Novartis Pays $422M For Off-Label Marketing

From Pharmalot by Ed Silverman Another week, another drugmaker agrees to settle off-label marketing charges brought by the federal government. This time, Novartis will pay $422.5 million for illegally promoting its Trileptal epilepsy med for unapproved uses, such as bipolar disorder and neuropathic pain... Go here to read the full story. UPDATE 10/1/10: More on this story at Law.com and The Wall Street Journal Law Blog. UPDATE: 10/8/10: More on the story from AboutLawsuits.com

FDA approves yet another new birth control pill; are they paying attention?

The FDA has approved a new birth control pill from Bayer Healthcare Phamaceuticals, Inc. The new pill, which will be marketed as Beyaz, was approved amid growing concerns about the increased risk of blood clots and other injuries from side effects of similar birth control pills Yaz and Yasmin which contain the same “fourth” generation progestin that will be used in Beyaz and the birth control patch Ortho Evra, about which I blogged recently (here).

Maryland Damage Cap Upheld

The Maryland Court of Appeals has rejected a challenge to the state’s cap on non-economic damages, which limits the amount of compensation plaintiffs can be awarded for pain and suffering in Maryland injury lawsuits. Go here for the full story.

Class action against Abbott for contaminated baby formula

A class action lawsuit has been filed against Abbott Laboratories by a mother who says that the company deceptively promoted Similac infant formula as safe, despite the fact that it may be infested with small beetles, which could cause gastrointestinal problems and difficulty feeding. The Similac class action lawsuit was filed by Kathleen A. Bradner in federal court in New Orleans. The lawsuit came the day after the announcement of a Similac recall for 5 million units of baby formula due to the possible presence of the bugs. For the full story go to AboutLawsuits.com.

Public Citizen criticizes FDA for not removing Avandia from the market

As reported five days ago, the FDA recently decided not to ban the diabetes drug Avandia. In response, Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group has issued a statement in which he argues that "[b]y failing to ban the dangerous diabetes drug, Avandia, . . . the Food and Drug Administration (FDA) again caved to industry pressure. Although the FDA has made progress highlighting the risks of using Avandia by severely restricting the drug, it did not go far enough. Too many people could still be exposed to this dangerous product. Rather, the FDA should have acted with its European counterpart and outright banned Avandia from the market." Read the full statement here. For more on the story go to AboutLawsuits here.

Med mal update pt 2

Here is a comment from the Tort Deform blog on the contradiction between the fact that diagnostic errors are the leading cause of malpractice suits, accounting for as many as 40% of cases and costing insurers an average of $300,000 per case to settle, while tort reformers continue to claim that doctors order more tests and procedures than needed to protect themselves against malpractice suits. In other words, as they point out "40,000 to 80,000 people die every year because doctors aren’t ordering enough tests. But on the other hand, 91% of physicians say that doctors are ordering too many tests." Read the comment here.

Med mal reform update

The PopTort blog is reporting that the Center for Justice & Democracy has just published two new articles that warn of some serious problems with state-based litigation “alternatives.” CJ&D Legal Director, Amy Widman, also just published an article in The Circuit, the online edition of prestigious California Law Review, which analyzes some of these proposals, concluding: None of the litigation alternatives currently proposed enhance patient safety while ensuring that injured patients are compensated. Limiting patients’ access to courts and compensation for their injuries does nothing to increase patient safety. Reducing financial accountability on hospitals when errors occur will likely negatively impact patient safety. And allowing hospitals to control the fact-finding process surrounding medical errors also reduces transparency and, ultimately, accountability. While there is much to praise in the health care reform bill, awarding grants to reinstitute litigation “alternatives” that have been already been tried and rejected by both courts and patients makes little sense. For more on this story go to The PopTort.

What's with all the lawyer shows on tv?!

I don't watch a lot of TV, but I try to check out shows about lawyers just in case they raise issues I can discuss in class. There have always been shows about lawyers, although many of them were (or are) disguised "detective" stories - more interested in the drama of figuring out "who did it" than on the legal issues that surround the case. But I don't remember so many lawyer shows running at the same time. Right now there are four new lawyer shows on - three of them at the same time on Wednesday nights. At some point there were promos going around about a fifth one, but I suspect that one may have been dropped since I have not seen or heard anything about it since it was announced back in the summer. In any case, the new lineup includes Outlaw, about which I have written before and which every report I have read agrees is crap, The Defenders, The Whole Truth and Law and Order LA. These last three run against each other on Wednesday nights. Here is a quick review of the Defenders by one of the law blogs I read regularly. In a nutshell, this appears to be just another disguised "detective" show (with a comic tone to it, I guess) in which lawyers do the detecting in order to help their clients. Last Wednesday I opted to watch The Whole Truth instead and here is my quick review: The show tries to be more serious than the others. It follows the work of a district attorney and a defendant's lawyer as they prepare for and try a criminal case. The editing is done so that you get to see the work of each side separately which is interesting, although perhaps not the best narrative model. Given time constraints, the pace of the show is a bit too fast or frantic and the defendant's lawyer (and his firm) follow a familiar Hollywood mold. What the producers are trying to sell as "different" about this show is that the lawyers never really know "the truth." Now, this is realistic, but unfortunately, the show then feels the need to fill the void for the audience by "solving" the uncertainty at the end. In other words, the audience will know in the end what really happened, even if the characters in the show do not. That's too bad. I think the show would be better if it left everyone with that realistic uncertainty of not really knowing, but I guess I understand this would not make for a popular choice among TV producers who want a happy audience....

