By Taylor Lindstrom

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A 30-year-old man needs a hip replacement. His surgeon recommends a DePuy ASR XL Acetabular system because its metal-on-metal design is more durable and allows for a more active life. Following the doctor's recommendations, the young man gets the DePuy hip implant.

Then the hip implant fails. The young man is in extraordinary pain. His revision surgery reveals dead tissue and deteriorated bone, making it extremely difficult for his new implant to take hold. He takes a blood test that reveals extremely elevated levels of cobalt and chromium. He is now hypersensitive to metal and the surgeon warns him he may contract early-onset osteolysis.

The young man blames the surgeon for recommending the ASR XL Acetabular system in the first place? But the surgeon isn't the culprit in this scenario; he made the best recommendation he could for his patient. The surgeon is simply another victim of the real culprit: an FDA approval loophole called "substantial equivalence."

A surgeon has countless medical devices to choose from. In the world of hip implants, he's looking at numerous options. The surgeon naturally wants to give his patients the best implant possible for their situation, so he chooses only FDA-approved devices that have been rigorously tested for safety.

Or so he thinks.

Does an FDA Endorsement Guarantee Hip Implants' Safety?

The FDA has two processes for approving a new medical device: the premarket approval process, and the premarket notification approval process. Similar as their names are, there is a world of difference between those two processes.

In the case of the patients who received an ASR XL Acetabular system, it may have been the difference between an improved quality of life with a working hip implant - and a drastically reduced quality of life with a faulty one.

The premarket notification process is also known as the 510(k) process, and it includes the loophole of “substantial equivalence." The 510(k) process allows a product to go directly to market without full clinical testing if the manufacturer claims the medical device is "substantially equivalent" to another device already on the market.

According to FDA documents, a substantially equivalent product is one that is created for the same intended use as the previously approved products; has the same design, materials and technology; and raises no new concerns about safety or effectiveness.

Substantial equivalence was designed to prevent the 2-3 year waiting period for testing. If one hip implant is so similar to another device that it could be expected to get the same test results, what was the point of testing it?

One might argue "safety," but one would be naive to do so. Medical device companies pushed for the substantial equivalence loophole for an entirely different and far less altrustic reason: profits. Every year spent in testing is a year that hip implant isn't on the market earning money for the company.

A Pyramid Built on Sand

For Johnson & Johnson and its subsidiary DePuy, the priority was on products, not patients. They claimed the ASR XL Acetabular System was "substantially equivalent" to no less than three other devices already on the market that had been tested for safety.

Every part of that statement would prove to be inaccurate.

Companies are allowed to claim that their new product is substantially equivalent to more than one other product. For example, since they have to show that they have the same materials and technology as a previously approved product, a company might show that they used the same materials as one product and the same technology as another.

For the ASR XL Acetabular system's 510(k) application, DePuy cited three different previously approved products saying that the ASR system was "substantially equivalent"-at least in part-to all three.

By this argument, you could get a safety approval from the FDA for a flying car with submarine without ever testing it - after all, it is "substantially equivalent" - at least in part - to an airplane, a car, and a submarine. What on earth would be the point in testing it again when the basic principles have already been proven safe?

The loophole gets even more absurd: companies are allowed to base their claims of "substantial equivalence" on products that were approved under the same 510(k) process.

One of the devices DuPuy used was approved with one device-that had been approved through another device-that had been approved through a third device-that was approved because it was substantially equivalent to a product grandfathered into the system prior to 1976.

Essentially, DePuy was claiming that their product was substantially equivalent to hip replacements manufactured before the FDA was ever in place.

Not a single hip implant in this chain of FDA was ever subjected to clinical trials before it was allowed to go to market. Even if it had been, it seems laughable that a hip implant "substantially equivalent" to a series of pre-1976 implant could ever make it through the FDA. Has technology developed so slowly that the best implants on the market are based on designs from 40 years ago?

