More than 70 percent of the drugs prescribed in the U.S. today are generic versions of brand-name medicines. These drugs are cheaper and considered identical to the original except for one critical component: their warning labels may be years behind reports of problems.
How is that again? According to the Food and Drug Administration, and acknowledged recently in a U.S. Supreme court ruling, generic drug makers are prohibited from updating dosing and side-effect information on labels even if they become aware of problems.
They must wait until the brand-name drug maker – who is filling fewer prescriptions and presumably seeing fewer side-effect complaints – updates its labeling information, according to FDA regulations. For some people, this might mean the difference between life, severe complications or even death.
Such was the case for two women whose lawsuits against generic drug manufacturers ended up in the U.S. Supreme Court.
The lawsuits involved the drug metoclopramide, brand-name Reglan. In one suit, Julie Demahy, claimed generic manufacturer Actavis should have warned her of the risks of developing a neurological movement disorder from the drug, prescribed for heartburn, nausea and vomiting.
In another case, Gladys Mensing sued the three generic drug makers in federal court after she developed the same disorder after taking generic versions of Reglan.
The FDA ordered that specific warnings about the disorder be added to both Reglan and metroclopramide labels in 2009, but this was years after both women began taking metroclopramide, the lawsuits claimed.
After hearing the arguments, the Supreme Court ruled that generic drug manufacturers cannot be sued for inadequate or false warning information because the FDA prohibits them from updating labeling information even if they were aware the information was inadequate. Obviously, the ruling was a big win for generic drug manufacturers, who don’t have to foot the bill for tracking adverse interactions.
This ruling in effect lets most of the drugs being prescribed these days off the hook legally for carrying the latest drug safety information. This presents individual consumers with a damning dilemma: spring for the higher-priced brand name drugs which are under a legal obligation to report adverse effect claims to the FDA, which can then prompt alerts and updates to labeling information, or go for the generic and cross their fingers.
At the public policy level, the FDA regulation and Supreme Court ruling denies consumer access to the only system set up in this country to hold wrong-doers accountable: the judicial system.
Threat of legal action for ignoring, delaying or obscuring the results of safety tests for medical drugs motivates drug companies to provide consumers with accurate, up-to-date drug information. Take away that obligation for one major group of drug manufacturers and you eliminate a major level of accountability.
Fighting back, the national consumer group Public Citizen has petitioned the FDA to change its regulations to allow generic drug makers to update prescription labels as soon as information becomes available, and to report to the FDA when any adverse effects from their drugs comes to their attention.
Consumers have a right to be outraged that most of their prescribed drugs lack basic protections.
Concerned about liver toxicity, the makers of Extra Strength Tylenol have lowered the maximum daily dose instructions from eight pills a day to six. McNeil health Care, a Johnson & Johnson company, also announced it plans to lower the maximum daily dose for Regular Strength Tylenol and other adult acetaminophen-containing products beginning in 2012.
The announcement underscores that over-the-counter medicines are some of the most dangerous drugs around. Overdosing on over-the-counter medicines send some 150,000 people to the hospital every year.
About 1,000 non-prescription medications are linked to liver toxicity, which kills 2,000 Americans a year. One of those is acetaminophen, which is reported to be the most common cause of drug-induced liver damage in the United States.
Why do people tend to overdose on this drug? One of the reasons is that most people don’t realize the number of drugs that contain acetaminophen, making it hard to judge how much is being taken. For example, other common drugs that contain acetaminophen include Sudafed, NyQuil, Excedrin, Anacin, Midol, Theraflu, Alka-Seltzer.
Another factor is that television and magazine advertising push popular over-the-counter drugs to make it seem like they are safe.
Even consumers who carefully read labels can be misled, as acetaminophen is frequently listed under the abbreviation “APAP,” which is short for N-acetyl-p-aminophenol, the chemical name acetaminophen.
Two years ago, an advisory panel to the U.S. Food and Drug Administration (FDA) also recommended that the FDA place a “black box” warning on prescription medications that combine acetaminophen with another drug. These would include pain medications that combine acetaminophen with hydrocodone (Vicodin), oxycodone (Percocet), or codeine (Tylenol 3). That recommendation has not been adopted.
However, in January, the FDA mandated all drug makers to include no more than 325 mg of acetaminophen in each tablet or capsule of combination pain meds. That change will be phased in over three years.
