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It’s hard to read any news about prescription drugs these days without wondering if you’ve somehow fallen into a Philip K. Dick novel. Just look at some of these titles over the past week:
- “2 new studies show the FDA is rushing more drugs to market based on shoddy evidence”
- “The True Cost of an Expensive Medication”
- “U.S. drug company sues Canada for trying to lower cost of $700K-a-year drug”
- “Outrage could lead to lowering price of high-cost drugs”
All of these stories are about different drugs, but the common theme among all of the stories is, of course, money. The Mayo Clinical Proceedings recently found “In the United States, the average price of cancer drugs for about a year of therapy increased from $5000 to $10,000 before 2000 to more than $100,000 by 2012, while the average household income has decreased by about 8% in the past decade. Further, although 85% of cancer basic research is funded through taxpayers’ money, Americans with cancer pay 50% to 100% more for the same patented drug than patients in other countries.”
We’re getting ripped off. These days, the public interest isn’t even an afterthought in the prescription medication industry. That’s how the FDA could approve flibanserin, a failed antidepressant, as the “women’s Viagra,” even though the drug is more likely to make women pass out than to improve their sex life. The drug’s effectiveness is questionable at best, whereas the risks are considerable, and the one and only study examining its effects in conjunction with alcohol included — and this isn’t a joke — just two women.
The concerns about prescription drugs generally break into three categories: (1) unreasonably high prices for effective drugs; (2) the incentive manufacturers have to sell and push doctors to prescribe drugs that don’t work as well as cheaper drugs; and (3) the potential for drugs causing unexpected side effects.
There are a variety of potential solutions, as Health Affairs recounted three weeks ago, with two of the most common ideas including allowing Medicare/Medicaid to negotiate drug prices and regulating the prices of drugs.
Let me float another idea: litigation. Continue reading
As everyone knows by now, Volkswagen admitted that nearly 482,000 of its “clean diesel” cars were actually pollution monsters equipped with special software designed to evade government emissions testing. As The Guardian reported, an analysis suggests that the amount of pollution caused was “roughly the same as the UK’s combined emissions for all power stations, vehicles, industry and agriculture.”
BuzzFeed rounded up news on the many class action lawsuits that have been filed, quoting me as saying, “the car you own is not the car you thought you bought. … Whenever you sell these things, you’re going to lose some value.” At the moment, it’s hard to know where to start on that value. Certainly, the cars will lose value when the fixes imposed by the recall are installed, because they’ll likely have worse mileage and lower horsepower. But there might be even greater economic harm than that, and the answer depends on why Volkswagen embarked on such a massive fraud.
The most likely answer is that the pollution controls probably had a negative impact on the car’s overall durability — they made the engines run hotter, made the cars wear out faster, and caused the car to get worse gas mileage than it would have without the pollution controls.
If that’s the case, then the damage is even greater than just a loss in horsepower or mileage. The cars just won’t be as durable and reliable as they should be. It’s difficult to imagine what could be more harmful to the resale value of a car than a generalized loss of reliability. Nobody buys a diesel Volkswagen to race it on the track with a maintenance crew on hand; consumers buy them for everyday use.
The most incredible part of this story is just how blatant the scam was, and how Volkswagen was able to do it for six years without anyone being the wiser. The scam wasn’t even exposed by a whistleblower, but by West Virginia University’s Center for Alternative Fuels, Engines and Emissions, which discovered the problem while actually trying to show the benefits of diesel passenger vehicles by way of testing a BMW, a VW Passat, and a VW Jetta. Continue reading
Earlier this week, a federal judge vacated Tom Brady’s “deflategate” suspension. At first blush it’s more than a little ridiculous that the federal courts are involved in NFL rule violations — but if we put aside the football aspect of this story, and instead look at it as an everyday union employee arbitration, then suddenly it looks less like a court getting involved in sports and more like an employer trying to make up the rules as it goes.
The NFL has rightly been under fire lately for it’s total lack of moral fiber, as shown by its belated, half-hearted measures regarding domestic violence, and the Court’s findings in “deflategate” reveal more of the same. The Court found, in essence, that the NFL’s collective bargaining agreement with its players is so vague about discipline that it doesn’t give sufficient notice to players that outright cheating could result in a suspension.
Some background: NFL players are unionized, and their collective bargaining agreement includes a provision calling for arbitration if the NFL and the Players’ Union have a dispute over a workplace grievance. That’s commonplace among unionized workers. It’s a standard method for resolving workplace grievances. It’s also standard for union arbitration awards to be appealed to federal court. See, Section 301 of the Labor Management Relations Act, 29 U.S.C. § 185, and Section 10 of the Federal Arbitration Act, 9 U.S.C. § 10.
