Articles Posted in Product Liability

What you’ll learn in this post: How the tobacco industry has used the doctrine of “commercial free speech,” and the First Amendment against the public interest in this country.

In case you thought that we as a society are making headway against one of the most pernicious and harmful industries in this country – the tobacco industry – I’m afraid I have some bad news. To fully appreciate this post will require that you have traveled to Europe in the past ten years or so. Because across the pond, a lot of things are looked at much more sensibly than they are here in the good old USA. Exhibit “A” on this point is the Europeans’ approach to tobacco and cigarette advertising. In 2001, the member nations of the European Union formally enacted a requirement that each nation pass regulations to assure that graphic warnings and images be placed on the front and back of each package of cigarettes. Member nations of the European Union can choose from a list of 14 to 42 graphic warnings and images – all of which communicate the very stark and morbid risk of not only death, but a variety of other chronic health risks. For a look at these images, click here. Now that you’ve seen these warnings, I trust you can see how very effective they are.

Back to the US: Here, it took decades for the federal government to come around to the reality that the tobacco industry has been knowingly marketing a highly lethal product for almost a century. While it took seemingly forever to bring these manufacturers to court and hold them accountable for their unsafe products under state and federal product liability laws, justice was finally found in a number of cases across the country, including class action litigation that several state attorneys general brought to recoup billions of state Medicaid dollars spent to treat illnesses caused by smoking and tobacco. Tobacco liability was finally something that the courts embraced. The next logical step was to emulate the European Union’s approach to cigarette advertising, and require that manufacturers place graphic warnings and images on all their packaging here in the United States. And the federal Food and Drug Administration (FDA) did just that, recently requiring that all cigarette advertising carry graphic warnings on their packaging, similar to that required in Europe. Makes sense, wouldn’t you think? A lot of people do.

Consumers and product safety advocates won a victory recently, with a decision from the U.S. Court of Appeals for the 1st Circuit. This court is the federal appellate court for Massachusetts and surrounding states; it hears appeals from the U.S. District Court in Boston, and other federal District Courts in this immediate area. Because this is a federal decision, it will hold significant precedential weight in similar cases filed throughout the United States in the future.

The case began when a construction worker suffered a severe injury to his hand when using a bench-top table saw. The saw’s blade cut into his hand, causing permanent injuries. The saw was a Ryobi Model BTS 15 bench-top table saw, purchased at a Home Depot. Following the injury, the plaintiff sued the manufacturer, Ryobi Technologies, Inc., in U.S. District Court in Boston, seeking damages for his injuries. His suit claimed negligence and breach of the “implied warranty of merchantability,” which is a Massachusetts law that regardless of what a manufacturer’s written warranty may expressly state, the product carries an “implied” warranty, that it is “merchantable,” (safely usable,) and that it is fit for a particular purpose.

“Negligence?”, I’m sure you ask. “Why should a saw manufacturer be held liable if someone using the saw suffers an injury from the blade?” Why? Because, as a Boston, Massachusetts product liability lawyer I can assure you, there’s always a story behind the story – and there’s a story behind this one. Which is: It seems as though Ryobi Technologies was aware of a certain technology that had become known as a flesh-detection system called “SawStop.” This device basically stops the saw blade immediately whenever it senses some kind of flesh pressing against the spinning blade. At trial before the U.S. District Court in Boston, the plaintiff argued that as manufactured and sold, the saw was defectively designed, unsafe, and that the “SawStop” technology represented a reasonable and viable alternative design. Supporting this argument, the plaintiff presented testimony of his expert witness, the man who invented “SawStop” in 1999. That inventor testified that he had presented SawStop to several major saw manufacturers, including Ryobi, in 2000. All had refused to adopt the new safety technology, despite the fact that it worked. And why? The plaintiff argued that it was due to a “silent agreement” among several manufacturers that if even one of them adopted the safety system, the others would be forced to do the same, or face heightened liability exposure to liability if they didn’t. That’s called a “conspiracy of silence.” Typical corporate America.

Usually, most of the legal stories giving rise to posts on this blog originate in or have to do with cases and legal issues in Massachusetts. However, a tragic incident at Yale University earlier this week, illustrates the importance of product liability law, and the impact it can have on making products safer for the Americans who use those products.

Scituate, Massachusetts resident Michele Dufault, a bright Yale University student, was killed earlier this week in a horrific incident involving a lathe at a machine shop on campus. Dufault, a senior at the Ivy League school who was majoring in physics and astronomy, was found at Yale’s Sterling Chemistry Laboratory at around 2:30 AM Thursday by other students in the building. The students immediately called New Haven police, but it was too late. A statement from Yale University president Richard C. Levin did not reveal whether Dufault died in the lab or later at a hospital. Nor was there a statement as of Friday evening, April 15, as to whether Dufault had been alone in the lab, or not.

