Last Wednesday was a watershed day for preventing power saw accidents. On Wednesday, the Consumer Product Safety Commission voted unanimously formulate new rules that would make power saws safer. Also on Wednesday, the First Circuit Court of Appeals upheld a $1.5 million jury verdict in favor of a worker whose hand was severely injured in a power saw accident, due to the fact that the Ryobi saw that he was using was not equipped with SawStop “flesh detection” technology.
We’ve blogged quite a bit about SawStop before. This incredible new (and old-fashioned) technology makes power saw accidents completely avoidable. But the major power saw manufacturers, companies like Black & Decker, Delta, Rigid and Ryobi, have not licensed the patented technology behind SawStop and so woodworkers, contractors and tradesman continue to lose fingers and suffer approximately 67,300 serious power saw accidents a year.
The principle behind the patented SawStop technology available in SawStop-brand saws is relatively easy to understand. Have you ever seen one of those old-fashioned touch lamps where you touch the base of the lamp and the light turns on and off? The way those lamps work is that a small electrical current passes through the base of the lamp and when your hand (which is largely water, a good electrical conductor) touches the base of the lamp, it interrupts the current and triggers the off switch. SawStop brand technology works in a similar way: the saw blade carries a small electrical current and, when that current gets interrupted, it triggers a brake mechanism that stops the blade, reducing its speed from 5,000 rpm to 0 rpm in several milliseconds.
The CPSC may or may not mandate SawStop-equivalent technology when it decides its new rules. But SawStop-type flesh detection technology is one option that CPSC is weighing. CPSC has 60 days to formulate its new rules and, during that period, will be welcoming comments from industry groups and consumers.
Regardless of whether CPSC decides to mandate the SawStop technology in all saws, product liability lawsuits will be able to continue.
On Wednesday, in Osorio v. One World Technologies, the First Circuit Court of Appeals (the federal appeals court seated in Boston), granted an expected boost to those lawsuits when it affirmed a $1.5-million jury verdict in favor of a worker whose fingers were injured while using a Ryobi BTS-15 table saw.
Even though SawStop does not presently manufacture a smaller saw like the Ryobi BTS, the First Circuit held that the jury could have concluded that it was feasible to incorporate SawStop technology into light-weight portable saws, as SawStop’s founder, Steve Gass, Ph.D., testified could be done.
The First Circuit also ruled that the plaintiff counsel’s urging the jury to “send a message,” although inadvisable, was a harmless error.
To read more about SawStop and preventable power saw accidents, click here, here and here.
I am preparing for a trial and swore I wouldn’t have time for anything as frivolous as a blog post until trial is over, but when I learned that Abnormal Use, the defense side legal blog that is the darling of The New York Times, National Public Radio and Jackie Childs (I’m in too much of a hurry to hunt for the links explaining the back stories to Abnormal Use‘s well-deserved blogospheric celebrity), had posted a response to a blog post of mine about driverless cars, I felt compelled to post a rejoinder to the folks at Gallivan, White & Boyd.
As Abnormal contributor and GWB attorney Frances Zacher points out, it is rather incongruous for me, as a plaintiff’s lawyer, to be calling for immunity for the manufacturers of driverless cars. But what can I say? I really want to see driverless cars ASAP. There’s nothing I’d like more than to have my time in the car be time where I can get something done – whether it’s working on a memo or watching a DVD. And driverless cars might make that happen.
I agree with Zacher that my proposal would grant immunity to the party “at fault” (the car manufacturer who is to blame for the defective software). It’s an interesting point and I wonder how I can square my position on immunity for manufacturers of driverless cars with my view that caps on non-economic damages in medical malpractice cases violate the Plaintiff’s Due Process right (some would say natural right) to be made whole by the party who wronged her and many other positions I hold — positions that depend on the basic moral insight that Zacher affirms.
I thought that pseudonymous Abnormal commenter John Galt also made a very good point in a comment to the post: Couldn’t we invoke the last clear chance doctrine in some driverless car accidents? I guess I was envisioning the type of driverless car accident where one driverless car suddenly swerves into the opposite lane and neither driver has time to override the machine. But certainly there are a variety of accidents that might not conform to the scenario that I envisioned: accidents where a driverless car malfunctions and the driver has time and opportunity to avoid the collision but does not. I would certainly agree that a different set of liability rules should apply to such a scenario and Galt’s comment suggests that maybe the courts should deal with driverless car accidents on a case-by-case basis in common law fashion. That said, I would reject Galt’s proposed doctrine inasmuch as it would require vigilance on the part of the human “driver” of a driverless car. To my mind, the point of having a driverless car would be to enable the human “driver” to devote his time to other tasks (email, etc.) rather than to navigating the roadways. If a driver constantly had to have his or her finger poised over the Emergency Override button, it would sort of defeat the purpose of a driverless car.