The fairness of an arbitration always starts with a basic question: who will be the arbitrator? By and large in America, arbitrations are done with an arbitrator that both parties agree upon, but there are exceptions, and some contracts allow one side to pick the arbitrator. As I wrote six years ago in The Very Worst Contractual Provision To Which You Can Agree, “anyone who demands they alone have the right to choose the arbitrator is trying to defraud you.”
That seems to be the case with the NFL’s collective bargaining agreement: the NFL gets to pick the arbitrator, and it can have the NFL Commissioner serve as the arbitrator. What sense does that make? Would you agree to an arbitration with your employer where the arbitrator was your employer? On the one hand, there’s a sound economic argument to be made that the NFL Players’ Union has ample bargaining power to negotiate this clause out of their collective bargaining agreement. On the other hand, there’s a simple legal argument that this sort of “I get to be my own judge” clause shouldn’t ever enter the picture. What’s the point of having a biased arbitration at all?
Brady rightly raised objections to Commissioner Goodell serving as the hearing officer at the arbitration, but the Court didn’t reach those claims. See opinion, pp. 38-39. Nonetheless, it’s hard to read the Court’s opinion without detecting the Court’s recognition that the process was, at its core, rigged. Continue reading
August was a rough month for the Food and Drug Administration. On August 7, a federal judge in New York entered a preliminary injunction in Amarin Pharma, Inc.’s lawsuit against the FDA, holding that the FDA could not prevent a drug manufacturer from marketing its drug for uses that haven’t been approved by the FDA, so long as the marketing was “truthful,” a loaded word we’ll get to in a moment. Then, on August 20, Forbes published an analysis that concluded the FDA approves 96% of new drugs or; in essence, “the FDA is basically approving everything.”
Let’s start first with the Amarin lawsuit. The primary weapon in the FDA’s legal arsenal is the “misbranding” statute, which allows the FDA to prosecute anyone who markets a drug or medical device “if its labeling is false or misleading in any particular.” For decades, the FDA has attempted to keep pharmaceutical companies in line by telling them that, if they market a drug for uses that were not approved by the FDA, so-called “off-label marketing,” the FDA will prosecute them. However, the pharmaceutical industry, emboldened by Citizens United, has tried to make this into a free speech issue in recent years.
On the one hand, the pharmaceutical companies have a point: why shouldn’t drug companies be allowed to “truthfully” market their drugs?
On the other hand, this argument about the “truth” falls apart when we consider the complexity of drug efficacy and safety, and when we recognize the billions of dollars that drug companies will use to push their “truth” on unwitting doctors and patients.
Amarin makes a prescription drug called “Vascepa,” which is essentially an expensive version of fish oil. The FDA approved Vascepa for use in patients with severe hypertriglyceridemia based on the results of a single clinical trial. The FDA did not, however, approve Vascepa’s use in patients with very high triglycerides for the rather straight-forward reason that it doesn’t work. Read for yourself the FDA’s 94-page Advisory Committee Brief. Vascepa lowers triglyceride levels, but it hasn’t been shown to actually reduce the risk of cardiovascular disease. This isn’t some sort of attack on Amarin or Vascepa particularly; medical science as a whole has come to realize that, apart from severe hypertriglyceridemia, omega-3 supplementation doesn’t do anything to reduce patients’ risk of “all-cause mortality, cardiac death, sudden death, myocardial infarction, or stroke.” As a matter of medicine, unless a person has truly severe hypertriglyceridemia, omega-3 supplementation isn’t going to make much of a difference.
From the FDA’s standpoint, this was a no-brainer: Amarin failed to show that Vascepa was effective. I doubt anyone at the FDA figured they would lose in court over this one. Continue reading
Over at Lowering the Bar, Kevin Underhill reports on a lawsuit filed against Lambert’s Cafe in Sikeston, Missouri, a place known as the “home of the throwed rolls.” It seems a roll was “throwed” and a patron was injured, suffering “a lacerated cornea with a vitreous detachment.” Ouch.
Underhill raises a lot of good points about the case, with case law to boot. Initially, there’s the question of whether the patron assumed the risk of being hit in the face with a roll. As Underhill says,
The Missouri Supreme Court [has] held that the question is whether the plaintiff was “injured by a risk that is an inherent part of [the activity].” … Obviously, the problem—and the reason that assumption-of-risk cases are so inconsistent—is defining “the activity.” … Here, is “the activity” eating dinner—in which case you generally don’t expect to have things thrown at your head (except maybe at Thanksgiving)—or is it “eating dinner at Lambert’s Cafe, the Home of Throwed Rolls,” in which case you’d be stupid not to expect it?