FDA decides not to remove Avandia from the market

In a move that many anticipated, the FDA is leaving the controversial Avandia diabetes pill on the market, but with restrictions for patients who are unable to control their illness by using other meds. The statement of FDA commissioner Margaret Hamburg is available here. At the same time, though, the European Medicines Agency is suspending use of Avandia but not revoking approval. That statement is available here. For a lot more on this go to AboutLawsuits, The PopTort and Pharmalot, which has two additional articles on the topic: Did FDA Make The Right Decision About Avandia? and Avandia: Lessons Learned & Unanswered Questions. UPDATE 9/30/10: Here is a comment from Abnormal Use blog

Today Show segment on the dangers of birth control patch

Last week, the TV show "The Today Show" had a segment on Johnson & Johnson's birth control patch Ortho-Evra that cites court documents showing J&J knew the patch is more than 12 times likely to cause strokes and 18 times more likely to cause blood clots than birth control pills. You can see the segment here. Interestingly, some of J&J's comments seem to be based on a preemption argument which is not frivolous and may find support in the courts. Yet, to date, J&J has preferred to quitely pay at least $68 million to settle hundreds of lawsuits filed by women who suffered blood clots, heart attacks or strokes in exchange for confidentiaility agreements. Meanwhhile, Public Citizen health research director Dr. Sid Wolfe has reiterated remarks filed in a 2008 citizen petition that the patch should be banned. The FDA, not surprisingly, has dragged its feet and claims the issue "is complicated." For more on this story go to Pharmalot and The PopTort.

Trial over brain cancer will address interesting question about cause in fact

Is a cluster of brain cancers and brain tumors in a small village on the shores of an Illinois lake just a random occurrence, or can the cause of those illnesses be attributed to the negligence of a chemical company with a plant about a mile north of the village? This is a question a jury in Philadelphia will have to address in the trial of Branham v. Rohm & Haas Co., which is expected to last for the next eight to ten weeks. Go here and here for more on the story. The plaintiff in the case, which began last Monday is one of 31 residents or former residents of McCullom Lake, Illinois, who filed a toxic tort lawsuit alleging that the high cancer rate in the small community is due to toxic chemical waste dumped by Morton International over 20 years which allegedly contaminated local groundwater. The defendant, Rohn and Hass, purchased the plant from Morton International in 1999. In turn, Rohm and Haas was bought by Dow Chemical Co. earlier this year.

This week's top stories

Go here for the list of last week's most interesting Tort Law stories as selected by the TortsProf Blog. In addition, go here and scroll down for my own selection of top news stories.

Jury finds the risks of an FDA-approved drug outweighed its benefits

In a case called Bartlett v. Mutual Pharmaceutical Co., No. 08-358 (D.N.H.) the plaintiff allegedly developed Stevens-Johnson Syndrome after taking a generic drug called Sulindac. The court dismissed part of the original claim but allowed plaintiff to proceed to trial on a design defect claim and earlier this month the jury returned a $21 million verdict in favor of the plaintiff. The Drug and Device Law Blog has argued that the design defect claim in this case raised serious preemption issues because it asked the jury to second guess the FDA’s decision that the benefits of the drug outweigh its risks. This is not a frivolous argument but I have not seen any of the documentation or read any details about the case to really know if it is accurate as applied to this case itself. What is clear is that the defendant will probably appeal and the case will probably result in an interesting decision on the subject of possible liability for generic drugs and on the preemption issue.

