d'Oliveira and Associates

Stryker Initially Ignores FDA Warnings, Then Recalls Hip Implants

tdoliveira@dmlaw.com (d'Oliveira and Associates P.C.) — Fri, 14 Aug 2009 17:16:00 +0000

July 31, 2009

On November 28, 2007, Stryker Corp., one of the world’s leading manufacturers of hip and other joint replacements was given a warning from the Food and Drug Administration (FDA) regarding their manufacturing facility in Mahwah, New Jersey. According to the letter, the FDA conducted an inspection of the facility and found substandard conditions. This marked the second time that the company had been warned about deplorable conditions in their plants. Stryker in a response letter stated that they did not believe that these conditions posed a threat to patients.

The FDA further told Stryker that they had received a number of complaints from patients regarding hip replacement components manufactured at the New Jersey facility. The patients cited implants that did not fit properly leading to problems including pain, difficulty walking, and “squeaky” joints. Others reported that parts of the implant broke off or had been wearing unevenly. Contrary to Stryker’s statements, the FDA letter said that the deficiencies found at the New Jersey plant directly contributed to these defects. The letter also states that Stryker “failed to perform corrective and preventive actions in order to prevent the recurrence of nonconforming product or other quality problems.”

Finally, after numerous warnings and numerous complaints from patients, on January 22, 2008, Stryker recalled two hip implant components made under the company’s Trident line. The recall, surprisingly, was announced in the same letter used to rebut the FDA’s allegations of deplorable conditions at the New Jersey plant. The recall included the Trident Acetabular PSL Cup and the Trident Hemispherical Cups. Stryker says that the recall was implemented amid concerns that the components could be contaminated with “manufacturing residuals” at levels that exceeded company standards.

It is clear that Stryker Corp. had no intention to take the FDA’s warnings seriously. Their failures allowed defective products to be manufactured and these products have caused patients to be injured. How many warnings are required before the FDA steps in and takes action to remove not only defective products from the market, but also rogue companies who think that they make their own rules? A few too many.

Click here for more info on Styker Hip Implants.

Getting Acquainted with ADD/ADHD

tdoliveira@dmlaw.com (d'Oliveira and Associates P.C.) — Fri, 26 Jun 2009 18:39:00 +0000

Everyone knows that parents these days are constantly being bombarded with warnings about new drugs or diseases or disorders to keep an eye out for. One of the most talked about of these disorders in recent years is undoubtedly Attention Deficit Disorder (ADD) or Attention-Deficit/Hyperactivity Disorder (ADHD). I am sure that every parent has had a discussion with his or her child’s pediatrician about ADD/ADHD. Children all around the country are being diagnosed with this disorder and being treated with drugs such as Ritalin, Adderall, and Dexedrine. The number of children and adults being diagnosed with these disorders is so staggering that these medications have become household names. So, what are ADD/ADHD all about? How are they treated? How do I know whether or not my child or I have the disorder? These are among some of the questions we’ll tackle today. NOTE: We are not doctors by any means and this information should not be used as a substitute for a legitimate medial opinion. This information is meant only to be informational.

What is ADD/ADHD?

ADD/ADHD is most common in children and teens, but adults can have it as well. The symptoms may vary in each person, and especially between children and adults. Some of the most common symptoms in children and teens include inattention, hyperactivity and impulsivity. Inattention in most children is noticed first in the school environment. Teachers, parents, and most importantly, the student themselves, often notice difficulty paying attention, making careless errors on schoolwork, being easily distracted, inability to concentrate on conversations, tasks, etc. Hyperactivity is another one of the symptoms of ADHD. Hyperactivity usually manifests itself in various forms and generally before the age of seven. Some examples of hyperactive behavior include fidgeting, squirming, restlessness in teens and climbing all over furniture in young children, always wanting to be busy, etc. The symptoms of hyperactivity vary with age and setting so it is important to note the age and setting of the alleged hyperactive conduct. Impulsivity is yet another of the most common symptoms of ADHD. Impulsivity includes actions such as impatience, blurting out answers before questions are completed, and interrupting conversations as well as initiating them at inappropriate times.

How is ADD diagnosed?

The first and most important step toward a correct diagnosis of ADD is to seek a medical opinion from a licensed psychiatrist. A psychiatrist is trained in various areas including behavioral issues and would be the most knowledgeable resource for a concerned parent or loved one. Although primary care physicians (PCP) are very knowledgeable, they are not specifically trained in this area and it is highly recommended that you see a psychiatrist to diagnose and treat possible ADD. It is also important to mention that because a PCP is often times not familiar with the disorder he/she may experience difficulty in prescribing the correct dosages.
The next step is to monitor your child’s behavior. In order to obtain a diagnosis of ADD, the person must demonstrate the three symptoms listed above in more than one setting. The symptoms can be demonstrated at home and school, home and work, school and work, etc. There must also be evidence that the symptoms interfere with the person’s ability to function in some specific setting. Finally, it must be demonstrated that these are long-term behaviors, generally occurring for at least six months. In sum, it is imperative that the person’s behavior be monitored in more than one setting, that the symptoms are long term, and that the diagnosis is obtained from a licensed psychiatric professional specializing in behavior disorders.

How is ADD Treated?

The good thing about ADD/ADHD is that it is treatable. The most common treatments are drugs classified as stimulants, i.e. Ritalin, Adderall, and Dexedrine. It is believed that these drugs are effective treatments for ADD because they increase dopamine levels in one’s brain. Dopamine is a neurotransmitter that is most frequently associated with motivation, pleasure, attention, and movement. By increasing the levels of dopamine in the brain, it is believed that the drugs boost concentration, decrease hyperactive behavior, and decrease impulsive behaviors. There are a number of side effects that are associated with these stimulant treatments including restlessness, increased irritability, depression, racing heartbeat and various others. The U.S. Food and Drug Administration (FDA) recently warned consumers and doctors that there was a study done that showed an increased risk of sudden death in children due to heart problems associated with ADHD treatments. A later article by the FDA admitted that there were limitations to the study that made it difficult to draw such conclusions from the earlier study. Nonetheless, the FDA highly recommends that anyone who has been diagnosed with ADD/ADHD have a thorough heart examination before being prescribed Ritalin, Adderall or Dexedrine.

