Many people owe their quality of life and even the fact that they are alive to medical devices such as artificial joint implants, pacemakers and pain pumps. However, the FDA often recalls medical devices after hundreds — if not thousands — of people have received these devices in their bodies.
What do you do if you find out that a medical device implanted in your body is later considered a defective product? Is there someone that you need to talk to before you go back to your doctor? Knowing the proper methods of moving forward to take care of your recalled product is important in order to make sure the problem is properly handled.
How do you know your device is defective?
Most people learn they have a defective medical device from a notice received in the mail froma device manufacturer. Many will never suffer any adverse consequences. Others may experience medical problems because of the defective device and suffer from the complications that prompted the recall in the first place. Recall notices can come through media channels as well, based on information released by the FDA, but few people pay close attention to such reports. Finally, they may learn about recalls through personal injury attorneys handling class action cases, who must make a reasonable effort to locate any patients who might have a stake in the suit.
Not Another Surgery!
The Food and Drug Administration (FDA) is careful to point out that, “A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs Continue reading
Manufacturers of toning shoes advertise that wearing their shoes will result in weight loss and toning of the wearer’s legs and lower torso. Despite the lack of any proof for their claims, the shoemakers charge extremely high prices for the shoes. Eventually, these companies faced an investigation and fines from the FTC for false advertising claims. They may also face defective product lawsuits from those injured by wearing the much-hyped footwear.
AOL’s Daily Finance reported on the Federal Trade Commission’s (FTC) investigation and September 2011 mandate that Reebok, maker of toning athletic shoes, reimburse customers $25 million to compensate for their false fitness claims. A Los Angeles Times article supported the FTC’s findings, citing a report from the American Council on Exercise. The council determined that Skechers Shape-ups, Reebok EasyTone and Masai Barefoot Technology shoes offered no additional benefit above normal walking or running shoes for weight loss or toning.
Hurtful Instead of Healthy
Not only have the fitness claims been proven to be inflated and false, toning shoes have been linked to a wide variety of injuries. Continue reading
When 10-year-old Halee Miller decided to make a cup of coffee with her grandmother, the last thing she expected was to end up in the hospital. According to a recent consumer report on ABC News, Halee’s mother, Susan Miller, had purchased a Tassimo Single Cup Brewer as a Christmas present for the family. Halee was making a cup of coffee when she heard a grinding noise that was followed by an explosion.
Halee was burned by hot coffee grounds that landed on her face and neck. Her mother rushed home from work and claims she could hear her daughter screaming in pain when she pulled in the driveway. Halee was taken to the hospital where she was treated in the burn unit and underwent surgery and synthetic skin grafting.
Susan Miller told ABC News, “To see a child go through something like this over a defective appliance is really a sad situation. I’m very happy to see they’re recalling it before anyone else gets hurt.”
Tassimo Issues Recall
According to Reuters, more than 1.7 million single cup coffee brewers made by Tassimo were recalled in early February. Continue reading
According to an LA Times article, a nationwide recall of Novartis’s over-the-counter medications, Excedrin, NoDoz, Bufferin and Gas-X, was issued January 8. The recall follows concerns that certain bottled versions of these drugs may contain other Novartis medicines. Powerful prescription drugs including those manufactured for Endo Pharmaceuticals, such as Zydone, Endocet, Percocet and Opana, are among the drugs that may have been mixed in with the over-the-counter medications. The Swiss pharmaceutical company’s Lincoln, Nebraska facility is at the center of manufacturing the defective medications.
Even though certain tablets are simply chipped or broken, the mix-up of different drugs could be far more serious. It could cause unintentional overdoses or allergic reactions for consumers who unwittingly take medications for which they have no prescription. Additionally, the interaction of different medications could also cause unwanted side effects and symptoms, with consumers unaware of the cause and at risk for serious injury.
The comprehensive recall only affects Novartis products produced in the United States and includes all bottle sizes with expiration dates of 12/20/2014 or earlier. Continue reading
Numerous farmers and produce distributors are under fire from consumers and health investigators for failing to meet safety criteria for the food they are growing and selling. Serious illnesses and even deaths have been traced to various products due to the bacterium listeria. The bacteria were found in cantaloupe that killed over 30 people between August 2011 and December 2011.
Cantaloupe Leads to Listeriosis
Local ABC news affiliate KMBC reported on the death of a 92-year-old Missouri man, Paul Schwarz. His family believes that cantaloupe contaminated with listeria was responsible for his death. Schwarz allegedly ate the affected cantaloupe in September 2011 and fell ill shortly thereafter. After spending over a month in the hospital, he was cleared to enter a nursing home. He passed away in December, three months after eating the cantaloupe.
An Albuquerque ABC news station, KOAT, reported a similar poisoning in New Mexico, where a wife grieves her lost husband. Continue reading
Businessweek reported that Build-A-Bear Workshop, Inc. is under investigation for failing to report a toy defect. The company allegedly took almost two years to confirm reports of poorly constructed toys and remove the products from the shelves. Although the first report came to Build-A-Bear Workshop’s attention in July 2007, the company did not report the injuries to the Consumer Product Safety Commission (CPSC) or recall the item until March 2009. The government requires all manufacturers, distributors and stores to report defective products that may cause injury or death to consumers within 24 hours after they obtain enough information to support the claim. At the same time, the company is facing several newer recalls.
