Wednesday, December 29, 2010

Article on lawsuits against gun stores

Here is a link to a story recently published in Wall Street Journal about lawsuits targeting stores for selling guns illegally. There were a few similar cases in the news in 2009. For posts on those cases go here, here and here.

Wednesday, December 22, 2010

Family of Rutgers student who committed suicide files notice of claim against the university

The family of Tyler Clementi, the student who committed suicide in September after video of his inimate encounter with another man was broadcast on the internet, has filed a notice of claim against Rutgers University. The notice contends the university failed to protect Clementi against “unlawful or otherwise improper acts." “It appears Rutgers University failed to act, failed to put in place and/or failed to implement, and enforce policies and practices that would have prevented or deterred such acts, and that Rutgers failed to act timely and appropriately,” the notice reads. myCentralJersy.com has the story. I have not read the notice so I can't comment in detail, but from this short statement it sounds to me the claim is not particularly strong. Unless the University had imposed on itself a duty to protect or help, the court is not likely to find a duty existed because, as you probably know, there is no duty to help at common law. There are many cases out there that have addressed the possible liability of a University to protect its students from dangers and temptation that are inherent in university life. I don't think many have been successful, although I admit I have not researched the question in some time. I wonder what the plaintiffs are going to argue the school could have done - or more accurately, had a duty to do. Also, the defendants are likely to argue that the decedent's decision to commit suicide operates as a superseding cause. Thanks to TortsProf blog for the update and the link.

Tuesday, December 21, 2010

New case combines preemption and "Twiqbal"

When discussing preemption I always tell my students it is a "powerful" defense and I remind them that it has been used to successfully dismiss claims in many different contexts about many different products. So I smiled when I read the first line of a recent post at the Abnormal Use website: "As a defense lawyer, I dream about preemption..." The rest of the post, however, is what is important. It relates to a new case that illustrates what is now becoming a common "one-two punch" by defendants in product liability litigation: preemption and pleading requirements. In this particular case, the court dismissed a claim by applying a combination of preemption and what some people have been calling "Twiqballing" - which is a reference to the consequences of two cases called Twombly and Iqbal on the requirement to plead cases fully. For a list of cases applying this doctrine go here. The case is called Gelber v. Stryker (S.D.N.Y. Sept. 14, 2010) and it involved a claim that a hip replacement device was defective. The court dismissed the claim on preemption grounds based on the rigorous review the FDA had used in approving the device. The plaintiffs tried to reply by arguing that the defendants violated FDA manufacturing requirements but the court held that the plaintiffs had not sufficiently plead claims "grounded in violations of federal law and/or requirements." Thus, the court dismissed the claims, although it will allow the plaintiffs to amend to attempt to meet the pleading requirements. Thanks to Abnormal Use for the information.

American Tort Reform Association releases its "judicial hellholes" report

The American Tort Reform Association, a corporate front group whose mission is to make it more difficult for people to recover compensation for their injuries, has released its most recent report on what they call "judicial hellholes" which is really an attack on judges and juries that have held defendants accountable in court. The report names Philadelphia as the #1 "hellhole" - which means, that according to the report, it is the worst venue for corporate defendants. "Traditionally, Judicial Hellholes have been considered places where civil judges systematically apply laws and court procedures in an unfair and unbalanced manner, generally against defendants in civil lawsuits," explained ATRA general counsel Victor Schwartz. "The jurisdictions we name as Judicial Hellholes each year are not the only unfair courts in the nation. . . ." (Thanks to the TortsProf blog for this quote). As expected, those who oppose tort reform have issued responses, both sarcastic and serious. More surprisingly, even the pro-defendant Drug & Device blog has criticized the report stating that "Philadelphia’s reputation as a pro-plaintiff venue is a bit overblown" and that "ATRA's "litigation tourism" charge [is] particularly unfair."

Hot Coffee at the Sundance Film Festival - UPDATED

I am sure you have heard about the case where a plaintiff was awarded compensation when she got burned by McDonald’s hot coffee. But do you really know the facts of the case? Do you really know why the case is important?

To find out more, maybe you can go to the world famous Sundance Film Festival and check out a new documentary called Hot Coffee that tries to explain why the case is part of the discussion over the civil justice system and how it was used (and misused) for propaganda purposes about tort reform.

For more on the film go to its website here. For more on the story go here. 

UPDATE:  For more comments, mostly critical of the case and the movie, go here, here and here.

Monday, December 20, 2010

Interview with FDA Commissioner Margaret Hamburg

Here are links to three videos of a recent interview of FDA Commissioner Margaret Hamburg by Michael Specter of The New Yorker. Part 1: Regulation and consumer safety Part 2: Label and Marketing Part 3: Personal Medicine

Proposed new rules for vehicle safety

Abnormal Use is reporting that the federal government proposed new rules aimed at improving rear visibility standards for vehicles. The requirements, which the Transportation Department intends to take effect by the 2014 model year, were created to address concerns about drivers unintentionally backing over children. The Associated Press reports that most car makers will comply by installing rear-mounted video cameras and in-vehicles displays, which the governments estimates will add approximately $200 to the cost of each new vehicle. Go here for the full story.

Settlement in cases claiming loss of smell from use of Zicam?

The makers of Zicam have indicated that they are offering a $15.5 million to settle lawsuits brought by consumers who allege that they lost their sense of taste and smell due to the company’s recalled line of nasal sprays. The company said that 1,014 plaintiffs and 1,127 claimants will be eligible to be a part of the settlement. Go here for the full story.

Podcast on injuries to soldiers from exposure to toxins in Iraq and Afghanistan

I have blogged a few times about veterans claiming compensation for injuries related to exposure to toxins and other hazards. In 2008, sixteen Indiana National Guard soldiers filed suit against military contractor Kellogg Brown and Root (KBR), for allegedly exposing them to a cancer-causing toxins. Go here and here for more on that story. More recently, I posted 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. Now, the Legal Talk Network has a short radio podcast discussing the most recent developments in this area. To listen to the program go here (if that link does not work for you try here or here).

Duty to the beneficiary of a will?

The Legal Ethics Forum recently reported on a case out of the California Court of Appeal called Hall v. Kalfayan, in which the court decided that "a prospective beneficiary of a will cannot maintain a cause of action for legal malpractice against the attorney who drafted the will but did not have it executed before the death of the testator." According to the court, "[t]he essence of the claim in the case. . . is that [the attorney] failed to complete the new estate plan for Ms. Turner [the client] and have it executed on her behalf by her conservator before her death, thereby depriving Hall [the plaintiff] of his share of her estate." The court based its ruling on the fact that "in the absence of an executed (and in this instance, approved) testamentary document naming Hall as a beneficiary, Hall is only a potential beneficiary." But isn't this a bit of an egg/chicken problem? The plaintiff can't have a cause of action because he is not a beneficiary, but the reason he is not a beneficiary is, arguably, the attorney's negligence. If the lawyer had not been negligent, he would have been a beneficiary... The court seems to realize this problem and makes a point of stating that the client "had not expressed a desire to have a new will prepared and had only limited conversation with [the lawyer] about the disposition of her estate." If that is the case, I can understand the court's reasoning. After all, lots of people can speculate that they would have been beneficiaries had the client drafted a will if the client hadn't made up her mind yet. I have no problem with the court's conclusion in a case like that. But I think it would be wrong to conclude that even if the client had expressed her desire to the lawyer, there is no duty to the beneficiary until the lawyer does the work. Let's assume that the client clearly expresses to the lawyer his desire to prepare a will in which a certain person would be a beneficiary and it is clear that without the will the person would recover less or nothing at all. Let's also assume that it is clear the will must be prepared quickly because the client is in poor health. Then the lawyer is negligent in doing the work, or waiting too long or whatever. Saying that the beneficiary does not have a cause of action because the will was never prepared allows the negligent lawyer to avoid any consequences for the negligence and results in an injury to the beneficiary. I don't see why not recognize a cause of action under those circumstances. It would serve the two main goals of tort law: providing incentives for avoiding negligent conduct and providing compensation to victims of negligent conduct.