E-trade settles suit with Lindsay Lohan; she fails drug test

In an ironic duo of news today, the ABA Journal is reporting in separate posts that E-trade has agreed to settle a claim filed by Lindsay Lohan and that Lohan recently failed a drug test. As you may remember Lindsay Lohan sued E*Trade Financial Corp for $100 million, arguing that the "milkaholic" baby girl who appears in the commercial (see video below) was modeled after her. Go here for my original story on this. E-Trade has now agreed to settle the claim stating that the settlement agreement was "a simple business decision. We always have to consider the cost and time involved in litigation, and we are pleased to have the matter behind us." For more on the story go here. Meanwhile, however, it is also being reported that Lohan has failed a drug test while on probation. A judge has revoked her probation and issued a warrant for her arrest. For more on the story, go here. Now, I don't know if the lawsuit against E*Trade was for defamation, but if it was it seems to me it would have been a very interesting test case for the application of the "libel proof" doctrine, which essentially holds that a plaintiff can't recover for damages to her reputation because her reputation is so low already or because the libelous aspects of the statements about her are irrelevant in comparison to the true ones. Oh, well... We'll have to wait for another day for someone to make the argument... Here is the commercial in question:

News from Congress

Pharmalot is reporting today that four Congressional Democrats have released what is called a ‘discussion draft’ that, if adopted, would increase funding and authority for the FDA to monitor drug production - both domestically and overseas - in hopes of improving safety in the wake of the Heparin scandal and other recent episodes that questioned foreign production of meds sold in the US. Go here for the full story. Also, AboutLawsuits is reporting (here) that a number of powerful lobbying groups, including business and grocery interests, are lining up behind legislation that would give the FDA more power to regulate the food industry, including the ability to quickly force recalls. Unfortunately, this bill is not likely to pass any time soon. As AboutLawsuits states, "although the bill has enjoyed bipartisan support, there are some Republicans who believe the bill will be too much of a burden on growers and food producers, and fear that the FDA will become “trigger happy” with its newfound recall power. The bill is currently stalled due to an objection by Senator Tom Coburn (R-OK). Reid has said that the Senate would be unlikely to overcome the objections by Coburn before the midterm election break." Picking up on this part of the story,The PopTort and the New York Times are reporting how Congress is stalling on a number of tort related bills, including a food safety bill, mine safety legislation and legislation to help the families of 11 workers killed in a recent mine explosion. Go here for the story in The PopTort, and here for the story in the New York Times.

If a criminal conviction is expunged, did it ever exist?

As you probably know, the first requirement for a defamation case is that the satement upon which the claim is based needs to be false. If it is true, there is no cause of action. That's an old question that has been answered a million times. Now here is a new question: suppose someone is convicted of a crime but the conviction is later expunged. Then someone publicizes the (true) fact that the person had been convicted in the past. Given that the conviction was expunged, can the statement give rise to a claim for defamation? This question is now pending before the New Jersey Supreme Court in a case called G.D. v. Hudson County Democratic Organization. Go to Law. com and the Wall Street Journal law blog for the full story. Not having read any of the details of the case, my gut feeling is that the answer should be NO. The statement is still true and the expungement does not all of a sudden mandate the rest of the world not to mention the conviction under penalty of (tort) law.

Law.com on the decision that rejects liability for corporations under Alien Tort Statute

Law.com picked up the story I reported last night about the Circuit Court of Appeals' decision rejecting the theory that corporations can be held liable in the United States under the Alien Tort Statute for violations of international law in foreign countries. See their report here.

Court of Appeals for Second Circuit issues a tremendously important opinion on the Alien Tort Statute

Just a few days ago, I posted a comment about a new decision under the Alien Tort Statute (see here). Today, the Court of Appeals for the Second Circuit has just issued a new opinion eliminating the right of plaintiffs to use the ATS against corporations. This is a tremendously significant shift in the interpretation and application of the ATS, which was enacted in 1789 and is codified in 28 U.S.C. §1350 and which provides jurisdiction to federal district courts over claims filed by aliens for injuries caused by conduct that constitutes a violation of the law of nations. In recent years, the statute became a very important source of support for litigation seeking compensation for the role played by corporations that helped others commit acts in violation of international law. (Go here and scroll down for posts on some of those recent developments.) It was based on this type of theory that in recent years plaintiffs supported their claims against Chevron for alleged human rights violations in Nigeria, against Pfizer for allegedly testing drugs without consent on African children, against Ford, General Motors, IBM, UBS and others for alleged crimes committed by the apartheid regime in South Africa and against Talisman Energy for allegedly providing substantial assistance to the Government of the Sudan. For comments on these cases go here and scroll down. This type of claims may have seen its end today. According to Wall Street Journal law blog, in an opinion issued today called Kiobel v. Royal Dutch Petroleum (available here), the Court of Appeals for the Second Circuit decided that US courts have jurisdiction only over alien-tort suits against individuals, not companies. Judge Leval issued an 88 page long concurring opinion in which he agreed the case should have been dismissed but in which he concluded he could not join "the majority’s creation of an unprecedented concept of international law that exempts juridical persons from compliance with its rules." I have not read the opinions yet, so I am just reporting what others are reporting: Go here for the WSJ article and here for a Bloomberg report.

This Week's Top Stories

Go here for the list of last week's most interesting Tort Law stories as selected by the TortsProf Blog. In addition, go here and scroll down for my own selection of top news stories.