I think we need to know more facts to really assess the role of assumption of risk here.
When I initially read the story, I pictured the patron asking for a roll and then being hit in the face with it when she failed to catch it — but what if the patron was just sitting at her table eating and an errant roll came flying at her? What if it came from outside of her peripheral vision?
In other words, when you’re at the “home of the throwed rolls,” do you assume the risk of rolls flying at you from all directions at all times? That strikes me as a dubious argument, like saying that everyone at a Chinese restaurant assumes the risk of a flaming pupu platter spilling on them as it is carried to another table.
As Underhill also notes, even if the patron assumed the risk in some fashion, the restaurant can still be liable if its employees “negligently altered or increased the risk and that caused the injury.” Did the employee throw it at her like a fastball? Did the employee check to see if she was looking? Was it an unusually large roll, or was it steaming-hot right out of the oven, or in some other unusually dangerous condition? Continue reading
Via TechDirt, I learned that Carl Malamud, proprietor of Public.Resource.org, was sued last week by the State of Georgia for copyright infringement. Malamud is perhaps the leading advocate in the world for putting primary legal materials — statutes, case law, dockets, etc — on the internet. He’s also the leading advocate for making those same legal materials part of the public domain under copyright law, so they can be freely copied and distributed.
This isn’t the first time Malamud has been sued for his efforts. He’s been sued before for publishing technical standards: check out this ABA Journal article from June 2014 and this opinion piece by Malamud from February of this year. (As far as I can tell, none of the cases have reached the point of dispositive rulings.) The lawsuit brought by the State of Georgia is, however, to my knowledge the first time he’s been sued by the government itself — a situation that raises a host of troubling questions aside from the details of copyright law.
Malamud is accused of distributing copies of the “Official Code of Georgia Annotated.” According to the Complaint:
The copyrighted annotations include analysis and guidance that are added to the O.C.G.A. by a third party publisher of the O.C.G.A. as a work for hire. These annotations include synopses of cases that interpret the O.C.G.A., summaries of Opinions of the Attorney General of Georgia, and summaries of research references related to the O.C.G.A.
The “third party publisher” in question in LexisNexis. I’m quite familiar with LexisNexis; I am the co-author of a legal guide published by LexisNexis, one that includes plenty of “synopses of cases” and “summaries of research references” related to Pennsylvania law. I know all too well that it takes a substantial investment of time and energy to produce these works and to keep them updated with current changes in the law, and I’d be awfully upset if Malamud posted the whole thing online.
It is impossible to overstate the impact that Atticus Finch has had on the American legal system and its members. Consider this opening from a case decided by the Florida Supreme Court in 2013:
In his final remarks to the jury, Atticus Finch, the heroic protagonist of Harper Lee’s iconic novel, To Kill a Mockingbird, proclaims
I’m no idealist to believe firmly in the integrity of our courts and in the jury system — that is no ideal to me, it is a living, working reality. Gentlemen, a court is no better than each man of you sitting before me on this jury. A court is only as sound as its jury, and a jury is only as sound as the men who make it up.
Harper Lee, To Kill a Mockingbird, 205 (Warner Books, Inc., 1960). The case before us today addresses the very heart in which Atticus’s faith roots — the integrity of our courts, the soundness of our juries, and the men and women who “make [them] up.” Id.
Matarranz v. State, 133 So. 3d 473 (Fl. 2013). Or consider this 1999 concurrence from a Justice of the Washington Supreme Court: “We would most likely agree with Atticus Finch’s advice to his precocious, six-year-old daughter, Scout: ‘[Y]ou just hold your head high and keep those fists down. No matter what anybody says to you, don’t you let `em get your goat. Try fighting with your head for a change.’” State v. Riley, 976 P. 2d 624 (Wa. 1999). Trial lawyer Jim Perdue wrote a book titled, I Remember Atticus: Inspiring Stories Every Trial Lawyer Should Know. In 2010, the Texas Bar Journal had an article about the origins of the character, and how he exemplified the best aspirations of lawyers. Atticus is to lawyers as Galileo is to scientists.
Tuesday is the release date of Go Set A Watchman, in which Atticus Finch is, twenty years after the events of To Kill A Mockingbird, a closed-minded bigot who believes “The Negroes down here are still in their childhood as a people” and that the civil rights movement is moving too quickly.
As one quipster remarked on Twitter, “It’s like finding out Santa Claus beats his reindeer.”
So what are we, as lawyers, to do with this information? In my humble opinion: nothing.
