Articles Posted in Product Liability

prescriptions-fdaAccording to its own website, the FDA “is responsible for protecting the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products, and medical devices.”

But does the FDA protect the public? As recently reported by Slate magazine:

“When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted. On the contrary. For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses. The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn’t get forthright answers. For an agency devoted to protecting the public from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.”

stryker-hip-implantsAt the annual conference of the American Academy of Orthopaedic Surgeons earlier this year, Mayo Clinic researchers reported that 2.5 million Americans are living with artificial hips, surgically implanted when their natural joints degenerated or were fractured. Most of these patients found themselves with a new lease on life after their surgery, able to resume the normal activities they had enjoyed before their hips gave out. For thousands, however, the hip replacement devices led to disappointment, debilitating pain, and do-over surgery.

According to the FDA, between 1992 and 2011, nearly 40,000 patients suffered ‘adverse reactions’ from metal-on-metal hip joint replacements, including the Stryker Rejuvenate Modular-Neck and the ABG II Modular-Neck devices. The adverse reactions included metallosis (the release of metal ions into the tissue and blood stream); necrosis (premature tissue death); osteolysis (bone dissolution); and pain and loosening of the hip implant, requiring revision surgery. In 2012, Stryker announced a recall of these two products. Thousands of lawsuits followed.

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dentist-teeth

I know some members of the Big Blue Nation (i.e., U.K. basketball devotees) who are such rabid fans that they are probably maniacally brushing with Crest in hopes that their gums will turn blue before the start of basketball season – and before Procter & Gamble removes the little blue microbeads from all of their products in the wake of scrutiny by environmentalists and concerned dental practitioners.

Many cosmetic products contain microbeads, tiny pellets of high-density plastic, either as abrasive additives or just for looks. The same plastic used in manufacturing garbage cans, grocery bags and knee replacements is also used in facial cleansers and exfoliant washes, chewing gum, and, yes, toothpaste.

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SC Remington Recall

Whether you’re a deer hunter looking forward to this autumn’s harvest or someone who enjoys indoor target shooting, if you own a Remington rifle you’ll want to check out whether it is included in the recent recall.

On April 11, the Remington Arms Company issued a voluntary nationwide recall of their Model 700 and Model Seven rifles equipped with the X-Mark Pro trigger that was manufactured between May 2006 and April 9, 2014. Their website gives detailed instructions for determining whether your gun is one of those recalled because it can accidentally discharge.

If you have one of the recalled Remington rifles, you’re certainly not alone. The Model 700 bolt-action rifles have been popular because of their accuracy and “smooth trigger,” with more than 5 million of them sold since 1962. The X-Mark Pro trigger on the recalled rifles can discharge when small amounts of rust, debris, or even a small jolt can cause the trigger connector to become misaligned. In some cases, rifles have discharged as the safety was moved to the off position to unload the gun or when the bolt was opened, closed or even just touched.

If you’re like most parents nowadays, you’re looking every year for something to make your child’s birthday party special. Pin the Tail on the Donkey gave way long ago to more adventurous activities, things like the increasingly popular bounce house, set up in your own backyard by one of thousands of party rental companies. Kids think they’re loads of fun, and parents assume they’re safe . . . that is, until an accident happens and a child is injured or killed. You should be aware that injuries on inflatable amusement structures are not uncommon.

The U.S. Consumer Product Safety Commission (CPSC) estimates that more than 4,000 emergency room visits a year in the United States are linked to inflatables. Bounce houses (also known as moonbounces) cause the vast majority of injuries, but they’re not the only inflatable amusement attractions. Slides, obstacle courses, climbing walls and interactive (such as boxing or jousting) inflatables also feature in the accident statistics.

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Laparoscopic Surgery ComplicationsLaparoscopic surgeries – those done “robotically” through small incisions – have become preferred by doctors and patients in many instances, because they mean less time in the hospital, quicker recovery and minimal scarring. On April 14, 2014, however, the FDA issued a Safety Communication about the device used to accomplish some of these surgeries, specifically hysterectomies and surgeries to remove fibroid tumors in women.