This incident must have been absolutely horrific. I remember working on a lathe in high school machine shop. When I look back on those times, I’m surprised that I wasn’t injured, as well — this machinery is very powerful, and extremely dangerous. For those unfamiliar with machine shop equipment, a lathe is a machine that is used to shape usually straight lengths of metal or wood by spinning it at extremely high speeds. (So fast that when spinning in the lathe, the length of wood or metal would look like a blur to the naked eye.) Carving tools are applied to the edges of the spinning wood or metal, to shape the material. By all available accounts of the incident, Ms. Dufault’s hair became caught in the lathe, pulling her head into the machinery.

While this post is about product liability law, it’s also about the age-old story of corporate greed and deception. Ever hear of on over-the-counter cold remedy called Zicam? Most people have. – Matrixx Initiatives Inc. and Zicam L.L.C., were jointly the developers, manufacturers and distributor of this product. Zicam was marketed with the claim that it could shorten the symptoms of the common cold, if taken at the onset of symptoms. The zinc gluconate formulation generated approximately 70% of the company’s sales. While the product used to be manufactured and sold as a nasal gel, it’s now sold as an oral spray. There’s a reason for that. And that leads us to a typical story of corporate deception.

It seems that in the late 1990’s, Matrixx became aware from several sources (it’s alleged,) of a very serious side effect of using Zicam. That serious side effect is called “anosmia“, which is the medical term for loss of the sense of smell. In 1999, it’s alleged that a Matrixx staffer was told by the neurological director of a research organization called the Smell & Taste Treatment and Research Foundation, Ltd. that a “cluster of patients” had suffered anosmia after using Zicam. Three years later, as reports of these side effects grew, Matrixx’s Vice President for Research and Development contacted a scientist at the University of Colorado Health Sciences Center , allegedly was told of the results of previous studies linking zinc sulfate [a slightly different zinc compound] to loss of smell. This scientist later buttressed these initial reports, by forwarding to Matrixx with further abstracts, confirming zinc’s toxicity.

About a year later, a colleague of that scientist (from the University of Colorado Health Sciences Center,) observed 10 patients suffering from anosmia following Zicam use. These scientists then prepared a poster for display at a meeting of the American Rhinologic Society, in connection with a substantive presentation they were going to make at this medical association meeting. After learning of the scientists’ plans, Matrixx warned them that they were not allowed to use the Matrixx company name or the product name (Zicam.) As a result, the scientists deleted this information from their posters and presentation.

I love to report and comment on stories like this: A Massachusetts personal injury case that results in solid justice to the plaintiff.

Readers of a certain age and above will remember that back in the late 1970’s and early ’80’s, tobacco companies would literally give away samples of their cigarettes to the public. They had been doing this since at least the early 1960’s. I’m dating myself here, but in the mid-’70’s, I can clearly remember riding the Green Line into and out of Boston during those years, and seeing young, healthy looking men and women standing outside subway entrances at peak commuting hours, handing out small sample packs of cigarettes to almost anyone who walked by. These tobacco company “hawkers” (usually college kids or recent grads trying to make a few bucks,) would hold trays of cigarettes samples (usually containing 4 or 5 cigarettes,) out in front of them, held by a strap around their necks. While downtown locations were usually the best fishing grounds for this activity, these hawkers could also be found outside nightclubs on weekend evenings, and at beach locations in the summer. Usually very attractive young women who could double as models, these hawkers conveyed beauty, youth, and health.

There was just one problem: What they were promoting was anything but healthy, and anything but beautiful. In point of fact, they were legal drug pushers, pushing a deadly, addictive product, for free, just to get people hooked on the nicotine. It was literally like handing out cocaine samples for free – and worse, they pushed these deadly products on anyone and everyone who walked by – usually without regard to age. If you were a twelve-year-old who looked 15, you got cigarettes. Fast forward about 35 years: A woman in her mid-40’s, Marie Evans, is dying of lung cancer. She remembers when her addiction began: At age nine, when these healthy-looking, tray-carrying cigarette hawkers regularly handed out samples of Newport cigarettes to her and other kids. She files suit against the manufacturer of those cigarettes, Lorillard Tobacco Co., of Greensboro, North Carolina, shortly before her death in 2002. This past month, in December of 2010, a Suffolk Superior Court jury awarded her estate $50 million in damages for negligence, and awarded her son $21 million, for her death due to lung cancer. Days later, the jury added another $81 million to the verdict, for punitive damages, bringing the total verdict against Lorillard Tobacco Co., to $152 million.

