Build-A-Bear Recalls Approximately 300,000 Teddy Bears

December 29, 2011, by Ronald V. Miller, Jr.
Build-A-Bear Recall Affects Approximately 300,000 Bears

The Build-A-Bear Workshop company is recalling almost 300,000 Colorful Hearts Teddy Bears due to risks of choking.

While no injuries have been reported, the U.S. Consumer Product Safety Commission is warning that it is possible for the teddy bear's eyes to loosen and fall out, posing a choking hazard to children.

Consumers are being instructed to immediately take the recalled teddy bear from children and return it to any Build-A-Bear store to receive a coupon for any available stuffed animal from Build-A-Bear.

The Chinese-made toy is a stuffed animal, approximately 16" tall with black plastic eyes. The toy sold at Build-A-Bear Workshops and through the firm's website from April through December for approximately $18.

Third Child Illness With No Connection to Enfamil

December 29, 2011, by Ronald V. Miller, Jr.

Sadly, a third infant has been hospitalized after testing positive for the Cronobacter bacteria that killed a newborn in Missouri last week. Reports of that infant's death prompted Wal-Mart to remove Enfamil from their store shelves, despite Mead Johnson's assurances that their Enfamil products were safe.

The most recent illness, a baby from Oklahoma, was given a different brand of formula than used in two previously reported cases of the infection. Mead Johnson Nutrition Co., the world’s leading seller of children’s formula, said that its tests showed no bacteria in a batch of formula used by the Missouri baby who died. Wal-Mart Stores has said that it will wait for the government results before deciding whether to return Mead Johnson’s formula to its shelves. In addition to Wal-Mart, Kroger Co. and Walgreen Co. pulled a batch of Mead Johnson’s formula after the Missouri baby’s death was disclosed.

The second case involved an Illinois baby who fell sick in Missouri during a trip, officials have said. Public health officials are checking to see if the bacteria in the infections have the same genetic fingerprint. If they do, that may suggest they came from the same source. Investigations are continuing.


Stryker Brain Stent Recall Sought

December 28, 2011, by Ronald V. Miller, Jr.

The consumer group Public Citizen has asked for a Stryker brain stent recall as the evidence grows that it causes heightened risk of stroke and death. Public Citizen is calling for the recall because it believes that the Stryker brain stents are doing more harm than good because "combined with aggressive medical treatment, they provide no additional benefit but cause significantly more harm than safer aggressive medical treatment alone."

Public Citizen carries with them a heavy hitter, former FDA medical device director Larry Kessler who also agrees that the FDA needs to pull these brain stents off the market and revoke their 510(k) backdoor clearance.

These Stryker brain stents are used by cardiac surgeons to open blocked arteries. Designed to prevent stroke and death, they may actually increase the risk of stroke and death. A New England Journal of Medicine study found that patients who got brain stents were found to have twice the rate of strokes and death compared to those without brain stents.

These brain stents got in through a backdoor. This stent, called the Wingspan system, cleared under the FDA's humanitarian device exemption pathway in 2005.

Let's forget for a second whether the 510(k) is an awful idea in general or even in this case. Should these brain stents be recalled? That is what matters now. Unless there is some incredible evidence to contradict this "twice the risk" data, let's pull these things off the market.

Cadillac Recall

December 26, 2011, by Ronald V. Miller, Jr.

There may be a problem with your new Caddy. GM has issued a recall for 8,789 Cadillac SRX vehicles as the result of concerns about the Cadillac's transmission shift cable. The National Highway Traffic Safety Administration said Cadillac SRX vehicles made from October 26, 2008 through June 23, 2011, included transmission shift cables that could come out of a transmission bracket, leaving this Cadillac unable to move or, of greater concern, it may result in the driver incorrectly believing the transmission is in the park position.

Enfamil Recall: Hopefully Nothing

December 25, 2011, by Ronald V. Miller, Jr.

Mead Johnson said today after retesting its product that its Enfamil baby formula, that allegedly caused the death of a 10 day old baby, is safe. Enfamil was pulled from Walmart after the report of the child's tragic death. The formula was feared to be positive for Cronobacter, a potentially deadly illness that can strike premature infants who have eaten contaminated powdered infant formula. Mead Johnson said it had tested the same samples and followed the same methodology used by public health officials.

"Based on both sets of tests, Mead Johnson can say with confidence that Enfamil Premium Newborn formula, like every infant formula the company produces, is safe," Mead Johnson said in a statement.

I suspect Mead Johnson is right and telling the truth about Enfamil. Still, the company does $3 billion in sales and Enfamil carries the lion's share of those sales. It always scares me when that many jobs and careers are on the line if I'm trusting a product to be safe.

Texas Alfalfa Sprouts Recall

December 25, 2011, by Ronald V. Miller, Jr.

Heads up if you are in Texas enjoying alfalfa sprouts on Christmas. Green Valley Food continues to increase - now 6,723 the number of cases - the size of its "Let's Grow Healthy Together!" alfalfa sprouts recall. The distribution of the product appears to be limited to Texas but the way it is growing, who knows?

Two weeks ago, a random sample of these alfalfa sprouts tested positive for Salmonella. Presumably, at this point, Green Valley Food chose the safest path for its customers. But the recall keeps expanding.

Be Safe This Holiday Season

December 23, 2011, by Ronald V. Miller, Jr.

Hopefully by now your holiday shopping is complete and you are ready to enjoy the long weekend. Not really? Me neither. Here is the good news by someone with experience in this field: it is really not so crazy at the mall at the end of the day tomorrow.

When pressed for time, and grabbing the last toy on the shelf, many won't take the time to stop and think whether or not the toy is safe. The U.S. Consumer Product Safety Commission (CPSC) wants consumers to know that while safety should be at the top of everyone’s toy list, stronger federal rules are making a positive impact and restoring confidence in the safety of toys.

Among many new toy safeguards that have been put in place, the lowest lead content and lead paint limits in the world have now been established. Additionally, the CPSC is also working with the U.S. Department of Homeland Security to track shipments in transit from other countries, thereby increasing seizure of dangerous imported toys. I know that a lot of people think there is just too much regulation and I'm not unmindful of that view. But when it comes to lead paint - this stuff causes brain injury in our children. Let's feel free to go a little overboard.

These safeguards, along with - and you can't emphasize this enough - safety-conscious steps taken by many toy makers and sellers have contributed to a continued decline in toy recalls since 2008. There were 34 toy recalls in fiscal year 2011. This is down from 46 toy recalls in fiscal year 2010, 50 recalls in 2009, and 172 recalls in 2008. In 2011, toy recalls related to lead declined to 4, down from 19 in 2008.

Toy-related deaths to children younger than 15 increased to 17 fatalities reported in 2010, up from 15 reported in 2009. Nearly half of these toy-related fatalities were attributed to choking on balloons, small balls, and rubber balls.

A recent report released by CPSC notes that about 181,500 children younger than 15 years of age were treated in U.S. hospital emergency departments due to toy-related injuries in 2010. Nonmotorized scooters continued to be the category of toys associated with the most injuries, injuries which included lacerations, contusions, and abrasions to the child's face and head.

People, please remember this:

  • Balloons - Children can choke or suffocate on deflated or broken balloons. Keep deflated balloons away from children younger than 8 years old. Discard broken balloons at once.
  • Small balls and other toys with small parts - For children younger than age 3, avoid toys with small parts, which can cause choking.
  • Scooters and other riding toys - Riding toys, skateboards, and in-line skates go fast, and falls could be deadly. Helmets and safety gear should be worn properly at all times, and they should be sized to fit.
  • Magnets - For children under age 6, avoid building or play sets with small magnets. If magnets or pieces with magnets are swallowed, serious injuries and/or death can occur.

