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.
It’s a problem we’ve blogged about many times before – patients receiving mega-doses of radiation from CT scans and other medical imaging.
There are several dimensions to this problem. One, these potentially lethal machines are being operated by under-trained and under-educated technicians who don’t understand all of their dangers. Two (and perhaps most importantly), the manufacturers of these machines, including General Electric and other companies, have defectively designed them, failing to implement any kind of failsafe mechanisms that would prevent technicians from administering radiation doses that would kill an elephant.
Thankfully, The New York Times’ Walt Bogdanich has not let up on this story and last weekend, published another follow-up piece. The piece details just how badly designed some of these CT machines are. As one victim of radiation overdose told Bogdanich, when a truck backs up, “it goes ‘beep, beep, beep.’ If you fill up the washing machine too much, it won’t work. [But on a CT scan] there is no red light that says your irradiating too much.”
Let’s hope these defective machines get re-designed and soon.
In March, I blogged about this $1.5 million jury verdict against saw manufacturer Ryobi for failing to equip its table saws with some form of flesh detection technology, such as that offered in SawStop-brand saws. This video illustrates the SawStop technology that’s been wowing contractors and other tradesmen over the last decade or so:
For more about SawStop, and the power saw industry’s refusal to license the patented technology for its own power saws, check out the stories here, here, and here.
To date, SawStop technology is credited with hundreds of “finger saves” – instances where the technology saved table saw operators from losing fingers.
PS – If you’re wondering how SawStop works, it relies on electrical conductivity. It’s the same principle that you see at work in those old “touch lamps” that would turn off and on whenever your hand came in contact with their base.
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.
Last year, over Memorial Day Weekend, twenty-seven people died in All Terrain Vehicle (ATV) accidents, including two riders under the age of sixteen.
This year, the Consumer Product Safety Commission (CPSC) is issuing a warning to ATV riders to be mindful of the dangers of off-roading.
It is easy to understand why Memorial Day weekend might be especially dangerous to ATV riders. Since it’s the unofficial beginning of the summer season, you probably have a greater number of riders who have just “come of age,” and are riding an ATV for the first time. Couple that with the “rust” that more experienced drivers accumulate over the winter months when they are not riding, and throw in some alcohol, and you have a perfect storm for ATV accidents.
If you own an ATV, you should know that, in April 2009, CPSC began mandating that ATV manufacturers offer free hands-on training for ATV purchasers through dealerships. So you can go to your dealer for a free course on how to operate your ATV safely.
The ad, and its litany of warnings, probably seems silly, just another vestige of an overly litigious society. People may watch and doubt whether there’s any sort of connection between the drug and gambling and suspect this warning is premised entirely upon some scientist’s conjecture that such drugs may cause such behavior.
But, as I was reminded this week, while reading “How We Decide,” a book on neuroscience, drug and product warning labels are there for our own benefit. Drugs like Requip are called “dopamine agonists” – they activate dopamine receptors in your brain even when your dopamine levels are low.
For many people these drugs are a miracle. For example, Parkinson’s disease is a disorder of the dopamine system that involves the irreversible death of dopamine neurons in the part of the brain that controls bodily movement. A Parkinson’s patient taking a dopamine agonist can see dramatic improvement in his control of his bodily movement because the agonist gets more horsepower out of the few surviving dopamine neurons.
One side effect of this is that the patient’s amped-up dopamine neurons make him more attracted to the “dopamine highs” he gets from gambling. Lehrer, the Rhodes Scholar author of “How We Decide,” tells the story of Ann Klinestiver, a fifty-one year old English teacher who was diagnosed with Parkinson’s and prescribed Requip. Klinestiver, who had never previously gambled, and who had religious objections to gambling, suddenly became a problem gambler. After a year of playing slot machines, Ann had lost more than $250,000 – wiping out her retirement savings.
Klinstiver’s story is not unique. As Lehrer informs us, medical research suggests that as many of 13 percent of patients taking dopamine agonists develop severe gambling compulsions.
So the next time you come across a product warning label or a prescription drug label reciting a litany of possible side effects, ones that seem like a barrage of nonsense, take heed. The labels may actually be there for your benefit.