He had a whole battery of tests just a couple months ago. He couldn’t eat well and his legs ached. He had nearly every doctor at Emory look at him. They ended up prescribing him Vitamin A and Vitamin D. After all that. He got the full work over and really just needed vitamins. If a 28 year old heart is going to go out, shouldn’t they have found that? Maybe, but they didn’t.
Indeed. It’s a tragic death that raises many questions.
Most of time, when grieving families contact me, they’re not looking to file a lawsuit, they’re looking for answers. Doctors and hospitals rarely tell family members much about the circumstances, or about what could have been done differently, and so those family members start looking for answers. I made it my policy long ago that, even if I didn’t believe a lawsuit was warranted or would be successful, I would try to explain to everyone who contacts me about a medical malpractice case what actually happened and if something could have been done differently.
From the information Jeremy’s family has provided publicly, we can start to figure out what might have gone wrong. The coroner hasn’t determined the cause of death yet, and apparently is not going to conduct an autopsy, but the circumstances strongly suggest a heart attack.
Jeremy was only 28-years-old. Coronary heart disease is rare in individuals younger than 40, but it’s not unheard of. In the famous Framingham Study, acute myocardial infarction occurred in men 30 to 34 years old at a rate of 12.9 per 1,000. One of the few studies to look at risk factors for coronary heart disease in men under 40 found that the risk factors were roughly the same as for older men, i.e., “age, serum cholesterol level, systolic blood pressure, and cigarette smoking.” Continue reading
Big Pharma is trying to ram two sweeping overhauls through Congress, the “21st Century Cures Act” and the “Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act.” (The latter is so obnoxiously named that it is typically referred to as the Cruz-Lee proposal.) Both of these bills include good provisions, like increasing funding for the National Institutes of Health and allowing the Food and Drug Administration more flexibility to review drug approvals in other countries. However, the bills also include truly terrible provisions, like instructing the FDA to abandon the use of clinical trials and giving Congress the power to approve drugs on its own.
In favor of the bills, there’s economist Alex Tabarrok, who argues there’s an “invisible graveyard” of patients whose lives could have been saved by drugs that were not yet approved. In opposition, there’s medical school professor Dr. Aaron Kesselheim, who argues there’s no evidence the FDA has blocked innovation that actually helps patients.
Tabarrok calls that “laughable” and “magical thinking,” apparently unlike his “invisible graveyard.” He lays down a challenge: “We live in a world of tradeoffs. Let’s debate the tradeoffs.”
Let’s start with some basic facts: Continue reading
Back in 2011, I wrote about how tort liability would apply to self-driving cars. As I wrote then, it made the most sense to go right back to the case that first adopted the “crashworthiness doctrine,” Larsen v. General Motors Corporation, 391 F.2d 495 (8th Cir. 1968), which held “We perceive of no sound reason, either in logic or experience, nor any command in precedent, why the manufacturer should not be held to a reasonable duty of care in the design of its vehicle consonant with the state of the art to minimize the effect of accidents. The manufacturers are not insurers but should be held to a standard of reasonable care in design to provide a reasonably safe vehicle in which to travel.” Liability for autonomous cars shouldn’t be any different: if an autonomous car causes a crash, then the manufacturer will be liable if they did not use “reasonable care” in designing, programming, and testing the car.
Via Jason Kottke, I saw a recent TED video raised a whole bunch of ethical dilemmas arising from self-driving cars. Namely, the TED talk raised the possibility that autonomous vehicles might find themselves in situations where they could “choose” — depending on the programming — to take actions that value certain lives over others. Continue reading
I’ve written several times before about deposition misconduct, such as in the posts “Be A Potted Plant: Sanctions For Deposition Coaching and Witness Conferences” and “Can A Lawyer Interrupt A Deposition For A “Conference” With A Witness?” Today’s post is about the venerable “objection to the form,” and the extent to which a lawyer is allowed or required to elaborate on the nature of their “form” objection. As I argue below, the weight of the precedent suggests that a lawyer raising a form objections should say nothing more than “object to the form” unless the lawyer taking the deposition asks them to elaborate.
Most motions for sanctions arising from depositions involve the lawyer defending a witness interjecting themselves into the deposition with speaking objections that are either so numerous that they obstruct the deposition or are so verbose that they coach the witness into giving a different answer.
Federal Rule of Civil Procedure 30(c)(1) is quite clear: “The examination and cross-examination of a deponent proceed as they would at trial under the Federal Rules of Evidence …” Fed. R. Civ. P. 30(c)(2) is similarly blunt: at a deposition, “An objection must be stated concisely in a nonargumentative and nonsuggestive manner.” Moreover, because depositions in federal court are conducted with the “usual stipulations” — which typically preserves all objections except for those to the form of the question — there is very little a lawyer defending a deponent needs to say except that which is necessary to preserve a privilege or to preserve those “form” objections. Courts have repeatedly sanctioned lawyers for coaching witnesses by “objecting” in improper ways that signal to the witness that they should say a question is “vague,” or that they “don’t want to speculate,” or that they “don’t know” an answer that they actually do know.
