Defective Product

May 23, 2013

When most people think of a burn injury, the first thing that comes to mind is exposure to a fire. What many people don’t realize though, is that using certain products, like tanning beds, present a significant risk of such injuries by emitting dangerous ultraviolet (UV) light onto the skin.

One woman discussed the burn injury she sustained through regular use of tanning beds. She stated that for close to seven years, she regularly used a tanning bed at a facility where she worked. Then one day, she noticed a brown spot had developed on her skin. When a doctor examined the area, they were able to determine that she had developed melanoma. The spot was surgically removed, but another melanoma developed several years later and had to be cut away as well.

The doctor who performed the surgeries stated that use of tanning beds can increase an individual’s chances of developing such cancers by as much as 75 percent. According to an article from WRAL News, these risks have forced the U.S. Food and Drug Administration to reclassify tanning beds and similar products as being a “moderate risk” to a person’s health. The agency has also issued several warnings against use of the potentially Defective Product by young people.

The North Carolina Personal Injury Lawyers with HensonFuerst recognize the risks that are associated with the use of tanning beds. The firm is here to help if such a product has harmed you.

Lots more information since we last wrote about defective metal-on-metal hip replacements. The first trial is underway, and plenty of details are emerging. From all the reports, this looks to be a particularly heinous story of corporate greed causing injury to many thousands of unsuspecting individuals.

First, a little background:

While all hip replacements pose risks, research has shown that metal-on-metal hip implants carry unique risks. In metal-on-metal hip implants, the metal ball and the metal cup slide against each other during walking or running, causing tiny bits of metal to “shed” from the device. These tiny metal particles may cause damage to bone and/or the soft tissue (e.g., muscle, cartilage) surrounding the implant and joint. Soft tissue damage may lead to pain, implant loosening, device failure and the need for revision surgery (a surgical procedure where the implant is removed and another is put in its place). In addition, some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause symptoms or illnesses elsewhere in the body (systemic reactions). The type and severity of physical symptoms and illness seem to be specific to individuals, with different patients having different reactions to the metal particles.

http://www.youtube.com/watch?v=18BkrJnKf3g

What’s New

Previously, we told you that recalls were issued for some DePuy metal-on-metal hip replacement devices after research revealed that the failure rate of some hip replacement devices was higher than usual. Back in 2010, at the time of the recall, Johnson & Johnson (J&J—manufacturer of DePuy hip replacements), reported a high 12% failure rate after five years.

BUT…new research shows that the failure rate was much, much higher than that. Australian data showed that the DePuy ASR LX hip had a failure rate of 22% after five years and 44% after seven years. The same study revealed that the ASR produced 16 times more potentially toxic chromium and cobalt debris than other DePuy products. At these levels, the ASR should have failed, but DePuy allowed the ASR device to pass.

According to an article in The New York Times, an internal J&J analysis reported a failure rate of nearly 40% within five years from date of surgery, but the company never released those projections. The article also mentions that DePuy officials were aware–as early as 2008–that one of the recalled devices was releasing high levels of metallic ions, particularly in women.

But DePuy didn’t test for the effects of those metals. According to Robert Harrison, a professor of medicine at the University of California, San Francisco:

“I would have advised to do a very thorough and careful analysis of chromium and cobalt toxicity and the potential that this could be a problem from this particular hip design,” Harrison said. He also said DePuy should have done studies “before the product was put on the market.” [from Bloomberg.com]

The California Poison Control System says that cobalt levels above 7 micrograms/liter are harmful. One patient, Loren Kransky, whose lawsuit is currently being heard, had his ASR hip implanted in December 2007. On September 1, 2011, he had blood cobalt levels of 53.6, or almost eight times the acceptable level. After Kransky had the ASR replaced in a revision surgery in February 2012, his level dropped to 5 micrograms/liter. According to Dr. Harrison:

“The higher the dose, the greater the poisonous effect”…. The poisoning can damage tissues near the hip, and it can be systemic as the metal circulates in the bloodstream. The metals can kill cells, he said.

A Pattern of Obfuscation?