So, while you are out tonight and tomorrow, fighting over parking spaces and standing in long lines, take an extra minute and think about what you are buying. Is it safe?

Happy Holidays everyone!

NFL Concussions Lawsuit

December 22, 2011, by Ronald V. Miller, Jr.

Four NFL players have filed a lawsuit claims they have brain injuries from concussions suffered while playing in the NFL. Clearly, the most prolific player is Jamal Lewis, who is one of the best players the Baltimore Ravens have ever had. Dorsey Levins, another extremely accomplished running is in lawsuit along with Fulton Kuykendall and Ryan Stewart. The common thread between the players? They all live in Atlanta so they found the same lawyer to bring their claim.

Earlier this month, 12 former NFL football players filed a concussion related lawsuit against the NFL about its concussion policies. If these concussion lawsuits are successful, you have to wonder how the NFL will survive. One win by one player would lead to thousands of claims.

I feel for the players. I really do. But I don't like the lawsuits. The NFL does not manufacturer a product about which it has unique knowledge of the risks. Opinions vary on the degree of the risk and those opinions are continuing to evolve with modern science. But everyone has equal access to the literature and people have a right to choose the course they want to take.

Walmart Recalls Baby Formula

December 22, 2011, by Ronald V. Miller, Jr.
Walmart recalls baby formula after infant death

Wal-Mart has announced that they are pulling a batch of powdered infant formula from more than 3,000 of its stores nationwide, after a 10 day old newborn boy who was given the formula became seriously ill with a suspected bacterial infection, and died after being taken off life support.

Wal-Mart has pulled the lot in an abundance of caution, though there has been no government recall ordered for the 12.5-ounce cans of Enfamil Newborn powder. The affected lot is stamped with lot number ZP1K7G. The lot could eventually go back on the shelves, depending on the outcome of the investigation, but customers who bought the cans have the option of returning them for a refund or exchange.

Manufacturer Mead Johnson Nutrition said its records showed the lot tested negative for the bacterium before it was shipped. At this point, it has not been determined whether the illness is linked to the formula or an outside source.

Really, it is hard to imagine something more terrifying than defective infant formula. We used Enfamil with our children as I am sure many people reading this have. Obviously, the big tragedy is any child who suffers or dies from a bacterial infection from this. But you also cannot minimize the fear that thousands of parents are having right now. I would be just freaking out if my child had had this formula.

More Celery Salt Recalls

December 22, 2011, by Ronald V. Miller, Jr.

Starwest Botanicals is recalling Starwest Organic Celery Seed (Whole) as it has the potential to be contaminated with Salmonella, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

The affected celery seed is packaged in Mylar 1lb and 2 oz pouches. The product was distributed in several ways. It was either shipped directly to customers, sold on-line or mail order consumers, or held for pickup by consumers at Starwest Botanicals, and was sold between April 26, 2011 and December 14, 2011.

This recall includes the following:

  • Starwest Botanicals Celery Seed (Whole) 2oz. with UPC 7-6796310619-3 and lot number F7073 found on the bottom of the pouch
  • Starwest Botanicals Celery Seed (Whole) 1 pound with UPS 7-6796307864-3 and lot number 40203 found on the bottom of the pouch
  • Starwest Botanicals became aware of the potential contamination after being notified by a customer

No other Starwest spices have been affected by this recall, and no illnesses have been reported to date.

Organic Celery Seed Recall

December 21, 2011, by Ronald V. Miller, Jr.

Two types of organic celery seed are being recalled due to concerns with possible salmonella contamination. B&M Inc. is recalling O Organics Organic Celery Seed, and Swanson Health Products is recalling Swanson Organic Celery Seed as it is supplied by B&M.

The Safeway's O Organics Organic Celery Seed affected is packaged in a glass bottle, with a net weight of 1.8 ounces. It was sold from May 25 to December 16. Swanson is recalling their whole celery seed, packaged in plastic bottles, with a net weight of 1.4 ounces.

The O Organics product is sold at all Safeway-owned stores, including Safeway, Carrs, Dominick's, Genuardi's, Pak 'N Save, Pavilions, Randalls, Tom Thumb and Vons. The Swanson celery seed was sold at the company's retail store in Fargo, N.D., or online or by mail order.

Recent Litigation Ongoings

December 21, 2011, by Ronald V. Miller, Jr.
  • Family of 15 Year Old Drowning Victim Sues

    The family of a 15-year-old boy who drowned at a Michigan camp last summer has filed a wrongful-death lawsuit against the camp and several camp employees.

    According to the suit, the victim, along with other boys, was swimming after 10 p.m. in an area of the water that was not illuminated. A lifeguard lost sight of the boy, who had gone under. Unbelievably, he was underwater for almost 30 minutes before police and camp employees found him.

  • New Claims in the Lawsuit Over Pregnant Inmate's Death

    Attorneys representing the estate of a pregnant woman, who died while in a Pennsylvania county jail, are asking for the judge to allow them to amend their complaint, adding new allegations to their lawsuit.

    The allegations here are sad. The 27 year old inmate died of pneumonia after being moved to a hospital from the jail. The amended complaint said that during December 2009, the woman’s cell block had "little or no heat" and inmates "could see their breath." It is alleged that the walls and ceiling were leaking water, and that there was a strong smell of sewage coming from her sink. It is further alleged that there was black mold growing on and around her toilet and wall. The conditions sound absolutely deplorable.

    On Friday, the Judge denied a motion by the county to dismiss the complaint, but has yet to rule on the request to amend.


Is a Clomid Class Action Lawsuit on the Horizon?

December 20, 2011, by Ronald V. Miller, Jr.

Recent medical studies have suggested an association between Clomid, a common fertility drug, to birth defects. Specifically, mothers on Clomid may cause children to have heart defects, esophageal atresia and brain injuries. Our lawyers are investigating potential lawsuits involving Clomid and birth defects around the country.

We have made a lot of progress in helping women get pregnant who otherwise can't. Clomid is believed to be a part of the solution. Clomid (Clomiphene citrate) is an oral fertility medication which has been available for use for over 40 years. Clomiphene citrate may also be sold under the brand name Serophene. Clomid is usually prescribed to women with ovulatory dysfunction. Clomid is used to induce ovulation in women who do not ovulate but wish to become pregnant. Similar to estrogen, Clomid causes eggs to develop/mature in the ovaries and be released. It is estimated that 1.6% of pregnancies in the US are conceived using Clomid.

It is advised that Clomid not be administered during pregnancy as it can cause fetal harm. But that might now solve the problem. Clomid accumulates in the body and can be detected in the blood up to a month after its discontinuation. Multiple studies have suggested a link between Clomid and birth defects. The following fetal abnormalities found in post-market surveillance for Clomid:

• delayed development
• abnormal bone development including skeletal malformations of the skull, face, nasal passages, jaw, hand, limb (ectromelia including amelia, hemimelia, and phocomelia), foot, and joints
• tissue malformations including imperforate anus, tracheoesophageal fistula, diaphragmatic hernia, renal agenesis and dysgenesis, and malformations of the eye and lens (cataract), ear, lung, heart (ventricular septal defect and tetralogy of Fallot), and genitalia

• dwarfism
• deafness
• mental retardation
• chromosomal disorders
• neural tube defects (including anencephaly).