Most people who know me, know that as a Massachusetts product liability lawyer, I have a natural mistrust for big business. I’ve seen too many examples of their disregard for consumers’ safety and related interests, whether dealing with insurance companies, big banks, auto manufacturers or drug manufacturers. If anyone doubts that, take a look at the U.S. Consumer Product Safety Commission’s work.

Today’s post reveals yet another chapter in how “Big Pharma” so often puts the bottom line first, and consumer interests, a distant second. To wit: Recent news that eleven drug manufacturers have agreed to a preliminary settlement in the United States District Court in Boston, within a lawsuit that alleged the companies artificially inflated the wholesale prices of approximately 200 separate drugs. The effect of this artificial price-spiking was (you guessed it) to increase the co-payments and full payments that consumers (as well as others) paid. The preliminary settlement amounts to almost $21.8 million dollars, which would be distributed to eligible consumers who paid either increased prescription drug co-payments, or full price for the prescription, from January 1, 1991 to March 1, 2008. Qualifying claimants would receive a minimum of $35 dollars back. The reason that the average payment to each claimant is so low, is that over 17 years, there are millions of persons who could qualify for the settlement distribution.

As part of standard practice within such settlements, the defendant companies denied any wrongdoing, but agreed to settle the claims “to resolve the litigation and avoid any further expenses and inconveniences” in continuing to contest the charges. (You can smirk now.) When will industries like “Big Pharma”, insurance companies, banks and others, be satisfied to make hundreds of millions in profits, without cheating the American consumer in the process? One may as well ask when will the sun stop rising in the east.

Today is Thanksgiving Day, and so if this post can offer anything to be grateful over, perhaps you can say that you’re grateful you weren’t injured or killed by the negligence of the people who built Boston’s famous Big Dig tunnels. (You know, the same tunnels which ended up leaking millions of gallons of Boston Harbor water into the tunnels, due to more negligence and graft than I care to cover right now.)

One of several dangerous defects in the design and construction of those tunnels, centers on the guardrails/handrails that were designed and installed at the sides of the tunnels. The rails were placed there to protect tunnel employees who would regularly be walking at the sides of the tunnels, from falling into traffic. The rails are slightly more than 3 feet off the ground, about the same height of a motorcycle seat or car window – extremely low. The dangerousness of these tunnel handrails was first brought to light last February 2010, when The Boston Globe published a story on how many injuries and fatalities had resulted by drivers literally being sliced to death after being caught in the rails. Between 2005 and 2008, a total of seven motorists and passengers were killed after striking the handrails which line the Big Dig tunnel system. Most of the seven victims who died were dismembered by the rails in the accidents; one other person lost an arm but survived. Four victims were riding motorcycles and three deaths involved people in vehicles.

One of those victims was a Massachusetts state police trooper, Vincent Cila, who was killed on duty when he lost control of his motorcycle, and was dismembered by the guardrails. Cila’s family sued the Massachusetts Turnpike Authority (now known as the Massachusetts Department of Transportation,) and several private contractors involved in the design and construction of the tunnels and the guardrails, alleging negligence in the design and installation of these particular guardrails.

Almost every other day, it seems, we hear of another case in the news where someone has been “tasered” by police or security personnel. The modern suspect-control device has grown in popularity with many police departments across the United States, as well as U.S. military and some private security agencies. The device’s advocates, led by its manufacturer, Taser International, argue that the device is safer than using mace or pepper spray, because mace can miss its target and harm bystanders since it’s applied in aerosol form, while a Taser stun gun can’t harm anyone other than the person who is tasered. As a matter of physics, that may be true, but the electric charge that most Taser stun guns are set at, can’t be altered on-site just prior to use, resulting in a standard electric shock being administered to most suspects being shocked. Unlike the old Star Trek TV series, Captain Kirk doesn’t give out an order to preemptively adjust the guns on a “stun” or “kill” setting, depending on the threat level.

The devices are in theory designed to temporarily stun someone, just long enough for police or security personnel to subdue and handcuff or restrain the suspect – but theory and practice exist in two different worlds, and it doesn’t take a genius to see that this one-size-fits-all approach was eventually going to cause some tragic results.

Four years ago, a Watsonville, California man was shocked with a Taser stun gun by a police officer in that city. The victim, Steven Butler, 49, was tasered by an officer using a Taser X-26 device, after Butler reportedly became combative with the officer when asked to get off a bus he was riding on. Butler was alleged to have been drunk and off his psychiatric medication in October 2006 when the incident occurred. After being tasered, Butler went into cardiac arrest and stopped breathing. It took medical personnel 18 minutes to resuscitate him and, as a result, Butler suffered an anoxic brain injury (loss of oxygen to the brain.) Butler was left with substantial brain damage and has no short-term memory. Additionally, he suffered a loss of mobility and the loss of his motor skills. As a result of the injury he will require around-the-clock care for the rest of his life, and cannot be left unattended, according to pleadings filed in the suit.