Friday, December 17, 2010

Boy left deaf in one ear by line drive sues bat manufacturer

The Chicago Sun Times recently published a story on a lawsuit filed against a baseball bat manufacturer by a boy who was left deaf in one ear after getting hit by a line drive. Go here for the story. The issue in a case like this is not new. Back in October of 2009 I published a comment on a similar case.  Here is my comment from back then.

Comment on the state of medical malpractice

The PopTort has a short comment here on medical malpractice in which it points out that malpractice continues at epidemic levels while state disciplinary boards are doing very little to properly police the small number of physicians responsible for most of it and lawsuits are dropping precipitously. Here is a new fact sheet from the Center for Justice and Democracy supporting the conclusiong that to the extent there is a medical malpractice “crisis,” the crisis is not because of the number of lawsuits filed but because of the extent of medical malpractice incidents actually taking place.

This week's top stories

Go here for the list of this 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.

Virginia may increase damages caps in med mal cases

Virginia lawmakers may be close to approving a plan to steadily increase the state’s limits on damage awards in medical malpractice lawsuits, with a proposed bill that would increase the $2 million limit over the next two decades. Go here for the full story.

Friday, December 10, 2010

Supreme Court agrees to review one more very important torts case - duty to warn by manufaturers of generic drugs

The Supreme Court announced today it has agreed to review three consolidated cases that will clarify the legal duty of makers of generic medicines to change their labels to warn consumers of a new threat of harmful side effects, and to decide whether state court lawsuits may be filed for failure to do so. The Court consolidated three separate cases on the issue: PLIVA Inc. v. Mensing (09-993), Actavis v. Mensing (09-1039), and Actavis v. Demahy (09-1501). The cases involved two women who developed tardive dyskinesia, a serious condition affecting neurological movement, after taking a generic version of the brand-name drug Reglan. (Reglan was manufactured by Wyeth.) The generic manufacturers involved in the new cases argued in their appeals that Congress did not intend for state court lawsuits to impede the marketing of generic drugs, as cheaper versions of brand-name drugs, and that should make a difference from the situation with a brand-name manufacturer like Wyeth. The Court granted review of the issue even though the Solicitor General argued it should deny review in Mensing. On that, go here. For details, including the lower court opinions and briefs, on PLIVA Inc. v. Mensing go here. For Actavis v. Mensing, go here and for Actavis v. Demahy, go here. For more on the story go to AboutLawsuits.com here. Here are some links to some of my previous entries on this blog related to this issue: Preemption debate regarding generic drugs (6/11/10) Video on preemption issues in generic drug cases and question about inadequate warnings (11/2/10) Solicitor General files brief on preemption debate regarding generic drugs (11/3/10)

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.

More on clinical trials

Yesterday I posted a link to a new article in Vanity Fair about drug companies' clinical trials in other countries (here). Now Pharmalot is reporting that a cable disclosed by WikiLeaks indicates that Pfizer hired investigators to uncover corruption links to Federal Attorney General Michael Aondoakaa in hopes of pressuring him to drop long-running litigation related the testing of Pfizer's Trovan antibiotic in Nigeria during 1996. Pfizer maintains the documents are false. Go here for the full story.

Thursday, December 9, 2010

Like Pfizer, Roche warns of risks in the UK but not in the US

Yesteday I posted (here) that Pfizer has not sent doctors in the US a letter warning them of certain risks related to one of its products even though it did send letters to doctors in the UK. Today, Pharmalot is reporting (here) that Roche has done exactly the same thing. Roche said it is submitting an updated label to US regulators, but that it will not be issuing warning letters to doctors in the US unless the FDA requires it.

Johnson & Johnson loses at trial

A federal court jury in Minneapolis has decided Johnson & Johnson failed to properly warn about the risk of tendon damage linked to its Levaquin antibiotic and awarded damages of $1.8 million in compensatory and punitive damages. Go here and here for more info.

Johnson & Johnson's list of problems

For those struggling to keep track of all the Johnson & Johnson recalls and misdeeds over the past year, Pharmalot has a short post (here) on the subject with helpful links to the information available in the FDA website, including a tally of all of the millions of bottles of over-the-counter medications recalled this year as well as a dirty laundry list of manufacturing problems at its McNeil Consumer Healthcare unit. The list includes nine separate listings for extensive recalls and the ‘phantom recalls’ that were disclosed by the House Committee on Oversight and Government Reform took place last year (see here and here).

Article on clinical drug trials

Back in August, I reported that a study in Pediatrics found more and more pediatric drug trials are being conducted overseas. See here. Now, the most recent edition of Vanity Fair has published an article titled "Deadly Medicine" in which the authors investigate the globalization of the pharmaceutical industry, and the U.S. Government’s failure to rein in what it calls "a lethal profit machine." The reason for this description is summarized in the article's first paragraph: "Prescription drugs kill some 200,000 Americans every year. Will that number go up, now that most clinical trials are conducted overseas—on sick Russians, homeless Poles, and slum-dwelling Chinese—in places where regulation is virtually nonexistent, the F.D.A. doesn’t reach, and “mistakes” can end up in pauper’s graves?" You can read the full article here. For a comment on the article by the PopTort go here.

9/11 Health and Compensation Act in danger

The 9/11 Health and Compensation Act, which already passed the House, is up for a Senate vote and still seems one vote short to prevent a fillibuster. The bill would provide $7.4 billion over 10 years to provide health care and payments to sick and dying 9/11 first responders (supplementing the recent legal settlement by covering care for far more victims). It calls for closing tax loopholes on foreign corporations to raise the money - a move opposed by Republicans. Go here for more on the story.

Possible tort reform in Florida

Bad news for victims of torts in Florida. The Legislature is apparently contemplating adopting a wide variety of reforms to protect defendants (mostly businesses and doctors) from liability. As reported in the St Augustine Record (here), the measures seek to increase the burden of proof for plaintiffs in "slip-and-fall" cases, to cap the fees that the attorney general's office can pay to outside attorneys, to provide some protections, perhaps through the state's sovereign immunity, to doctors who treat Medicaid patients and to make it more difficult for witnesses to qualify as expert witnesses. As all tort reform measures, these are designed to make it more difficult for plaintiffs to get representation, to get to bring claims or to recover. Thanks to the TortsProf blog for the link.