In addition to the stimulant drugs, ADD can be treated with non-stimulants including the prescription drug Strattera. Strattera, being an anti-depressant has some benefits, especially for those who also suffer from depression and anxiety. Strattera is not quite as effective as the stimulant drugs in treating the symptoms of hyperactivity, however. Strattera is not without its safety risks. The FDA has confirmed that Strattera has been known to increase suicidal thoughts in some teens. It is important to monitor your child’s behavior when taking these drugs and to notify your physician if there are any odd changes in behavior or if the child complains of things such as shortness of breath, increased heart rate, suppression of appetite, etc.

Some Final Thoughts

In order to maximize the effectiveness of your ADD/ADHD treatment it is important to be informed about the disorder as well as the treatments and their side effects. It is important to know about the medication that you or your child are taking, including correct dosage, possible side effects, and other things to avoid while taking the drug- such as over-the-counter cold medications. It is also important to be patient, finding the correct drug and dosage can be a long process because it is mostly trial and error. For this reason it is important to remain honest and open with your doctor so that he/she can provide you with the best advice possible. Pay close attention to the drug’s effects on the person taking them. It is important to monitor the minor side effects in order to prevent it from becoming a safety risk. Finally, keep open lines of communication among everyone involved, doctors, parents, children, and family members. The more communication there is the better the outcome will be. Always remember that the vast majority of people with these disorders are treated successfully and effective communication is the key to success.

Sun Safety Tips

tdoliveira@dmlaw.com (d'Oliveira and Associates P.C.) — Tue, 28 Apr 2009 17:11:00 +0000

Summer is just around the corner and many of us are excited about the warm weather and sunshine. Because of the long winters and great local beaches, most New Englanders look forward to spending time outdoors in the sunshine. However, without adequate protection, the sun can be very dangerous. Skin cancers, such as melanoma, are a huge concern. According to the Centers for Disease Control and Prevention (CDC) there are 47,000 new cases of melanoma each year. But, melanoma causes 79% of skin cancer deaths. These sobering statistics emphasize the importance of protecting yourself while still enjoying the sun. Some sun safety tips are:

Always wear sunscreen. You should always wear sunscreen, even on cloudy days. It is important that it have an SPF of 15 or higher. Put on sunscreen at least 30 minutes before you plan to be in the sun; this allows time for the sunscreen to be absorbed into your skin. Sunscreen needs to be reapplied every two hours.

Re-apply sunscreen. Sunscreen must be reapplied throughout the day. It is very important to reapply after sweating, swimming or drying off with a towel. All of these activities actually wipe off the sunscreen you have applied.

Check the expiration dates. Sunscreen can expire and usually products have a listed expiration date. If there is not a date listed, you can use the sunscreen for 3 years. The U.S. Food & Drug Administration requires a 3-year effectiveness for sunscreen.
Avoid the sun during the middle of the day. The atmosphere does not absorb as many harmful UV rays during the middle of the day. That is way it is important to avoid the sun between 10a.m. and 4 p.m.

Wear sunglasses and protective clothing. Sunglasses help to shield your eyes from the direct sunlight. A wide-brimmed hat is a great way to protect your face from exposure to sunlight.

Avoid tanning. Having a tan, may look good now, but in the future can lead to wrinkles and age spots. There is not any safe way to tan. A tan is actually your body’s way of telling you the sun has injured your skin.

Be careful of tanning products. If you must tan, be aware of the products you are using. Not all tanning products contain sunscreen. Make sure to check the label. The U.S. Food & Drug Administration (FDA) requires a warning on tanning products that do not contain sunscreen or protect against sunburn.
Spend time in the shade. You can still enjoy the warm weather and sunshine without being directly exposed to the sun.

Carefully monitor your skin. If you notice any growths, bleeding or changes to your skin, it may be early signs of skin cancer. Skin cancer is highly treatable if caught early.

New Recalls Issued

tdoliveira@dmlaw.com (d'Oliveira and Associates P.C.) — Tue, 28 Apr 2009 17:08:00 +0000

On April 22, 2009, the U.S. Consumer Product Safety Commission (CPSC) issued two recalls involving outdoor activities, playground equipment and bicycles. The playground equipment was recalled because lead paint, while the bicycles were recalled because of defective parts.

The playground equipment was manufactured in Turkey, but it was distributed in the U.S. by SportsPlay Equipment Inc. The recalled equipment was sold nationwide, from January 2003 to December 2007. The equipment was recalled because it contained high levels of lead paint. Specifically the handrails and posts on the playgrounds had very high levels of lead. The lead paint on the equipment violates the lead paint ban. The new lead paint ban was passed last year in Congress. The ban was passed in response to the problems with Chinese toys and lead. There are new lead standards in place. Children’s products, such as playground equipment, are not supposed to contain any lead.

According to the CPSC, consumers should immediately stop using the recalled equipment. Owners of the playground equipment should call the CPSC to receive free replacement parts. There were many types of models are equipment recalled. The complete list can be found on the CPSC’s website.

It is very important that consumers stop using the playground equipment immediately, especially children. Children are at an increased risk of developing lead poisoning if they ingest chipping lead paint. Lead poisoning is very dangerous to children and can lead to learning problems, behavioral problems, slowed growth, mental retardation and brain damage.

The other recall focused upon bicycles. The recalled bicycles were manufactured in Taiwan and sold in the U.S. by Specialized Bicycle Components Inc. They were sold throughout the U.S. from September 2003 to August 2004. It is the parts of the bicycle that are defected and the reason for the recall.

The cable stop on the bicycle frame can loosen. When the cable loosens, the bicycle rider can lose control of the bike and fall off. There have been reports of two falls by riders. Both falls were serious, as the riders suffered fractures, which required surgery and other medical attention. Only bicycles with a single rivet attaching the cable stop to the bike frame are recalled. Other bicycles with two rivets are not included in the recall.

The CPSC advises consumers to stop using the bicycles immediately. Bike owners should return the bicycles to Specialized Bicycle Competent Inc. The bicycle will then receive free repairs. More information about both recalls can be found on the CPSC’s website.