Put it into perspective: the ASR XL Acetabular system was marketed to younger people who needed a longer-lasting, more durable hip replacement. That means many of the recipients got a hip implant based on a design older than they were.

Only 10% of applications submitted under the 510(k) process are ever returned with a request for clinical trials. That means that 90% of the Class III hip implants available today were never tested in a clinical setting before being marketed to the public.

It's a wonder there haven't been more problems with these hip implants. How many of us would willingly submit to the medical procedures of 40 years ago?

Testing the DePuy Hip Implant Takes a Backdoor to Profits

Had thorough clinical testing been done, it would have become clear long before the product went to market that the ASR XL Acetabular system had a revision rate of at least 15% and possibly more, not to mention a much higher rate of metallosis, metal poisoning, bone deterioration, and tissue damage.

Had DuPuy gone through the more rigorous PMA process with the FDA, its likely the ASR system would never have been sold to the public.

But then again, that was probably why DePuy didn't go through the more rigorous process. The 510(k) process and substantial equivalence meant that DePuy could start making profits off their hip implants much more quickly. Why risk losing the profits just because the device can't be proven safe?

While we acknowledge that companies need to make profits, companies who make medical devices such hip implants must be driven by consumer safety above all else. Willingly causing pain and suffering to thousands of people in exchange for a payoff makes DePuy "substantially equivalent" to a hired thug.

It's a harsh comparison - but one that holds up much better under scrutiny than the ASR XL Acetabular System.

If you're among those who received a DePuy hip implant, we'd like to help answer any questions you may have, both medical and legal. DePuy didn't care about your safety enough to compromise their profits; we do.

When DePuy issued their hip recall, they offered to pay for the revision surgery needed to replace the faulty hip with a new implant. They appear to believe this is the full extent of their responsibility in repairing the damage they've done to thousands of people who had a hip replacement implanted in their bodies.

It's not enough. Because the damage the ASR XL Acetabular system caused doesn't end when the hip is removed. It's only just beginning.

How Your Hips Work

If this were an after-school special, we'd show you a few clips at this point: Elvis shaking his hips on stage back in the day, or a ballet dancer extending her leg over her head. The after-school special would be missing the point, however - your hips are essential to nearly every movement you make. You use them every time you stand, sit, crouch, or lean over. You use them getting into and out of cars, climbing up the porch steps to your front door, even just standing there.

A hip is a little bit like oxygen. You don't notice how essential it is until it's gone.

There's a reason you barely notice your hip's contribution to your everyday movements: your body has constructed it more or less perfectly. The hip bone is a portion of your pelvis, and it has a rounded cup-shape in its center into which the top of your femur bone fits, called the acetabulum.

How a Hip Implant Works

There are two basic ways of affixing the hip implant to the rest of your skeleton. In both, the top of your femur is sawn off and replaced with an artificial new head; while the hip bone itself is shaved down to accommodate a man-made socket. Essentially, the acetabulum is carved out to the shape of the new socket.

The difference lies in how the new femur head and socket are attached to the surrounding bone. In older patients, the most common tactic is to use a bone cement to attach them. In younger patients, however, the surrounding bone is still versatile and capable of regrowth. Since cement has some serious drawbacks, including the risk that it will shrink or crack over time and the fact that it is not especially secure when it comes to withstanding forceful movements like jumping, another procedure has been developed for younger patients.

The cement-free procedure involves creating an environment that encourages the hip bone to grow onto the implant and hold it into place. To do this, the ASR XL Acetabular system included a cup with a pitted exterior, giving the bone lots of small holes to grow into and secure the implant further.

This is more or less what DePuy promised the surgeons who recommended the ASR XL Acetabular System to their patients. 20 years turned out to be a gross overestimate.

How the ASR XL Acetabular System Failed

The ASR XL Acetabular System was a cement-free hip implant. Its design inserted a long stem into the femur bone for increased stability, and featured a socket that had that moon-crated surface which would encourage the hip bone to grow onto it and secure the implant in place.

