Asthma and Pregnancy

January 31, 2012, by Ronald V. Miller, Jr.

I remember kids in elementary school in the '70s with asthma. It seemed rare back then. Not anymore. Statistics seems to bear this out. The prevalence of asthma is increasing worldwide and in particular in the United States. Asthma has risks for all who suffer from it, but people are playing a lot more attention to the issue of pregnancy and asthma and whether asthma medications can cause injury to the expectant mother or the unborn child. Specifically, people are questioning whether asthma drugs like budesonide (Pulmicort) that contained glucocorticoids increase the infant's risk of developing metabolic and endocrine disorders.

Between 4 and 12% of pregnant women have asthma and 3% use asthma medications during pregnancy. Women with asthma are at an increased risk of complications during pregnancy due to inadequacy in controlling asthma and/or some medications used to manage asthma.

Certainly, doctors are in a Catch 22. Poorly controlled asthma can result in an inadequate supply of oxygen to the fetus. Asthma during pregnancy can lead to preterm labor, cesarean section, and hypertensive disorders, including preeclampsia and placental previa. Severe asthma can result in maternal mortality, fetal mortality or both. Therefore management of asthma during pregnancy may be necessary to improve the mothers' asthma, even if risks are present with the use of such medications. It is always important to weigh the potential risks to the fetus against the benefit of the mother. To do this accurately, drug companies have to tell us what the risks of asthma and pregnancy are. What are they? We don't know what the drug companies know, but what we do know is mixed.

Continue reading " Asthma and Pregnancy " »

Recall of Aveeno Baby Calming Comfort Lotion

January 31, 2012, by Ronald V. Miller, Jr.

Johnson & Johnson has announced the recall of Aveeno Baby Calming Comfort Lotion. The recall only affects one lot that was shipped only to a few states.

The recall was initiated as a precautionary measure after testing indicated that the lot exceeded the specifications for common bacteria. Extensive testing has been performed since by an independent lab, and has not shown that specifications were exceeded; however, Johnson & Johnson Consumer Companies initiated the recall out of an abundance of caution.

The only affected lot is lot number: 0161LK with a UPC Code of: 38137-0036456. The recalled product was shipped to Alabama, Arkansas, Florida, Georgia, Kansas, Louisiana, Mississippi, Tennessee and Texas.

Aunt Jemima Frozen Pancakes Recalled

January 30, 2012, by Ronald V. Miller, Jr.

The Food and Drug Administration (FDA) has announced a recall of Aunt Jemima Frozen Pancakes as there is concern that the pancakes may contain soy protein. People who have an allergy or severe sensitivity to soy protein may run the risk of an allergic reaction.

The recall was initiated after it was discovered that there may have been potential cross-contact with a product that contained soy, and applies only to the following Aunt Jemima Frozen Pancakes:

  • UPC Code: 19600-05100 - Aunt Jemima Pancakes Buttermilk Low Fat - 12/14.5oz
  • UPC Code: 19600-05490 - Aunt Jemima Oatmeal Pancakes 12/14.8oz
  • UPC Code: 19600-05820 - Aunt Jemima Pancakes Buttermilk 12/14.8oz
  • UPC Code: 19600-05910 - Aunt Jemima Pancakes Homestyle 12/14.8oz
  • UPC Code: 19600-05955 - Aunt Jemima Confetti Pancakes 12/14.8oz
  • UPC Code: 19600-06040 - Aunt Jemima Whole Grain Pancakes 12/14.5oz

The affected pancakes are packaged in cardboard cartons with a ‘Recommended Use By Date’ between November 1, 2011 up to and including October 16, 2012, which can be found in the white box on the end of the carton.

There have been no reports of illness as a result of this incident.

Mazda Tribute Recall: Break Problems

January 29, 2012, by Ronald V. Miller, Jr.

Mazda Motor Corp. will recall some of its Tribute SUVs from the 2001 and 2002 model years to remedy a brake-system problem that cause fires. This Mazda Tribute recall should impact 52,390 SUVs.

The problem with the Mazada Tribute is that the cap on the brake master cylinder reservoir can leak brake fluid. Leaky fluid meets wiring on the anti-lock brake system, you get a little corrosion and you have yourself a fire.

Vehicles in the recall will get new brake master cylinder reservoir caps and a modification of the Mazda's antilock-brake electrical system.

I realize that it takes some corrosion for this problem to kick in, I really do. But should it take 11 years to figure it out? I have my doubts.

Malpractice Caps in Oregon

January 26, 2012, by Ronald V. Miller, Jr.

The fight continues on medical malpractice caps in Oregon.