3rd Circuit Rules Some Asbestos Cases Are Pre-Empted

Railroad workers cannot pursue state law-based personal injury claims stemming from occupational exposure to asbestos because such claims are pre-empted by the federal Locomotive Inspection Act, the 3rd U.S. Circuit Court of Appeals has ruled. Go here for the full story.

Federal Court finds cap on damages constitutional

A U.S. magistrate judge has concluded that the cap the Texas Legislature set on non-economic damages in health care liability suits is constitutional. Go here for the full story.

Story about a sponge left in patient after surgery

Here is a story in the Wall Street Journal about a judge who suffered injuries because of a sponge left in his abdomen after surgery. He settled a claim with the hospital and now reportedly plans to sue the doctors. What I find most interesting here is the discussion among readers in the "comments" section (here) which turns to the question of tort reform and whether patients in a clear case of negligence such as this one should be subject to caps on the amount of money they can recover.

Toyota files motion to dismiss cases related to sudden acceleration

Toyota Motor Corp. recently filed a motion to dismiss hundreds of product liability lawsuits arguing that that the plaintiffs can not prove that there is actually a defect in the vehicles. Plaintiffs allege that documents from as early as 2003 show that Toyota was aware of problems with the electronic throttle, which could cause vehicles to accelerate out of control. A hearing will be held on the motion to dismiss on November 19. Go here and here for the full story.

Forest Labs Pays $313M For Illegal Marketing

As reported in Pharmalot, "[a]nother week, another guilty plea by a drugmaker charged with illegal promotion. This time around, Forest Labs has pleaded guilty to obstruction of justice, distributing an unapproved drug and illegally promoting two other meds (see the plea agreement). The drugs in quetion were Levothroid, an oral med for thyroid conditions, and two antidepressants - Celexa and Lexapro. The $313 million payment includes $164 million in criminal penalties." Go here for the full story.

Podcast on California medical malpractice laws

Go here for a podcast on California's medical malpractice laws featuring Doug Merritt, a lawyer from San Francisco and Jeffrey S. Mitchell, partner with the firm, Bostwick, Peterson & Mitchell LLP. They discuss tort reform measures including the Medical Injury Compensation Reform Act (MICRA) and California’s current political climate, the defense and plaintiff perspective of medical malpractice cases and how structured settlements have impacted clients.

Michael Jackson's mother files wrongful death suit

Michael Jackson’s mother Katherine Jackson has brought a wrongful death action against concert promoter AEG. on behalf of Jackson’s three children. According to the article, the promoter was negligent in allowing Dr. Conrad Murray to care exclusively for Jackson. For analysis and commentary go here and here.

FDA Panel Splits on whether to withdraw Meridia diet pill from the market

The FDA panel asked to decide whether Abbott Labs’ Meridia diet pill should be withdrawn from the US market has issued a split vote (8-to-8). The vote came after the a year-long safety review conducted by the FDA due to concerns about the pill's risk of heart problems. The drug was withdrawn in Europe eight months ago. According to a story in Pharmalot, the eight members of the committee who voted to keep Meridia on the market also agreed the pill should have a boxed warning. Six members said the drug should also have limited distribution by way of only specially trained doctors. None of them, however, thought Meridia should remain available without at least some labeling changes. Go here for the full story in Pharmalot. For more information go to AboutLawsuits.com.

Outlaw: the reviews are in...

The Abnormal Use blog has posted a review of the tv show Outlaw, about which I wrote yesterday. You can read the full review here. It concludes that "the premise of the show is absurd" and that "the absurdity of the premise will likely mean the end of the show." I have to agree. The show is heavy on the rhetoric and weak on logic, acting and storytelling. You can find more reviews here and here. Not surprisingly, it looks like they are all negative. I wonder if the show will last longer than "The Deep End." Anyone remember that one?! I will continue to update this post with more links if I see more reviews during the day...in case you are interested. UPDATE: here is the review from the Blog of the Legal Times. It concludes that "[t]he show in every way seemed to fulfill most critics' expectations, which were that 'Outlaw' is a stinker that won't and shouldn't last longer than it takes to say non compos mentis."