Unfortunately, the design was deeply flawed. The head and socket did not fit together properly, causing too much friction. There was no room for lubrication to seep into the space between the head and the socket, which meant the patients were in constant pain as the two parts of the hip implant ground together. Even worse, the friction was causing pieces of the implant - tiny metal ions - to rub off and seep into the bloodstream, poisoning the surrounding tissue and bone.

Under circumstances like that, it's no wonder the surrounding bone couldn't grow onto the implant to secure it in place. The bone was under an onslaught of abuse from increased friction and pressure as well as metallosis. Since there wasn't sufficient lubrication around the hip implant, the metal couldn't circulate freely throughout the body - not that this would have been much of an improvement, since the materials the ASR XL Acetabular System are made of include cobalt and chromium.

Since the metal ions couldn't circulate, they stayed put in the hip joint, causing massive bone deterioration, metallosis, metal poisoning, tissue damage and necrosis.

Why You Can't Just Take the Hip Implant Out

The obvious solution to a hip implant that is slowly poisoning you from the inside is to remove it. However, DePuy seems to think the problem ends there - which it doesn't.

As we've explained, you need healthy, living bone to make a hip implant succeed. Once the surgeon removes the ASR XL Acetabular System, there isn't much in the way of healthy bone left.

There are two reasons for this: one is that the hip implant has been slowly poisoning the surrounding bone and discouraging growth. The second reason is much more simple: the hip bone simply hasn't had time to recover from the abuse of the initial surgery. The surgeon shaved away part of the acetabulum to make room for the implant, which is traumatic for the bone. It takes time to recover.

Normally, the hip bone would have 15 or 20 years to recover

With the DePuy hip recall, many patients' hip bones have had as few as two or three years, which simply isn't enough time. When a new device is put in, odds are very good that their bodies will reject the hip implant. That area has suffered a great deal of trauma and the body hasn't had time to forget it - so it will attack, and reject, any new foreign material.

Even a new hip implant - one that works the way it should.

Every hip implant causes more bone trauma and increases the chances that the next 510 will be rejected. Patients with working implants can expect to get a good 15 to 20 years out of their hips before they confront the fact that a new implant may only last half as long.

Those who received the ASR XL Acetabular System? They have to confront it now - along with the myriad side effects of the implant's poor engineering.

By Megan Breckenridge, Staff Writer

HOUSTON — On August 26, 2010, DePuy Orthopedics, Inc., a subsidiary of Johnson & Johnson, announced it is voluntarily recalling two types of hip implants due to high early failure rates.

The recall affects the ASR™ XL Acetabular System, which is used for total hip replacements, and the DePuy ASR™ Hip Resurfacing system, which is used in a newer kind of bone-conserving procedure. To date, more than 93,000 of the devices have been implanted worldwide.

DePuy said that it was issuing the recall after new data from a British joint replacement registry showed about 1 in 8, or around 12 percent, of those who received the implants needed corrective procedures, called revision surgeries, within five years. Typically, the devices are supposed to last 15 years before requiring any corrective revision.

DePuy’s hip replacement system—a metal-on-metal implant—has been linked to metal poisoning or metallosis, which, according to the Journal of Bone & Joint Surgery, is “aseptic fibrosis, local necrosis or loosening of a device secondary to metallic corrosion and release of wear debris.” Design problems with the devices cause the metal components to rub against each other and shed microscopic metal particles into the body, which can result in soft tissue damage, inflammatory reactions and bone loss.

Symptoms of metallosis from metal-on-metal hip replacement devices can include pain, inflammation, tumors and difficulty walking. Specialized blood tests can be used to detect levels of toxic metals in patients experiencing these symptoms. In some cases, patients with DePuy implants have been found with 100 times the normal levels chromium and cobalt in their bodies.