The FDA also is looking into adding dosing instructions to acetaminophen-containing medications given to children younger than 2. The revised instructions for Extra Strength Tylenol will appear on packages in the fall.
So be safe and read dosing instructions even for over-the-counter drugs, especially if they contain acetaminophen.
Symptoms of a failed hip implant include severe pain, swelling in the hip, groin and/or lower back and difficulty walking and standing.
When Judy Walters of Marshall, Texas experienced these systems, she discovered that her hip implant was an ASR XL Acetabular System, which had been recalled in August 2010, because of a higher than average failure rate.
She is one of about 1,000 hip implant patients who have filed lawsuits against Johnson & Johnson, which manufactured the system, along with the DePuy ASR XL Acetabular System, which was also recalled. About 90,000 of the systems were sold before the recall.
Walters’ lawsuit states that since her surgeries she has suffered from cracking of her bones, metal shavings in muscles, muscle damage, intense pain and problems standing and sitting.
According to the lawsuit, there is a high failure rate of the medical device due to the design of the Acetabular metal cup which is shallower than other similar devices. The cups include a beveled edge which reduces the surface arc that contacts with the femoral head.
According to a story in the Wall Street Journal, Johnson & Johnson could be facing $1 billion in payouts to patients who received the implants, which reportedly are prone to failing within five years.
The manufacturers have acknowledged that data so far has shown that about 12% to 13% of these hips will fail within five years. However that number is expected to rise as people who received the implants continue to be monitored by their doctors.
This is another example of faulty medical devices being rushed to market before they are adequately tested.
Lawsuits over the recalled hip implants continue to be filed in state and federal courts throughout the United States, and it is likely that many more cases will be brought by individuals who received one of the defective hip replacements.
Metal-on-metal hip replacements, which use cobalt and chromium in their construction, account for about one-third of the 250,000 hip replacements performed each year in the United States. However, in recent years, concerns over problems with metal-on-metal hip replacements have been growing.
The Federal Food and Drug Administration is investigating these concerns, which center around toxic metal particles that may enter the blood stream. Because the metal ball and the metal cup slide against each other during walking or running, some tiny metal particles may wear off of the device and enter into the space around the implant. Some of the metal ions from the metal implant or from the metal particles may even get into the bloodstream. This can result in metal poisoning, also known as metallosis. This may result in soft tissue damage, inflammatory reactions, bone loss, genetic damage, asceptic fibrosis, local necrosis or other problems that may lead to the need for a risky hip revision surgery.
Device manufacturers tried to stem the tide of lawsuits over the device early on by offering to pay out-of-pocket medical expenses for victims. However, this kind of settlement would not pay for lost job income or other non-financial losses such as pain and suffering. For that reason, if you are one of the thousands of people who had this hip implant and you begin to experience problems, you should talk to an attorney before you sign any papers related to any offers of compensation.
Table saw makers are on the hot seat for not responding to the rising number of table saw accidents with better safety features. They should be. Table saw accidents now number 40,000 annually in the U.S., including 4,000 amputations. This number has risen 80% over the last decade, according to the Consumer Product Safety Commission.
The technology currently exists that can stop a table saw blade the instant it senses flesh. It’s called StopSaw. (Watch a demo of the StopSaw in action). But manufacturers say the cost of adding this technology, or something similar, is too high. They’ve also argued before the CPSC that using the technology might encourage consumers to engage in ”risky behavior.” Huh?
Saws now on the market are equipped only with flimsy plastic guards shielding the blade, and because they interfere with the work of the saw, many people remove them. If that isn’t risky, I don’t know what is. Making these saws safer would lessen the risk, not add to it.
According to Sally Greenberg, executive director of the National Consumers League, design of table saws hasn’t changed in 50 years, but because use of them is up, injuries have skyrocketed.
Stronger safety regulations for table saws were proposed several years ago, but they have languished before the CPC, probably due to manufacturer opposition. But the National Consumers League recently made headway when it held a press conference in Washington along with people who have been seriously injured by the saws.
Putting faces to the statistics appears to have helped. CPC Chairman Inez Tenenbaum told the Wall Street Journal she will consider tougher safety rules for saws over manufacturers’ objections.
“The safety standard for table saws needs to be strengthened,” she said. “I have reached out to the industry, but I am prepared to support the start of federal rule making if that is what is needed to prevent these life-altering injuries,” she added.