As the first lawsuits began, documents relating to the case became public. The more one reads about the DePuy executives and their decisions, the more it sounds as though negative information was deliberately hidden, withheld, or downplayed. Some examples include:

• In 2008, a surgeon who served as one of DePuy’s top consultants told company officials that he was concerned about one of the ASR components and believed it should be redesigned. That surgeon’s suggestions were ignored.
• In the face of high failure rates, company officials maintained that the problems were related to how surgeons were implanting the device, not to the device design. But at least one executive wrote to marketing officials in early 2009 that failures were related to the product’s design.
• Later in 2009, the FDA asked DePuy for more safety data about the ASR. Shortly afterward, DePuy decided to “phase out” the ASR device, and sell existing inventory–not stop selling the unsafe product, but stop manufacturing it.
• The FDA did not approve one version of the hip implant, the “resurfacing” version, but DePuy didn’t disclose the FDA ruling to regulators in other countries where the device was being sold.

Recommendations for People Who Have Metal-On-Metal Hip Implants

You and your doctor should pay close attention to any signs or symptoms that may be associated with metal-on-metal hip implants. These include:

• Pain or swelling at or near the hip
• A change in walking ability
• A noise from the hip joint
• Local nerve palsy
• A palpable mass or lump at the hip
• Infection
• Hypersensitivity
• Skin rash (not just at the hip)
• Neurological changes, including sensory changes (auditory or visual impairment)
• Change in psychology (depression)
• Thyroid dysfunction (neck discomfort)
• Fatigue
• Weight gain

The FDA recommends routine long-term follow-up of patients every one to two years, for life. People experiencing symptoms should be seen by a physician every 6 months to monitor the progression of symptoms.

Along with a general physical examination, patients may also receive an x-ray or MRI to look for bone and soft tissue damage. Patients with severe symptoms may also have metal ion testing, although there isn’t necessarily a link between blood ion levels and actual damage–some people may have physical damage without having elevated levels of ions.

When To See an Attorney

HensonFuerst Attorneys has been investigating the legal side of metal-on-metal hip replacement devices for years, ever since DePuy Orthopaedics issued a recall of two of their top-selling hip implants. Since then, other metal-on-metal hip manufacturers have also issued recalls or warnings about their products.

If you know that you have one of the recalled hip replacement devices… OR if you have severe pain around your hip… OR if you have been told that you have a defective hip replacement, call HensonFuerst Attorneys for important information about your rights. You may have a legal case and we will fight to help you collect compensation for the injury caused by the faulty medical device.

What’s most important: DO NOT contact any medical device manufacturer, or SIGN RELEASES OF YOUR MEDICAL RECORDS to any company before you talk with a lawyer. Don’t “register” or attempt to file a claim on your own. Let a lawyer handle everything. Big corporations look out for their own financial interests, not the interests of people who may have been harmed.

If you are worried about your future health, or if you would finally like your questions answered, call us at 1-800-4-LAWMED. Or, visit our website at www.lawmed.com for more information.  At HensonFuerst, your health is at the top of our priority list. We dedicate ourselves to protecting individuals from the greed and callousness of large corporations. Let us work for you.

Life Doesn’t Wait…get help today. Call HensonFuerst.

Whether you’re looking for the blood-red eyes of a vampire, or the striking eyes of a cat with vertical irises, decorative contact can be a dramatic way to enhance a Halloween costume. BUT…(you knew there had to be a “but”) there are some serious risks to be considered before getting dressed for trick-or-treat.

According to the U.S. Food and Drug Administration (FDA), decorative contact lenses are considered medical devices, and they should only be purchased from an eye doctor–an optometrist or ophthalmologist. That’s because contacts are not “one size fits all.” Without proper fit, your eyes can be damaged, sometimes seriously.

Poorly fitting contacts could potentially lead to scratches on the cornea, corneal infection, conjunctivitis, decreased vision, or even blindness. According to Bernard Lepri, O.D., M.S., M.Ed., an optometrist at FDA:  “Bacterial infections can be extremely rapid, result in corneal ulcers, and cause blindness—sometimes within as little as 24 hours if not diagnosed and treated promptly.”