TV show Outlaw previews tonight on NBC

Back in June, I posted the comment that appears below about three new TV shows expected to start this fall. One of them - Outlaw - previews tonight on NBC and I have seen commercials for one of the others - "The Defenders". But I have not heard anything at all about the third one. Unfortunately, although as I expected, the (p)reviews for Outlaw are not good. The Washington Post wrote that "the show is so ludicrously dumb that your eyeballs will hurt from rolling so much." See the full review here. It concludes the show "should be dismissed." Go here for more on the story. The Blog of the Legal Times said it will blog on the show tomorrow. Here is my post from last June: With the recent demise of the original "Law & Order" and "Raising the Bar," the major networks are apparently feeling the need to introduce new law related shows. Here are the trailers. One is called "Outlaw" about a Supreme Court Justice who decides to retire and go into private practice. Another is called "The Defenders" and is about a pair of criminal defense lawyers. The third one is "Harry's Law" about people brought together by fate to form a law firm. I enjoy watching law related shows and movies and reading "legal thrillers" as much as anyone, but I often wish they were much better than what they usually are. I will give all of these a chance but from what I can see in these trailers at least two of them appear to be based on tired old stereotypes: either every client is innocent (Outlaw) or criminal defense lawyers are sleazy (The Defenders), aside from the fact that apparently all lawyers are young, beautiful, fit, sexy and have lots of sex in the office and law libraries. Outlaw also seems to have the stereotypical "team" of characters (common to so many "heist" type movies): the outlaw, the rebel, the intellectual, the smartass, the computer genius, etc. If they add a demolitions expert maybe they could compete with the A-team. The Defenders looks like it might be more of a comedy "detective" show; more about trying to figure out "who did it" than about legal issues. Harry's Law seems to escape the mold - or at least part of it. This one is produced by David E. Kelley, producer of three relatively successful law related shows. The trailer has some pretty funny lines and Kathy Bates is always entertaining. But, given that I didn't like any of the three previous David E. Kelley shows, I will have to wait and see... But I am getting way ahead of myself. Let's give them all a chance.... Maybe they will last longer than the last few attempts ... Does anybody remember "Shark" or "Eli Stone"?

Foreign Toyota owners may file claims for unintended acceleration problems

A federal judge has granted permission for millions of Toyota owners in foreign countries to file a separate consolidated complaint against Toyota Motor Corp. over claims associated with the unintended acceleration recalls. Go here for the full story.

Glaxo asks to delay trials on Avandia to attempt to settle the claims

GlaxoSmithKline is asking a federal judge to delay trial dates in the remaining lawsuits over Avandia heart problems, indicating that the drug maker is attempting to reach an agreement to settle the Avandia cases with the plaintiffs. Go here for the full story.

Football is not an "obviously dangerous activity" ..?

Playing tackle football without equipment is not an obviously dangerous activity, a federal appeals court has ruled in a decision that upholds the dismissal of a claim brought by a Pittsburgh teenager who was rendered quadriplegic while playing football at a state juvenile detention facility. The court held among other things that there was insufficient evidence of a "substantial risk of serious harm." Go here for the full story.

Mass. Appeals Court adopts "apparent manufacturer" approach to products liability

A little over a week ago the Appeals Court of Massachusetts upheld a $3.35 million jury verdict against Otis Elevator Company for an injury to a four-year old boy caused by a defective escalator that bore Otis Elevator's name but that was in fact manufactured by an independent Chinese company, thus applying part of the "apparent manufacturer" doctrine from the Restatement (Third) of Torts: Product Liability. Other Massachusetts cases had previously applied the apparent manufacturer doctrine, but no reported Massachusetts case had previously applied the doctrine to a person or entity outside the distribution chain (i.e., a nonseller). The Court concluded that a nonseller trademark licensor who participates substantially in the design, manufacture, or distribution of the licensee's products may be held liable under Massachusetts law as an apparent manufacturer. You can read the case here: Lou v. Otis Elevator Co. Go to the Boston Personal Injury Lawyer blog for more information and links.

FDA to consider whether to withdraw Meridia from the market

The FDA will ask an advisory panel meeting this Wednesday whether Abbott Labs’ Meridia diet pill should be withdrawn from the US market. The drug was withdrawn in Europe eight months ago. The FDA meeting follows a nearly year-long safety review conducted by the FDA, which was launched after a study published last November found that Meridia helped its users achieve only a small amount of weight loss while increasing their risk of heart problems. Go here and here for the full story.

Ninth Circuit upholds verdict in favor of Chevron for aiding and abetting

Back when I first started this blog in late 2008, there were a number of cases in the news related to the Alien Tort Statute (see here). One that gathered a lot of attention was a case by Nigerian citizens who alleged that oil giant Chevron Corp. cooperated with the Nigerian government in human rights abuses of protesters at the company's off-shore Nigerian facilities. That case ended up with a jury verdict in favor of Chevron. For that story (with links to more information) go here, here and here. Now, almost two years later, Law.com is reporting that the Ninth Circuit Court of Appeals has upheld the jury verdict clearing Chevron Corp. of the alleged human rights abuses. Go here for the full -- although extremely short -- story. The court's opinion can be found here.

This Week's Top Stories

Go here for the list of last week's most interesting Tort Law stories as selected by the TortsProf Blog. In addition, go here and scroll down for my own selection of top news stories.

