards soldiers are getting exposed to in Iraq and Afghanistan as a result of the burning of hazardous and medical waste.
False arrest story
Those of you familiar with the Prosser Torts textbook might remember Enright v Groves, the case used in the book to illustrate the concept of false arrest. In that case, the plaintiff was arrested after she refused to produce an ID when ordered to do so by a policeman -- which he had no authority to do.
I thought of that case when I read a story today about Minnie Carey, then 61, who was arrested, cuffed, and thrown in jail for challenging the authority of a policeman who told her and other women to go away. According to the story, the women were standing outside of a convenience store talking when the cop pulled up in a cruiser and told them to “move it.” Carey replied by asking "why?" and the cop said “because I said so.” She was first held in a patrol wagon and then jail for nine hours. She is a diabetic and went without food until she returned home. She was charged with disorderly conduct. The Citizen Review Board found that the cop falsely arrested Carey. For the full story, click here.
Thanks to Prof. Jonathan Turley for the the story. See here.
Controversy over diabetes drug
The New York Times is reporting that, according to confidential government reports, diabetes prescription drug Avandia is needlessly causing hundreds of cases of heart attacks and heart failure each month. Avandia was linked to 304 deaths during the third quarter of 2009, and a report by the FDA’s David Graham and Kate Gelperin concludes the pill should be withdrawn from the market. (For more on that see here). Go to Pharmalot for more on this story.
Labels:
FDA,
Pharmaceuticals,
Products liability
Looking for proof that tort reform reduces health costs?.... Keep looking, part III
Here is yet another article about the fact that there's no proof tort reform reduces health costs. This one comes from the website St. Louis Today.
Labels:
Medical malpractice,
Tort reform
$25 million verdict vs manufacturer of Accutane acne drug
Last year, I reported that Roche Holding AG pulled its Accutane acne medicine from the U.S. market. Much of the debate over the drug related to whether it caused inflammatory bowel disease (see here and here).
Interestingly, this week a New Jersey jury awarded $25.16 million in damages to a plaintiff who alleged that the acne drug caused the plaintiff to develop inflammatory bowel disease. Go here, here, here and here for more on this story . For more information on the debates related to Accutane go here.
Labels:
Pharmaceuticals,
Products liability,
Verdicts
More problems for Toyota
A growing number of complaints over steering problems with Toyota Corolla vehicles has sparked a federal investigation, and may result in yet another Toyota recall. The troubled auto-maker has already recalled millions of vehicles in recent months over defective gas pedals, floor mats and problems with brakes. Go here for the full story.
Labels:
Auto industry,
Products liability
Saturday, February 13, 2010
Looking for proof that tort reform reduces health costs?.... Keep looking, part II
Last December I posted a note called "Looking for Proof That Tort Reform Reduces Health Costs?... Keep looking..." about an op-ed piece that argued that there's no proof tort reform reduces health costs.
Now, here is a link to a very short comment by the Civil Justice Defense Blog called "Medical Malpractice Reform May Cost More Than It Saves."
Labels:
Medical malpractice,
Tort reform
Podcast about Toyota's legal problems
Here is a link to a podcast on the recent developments regarding Toyota's legal problems. You can listen to the podcast online or download it.
Labels:
Auto industry,
Podcasts,
Products liability
Assumption of the risk hypothetical
Take a look at the first 5 seconds of the video below (the rest of it is the same scene repeated way too many times). Assume the runner in the video had signed a waiver that says "the participant waives all rights to sue the marathon organizer or its sponsors for damages suffered during, or in any way related to, his or her participation in the race." Assume that the mat on which he slips was placed there by the marathon organizer and that experts will argue it was too slippery. Also assume the runner suffered an injury to the back of his head from hitting the ground, that he is a professional runner who makes a lot of money running marathons around the world and that he won't be able to compete again for some time. Should the court dismiss the claim based on the affirmative defense of express assumption of the risk?
Friday, February 12, 2010
Utah considers lowering cap in med mal cases
While the Supreme Court of Illinois just declared caps on medical malpractice awards unconstitutional, victims of medical malpractice could see the amount of damages they could receive cut in half under a bill before the legislature in Utah. Go here for the full story.
Thanks to the TortsProf blog for the link.
This Week's Top Stories
Tuesday, February 9, 2010
$300 million verdict overturned
Last November I reported that a Florida jury has awarded a 61 year old smoker suffering from emphysema $56.6 million for past and future medical expenses as well as pain and suffering and $244 million punitive damage award against Philip Morris USA.
I then stated "I suspect the punitive damage award will be reduced or vacated on appeal but we'll have to wait and see." See here.
Well, we don't have to wait any longer. Law.com is reporting today that the verdict will definitely be reduced on appeal. Calling the verdict "excessive" and "shocking," Judge Jeffrey Streitfeld said he would determine a lower award but gave no indication when he would rule.
Go here for the full story.