Build-A-Bear Workshop Must Pay $600,000 Penalty
Due to the allegations that Build-A-Bear Workshop failed to report the risk of injuries in a timely manner, the company must pay a civil penalty of $600,000. The toy in question is a beach chair sold in stores and online from March 2001 and October 2008. The chair is allegedly fitted with sharp edges on the wooden frame. There is a serious risk for pinching of fingers, laceration and even amputation if a child’s small finger is caught as the chair folds. The company eventually recalled roughly 260,000 chairs. Build-A-Bear Workshop maintains it was not aware of any injuries until more than 200,000 units of the product had already been sold, mainly during late 2008 and early 2009.
Build-A-Bear Workshop Issues Three Recalls in 2011
Earlier in 2011, Build-A-Bear Workshop recalled an inflatable inner tube that poses a strangulation risk if children pull it over their heads. Continue reading
With the growth of giant corporations, greed and corruption, class action lawsuits are rising in number to fight them. Intended to help the “common man” or the “little guy,” class action lawsuits are one of the few protections available to American consumers when federal and state laws fail to defend them.
The Ohio State Bar Association defines a class action lawsuit as “a lawsuit in state or federal court that is brought by one individual, or a few individuals, on behalf of a larger class of people similarly situated.” The group may have similar wrongs and damages, such as:
- People who have been hurt by defective products, such as parents of children who were harmed by malfunctioning toys or people who were injured using a particular product
- Victims of unsafe drugs that cause complications such as illnesses, permanent injury or even death
- Employees bringing action against an employer for a common complaint
- Residents in a specific geographical area who have been harmed by environmental pollution
A class action lawsuit typically seeks some type of compensation for the harm that has come to members of the class. Often, the claims of each individual are not large enough to justify expensive litigation, but by combining all the small dollar claims of a bigger group of people, the expense of litigation can be justified.
Class Action Lawsuits Common
American corporations have a duty to increase profits every year. Sometimes, they cut corners on consumer protections and safety to reach their profit goals. Because of this, class actions are common.
Without class action lawsuits, companies could harm consumers and face no consequences. Continue reading
In August 2011, CooperVision had begun to recall 600,000 Avaira Toric contact lenses. The company is how expanding the recall to include their Avaira Sphere line, a move that involves taking more than 6.6 million total units of contact lenses off the market.
Why is CooperVision Recalling Lenses?
All of the contact lenses in question have been linked to severe pain, eye discomfort and hazy vision, symptoms that were first pointed out in August of 2011 and resulted in the original recall of nearly 600,000 contact lenses in the United States. The company believes that there was too much silicone oil residue after the manufacturing process of the lenses, so they attempted to change their manufacturing processes and increase their quality control levels.
CooperVision maintains that they upgraded their quality processes prior to customer complaints, and that is how they originally caught the excess residue and initiated the recall on their own. On November 16, 2011, they continued their collaboration with the Food and Drug Administration (FDA) to expand the recall that was already in motion since August.
CooperVision is not disclosing which, and how many, lot numbers are involved in their recall, but all optometrists, eye-care specialists and other retail stores that sell contact lenses are aware of the specific lot numbers. Roughly 6.6 million contact lenses were recalled from CooperVision’s Avaira Sphere line, with over 4.9 million already in transit to consumers around the globe. Continue reading
The Boston.com on the story of the Aleo family and the tragic death of Robin Aleo, a 29-year-old wife and mother, who hit her head on the side of a swimming pool while sliding down a Banzai Falls inflatable pool slide. She was unable to breathe on her own because of a broken neck and died the next day. Her young daughter witnessed the tragedy.
Family Filed Suit
It was later discovered that the slide, purchased only a month before the accident, was defective. According to government regulations, pool slides are meant to hold at least 350 pounds without failing or sustaining damage. In this case, the slide was unable to handle Aleo’s 150 pounds and gave out easily. The slide, purchased from Toys “R” Us via Amazon.com, had not been tested by the toy company. The family took its case to court and was awarded $20.6 million. Of that, $2.5 million compensated for Aleo’s lifetime of lost wages, $18 million covered punitive damages and $100,000 was in recognition of the pain and suffering Aleo endured before her death.
Pool Slide Defects
Proper testing will expose the kind of defect that killed Aleo. Continue reading
Many in Wisconsin are upset over tort reform bills in consideration under a special legislative session that is intended to focus on jobs creation. Why Governor Scott Walker included these bills under jobs creation is difficult to understand. The bills do not create jobs or help the public in any way.
According to the JSOnline, the online publication from Milwaukee’s Journal Sentinel, Sen. Rich Zipperer (R-City of Pewaukee) submitted the bills in question. He proposes that pharmaceutical and manufacturing companies involved in marketing defective medical devices and drugs should be immune from lawsuits as long as the FDA approved the medical products. He also wishes to put a cap on attorney fees.
Those who support the bills, including the American Legislative Exchange Council (ALEC), say consumers can file lawsuits against doctors, drug companies and medical device manufacturers too easily. Opponents see the tort reform bill for what it is – another way for big corporations and insurance companies to evade justice when they injure patients.
Bills Favor Drug and Medical Device Companies, Put Consumers at Risk
One bill includes a proposal that would grant manufacturers of drugs and medical devices immunity from lawsuits when the drug or device in question was approved by the Food and Drug Administration (FDA). The opposition points to the numerous FDA-approved products that have injured and killed patients. Such a law would be recklessly unfair to injured patients, barring them from compensation.
The FDA’s bias towards approving devices and drugs under manufacturer pressure is well documented. The law would remove the only fallback available for patients who suffer from weaknesses in the FDA approval system. Continue reading