In 2010, researchers from the CDC published a study in the journal Human Reproduction (2010) that substantiated some of the findings of previous researchers as well as finding possible new links between some birth defects and Clomid.

Researchers at the CDC are trying to figure out just what we are dealing with here. They are using data from the National Birth Defects Prevention Study (NBDPS) in order to determine the connection between Clomid and birth defects. The NBDPS is an ongoing population based study of major birth defects caused by unknown sources. Women who had used during the 2 month period prior to or first month of pregnancy were included in the analysis and those using Clomid with other combinations of fertility drugs were excluded. Of the 19,059 mothers of children with birth defects and 6807 mothers of children without birth defects that were interviewed, 440 women had reported use of Clomid. This study on Clomid has been found to have a significant association with nine types of birth defects:

• Dandy Walker malformation
• muscular VSD
• cloacal exstrophy
• anencephaly
• septal heart defects
• coarctation of aorta
• esophageal atresia
• craniosynostosis
• omphalocele

CDC researchers feel like they need to confirm this data to draw conclusions. Though the incidence rate for birth defects is relatively low, the serious impact that such defects can have in a child supports the need for further research on this drug to better understand potential links between Clomid and birth defects, so that patients can be properly advised on the risks of taking Clomid.

If you believe you and your child may have a potential Clomid birth defect lawsuit, get a free on-line consultation from our law firm.

And Even More Recent Jury Awards

December 20, 2011, by Ronald V. Miller, Jr.
  • Lawsuit in the Hit-and-Run Death of a Police Officer Ends in Settlement
  • A civil lawsuit filed by the wife of a fallen officer, struck and killed while on duty last year, has ended with a settlement.

    The details here are tragic. The officer, who is survived by his wife and young son, was on duty and investigating a routine complaint. The Defendant, who was originally charged with murder, was said to have intentionally struck the officer while he was standing by the open door of a vehicle parked on the street. The Defendant was eventually convicted of second-degree manslaughter in the officer’s death, and sentenced to 20 years. The Judge stated that he regretted that the state law didn’t allow him to follow the jury’s recommendation of 30 years.

  • Lawsuit Filed Following the Shooting Death of a Concert-Goer
  • The mother of a nineteen year old man has filed suit following the death of her son, while attending a concert featuring the rapper, Big Tone.

    This type of incident is unthinkable. According to the lawsuit, just as the concert was concluding, a dispute broke out among the guests and gunshots were fired randomly over and into the crowd. The young man was struck in the chest. Two other people were shot, while two others were stabbed. In the confusion to get medical help for those hurt, the decedent was the last person to be taken to the hospital, and subsequently died at the hospital.

    The lawsuit claims that the Defendant was negligent by not providing supervision and adequate security to insure the safety of the patrons at an event where the rapper’s audience required that due care and security be maintained.

    Sadly, there are no arrests, no leads, no nothing.

Recalled Ground Beef

December 20, 2011, by Ronald V. Miller, Jr.

I am getting tired of writing this post. I feel like I write some version of it every month....

The Hannaford supermarket chain, which has stores in New England and New York, is recalling ground beef with a sell-by date of December 17 or earlier, as it may be contaminated with salmonella. The precise amount of beef being recalled is undetermined.

The ground beef recall was made after receiving reports of fourteen ill people, ten of which reported purchasing ground beef at Hannaford stores in Maine, New York, New Hampshire and Vermont between October 12 and November 20. Seven of the fourteen people were hospitalized.

Among the varieties being recalled are Hannaford's regular ground beef and its Taste of Inspirations Angus and Nature's Place brands, with content ranging between 73 percent and 90 percent lean.

The chain has approximately 170 stores in Maine, Vermont, New Hampshire, Massachusetts and New York, and all the beef affected by the recall has been removed from stores.

Georgia Appellate Court Slams Trial Court

December 20, 2011, by Ronald V. Miller, Jr.

The First Division Georgia Court of Appeals overturned directed verdict in a carbon monoxide brain injury lawsuit after the trial court made multiple errors on what are frankly, some pretty basic issues.

First, the trial court erred in jury selection. Two possible jurors said they could be biased yet no effort was made to follow up with those prospective jurors to inquire about the bias. This is a no-brainer. Jurors at risk for bias have to be examined and bias concerns must be resolved. This is made pretty clear in Being a Judge 101. Apparently, this case was in a Mayberry-like town and both jurors were biased in favor of the defense lawyer, who they knew, and said they would be biased in favor of deciding the case. Check this out:

    JUROR: I'm a CPA in Cordele.

    [LAWYER]: You know—

    JUROR: I mean, he's my client and my attorney, so you know I've worked on many occasions with him.

    [LAWYER]: I'm not sure this is-I don't want to be inappropriate with the question, but is he your current client?

    JUROR: Yes.

    [LAWYER]: Is it on a personal basis?

    JUROR [30]: Yes.

    [LAWYER]: Well, I've asked a few times, but I'm going to have to ask again if that would—he's your client, would you be inclined to try to find in his favor?

    JUROR [30]: What do you think? Of course. (I love this. What do you think?)

Continue reading " Georgia Appellate Court Slams Trial Court " »

Recent Jury Awards

December 19, 2011, by Ronald V. Miller, Jr.
  • Jury Awards $11.35 Million Dollars to Plane Crash Victims

    A Philadelphia jury awarded an Akron doctor and his fiancé, a pilot, $11.35 million as compensation for injuries suffered in a 2007 plane crash, one of the largest air crash disaster verdicts awarded to Ohio residents. The verdict was against the company that maintained the plane, as the jury found that the plane had not been properly maintained prior to the crash.

    The plane, owned by the doctor and flown by his fiancé, developed engine problems shortly after taking off from DeKalb-Peachtree Airport in Atlanta, and crashed in a non-populated area near a water treatment facility. The doctor was rendered unconscious, but was revived by his fiancé whose legs were crushed. Incredibly, making matters much worse, while the doctor was helping his fiancé out of the plane, a wing exploded - engulfing both in fire. He suffered lung and respiratory system injuries from breathing in flames and fuel and third-degree burns, while she suffered third-degree burns to 40 percent of her body. Sadly, she can no longer fly because she has been unable to pass the FAA's medical examination.

  • Woman and Children Awarded $8.5 Million in Wrongful Death Claim
  • A federal court jury has awarded a New Hampshire woman and her two children $8.5 million in a wrongful death lawsuit against a trucking company. Tragically, the husband and father was killed when a tractor-trailer ran over him while he was bicycling in Porter, Maine.

    Court records detail that, in mediation, the plaintiffs asked for a $5 million settlement, and the company offered $100,000 to avoid a trial.

No Class Action for Plavix

December 19, 2011, by Ronald V. Miller, Jr.

Plavix lawsuits will not become a class action lawsuit for discovery purposes because there are not enough cases to justify an MDL, according to an MDL panel of judges.

The court did not suggest that the Plavix cases were not viable lawsuits. The court also believed that the Plavix personal injury or wrongful death cases, do involve the same important common factual issues concerning the development, manufacture, regulatory approval, labeling, and marketing of Plavix. But the panel found that centralizing the cases in a pseudo class action (which is what an MDL is) would delay the progress of the long-pending actions in the District of New Jersey where most of the cases have been filed. Moreover, the court indicated that the "limited number of actions and relatively few involved counsel also weigh against centralization." In other words, the benefits of getting all of the lawyers together and performing common discovery would not be furthered significantly with an MDL.