Now back to my regularly scheduled trial prep. Until trial is over, our faithful readers (who make up for in devotion what they lack in numbers) will be treated to the musings of colleague, Patrick Banfield, and some canned/set-to-publish blog posts by me. Even further attention from the blogerati at Abnormal shall not drag me from my seclusion.
PS I know the picture is of a flying, rather than a driverless, car, but I’m in a hurry.
On March 11, the Consumer Product Safety Commission (CPSC), as part of the Consumer Product Safety Improvement Act passed in 2008, launched a new easily-searchable database of dangerous and defective products – SaferProducts.gov. (H/t Professor Bernabe). The new website allows consumers to register complaints that they have about product safety.
The products’ manufacturers then have ten days to respond and then both consumer complaint and company response are uploaded to the web unless CPSC finds some reason to determine that the consumer complaint is bogus.
Seems like a valuable resource, right? I mean, why shouldn’t you have access to this information before you shell out for some big ticket item or a toy for your child that you want to make sure is safe? The database gives you virtually real-time feedback on products; there’s no lag time where you could be oblivious to a product’s dangers while the government dithers about whether to order a recall.
But Republicans in Congress, led by Rep. Mike Pompeo, managed to yank funding for the website two weeks before it debuted, saying it will “drive jobs overseas,” without explaining how or why the website could conceivably have that effect. So the future of SaferProducts.gov is in doubt. Check it out now before Congressional Republicans get their way and you can no longer see what products might hurt you.
It’s a common refrain whenever drug makers are asked about the astronomical costs of some of their pills: the price of drugs reflects the billions of dollars of research and development that go into them. We hear the same refrain when drug makers get sued for selling dangerous and defective drugs: the drug makers complain that they should be entitled to some sort of immunity after spending billions of dollars developing the drug and getting FDA approval before bringing it to market.
However, as Timothy Noah revealed in an article in Slate this week, pharmaceutical companies spend nowhere near one billion dollars in bringing the typical drug to market. Big Pharma actually spends $55 million on R&D for the typical drug, according to a new study published by the London School of Economics.
So where did the $1 billion figure come from then?
Answer: It’s pharmaceutical-sponsored propaganda.
The $1 billion figure originally appeared in a 2003 study (that we’ll call the “Tufts study”) that was published in the Journal of Health Economics. The article’s lead researcher is from Tufts University and the article’s research was sponsored by the (drug company-funded) Tufts Center for the Study of Drug Development.
There are a number of methodological problems with the Tufts study. First of all, it was based off proprietary numbers that the drug companies supplied to study’s authors, that the researchers have not shared with others and that they themselves apparently made no effort to verify.
Another error with the study, a glaring one, is that the Tufts study considers basic “pure science” R&D that is funded by the government as a cost of drug development, even though it is not borne by any of the pharma companies and is, in fact, one hundred percent taxpayer-funded.
The Tufts study also ignores all of the tax breaks that pharma companies receive for R&D. When you factor in those tax breaks, the cost of R&D is reduced by thirty-nine percent.
Lastly, the Tufts study’s estimates of the costs of clinical trials and the amount of time that it takes to obtain FDA approval are flatly at odds with publicly-available government data. The Tufts study’s estimates of the costs of clinical trials are six times higher than data that’s available from the National Institutes of Health (NIH). The Tufts study’s estimate of the time it takes for a drug to get FDA approval – 7.5 years – is about twice what other data reveals. That’s no mean difference when a patent monopoly has a lifespan of twenty years.
Several months ago, there was a big controversy in the blogosphere about whether economists should adopt a code of professional ethics (they currently have none and many conflicts of interest in economics research go undisclosed). Matthew Yglesias had a great post on the top entitled, “Economists and Incentives.” The Tufts study, and the oft-repeated $1 billion pricetag for pharmaceutical R&D, suggests that it may be high time for such a code.
Awhile back I blogged about the FDA’s massive recall of DePuy A.S.R. artificial hips. The DePuy artificial hips were touted as a leap forward in artificial hip technology when they debuted. They were supposed to last to last for fifteen years or more (much longer than other artificial hips) and their Articular Surface Replacement (A.S.R.) technology was supposed to help resurface portions of the hip once implanted.
As it turned out, the DePuy ASR artificial hips have worn out quickly due to metal-on-metal contact within the device and this metal-on-metal contact has resulted in toxic heavy metal ions being deposited in the bloodstream of patients, causing chronic pain, toxic reactions and, in some patients, the development of pseudotumors.