Given the above, most ethically-minded lawyers limit themselves at deposition to simply saying “object to the form” and little more. I was thus quite alarmed to come across this post by Adam Glazer which argued, “Those seeking to avoid waiver by asserting form objections may actually have it backward[.]” Continue reading
Over at Drug and Device Law, Jim Beck highlights a new law review article, “Researchers’ Privilege: Full Disclosure,” published by Dr. Frank Woodside, described by the article as “of counsel to the law firm of Dinsmore & Shohl and [ ] a nationally known trial lawyer representing manufacturers of pharmaceutical and medical devices, chemicals, and flavorings, as well as producers of consumer products.”
Sometimes the authors of published studies or counsel relying on these researchers’ work have attempted to place barriers in the way of academicians or counsel who wish to challenge the validity of the published studies and their underlying data. These barriers originate from a misunderstanding, or misuse, of the concept of academic freedom—a litigation strategy that asserts the existence of the so-called “researchers’ privilege,” also known as “academic privilege,” “academic freedom privilege,” or “the research scholar’s privilege”—as well as the improper application of the Freedom of Information Act (“FOIA”). These challenges create a legal environment where opinions based on the published results of flawed research are admitted into evidence without providing opposing parties the opportunity to develop the facts necessary to assess the opinion’s validity. This admission of uninvestigated evidence creates the potential for unjust results.
Although published literature plays a big role in large-scale litigation these days, subpoenas against third-party researchers have generally fared poorly in the courts. One of the few successful examples I know of involves the Prempro products liability litigation, where Wyeth was able to compel the Women’s Health Initiative to turn over hormone treatment assignments and trial data collected. (In case anyone is wondering how that issue turned out, although Wyeth continues to fight these cases in the courts, there is a scientific consensus that hormone therapy increases the risk of breast cancer.) Continue reading
The lawsuit brought by financier Amir Shenaq against mass-torts law firm AkinMears has made the rounds of the tort reform blogs (e.g., SETexas Record, Daniel Fisher at Forbes, and Paul Barrett at Bloomberg), so I figured some plaintiff-side commentary was in order. The details of the lawsuit confirm what I’ve been saying for years: “Mass torts is not an area in which you want to dabble and start throwing around discounts. It’s work, it’s risky, and it can be very, very expensive.”
In essence, a former hedge fund executive filed suit against the law firm claiming that he was hired to raise millions of dollars in funding so that the firm could acquire thousands of transvaginal mesh lawsuits. He alleges that he brought in the funding (through his connections in the finance world), but, once he did, the firm fired him.
Shenaq’s complaint was filed publicly then sealed by the court. As Forbes recounts, the Complaint alleges:
“AkinMears is not run like a traditional plaintiff’s law office, and the Firm’s lawyers do not do the types of things that regular trial lawyers do,” like meet clients, file pleadings and motions, attend depositions “or, heaven forbid, try a lawsuit,” Shenaq claims in his suit. “Despite the fact that AkinMears’ lawyers do not have to dirty their hands with the mundane chores that come with actually practicing law,” the firm charges a 40% contingency fee “which is then divided in some fashion among the participants in its ever-shifting syndicate.”
And, of course, there’s also an allegation about the plaintiff’s lawyers buying themselves an interest in a private jet. Continue reading
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
Update, April 25, 2016: It seems Tom Brady isn’t so special after all, with the Second Circuit reversing the District Court and reinstating the arbitration award against him. I have zero sympathy for Brady, who is quite simply a cheater, but I do consider the reversal a bummer for every day employees who have similarly one-sided employment arbitrations but don’t have millions of dollars in the bank to cushion their loss.
The Second Circuit’s key conclusions were:
Article 46 gives the Commissioner broad authority to deal with conduct he believes might undermine the integrity of the game. The Commissioner properly understood that a series of rules relating to uniforms and equipment does not repeal his authority vested in him by the Association to protect professional football from detrimental conduct. We have little difficulty in concluding that the Commissioner’s decision to discipline Brady pursuant to Article 46 was “plausibly grounded in the parties’ agreement,” which is all the law requires. See Wackenhut, 126 F.3d at 2.
Here, the parties contracted in the CBA to specifically allow the Commissioner to sit as the arbitrator in all disputes brought pursuant to Article 46, Section 1(a). They did so knowing full well that the Commissioner had the sole power of determining what constitutes “conduct detrimental,” and thus knowing that the Commissioner would have a stake both in the underlying discipline and in every arbitration brought pursuant to Section 1(a). Had the parties wished to restrict the Commissioner’s authority, they could have fashioned a different agreement.
These conclusions say, in essence, that there really is no limit to how bad an arbitration can be — you can “agree” to have the opposing party be the one to determine if you’ve breached a vague clause in the contract, and then to be the one who decides if they’re wrong or not in the arbitration. That strikes me as so fundamentally unfair as to exceed the bounds of law, even if it is “plausibly grounded in the parties’ agreement.”
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