Metal-on-metal devices gained popularity in recent years among orthopedic surgeons and patients who believed they would be more durable than those made of other materials, such as ceramics. But it soon became apparent that many of the devices were deteriorating quickly, shedding metallic debris that was readily absorbed into the bloodstream.

The New York Times reported in March that it was “not clear whether some makers’ devices are more prone to the debris problem than others. But some experts argue that some manufacturers, in a rush to meet the demand for metal-on-metal devices, marketed some poorly designed implants and that some doctors fail to properly implant even well-designed ones.”

But it appears that DePuy’s ASR devices are more prone to debris problems than other brands. The first lawsuit filed in the United States against DePuy over the defective ASR hip implants was in March 2009—almost 18 months before the device was recalled. In fact, the Food & Drug Administration (FDA) had received over 500 complaints about the devices through the years leading up to the recall, but no action was taken as a result.

Countless patients are now left to struggle with the serious side effects of receiving a faulty hip implant, including pain, inflammation, metallosis, and costly revision surgery to correct these problems. And while DePuy’s recall notice stated that, “DePuy intends to cover reasonable and customary costs of testing and treatment if you need services, including revision surgery if it is necessary,” the company did not elaborate on what it perceives is “reasonable” or mention compensation for injury, such as the damages to overall physical and mental health, pain and mental anguish, disfigurement and scarring, or future medical expenses.

If you or someone you know received a defective DePuy ASR hip implant, it is imperative that you obtain the counsel of an experienced personal injury attorney. The litigation team at Sullo & Sullo, LLP will aggressively defend you and make sure you receive the finest legal representation in the country. Call us at 800-730-7607 or visit our website at www.sullolaw.com for a free legal consultation today.

By Taylor Lindstrom

Johnson & Johnson has announced that its subsidiary company Depuy issued a voluntarily recall of their ASR hip implant due to a number of patients who required a second hip replacement procedure, called a revision surgery."

No mention was made of metallosis in the Johnson & Johnson press release. In fact, Johnson & Johnson didn't mention any of the more significant symptoms patients are suffering after receiving a DePuy ASR XL hip implant. They would prefer that the public believed the revision surgery process is simple and fixes the problem of a faulty hip implant with absolutely no long-term effects.

We're recommending you get a second opinion - and a blood test.

Metal-on-metal hip replacement bearings like the DuPuy ASR XL Acetabular System total hip replacement were originally reintroduced as an alternative to metal-on-plastic or ceramic hip replacement systems. Metal-on-metal implants (for a hip implant, this is a design that involves both a metal ball and a metal socket) have certain advantages over plastic or ceramic when the design is properly engineered. They last longer, have high resistance to wear and tear, and can withstand more vigorous activity, making metal-on-metal the usual choice for surgeons with younger, more active patients who are going to put more strain on their implants.

However, a poorly engineered metal-on-metal hip resurfacing system has considerable complications, many of them more serious than their ceramic or plastic counterparts.

The Blue Cross Blue Shield Association Technology Evaluation Center report on metal-on-metal total hip resurfacing notes that metal-on-metal systems have risks of elevated heavy metal ion levels, delayed hypersensitivity to metals, and even carcinogenesis - cancer, to the layman.

All hip replacement systems release tiny particles of the implant's material into the body when the two parts of the hip replacement rub against one another. In metal-on-metal implants, a small amount of friction and metallosis is predictable and part of the considered risks when the surgeon recommends a certain type of hip implant.

However, when the metal parts are improperly made or installed, the friction releases much more metal into the bloodstream, causing serious metallosis and metal poisoning.

Engineers who have examined the DuPuy ASR hip replacement system noted several design flaws that contributed to increased metallosis and metal poisoning in patients. The implant is shallower than most other hip replacement systems, which made it much more challenging to implant than other systems. DePuy was fully aware of this setback; their instructions to the surgeon recommended a much more precise placement than other implants.