As I originally blogged about, the shocking part of all this is that the DePuy ASR never had to be subjected to clinical testing prior to its being marketed to the public. The FDA regulatory process contains a loophole – known as the “510(k) process” – that allows medical device manufacturers to sell new medical devices without any clinical trials of the device if the new device is “equivalent” to one already on the market. Even though the DePuy ASR was touted as offering next-generation advances – like the Articular Surface Replacement technology and being more durable – Johnson & Johnson, its manufacturer, never had to subject the DePuy ASR to clinical testing because it was deemed “equivalent” to other artificial hips already on the market.
Now, as reported by The New York Times, comes a new study from the Institute of Medicine showing that 81 percent of the medical devices recalled by the FDA from 2005-2009 were devices that made it to market through the 510(k) loophole. Only one-fifth of the medical devices subject to recall had been clinically tested prior to approval.
I think the DePuy ASR recall and this new study from the Institute of Medicine show that the 510(k) loophole needs to be tightened up a little. Medical devices subject to FDA regulation run the gamut from ear wax cleaning kits you buy at the drug store to implantable defibrillators that are supposed to restart your heart after cardiac arrest. Having a regulatory loophole for new-to-market devices that are equivalent to older technology benefits consumers by driving down the prices of medical devices and fostering competition. However, medical device manufacturers cannot be allowed to get away with selling cutting-edge surgically-implanted devices without any prior testing on the grounds that such technology is “equivalent” to older devices.
As underscored by a story in today’s New York Times, the recent recall of DePuy A.S.R. artificial hips shows how a hole in the FDA’s regulatory framework for medical implants endangers millions of Americans who receive medical implants. DePuy A.S.R. artificial hips were touted as next generation of artificial hips – a new technology that would allow for hip replacement surgeries involving the removal of less of a patient’s thigh bone. The A.S.R. or Articular Surface Replacement technology, it was thought, would resurface portions of bone that were removed in conventional hip replacements. DePuy, a Johnson & Johnson subsidiary, also promoted the A.S.R. technology as likely to last longer than rival hip replacements – predicting a product lifetime of 15 years or more.
What steps did DePuy have to go through to bring the A.S.R. artificial hips to market? Were there years and millions of dollars spent double-blind randomized clinical trials before the FDA finally approved the DePuy ASR? No. In fact, because FDA regulations allow medical implants to be sold without clinical testing if they resemble devices already approved for use in patients, the DePuy ASR made it to market without clinical trials.
DePuy claimed the A.S.R. resembled another hip prosthesis that it had already brought to market called the Ultima. The Ultima, however, had a completely different cup design than the ASR. Despite the dissimilarities between the A.S.R. and the Ultima, the FDA regulations allowed the A.S.R. to be sold without testing.
Because of the absence of any clinical testing of the DePuy ASR, orthopedic surgeons who were implanting the ASRs had no data to go on about the ASR’s effectiveness. All they had were DePuy’s very compelling promotional materials – their advertising – which seemed to demonstrate that the ASRs were much more durable and longer-lasting than conventional hip replacements.
When the DePuy ASRs began being implanted in patients, problems almost immediately began cropping up. The grinding on metal-on-metal parts within the ASR released cobalt ions that killed tissue, causing pain and, in some cases, permanent disability.
But doctors had no idea how widespread the problems were with DePuy ASR artificial hips because FDA regulations do not require reports of problems relating to this type of implant to be maintained in any sort of central database. Orthopedic surgeons who reported problems with the A.S.R. to DePuy were told that the problem lay with their surgical technique and not with the implant.
As a result of the mounting complaints about the ASR, DePuy reportedly knew of its defects as early as 2008. However, DePuy did not recall the XL Acetabular Head System until late August of this year.
There are basically two frameworks for addressing the safety of medical devices. One is regulatory: government agencies insist on certain testing and safety precautions before a product can be brought to market. The other lies in tort: people injured by devices like the DePuy ASR hire trial lawyers to sue for their injuries. We’ve blogged before about how famous economists like Milton Friedman have favored robust tort remedies in protecting consumers. But it seems that increasingly we are moving to a regime that favors regulatory protections over tort rights.
Thankfully, those who were injured by DePuy ASR hip prostheses still have the right to hire lawyers to bring suit for the injuries they’ve suffered. If it were up to some people, however, injury lawyers would not be protecting the DePuy ASR victims, only a hollow patchwork of regulatory protections would be.