You can get more information here on Plavix lawsuits.

Chinese Dry Wall Settlements at Hand?

December 19, 2011, by Ronald V. Miller, Jr.

There is a proposed settlement in the Chinese drywall MDL that may resolve thousands of lawsuits that have been filed over defective drywall.

The deal announced Thursday has Knauf Plasterboard Tianjin Co. - a German Company - agreeing to pay approximately $1 billion to create an uncapped fund to pay for repairing some 4,500 properties, mostly in southern states like Florida, Louisiana, Mississippi and Alabama. This settlement also includes a $30 million will fund to pay people who claim heath related consequence from the defective drywall.

Our law firm handles only personal injury case. We did not get involved because the claims were largely - although not exclusively - property damage claims. The billion dollar number - which, keep in mind, is the estimate from the MDL plaintiffs' lawyers - is an incredibly big number.

Vaginal MeshLawsuits: December, 2011 Update

December 19, 2011, by Ronald V. Miller, Jr.
Vaginal Mesh Lawsuit Moving Forward

The vaginal mesh cases are in high gear as we approach the end of 2011. There are a number of litigation battlefields for these product liability cases. Where a particular case ends up depends largely on which company manufactured and distributed the product. Below is a description of the major vaginal mesh/bladder sling litigation:

GEORGIA

The most well-known corporation to supply vaginal mesh is Mentor Corp. Federal cases against Mentor were assigned to Judge Clay D. Land in December 2008, in the United States District Court for the Middle District of Georgia. As of mid-November there were 36 pending actions (MDL - 2004 IN RE: Mentor Corp. ObTape Transobturator Sling Products Liability Litigation).
In November 2011 the required corporate disclosure statements were filed. Those statements didn’t reveal anything new, but affirmed the following:

1. Mentor Corporation merged with Mentor Worldwide LLC as of December, 2009. Mentor Worldwide is owned by Ethicon, Inc. Ethicon, in turn, is completely owned by Johnson & Johnson (you remember them—the family company).

2. C.R. Bard, Inc. has no other corporate affiliations

3. Tissue Science Laboratories Limited is an indirect affiliate of Covidien plc.

Mentor’s defense strategy so far is to blame plaintiffs by suggesting that the problem is a result of age, individual medical history, body type, and history of prior childbirth. They are also blaming plaintiffs’ doctors, suggesting that their data indicates the failure rate is directly related to doctors with less experience.

WEST VIRGINIA

C.R. Bard, Inc. and Covidien plc are also involved in the vaginal mesh litigation assigned to Judge Joseph R. Goodwin in the United States District Court for the Southern District of West Virginia (In Re: Avaulta Pelvic Support Systems Products Liability Litigation, MDL No. 2187). These cases were consolidated in July, 2010, and are not as far along as the Mentor cases. Yesterday the court entered orders regarding outstanding motions to compel discovery. Plaintiffs sought information about Bard’s testing process. The motion was formally denied, but a compromise was reached allowing extra corporate depositions so plaintiffs could gather the necessary information.

AMERICAN MEDICAL SYSTEMS

American Medical Systems (AMS) is another manufacturer of vaginal slings. Right now they have approximately 85 federal lawsuits against them, and they recently asked the Judicial Panel on Multidistrict Litigation (JPML) to consolidate those cases for joint discovery and early trials. In November 2011 they requested that all federal cases be sent to the United States District Court for the District of Minnesota. The case is In Re: AMS Vaginal Surgical Mesh Products Liability Litigation, MDL No. 2325).

NEW JERSEY STATE COURT

Cases pending in New Jersey are not formally part of the MDL, but the state has established its own mini-consolidation of vaginal mesh cases, overseen by Judge Carol E. Higbee. These cases are moving apace, and preliminary discovery is set to finalize by the end of March, with initial bellwether settlement trials to begin in November, 2012.

FOR MORE INFORMATION

Recall on Riata and Riata ST Silicone Defibrillation Leads

December 19, 2011, by Ronald V. Miller, Jr.

The U.S. Food and Drug Administration (FDA) has classified a recent advisory letter regarding Riata and Riata ST Silicone Defibrillation Leads to be a Class I recall.

On November 28, 2011, St. Jude Medical, Inc., a global medical device company, sent an advisory letter to physicians regarding the performance of Riata and Riata ST Silicone Defibrillation Leads. The classification of this recall is part of the process that follows any medical device advisory issued to physicians by a manufacturer.

The FDA’s classification updates the recommendations provided in the November 28th Physician Advisory Letter. An estimated 79,000 Riata and Riata ST family of silicone leads remain active in patients in the U.S. The company stopped distributing the Riata and Riata ST family of silicone leads in December 2010. The affected model numbers are the Riata (8F) Silicone Endocardial Defibrillation Leads (Models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, and 1592), and the Riata ST (7Fr) Silicone Endocardial Defibrillation Leads (Models 7000, 7001, 7002, 7010, 7011, 7040, 7041, and 7042).

The recall has been issued because of the potential risk of serious injury or patient death if affected devices malfunction. As communicated in the advisory letter, the clinical implications of externalized conductors in a defibrillation lead without electrical anomalies are not fully known or understood at this time. Externalized conductors can present as only a visual observation on x-ray or fluoroscopy without any associated clinical or device-related observations. If the electrical integrity of a lead were to be compromised, failure to deliver appropriate therapy, or the delivery of inappropriate therapy, could potentially occur, and could lead to a serious adverse event or death. Reports of injury include two patient deaths and one serious injury (effusion requiring thoracotomy). There was one additional patient death, as well as a serious injury in patients with externalized conductors were reported, but were determined not to be due to the presence of externalized conductors.

Ford Truck Recall

December 16, 2011, by Ronald V. Miller, Jr.

Ford Motors will recall of some of its F-150, F-250, F-350, F-450 and F-550 trucks after reports the trucks can be shifted out of "park" without pressing the brake. Ford says there is a problem with the brake/shift interlock, which increases the risk of truck crash or injury to a nearby pedestrian.

Runaway Golf Cart Recall

December 15, 2011, by Ronald V. Miller, Jr.

The U.S. Consumer Product Safety Commission and E-Z-GO have announced the recall of appromiately 22,000 TXT golf cars, Cushman shuttle vehicles and Bad Boy off-road utility vehicles.

It has been determined that the threaded end of the rack rod ball joint can break and the ball joint can become displaced, causing the driver to lose steering control and result in a crash.

While there have been no reports of injury, the company is aware of 71 reports of the ball joint breaking, 13 of which resulted in the ball joint displacing.

The recalled vehicles are gas- and electric-powered, four-wheeled vehicles with bench seats for the driver and passengers. The following models are included:

  • E-Z-GO TXT Fleet golf cars, Serial Number: 2748187 thru 2770316
  • E-Z-GO Freedom TXT golf cars, Serial Number: 2748187 thru 2770316
  • E-Z-GO TXT shuttle vehicles, Serial Number: 2748187 thru 2770316
  • Cushman Bellhop shuttle vehicles, Serial Number: 2748187 thru 2770316
  • E-Z-GO ST utility vehicles, Serial Number: 2748187 thru 2770316
  • Bad Boy Buggies HD, LD and LTO utility vehicles, Serial Number: 8000035 thru 8002809

The brand and model names are printed on the side and front panels of the vehicles. Serial numbers are printed on a plate or label located on the exterior of the vehicle below the driver's seat.

The recalled products were sold at E-Z-GO and Bad Boy dealers nationwide, from February 2011 through July 2011. They retailed between $6,650 and $10,650.