One engineer we consulted with went on to note that the requirements for placement were so specific that only about 3% surgeons would be able to place the hip implant properly. This is not a comment on the surgeon's skill; the engineer was quick to note that the placement demands would be impossible for all but the most skilled and experienced surgeons, and even then the surgeon would have to be fully informed of the importance of precise placement.

What's more, even with proper placement, the DePuy ASR hip replacement was made with a poorly designed cup and socket that did not fit together properly. If they had, friction would have been minimal and the metallosis risk would have been akin to other metal-on-metal hip implants. That said, a study by The Journal of Bone and Joint Surgery on metal-on-metal hip implants (not specifically DePuy implants) showed that patients had cobalt levels thirty-nine times higher than normal and chromium levels twenty-eight times normal.

Among patients who were experiencing pain with their DePuy ASR XL Acetabular system and took a blood test, we're seeing levels even higher than that.

These metal particles, or ions, are released enter the bloodstream where they encounter and bond with proteins normally found in the body. The resulting new particles look foreign and activate the body's immune system. White blood cells are dispatched fight the foreign particles, and the white blood cells create antibodies to fight off what the body believes to be an infection.

The body is really fighting a losing battle against the hip implant itself. The increased friction from the DePuy hip replacement system produces more metal ions with every movement of the hip, the immune system can never fully fight off or cure what it believes to be an infection. As the body tries to clean up the mess made by the hip implant, it can trigger an autoimmune response: the body starts to fight itself.

When the body is trying to fight off the foreign metal ions that have been released into the blood by the metal-on-metal hip replacement, other healthy body tissues can get caught in the crossfire. The soft tissue and bones surrounding the hip implant get infected, which means the blood supply to the bone or tissue is cut off. Without blood, the tissues starve and die, leaving behind black, dead tissue rotting in the body. This condition is called necrosis.

Studies have shown that people at greater risk for metallosis include women, people of small stature, and the obese. Any of these groups are more likely to get metallosis because more weight is put on the joint, and therefore the two metal surfaces grind together more, releasing more metal particles into the blood. Add in the addition of a poorly engineered hip implant, and the amount of metal being released into the bloodstream becomes catastrophic.

A study done in England tested a group of patients who had received a DuPuy hip replacement and found a high percentage of patients developed metallosis-compared to almost no incidents in a group of patients who received a different brand of implant.

Some studies have further found that the metallosis could be the cause of early onset osteolysis, a process in which the body begins to reabsorb living bone tissue, causing bone deterioration. Osteolysis makes revision surgery nearly inevitable in implants that are designed to grow onto the surrounding bone, such as the ASR XL Acetabular system. With no bone to hold onto, the hip replacement system fails.

The DuPuy modular hip system is made from a chromium- and cobalt-based alloy. According to the International Agency for Research on Cancer (USA), cobalt is considered to be a possible carcinogen in humans. Animal studies have shown that cobalt is a direct cause of cancer when placed under the skin or in the muscle. Chromium has been linked to cancer as well, and there is no proven antidote for chromium poisoning.

In a study of nine patients who had received a DuPuy hip replacement and showed signs of early osteolysis, eight of the nine patients tested positive for a sensitivity to cobalt. In fact, metal sensitivity is twice as likely to be found in anyone with a well-functioning metal implant, and more than six times as common in those with a poorly functioning implant. (Y. Park)

The metal-on-metal ASR hip replacement system released far more metal into the bloodstream than other implants of its type due to poor design, which means that in addition to a revision surgery, DePuy should also be accountable for the serious complications of metallosis, metal poisoning, metal hypersensitivity, and early-onset osteolysis - as well as increased risk of cancer.

If you received a DePuy ASR XL Acetabular system, your medical complications far exceed what DePuy has offered to pay for. Before agreeing to their offer of a revision surgery, please contact our offices, and and we'll help you understand any legal rights you may have.