Bicycle Safety

tdoliveira@dmlaw.com (d'Oliveira and Associates P.C.) — Mon, 20 Apr 2009 18:32:00 +0000

As the weather is starting to get warmer, people want to spend more time outdoors. Bike riding is a fun outdoor activity for people of all ages. However, bike riding can be dangerous if riders are not safe. According to the U.S. National Highway Traffic Safety Administration, there were nearly 700 died while riding a bike in 2007 and 43,000 bicyclists suffered injuries. There are a few basic safety tips to follow to keep you and your family safe when riding a bike:

Fit the bike to the child. Make sure the child can sit on the seat and balance the bicycle with the balls of both feet touching the ground without leaning to either side.
Measure your child before allowing your child to ride a bike. Measure your child’s inseam to the ground. Then measure the bike, from the top horizontal bar to the ground. The measurement should be 1-2 inches shorter than your child’s inseam. When looking at girl’s bikes, measure where the top bar would be if it were designed as a boy’s bike.
Look at the type of brakes on the bike. Bikes are designed with hand brakes or coaster brakes (stop when pedal backwards). Children under 10 should not use bikes with hand brakes. Only when children are 10 and older are their hands and wrists strong enough to use hand brakes.

Always wear a helmet. Children under the age of 15 are required to wear bicycle helmets in Rhode Island. Massachusetts does not require helmets to be worn, but they are strongly encouraged. However, helmets protect against head injuries. Wearing a helmet can reduce the risk of hear injury by 85%. Helmets should be wore level and low on the forehead, with two-finger widths space between the eyebrows and the helmet.

Measure your child’s head for the helmet. A correct fitting helmet is very important. Measure your child’s head at the forehead to determine what size helmet to purchase. Make sure the Snell Foundation or ANSI approves the helmet.

Always ride on the right side of the road. You should always be riding with the flow of traffic, which is normally on the right side of the road.

Obey all traffic laws, signs, lights and signals. When on the road, bicyclists are subject to the same traffic rules and laws as automobiles. Learning and using the appropriate hand signals is very helpful on the road.

For more Information about Bicycle Safety and Area Bike Paths, check out:

Rhode Island: http://www.dot.state.ri.us/bikeri/

Massachusetts:http://www.mhd.state.ma.us/default.asppgid=content/bikepaths01&sid=about

Volumetric Infusion Pumps Get Class One Recall

tdoliveira@dmlaw.com (d'Oliveira and Associates P.C.) — Fri, 10 Apr 2009 16:30:00 +0000

On March 11, 2009, the U.S. Food & Drug Administration (FDA) issued a Class One Recall for Single and Triple Channel COLLEAGUE Volumetric Infusion Pumps. Baxter Healthcare Corporation manufactures these infusion pumps. This is not the first recall for Baxter’s infusion pumps; it is the 7th recall in the past FOUR years. The FDA has failed at its job to protect the public’s safety. The FDA is allowing this product to remain on the market after seven recalls!

Volumetric infusion pumps are a type of medical device. The pump delivers intravenous medicine and fluids to patients. The drugs and fluids are delivered to the patient in controlled doses through intravenous (the vein), intra-arterial (the heart) or an epidural (through the spine). However, Baxter’s infusion pumps are defective.

On January 23, 2009, Baxter sent an Urgent Device Correction Letter to its users of the infusion pumps. According to the letter from Baxter, there were failure codes in the pumps. This caused the pumps to stop infusing when delivering medication and fluids to patients. In addition, the letter warned of a possibility the pump would overheat. If the pump overheated, this could lead to smoke and fire. These delays or failures to infuse medicine can be deadly. Patients may experience serious injury or even death. That is what a Class One Recall means; it is the most serious recall the FDA can order. In ordering a Class One Recall, there is a “reasonable probability that use of the product will cause serious injury or death.” This most recent recall pertains to several model types: Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161 and 2M9163.

What’s worse, the FDA has known about the problems with Baxter’s pumps for years. In July 2005, the FDA issued its first of seven recalls for Baxter Volumetric Infusion Pumps. The July 2005 recall involved a WORLD-WIDE recall of ALL models. The infusion pumps shut down while they were delivering medication to patients. As a result, the pump failure caused six serious injuries and three deaths. There were two more Class One recalls in September and December 2005. Not to mention, the THREE recalls in 2007. With the most recall, that makes seven recalls in less than four years.

Even knowing all of this information, the FDA waited nearly two months before issuing the current recall. Baxter sent the letter to customers on January 23rd, but it took the FDA until March 11th to issue a formal Class One Recall. Why did the FDA wait so long? People’s lives are at stake. Since 2005, Baxter has not sold the infusion pumps in the U.S. However, that does not mean pumps are not still being used. It is estimated that 200,000 pumps are currently in use in the United States, at hospitals and clinics. Patients are obviously still been affected these pumps. There have been at least 16 more deaths reported because of Baxter’s pumps, since the initial 2005 recall.

Why has the FDA not done more? The FDA needs to order hospitals to discontinue use of Baxter infusion pumps. Obviously Baxter will not do it. Even in their letter to users, Baxter did not mention recalling their pumps. Instead, Baxter advised users on how to replace their defective pumps. The FDA has failed the public by allowing seven recalls to occur. What more reasons does the FDA need to act? Seven recalls and nearly 20 deaths should be enough to make the FDA do its job.

U.S. Supreme Court Decision Favors Consumers

tdoliveira@dmlaw.com (d'Oliveira and Associates P.C.) — Fri, 10 Apr 2009 13:30:00 +0000

The U.S. Food & Drug Administration (FDA) recently gave a Black Box Warning the drug Reglan. This warning is needed because of the serious risks caused by Reglan.

Chronic use of Reglan causes a neurological disorder called tardive dyskinesia. This disorder is characterized by Parkinson-like symptoms. Patients suffer from repetitive and involuntary movements throughout their body. These symptoms are often irreversible. In addition, there is no treatment for tardive dyskinesia; people will suffer with these symptoms for the rest of the lives. In addition, Reglan can actually mask symptoms of tardive dyskinesia. The active drug in Reglan, metoclopramide, suppresses symptoms of tardive dyskinesia.

The FDA knows people are taking Reglan too long. Anything beyond three months is considered chronic use. The FDA knows these people are at risk for developing tardive dyskinesia. According to a study data from the FDA, over 20% of patients take Reglan for more than three months. In addition, two studies have shown that nearly 30% of patients who take Reglan for over a year develop tardive dyskinesia. These patients will constantly suffer from involuntary movements of their face, mouth, jaw, tongue, eyes, neck, shoulders, torso, larynx, diaphragm, arms, legs, feet, and hands. Clearly patients are not being made aware of the dangers of long term use. The FDA is not doing enough to warn patients about the risks of developing tardive dyskensia. In addition, the FDA has reports of people developing tardive dyskensia even though they took Reglan for less than three months.