Consumers are being instructed to immediately stop using the recalled vehicles and contact E-Z-GO or an authorized dealer for a free repair. E-Z-GO and E-Z-GO dealers are contacting known owners.

Child Product Recalls

December 13, 2011, by Ronald V. Miller, Jr.

The U.S. Consumer Product Safety Commission (CPSC) has announced a few recent recalled children's products.

Approximately 2,300 sets of Children's Henley Pima Cotton Pajamas, imported by Bella Bliss of Lexington, Kentucky have been recalled, as the pajamas fail to meet the federal flammability standards for children's sleepwear, and as such, pose a burn hazard for children. The pajamas, a two-piece, cotton sleepwear set, came in white, blue, pink or red, with "Bella Bliss" written on the neck tag. They were sold in the Bella Bliss catalog and website, as well as specialty clothing retailers and online stores from January 2008 to June 2011 for about $48 to $58.

Next on the recall are Keds Girls' Shoes, which are being recalled due to laceration hazard. Manufactured in China, approximately 45,000 Keds"Know It All" girls' shoes are being recalled as the metal stars on the back of the shoes have been known to loosen and cause cuts and scratches. The maker has received 27 reports of cuts and scratches. The affected shoes are black and pink with white trim and a pink loop on the heel. "KEDS" appears on the tongue and heel of the shoe. The style number, printed on the underside of the tongue, is KY40098A. The shoes were sold in girls' sizes 12 to 5 and were sold at various department stores and online retailers from June through October 2011, and retailed for approximately $23.

Next recall for the holiday season, Kidgets Animal Sock Top Slippers are being recalled due to a choking hazard. The recalled children's slippers have brown or tan dog faces, yellow duck faces and tan lion faces. Approximately 160,000 slippers have been recalled as the animal's eyes can detach, posing a choking hazard. The name "Kidgets" and the size appear inside the slippers on the soles, and "FD9619108020690611" is printed inside the slippers on the side. The affected slippers were sold exclusively at Family Dollar stores nationwide from September 2011 through October 2011. Family Dollar has received one report of the eyes detaching from the slippers, though no injuries have been reported.

And last, for today anyway, Build-A-Bear Workshop has recalled their Teddy Bear Swimwear Set as it may pose a strangulation hazard. Approximately 19,720 units in the United States and 1,100 units in Canada have been recalled as Build-A-Bear received one report of an incident in which a 3-year-old girl pulled the inner tube over her head and had difficulty removing it. The set, sold at Build-A-Bear Workshop stores nationwide and online from April 2011 to August 2011, has a Fruit Tutu Bikini for teddy bears, and includes an inner tube. The inner tube is 9" in diameter and is pink with white and yellow flowers printed on it. The model number of the swimwear set is 017220 and is located on the price sticker on the "Build-A-Bear" cardboard tag.

Being a parent myself, I understand that we can't be everywhere and see everything, but at some point, we have to hold ourselves accountable for something. Otherwise, every toy, every piece of clothing, every everything is going to be recalled at some point. While maybe not every set of pajamas is going to ignite, given enough time, every stuffed animal is going to lose an eye and pose a strangulation hazard. Recalls should just remind us to pay a little more attention and be a little more cautious of the potential hazards out there. Kids are kids, let them have their toys - just keep a closer eye on them.

Zimmer NexGen Knee Replacement Lawsuits Leap Forward

December 13, 2011, by Ronald V. Miller, Jr.

The Zimmer NexGen knee replacement lawsuits were initially scattered in courts around the country, until Plaintiffs with cases in federal courts requested consolidation of all federal cases before the MDL (multidistrict litigation). A hearing was held on July 28, 2011, and Zimmer opposed consolidation. The judicial panel noted:

    On the basis of the papers filed and hearing session held, we find that these… actions involve common questions of fact, and that centralization… in the Northern District of Illinois will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation. The subject actions share factual issues arising from allegations that Zimmer’s “high-flex” femoral components… and/or the MIS Tibial component—all of which are used in knee replacement surgery—are prone to premature loosening, causing affected individuals pain and loss of movement, and often forcing them to undergo revision surgery.

On August 8, 2011 the MDL was approved, designated as In Re: Zimmer NexGen Knee Implant Products Liability Litigation (MDL No. 2272). There are approximately 117 (as of November 16 ) federal Zimmer NexGen knee replacement cases pending in the MDL in the U.S. District Court for the Northern District of Illinois. Judge Rebecca R. Pallmeyer is presiding over these cases.

In the MDL, cases are continually being transferred from federal courts around the country. A number of the initial cases are fighting transfer to the MDL, essentially arguing that the cases did not belong in federal court in the first place (if a case should be filed in a state court, it is not eligible for the federal MDL). This is taking up the majority of the court’s time at this point. There have been two status conferences before the judge—the first devoted to selecting plaintiffs’ attorneys to run the show. The second hearing covered issues relating to protective orders and initial discovery plans. In the upcoming months, it is expected that substantive discovery will take place, including the ever-important exchange of documents about the Zimmer knee replacement parts and marketing.

The defective Zimmer components have long-since been recalled by the company, specifically the NexGen MIS Tibial parts.

More Information

Recall of Tejava Premium Iced Tea

December 12, 2011, by Ronald V. Miller, Jr.

Certain production lots of Tejava Premium Iced Tea are being recalled nationwide due to the possible presence of glass fragments, which could be harmful if swallowed. The recall affects the 12 oz glass bottles of Tejava Premium Iced Tea, and the production lot codes are as follows:

  • 1BT220; 1BT221; 1BT222; 1BT223; 1BT252; 1BT253; 1BT254; 1BT255; 1BT277; 1BT278; 1BT279; 1BT280; 1BT313

These production codes can be found on the back of the bottle label,and on the long panel of the case tray. They UPC codes are:

  • Case: UPC 6-54871-24901-2
  • Four Pack: UPC 6-54871-04901-1
  • Single Bottle: UPC 6-54871-00901-5

Consumers who have purchased the recalled products are asked to return the product to the store where it was purchased and coupons, product replacement, or credit will be issued.

The 1 liter size of Tejava Premium Iced Tea is NOT affected and is NOT part of this recall. There have been no reports of injury or illnesses to date.

The Weight Loss Drug Mess

December 9, 2011, by Ronald V. Miller, Jr.

In the United States, the FDA is responsible for the legitimacy of the claims on product labels. The FTC is responsible for regulation of product advertising. Not many people understand this and the two do step on each other's toes at times. What the FTC has advertised, approval must be obtained from the FDA in order to make treatment or prevention claims.

People that make weight loss drugs are not scared of the FDA and FTC. The FDA and FTC have issued 7 joint warning letters to companies marketing over the counter (OTC) drugs advertised as homeopathic for weight loss. Warning letters have been issued as the claims are unsubstantiated (thus fraudulent), unapproved and in violation of federal regulations.

The weight loss product at issue contains human chorionic gonadotropin (HCG), a hormone found in the urine of pregnant women, produced by the human placenta. This alone should scare you off. HCG is currently only approved in the US as an injectable drug for the treatment of certain cases of female infertility and hormone therapy in men. The products subject of the current advisory are available as oral drops, sprays and pellets.

Labels state that the products should be taken along with a very low calorie diet (as low as 500 calories per day). The FDA has concerns with this labeling as patients following a very low calorie diet are at increased risk of gallstone formation, electrolyte imbalance, heart arrhythmias and other adverse effects, and should only be following such a diet under medical supervision.