Lead Paint Toy Recall

January 25, 2012, by Ronald V. Miller, Jr.

A toy manufacturer will recall 7,000 Mexican made packs of Super Luchamania Action Figures due to high levels of lead paint. The U.S. Consumer Product Safety Commission discovered that the surface paints on the figures contained levels of lead that exceeded federal standards.

There have been no injuries reported. Of course, a child who suffers a brain injury from lead paint does not have immediate symptoms anyway. No lead paint. No lead paint. Isn't this a simple rule we can get right?

Actos Bladder Cancer Lawsuits Consolidated

January 25, 2012, by Ronald V. Miller, Jr.

The Judicial Panel on Multi-District Litigation has consolidated over 100 federal lawsuits involving Actos. Plaintiff's lawyers have alleged in these lawsuits that they have developed bladder cancer from the use of Actos. The Actos MDL (which is a class action for discovery purposes) will consolidate all Actos lawsuits around the country in the Western District of Louisiana.

Actos (Pioglitazone) is prescribed to treat type 2 diabetes. Pioglitazone is in a class of medications called thiazolidinediones, and works by increasing the body's sensitivity to insulin. Actos is taken orally, typically once a day. Actos is approved as an adjunct to diet and exercise, to improve glycemie control in patients with Type 2 diabetes (non-insulin-dependent diabetes mellitus). Actos is also used in combination with a sulfonylurea, metformin, or insulin when diet and exercise is unable to get a patient's glycemie under control. Plaintiff's lawsuits allege that taking Actos has caused them to get bladder cancer.

If you are considering an Actos bladder cancer lawsuit, you can find more information on bringing a claim here.

Personal Injury Lawyers Not Helped by This

January 23, 2012, by Ronald V. Miller, Jr.

A Plaintiff's attorney in Texas has filed a wrongful death suit on behalf of the estate of a woman that was murdered.

These claims are not uncommon and they are a great way for plaintiffs' lawyers to add million dollar verdicts to their resume. There is only one caveat: very rarely do they get a single penny for their clients because the defendants are not in a position to pay out a verdict.

This Texas case adds a new and I think bizarre wrinkle: the claim is not only against the murderer but his parents and his 92-year-old grandmother. Adding to the insanity, the murderer was a Dallas personal injury lawyer.

The Plaintiff's lawyer also made what I think were odd comments: "You don't see it often, but unfortunately I don't have the liberty to discuss the facts we have to support our allegations, but we do have a basis to bring all of the claims we've brought," the lawyer says, referring to naming the murderers' parents and grandmother as defendants.

Not at liberty? Why? You have filed a lawsuit.

So we have a personal injury lawyer who is a murderer, whose 92 year-old grandmother is being sued for the murder he committed. It sounds like something personal injury claims tort reform advocates made up.

Continue reading " Personal Injury Lawyers Not Helped by This " »

CareFusion Updates Recall of Neurological Monitoring Software and Devices

January 20, 2012, by Ronald V. Miller, Jr.

CareFusion is updating their recall of the Nicolet Cortical Stimulator Control Unit, Nicolet C64 Stimulus Switching Unit (SSU) Amplifier, and the NicoletOne Software with Cortical Stimulator License. The recall, originally made in October 2011, affects 125 devices and 58 software licenses that were distributed to 38 customers between May 7, 2009 and July 11, 2011. The recall has no effect on the manufacture or distribution of current products.

In October 2011, an urgent Medical Device Recall Notification was issued to customers advising that a potential risk had been identified in the Cortical Stimulator Control Unit, SSU Amplifier and related software applications. The units affected by the recall have the potential to develop a short circuit, and affected software licenses may display or capture the incorrect electrode annotation label on the unit screen and in the associated report.

Colorado Collateral Source Rule

January 20, 2012, by Ronald V. Miller, Jr.

A federal judge in Colorado issued an opinion protecting the integrity of the Collateral Source Rule in Colorado, finding that a personal injury victims' Medicare lien is inadmissible at trial in a police brutality case.

Two Adults Arrested in Teen DUI Fatality

January 20, 2012, by Ronald V. Miller, Jr.

Tragically, hours after having purchased alcohol at a local market, a teenage girl was killed in an alcohol related crash. The driver, also a teen, was arrested for allegedly driving under the influence of alcohol.

Also under arrest? Two adults...and they are facing possible criminal charges of furnishing alcohol to a minor. The first is the clerk of the local market who sold alcohol to the teenager. The second is the mother of a friend of the deceased, who accompanied the teen into the market when she purchased the alcohol.

