Source: https://www.litigationandtrial.com/attorney/consumer-protection/
Timestamp: 2019-04-19 02:46:32+00:00

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I’ve been writing about the law of driverless cars since 2011. For more than forty years, the general rule for when a car was defectively designed is whether the manufacturer met “a reasonable duty of care in the design of its vehicle consonant with the state of the art to minimize the effect of accidents.” Larsen v. General Motors Corporation, 391 F.2d 495 (8th Cir. 1968).
In other words, Volvo agreed to nothing at all. Volvo simply agreed it would be held responsible in the same circumstances under which it would already be held responsible: when there was a flaw in the car’s design.
Thirty-one states have passed “Right To Try” legislation that, in theory, makes it easier for patients with terminal diagnoses to use drugs that are in the investigational stage but haven’t yet been approved by the FDA. I use the phrase “in theory” because state legislation doesn’t mean much in the field of drug regulation: it’s all determined by the federal government, which has the power to shut down unapproved uses of medications, even if the state government says otherwise.
The idea behind “Right To Try” state legislation is compelling: from a common-sense perspective, there aren’t many good reasons why terminally ill patients should not be allowed to “try” medicines their doctor believes might help them, even if the medicine isn’t yet approved. After all, many of the approved medicines for terminally ill conditions aren’t that useful. For example, most pharmaceutical cancer treatments have been approved on the basis of “surrogate markers” (like reduced tumor growth rates) instead of being actually shown to improve mortality.
I think we all know perfectly well that Curiel is just an ordinary judge, and Trump is ranting against him because that’s what Trump does whenever something doesn’t go his way. He whines. Endlessly. Still, I’m kind of curious. It would be interesting if some kind of qualified lawyer type went through the records of these trials and reported back on whether Curiel seems to be conducting things fairly. Maybe he’s not! Maybe he really does hate Trump. Unfortunately, I suppose that would be a lot of work. Oh well.
It’s true that researchers typically use statistical formulas to calculate a “95% confidence interval” — or, as they say in the jargon of statistics, “p < 0.05” — but this isn’t really a scientifically-derived standard. There’s no natural law or empirical evidence which tells us that “95%” is the right number to pick to call something “statistically significant.” The number “1 in 20” was pulled out of thin air decades ago by the statistician and biologist Ronald Fisher as part of his “combined probability test.” Fisher was a brilliant scientist, but he was also a eugenicist and an inveterate pipe-smoker who refused to believe that smoking causes cancer. Never underestimate the human factor in the practice of statistics and epidemiology.
(Links omitted; they’re still in the original post.) As expected, defense lawyers criticized my post.
Practices that reduce data analysis or scientific inference to mechanical “bright-line” rules (such as “p < 0.05”) for justifying scientific claims or conclusions can lead to erroneous beliefs and poor decision-making. A conclusion does not immediately become “true” on one side of the divide and “false” on the other. Researchers should bring many contextual factors into play to derive scientific inferences, including the design of a study, the quality of the measurements, the external evidence for the phenomenon under study, and the validity of assumptions that underlie the data analysis. Pragmatic considerations often require binary, “yes-no” decisions, but this does not mean that p-values alone can ensure that a decision is correct or incorrect. The widespread use of “statistical significance” (generally interpreted as “p ≤ 0.05”) as a license for making a claim of a scientific finding (or implied truth) leads to considerable distortion of the scientific process.
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.
The Family and Medical Leave Act (FMLA) turned 20 this year, with enforcement first taking effect on August 5, 1993. Sure, the FMLA is a “burden” on employers in the same way that weekends, lunch breaks, and the minimum wage are a “burden,” but it’s hard to argue with the basic precept that employees who work 1,250 hours a year at a company with the resources to handle employees calling out shouldn’t be entitled to a little bit of unpaid time off when they’re too sick to work or when they need to be good spouses, children, and parents by caring for their immediate family members.
But there’s always someone to complain about people doing the right thing instead of grinding themselves down making money for a big company. Thus, there’s been no shortage of complaints by begrumpled management-side lawyers about the “Friday-Monday Leave Act.” The Department of Labor looked into these concerns and found them mostly unfounded — few employees ever take out intermittent leave for self-care conditions like chronic pain, and few business can credibly report a loss in productivity or profitability — but that hasn’t stopped calls to weaken the FMLA.