Reglan is prescribed to treat gastroesophageal refleux, gastroesophageal relflux disease and diabetic gastroparesis. Older, female patients are at a high risk of developing tardive dyskinesia. However, children and infants have a greater risk of developing tardive dyskinesia than adults. Children and infants will also have to suffer from the symptoms of tardive dyskinesia for their entire lives.

The FDA is failing the public by not putting the Black Box Warning on Reglan sooner. The FDA also needs to make it clear that Reglan should only be used as a drug of last resort, meaning if all other treatments have failed. Because of the risk of developing an irreversible disorder, the FDA has to be better about warning the public of the dangers associated with Reglan. Patients should know the risk that taking a drug to treat acid reflux can lead to neurological disorders.

CPSC Requires New Phthalates and Lead Guidelines

tdoliveira@dmlaw.com (d'Oliveira and Associates P.C.) — Mon, 23 Feb 2009 18:22:00 +0000

Beginning on February 10, 2009, the U.S. Consumer Product Safety Commission (CPSC) issued new requirements for child products. The guidelines are necessary in order to comply with the New Child Safety Law. The guidelines apply to children’s toys, childcare articles and consumer products intended for children. The new guidelines apply to phthalate and lead levels. Phthalates are chemicals used to make vinyl and plastics soft and flexible. It is because of these qualities, that phthalates are used to make toys.

The new phthalate requirements apply to six different types of phthalates (DEHP, DBP, BBP, DINP, DIDP and DnOP). Children’s toys and childcare articles cannot contain any more than 0.1% of any of these six phthalates. According to the CPSC, a children’s toy is defined as “a product intended for a child 12 years or younger to use when playing.” However, bigger items, such as bikes, playground equipment and musical instruments are exempt. Childcare articles are defined as products that a child three years and younger would use for sleeping (ex: blanket), feeding (ex: cup), teething (ex: teething ring) and sucking (ex: pacifier).

As a result of the new requirements, companies have a reporting obligation under federal law. Companies must tell the CPSC if they know of any toy or childcare article that exceeds the new phthalate requirements. The new requirements also apply to all toys and childcare articles regardless of when they were manufactured, meaning these new requirements apply to toys currently on the market, not just those made after February 10th.

Also beginning on February 10th new lead guidelines will be implemented. The guidelines apply to consumer products intended for children who are twelve years or younger. Lead is often found in the paint of children’s toys. None of the consumer products for children can have more than 600 parts per million of lead.

However, these new guidelines do not apply to all products. The CPSC will issue alternative lead limits for some electronic devices. In addition, on January 30, 2009, the CPSC approved a one-year stay on the enforcement of testing for these new guidelines. Manufacturers and importers do not have to comply with certain certification and testing requirements on their products for another year. Manufacturers will not be required to complete testing, but they will still be required to meet lead and phthalate limits along with other mandatory toy standards. Testing is required for painted products and in the future it will be required for metal jewelry. Companies still have a reporting obligation to inform the CPSC if they learn of any products for children, which exceed the lead limits.

Court Decision: Vaccines Don’t Cause Autism

tdoliveira@dmlaw.com (d'Oliveira and Associates P.C.) — Mon, 23 Feb 2009 18:19:00 +0000

On February 12, 2009, a special court ruled that vaccines do not cause autism in children. The court began hearing three types of autism related cases in 2007. The ruling today concerned only one type of cases, the allegation that autism was caused by the Measles, Mumps and Rubella (MMR) vaccine and other vaccines containing thimerosal, which contains mercury. With these types of cases, the court found there was no association or causal link between vaccines and autism. The court has yet to rule on the other two types of cases: autism caused by the MMR vaccine alone and autism called by thimerosal containing vaccines alone. The parents of autistic children filed petitions with the Vaccine Injury Compensation Program (VICP) seeking compensation, which led to the special court hearing.

Understandably, both the medical and scientific communities are anxious to find what exactly causes autism. Autism is a very complicated developmental and neurological disorder. Autism affects the brain, which leads to abnormal communication skills and social interactions. Autism is one of five disorders, collectively called PDD (pervasive developmental disorders). The other disorders include Asperger’s, Childhood Disintegrative Disorder (CDD) and Rett’s Disorder.

Autism is the most common PDD disorder and affects roughly 1.5 million people. According to recent statistics, the number of people with some form of autism is rising. In Rhode Island public school’s the number of autistic children increased by 1,500 from 1992 to 2002. Current statistics from the Centers for Disease Control and Prevention found that 1 out of 150 babies are born with some form of autism. In addition, the rate of autism is much higher for males, than females. Boys are four times more likely to be autistic than girls.

The debate over the cause of autism has been raging for some time. There is not any single known cause of autism. Potential causes suggested by scientists, medical professionals and parents include genetics, medical problems, pregnancy problems, environmental factors and toxins and vaccines. There is a lack of consensus among scientists and medical professionals as to the potential causes of autism. Although the special court determined vaccines do not cause autism, it is unclear whether others will agree with their decision.

Peanut Corporation of America Knew about Contaminated Products

tdoliveira@dmlaw.com (d'Oliveira and Associates P.C.) — Sat, 31 Jan 2009 16:19:00 +0000

Peanut Corporation of America (PCA) is expanding the scope of its peanut butter and peanut products recall. Their recall initially included products produced at its Blakely, Georgia plant since August 1, 2008. Now the recall is for all products produced at the Georgia plant since January 1, 2007. PCA is recalling two years worth of peanuts and peanut products. The number of recalled products has also expanded to include all peanuts (dry and oil roasted), granulated peanuts, peanut meal, peanut butter and peanut paste. Pet food is also included in this new expanded recall. Some of PCA’s peanut products are used in the manufacturing of pet food.

These additional recalls are all the result of a salmonella outbreak, that PCA KNEW about and did NOTHING to prevent. Over 500 people have fallen ill from salmonella caused by tainted PCA products. Eight people have died as a result. Salmonella is a very serious infection and it can be fatal. Even pet food infected with salmonella can be dangerous if people do not thoroughly wash their hands after handling pet treats. Pets can also suffer from salmonella infections caused by contaminated pet food.