It’s about time. The high cost of losing the full use of hand, not to mention emergency care, far outweighs what consumers would have to pay for a safer saw. I imagine most consumers would be happy to pay extra not to lose a finger or a hand.
The government has launched a massive recall of pool and hot tub drain covers at the start of the nation’s summer season. The Consumer Product Safety Commission announced the voluntary manufacturer recall May 27, because it said the covers may not have been tested properly and may pose an unreasonable risk of entrapment to young swimmers.
The issue is not so much with the design of the covers – the government mandated design changes to deal with entrapment risk starting in 2008 – but with the laboratories that safety test the covers. The CPSC said the recall of an estimated one million covers is because they may carry an improper flow rating.
As I blogged about recently, the CPSC has been investigating the three labs that test pool and drain covers because of allegations they weren’t following proper testing procedures. The investigation turned up enough evidence to warrant the recall.
Several deaths prompted the government in 2007 to mandate a new design for pool and hot tub drain covers. The problem was a combination of pressure and design. Pool and hot tub drains can exert up to 500 pounds of vacuum pressure. If a swimmer or someone in a hot tub, particularly a child, got too close, the pressure could pull them down. If the drain is designed flush with the bottom of the pool, the body could cover the drain in such a way that it exerted even more pressure, in effect, trapping them underwater.
The new drain covers are designed with a raised dome, so that even if someone is pulled against it, water running into the drain from the sides will keep the pressure from becoming strong enough to hold them.
The consumer product safety commissioner says drain entrapment caused dozens of deaths between 1999 and last year. The models subject to this new recall were manufactured by A&A Aquastar, Color Match, Custom Model Products, Rising Dragon, and Waterway. Pool operators and home owners should contact the maker of the drain cover to see what action if any is needed to make their pool or spa safe.
The Association of Pool and Spa Professionals is operating a 24-hour recall hotline at 866-478-3521, or visit www.APSP.org/draincoverrecall.
By Rick Garcia
As the Memorial Day weekend approaches, I find myself thinking about a newspaper story last summer about a terrible boating accident on Lake Conroe. A young woman accidently drove the family boat and its propeller over a father and son as they were being towed. They were seriously hurt, and the son was in critical condition. The driver was only 20, with little experience operating a boat. The story said she’d accidently put the boat in reverse.
My gut reaction to the story was fear. I’ve been on the Gulf many times and seen how many young and perhaps inexperienced operators are out there (although age and experience don’t necessarily equate) and how easily such accidents can happen.
In 2009, there were 4,730 boating accidents in the U.S., which injured 3, 358 and killed 736 people. Of the people who died, 34 were Texans, according to figures compiled by the U.S. Coast Guard. All were people who’d gone out to have a good time with family or friends and just get away from it all and relax. It didn’t turn out that way.
Operator inexperience (86%) was cited among the top five contributors to boating accidents. The others were operator inattention, excessive speed, improper lookout and alcohol. Another statistic that stood out was that almost three-fourths of all fatal boating accident victims drowned, and of those, 84% percent were not reported as wearing a life jacket. Alcohol was listed as the leading contributor in the fatal accidents
So right off the bat you see you can significantly reduce the likelihood of being killed or killing those you love in a boating accident by making sure:
- Everyone wears a life jacket
- Anyone who operates the boat has formal boating instruction
- Alcohol is left on shore.
For some reason, formal boating instruction is not publicized as being as important as it is. Maybe because there didn’t used to be as many recreational boats out there and the people on the boats had grown up on the water. But as water becomes more crowded and more first-timers are allowed to take the helm it’s important that boating instruction be made a priority.
A good resource is the free boating instruction course offered online by the Texas Parks and Recreation Department. It comes with an interactive, animated movie. And, for $13, an official boating safety certificate that might save on insurance.
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By Rick Garcia
What do space heaters sold by Wal-Mart, Char-Broil vertical gas grills and Simplicity TV wall mounts sold through Costco this year all have in common? They were all made in China, bought by unsuspecting Americans and later recalled due to serious safety concerns. And because the U.S. legal system is lagging the realities of global trade, most of these Chinese manufacturers will face no penalties or sanctions for dumping these defective products on our markets.
This is not a small problem. According to the Consumer Product Safety Commission, more than half the consumer products recalled in 2008 in the U.S were made in China.
Poor and elderly Americans on fixed incomes are often the hardest hit. Chinese products are often the cheapest on the shelves and sold through stores that cater to low-end shoppers.