In this area of the state, a program known as TRACE (Target Responsibility for Alcohol Connected Emergencies) has conducted hundreds of alcohol investigations during the past eight years. It is that type of investigation that lead to the determination that these two supplied alcohol to the girl. What were these people thinking? Do they not know about the program? Do they think this was going to be swept under the rug? A young girl has died for goodness sake. How tragic.

My thoughts on the dram shop laws are here.

Lawsuit Settles Stemming from Bus Crash Death

January 19, 2012, by Ronald V. Miller, Jr.

A wrongful death lawsuit filed by the widow of a bus driver has come to a close, a month before it was scheduled to go to trial. The terms of the settlement are unknown.

The facts here are sad, as the accident could have completely been avoided. The story goes that a bus driver was traveling with a bus load of people when it struck a tractor-trailer that had overturned on the interstate. The driver was killed instantly, while 29 passengers were taken to the hospital.

The lawsuit accused the tractor-trailer driver of failing to use flares or emergency triangles to warn drivers that his truck was partially blocking the highway. The driver's employer was also named in the suit, alleging that the employer hired the driver with the knowledge that he had multiple traffic citations in his past.

The defense maintained that the driver of the tractor trailer, who had been driving for 11 straight hours, wasn’t able to set flares or emergency triangles because he was still trapped in the tractor trailer. The driver claimed to have swerved to the left to avoid deer on the highway, though an investigation showed that two troopers walked the area, but did not find any tracks in the snow.

Several passengers have also filed lawsuits, in which some have stated that the bus driver was driving too fast for the road conditions and appeared distracted during the drive.

Of note, the tractor-trailer company is no longer in business.

Steelcase Recalls 11,000 Desk Chairs

January 19, 2012, by Ronald V. Miller, Jr.
11,000 desk chairs are being recalled

Steelcase Inc. is recalling the Amia desk chair as it has been discovered that the pivot pins installed in the control mechanism under the chair seat can fall out, posing a fall hazard to the user.

This recall affects the model 482 Series Steelcase Amia desk chairs that were manufactured in the United States between March 1, 2011 and June 6, 2011. The model number and manufacture date of the affected chairs are printed on a label on the underside of the chair seat.

Consumers should immediately stop using the chairs and contact Steelcase to receive adhesive covers to apply over the pivot pins on their chairs.

I don't know how many injuries there have been. I wish when the feds sent out these reports there was a comments section that said things like, "Maybe this recall was unnecessary, I don't know" or "Man, this thing is awful. It is going to kill people and I can't believe these idiots built this thing like this." Unrealistic, sure, but a lot more informative for readers.

Mini Cooper Recall

January 18, 2012, by Ronald V. Miller, Jr.

Nearly 300,000 Mini Coopers are being recalled after makers detected an electrical fault which could lead cars to catch fire. The recall affects approximately 30,000 vehicles in Britain and 235,000 worldwide.

Safety checks have revealed a problem which can cause the water pump to fail, potentially causing the car to overheat. The recall relates to two models – the Mini Cooper S and the Mini John Cooper Works, manufactured by German car maker, BMW.

Amazingly, a spokesman has insisted that the vehicles remain safe to drive, as there is a "very low incidence" of the fault. He goes on to say that "In more extreme cases, it could create a heat build-up in the wiring and some smoldering," and that "Potentially it could cause a fire".

Really? Low incidence or not, I don't want to be part of the "very low incidence" and driving the one vehicle that does catch on fire.

Owners will be issued with a recall notice in the next few weeks and are being encouraged to "simply" go to the dealer and have it fixed.

Honestly, I didn't like these cars before I heard about this recall.

Smith & Nephew Knee Replacement Defect Lawsuits

January 16, 2012, by Ronald V. Miller, Jr.
Smith & Nephew knee replacements are failing at an unacceptable rate

Our lawyers are investigating knee replacement lawsuits against Smith & Nephew. These knee replacements have been on the market for some time. The reason for the lawsuits is simply: the Smith & Nephew knee replacements are simply failing at an unacceptable rate. These were supposed to be knee replacements that would last for 10 to 20 years. Patients who have these devices implanted may be entitled to revision surgery, medical expenses, lost wages and pain and suffering damages. If your knee failed and you think you have a potential knee replacement lawsuit, call 800-553-8082 or get a free on-line consultation.

Smith & Nephew

Smith & Nephew is a company that started with a pharmacy in England in 1856, eventually growing into an international company that develops orthopedic medical devices, wound-care treatments, and endoscopy devices. Smith & Nephew is no stranger to defective knee implants—in September 2003 it recalled its cementless Oxinium Profix II and Oxinium Genesis II knee implants, which had a tendency to come loose and require corrective surgery.