The worst part about all of this is PCA knew about the risk of salmonella. According to the U.S. Food & Drug Administration (FDA), PCA’s own tests found strains of salmonella 12 different times in 2007 and 2008 at their Georgia plant. PCA failed to properly respond to the discovery of salmonella. Instead PCA “lab shopped,” meaning it had the infected products re-tested at a different lab. The second test found the products were negative for salmonella and then the company shipped them out. PCA knew salmonella contaminated these products and yet they did nothing. Proper procedure dictates once salmonella is discovered, the entire lot is supposed to be destroyed, not shipped out for consumption. In addition, PCA never took any steps to clean their facility or other measure to prevent cross-contamination once they discovered the salmonella.

These problems have been ongoing at PCA and STILL were not rectified when the FDA inspected the Georgia plant in the month of January. According to the FDA testing, it found salmonella in peanut butter paste, peanut meal, peanut butter, peanut granules and oil-roasted, salted peanuts. But salmonella was not the only problems found at PCA’s plant. The FDA also found roaches near the production and packaging areas. PCA’s ventilation system was also inadequate to prevent salmonella contamination in other parts of the plant. PCA’s actions are deplorable. They knew about the salmonella contamination of their products but sent them to consumers anyway. Because of PCA, eight people have died and over 500 have gotten sick. These numbers will rise as more products get recalled. The FDA is still investigating PCA and more horror stories are likely to appear. Click here for more info.

RI Office of Food Protection

tdoliveira@dmlaw.com (d'Oliveira and Associates P.C.) — Fri, 16 Jan 2009 15:25:00 +0000

Health Department food safety inspection reports completed since January 2007 are available online for all retail establishments including restaurants, markets and health care facilities. These reports consist of all inspection types including routine and reinspections, illness investigations and preoperational inspections.
http://www.health.ri.gov/environment/food/inspections.php

Childproofing Your Home

tdoliveira@dmlaw.com (d'Oliveira and Associates P.C.) — Fri, 16 Jan 2009 14:48:00 +0000

Childproofing your home is a key step in protecting your children from harm. It is important to childproof your home multiple times. First before your child is born, again once the child is crawling and also once your child is walking. The best way to childproof your home is to get down on your hands and knees so you can see everything from your child’s height. This will help you find hazards you might have otherwise missed. The best way to protect your child is with adult supervision. However, these helpful childproofing tips will keep your children safe and happy inside your home:

Kitchen:

1. Stoves & Ovens – risk of child turning on the burners or knobs. Children can also open ovens and crawl inside and suffocate.

Childproofing Tip: Install locking latches on stoves and ovens. Install knob covers to prevent children from accessing knobs. Have a stove guard to protect their hands.

2. Dishwashers – risk of child cutting themselves on any knives, cups, glassware or items in the dishwasher. Children can also open dishwashers and crawl inside and suffocate.

Childproofing Tip: Install locking latch.

3. Refrigerator – risk of choking hazard from any food inside the refrigerator. Children can also open the refrigerator and crawl inside and suffocate.

Childproofing Tip: Install locking latch.

4. Cabinets & Drawers – risk of children having access to knives, sharp objects, cleaning supplies, chemicals, poisons and medications, which create a choking hazard.

Childproofing Tip: Install locking latches. Remove all poisons, chemicals and cleaning supplies from any cabinets your children may have access to and keep them locked away and out of reach.

Living Room:
1. Plants – risk of children ingesting plants, some of which can cause illness or death. Potting soil, rocks, marbles or other materials can cause choking hazards.

Childproofing Tip: Do not use any rocks or marbles in your plants. Do not keep any poisonous plants inside your home. Make sure you are aware of the types of plants inside your home and label them accordingly.

2. Decorative Knick-Knacks – risk of children receiving cuts from broken glass, china or other fragile materials.

Childproofing Tip: Keep all breakable decorations out of the reach of your children. The best thing is to remove such items until your children are older.

3. Coffee Tables & End Tables – risk of children injuring themselves on sharp corners.

Childproofing Tip: Install table cushions on each corner of the table. There are table cushions to go around all edges of the table.

Around the House:

1. Stairs – risk of children suffering injuries from falls.

Childproofing Tip: Place child safety gates at the top and bottom of stairs.

2. Smoke Detectors – risk of burns, severe injury and death.

Childproofing Tip: Install smoke detectors in each bedroom and every floor of your home. Children and babies are most at risk because they cannot escape fire themselves.

3. Carbon Monoxide Detectors- risk of carbon monoxide poisoning, which can cause memory loss, learning disabilities and neurological problems. Expecting mothers can experience miscarriages or stillbirths.

Childproofing Tip: Install carbon monoxide detectors.
4. Water Heaters – risk of burns and death.

Childproofing Tip: Keep your water heater’s thermostat at 120 degrees or below. Test bathwater before putting your child in the bathtub.

5. Electrical Outlets- risk of electrocution.

Childproofing Tip: Place outlet covers or tamper-resistant outlet covers on all electrical outlets.

6. Electrical Cords – risk of injury from pulling cords and having heavy items fall on children. Teething children may also chew on the cords and be electrocuted.

Childproofing Tips: Install cord bundlers and secure cords to prevent pulling. Install cord shorteners.

7. Doors – risk of injury to children’s fingers. Children may also be injured if they are able to gain access to the outside or closed off areas of your house.

Childproofing Tip: Place safety covers on the doors to prevent your child from opening the door. Install doorstops.

8. Windows - risk of injury from falls.

Childproofing Tip: Lock your windows. Remove any furniture or anything your child could climb on to reach the window. You may want to install window guards.

9. Toilets – risk of injury and drowning if a child falls in and cannot get out.

Childproofing Tip: Install a toilet lid lock. Never leave children in the bathroom alone.

10. Floors- risk of injury from falling on carpet, uneven surfaces and slippery floors. There is also a risk of choking from items dropped on the floor.

Childproofing Tip: Keep floors clean by vacuuming and sweeping. Pick up any dropped items or food immediately. Keep any pet food out of the reach of children.

Drinking & Driving a Devastating Combination

tdoliveira@dmlaw.com (d'Oliveira and Associates P.C.) — Mon, 22 Dec 2008 15:51:00 +0000

Here we are in the midst of the hustle and bustle of the holiday season. Unfortunately, for some it is a very sad time of year because their loved ones have been involved in some type of alcohol-related accident. Whether the innocent victim or the careless driver the consequences of drunk driving can be devastating. It is estimated that as many as 3 out of every 10 Americans will be involved in an alcohol-related crash at some time in their lives. Make the decision now to be responsible. Do not drive a vehicle under the influence of alcohol and do not assume the risk of letting someone intoxicated drive you. Drink responsibility the life you save may be your own!