Many people assume that contact lenses are harmless bits of plastic. Unfortunately, that’s not true, and problems can occur if the contacts are made improperly, fit incorrectly, or have been exposed to contaminates. The FDA recommends that you NEVER, EVER buy contact lenses from street vendors, salons or beauty supply stores, boutiques, flea markets, Halloween or novelty stores, other non-optometry shops, or from the Internet.

Again, the only valid place to purchase decorative or fashion lenses is from an eye doctor–even if you have perfect vision. To learn more about the FDA’s recommendations regarding decorative contact lenses, click here:  Is Your Vision Worth It?

photo by Barry Chin/Boston Globe

Less than two weeks ago, we told you about the meningitis outbreak from spinal steroid injections. At that time, 105 people had developed meningitis, and 9 had died. The numbers have been steadily rising.

Now, 247 people have become ill, and 19 have died.

According to an article in the News & Observer, the infections seem to have been caused by three types of fungus–most of them a form of black mold. The steroid suspected to be the cause of the illnesses was made by the New England Compounding Center of Framingham, MA.

Now, officials at the U.S. Food and Drug Administration (FDA) say they are investigating other drugs made by the same company–another steroid and a solution used during heart surgery. Criminal investigators for the FDA visited the New England Compounding Center on Tuesday, and the government is preparing a case against the company.

According to an article in The New York Times, the FDA’s Criminal Investigation’s unit typically looks into suspected violations of federal laws meant to protect public health, including making and selling unapproved drugs, and illegally importing FDA-regulated products. The FDA isn’t saying exactly what they are looking for in their investigation, but for the victims of the contaminated steroid and their families, the investigation is coming way too late.

If you have been injured by a drug made by the New England Compounding Center or other company, and you would like to learn about your legal options, feel free to call HensonFuerst Attorneys at 1-800-4-LAWMED, or visit our website at www.lawmed.com/druginjury. If you have question, HensonFuerst is here to help.

RESOURCES

To read the full article in the N&O, click here: Meningitis outbreak deaths rise to 19

To read the full article in The New York Times, click here: Investigators visit company tied to meningitis cases

Another hip replacement recall.  Stryker Corp. has recalled two hip replacement devices: the Rejuvenate, and the ABG II modular-neck stems.

The devices are being recalled because of risks of corrosion and “fretting,” or corrosion made worse by abrasive wear. The company says that the corrosion “may result in adverse local tissue reactions manifesting in pain and/or swelling.” Other adverse effects can include bone damage, tissue death (necrosis), or metallosis–when metal debris causes inflammation in the surrounding tissue. This type of inflammation may cause long-term, or even permanent damage.

HIP REPLACEMENT DANGERS

In 2010, we told you about a recall of two hip replacement devices by DePuy Orthopaedics:  the ASR XL Acetabular System, and the ASR Hip Resurfacing System. The recall was due to higher-than-usual failure rates, which caused thousands of patients to require second surgeries to replace the replacement. (To read that original blog, click here:  DePuy Hip Replacement Recall Raises Mores Questions)

Now, the Stryker recall.

At this point, many experts are saying that people who have had any brand of metal-on-metal hip replacement should contact their physicians and request testing to make sure that their hip replacement devices aren’t harming them. That’s especially true if you have had a Stryker or DePuy hip replacement.

WHAT TO DO

If you already know that you received one of the recalled Stryker or DePuy hip replacement systems, we recommend two things:

1. Schedule a follow-up appointment with your surgeon, even if you’re not currently having symptoms. It is possible that you could have early signs of failure before you recognize the pain. Your doctor will be able to evaluate how your hip is functioning and whether the recalled implant is in need of replacement.

In that visit, your orthopedic surgeon may also want to test for the presence of microscopic metal particles around your hip. Metal particles are a sign that recalled implant is failing. 

2. Call HensonFuerst Attorneys for important information about your rights. If you or someone you care about received one of these defective joint replacement components, we would like to speak with you right away.  You may have a legal case and be able to collect compensation for the injury caused by a faulty medical device.