Wednesday, December 8, 2010

Pfizer sends new warnings to doctors in the UK but not in the US

Pharmalot is reporting that last week, Pfizer sent doctors in the UK a letter warning them of the risk of osteonecrosis, or jaw bone damage, in cancer patients who are being treated with its Sutent medication However, the letter was not distributed to doctors in the US. Pharmalot asked Pfizer why and received what it calls a "non-committal reply." Read Pharmalot's story here. As Pharmalot concludes, the bottom line is that "doctors and patients in the US . . . are not being alerted to the same possible side effects as those in the UK. Perhaps the FDA may want to take a closer look, since Pfizer appears unwilling to treat all patients equally."

Tuesday, December 7, 2010

Access to Facebook

Facebook appears to be in the news almost daily these days and, for a number of different reasons, it is now clear that all lawyers need to educate themselves (and their clients) on how to use it and not to use it. That includes me, but I do know one thing: very little (if anything) is private on the internet. For more on the issues related to professional conduct and social media go to this section of my Professional Responsibility blog, particularly to this post with examples of some of the uses of social media that have created problems for lawyers and judges recently. Now here is the latest, via the Legal Profession Blog: Last year, the Philadelphia Bar Association issued an opinion (available here) concluding that seeking to surrepticiously “friend” an opposing party or witness on social media (such as Facebook), personally or through an agent would constitute unethical conduct. However, a Pennsylvania Court of Common Pleas recently held that a party may be compelled through the discovery process to provide an opponent with access to his Facebook and MySpace accounts. In a decision in the case of McMillen v. Hummingbird Speedway, Inc., handed down September 9, 2010, President Judge John Henry Foradora of the Court of Common Pleas of Jefferson County held that access to one’s social networking sites is not protected by any privilege, and that the plaintiff in a personal injury action could be compelled to reveal the usernames and passwords of his Facebook and MySpace accounts to counsel for the defendants (but not to the defendants themselves). The court looked closely at the privacy and disclosure policies of the sites in question, and concluded that users are on notice that information posted on them may be revealed to persons who have access to such information by process of law. A New York trial court decision reached the same result by a very similar analysis.

Saturday, December 4, 2010

Is Congress going to abolish the learned intermediary doctrine?

In a recent interview, I argued that the time has come to take a careful look at the concept of the so-called "learned intermediary doctrine" in prescription drug cases. I am clearly not alone on this. At least two states have abolished the doctrine and Professor David Owen, author of leading textbooks and hornbooks on Products Liability has argued that "[i]n this day of mass merchandising of prescription drugs in the media, where drug manufacturers have chosen to jump over doctors and market their drugs directly to patients, it seems that manufacturers logically should have a corresponding duty to supply warnings of dangers directly to patients, too." (See here). Not surprisingly, those who favor defendants in these types of cases, disagree. That's why the Drug and Device Blog calls a bill to abolish the learned intermediary doctrine "something completly stupid." For their arguments in favor of the doctrine you can go here and here. Apparently, Rep. Bob Filner (D-CA) has introduced a bill (H.R. 6421) that seeks to abolish the learned intermediary rule. In summary, the bill says that "[i]t shall not be a defense to any tort claim in any court in the United States that a manufacture of a product has fulfilled that manufacturer's duty of care when the manufacturer provides all of the necessary information to a learned intermediary who then interacts with the consumer of the product." Unfortunately, the bill is probably not going anywhere. I would be incredibly surprised if it did - not only because of Congress is in a "lame duck session" but because of the powerful lobbying by the pharmeceutical industry.

Illinois Supreme Court to decide on manufacturer's post sale duty to warn

About three weeks ago, the Illinois Supreme Court heard oral arguments in a very interesting case that asks the court to decide whether to impose a post sale duty to warn as recognized in the Restaement of Torts (Third). The case is called Jablonski v. Ford Motor Company. The plaintiff in the case sued Ford after the 1993 Lincoln Town Car she and her husband were driving in was rear-ended. The collision forced a pipe wrench in their trunk through the walls of the fuel tank, causing a fire that killed her husband and left her severely burned. The 1993 Lincoln Town Car was one of four Ford vehicles, including one specifically designed for police, that was built with a fuel tank behind the rear axle. (I could be wrong about this, but I think that was the same design that caused problems for the infamous Pinto model.) In 2002, Ford contacted the owners of one of its models (one manufactured mostly, if not exclusively, for police departments) to notify them of the risk of fire, but Ford did not notify the owners of the other models. Those notifications informed owners of the availability of an upgrade kit, which consisted of shields designed to protect the fuel tank, as well as a drop-in trunk liner and a series of recommendations on how to pack things in the car's truck to avoid item puncturing the gas tank -- precisely what happened in the plaintiff's case. In her complaint against Ford, the plaintiff argued that the car manufacturer should be liable for failing to warn her when it knew of the risk and had warned owners of a different model car. The oral argument is worth watching. You can listen to the audio by going here or watch the video by going here.

Dermatologist Group Says Accutane Health Risks Outweighed by Benefits

An organization representing U.S. dermatologists say that they believe that the potential risk of bowel problems and suicide from side effects of Accutane are outweighed by the benefits provided by the drug in fighting severe acne. Go here for the full story. The drug's manufacturer discontinued the drug in the United States in June 2009, citing the increased costs associated with litigation over alleged health risks associated with the medication (more than 1,600 people are currently pursuing an Accutane lawsuit), but a number of generic Accutane versions remain available under names such as Claravis, Sotret, Amnesteem and generic isotretinoin.

Class action vs Toyota still alive

A federal judge has rejected a motion to dismiss Toyota class action lawsuits filed by people who claim that they suffered economic loss as a result of recalls issued due to the risk of sudden acceleration. Go here for the full story. UPDATE: Dec 10, 2010: AboutLawsuits.com has the story here.

Friday, December 3, 2010

Week's top stories

I am sorry I have not been updating the blog as consistently as usual during this week. I have been working on finishing my last few classes of the year and preparing for exams and other things. Hopefully, I will have a few days before I have to start grading to catch up. Meanwhile, here is a link to the TortsProf list of most interesting stories of the week. For my own list go here and scroll down.

Tuesday, November 30, 2010

New study on hospital safety

The findings of a new study suggest that efforts to decrease the number of medical mistakes in U.S. hospitals have generally failed, reports AboutLawsuits. According to the study, published in the most recent issue of The New England Journal of Medicine, patient safety has not improved since a landmark study ten years ago that put the number of patient deaths due to medical error at 98,000 annually in American hospitals. Alan Crede has more on the story here, including links to more sources.

Monday, November 29, 2010

Sept. 11 litigation finally settles

The September 11 suit concerning 10,000 emergency response and clean-up workers at the World Trade Center settled in June for $712M, with an important provision: At least 95% of the plaintiffs had to agree. And apparently that number has been reached. Go here for more details. Go here for the full story.

Yet another Johnson & Johnson recall!

About a week ago I reported on another J&J recall (for bottles of Benadryl). Today there are news on yet another recall, this time for Tylenol-cold. Pharmalot has the story here. AboutLawsuits has it here.