Click on the link below and gauge your knowledge about other drinking and driving facts.

Holiday Driving Safety Quiz

Snow blower Safety Tips

tdoliveira@dmlaw.com (d'Oliveira and Associates P.C.) — Fri, 12 Dec 2008 19:01:00 +0000

Snow blowers are a great tool to help clean up driveways and sidewalks. They are helpful to maintain your property and are much faster than the traditional shovel. But remember, snow blowers are still machines and must be handled with care. Snow blowers can cause serious injuries including cuts, burns, broken bones and loss of fingers and toes. According to the Consumer Products Safety Commission more than 1,000 amputations and 5,000 hospital emergency room injuries are the result of snow blowers each year. Snow blower accidents are the fourth leading cause of finger amputations. These helpful tips can reduce your risk of injury.

Always read the owner’s manual and all safety tips before using your snow blower. Make sure your snow blower is properly maintained.
Keep the gas tank full. Always add gasoline before starting the snow blower. Do not add gasoline to a hot or running engine.
Plan a route before you start.
Clear the area of any objects or other items, which could clog the snow blower chute.
Never put your hands inside the snow blower chute. If the chute becomes clogged for any reason, turn the snow blower off. Then use a stick to help clear out the chute.
Keep young children and pets inside while operating the snow blower.
Keep your hands and feet out of the way of moving parts.
Dress appropriately for the weather. Be sure to have the proper footwear to avoid slipping on the snow, ice or other surfaces. Wear protective eyewear. Avoid wearing loose clothing or anything that could get tangled in the snow blower.
Do not rush while using a snow blower. Walk carefully and keep both hands on the handles. Utilize the “dead-man” controls, which will only operate the snow blower if the lever is being pushed.
Never leave the snow blower running unattended. Always turn the machine off when it is not in use. Never leave the machine running in a garage or other enclosed area.
If you have an electric snow blower, be mindful of the electric cord and keep it away from moving parts.
Always use extreme caution when changing directions on slopes.
Shut off the snow blower and remove the spark plug wire before making any repairs.

To Do List Before Winter Driving

tdoliveira@dmlaw.com (d'Oliveira and Associates P.C.) — Fri, 05 Dec 2008 19:32:00 +0000

Winter is fast approaching. Winter means driving in less than perfect conditions, with snow, sleet and ice. Winter driving can be dangerous. Almost 70% of deaths that occur during the winter months are the result of car accidents. These accidents are caused by snow and ice. Helpful information, including these tips can improve your winter driving experience. It is important to review this before the snow begins to fall.

1. Inspect your tires.

You should replace any tires that look worn out. Special snow tires or chains for your tires may be necessary. Snow tires are studded or have treads that are designed to grip the snow and ice. Even if your tires do not need replacing, check the tire pressure. Underinflated tires can interfere with the car’s handling on the road.

2. Check your car’s cooling system.

Cold can make rubber brittle. This can cause cracking or leaking in parts of the car. Radiator and heater hoses are especially at risk. If the hoses are brittle or feel too soft, replace them. It is also important to flush out your car’s cooling system every 2 years. The system should be filled with a mixture of antifreeze and water to prevent the coolant from freezing in cold temperatures.

3. Keep your gas tank full.

It is important to keep the gas tank at least half full during the wintertime. This will help keep the gas from freezing.

4. Test your car battery.

Check your car battery to determine its charge. You should test your car battery if it is over two years old or if you live in a colder climate.

5. Pack your trunk with necessary tools.

It is always important to have useful items in your car in case of an emergency. Be sure to have a shovel to dig the car out of the snow. A bag of cat litter is helpful to provide traction on snow and ice. If case your car breaks down, you should have a winter hat, gloves and blanket in your car to keep warm. Remember, the heat will not be working and you need to keep warm until help arrives.

6. Always clean off your car.

Purchase an ice scraper and snow brush to clean off your car. Wipe off your headlights too. It is necessary to ensure you have maximum visibility when driving in the winter.

Tips for Winter Driving

1. Allow for longer time when braking.

The roads are wet and slippery and your car will take longer to brake in snow than other conditions. It is also important to put less pressure on the brake pedal.

2. Drive at a slower speed.

3. When increasing your speed, do it slowly.

4. Do not lock the wheel when braking.

Locking the wheels can cause the car to slide. If your car has an anti-lock brake system, then press on the brake and hold it down. If your car does not have anti-lock brakes, apply the brakes repeatedly to prevent the wheels from locking.

5. Try to avoid any sudden action when making turns.

6. How to correct a slide or skid.

If the back part of your car begins to slide, let off on the accelerator and turn your steering wheel in the direction of the slide. If the front part of your car begins to slide, let off on the accelerator and turn in the direction you want to go. Both of these tips should help to straighten out your car.

7. Don’t think you are automatically safer because your car has all wheel drive or four-wheel drive.

Buying Safe Toys

tdoliveira@dmlaw.com (d'Oliveira and Associates P.C.) — Fri, 05 Dec 2008 19:27:00 +0000

All parents want to make sure their children are safe and protected. However, not all parents may realize the dangers associated with some toys. Unfortunately each year children are injured or killed because of toys. The most common causes of death are from choking or asphyxia. According to the Consumer Product Safety Commission, in 2003, 11 children died from toy related causes and 206,500 were injured. The majority of toys are extremely safe for children. But, it is important to learn these beneficial tips in purchasing safe toys for your children this holiday season. These tragic incidents can be avoided. These tips can help make your holiday safe and happy.

1. Follow the age standard listed on the toy packaging.

It is important to only buy toys, which correspond to your child’s age. The age standards are there for protection, meaning the toys are only safe for child that age or older. It is unsafe to give a three-year-old child a toy designated for a four-year-old child.

2. Check for any small parts or pieces that can be removed or bitten off from the toy.

Children chew toys and put toys in their mouth. It is dangerous if they bite off a piece of the toy and swallow it. There is a risk of choking. The best test to determine if pieces are too small is the toilet paper roll test. If the pieces fit through the tube opening, they are too small to give to a child who is younger than three years old.