Defective Knee Replacements

The American Academy of Orthopaedic Surgeons conducted a study evaluating 36 devices implanted in 32 patients from January 2008 to January 2009. Eight patients had persistent knee pain well after the surgeries, and only 19% of patients were completely pain-free. Those patients with significant problems had the surgery redone in the form of a total knee replacement. During that second surgery, the baseplate was found to be loose or fractured in all patients. The AAOS reported:

Implantation of the Deuce BKA provides unreliable pain relief and functional results. A survival rate of 86% at 21 months is unacceptable in comparison to reported results of TKA. We report one catastrophically failed device in our series of 36 cases.

Defective Parts

  • Smith & Nephew Journey-Deuce Uni Tibial Baseplates: Recalled in 2010 (40,000 units recalled)

The baseplate (circled in red) rests on the tibia (the bottom leg bone), and attaches to the knee replacement hardware on the femur (the top leg bone). Because these baseplates are breaking, the entire knee replacement can become compromised and unstable.

Symptoms

Patients with defective Smith & Nephew knee replacements may experience pain and limited range of motion. Most patients will require additional surgery to repair the damage.

Status of Smith & Nephew Knee Replacement Lawsuits

Individual lawsuits are being filed against Smith & Nephew for their defective knee implants. There is no class action or MDL yet, but it is possible that plaintiffs will seek to combine many of these cases in a federal MDL as more are filed. Some of the claims plaintiffs' attorneys are alleging include:

  • Negligently manufacturing the knee replacements
  • Strict product liability
  • Failure to warn consumers and healthcare providers about the risks of the knee replacements
  • Breach of warranty

What To Do If You Have A Defective Smith & Nephew Knee Replacement

If you believe you have a Smith & Nephew defective knee implant claim, contact our product liability lawyers at 1-800-553-8082, or click here for a free evaluation of your case.

More Information

  • American Academy of Orthopaedic Surgeons (Feb. 2011): 16% of Smith & Nephew Journey-Deuce knee implants fail within two years of surgery http://www3.aaos.org/education/anmeet/anmt2011/podium/podium.cfm?Pevent=006
  • FDA Journey Knee Replacement Recall (Mar. 3, 2010) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=88048

ATV Crash Settlement

January 13, 2012, by Ronald V. Miller, Jr.

I saw the headline "Fatal ATV Crash Suit Settled for $2.7 Million" and my first reaction - without really thinking about it - was that there must have been a verdict in the AVT product liability cases involving the Yamaha Rhino or some other ATV.

Not quite. This case involved a college student who live in Sykesville, Maryland near where I grew up. The young man was killed as a passenger on an ATV written by someone who was drunk and driving the ATV at an excessive speed.

Now that did not make sense either. Who was paying out the $2.7 million? Turns out, the driver of the vehicle came from a very rich family.

You can read the story on the verdict here.

J&J Sold Insulin Pumps After Learning of Defects

January 11, 2012, by Ronald V. Miller, Jr.

Johnson & Johnson is in hot water. Again. This time, their Animas unit continued to sell insulin pumps last year, after having learned of a malfunction with the pump. The malfunction, involving the pump’s keypad, prompted a design change of the One Touch Ping and 2020 pumps, which included switching manufacturing to a different supplier.

The FDA has released a letter inquiring as to why J&J continued to manufacture the insulin pumps after being made aware of their failures, and has given J&J 15 days to respond. J&J has stated that the warning letter from the FDA only requested further clarification on their internal quality systems and processes, and that the insulin pumps they manufacture meet all product specifications. They do, however, claim to be dedicated to quickly resolving the FDA’s outstanding concerns.

All of this begs the question, why did Johnson & Johnson continue to sell the pumps? J&J, the world’s second-biggest seller of health-care products, has faced a series of safety recalls and FDA warnings over the last two years. Last month’s warning could lead to fines or affect J&J’s chances of winning federal contracts. Was this most recent impropriety worth it? J&J continues to besmirch its once great name. I really can't believe more people are not talking about this. Can this get a mention on CNBC at least? Unbelievable.

Target Flashlight Recall

January 10, 2012, by Ronald V. Miller, Jr.

There is a recall for 55,000 flashlights sold at Target, according to the U.S. Consumer Product Safety Commission. The problem? These recalled LED flashlights are a fire hazard.

The recall involves 6-piece LED Flashlight Sets with flashlights made of silver plastic with black rubber around the handle and light base.The flashlight sets have the UPC code 490021010049 on the back of the flashlight's packaging.