Take one of the most recent examples of a massive recall of a Chinese-made product: three brands of space heaters sold through Wal-Mart. From December 2001 to November 2009, some 2.2 million of these $18 heaters were sold. It’s not hard to assume a lot of them served as substitutes for inadequate heating systems or too-expensive-to-turn on central heat. Wal-Mart voluntarily recalled the heaters after reports of 21 instances where a defect caused the heaters to overheat, smoke, melt or catch fire, causing serious injury or property damage.
No doubt some of these instances, and many more unreported, will end up in lawsuits against Wal-Mart and other U.S.-based companies. But what about the Chinese manufacturers? Lawsuits are difficult or impossible to pursue against these companies because our laws are not yet set up to reflect foreign product liability issues.
Legislation pending before Congress could change all that. Senate Bill 1606, the Foreign Manufacturer Legal Accountability Act, would:
- Make it easier for an injured consumer to serve the foreign manufacturer with notice of pending claims. (Basically, legally notify the defendant that a court with jurisdiction has received a claim against a company so the company can respond).
- Require that foreign manufacturers or producers of covered products register an agent, located in a state where the company does business, who would be able to accept notice of civil and regulatory claims.
- As part of the registration, the foreign manufacturer or producer also would consent to state and federal jurisdiction for civil and regulatory claims.
- Cover the following products – drugs, devices, cosmetics, biological products, consumer products, chemical substances, and pesticides manufactured or produced outside of the United States.
- Direct the FDA and the Department of Agriculture to jointly study the possibility of requiring foreign food producers to have registered US agents.
This bill is awaiting a vote by the next Congress. Our lawmakers should vote for it for three important reasons:
- U.S. businesses should not be forced to unfairly compete against foreign businesses that can easily skirt the law.
- Chinese companies should face penalties that would, in turn, put pressure on them to put their products through rigorous safety testing, just like U.S. companies are required to do.
- A fundamental right of Americans is to be able to use the U.S. Civil Justice System to hold companies accountable for deaths and injuries as the result of product negligence.
Hopefully this space heater fiasco will turn up the heat on lawmakers to enact this important legislation in 2011
By Rick Garcia
The recall of about 3,700 Toro Z Master ZRT Mowers should remind all of us as summer approaches of the dangers of riding lawn mowers, especially for children.
This particular recall was instituted this month by the Toro Company and the Consumer Product Safety Commission. It is related to a problem with a switch that could accidentally activate the mower after the user leaves the seat. Already, the company said it has received one report of a foot laceration because of the defect.
Riding lawn mowers are dangerous, especially to young children. Every year, 2,000 children under the age of 10 are seriously injured in riding lawn mower accident s — including 15 who are killed, according to the American Academy of Pediatrics. In fact, riding lawn mowers are the number one cause of amputations among children in the U.S. each year – and have been for a decade, says the academy..
A big part of the problem is that many models still allow operators to mow in reverse. Many of the serious accidents occurred when a mower operator, who wasn’t looking behind him and couldn’t hear above the roar of the machine, backed over a small child. In certain John Deere models, and maybe other models, the button that allows mowing in reverse is located on the front of the machine. This encourages drivers to hold down the button and back up without looking behind them.
The AAP has urged for decades that riding lawnmowers be equipped with “no mowing in reverse” safety devices that cannot be overridden by the operator. Or, that over-ride buttons be placed on the back of the mower so that the operator has to turn all the way around and look behind him while disengaging this child safety feature.
“Pediatric lawnmower injuries, particularly due to riding mowers, are a highly preventable cause of morbidity and mortality. Increased public safety awareness and further manufacturer safety modifications should be strongly encouraged in order to limit this cause of pediatric trauma,” the academy advises.
Although the CPSC studied riding lawn mower hazards in the 1980s and 90s, problems still remain, the academy noted. “Voluntary safety standards by the industry have addressed some of the safety hazards of lawnmowers, but further standards could help lower the injury rate. Currently, some riding lawnmowers have a ‘no mowing in reverse’ (NMIR) option that disables the mower blades while the machine is backing up. However, this option is not required and is available only on certain models. Furthermore, the option can be disabled, negating the safety benefits of the device. If this option were a mandatory feature that was not able to be disabled the operator, the majority of severe injuries in children would be prevented.”