Last week, the Massachusetts Supreme Judicial Court upheld a $3.35 million jury verdict against Otis Elevator Company for an injury to a four-year old boy caused by a defective escalator that bore Otis Elevator’s name but that was in fact manufactured by an independent Chinese company, China Tianjin Otis Elevator Company, Ltd. (CTOEC). The case is an important decision that adopts part of the “apparent manufacturer” doctrine from the Restatement (Third) of Torts: Product Liability. (The Restatements are publications put out by the American Law Institute, an influential body of legal scholars; the Restatements attempt to summarize existing law and, sometimes, will suggest more progressive approaches for the law to develop.)
The boy was visiting his grandparents in China when his hand became trapped between the escalator skirt panel and the step tread. His hand was nearly severed mid-palm and he has suffered a permanent thirty-one percent whole-body impairment as a result.
Otis argued that it could not be held legally responsible for the defective escalator because, although the escalator bore its name and trademark, it never sold anything; it simply licensed its name and trademark to the Chinese company for the Chinese company to use in elevators it sold and provided some technical support. Otis insisted that product liability law requires it to be a seller at some point in time in order for it to be held liable for a defective product.
The Supreme Judicial Court rejected Otis’ arguments and agreed with Judge Lemire, the trial judge, who told the jury that the fact Otis need not have actually sold or manufactured the defective product in question, so long as it allowed the escalators to be sold bearing Otis’ trademark.
You can read the case here: Lou v. Otis Elevator Co.
In January, on the heels of the terrifying tale of a state trooper and his family killed in a crash caused by their out-of-control Lexus, more reports of sudden uncontrolled acceleration problems with Toyotas began pouring in. Of course, skeptics were quick to point out that reports of uncontrolled acceleration problems with Toyotas resembled past claims of acceleration problems with various makes and models that had come to naught, especially the Audi acceleration flap of the early 1980s.
Since no one could point to any mechanism in Toyota’s (computerized) accelerators that would cause uncontrolled acceleration, these skeptics insisted that the problem must be driver error. At the time, I cautioned that we should keep an open mind – that the block box computer programs that regulate Toyotas’ acceleration and braking could conceivably have a bug, the same sort of bug that caused the Great Northeast blackout of 2003.
This week, the acceleration skeptics got welcome news as the National Highway Traffic Safety Administration announced its preliminary findings: in all of the Toyota acceleration cases investigated thus far, driver error has been found to be the cause of the braking failures. Yes, pedal misapplication – hitting the accelerator instead of the brake – is the leading culprit at this point in time.
Meanwhile this week came another story, a story about malfunctioning black boxes. Wall Street traders and government regulators are still probing the May 6 “flash crash” in which the Dow Jones inexplicably plunged nearly 1,000 points within a couple hours. Of course the bulk of stock trading is done by computers running proprietary algorithms that Wall Street banks have invested many more billions in than Toyota has spent engineering the computer systems in its late model cars. Investigators probing these trades are finding the black box computer algorithms used by traders produced bizarre “crop circle” graphs over the course of the flash crash.
It seems one might draw some parallels between the 2010 “flash crash” and an older stock market mystery that occurred around the same time as the 1980s Audi debacle: the Black Monday 1987 stock market crash that some chalk up to computer trading.
My position on the Toyota uncontrolled acceleration phenomenon has always been the same: when people complain that their cars (increasingly controlled by complex computer systems) are going haywire, we should take them seriously and investigate thoroughly because even the best-engineered systems can behave unpredictably. If investigation reveals that root of the problem is not a defectively designed product, but rather human-fueled hysteria, then so much the better for society.
I just wish the same people who are so quick to point to human error in the driver’s seat would be as quick to recognize human error in some of Wall Street’s follies.
In cooperation with the Consumer Product Safety Commission, seven crib manufacturers announced today that they are recalling more than two million drop-side cribs. A drop-side crib is simply a crib in which one side of the crib raises and lowers in an up-and-down fashion, making it easier to place an infant in the crib or remove her from it. Drop-side cribs pose a risk of entrapment and suffocation to infants who may fall into gaps between the crib’s bedding area and other parts of the crib or have their necks stuck between the crib’s slats.
The dangers associated with drop-side cribs are especially pronounced when bolts and other hardware become loosened over time. Loose hardware in drop-side cribs gives even more play to the cribs’ moving parts, providing more space in which a baby may be entrapped. This public service video produced by the Consumer Product Safety Commission illustrates how a baby may become trapped or suffocate in a drop-side crib. It also illustrates the dangers posed by loose hardware:
Today’s recall brings the total of drop-side cribs recalled in the past five years to over nine million. ASTM International, which sets manufacturing standards for cribs, has proposed the elimination of drop-side cribs. Major retailers such as Walmart and Toys R US no longer stock drop-side cribs.