Man Falls To Death During Bears-Eagles Game in Chicago

The Chicago Bears' victory over the Philadelphia Eagles yesterday was marred by the death of a fan at Soldier Field — the second recent death at a major sporting event this month - reports Prof. Jonathan Turley today. He also comments on the other case - the death of a two year old boy who was able to climb over a glass barrier to plummet to his death at the Staples Center in Los Angeles. Go here to read his comment on the possible torts implications of these events.

Sunday, November 28, 2010

Would allowing "medical malpractice waivers" be a good idea?

Would it be a good idea to encourage patients to sign "medical malpractice waivers" to give up their rights to sue their doctor for any medical malpractice? In a chapter in his book "Nudge," Professor Cass Sunstein suggests that patients would benefit from such waivers because the cost of health care would be lower (because doctors wouldn't have to pay for medical malpractice insurance or order unnecessary tests to make sure their patients didn't sue them) and doctors could pass on the savings of avoiding those costs to their patients. Alan Crede has recently published a good response to this idea here. He also points out to an article by professors Tom Baker and Timothy Lytton in the Northwestern Law Review entitled, "Allowing Patients To Waive The Right To Sue For Medical Malpractice: A Response to Sunstein and Thaler." You can read the article here. Crede argues that the article is a devastating and complete knockdown of the chapter in "Nudge" in which Sunstein proposes medical malpractice liability waivers. Long time readers of this blog, and my students, may remember Baker as the author of a very good little book called the Medical Malpractice Myth (for an excerpt, go here). For a recent interview with him go here.

Study finds that hospital errors play role in 15,000 deaths a month

Go here for the full story. UPDATE 11/29: About Lawsuits have a similar story here.

The number of torts claims continues to decline

The PopTort is commenting on the most recent report from The National Center for State Courts on civil litigation in the United States. The report covers the year 2008 and according to the comment by The PopTort, it concludes that tort caseloads fell by 6 percent from 2007 to 2008 in 13 general jurisdiction courts reporting, whereas contract caseloads rose sharply, increasing by 27 percent in those courts over the same time period. Go here for more on the story. I have not had a chance to look at the report itself, but I will keep it handy so I can take a look at it the next time someone claims we need "tort reform" to deal with the massive numbers of "frivolous lawsuits" our court supposedly have to deal with all the time.

The FDA now says there is no problem with generics

About a month ago, Bloomberg News reported (here) that Dr. Janet Woodcock, head of the Food & Drug Administration’s Center for Drug Evaluation and Research has stated publicly she has ongoing concerns about the level of equivalence between generic drugs and name brand drugs on which the generics are based and about whether generics really meet quality standards. I posted a comment about this here. However, as part of a response to a state senator from New Jersey, the FDA is denying there is a problem. The senator had asked the FDA for its views on a proposed bill in the New Jersey legislature that would prevent pharmacists from switching anti-epilepsy pills over concerns that some patients have reacted poorly to generics that are deemed bioequivalent (read here). In its reply to the senator, the FDA wrote that it has many years of experience reviewing, approving and monitoring of generics and asserted that "we have not seen evidence that demonstrates a problem with therapeutic equivalence for this group of products [generic drugs].” However, it went on to say that the concerns “can not be dismissed lightly” and that out of respect and concern “that patients may lose confidence in their prescribed medications, we have sought to conduct further study.” Go to Pharmalot for the full story. In response to this, the Washington Legal Foundation again reacted with strong criticism of the FDA stating: "Either FDA felt it didn’t owe this state senator any information about impending studies, or nothing in fact is pending. In denying the existence of any problems with any generic drugs and stressing that there is no doubt at the agency, FDA seems to betray its extreme sensitivity to scrutiny of its generic drug approvals. FDA’s own senior leadership has called the Office of Generic Drugs on the carpet for public concern over generic quality, and the agency has been strongly challenged recently over its sudden alterations of bioequivalence criteria for generic versions of complex medicines including extended-release products and locally acting drugs. The bureaucratic hubris FDA exhibits on bioequivalence is irresponsible and unhealthy, given the dire potential consequences of breakthrough seizures if a generic [Anti Epileptic Drug] is ineffective, or if a copycat locally acting anti-bacterial medicine fails to stop an infection. FDA certainly doesn’t feel accountable for any of this to a state senator who represents epilepsy sufferers. Nor is the agency in any hurry to be accountable to Congress on concerns over epilepsy drugs – FDA is almost two months overdue with a report federal elected officials sought on generic AED bioequivalence standards . . ." Go here for the WLF's full comment. For more go to the FDA law blog.

Saturday, November 27, 2010

Turkey torts

To commemorate Thanksgiving day, here is a link to this year's collection of "turkey torts" as compiled by Prof. Jonathan Turley.

Monday, November 22, 2010

Plainfiffs survive motion to dismiss in claims vs Toyota for sudden acceleration

A federal judge has ruled tentatively that he would reject most of Toyota’s legal challenge to the hundreds of suits filed in the wake of claims that the company’s vehicles were mysteriously accelerating. Go here for the full story.

Friday, November 19, 2010

Full interview with former Toyota attorney

A couple of days ago, I reported that the magazine Corporate Counsel was going to publish a long article about a former lawyer for Toyota who has accused the company of hiding important and relevant documents in product liability cases. Here is the link to the article. (Note it is six pages long; you have to keep hitting "next" at the bottom of each page to keep reading.)

Thursday, November 18, 2010

New York's erroneous approach to assumption of the risk is back in the news

Long time readers of this blog will remember that I have criticized New York courts on more than one occasion for their sloppy analysis when it comes to the concept of assumption of the risk. See here and here, for example. The first of these cases, about which I reported on back in April of 2009 is back in the news because the Court of Appeals just heard oral arguments. I am hoping the Court corrects the mistake.The case is called Anand v. Kapoor and it is available here. My original comment about it is availble here. This is the case in which the New York state Appellate Division, Second Department, discussed the issue of whether a golfer can be liable for his conduct on the golf course if this conduct creates an unreasonable risk of harm to others. In the end, the court held that the voluntary decision to participate in the game means that golfers assume the risk of injury regardless of how the injury occurs. As I said last year in my original post on this case, I disagree with this holding as a torts professor and as a golfer! Sports activities do present risks to participants but that does not mean that other participants do not have a duty to act like reasonable people. Even if there is an inherent risk of getting hit by a ball on the golf course -- something I am not sure I agree with -- I don't think that means a golfer assumes the risk of getting injuried because of another golfer's negligence ... unless what the court is trying to say is that golfers simply have no duty to exercise due care when playing the game, which, in my opinion, would be contrary to public policy. For my full comment on the case go here. For more on the case go to the Wall Street Journal law blog.

Tuesday, November 16, 2010

Med mal, tort reform and the deficit part 2

Following up on my post from two days ago on this topic, the PopTort is offering today a short comment (with links to more) on the "“not so well thought out” ideas of the Co-Chairs of the deficit reduction commission" to enact a national cap on damages. Such a measure would disproportionately hurt seniors and other injured victims like women who work inside the home, children and the poor, who are more likely to receive a greater percentage of their compensation in the form of non-economic damages if they are injured. Go here for the full story.