Labels:
Damages,
Products liability,
Punitive damages,
Verdicts
Friday, February 5, 2010
Prosecutor is immune from civil liability even though guilty of hiding evidence
The Court of Appeals for the 6th Circuit has held that a former federal prosecutor who was tried and acquitted of conspiring to hide evidence in a terrorism case is immune from civil liability because of his prosecutorial role on the case. The case is Koubriti v. Convertino and it is available here. For more on the story go here.
Labels:
Government liability or immunity,
Immunity
More problems to come for Toyota
Law.com is reporting that legal attacks against Toyota Motor Sales USA Inc. escalated this week following fresh reports of product safety defects afflicting some of the most popular vehicles in the automaker's fleet. And more suits are coming. Go here and here for the full story on Law.com. In addition, The Wall Street Journal Law Blog has a story on Toyota's legal troubles here. Reuters has a story here and, finally, The National Law Journal will have a story on the subject in next week's edition which you can access now here if you have a subscription.
Thanks to the TortsProf Blog for the tip on the Reuters story.
Labels:
Auto industry,
Products liability
Article on the National Highway Traffic Administration and Toyota
Here is the link to an article on the National Highway Traffic Administration and its role in the Toyota quality control problems.
Article on med mal, tort reform and health care
"[W]ho wants to walk into a hospital these days knowing that there is no legal accountability for unsafe medical care? Like in Texas, . . .where you can just about forget ever being able to file a lawsuit if you or your child is injured due to incompetent medical care. It's worse than that, though. Patient safety has taken a huge nose-dive in Texas. The doctors haven't returned, and lots of them are now lining their pockets performing unnecessary tests for reasons having nothing to do with lawsuits because, well, they are nearly gone. I took a quick survey of the news in the past week to try to diagnose which is the bigger medical malpractice problem - too many "frivolous" lawsuits by patients, or too much malpractice on patients. Couldn't find any articles about frivolous medical malpractice lawsuits. Instead, I found this: . . . ."
This is the beginning of an article by Joanne Doroshow published in the Huffington Post two days ago. To keep reading and to check out the many links she uses to support her arguments (including links I omitted from the section I just quoted above), go here.
Labels:
Medical malpractice,
Tort reform
This Week's Top Stories
News on the Illinois Supreme Court's decision on the constitutionality of the med mal caps
As you would expect, news is spreading now around the internet and other media of yesterday's Illinois Supreme Court's decision declaring the caps on non-economic damages unconstitutional. Here are some links to articles I have seen so far: LegalNewsline.com , The National Law Journal (you may need a subscription for this one). Check this post later as I will keep adding links if I see more.
UPDATE: ABA Journal.com
UPDATE (2/06): Law.com
UPDATE (2/8): Aboutlawsuits.com
Thursday, February 4, 2010
Illinois Supreme Court declares med mal cap unconstitutional
The Illinois Supreme Court has just published its eagerly awaited opinion in Lebron v Gottlieb Memorial Hospital. In it the Court affirms the lower court's finding that the statute that sets caps on non economic damages in medical malpractice cases is facially invalid under the Illinois Constitution. The Court said that the damage limitation violates the constitutional principle of separation of powers. The full opinion is available here. The Wall Street Journal Law Blog has a story on it here.
Tuesday, February 2, 2010
False arrest claim over arrest for taping arrest
Just in time for our class discussion on False Arrest, the National Law Journal.com is reporting that a Massachusetts lawyer is suing three Boston police officers and the city in Boston federal court for arresting him after he used his cellphone to record an arrest. Go here for the full story.
FDA warnings double in Pres. Obama's first year
The number of FDA warnings issued for questionable promotions has nearly doubled since President Obama took office. Story here.
Labels:
FDA,
Legislation and regulation,
Pharmaceuticals
Is the NHTSA to blame as much as Toyota?
Here is a link to an article in The New York Times about the problems in Toyota cars that recently resulted in a massive recall. And here is a link to a review of it by The PopTort Blog in which it concludes that "the NHTSA is not innocent here, and of course, there was good reason to distrust that agency’s ability to protect us from unsafe cars . . ."
More problems for Toyota: wrongful death claim
Already facing a blitz of negative media coverage and a growing wave of class-action suits, the Wall Street Journal Law Blog reports, Toyota has now been hit with another serious-sounding wrongful death lawsuit. Go here for the full story.
Labels:
Auto industry,
Products liability
FDA to review approval process for medical devices
The FDA has scheduled a public meeting for late this month to review review the controversial process used to swiftly approve medical devices, which some say has been overused and allowed dangerous devices to be implanted in patients. Go here for the full story.
Labels:
FDA,
Legislation and regulation,
Products liability
Monday, February 1, 2010
Cause of action for trespass vs Google maps
The ABA Journal.com is reporting today (here) that the Federal Court of Appeals for the 3rd Circuit has recognized a claim for trespass on behalf of homeowners against Google Maps over its “Street View” feature. The court affirmed that the couple can’t pursue their claims for invasion of privacy, but held they can sue for trespass. The trespass claim is based on the rather simple argument that a representative of the defendant entered upon the plaintiff's property without permission to take photos of their house. The opinion is available here.
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