Consumers are advised, obviously, to stop using these flashlights because of the fire hazard and return them to Target. I would love to see the stats on how many of these flashlights are returned to target. I'm betting less than 1,000.

Triple Eight Bike Helmets Recalled

January 10, 2012, by Ronald V. Miller, Jr.
Approximately 30,400 children and youth helmets are recalled

Triple Eight Distribution has announced the recall of approximately 30,400 children and youth bicycle helmets, as recent testing has demonstrated that these helmets do not comply with the CPSC's safety for impact resistance.

The helmets, manufactured in China, are multi-purpose helmets, and also sold for use as bicycle helmets. The "Little Tricky" helmets are marketed for children and youth, and feature a large Little Tricky logo on both sides of the helmet. The "Triple Eight" Liner helmets feature a hard black inner EPS foam liner, and the "Sector 9" Liner helmets feature the same EPS liner. Both the Triple Eight and Sector 9 helmets have an interior label indicating the size “S/M” for small/medium and a manufacture date indicated as month/year (ex. APR/2011), but only the Triple Eight and Sector 9 size “S/M” EPS Liner helmets are affected.

Ultimately, a helmet does not have to accomplish to many things. Just protect the child's head. It would seem like a pretty easy score for a helmet.

Excedrin Recall

January 9, 2012, by Ronald V. Miller, Jr.

Novartis has recalled a number of products that contain broken tablets. Most notable is Excedrin but the recall also includes NoDoz, Bufferin and Gas-X Prevention.

This certainly does not appear to be a big deal. Novartis issued these recalls as a precaution due to an internal product review and complaints that identified issues such as broken gelcaps, chipped tablets and inconsistent bottle packaging line clearance practices, where a potential for a tablet mix up could not be ruled out. Certainly, I bash drug companies enough on here. Novartis should be praised for taking this precaution.

Apple Cider Recall

January 5, 2012, by Ronald V. Miller, Jr.

I have been trying to lay off apple cider in the new year. I love it and it is good for you but the calories just kill you. This was, inadvertently of course, maybe a wise call. Certain production lots of Martinelli’s Gold Medal Sparkling Cider are being recalled in the Western United States.

Six-pack, shrink-bundled, 250 mL glass bottles are being recalled due to the possibility of a defective seal that could break when opening the bottle.

The affected cider being recalled have the following "Best By" dates:

  • 11 APR 2014
  • 12 APR 2014
  • 13 APR 2014
  • 14 APR 2014

These production codes can be found on the front, lower corner of the bottle label under the words “BEST BY:” in a gold colored box. They are for case UPC 4124499932, six-pack UPC 4124446256, and single bottle UPC 4124400256.

The 750 mL size of Martinelli’s Gold Medal Sparkling Cider is not affected and is not part of this recall.

Of course, by March I'll probably be back to chugging apple cider like I was in 2010.

Pottery Barn Bed Canopies Recalled

January 4, 2012, by Ronald V. Miller, Jr.

The U.S. Consumer Product Safety Commission (CPSC) has announced the recall of Pottery Barn Kids' Madeline Canopy Bed, as the connections of the posts to the top rails of the canopy can come apart, allowing components of the canopy to fall. To date, there have been 33 reports of components of the canopy falling, causing nine reports of minor cuts and bruises, and one report of a cut that required stitches.

The canopy is part of the Madeline Bedroom Collection. It is made of wood and consists of four posts that connect to the headboard and footboard of the bed, and four rails that connect to the top portion of each post.

Consumers are being instructed to immediately remove the canopy from the bed and contact Pottery Barn Kids to schedule a free repair.

Vaccine Ruling Filters Down

January 2, 2012, by Ronald V. Miller, Jr.

The Pennsylvania Supreme Court last week reversed itself on its ruling to maintaining a Pennsylvania state court thimerosal claim in light of the Supreme Court's decision in Bruesewitz v. Wyeth. The court returned the case for further proceedings in light of Bruesewitz, which is the same as granting summary judgment for the defendant.

For reasons that escape me, the court held that section §22(b)(1) of the National Childhood Vaccine Injury Act of 1986 pre-empts all vaccine related design defect claims. I don't think - and neither do two other justices on the Supreme Court - that it's a fair reading of the Act. But it is the Supreme Court's call to make so it is no surprise the Pennsylvania court did what it did.

These are tragic cases but they were tough to prove even before the Supreme Court raised the bar even higher.

Merck was represented in the case by Stephen E. Marshall, who is real good lawyer with Venable in Baltimore.

You can read the court's terse opinion here.