The FDA has posted a list of 7 companies subject of the warning letters, but state that all products currently on the market labeled as "homeopathic" are being sold illegally:

  • HCG Diet Direct, LLC Product name - HCG Diet Homeopathic Drops
  • HCG 1234 LLC (The hCG Drops LLC) Product name - Homeopathic HCG
  • HCG Platinum, LLC Product names - HCG Platinum, HCG Platinum X-30, HCG Platinum X-14
  • Hcg-miracleweightloss.com Product name - HCG Extra Weight Loss Homeoapthic Drops
  • Natural Medical Supply, LLC DBA HCG Complete Diet Product name - HCG Extra Weight Loss Homeoapthic Drops
  • Nutri Fusion Systems, Inc Product names - HCG Fusion 30, HCG Fusion 43
  • Theoriginalhcgdrogs.com Product name - Homeopathic Original HCG, Homeoapthic HCG

Currently, HCG drug products for use in hormone treatment and infertility are labeled with the following statement regarding use of HCG for weight loss as the FDA is aware that some health care professionals may prescribe injectables for "off-label" uses:

    HCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity. There is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or ‘normal’ distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets.

The FDA is advising that consumers using the HCG products for weight loss stop taking the product, and stop any very low calorie diets they may be following immediately. Consumers should also discard the product. Any harmful effects experienced should be reported to the FDA.

These over-the-counter weight loss pills are really not the answer to any question other than how to make money off desperate people.

Government Moves Against Yaz

December 9, 2011, by Ronald V. Miller, Jr.

The government is now saying that Yaz is more likely to cause blood clots than other birth control pills. Of course, our government has not said that yet.

Health Canada this week posted an advisory after taking a long look at safety data on Yaz and Yasmin, a popular oral contraceptive. Their conclusion is what Yaz plaintiffs' lawyers - and their clients who are filing lawsuits in massive number - have been saying: Yaz and Yasmin have 1.5 to 3 times higher risk of causing blood clots than other oral contraceptives. Health Canada stated that the risk of clotting is estimated to be 1.5 to 3 in every 10,000 women annually. Put that on the box.

Yaz and Yasmin contain drospirenone, which has been previously reported to cause blood clots. In a study published earlier this year in the British Medical Journal (BMJ) is one of five recent studies that has found drospirenone to have a higher risk of blood clot formation compared to other birth control pills. Any increase in risk is significant as blood clots can trigger more severe events including heart attacks, stroke or death.

Evidence on Yaz and Blood Clots Gets Stronger

Bayer has updated labels to include information to advise health care professionals to consider the risks and benefits of a specific patient in light of the possibility of developing blood clots while on drospirenone, relative to the risk and benefits of other oral contraceptives.

A panel of experts assembled by the FDA met yesterday to discuss the safety of drospirenone and voted 21 to 5 that the current labeling of Yaz and Yasmin was insufficient and should include more information about the risk of blood clots of the lungs and legs. The panel voted 15 to 11 that the benefits oral contraceptives containing drospirenone outweigh the risks. Though the FDA is not required to follow the expert panels recommendations, they often do.
The birth control pill was introduced in 2006 and by 2008 was the best selling oral contraceptive. In the past two years prescriptions have dropped 80% due to concerns regarding its safety. Drospirenone containing birth control pills accounted for approximately 16% of hormonal oral contraceptives prescribed last year in the United States.

The FDA expert panel found that the magnitude of the risk could not be properly assessed as many of the studies reviewed did not clearly identify other risk factors that may have been present and as such recommended that specific risk factors be studied in future trials.
On December 9, the FDA will vote on the risk/benefit ratio of a birth control patch, Ortho Evra, manufactured by Johnson & Johnson, which has also been linked to an increased risk of blood clots.

Women at risk of developing blood clots are advised to discuss their risk factors with their physicians. Risk factors include smoking, obesity and family history of blood clots. Women over the age of 35 who smoke more than 15 cigarettes per day are advised not to take any birth control pills as they are considered high risk of developing blood clots.

These Yaz lawsuits start going to trial next month. Hopefully, settlements and a drastic change in the warning label is on the way.

More Medicaid Fraud

December 8, 2011, by Ronald V. Miller, Jr.

Another day another Medicaid fraud settlement. In this one, Shield Healthcare, a California medical supplier, paid $5 million to settle a whistle-blower lawsuit that alleged that Shield submitting inflated bills to California's Medicaid program. The suit claimed that the company submitted false claims and evaded the regulation’s upper billing limit. (I'd be curious how they did that. You have to admire the scope of the evil).

In a related story, California is going bankrupt.

Class Action Settlement in Oklahoma

December 7, 2011, by Ronald V. Miller, Jr.

A settlement was reached this week in a class action lawsuit involving claims that a dental insurance policy sold to Medicaid recipients living in nursing homes was in violation of Oklahoma law.

Under the $900,000 settlement agreement, the lawyer would get a third in attorneys' fees and the named plaintiff would get $10,000. Everyone else - the 1,600 people that ostensibly got the raw deal - would get about $ 21 for each month they were in the Oklahoma Medicaid program and paid their premiums for dental insurance.

Lawyers make out pretty good in these consumer class action lawsuits. The actual victims usually don't fare as well.

You can read about the court's approval of the settlement in Childs v. Unified Life Insurance Company (that just sounds made up) here.

Ocean Spray Expands Recall of Craisins

December 7, 2011, by Ronald V. Miller, Jr.
Ocean Spray Recalls Craisins

Ocean Spray has announced that it is expanded the recall of certain production lots of its Original Flavor Craisins, Dried Cranberries product in 5-ounce, 10-ounce and 48-ounce packages, and bulk sweetened dried cranberries in 10-pound packages. The recall was made after it was determined that there may be the possible presence of very small hair-like metal fragments, though they are saying that it is unlikely to cause consumer injury.

The additional five recalled lots were only shipped to retailers in the following eight western U.S. states: Arizona, California, Colorado, Montana, Nevada, New Mexico, Oregon, and Washington. The current affected lots are as follows:

  • 5 oz Craisins: UPC: 00293-000
  • Best By Dates (ONLY THESE DATES FOLLOWED BY THE LETTER “M” ARE AFFECTED): Oct 27 2012 M and Oct 28 2012 M
  • 10 oz Craisins: UPC: 29456-000 and 29464-000
  • Best By Dates (ONLY THESE DATES FOLLOWED BY THE LETTER “M” ARE AFFECTED): Oct 27 2012 M; Oct 28 2012 M; Oct 29 2012 M; Oct 30, 2012 M
  • 48 oz Craisins UPC: 00678-318
  • Best By Dates (ONLY THESE DATES FOLLOWED BY THE LETTER “M” ARE AFFECTED): Oct 27 2012 M; Oct 28 2012 M ; Oct 29 2012; Nov 3 2012 M; Nov 4 2012 M; Nov 5 2012 M; Nov 6 2012 M; Nov 7 2012 M; Nov 8 2012 M; Nov 10 2012 M; Nov 11 2012 M; Nov 12 2012 M
  • 10 lb bulk ingredient & foodservice: UPC: 03477-000
  • Best By Dates (ONLY THESE DATES FOLLOWED BY THE LETTER “M” ARE AFFECTED): 30 Oct 2013 M; 31 Oct 2013 M; 1 Nov 2013 M; 5 Nov 2013 M

No illnesses or adverse effects have been reported regarding these products, and the company has received no customer complaints.