The Toro recall involves mowers with the optional deluxe set that has a switch built-in that may activate the mower when the operator gets off, the company explained, noting the sudden activation of a blade could hurt whoever might be standing nearby.
It said the mowers were sold at Toro dealers in the U.S. and Canada from September 2005 through January of this year. It said owners can have a modification installed at no charge by a Toro dealer. Consumers can contact Toro at (866) 946-3109.
You’d think an industry that could come up with a seat-activated turn-on switch could design a product that doesn’t kill or main a couple of thousand children every year. Listen up mower industry.
Virginia Graeme Baker was seven-years-old when she drowned after family members, fighting desperately, were unable to free her from the powerful suction of a hot tub drain. Today her name lives on in the Virginia Graeme Baker Pool & Spa Safety Act, which requires anti-entrapment drain covers and other safety devices in all pools and hot tubs in the United States.
The act no doubt has saved lives. There were no reported entrapment fatalities for 2009, the latest figure available, but there were eight reports of entrapment incidents in which seven people were injured during 2009.
The safety of drain pool covers is back in the news. In March, the Consumer Product Safety Commission launched an investigation into pool drain cover safety and the laboratories that certify them. Federal investigators say that laboratories used to test whether pool and spa drains are safe may not be using correct testing protocols, resulting in drains that could create enough suction to entrap limbs or potentially cause children to drown.
The pool and safety act was passed by Congress in December 2007 and went into effect in December 2008. Since then all public pools and spas have been required to install new anti-entrapment drain covers and other secondary devices or systems in order to be compliant with the law. Homeowners with pools may have been notified by their pool service operator and made these changes. Any newly constructed pools or spas since early 2009 should have these new covers.
The result of the agency’s investigation is expected to be announced by Memorial Day, which traditionally kicks off the summer swimming season in the U.S. One possible remedy would be a recall of all suspect drain covers.
Meanwhile, what should pool owners do? Here’s what the Commission recommends for pool owners:
- Contact your pool service provider to determine what type of drain cover and system you have and when it was installed.
- If it is a non-compliant drain cover (installed before 2009), be aware that it will need to be replaced by a certified cover. Talk to your service provider about your options.
- Keep children away from pool and spa drains.
- Be aware that the risk to swimmers from a non-compliant drain cover is greatest in shallow kiddie pools, wading pools or pools or spas with single main drain systems.
As you take these safety precautions, remember Virginia Baker and have a safe summer.
Tweets, twitter, flash mobs. We live in a world of instant communication. Now, the government arm that regulates the safety of consumer products has gotten on board. Those of us who see first-hand how dangerous products can ruin lives and families couldn’t be happier.
This month the Consumer Product Safety Commission launched a new product safety website, www.saferproducts.gov, where consumers can search a database of products that have been identified as having potential safety issues and file new reports about problems they have experienced.
The database can cut years off the time it sometimes takes manufacturers to report injuries to the government, the government to review them and then for either to take action to alert consumers to product dangers. For example, consumer advocates complained for years about drop-sided cribs after reports of at least a dozen deaths. But it wasn’t until late 2009 that large-scale recalls were implemented. The CPSC later banned the sale of such cribs.
The new database collects defect reports from consumers and product recall announcements from manufacturers and publishes them on the website. The reports submitted by consumers are reviewed. Reports that are deemed valid are posted to the website and are searchable by other consumers in a little more than two weeks after being submitted.
Businesses can go to the website and see what reports have been filed on their products or have those reports e-mailed to them. Each business gets 10 days to respond to any consumer complaint before it is published online. Reports that the CPSC determines are invalid will not be posted.
About 1,500 comments by consumers were accepted, processed and posted before the website launch on March 11. New consumer reports will likely begin appearing in early April, the CPSC estimates.
The database is being hailed by consumer groups as educating and empowering buyers. Not surprisingly, it is being attacked by some Republicans as being too hard on business. The effort to shut down SaferProducts.gov is being led by Rep. Mike Pompeo of Kansas, whose district is home to Koch Industries, an oil, manufacturing and trade conglomerate. The company owns Brawny paper towels, Dixie cups, Stainmaster carpets, Georgia-Pacific Lumber and is one of the largest privately owned companies in the United States. Koch Industries was Pompeo’s top campaign contributor.
Consumers, armed with the internet, have gained valuable new territory in the battle for information about the products they buy, use and rely on every day. Now we have to fight to keep it. Let your local lawmakers know you support the new CPSC database.
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