Sunday, November 14, 2010

Med mal reform and the deficit

The New York Times' Room for Debate - a page dedicated to publish short opinion pieces on interesting timely topics - has just published a series of entries on the topic of "ways to cut the deficit." (Available here). Not to be missed among the 16 different short pieces is one by Michelle Mello, a professor of law and public health at the Harvard School of Public Health in which she tries to (very weakly) advance the myth that tort reform is worth pursuing as a way to reduce the deficit (here). Because, I guess, eliminating or obstructing the rights of victims of medical malpractice to recover is a good way to help the economy! To her credit, Prof Mello admits to the weaknesses of her position and to the lack of support for her conclusions. Unfortunately for her argument, though, what she is left with is a position with no support. She starts by pointing out that medical liability costs amount to about 2.4 percent of total health care spending and that, as a result, the potential for reducing our health care bill through liability reform is modest. "Modest" is an understatement. As has been demonstrated by a number of reports (including one authored by Prof. Mello herself) tort reform would not reduce the costs of health care. Go here for previous posts on this issue. Prof. Mello even admits that the Congressional Budget Office estimates that nationwide implementation of a package of five traditional tort reforms, including caps on noneconomic damages, would save 0.5 percent of health care spending. But, of course, the myth persists, because despite the evidence and the reports available, as she puts it, "it is difficult to precisely estimate the savings . . . especially if the particular reforms that Congress adopts prove more effective than the traditional reforms . . ." In other words, maybe we'll save more if Congress comes up with better alternatives than the ones that don't work. Can't argue with that logic! Prof. Mello suggests better alternatives include reforms that encourage early settlement of disputes, alternatives to litigation, and “safe harbors” for doctors who practice according to well-accepted practice guidelines. Yet, these alternatives have also been discredited. See here, here, here, here, here, here, here, here, here, here and here for just some examples. I am all for alternatives to litigation but not for alternatives that eliminate the right of victims to recover for their injuries or that make it more difficult for them to have access to the courts. I am also intrigued by this notion of "safe harbors" for doctors, which as she describes it does not need to be legislated. This "reform" already exists and works well. It is called the burden of proof that all plaintiffs need to prove when it comes to duty and breach of duty. Her comment seems to be based, again, on the myth that plaintiffs can just go to court and accuse a doctor of negligence without having to support the argument with actual evidence that they deviated from the standard of care - which anyone who knows anything about tort law knows has to be supported with expert evidence too and which is not an easy burden to meet. In the end, having spent more words weakening her own argument than supporting it, Prof. Mello concludes that "[g]iven the abysmal performance of the liability system in serving the needs of injured patients . . . reform is well worth pursuing even if it does not prove to be the next big deficit buster." I wonder what evidence there is about this claimed abysmal performance. What is it so bad about the liability system? Is it that plaintiffs don't get compesated fairly? Hm, could that be because of the many states that limit liability arbitrarily by imposing caps on damages? Or is it that victims don't have easy access to justice? Well, let's see, could that maybe be because of the many states that require plaintiffs to provide certificates of merit even before they have access to the evidence they need to prove their claims? It seems to me that, if the litigation system has resulted in an abysmal performance, maybe the reason is tort reform and not the litigation system itself. All that aside, the question remains, is medical malpractice reform really something to consider in the debate over the deficit? Even assuming it could save some money, what would be the real cost? Do we really want to go tell the victims of medical malpractice that they should give up their rights in order to save a minimal amount of money to help reduce the deficit?

Interview with former Toyota attorney who claims the company is guilty of discovery fraud

As you know, Toyota has been in the news recently because of claims of defects in its cars that cause sudden acceleration problems. A side story to that on-going litigation is the litigation against one of its former lawyers who has accused the company of hiding important and relevant documents in product liability cases. I reported on this back in March (here). A couple of days ago, Law.com posted a video previewing an upcoming story in Corporate Lawyer on the lawyer who has accused Toyota of discovery fraud. The video of a conversation with the lawyer is available here.

Friday, November 12, 2010

Hair salon product in the news for possible injuries to consumers

When discussing the difficulty of making the distinction between sales and services for products liability claims, I often use the example of a hair salon that uses a product on a customer's hair. Is the hair salon "selling" the product (which could make it subject to strict liability for defects in the product as a seller in the chain of commerce) or is it merely providing the service of applying the product (which would not). Along those lines, I just came across this story in the PopTort Blog about claims that a certain, and apparently very popular, new hair salon service/product is placing workers and customers at risk of serious injuries. Several lawsuits have been filed already. For more details go to The PopTort.   For a couple of news reports/videos on the issue go here and here.

New Study Suggests Accutane May Be Linked To Suicide Risk

Whether the Accutane acne medication (now off the market) was capable of causing someone to attempt suicide has been a long-standing debate. Pharmalot is reporting today that a new study suggests Accutane may be linked to suicide risk. Go here for the full story. UPDATE 11/17/10: AboutLawsuits.com has the story (including a link to the study itself) here.

Utah Sues GlaxoSmithKline Over Avandia Fraud

This is not really a torts story but since I have posted so many stories on the Avandia debacle, I am posting the headline and you can go read the full version here. The gist of it is that the Utah Attorney General has filed a lawsuit arguing that GlaxoSmithKline illegally marketed its Avandia diabetes pill and should repay the state $7.8 million, which is the amount Utah spent to purchase Avandia between Jan. 1, 2001 and June 30, 2010 for its Medicaid program. UPDATE 11/17/10: AboutLawsuits.com has the story here.

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.

Thursday, November 11, 2010

Veterans day

As we observe Veterans day today, I would like to invite you to take a look at this page where I have stories about torts that affect veterans and people in the military. Scroll down and read the headlines as you go up to see them in chronological order. There are a number of very interesting stories there.

Tuesday, November 9, 2010

Yet another report criticizing the FDA

AboutLawsuits.com is reporting today on yet another new report criticizing the FDA's shortcomings in its oversight and inspection functions. According to the story, this new report, published last week in the British Medical Journal, indicates that the FDA is currently unable to protect the public from harmful medical devices because it lacks the manpower, the budget and the authority to do so. Go here for the full story and more links. This is just the latest in a series of reports criticizing the FDA. For more information on some of the other reports that have found the FDA is not an efficient or reliable agency go here, here, here, here, here and here.

Friday, November 5, 2010

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.

Thursday, November 4, 2010

More comments on Williamson v Mazda

Go here for a recap of the oral argument in Williamson v Mazda in the Supreme Court blog. According to the Wall Street Journal, the Court appeared divided on whether to allow state product liability lawsuits against car makers for installing lap-only seat belts. Click here for Brent Kendall’s story in the WSJ and here for more from the Wall Street Journal law blog.

Wednesday, November 3, 2010

Transcript of Williamson v Mazda

Here is the link to the transcript of the oral argument in Williamson v Mazda. For the background on this case, go here, here and here. Go here for copies of the briefs and other legal documents.

On the new allegations against Toyota

A few days ago I reported (here) that plaintiffs in the lawsuit against Toyota for damages caused by sudden acceleration have alleged that Toyota investigated sudden-acceleration incidents and then bought back vehicles from the customers who reported problems making them sign confidentiality agreements. AboutLawsuits has picked up the story today here.

Prof. Bernabe's abnormal interview

The products liability blog Abnormal Use recently asked me to participate in their interview series. Here are my comments.