Another CooperVision Contact Lens Recall

December 7, 2011, by Ronald V. Miller, Jr.

Last time it was the CoperVision Avaira lense, this time it's the Avaira Aquaform Comfort Science enfilcon lenses. The Avaira Aquaform, a daily wear sphere soft contact lens, is being recalled as there is the unintended presence of a silicone oil residue on the lenses. Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment.

These lenses were manufactured from February 1, 2011 through August 24, 2011 and distributed from March 2, 2011 through November 15, 2011.

Affected contact lens wearers should stop wearing their lenses immediately and contact their eye care practitioner for advice. Avaira Sphere contact lens wearers should check CooperVision’s recall web site and enter the package lot number to determine whether their lenses have been recalled, or contact the toll-free consumer hotline at 1-855-526-6737.

Iams Dog Food Recall

December 7, 2011, by Ronald V. Miller, Jr.

Dogs are people too. Pretty much. For many of us.

So we report here on Proctor & Gamble Company has retrieved a single production lot of dry dog food as aflatoxin levels, above the acceptable limit, have been detected. This product has already been retrieved from store shelves.

Aflatoxin is a naturally occurring by-product from the growth of Aspergillus flavus and can be harmful to pets if consumed in significant quantities. Pets who have consumed this product and exhibit symptoms of illness including sluggishness or lethargy combined with a reluctance to eat, vomiting, yellowish tint to the eyes or gums, or diarrhea should be seen by a veterinarian.

The affected dog food is as follows:

  • Product Name: Iams ProActive Health Smart Puppy dry dog food with Use By/Expiration Dates of February 5 or February 6, 2013
  • Version: 7.0 lb bag; Code Date: 12784177I6; UPC Code: 1901402305
  • Version: 8.0 lb bag; Code Date: 12794177D2 and 12794177D3; UPC Code: 1901410208
  • Version: 17.5 lb bag; Code Date: 12794177K1 and 12794177K2; UPC Code: 1901401848

The affected product lot was distributed to a limited number of retailers located in the eastern United States: Alabama, Connecticut, Delaware, Florida, Georgia, Louisiana, Maryland, Maine, Mississippi, North Carolina, North Carolina, New Hampshire, New Jersey, New York, Pennsylvania, South Carolina, and Virginia. These retailers have already removed this product from store shelves.

While no health effects related to this product have been reported, P&G retrieved this product from the shelves as a precautionary measure. Consumers who purchased the affected dog food should stop using it, discard it, and contact Iams a replacement voucher.

No other dry dog food, dry cat food, dog or cat canned food, biscuits/treats or supplements are affected by this announcement.

Dogs matter. I'm glad Proctor is doing the right thing by making sure our animals are safe.

Recall of Uncle Ben's Whole Grain Rice

December 7, 2011, by Ronald V. Miller, Jr.

Mars Food has recalled two date codes of Uncles Ben's Whole Grain White Rice Garden Vegetable, due to an undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

The recall, affecting ONLY the Whole Grain White Rice Garden Vegetable, affects the 4.7 oz. (133 g) boxes with the following:

  • UPC code of 54800 40778
  • Best before: 08/12
  • Code dates: 133BA4RP06 and 133BB4RP06
An ingredient supplier improperly included an undeclared milk ingredient in the seasoning mix used for this product. As such, consumers with milk allergies are advised not to eat the product, and consumers should return the product to the store where it was purchased for a full refund.

This product was distributed through retail stores in Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont and Wisconsin.

Mars Food US has not received any reports of illness or other consumer complaints related to this matter. No other flavors of Uncle Ben's Whole Grain White Rice or any other Uncle Ben's products are affected.

Nissan Recalls Vehicles for Power Steering Issue

December 6, 2011, by Ronald V. Miller, Jr.
Nissan recalls more than 7,000 Rogue crossover vehicles

Nissan will recall of more than 7,000 of its 2011 Rogue crossover vehicles in the U.S., as the electric power steering can fail. The recall affects vehicles manufactured between August 17, 2010 and October 30, 2010.

Documents filed with NHTSA say that the circuit boards controlling the power steering may not have been installed correctly, and that the solder between the terminal and the circuit board can crack, causing the board to fail. It is being said that as the circuit board fails, the power steering assist feature will stop functioning, increasing the force needed to steer the vehicle and increasing the risk of a crash.

To correct the problem, authorized Nissan dealers will inspect and replace the EPS control unit as necessary. Nissan is expected to notify customers during the month of December, 2011.

There have been no reported accidents or injuries because of that defect.

Honda Recalls Vehicles Brake Issue

December 6, 2011, by Ronald V. Miller, Jr.
Honda recalls 126,000 motorcycles

Honda is recalling 126,000 GL-1800 motorcycles from the 2001 to 2012 model years. Federal safety regulators say that the brakes may not fully release. A problem with a secondary brake master cylinder can cause the rear brake to drag, possibly causing a crash or a fire in the rear brake.

Honda has received 26 complaints to date, two of which involved fires, though they are reporting that there have been no reports of crashes or injuries.

Honda customers will be instructed to take their cars to dealers for an inspection, with the recalls to begin next month.

Honda has been busy:

Subaru Recalls Vehicles for Brake Issue

December 6, 2011, by Ronald V. Miller, Jr.
Subaru Recalls nearly 32,000 vehicles

Subaru has announced today that it is recalling three of its car models because of problems with the brakes.

Nearly 32,000 of the 2012 Legacy, Outback and Impreza models are being recalled as a defective brake part could cause the brake pedal to travel farther than expected. Federal safety regulators say this could cause a driver to misjudge that amount of pressure needed to stop quickly.

Subaru says no crashes or injuries have happened because of the defect. The company has received 112 reports of the problem, mostly through its dealer network. Only about 3,000 of the cars were sold, and the rest are either on dealer lots or en route to dealers. Subaru says that they will be fixed before being sold, the company said.

Subaru customers will be instructed to take their cars to dealers for an inspection, with the recalls to begin this month.

The recall does not include WRX/STI models of the Impreza.

Halloween Projection Flashlights Recalled Due to Fire and Burn Hazards

December 6, 2011, by Ronald V. Miller, Jr.
Halloween flashlights are recalled
Nygala will recall approximately 10,000 Halloween Projection Flashlights, as the flashlights can overhead, blister and melt, posing a fire and burn hazard to consumers. Better late than never. I guess.

These Chinese made flashlights are black and orange plastic, and the flashlight is 6 ½ inches long with pumpkins, bats, witches, haunted houses and cats on the handle. The flashlights came with six different plastic lenses that attach to the flashlight to project various images, including a pumpkin, bat, witch, haunted house and cat. The flashlights packaging is imprinted with “Flomo,” “HW189” and UPC 677916518266 on the packaging.

The recalled Halloween flashlights were sold at discount stores in California, Connecticut, Florida, Maryland, New Jersey, New York, Pennsylvania, Texas and Utah from August 2010 through October 2011 for about $1.

The firm has received one reported incident involving a flashlight that overheated, blistered and melted.

Golden Glen Creamery Issues Recall for Butter

December 5, 2011, by Ronald V. Miller, Jr.
Butter - Another popular item at the Thanksgiving table recalled

Golden Glen Creamery of Washington state is recalling butter, produced on November 2, 2011, as it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

21 - 4 oz. packages of Herbes de Provence Butter were available at the Whole Foods Market in Redmond, WA. 68 - 4 oz. packages of NW Mushroom Trio Butter were available at the Whole Foods Market in Redmond, WA, and at various Metropolitan Market locations in Washington. The recalled products were distributed between November 7, 2011 and November 28, 2011, and are in circulation to date.