What’s most important: DO NOT contact Stryker or DePuy, or SIGN ANY RELEASES OF YOUR MEDICAL RECORDS to any company before you talk with a lawyer. The hip replacement companies are asking patients to register with them and receive a claim number. DO NOT DO THIS YOURSELF. Let a lawyer handle everything. Big corporations look out for their own financial interests, not the interests of people who may have been harmed.

HensonFuerst Attorneys is continuing its investigation into hip replacement failure rates. If you have questions and would like answers, call us.

If you are worried about your future health, call us.

If you can’t get straight answer from your surgeon or hospital, call us.

With HensonFuerst, your health is at the top of our priority list. We dedicate ourselves to protecting individuals from the greed and callousness of large corporations. Let us work for you. Our attorneys are available 24 hours a day, every day of the year at 1-800-4-LAW-MED (1-800-452-9633). Or, visit our website at www.lawmed.com for more information. You can also fill out a free online consultation form for an immediate evaluation of your case.

Life Doesn’t Wait…get help today. Call HensonFuerst.

This law firm is not affiliated with, sponsored by, or associated with the Stryker Corp., DePuy Orthopaedics, Inc., Johnson & Johnson, or any other hip replacement manufacturing company.

If your plans for the rest of the summer involve a visit to an amusement park, you’re not alone. Every year in the United States alone, about 290 million people visit amusement parks, and they enjoy more than 1.5 billion rides. (It gives me whiplash just thinking about it!)

Given those statistics, it’s amazing that the injury rate is as low as it is. According to the Consumer Product Safety Commission, about 12,500 people annually are injured severely enough to be treated in a hospital emergency room. Most of the injuries–60%–are caused by mechanical amusement rides (such as rollercoasters), while the remaining injuries are caused by inflatable amusement devices (such as bouncy houses) and waterslides.

While the majority of the injuries are relatively minor, some are catastrophic or even fatal. The most serious injuries happen to children, and they occur when a child falls or is thrown from a ride. But the most common injuries are due to impacts and body strains caused by the ride’s normal motion, including whiplash or being thrown against part of the seat or carrier during the regular course of the ride. Other injuries include:

• falls during loading or unloading;
• being hit or pinched between moving parts;
• seizures or other neurologic symptoms;
• ejection from the seat or carriage;
• unintended collision.

It sounds like a lot of risk, but there’s no reason to avoid the fun. There are ways to stay safer during your visit to an amusement park.

Tips for Staying Safe 

• Observe and obey the listed age, height, weight, and health restrictions. Those are posted for a reason, based on physics and ride construction. Don’t think that just because your child is “mature” that he or she will physically be able to handle a ride.
• Keep hands, arms, legs, and feet inside the ride at all times.
• Remain seated in the ride until it comes to a complete stop–many injuries occur after the ride is over.
• Never force anyone–especially children–to ride if they don’t want to.
• Don’t assume your child will be safe on a ride simply because the ride operator says it’s okay–use your own judgment about what looks and feels safe. There are no mandatory federal safety standards or regulatory oversight of amusement rides.
• Explain ride regulations to your child.
• Tell children to hold on tightly with both hands.  Solid metal lap bars and handholds are part of the safety equipment. Many kids raised in the era of five-point car seat restraint systems don’t know that holding on is important.
• Don’t put your child on a ride he or she has outgrown. Maximum height and weight limits are just as important as minimum limits.
• Teach small children what to do if they get separated from you. Point out uniformed park employees so that they know who is in charge of finding “lost parents.” Choose an obvious landmark as a meeting place.
• Remember that just because you may be in a place your child might view as “magic,” rides are heavy machinery, and water parks have very real drowning risks. Let your child enjoy the day…even if it means staying hyper vigilant yourself.

To read more about amusement park safety, visit SaferParks.org

If you have been seriously injured at an amusement park and want to explore your legal, please feel free to call one of the experienced lawyers at HensonFuerst Attorneys at 1-800-4-LAWMED, or visit our website at LawMed.com. Life Doesn’t Wait.

April 26, 2012

For more than two million Americans who are allergic to insect bites or stings, such as those from bees and ants, spring is a time for heightened awareness when outdoors.