Pharma begins to settle cases alleging connection between antidepressants and suicide

AboutLawsuits.com is reporting that Forest Laboratories is beginning to settle lawsuits that allege that its antidepressants Celexa and Lexapro caused teenagers to attempt suicide or take their own lives. The Celexa and Lexapro settlements come about a month after the company pled guilty to illegally marketing of the drugs to children. There are 54 lawsuits pending against the company, which were consolidated and centralized in federal court in St. Louis. The defendant agreed to settle four of the cases last week, two others in the weeks before that and more settlements are expected in the coming months. Go here for the full story.

Solicitor General files brief on preemption debate regarding generic drugs

Here is the perfect follow up to my most recent post! As I reported back in June (here), the U.S. Supreme Court has asked the U.S. Department of Justice to "express the view of the United States" on whether the FDCA preempts failure to warn claims against generic drug manufacturers. This morning, the FDA law blog is reporting that the U.S. Solicitor General of the United States has filed its highly anticipated amicus brief. The Solicitor General’s recommendation is that the Supreme Court deny review given the current lack of a split of authority among the Circuit Courts on the issue of preemption and state law failure-to-warn claims against generic drug manufacturers, as well as several uncertainties in Mensing that “further counsel against review at this time.” For the quick background to understand this story go here. Go here to read the story in the FDA law blog. Go here for a copy of the brief itself. For my previous posts on this topic go here, here, here, here, here, here and here. Here is the bottom line of the Solicitor General's brief: "The court of appeals correctly held that respondent’s failure-to-warn claims are not categorically preempted, because a generic pharmaceutical manufacturer, like a brand-name manufacturer, can (and indeed, must) inform FDA of new information about risks that may require a change in the labeling of its drug." UPDATES: 9:45am: More on the story at SCOTUS blog here. 10:15am: Pharmalot has the story here. Nov 4: Drug & Device law blog has a comment here. Nov. 5: AboutLawsuits.com has a comment here.

Tuesday, November 2, 2010

Video on preemption issues in generic drug cases and question about inadequate warnings

Here is a short video, courtesy of the Washington Legal Foundation, on some intereting issues related to preemption and generic drug manufacturers. The whole topic is very interesting, but I want to hightlight one related issue. Note how the speaker argues in favor of preemption by arguing that generic manufacturers are obligated by law to provide the exact same warning that brand name manufacturers provide and that generic manufacturers are not allowed to change or update the warning unless the brand name manufacturers do so first. Brand name manufacturers, on the other hand, are permitted to update the warnings when newer information becomes available to them that suggests the warning should be improved or strengthened. But generic manufacturers can't do this; they can't change the warnings unilateraly. Here is what I find intersting about that argument: there has been a lot of discussion (see here) about whether a brand name manufacturer should be held liable for injuries suffered by the user of a generic equivalent. I understand that sounds unfair, and I think it would be unfair if the drugs are not really "equivalent" (for more on that issue go here). But what if the claim is for lack of adequate warnings? If the warnings in the generic drug are essentially controlled by the brand name manufacturer and they are inadequate, can't you say that the brand name manufacturer contributed to the injury and should be partly responsible? I don't see why not. For my previous posts on this topic go here, here, here, here, here and here.

Articles on tomorrow's Supreme Court oral argument

I have mentioned several times that tomorrow the Supreme Court will hear oral arguments in Williamson v. Mazda Motor, which asks the Court to determine the preemptive effect of the National Highway Transportation Safety Administration regulations on seat belts and which will allow the court to review its 2000 decision in Geier v. American Honda Motor Co. Here is a link to an article on the case, via the SCotUS blog. The PopTort also has a preview here.

On the most recent criticism of the FDA

A few days ago I reported (here) that the Government Accountability Office (“GAO”) recently published a report that sharply criticizes FDA for persistent shortcomings in its oversight and inspection of foreign drug establishments. Two other blogs have picked up the story. For more go to AboutLawsuits.com and Pharmalot.

Monday, November 1, 2010

Short comment on torts and the insurance industry

Jay Feinman, Distinguished Professor of Law, Rutgers-Camden, has posted a very good short comment on the TortsProf Blog titled "Tort Law and the New Economics of Insurance." Here are the first two paragraphs: There is widespread acceptance of the idea that tort law and insurance are intimately related. The growth of liability insurance permitted the expansion of tort liability through the twentieth century, and the expansion of tort law in turn spurred the further development of liability insurance. The compensation objective of tort would not be served without the presence of insurance. First-party insurance obviates the need for tort in some circumstances and, through the collateral source rule, effectively funds contingent fees in other circumstances. And so on. All of these ideas are based on the assumption that insurance works—that companies assess risks, insureds purchase policies against those risks, and the companies pay claims that are within coverage. Unfortunately, the facts about insurance are increasingly at odds with this assumption. Most companies pay out most claims most of the time, of course. But more and more, insurance companies deny valid claims in whole or part and force policyholders and tort victims to litigation to obtain the benefits to which they are entitled. Go here to continue reading the full comment.

Sunday, October 31, 2010

More criticism of the FDA

The FDA Law Blog is reporting today that earlier this week, the Government Accountability Office (“GAO”) publicly released its September 2010 Report to the House Committee on Oversight and Government Reform concerning Drug Safety, titled “DRUG SAFETY - FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed (available here).” The report sharply criticizes FDA for persistent shortcomings in its oversight and inspection of foreign drug establishments – functions essential in GAO’s view to “safeguarding the nation’s drug supply in today’s global marketplace.” Go to the FDA Law Blog for the full story. UPDATE Nov 2: For more go to AboutLawsuits.com and Pharmalot.

Saturday, October 30, 2010

On the risks of taking generic drugs and the hypocrisy of tort reformers

Last week, Bloomberg News reported (here) that Dr. Janet Woodcock, head of the Food & Drug Administration’s Center for Drug Evaluation and Research has stated publicly she has ongoing concerns about the level of equivalence between generic drugs and name brand drugs on which the generics are based and about whether generics really meet quality standards. This is a serious concern, which again highlights the deficiencies of the FDA as an oversight agency over an industry that affects - and puts at risk - millions of consumers every day. There are many reports out there of consumers of drugs for depression, epilepsy and other common problems who have complained to the FDA about the negative effects of being switched from brand name drugs to their generic "equivalent." Generic drugs account for the vast majority of all prescriptions in the U.S. so it is imperative to determine if we can trust the FDA to protect our safety. That aside, it is interesting to point out the response to the Bloomberg News story by the Washington Legal Foundation, a think tank that supports, among many other things, tort reform. Here is what they had to say: "Generic drugs account for over 70% of all prescriptions written in the U.S. Scores of branded drugs of increasing complexity are soon to lose their patent protection and become subject to generic competition. It is the ideal time for FDA and its overseers to consider whether FDA’s testing sufficiently protects patient safety. In the least, FDA should responded with more urgency to Dr. Woodcock’s caution this year than it did to her “tide of skepticism” statement in 2009. More must be done than simply publishing informational ads and asking that pharmacies display government posters assuring consumers that FDA is protecting them." You can read the full comment here. Stop the presses!!! The WLF and I agree on something?!! Wow! What is going on at the WLF?! I mean, I would have expected them to argue we should trust the FDA. This would have been consistent with the position that the FDA are the experts and that we should oppose allowing litigation in state courts over defective drugs or inadequate warnings as long as the FDA had approved the drug. So how come they are now saying maybe we should not trust the FDA? Oh... wait. I get it. You see, generics create competition for the name brand manufacturers, so "big pharma" does not want generics on the market. I see.... Federal regulation, and, who knows?, maybe even a little litigation, is OK to make sure generics are safe; but totally out of the question when it comes to questioning the safety of products by the big brand name pharmaceutical companies. Makes total sense now.