The product is sold in 4 oz. plastic round containers. The labels read in part: “Herbes de Provence Butter”, or “Northwest Mushroom Trio Butter”, along with “GOLDEN GLEN CREAMERY”and“Natural handcrafted cheese produced by the Jensen ladies.” The top label on the products has a three-digit code “767.”

A surveillance sample, collected and analyzed by the Washington State Department of Agriculture was found to be positive for Listeria monocytogenes. The company has ceased the production and distribution of the product while an investigation as to what caused the problem continues.

To date, no illnesses have been reported.

Battery Recall

December 2, 2011, by Ronald V. Miller, Jr.

Mophie will recall approximately 6,100 rechargeable external batteries due to a burn risk. The problem is that the battery's case can overheat and pose a burn risk. The batteries were sold at various retailers across the country since April 2011. To date, there have been nine reports of users suffering minor burns.

Honda Announces Airbag Recall

December 2, 2011, by Ronald V. Miller, Jr.
Honda's new recall affects 304,000 vehicles

Honda Motor Co. has announced a new global recall of 304,000 vehicles due to potentially faulty air-bags.

The models, all built between 2001 and 2003 and include the popular Civic and Accord, were found to have airbags that may inflate too much during a car crash, causing the airbag to burst due to excessive pressure. The excessive air pressure can cause metal and plastic pieces to project, and can cause injuries or deaths.

Honda said there have been 20 accidents so far related to this problem, including two deaths in the U.S. in 2009. One of the deaths was a high school student who died after a crash in the parking lot of her school.

The Japanese automaker announced the recall Friday, which affects the Accord, Civic, Odyssey, Pilot, CR-V and other models, manufactured in 2001 and 2002. The recall spans 273,000 vehicles in the U.S., approximately 27,000 in Canada, almost 2,000 vehicles in Japan, and another 2,000 in other countries.

The latest recall is an expansion of a 2008 recall for the same problem, which was again carried out in 2009 and again in 2010. According to Honda, the recall now covers approximately 2 million vehicles worldwide.

A Honda spokesman said that the cause was due to the use of incorrect material in the chemical used to deploy the air bags. The problem was later found to affect more vehicles than initially estimated, and the recall had to be expanded.

Continue reading " Honda Announces Airbag Recall " »

All-Metal Hip Replacements: No Advantage Over Older Implants

December 1, 2011, by Ronald V. Miller, Jr.

We recently reported on a study that revealed that the metal-on-metal hip replacements failed three times more often than other artificial hips. In fact, the U.S. Food and Drug Administration (FDA) ordered twenty-one (21) artificial hip manufacturers to conduct studies of the Metal-on-metal (MoM) hip replacement devices, and how they can adversely affect patients, after having received close to 11,000 reports of defective hip failures from January through September of 2011.

All of this concern may be for nothing, as findings of a new study reveal that the all metal artificial hip replacements provide no advantage when compared to older types of hip implants - they just appear to carry a greater risk of problems.

FDA researchers just published a report in the British Medical Journal in which the effectiveness of a number of types of hip implants were examined. Metal-on-metal hip implants were examined, as were ceramic-on-ceramic implants, and they were compared to older metal on polyethylene implants and ceramic on polyethylene implants. The comparative study looked at 3,139 patients in 18 comparative studies. Data from 83,000 operations worldwide was reviewed.

What was discovered was that there is no advantage to metal-on-metal hip implants over the older designs that use other materials. As previously reported, there have been a number of problems identified in recent years with the metal-on-metal hip replacements.

Now, the FDA researchers are saying that, "Evidence on implant revision did not favor metal on metal implants." The study further reveals that there is limited evidence regarding comparative effectiveness of various hip implant bearings, and the results do not indicate any advantage for metal on metal or ceramic on ceramic implants compared with traditional bearings.

In May 2011, the FDA asked device manufactures to obtain more information about the level at which the metal particles shed becomes dangerous, how much metal they actually shed, and what the potential side effects of metallosis are. As designed, the metal ball and the metal cup in a metal-on-metal implant slide against each other during walking or running, which can cause tiny metal particles to wear off of the device, and enter into the space around the implant. These metal ions can be detected in blood and urine samples, and the levels tend to increase as time passes. The metal particles, cobalt and chromium, enter the blood stream and can be distributed to other areas of the body, and have effects on the heart, nervous system, and thyroid gland. The discovery that these metal ions can slowly accumulate in the body have people concerned about higher rates of cancer and allergy-like reactions to the metal.

Where does that leave all of the people who have had metal-on-metal implants, and are now facing problems with them? People who were originally told that these implants wear much less than metal and plastic implants, but are now being told that there is no advantage over older implants. With lawsuits, where else. Patients have brought suits against hip makers in massive numbers. More than 90,000 of the recalled implants were sold worldwide before the problems were acknowledged by the manufacturer, and hundreds of individuals in the United States have filed lawsuits after experiencing complications with the implant.

I'm sure with the most recent findings that there is no real advantage over the older implants, the suits filed will continue to increase by the thousands.

Recalled Grape Tomatoes

December 1, 2011, by Ronald V. Miller, Jr.
Recall for grape tomatoes

Front Row is recalling its 10oz pint and 10lb bulk grape tomatoes. The tomatoes, supplied by Rio Queen Citrus of of Texas have been recalled because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

The recalled grape tomatoes were distributed throughout Missouri and Illinois to foodservice distributors and retail stores.

The product for retail sale is packaged in a 10-ounce, clear plastic package marked with a Front Row Produce “Grape Tomatoes” label on the top of the package. Currently, the lot number does not appear on the clear plastic package but it does appear on the case label. The lot numbers on the cases containing the 10-oz. packages are 2310802, 2310405, or 2510401. The 10lb bulk grape tomatoes are packaged for wholesale in a plain brown cardboard box labeled only with lot # 2310801.

As of 12/1/2011, all shipments of Front Row Produce Grape Tomatoes packaged in clear 10-oz. plastic packages sold in retail stores will now have a green lot number sticker placed on the bottom side of each package. The lot number will consist of a 7-digit number used to aid in identifying specific shipments of product. Any packages that do not contain this green sticker should be considered suspect and under recall.

No illnesses have been reported, but production of the product has been suspended while the FDA and Front Row continue their investigation as to the source of the problem.

Reissued Warning About Bumboo Baby Seats

December 1, 2011, by Ronald V. Miller, Jr.
The Consumer Product Safety Commission warns parents again

The U.S. Consumer Product Safety Commission and Bumbo have issued another warning to parents who use Bumboo baby seats.

Parents and caregivers should never place Bumboo Baby Seats on tables, countertops, chairs or other raised surfaces. Infants aged 3-10 months old have fallen out of the Bumboo seat and suffered skull fractures, concussions and other serious injuries.

There currently have been at least 45 reported incidents resulting in injuries after a recall of the product in 2007. The children fell out of the Bumboo seat while it was being used on an elevated surface. Seventeen of those infants suffered skull fractures. There have also been at least 50 reports of infants falling or maneuvering out of Bumboo seats that are being used on the floor and suffering injuries.

The Bumboo seat is designed to help infants sit in an upright position as soon as they can support their head. A warnings on the seat states that the seat "may not prevent release of your baby in the event of vigorous movement," however, infants as young as 3 months can fall or escape from the seat by arching backward, leaning forward or sideways or rocking.