3. Check for any cords, strings or anything that dangles, which is longer than 6 inches.

Children can wrap themselves around cords and strings and there is a risk of strangulation. If the string can be removed, the danger is removed and you can still purchase the toy.

4. Make sure the paint or finish on the toy does not contain any lead and is non-toxic.

Toys with an ACMI (Art and Creative Material Institute Inc) symbol mean the toy is non-toxic. Be sure to check the Consumer Products Safety Commission website to find out any toys, which were recalled due to lead. Exposure to lead, including lead poisoning can lead to slowed development in your child and other problems.

5. Be careful about magnets and magnetic toys.

Not all magnets are dangerous. However, some toys containing very strong and powerful magnets known as “rare earth magnets.” If ingested, these magnets can cause serious intestinal injuries. Do not give magnets to children under the age of three.

6. Check the stability of ride on toys.

Toys like tricycles, bicycles, rocking horses and other ride on toys need to be stable and well built to make sure they can hold your child. Make sure the toy can handle your child’s weight and it safe for your child to move around on.

7. Avoid toys with any sharp edges, points or fragile parts.

Fragile parts can break while your child is playing with the toy, causing cuts, scratches and bleeding.

8. Avoid any shooting toys, toys with projectiles or throwing toys.

They can cause serious injuries, specifically to the face and eyes.

9. Check the Consumer Products Safety Commission website for recent recalls for any reason.

Keeping Your Children Safe Once Toys Are At Home

Purchasing safe toys is only part of the process to protect your children’s safety. Parents can take additional steps once they get home from the store to make sure your child can play, but play safely.

1. Read and keep all instructions and directions for the toys use. Take careful note for any instructions on what NOT to do with the toy.

2. Use any safe gear, like helmets, kneepads and elbow pads if they are recommended when using the toy.

3. Throw out any packaging, bags or other unnecessary wrapping, which come with the toy.

4. If any of the toys are battery operated, put the batteries in yourself and keep them out of the hands of your children.

5. Store each child’s toys separately when you have more than one child. Some toys, which are fine for older children to use, are not safe for younger children.

6. Look over any toys given to your child that you did not personally buy, to make sure they are safe before letting your child play with them.

7. Check the condition of your child’s toys periodically. If toys can be repaired, be sure to fix them immediately. If not, throw the toy out.

8. If your children are old enough to understand, make sure to warn them about putting toys in their mouth, chewing toys or putting toys up their nose.

9. Supervise your children when they are playing with the toys.
If you think you purchased a toy that has been recalled, remove it from your child immediately. Check the Consumer Products Safety Commission or the toy manufacturer’s website to find out more information about the recall click here.

Asbestos: Why Won’t the Federal Government Do More?

tdoliveira@dmlaw.com (d'Oliveira and Associates P.C.) — Fri, 05 Dec 2008 18:08:00 +0000

Asbestos causes serious diseases and death. Although people have likely heard of asbestos and the diseases it causes, like mesothelioma, they may not be aware of all its dangers. Asbestos is an on-going problem, which will continue to inflict pain and suffering until its use in products is prohibited.

Asbestos is a naturally occurring mineral, which forms fibers. There are three types of asbestos found throughout the world. It is used in building materials, such as insulation. Millions of tons of asbestos have been used in industrial sites, homes, mills, factories, schools, shipyards and commercial buildings. Asbestos fibers are inhaled through the air. Most people are exposed while working and never know it. Even family members of workers may be affected as asbestos fibers can be transported on clothing. The dangerous side effects of asbestos has been known for years. In the early 1900's, doctors were beginning to notice the connections between asbestos dust inhalation and the death of industrial workers. By now, the evidence is undisputed about the dangers of asbestos. It has been linked to many devastating illnesses.

Asbestosis is a benign, non-cancerous disease caused by asbestos. The fibers of the asbestos are inhaled through the air and cause irritation to lung tissue. The asbestos fibers cause scarring and inflammation of the lungs. This can lead to breathing difficulties, including respiratory failure. Unfortunately asbestosis can also lead to mesothelioma and lung cancer. Other complications include tuberculosis, inflammation of the tissue lining the lungs (pleurisy) and heart failure.

Mesothelioma is a cancer caused by asbestos exposure. Mesothelioma has a latency period of 20-50 years, meaning you could be exposed to asbestos in 1960 and could still develop cancer in 2010. Due to this extremely long time period, it is estimated there will be roughly 250,000 cases of mesothelioma before 2020. Mesothelioma can be treated with surgery, which involves the removal of the cancer, chemotherapy or radiation. Mesothelioma is an unusual cancer because it is not caused by cigarette smoking, but caused by asbestos exposure. Asbestos exposure has also be linked to other cancers including: larynx cancer, upper throat cancer, kidney cancer, esophageal cancer and cancer of the gall bladder.

Asbestos exposure can also cause problems in the lungs, lung cancer and pleural disease. The latency period for lung cancer is between 20-30 years. It has been shown that cigarette smokers who are exposed to asbestos are more likely to develop lung cancer than a person who is either a cigarette smoker or exposed to asbestos. Pleural lung disease is caused by asbestos exposure affecting the lining of the lungs. The asbestos fibers cause scarring of the lungs and pleural calcification. Pleural calcification is calcium deposits in the areas of the lung where there was damage. The lining of the lung can also thicken and affect the ability of the lung to expand, which impairs breathing.

Even knowing all of the dangers associated with asbestos and how people are exposed, the federal government has not done enough to lower exposure levels. In 1989, the U.S. Environmental Protection Agency (EPA) did pass an Asbestos Ban & Phase Out Rule. The rule banned most asbestos containing products. But only two years later, the rule was overturned in a courtroom proceeding. However, there has been some success. Some asbestos containing products are banned: roll board, flooring felt and corrugated, commercial and specialty paper. Any new products, those that did not historically contain asbestos, are also banned.

But why hasn’t the government done more? Current estimates the cost of asbestos litigation in the U.S. is $250 billion. Even the financial cost, much less the human cost has not prompted a complete asbestos ban. Asbestos containing materials are still being used in the United States. The U.S. Occupational Safety and Health Administration (OSHA) has established a permissible asbestos exposure level for workers and other safety measures to reduce exposure, such as protective clothing, labeling and record keeping of exposure. Nevertheless, with new advances in technology, it seems we could find an asbestos substitute that doesn’t have these dangerous side effects. We have known about the dangerous of asbestos for almost 100 years, what does it take for the government to realize a complete asbestos ban is necessary to protect the health and safety of U.S. workers?