Whether it’s Big Finance, Big Insurance, Big Tobacco or Big Pharma, overall, Big Business never seems to “get it” when it comes to acting ethically and obeying the laws they’re required to operate under in this country. This time the focus is on Big Pharma, though that’s nothing new.

Pfizer, Inc., that giant of the pharmaceutical industry, was found by a jury in U.S. District Court in Boston last week, with violating the federal Racketeer Influenced and Corrupt Organization Act (RICO,) a law designed to thwart and punish a variety of illegal activities dealing with financial transactions. Oddly enough, (or not so oddly,) RICO was first passed by the U.S. Congress in response to organized crime’s (read: The mob’s) activities in transferring and hiding financial transactions across state lines. Now, Pfizer’s been found to have violated the Act.

What was Pfizer up to? It seems that for the past ten years, Pfizer embarked on a targeted campaign to promote their epilepsy drug, Neurontin, for officially unapproved uses. Kaiser Foundation Health Plans, Inc., and Kaiser Foundation Hospitals, alleged that over the course of ten years, Pfizer consistently promoted Neurontin to it for unapproved uses, representing to its doctors that Neurontin could effectively treat a number of different medical conditions, including migraines and bipolar disorder. Neurontin was approved by the FDA in 1993 to treat epilepsy, and nothing more. According to Tom Sobol, a lawyer for Kaiser ,”The jury found that Pfizer engaged in a racketeering conspiracy over a ten-year period. That bodes well for future (similar) cases.” The jury deliberated for two days before finding Pfizer guilty of violating RICO. They determined the damages owed Kaiser to be $47 million, but under RICO, the damages are tripled. Hence, the total cost to Pfizer is $142 million. The federal trial was based in Boston, as U.S. District Court Judge Patti Saris is charged with overseeing a number of federal lawsuits from across the United States, targeting Pfizer with personal injury claims and allegations of fraudulent marketing of this drug. These injury claims would take the form of Product Liability suits, rather than Medical Malpractice.

It’s no secret among people who know me, that, as a Boston Massachusetts product liability lawyer, I’m one of the sharpest critics in the legal community of the pharmaceutical industry, and particularly, pharmaceutical advertising. Yes, I’m fully aware of the societal value that pharmaceutical companies can and do bring to bear, in addressing a number of diseases and medical conditions. And I believe that they are entitled to make a healthy profit in so doing. But what I’ve – and we’ve – all witnessed in the last 10 or 12 years, is the way that pharmaceutical companies pimp their products to the general public through television, radio, and print advertising. It is often obscene, and in my opinion ought to be legislated as illegal. However, there’s a sticky little thing called “commercial free speech”, which delves into an entirely separate subject of First Amendment issues, which I won’t distract my readers with right now. Not that it isn’t very important, but I’ll save that for another day.

Long gone are the days when pharmaceutical company sales reps solely called on – of all things – doctors’ offices – to sell their products. No, they got around that. Their thinking: “Why rely on doctors to write prescriptions for our products, when we can generate demand at the consumer level? Yeah, we’ll flood print and broadcast media with ominous-sounding ads showcasing all kinds of diseases and medical problems, and in the process, get millions of people to march into their doctors’ offices, and demand to be given prescriptions for our products.” This seemed like an even surer bet than taking doctors out to lunches and dinners, and hosting them with everything from golf outings to “professional seminars” at warm, sunny destinations. (Which they still do, but that practice has been gradually dropping, as regulators see more and more how incestuous and unethical a practice it obviously is.)

Take a little test: The next time you’re watching a TV show (ideally during prime time, (8:00-11:00 PM,) keep a pen and paper next to you. Write down the number of advertisements that you see about any kind of drug or health product. Ninety per cent of the time, it’s a pitch from a pharmaceutical company, talking about the horrors of this or that medical condition, and urging you to “Ask your doctor about_______.” Do the same thing the next time you’re reading a newspaper or a magazine. Or listening to the radio (except when driving.) Chances are you’ll realize that the average viewer, reader or listener is inundated, constantly, by drug companies trying to get you to “Ask your doctor” about whether you “might have” some medical problem or condition, and whether their product “might help you.” Not only are ads in newspapers across the country regular fare, but full page ads. Any idea what a full page ad in an average major city daily newspaper goes for, say, Monday through Friday? About $10,000.00 – and more on weekends. Hawking everything from Aspirin to Zithromax, for every condition from high cholesterol to depression to heart disease to smoking, they never cease their constant drumbeat to “Ask your doctor about ______.”