Can you guess the best-selling class of drugs? It may be that a fifth of Americans suffer gastroesophageal reflux disease at least once a week, over 30% have hypertension, and over a third of U.S. adults have high LDL cholesterol, but the best-selling class of drugs isn’t proton-pump inhibitors for reflux, or angiotensin II receptor antagonists for blood pressure, or statins. It’s anti-psychotics.
It’s commonplace for people to refer to themselves or others as “depressed” or “bipolar,” but that’s a far cry from a diagnosis. The NIH has a handy page with the statistics on mental illness. At the most generous estimate, 5-8% of the adult population can be diagnosed with Major Depressive Disorder, and Abilify isn’t even indicated for them — it’s indicated only for those who haven’t responded to typical antidepressants, which is half or less. Bipolar Disorder affects 2.6% of the popular, but Bipolar I, the more severe version defined by a week or more of mania or mania so severe it requires hospitalization, is only a small fraction of that. Schizophrenia affects 1% of the population. Finally, depending on your definition, between 0.8% and 1.2% of children have autism.
Adding all of those up gets us to 5% or so of the population that could even qualify for Abilify, less than a quarter of the people with GERD, hypertension, or high cholesterol. So who is taking all of this Abilify, and why? As the Wall Street Journal reported last week, “Federal health officials have launched a probe into the use of antipsychotic drugs on children in the Medicaid system, amid concern that the medications are being prescribed too often to treat behavioral problems in the very young.” The quote Mark Duggan, a health-policy expert at the University of Pennsylvania’s Wharton School, saying that more than 70% of the cost of the five leading antipsychotics was paid for by Medicaid and other government programs.
Let’s take a refresher course on 1L Civil Procedure. The federal courts have limited jurisdiction; they don’t exist to hear every case, they exist to hear cases that arise under federal law. Additionally, the federal courts have “diversity jurisdiction,” a narrow addition created “to provide a federal forum for important disputes where state courts might favor, or be perceived as favoring, home-state litigants.” Exxon Mobil Corp. v. Allapattah Services, Inc., 545 US 546, 553–554 (2005). Diversity jurisdiction is disfavored — the federal courts aren’t supposed to be hearing garden-variety state-law tort and contract lawsuits — and since the founding of the country federal courts have been instructed to avoid diversity jurisdiction unless there’s really an obvious risk of home-state favoritism.
For example, “In a case with multiple plaintiffs and multiple defendants, the presence in the action of a single plaintiff from the same State as a single defendant deprives the district court of original diversity jurisdiction over the entire action.” Id., citing Strawbridge v. Curtiss, 3 Cranch 267 (1806). The Founders didn’t waste time clogging the federal courts with state-law tort cases, and would deny diversity jurisdiction to corporate defendants if even a single shareholder was in the same state as the plaintiff. See Bank of United States v. Deveaux, 5 Cranch 91–92 (1809)(“In conformity with the spirit of the constitution, the federal courts have always inquired after the real parties. Although the nominal parties are really persons competent to sue in those courts, yet they will inquire into the character of the real litigants, and if they find them unable to sue there, they will dismiss the suit. They will allow no fiction to give jurisdiction to the court where the substance is wanting.”) Applying the same rule today would preclude large publicly-owned corporations from forum shopping for federal court, and rightly so: does anyone really believe that, e.g., Wal-Mart needs the protection of the federal courts because it can’t get a fair trial outside of Arkansas?
In Glenda Johnson v. SmithKline Beecham Corp, decided last Friday by the Third Circuit Court of Appeals, a woman from Louisiana and a man from Pennsylvania born with birth defects caused by their mothers‘ use of thalidomide (more about thalidomide here) during pregnancy filed a state-law negligence and strict liability suit in Pennsylvania state court against several corporations, including GlaxoSmithKline LLC. The defendants removed the case to federal court.
It’s an easy case, no? It’s a state-law tort lawsuit filed in Pennsylvania. One of the plaintiffs is from Pennsylvania. One of the defendants plainly has its “nerve center” in Pennsylvania, and so, under the “principal place of business” test established by the Supreme Court’s 2010 Hertz v. Friend decision, “the majority of [GlaxoSmithKline LLC’s] executive and administrative functions are performed” in Pennsylvania, and thus GlaxoSmithKline LLC is plainly a citizen of Pennsylvania.

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