Tort reformer Ted Frank and I have had our disagreements over the years. (See here and here.) In recent years, he has focused his work on filing objections to class action settlements through the Center for Class Action Fairness. Some of his work has focused on getting a better deal for class action members who, he alleged, weren’t receiving fair portions of the proposed settlement, but the bulk of his objections — at least to my knowledge — have focused on reducing the attorney’s fees claimed by the class counsel.
As Alison Frankel reported yesterday, it seems that, in the course of his contingent-fee work on behalf of people objecting to class action settlements, Frank has found himself in a situation he himself describes as “lurid, complex and Grishamesque.” The situation seems to have arisen from his personal goals as a lawyer being different from one of his client’s goals, and from his fee-splitting relationship with another firm, the very same issues he so frequently raises in his objections.
It would seem like a perfect opportunity for schadenfreude, but, in fact, all I can feel for him is sympathy — and his misfortune in the In Re: Capital One Telephone Consumer Protection Act Litigation presents a tremendous opportunity for tort reformers, politicians, the press, and the public to see just how difficult class actions, mass tort, and other large-scale litigation can be. In that case, Frank filed an appeal on behalf of a class member objecting to the fee claimed by Lieff Cabraser, and then everything went south. Continue reading
As I wrote three years ago, one of the ‘basics’ as a young litigator is to learn how to take a deposition. Depositions are so commonplace in civil litigation — even the smallest of soft-tissue limited-tort car accident cases will typically have a couple — that it’s easy to forget how truly strange they are. Preparing for and taking a deposition is part psychology, part detective work, and part pure habit. The latter is what I want to focus on today.
Neither the Federal Rules of Civil Procedure nor most state rules provide much guidance on the conduct of depositions. As a result, most depositions are typically free-form. There aren’t many basic ground rules. Even critical issues like when a lawyer can demand a break in the deposition to confer with the witness remain unsettled. Indeed, most depositions start with the questioning attorney giving “instructions” to the witness that have no basis anywhere in the case law, they’re just a custom the lawyer has learned through their practice.
Which brings me to an issue I saw arise last week: when a questioning attorney gets an answer they believe wasn’t responsive to the question, what should they do?
This situation happens quite frequently, particularly when it comes to sophisticated parties and expert witnesses. These types of witnesses often come into depositions with a story they want to tell, and they are hell-bent on telling it, regardless of the questions asked.
I’ve addressed this issue before in a prior post, arguing that the key is persistence. (Sitting here today, I’d add that asking a clear, concise question is equally important.). But some lawyers respond by aggressively saying, “move to strike!”
Huh? Why? Where in the rules does it say an attorney can “move to strike” an answer they don’t like? Continue reading
Rolling Stone’s recent article, “A Rape on Campus,” needs no introduction. (If you really need one, check the extensive Wikipedia article.) On April 5, Rolling Stone formally retracted the article and published an extensive outside critique of its fact-checking and reporting methodology by Steve Coll, dean of the Columbia School of Journalism. The next day, the Phi Kappa Psi chapter at UVA issued a press release announcing “plans to pursue all available legal action against the magazine.”
As the press release begins:
“The report by Columbia University’s School of Journalism demonstrates the reckless nature in which Rolling Stone researched and failed to verify facts in its article that erroneously accused Phi Kappa Psi of crimes its members did not commit,” said Stephen Scipione, President of the Virginia Alpha Chapter of Phi Kappa Psi.
Scipione’s use of the word “reckless” is undoubtedly a reference to part of the standard for proving defamation, i.e. showing “the statements were made with knowledge that they were false or with reckless disregard for their truth.” Cashion v. Smith, 749 SE 2d 526, 533 (Va. 2013). But that magic word, “reckless,” is just one small part of the analysis. As explained below, whatever that critique by Steve Coll says about Rolling Stone’s journalistic practices, that critique also includes a lot of information and conclusions that will make it difficult for the fraternity to prevail in a defamation lawsuit.
Defamation has a special place in our firm’s history (see some of our cases here, here, and here — they all settled confidentially), and the truth is: defamation cases are tough. By and large, the vast majority of people whose reputations have been unfairly damaged in the media do not have a viable legal claim. Defamation cases can fail for a million reasons, and here I want to focus on just two problematic issues: the fact that the fraternity is bringing the case, and the Coll report’s findings about the mindset of Rolling Stone.
Let’s start by being clear about what this post is not about. This post is not about sexual assault on college campuses; for that, watch The Hunting Ground. This post is not about journalistic standards; for that, Poynter has compiled more than a dozen reactions to the article’s retraction.
Rather, this post is about the single issue raised by the press release: whether “the Virginia Alpha Chapter of Phi Kappa Psi” has any “available legal action against the magazine.” Continue reading