For most insect allergy suffers, being prepared for this time of year means carrying an EpiPen. These are devices that are used to inject epinephrine into an allergy sufferer’s bloodstream in the event of a bite or sting. The epinephrine then works to stop the body from swelling, which is a reaction to the poison from the sting or bite.

Hospitals also use the drug for a variety of procedures such as resuscitation from cardiac arrest following anesthetic accident or to prolong the action of intraspinal and local anesthetics.

However, the Food and Drug Administration issued a recall yesterday on a batch of American Regent’s Epinephrine injections. The company recalled Lot # 1395 of the drug because of discoloration of the medication and visible parts and debris floating inside the vials. The company has asked anyone with the affected medications to contact the manufacturer or the location where you received the medication to get a full refund or replacement.

The North Carolina Defective Product Lawyers with HensonFuerst Injury Lawyers would like to remind all EpiPen users to check their devices to ensure they are not part of the affected lot, and also to check the expiration dates on old pens to make sure the medication is still viable.

For over a year, we’ve been telling you about the problems with metal-on-metal hip replacement devices. Some, such as the DePuy devices by Johnson & Johnson, were recalled due to a higher-than-usual failure rate, causing patients to require second surgeries to replace the replacements. In May 2011, the U.S. Food and Drug Administration (FDA) ordered all producers of “metal-on-metal” hip replacements to study the implants to make sure patients remain as safe as possible.

You can read those earlier blogs here:

Hip Replacements Fail, Sometimes Without Symptoms

Diagnosing Hip Replacement Injury

Now, according to an article in The New York Times, British help regulators recommend that patients in Britain who received metal-on-metal artificial hips — which were also used widely in the United States — should undergo annual examinations for as long as they have the device to make sure they are not suffering tissue damage or other problems. This recommendation was made out of concern that serious problems could surface 15 or even 20 years after the original surgery.

“By monitoring patients every year, any complications will get picked up earlier and more complex surgery on the patient can be avoided,” said Dr. Susanne Ludgate, the clinical director of the Medicines and Healthcare Products Regulatory Agency.

It has been estimated that about 500,000 people in the United States received an all-metal hip during the past 10 years. Thousands of them have been forced to undergo second surgeries to have the replacements replaced. Hundreds have suffered crippling injuries due to the tissue and muscle tissue damage caused by metallic debris shed by the devices.

In the U.S., the FDA is not changing its recommendation that all hip replacement patients undergo “regular” follow-up with their physicians. That’s good advice…and we recommend that these follow-ups occur even if patients don’t think they have any special problem with their hip replacements. Some people with significant damage to the surrounding muscle tissue don’t have any pain until the injury is severe.

If you have had a metal-on-metal hip replacement that failed early, or if you have had tissue damage due to the device and would like to explore your legal options, feel free to contact the attorneys of HensonFuerst. Someone is available 24 hours a day, 7 days a week at 1-800-4-LAWMED…or view our website at http://www.lawmed.com/.

If you have questions, HensonFuerst has answers.

To read the full article in The New York Times, click here:  Britain Extends Monitoring for People with Metal Hips

In 2010, DePuy Orthopaedics, a division of Johnson & Johnson, sent a letter to doctors announcing a recall of two of their hip replacement systems, the ASR XL Acetabular System, and the ASR Hip Resurfacing System due to their higher-than-usual failure rates. The failures necessitated that patients have a second surgeries to replace the replacement, but some people still ended up with severe tissue damage that left them in pain.

Before the recall, Johnson & Johnson refused to acknowledge that the medical device was flawed. But now, in an article published in The New York Times, it seems that Johnson & Johnson was aware of the high failure rate—and an email stating so was written by a DePuy vice president and sent to top executives in the corporation. In the email, Pamela Plouhar:

…reported that the device had not met F.D.A. approval standards and that a major concern was its high rate of early failure, or “revision,” during clinical trials. She also cautioned that providing the F.D.A. with more data might not change its stance and that it might take years to conduct new studies of the hip, known as the ASR, or articular surface replacement.

In addition, Ms. Plouhar’s email stated that there had been “a significant number of revisions in the ASR group” compared with “very few in the control group.”