Prof. Turley's annual collection of halloween stories

Here is the link to Professor Jonathan Turley's Annual Halloween Special of Spooky Torts and Crimes.

Supreme Court will hear oral arguments on seat belt preemption this Wednesday

This coming Wednesday the Supreme Court will hear oral arguments in Williamson v. Mazda Motor of America, Inc., which asks the Court to decide whether a claim for damages in state court caused by a car manufacturer's failure to install a three point seat belt in a 1993 car is preempted by federal regulations that allow vehicle manufacturers to install either lap-only or lap/shoulder seatbelts in certain seating positions. For my previous posts on this case go here and here. Go here for copies of the briefs and other legal documents. I will post the links to the transcript and audio files on Wednesday night.

Friday, October 29, 2010

West Virginia Supreme Court to decide on the validity of the state's cap on damages for medical malpractice

AboutLawsuits.com is reporting today that the West Virginia Supreme Court has before it a claim challenging the damage cap in medical malpractice cases imposed by the state legislature as an unconstitutional intrusion on the right to a trial by jury. The claim also argues that the statute is invalid because the statute makes an arbitrary legal decision, regardless of evidence and circumstances. The West Virginia cap on pain and suffering was first instituted in 1986, but then the cap was set at $1 million, which would be adequate in most cases and which is much higher than in all other states that have a cap. Since then, however, the cap has been lowered and now limits recovery for pain and suffering to $250,000 in most cases and $500,000 for the most serious injuries but regardless of the number of defendants involved in a case. In the case before the court, the jury awarded the plaintiffs a little over $1.6 million. Applying the statute, the lower court reduced the jury’s award to $500,000. Not suprisingly, lobbyist groups representing doctors and insurance companies have filed a brief in an attempt to ensure the cap remains in place, arguing that it is acceptable for the legislature to interfere with the cases to keep the price of medical insurance low and keep doctors from fleeing the state for fear of being targeted by medical malpractice lawsuits- two arguments that have been thoroughly discredited by all recent studies on the subject. See here. Oral arguments in the case are scheduled for January, with a decision expected later in 2011. State Supreme Courts in Illinois and Georgia have invalidated similar damages caps over the last year. For more on that, go here, here, here and here.

At what age can a child be considered old enough to be sued for negligence? Four is old enough in NY

The Wall Street Journal law blog is reporting today that a trial court judge in Manhattan has held that a 4-year-old girl is old enough to be sued in a personal injury action. The girl allegedly ran into an elderly woman as she raced her bicycle with another child on the sidewalk in front of her house. She was riding her bicycle with her training wheels under the supervision of her mother. Go here for the story in the WSJ, here for the story in the New York Law Journal; here for the NYT article. UPDATE: two more comments on this case here and here.

WLF comment on the Alien Tort Statute

The right-wing think tank the Washington Legal Foundation has posted a comment on the Order of the Court of Appeals for the Ninth Circuit sending the Rio Tinto case to mediation - about which I wrote yesterday (here). Nor surprisingly, it sides with the dissenting judge in questioning the application of the statute and argues the court should have followed the Court of Appeal for the Second Circuit approach to eliminate plaintiffs' rights under the statute. You can read the WLF's comment here.

Thursday, October 28, 2010

More interesting decisions on the Alien Torts Statute

About a month and a half ago, I reported on a decision by the Court of Appeals for the Second Circuit holding for the first time that plaintiffs could not bring claims against corporations under the Alien Tort Statute. This view departs from decades of case law under the ATS. (See here and here.) Now comes news that in a dissenting opinion from an order by the Court of Appeals for the Ninth Circuit a federal judge is suggesting yet another radical departure from accepted doctrine. The Court's order (available here) was surprising too, but for a different reason. Nearly a decade into the litigation of a class action filed on behalf of some 10,000 people who say they suffered from violence, threats of violence and pollution from Rio Tinto's copper mining in Bougainville, Papua New Guinea, the Court has decided to refer the case to a judge to explore the possibility of mediation. In dissent, Judge Kleinfeld argues that the case should not be referred to mediation because he does not think the court has jurisdiction over the case to begin with, stating that "We have not yet decided whether we have jurisdiction over this dispute. I very much doubt that we do. I suspect that we lack jurisdiction both because the case involves a political question and because we lack subject matter jurisdiction on account of extraterritoriality. This case is entirely extraterritorial. The claims are by Papua New Guineans against a British-Australian company for wrongs committed in Papua New Guinea. Although Rio Tinto has operations in many countries, including the United States, and Sarei lived in the United States as a resident alien when the complaint was filed, nothing done by Americans or in America, is at issue." This is a remarkable statement. The notion that the court may not have jurisdiction because the case involves a political question is correct, but the suggestion that the court may not have jurisdiction because the claim is filed by an alien and relates to conduct outside the US departs from the current interpretation given to the statute by the Supreme Court. The ATS exists precisely to provide jurisdiction to aliens to recover for injuries committed outside the US. Most, if not all, the cases decided by the Supreme Court and other federal courts under the ATS involve claims in that context. If the court were to follow the judge's suggestion and hold the court does not have jurisdiction, it would be using a radical interpretation of the statute not based on any previous ATS case. Go here for more on the story. Go here for all my comments on recent developments related to the Alien Tort Statute.

Ct dismisses claim vs brand name pharma in case where the plaintiff had used the generic version

A federal judge in Louisiana has dismissed a lawsuit that was filed by a man who took a generic version of the Reglan heartburn med, but charged that Wyeth and Schwarz Pharma, among others, were liable for failing to warn of serious side effects. The decision continues the trend to dismiss the theory that brand-name drugmakers can be held liable not only for harm caused by their own meds, but also for injuries caused by generic drugmakers selling a copycat version because the law allows generic drugmakers to rely on research and labeling contained in the application for the brand-name med. For more on the story go here. You can read the opinion here. For older stories on the same topic go here, here, here, here and here.

New allegations that Toyota tried to cover up acceleration problems

The Wall Street Journal law blog is reporting today that the plaintiffs in the lawsuit against Toyota for damages caused by the sudden acceleration of some of Toyota's vehicles have amended the complaint to add a few new claims, including the allegation that Toyota investigated sudden-acceleration incidents and then bought back vehicles from the customers who reported problems making them sign confidentiality agreements. Go here for the full story.