Safety Tips for Home Heating & Space Heaters

tdoliveira@dmlaw.com (d'Oliveira and Associates P.C.) — Fri, 05 Dec 2008 16:53:00 +0000

Home heating equipment, particularly space heaters are the one of the leading causes of home fires. Almost 50% of home heating equipment fires occur during December, January and February. Heaters cause over 60,000 home fires per year resulting in 670 deaths, 1,500 injuries and over $900 million dollars in property damage. Space heaters specifically account for one third of all home heating fires and nearly three fourths of deaths. Some people use space heaters as their primary heating source. However, space heaters are not meant to be used that way. In addition, other attempts to heat homes with generators or stoves can cause dangerous problems. They emit carbon monoxide or CO, which is a colorless, odorless and tasteless gas. CO is toxic and the leading cause of accidental poisoning deaths. Following these few tips can help ensure you are both warm and safe during the wintertime.

1. Keep anything that can burn at least three feet away from heating equipment, such as the furnace, fireplace, wood stove, or portable heater.

2. Only use heating equipment that has the label of a recognized testing laboratory.

3. Never use your oven for heating.

4. Have a qualified professional install stationary space heating equipment, water heaters or central heating equipment according to the local codes and manufacturer’s instructions.

5. Maintain heating equipment and chimneys by having them cleaned and inspected annually by a qualified professional.

6. Turn portable heaters off when leaving the room or going to bed.

7. For fuel burning space heaters, always use the proper fuel as specified by the manufacturer.

8. Make sure the fireplace has a sturdy screen to prevent sparks from flying into the room and burn only dry, seasoned wood. Allow ashes to cool before disposing in a metal container, which is kept a safe distance from the home.

9. For wood burning stoves, install chimney connectors and chimneys following manufacturer’s instructions or have a professional to the installation.

10. Make sure all fuel-burning equipment is vented to the outside to avoid carbon
monoxide poisoning.

11. Install and maintain carbon monoxide (CO) alarms to avoid the risk of CO poisoning.

12. If you smell gas in your gas heater, do not attempt to light the appliance. Turn off all the controls and open doors and windows. Call a gas service person.

13. Test smoke alarms at least monthly.

Holiday Safety Tips

tdoliveira@dmlaw.com (d'Oliveira and Associates P.C.) — Mon, 24 Nov 2008 15:51:00 +0000

The holiday season is almost here and many people celebrate with trees and decorations which may cause fires. It is important to make sure your holiday celebrations are not destroyed by any mishaps. Sadly tree related fires are more common than people think. Each year tree fires cause devasting results, 40 fatalities, 250 injuries and $80 million in damages. The U.S. Fire Administration estimates between December 1st-14th there are an average of one Christmas tree fire per day. That risk doubles to almost eight Christmas tree fires per day between December 15th-January 1st. Usually electrical light shorts and candles are the main cause of Christmas tree fires. Tree fires spread very quickly, in less than a minute; the entire tree can be engulfed with flames and start spreading to other parts of the room. Fires caused by open flame candles are another concern. Roughly 13,000 house fires are caused each year by candles, which result in nearly 200 deaths. These tragic incidents can be avoided. These tips can help make your holiday safe and happy.

Trees:

1. When buying an artificial tree, make sure the label says it is fire resistant.

2. When buying a live tree, look for a fresh tree.

A fresh tree is green and the needles are hard to pull off. When you shake the tree on
the ground, only a few needles should fall off. Check the bottom of the tree to make sure the tree has resin. Be sure to cut off a few inches of the tree’s trunk before setting it up. This helps to prevent the tree from drying out and becoming a fire hazard.

3. Be careful to set up the tree away from any heaters, fireplaces or other sources of heat. Do not put the tree in front of any doorways.

4. Make sure the tree is secure and stable to prevent it from tipping or falling over.

5. If you have a live tree, water it frequently.

Water keeps the tree from drying out and becoming a fire hazard. Cutting the tree’s
trunk makes it easier for the tree to absorb water. A wet tree is a safe tree.

6. Keep candles and other flammable materials away from the tree.

Tree Decorations & Holiday Decorations:

1. Do not decorate the tree with any flammable or combustible materials.

2. Keep fragile or sharp ornaments out of the reach of children.

3. Avoid using any ornaments or decorations, which children might think are eatable.

4. Avoid using tinsel or ribbons around small children.

5. Make sure any tree lights have a UL listed tag.

6. Do not use any light strings with broken sockets, loose connections or frayed wires.

7. Replace any missing or broken light bulbs.

8. Turn off the tree lights when going to bed or leaving the house.

9. Never use an extension cord to hold more than three strands of lights.

10. Keep poinsettias away from pets, as they can be poisonous.

11. Keep fragile decorations out of the reach of children.

12. Keep candles out of the reach of children and never leave a burning candle unattended.

Fireplaces:

1. Before lighting a fire, make sure the flue is open and the chimney has been cleaned.

2. Remove all decorations on the fireplace mantel and decorations around the fireplace.

3. Be sure to place a protective screen in front of the fire.

4. Instruct children to stay away from the fire and do not leave children unattended near the fireplace.

5. Do not burn wrapping paper.

6. Remove any combustible or flammable materials near the fireplace.

Hanging Outside Holiday Lights Tips

Hanging lights outdoors can be dangerous. According to the Consumer Product Safety Commission there are over 180,000 ladder related emergency room visits each year. There are also 150 deaths reported as a result of ladder accidents. It is always important to use a ladder and have another person to help you hang lights. Never hang lights if there is a strong wind or rain. Most ladders are metal and can conduct electricity. Follow these tips to safely hang outdoor lights.

1. Check the label on the lights; make sure they are designated for outside use.

2. Outside lights are usually only good for about 90 days, so discard outside lights after three seasons.

3. Discard any light strings and extension cords if broken bulbs, frayed wires or loose connections.

4. Check your ladder for any problems before using it.

5. Make sure your ladder is on a firm stable surface.

6. Only use your ladder for its designated purposes.

7. Do not reach more than 12 inches off the ladder.

8. Never move the ladder while still standing on it.

9. Keep both feet on the ladder. When moving up and down the ladder be sure to face it at all time. Never step above the topmost-labeled step.