Looking for Proof Tort Reform Reduces Health Costs?... Keep looking... Part V

During the height of the debate over the health care bill, there were a number of studies and reports published that documented how tort reform efforts would not lower health costs. For links to those articles go here, here, here and here. Lawsuits.com is now reporting on a new study from the Harvard School of Public Health, published in the September issue of the journal Health Affairs, that finds that the combined costs of medical malpractice and so-called defensive medicine make up only 2.4% of the total costs of health care in the United States. The study found that attempting to reduce the number of medical malpractice lawsuits would result in only a negligible effect on the cost of health care, and reducing the cost of defensive medicine would do little more. Go here for the full story. UPDATE 9-10-10: The PopTort has a comment on the study here.

Settlement news

Several settlements in the news today: 1. A New Jersey appeals court has upheld a $7.5 million verdict in a mesothelioma lawsuit that was awarded for a woman who was exposed to asbestos fibers while washing her husband’s work clothes for three decades. Go here for the full story. 2. Ford Motor Co. has reached a settlement with the family of a 22-year-old Mississippi man who died in a Ford Explorer rollover accident following a tire blowout. The undisclosed settlement came after a Jasper County jury awarded the family of Brian Cole $131 million at trial. Ford agreed to a settlement after the verdict to avoid a punitive damages award that could have been many times the compensatory amount. Go here for the full story. 3. Continental Airlines has reached a settlement agreement in at least two wrongful death lawsuits filed as a result of a 2009 airplane crash in Buffalo, New York that killed 50 people. Go here for the full story. 4. A California nursing home operator has agreed to pay $50 million to settle a lawsuit that threatened to bankrupt the company after a jury ordered it to pay $677 million for failing to provide enough nurses and staff. Go here for the full story.

South Carolina Adopts the Risk-Utility Test as the Exclusive Test in Products Liability Design Cases

As you probably know, one of the most debated questions in product liabiity law is the proper standard to use to determine if a product is defective in its design. The Restatement 2d originally suggested a consumer expectations test while many jurisdictions adopted a risk-utility analysis. Many -probably most, at least until recently - jurisdictions recognized both. Then, the Restatement 3d adopted a different view which includes a requirement that the plaintiff show a reasonable alternative design, a new approach that a number of jurisdictions have rejected. About three weeks ago, the Supreme Court of South Carolina had a chance to clarify the state of the law on the subject and adopted the use of a risk utility analysis as the exclusive test to determine design defects. The case is called Branham v. Ford Motor Company and it is available here. For comments on it, go here and here. I don't have a major problem with adopting a risk-utility analysis but I do have a problem with the requirement that the plaintiff show a reasonable alternative design. It is an unecessary requirement, the only purpose of which is to make it more difficult for victims to be able to support their claims and it goes contrary to the goal of encouraging the design of safer products.

6th Circuit decides preemption case related to a manufacturer's decision to place a drug on the market

Last year, the Supreme Court decided in Wyeth v. Levine that federal law did not preempt certain state law failure to warn claims. The Abnormal Use product liability blog is now reporting that the Sixth Circuit has just extended the holding in Levine in a case called Wimbush v. Wyeth, decided about three weeks ago holding that a plaintiff could pursue negligence claims relating to a manufacturer's decision to bring a drug to market, i.e., a pre-labeling, pre-approval claim. Go here for a comment on the case.

Learned intermediary doctrine protects pharmacy from having to alert customer of dangerous drug interaction

While some jurisdictions are adopting the learned intermediary doctrine (here) and others are abandoning it (here), the Illinois Court of Appeals has just issued a short but interesting case on the issue of whether the learned intermediary doctrine relieves a pharmacy from a duty to warn a customer of a potential drug interaction.

As you probably know, the learned intermediary doctrine provides that manufacturers of prescription drugs do not have duty to warn consumers directly of the risks involved in using prescription drugs because they can rely on the physicians who prescribe them to do so. In Illinois, the doctrine has for a long time, and with only one exception, been applied to exempt pharmacies and pharmacists from liability for failing to give warnings to patients. Part of the reasoning for extending the use of the doctrine in this manner is to prevent the pharmacist from second guessing the physician -- who the doctrine assumes is the best qualified and best positioned person to determine what is best for the patient -- and thus to prevent having the pharmacist interfere with the doctor-patient relationship.

The new case decided by the Illinois Court of Appeals is called DiGiovanni v. Albertson's Inc and it is availble here. In it, the court follows the long standing rule in the state that recognizes the protection provided by the learned intermediary doctrine for pharmacists. Given the long standing approach on the issue in the state and given the specific facts of the case, the case is correctly decided, but I have some mixed feelings about it.

As I have commented before (here), it may be time to revisit the whole LID doctrine to begin with. And, I believe it is unnecessary to apply it to pharmacists. I do not see a problem in holding pharmacists to the same standard of care that we hold everyone else. They should act like reasonable people under the circumstances. If they do, there will be no liability. The result in this case would have been the same had we applied that simple rule.