Feds finally take action against small pharma company known for its repeated manufacturing problems

Pharmalot is reporting today that earlier this week, the FDA seized prescription and over-the-counter products from a little-known company in New Jersey, Tri-Med Laboratories, for repeated manufacturing deficiencies - a lack of protocols, questionable test results and non-existent cleaning methods, among other things - that caused various products to be considered adulterated. That's bad, but what makes the story worse is the fact that the FDA had known of the problems since 1997! Back in 1997, the FDA issued a warning letter to the company outlining the problems. Seven years later, the same thing happened and again in 2009. The most recent letter also noted that, two years ago, Tri-Med recalled gas relief drops for infants due to microbial contamination. So I guess that after 13 years, someone decided it was time to take action. During those 13 years, however, the company was allowed to put adulterated products in the market placing customers of all ages at risk of injury without oversight. Tort reformers and the pharmeutical industry constantly argue we should not allow state tort claims under the preemption doctrine because we need to trust the federal government agencies who are "the experts" at deciding what is safe for us. We can't trust the litigation system to do this, they say. With stories like this one and many others over the years about the deficiencies of the FDA as an oversight agency (see here and here, for example) , I think this is a difficult argument to make. For more details and links to relevant documents go to Pharmalot.

Wednesday, October 27, 2010

Glaxo To Pay $750M For Manufacturing Fraud

GlaxoSmithKline has agreed to pay a $750 million fine to settle charges over numerous production problems - contaminated meds, mislabeled packaging and incorrect dosages - at a facility in Cidra, Puerto Rico. For more on the story go to Pharmalot, Law.com, FDA Law Blog, AboutLawsuits.com and the Wall Street Journal Law Blog.

Sunday, October 24, 2010

Another reply to Peter Orszag's Bad Medical Malpractice Idea

Last week I posted a link to a reply to Peter Orszag's column in the New York Times in which he complained that the health insurance reform bill did not do enough to federally "reform" state medical malpractice laws. Here is a link to another critical response. In this new reply, Alan H. Crede argues that Orzag's proposal "is both scientifically and legally illiterate" and that "it's not even clear that he understands what he's proposing." Go here to read the full comment.

Friday, October 22, 2010

Dept of Justice to investigate Glaxo over issues with Avandia

Amid ongoing accusations that the pharmaceutical giant GlaxoSmithKline knew their diabetes drug Avandia increased the risk of heart attacks and tried to suppress that information, the Department of Justice (DOJ) has subpoenaed the drug maker to gain access to clinical data and marketing information. For more on this story go here.

Problems in the auto industry

The Pop Tort has a short comment on safety issues in the auto industry here. Among other things, it reminds us that about 10 million Toyota cars and trucks have been recalled worldwide this year (for faulty gas pedals and floor mats, braking problems,stalling engines). Toyota had to pay a $16.4-million fine as a result of what the National Highway Traffic Safety Administration argued was a failure to report the problems to government regulators in a timely manner. Meanwhile, Honda has recalled an unspecified number of Acura RL sedans and Odyssey minivans. Chrysler recently recalled over 26,000 vehicles with power steering problems. Volvo recalled almost 10,000 cars for problems with airbags. GM and Nissan had seven recalls while BMW, Chrysler and Ford had five each. In all, the auto industry has had 56 safety recalls for passenger vehicles in the last six months, according to government data.

Thursday, October 21, 2010

Peter Orszag's Truly Bad Medical Malpractice Prescription

Yesterday's New York Times published a column by Peter Orszag in which he complains that the health insurance reform bill did not do enough to federally "reform" state medical malpractice laws. He argues that Congress should "shield from malpractice liability any doctors who followed evidence-based guidelines in treating their patients" and "provide safe harbor for doctors who follow evidence-based guidelines." He says, "[A]nyone who could demonstrate that he has followed the recommended course for treating a specific illness or condition could not be held liable." In response, Joanne Doroshow replies "This is a horrendous idea." I agree. Go here to read her full response.

Comment on unsafe baby products

In my class we are getting ready to discuss Ayers v. Johnson & Johnson, 818 P.2d 1337 (Wash. 1992), a case that many of my students find very scary, in which the court discusses the dangers of baby oil. As if on cue, the PopTort blog has just published a short comment on unsafe baby products here.

Short documentary on BMW v. Gore

As I am sure most of the readers of this blog already know, BMW v. Gore, was the first case where the Supreme Court developed an analysis to determine if the amount of punitive damages imposed on a defendant was excessive. It openned the door to other cases in which the Court then continued to develop its approach to the constitutionality of punitive damages. As part of its “Voices of American Law” series, Duke University has produced a 14 minute documentary on this case. The video, as well as links to many relevant documents is available here.

Federal Court finds South Dakota would adopt learned intermediary doctrine because another federal court had found North Dakota would

The Federal District Court for the district of South Dakota has issued an interesting opinion in which it dismisses a claim against a prescription drug manufacturer by applying the learned intermediary doctrine even though the state courts in South Dakota have not yet decided whether to adopt that doctrine. The case is called Schilf v. Eli Lilly & Co., and it is available here. In this case, the plaintiffs’ 16-year-old son committed suicide while on Cymbalta, an Eli Lilly antidepressant. The parents sued, claiming that the drug's warnings were inadequate because they did not warn about an increased risk of suicidal thoughts and behaviors in children and adolescents on antidepressants. After discovery, Eli Lilly moved for summary judgment based on the learned intermediary doctrine (which allows a manufacturer to avoid liability as long as it adequately warns the physician who then has to duty to warn the patient). One interesting thing about the case is that the courts in South Dakota had not decided whether to adopt the learned intermediary doctrine, so the federal court had to predict whether it was likely that the South Dakota Supreme Court would adopt the learned intermediary doctrine. In deciding that it would be likely, the court cited Ehlis v. Shire Richwood, Inc., 367 F.3d 1013 (8th Cir. 2004), in which the Eighth Circuit predicted that the Supreme Court of North Dakota would adopt the doctrine. I have not idea whether this will be well received in South Dakota. Does South Dakota always follow what North Dakota does? Do South Dakotans resent being compared to North Dakotans? I just don't know. Why what North Dakota does in terms of tort would be relevant to what South Dakota would be likely to do is a mystery, but there you have it. I think the court could have reached the same result (and avoided this potentially politically incorrect approach) by simply basing its decision on an analysis of South Dakota law and tort policy. The fact of the matter is that the learned intermediary doctrine is still applied in most jurisdictions and that there are policy reasons to support it in most cases. (I say "most cases" because I think the argument is weaker in cases that involve direct to consumer advertising, but that does not seem to have been an issue in this case.) Adopting the learned intermediary doctrine does not, by itself, absolve the manufacturer of liability, though. The court still has to determine that the manufacturer provided warnings to the doctor and that the warnings were adequate. Having done that, then the court addressed cause in fact: would the doctor have prescribed the drug anyway? In a comment about the case, the folks from the Drug and Device Law Blog describe this part of the case this way: The prescriber also was asked whether he still believed that the decision to prescribe Cymbalta was correct. That question is often a key moment in a prescriber’s deposition. The deposition room goes quiet; many people subconsciously hold their breath, as they know that the entire case could hinge on this one answer. Experienced defense counsel will act nonchalant, trying to communicate nonverbally to the prescriber that the answer is a given rather than communicating that the answer is a really big deal. Then the prescriber answers, and everyone exhales. Here, the prescriber said yes. Based on that testimony, the court held there was not sufficient evidence of causation to allow the question to be submitted to the jury.