That means that the FDA, Ms. Plouhar, and—after the email was sent—other J&J executives all knew that there were significant problems with the hip replacement devices. And yet, the company did not notify doctors or patients about the problems. In fact, they continued marketing and selling the device in the United States and around the world…at least until the recall was announced in August 2010. In all, about 93,000 people received a DePuy hip replacement.

Throughout the episode, DePuy blamed orthopedic surgeons for the model’s failures, saying that doctors were not positioning a component properly. But the clinical findings rejected by the F.D.A. came from A.S.R. studies run by surgeons hand-picked by DePuy, including some who had developed the implant and received royalties or consulting fees in connection with it.

This new information is not going to help Johnson & Johnson’s reputation, which has recently been turning from gleaming to rusty.  Perhaps this is why J&J CEO William C. Weldon announced that he will step down in April. Analysts believe he would rather retire by choice than be forced to resign.

HensonFuerst Video about the DePuy recall:  DePuy Orthopaedics Hip Replacement Recall

If you believe you have been injured by a DePuy hip replacement and would like to discuss your legal options, please feel free to call HensonFuerst Attorneys at 1-800-4-LAWMED, or visit our website at http://www.lawmed.com/. If you have questions, HensonFuerst has answers.

RESOURCES

To read the full story in The New York TImes, click here:  Hip Maker Discussed Failures

To read our blog about the DePuy recall, click here:  DePuy Hip Replacement Recall

On August 24, 2010, DePuy Orthopaedics, a division of Johnson & Johnson, sent a letter to doctors announcing a recall of two of their hip replacement systems, the ASR XL Acetabular System, and the ASR Hip Resurfacing System. Why? Because they have a higher-than-usual failure rates, causing people to have to have second surgeries to replace the replacement. Since then, we’ve written extensively about DePuy and other metal-on-metal hip replacement devices, and the sometimes-extensive destruction they can cause in the human body.

Now, The New York Times reveals that Johnson & Johnson continued to market the defective devices in Europe and elsewhere overseas. In addition, the company also continued to sell a related model in the United States, which earlier went on the market using a regulatory loophole. However, the U.S. Food and Drug Administration (FDA) wrote a confidential letter to Johnson & Johnson in August 2009 basically saying that the agency couldn’t determine the implant’s safety and effectiveness, and therefore couldn’t approve it for sale in the U.S.

According to the article:

There is no suggestion that Johnson & Johnson broke the law. Regulatory standards in other countries, like those in Europe, for approving the sale of medical devices are typically lower than here. A spokeswoman for a British regulatory agency, the Medicines and Healthcare Products Regulatory Agency, said that companies like Johnson & Johnson were not required to notify it when the F.D.A. refused to approve a product that was used in patients there.

However, the F.D.A.’s rejection may further deepen the company’s legal and financial problems surrounding the ASR. Last month, the company took a special $3 billion charge, much of it related to anticipated legal and medical expenses associated with the recall. An estimated 5,000 lawsuits involving the device are pending, including some from patients crippled by tiny particles of metallic debris shed by the implants.

There seem to be two moral issues at stake here:  The morality of Johnson & Johnson continuing to sell a product that was clearly raising safety flags…and the morality of the FDA, which keeps its evaluations secret and confidential. A lawyer who specializes in FDA regulation said that companies that withhold a non approval letter containing important safety information could face damage to its brand. Funny, that doesn’t seem quite as important as the damage done to the unwitting patients who received these potentially harmful devices. And if the FDA is keeping secrets on behalf of corporations, who is looking out for our health?

To read the full article in The New York Times, click here:  Hip Implants U.S. Rejected Sold Overseas

If you believe you have been injured as the result of a metal-on-metal hip implant and would like to investigate your legal options, feel free to contact HensonFuerst Attorneys at 1-800-4-LAWMED, or visit our website at http://www.lawmed.com/.

Previous HensonFuerst blogs:

DePuy Hip Replacement Recall Raises More Questions

Hip Replacements to be Evaluated for Safety

Hip Replacements Fail, Sometimes Without Symptoms

Diagnosing Hip Replacement Injury

VIDEO: DePuy Hip Replacement Recall (http://www.youtube.com/watch?v=18BkrJnKf3g)