 The facts were clear that the pharmacist acted reasonably. The record indicates that the pharmacist called the physician prior to filling the prescription regarding the potential interaction, and the physician indicated that he would monitor the patient. Under those circumstances, the pharmacist was reasonable in relying on the expertise of the doctor. Perhaps the pharmacist could have told the patient to check with his doctor about the possible drug interaction too, but I am not sure that we can say that - under the circumstances - failing to do so should result in liability.

I guess my point is that the main concern here should be to develop a doctrine that seeks to provide the consumer with more protection. If it requires that pharmacists use their expertise by double checking with the doctor or telling the patient do double check with the doctor before exposing the patient to a known risk, so be it. The burden on the pharmacist to make a phone call or give a word of warning to a customer seems well worth it to me.

Some surprising risk factors that play into many car accidents

Don't ride in a pick-up truck with a beer-drinking recently divorced doctor on Super Bowl Sunday. Go here for an explanation.

Video Quiz

Here is a video quiz. How many torts can you spot? (If you are getting this by email, you may have to go to the actual website to see the video). According to reports I have read, the video was taken during an early round tennis match at the US Open. Apparently, the young man arguing with the woman had been swearing loudly and acting obnoxious in the stands before being confronted by the woman. I imagine she asked him to "watch his language" or something like that. This, as recorded by another fan in the stands, is what happened next:

Thanks to Jonathan Turley for the link to the video.

Attorney files for false imprisonment after being arrested for refusing to show ID

Readers 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, an officer of the law arrested a woman when she refused to show him an ID after he had spotted her walking a dog without a leash. Yesterday, the Baltimore Sun published a similar story. In this instance, a lawyer arrived at a courthouse about 20 minutes before closing time to file some documents in the clerk's office. In a hurry, he refused to show an ID to a police officer who was serving as courthouse security guard. He was arrested, left in a hot police car until he vomited, and transported to the police station where he was cuffed to a basement pipe. The charges were later dropped and he has now filed a $700,000 lawsuit claiming false arrest, false imprisonment and assault. Go here for the full story. Interestingly, the story says the officer said the plaintiff did not look "lawyerly." I wonder if that is a tacit admission that officials only ask people who have a certain "look" for IDs. Wouldn't that be a good question to ask during discovery? Someone should tell this guy to stop talking to the press.

Jury awards $1.8 million in legal malpractice case

Typically, a plaintiff in a legal malpractice case arguing that the defendant was negligent in handling litigation has to show she would have won the original case had it not been for the conduct of the defendant. And, typically, this is a very difficult standard to meet, which makes this news item very interesting. Law.com is reporting today that a Philadelphia jury has awarded nearly $1.8 million in a legal malpractice case in which the plaintiff alleged her attorney failed to plead all of the relevant theories in her medical malpractice case, leading to the necessity of settling her case for $1 million, despite having received a $2.5 million verdict. As you can see, the other intersting aspect of the case is that the plaintiff actually won her underlying case. Her argument was that she could have done even better -- that her lawyer's negligence resulted in her having to settle for less than the value of the judgment. Go here for the full story.

Blame the lawyers...

There is a story running around the internet about a school district in West Virginia that has dismantled all playground swing sets. "Swings are being removed from Cabell County schools in southern West Virginia in part because of lawsuits over injuries," says the story. ("In part?" I wonder what the other part is.) Yet, other equipment, such as "monkey bars" will remain. Then there's an editorial in something called "Investors.com" that says: "Fearing lawsuits over injuries, a West Virginia county is removing swing sets from elementary schools. A minor, local issue? No. America's litigious society has changed the way kids play." So, lawsuits have changed the way kids play. They are no longer exposed to dangerous surfaces or products. Isn't that sad?! Boy do I miss the days when my kids could really hurt themselves!! What the "investors" are not telling you is that, perhaps, just perhaps, changes in playground equipment have been a possitive thing. Maybe, just maybe, our kids are safer now thanks, "in part," to lawsuits.... As Eric Turkewitz eloquently states in his comment about the subject, "In the parks we’ve gone to over the past years, we’ve seen an abundance of swings, slides and things to climb on and scamper over. I see happy faces running up, over and around equipment that was far safer than the public parks I went to as a kid. The only thing I see missing from my youth is the merry-go-round you stood on that others would spin ’round and ’round ’till you puked or were catapulted off onto the concrete. I know, some people liked to see their kids in danger. Perhaps Investors Business Daily would like to return to the days of dangerous products, exploding Pintos, crippled children and Dalkon Shields." Jonathan Turley adds "The position of the district in my view is nonsensical. Monkey bars and other equipment will remain and could also be used as launch pads for Spiderman-wannabes. Moreover, such obvious and patent dangers are generally not the basis for liability so long as the equipment is not defective. One area of liability for playgrounds has been the lack of cushion on the ground such as wood chips or the use of particular rubber mats that heat up to a dangerous level. Just having a swing set is not a particularly strong torts case." His full comment can be found here.