The surgical device is called a morcellator, and it is produced by five companies, including Johnson & Johnson. The surgeon inserts the morcellator into the uterus through a small incision. Its blades chop up the tissue so it can be removed through the same tiny incision. What they are finding, however, is that when women have an undiagnosed cancer, a uterine sarcoma, the cancerous tissue also gets divided and may spread malignant cells throughout the abdomen and pelvis, “significantly worsening the patient’s likelihood of long-term survival.”

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For four years now, April has been designated Parkinson’s Awareness Month by resolution of the U.S. Senate. We’d like to make you aware of some of the issues surrounding Parkinson’s and how Louthian Law might assist you or a loved one afflicted with the disease.

parkinsons-south-carolina

What is Parkinson’s disease?

Parkinson’s disease is a neurological disorder which affects motor functioning. The symptoms include shaking (tremors), rigidity of muscles, problems with walking, difficulty speaking or an inability to speak, diminished higher brain functions, loss or slowing of physical movement, and depression.

FDR said, in his second inaugural address, “We have always known that heedless self interest was bad morals, we now know that it is bad economics.” He was referring to the abuses that led to the 1929 stock market crash and the Great Depression.

GM Auto Recall

Even now, nearly eight decades later, we find that corporate greed has led to unconscionable decisions which, in turn, have resulted in peril for one of America’s industrial giants and for millions of American citizens. I’m referring to the choice by GM not to spend one dollar per car to correct the problems with the ignition switch that has cost at least 12 people their lives and caused 31 accidents. GM itself faces a criminal investigation and multiple lawsuits alleging they knew about the faulty ignition switches in 2002 but waited until 2014 to recall a total of 2.5 million vehicles that have ignition switches that may easily be moved out of the “run” position and into the “auxiliary” position, causing loss of power, steering, braking, airbags and lighting. That’s bad economics any way you look at it.

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And the answer, announced last month by the National Highway Transportation Safety Administration (NHTSA) is 2V . . . or, more precisely, V2V.

South Carolina Auto Safety
V2V technology allows vehicles to communicate with each other and to share important data with the driver. For instance, basic safety data like speed, location and direction of travel are collected from a 360-degree radius, analyzed for risk, and used to warn the driver to take action (like removing a foot from the gas pedal) to avoid common types of crashes like rear-end and intersection collisions.

This advancing technology was tested in a year-long pilot program run in Ann Arbor, Michigan, by the U.S. Department of Transportation. They outfitted almost 3,000 vehicles with Dedicated Short Range Communications (DSRC) capability – a technology similar to Wi-Fi ; recruited and trained volunteers; and sent the vehicles out onto 73 lane-miles of city streets and freeways.

We seem to be stuck on the topic of car seats lately, having written about regulation reforms and how-to’s. But a recent recall by Graco, one of the world’s largest manufacturers of car seats and other equipment for children, deserves attention since it affects a massive number of seats in which a child can become trapped due to a sticking latch mechanism.

The National Highway Traffic Safety Administration (NHTSA) asked Graco to recall the car seats and booster seats out of a concern that children could be harmed when the quick-release button isn’t quick and, in fact, in some cases doesn’t release at all. Graco “voluntarily” recalled 3.7 million toddler seats but so far has declined to recall an additional 1.8 million infant seats found by NHTSA to “contain a defect related to motor vehicle safety,” i.e., a latch that impedes the quick removal of a child in an emergency situation.

Graco says no injuries have resulted from the stubborn latches, even though desperate parents have reported having to cut the harness straps or call emergency personnel to extricate their child. NHTSA’s January 14 letter to Graco, however, mentions a pending California lawsuit that describes just the tragic situation NHTSA hopes to prevent. In that case, a two-year-old child was fastened into a Graco car seat and perished in a fire resulting from a car accident, allegedly because she could not be quickly removed.