Published By: Maxwell S. Kennerly, Esquire

Consumer Protection

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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).


Volvo got a lot of free press last year when it said it would accept legal responsibility for crashes involving self-driving cars, but, as always, the fine print said otherwise:

Volvo also told the BBC it would only accept liability for an accident if it was the result of a flaw in the car’s design. “If the customer used the technology in an inappropriate way then the user is still liable,” said Mr Coelingh. “Likewise if a third party vehicle causes the crash, then it would be liable.”

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.


That aspect raises an obvious question: how should driverless cars be designed? Most of the media attention has been devoted towards philosophical questions like “the Trolley Problem.”
Continue Reading In Praise Of Mercedes-Benz’s Killer Robot Car

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.

 

Continue Reading Why Drug Companies Oppose “Free To Choose” Medicine

Popehat already explained in general why there’s nothing unusual about Judge Curiel’s rulings in the Trump University case, i.e., that denying summary judgment is the norm. Nonetheless, Kevin Drum recently mused:


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.


Let’s take a trip “through the records” of Makaeff v. Trump University, No. 10-cv-0940, in the United States District Court for the Southern District of California. (Coincidentally, I’ve argued in that courthouse many times over the past few years, most recently in April. None of those cases were in front of Judge Curiel.)
Continue Reading The Details Of Judge Curiel’s Trump University Orders

On Monday, a jury in Missouri hit Johnson & Johnson with a $55 million verdict in favor of a woman who developed ovarian cancer after decades of using talc baby powder in her vaginal area as part of her normal routine. Younger readers might find this practice unusual, but this was commonly recommended and encouraged through advertisements with slogans like, “just a sprinkle a day keeps odor away.” To this day, Johnson & Johnson still doesn’t warn against use in the vaginal area, and instead continues to encourage adults to use it all over their bodies, because it “gives a cooling sensation, and helps to prevent chafing.”

The case was the second such huge verdict this year, following a $72 million verdict in February. But this verdict is in many ways a better indicator of the strength of these lawsuits: this case was selected for trial by the defendants, apparently based on the belief that the woman’s pre-existing endometriosis would absolve Johnson & Johnson. As the defense lawyer told the jury:
Continue Reading The Science Connecting Talcum Powder And Ovarian Cancer

Back in July 2014, I wrote a post about the misuse of “statistical significance” by defendants and courts trying to apply the Daubert standard to scientific evidence. As I wrote,

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.

Last week, the American Statistical Association published its very first “policy statement” on “a specific matter of statistical practice,” making clear that tossing around the term “statistical significance” is a “considerable distortion of the scientific process:”

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.

Hallelujah!
Continue Reading Statistical Significance Has No Place In A Daubert Analysis

I’ve written about transvaginal mesh so many times I feel like a broken record. But it’s still an issue affecting tens of thousands of families and will continue to be an issue as long as that infernal implant keeps being sold and the manufacturers keep refusing to do right by the families that have already been hurt by them.

Yesterday, the FDA announced:

The U.S. Food and Drug Administration today issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.

On the surface, this is quite a victory, and it may mean the end for many of these implants.The requirements for a “class III” premarket approval device are far stricter than those for the “class II” medical devices.

As I wrote several years ago, that “class II” status was a big reason why the transvaginal mesh health debacle happened in the first place:

Highly similar surgical meshes have been used by surgeons to repair hernias and other abdominal issues, and so the FDA allowed the use of those meshes for pelvic repairs, including when implanted into the vaginal wall, without first requiring controlled human studies. This loophole — called the “510(k) clearance” — has been sharply criticized by the Institute of Medicine, which has recommended eliminating the “510 (k) clearance” program entirely. Those studies would have likely revealed the problem before the surgical meshes were implanted in over 70,000 pelvic and vaginal wall procedures a year.

With the “class II” status gone, the mesh manufacturers can no longer use that loophole. But the FDA left open a pretty big loophole themselves, as revealed in the FDA’s discussion of the orders in the Federal Register, which includes this:
Continue Reading The FDA Is Doing Too Little, Too Late About Transvaginal Mesh

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 Ted Frank And The Real Risk Of Class Actions

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.

I don’t tend to litigate FMLA cases, but I most certainly need Continuing Legal Education credits to remain a licensed attorney, so last week I went to a seminar on the FMLA hosted by a bunch of defense lawyers and, the lone employee-side lawyer, Ari Karpf of Karpf & Karpf out in Bensalem. What struck me most was how many employers just plain didn’t get it, and didn’t seem to recognize when they were doing something prohibited by the FMLA. So, as part of my real continuing legal education — i.e., reading up on new cases and discussing the law with other attorneys, instead of just sitting through a PowerPoint in a subzero, windowless conference room — I thought I’d do a brief survey of some recent FMLA cases to see how well businesses are doing in actually complying with the law.
Continue Reading 20 Years Later, Employers Still Don’t Understand Family And Medical Leave

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.

The best-selling drug in America is Abilify, the prescribing information for which says it is only approved for:

  • Use as an add-on treatment to an antidepressant for adults with Major Depressive Disorder who have had an inadequate response to antidepressant therapy
  • Treatment of manic or mixed episodes associated with Bipolar I Disorder in adults and in pediatric patients 10 to 17 years of age
  • Treatment of Schizophrenia in adults and in adolescents 13 to 17 years of age
  • Treatment of irritability associated with Autistic Disorder in pediatric patients 6 to 17 years of age

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.

While the public school system in many urban areas is in collapse — a problem we feel quite acutely here in Philadelphia — and there’s still no interest in putting tax dollars into early childhood education or after-school problems, and even the upper-middle-class can’t afford childcare so both parents can work, it seems Medicaid has $3.6 billion to spend on antipsychotic medications like Abilify, Zyprexa, Geodon, and Seroquel. (That’s just as of 2008 — the number is likely double or higher now given how rapidly prescriptions have grown.)

So what happened? Maybe it has something to do with this: 
Continue Reading Taxpayers Spend Billions Giving Children Antipsychotic Medications

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.

As was undisputed, GlaxoSmithKline LLC is “a large pharmaceutical company that is responsible for operating the U.S. division of GlaxoSmithKline PLC, the British entity that is the ‘global head’ of the GlaxoSmithKline group of companies.” As the Court continued, “[GlaxoSmithKline LLC’s] headquarters is still in Philadelphia, Pennsylvania, where it occupies 650,000 square feet of office space and employs 1,800 people. Its management is substantively intact. .. [GlaxoSmithKline LLC’s] managers operate from … three [offices] in Philadelphia and a fourth in North Carolina.”

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.

The case was thus remanded back to state court, right? 
Continue Reading The Legal Fiction That GlaxoSmithKline Is In Delaware