New article on intentional infliction of emotional distress

We just started to cover Intentional Infliction of Emotional Distress in my torts class, so I thought the following announcement (taken from the TortsProf Blog) is rather timely: Geoffrey Rapp (Toledo) has posted to SSRN Defense Against Outrage and the Perils of Parasitic Torts. The abstract provides: "In Snyder v. Phelps, the Supreme Court will soon weigh whether protestors at a slain soldier’s funeral committed the tort of Intentional Infliction of Emotional Distress (IIED) or engaged in protected speech. Imagine that Mr. Snyder, the IIED plaintiff and soldier’s father, had, rather than bring a tort claim, used physical force to defend himself from the arguably tortious conduct of Phelps and his crowd. Can force be used to defend against intentional extreme or outrageous conduct threatening a person with severe emotional distress? The answer in the case law and articulated doctrine appears to be “no.” Two prominent narratives in tort law scholarship address the increasing recognition of claims for loss of emotional tranquility and the expanding privilege to use force in defense of self and others. This Article explores a puzzle in tort law that challenges these traditional accounts. The law permits the use of force to protect dignitary interests, in the case of offensive battery and assault, but seems to deny the use of force to protect against IIED. No basis for this distinction appears in the leading theoretical accounts of tort law – economics, corrective justice, and civil recourse theory. Rather, the basis of the rule seems to be the childhood maxim, “Sticks and stones…,” without strong theoretical or policy justification. Two implications arise. First, the law continues to privilege physical security above emotional well-being. Second, although it is arguably the most successful “new” tort of the twentieth century, IIED remains a tort whose boundaries are murky and whose place in tort doctrine is unclear. The parasitic nature of IIED has complicated the effort to build clear doctrine around all but the most essential elements of the claim." Thanks to Chris Robinette of the TortsProf blog for the information.

Michael Douglas and medical malpractice

New York personal injury lawyer and blogger Eric Turkewitz wonders if Michael Dougals was the victim of medical malpractice. See his comment here.

Easter District of PA denies preemption argument

Yesterday, Judge John Fullam (Eastern District of Pennsylvania) denied Wyeth’s preemption-based summary judgment motion in a number of Effexor SSRI suicide cases. The court concluded that the plaintiffs’ failure to warn claims were not preempted because Wyeth had not presented “clear evidence” supporting its defense. The case is called Baumgardner v. Wyeth Pharm and the opinion of the court is available here. For a comment on the decision from the defendant's perspective go here.

Pharma products news roundup

There are many stories on different aspects of the pharmeceutical industry related to products liability today. Here is a quick roundup with links... 1. A panel of judges has decided to give AstraZeneca Plc. more time to settle as many Seroquel lawsuits as possible, vacating a prior order that would have sent thousands of cases back to the federal district court where they were originally filed for trial. Go here for the full story. 2. Remember the salmonella oubreak that was traced back to a peanut processing plant a couple of years ago? AboutLawsuits.com is reporting today that a $12 million settlement has been approved by a federal judge to be distributed among victims of the massive food poisoning. Go here for the story. 3. The FDA has sent a warning letter to Baxter CEO Robert Parkinson, Jr., accusing the company of deceptive advertising in a physician brochure for Aralast NP. The FDA has determined that the brochure misbrands Aralast NP illegally, making overstated claims of efficacy reportedly also saying the company has a disturbing trend of overstating the effectiveness of its drugs and medical products. Go here for the story. 4. Pharmalot has a comment called Should The FDA Have Moved Faster On Meridia? 5. A clinical study funded by Abbott Laboratories has concluded that the side effects of Meridia, a weight loss drug, may increase the risk of heart attack and stroke. Story here. 6. Pharmalot asks "Did the American Heart Association’s Circulation journal publish a ghostwritten article about Avandia?" Go here for the story.

Pharmaceutical Co. pleads guilty to charges it illegally marketed drug

Allergan Inc. has agreed to plead guilty to charges that it illegally marketed Botox for off-label uses, and will pay $600 million to settle the charges brought by the U.S. government. Although not strictly a torts story, I am posting it here because I think it is of interest to anyone following issues related to the pharmaceutical industry. The story is being covered widely over the internet. For details you can check the following: WSJ Law Blog, AboutLawsuits, Law.com, Pharmalot and the FDA Law Blog. As part of Allergan's Botox settlement, the company was forced to drop its First Amendment-based suit against the FDA's restrictions on truthful promotion of off-label use. For a comment on that part of the story, go here.