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Since 1976, all medical devices must be classified and approved by the U.S. Food and Drug Administration (FDA) before they can be legally marketed to the public. It is the fond belief of many Americans that FDA approval is a ringing endorsement of a product's safety, a guarantee that the device has been tested and re-tested by professionals who are presumably trained to put the device through all kinds of rigor to triple-check its safety and effectiveness before allowing it anywhere near our fragile human bodies.

It is, as we say, a fond belief, but not an accurate one. It seems that many medical devices - including the recently recalled DePuy ASR XL Acetabular System - are given an FDA approval and subsequently placed inside people's bodies without ever going through a single test at the FDA.

The FDA department responsible for the regulation and review of medical devices is the Center for Devices and Radiological Health (CDRH). CDRH divides medical devices into three classes: life-sustaining, life-supporting or implantable devices are designated as Class III.

Hip replacements, including the ASR XL system, qualify as a Class III device and are considered high risk to the patient's health.

Class III devices can be approved by the FDA through one of two processes. The first, the premarket approval process (PMA) is more or less what we think of when we imagine our device being tested by the FDA: an extensive review including rigorous clinical trials that show it to be safe for use in humans. The PMA is quite detailed, lengthy, and expensive, usually costing the manufacturing company upwards of $250,000 and taking as much as two years to complete.

A quarter of a million is a large chunk of change - but thankfully for companies with a firm eye on their bottom line, there's always the second FDA approval process.

The premarket notification approval process, also known as the 510(k) approval process, is a sort of shortcut to approval that lowers the price point considerably - and also, conveniently, doesn't involve any pesky testing that might reveal a flaw in the product that would then have to be revamped and retested for another quarter-million.

The 510(k) process basically pre-approves any product that is deemed "substantially equivalent" to another product already legally approved for sale. It costs less than $5,000, requires no clinical trials, and only takes an average of 3-6 months to complete. It's a good shortcut for products that are essentially identical to their forebears. After all, it hardly makes sense to waste the FDA's time when they could be helping get new, innovative, life-saving products to market. But what's to stop companies from claiming their products are "substantially equivalent" to other FDA-approved devices even if they're not remotely the same?

What, indeed.

The ASR XL Acetabular hip replacement system got its seal of approval from the FDA using the 510(k) process, claiming that its product was substantially equivalent to other hip replacement devices already on the market. The FDA official in charge of approving the device would have gone through a checklist that included the following questions (simplified; the actual document is fairly dense):

• Does the new product treat or solve the same problems as previously approved products?
• Does the new product have the same design, materials, and energy sources as previously approved products?
• Could any new characteristics or combinations of characteristics affect safety or effectiveness?

The first question is easy: there are dozens of hip replacement devices on the market, all designed to help people walk even after their bum hip throws them out of commission. The second question gives us a bit of a hiccup: the ASR XL Acetabular hip replacement system had two parts, a ball and socket

The ball was equivalent to an approved product; the socket was equivalent to an entirely different approved product; and the materials were equivalent to still a third approved product.

Thankfully for DePuy, the FDA had thoughtfully included a caveat that allowed for such an eventuality. Which brings us to question three: could any new characteristics affect safety?

In Depuy's 501(k) application, it declared that the "subject device does not raise any new issues of safety or effectiveness." A brave statement, though one wonders how the company confirmed such a diagnosis without going through any clinical trials. Perhaps if it had, the problem of metallosis would have become evident before the hips were implanted into approximately 93,000 people.

With such prerequisites for FDA approval, it is perhaps not surprising that only 10% of 510(k) applications are referred back for supporting human, clinical or animal testing.

Which is to say that 90% of claims require no clinical testing whatsoever before being sold to patients?

That's not to say that there is no testing at all. If a mechanical test is available, 510(k) approval process requires that the new product show that it yields similar results to a previously approved product. The DuPuy ASR hip replacement system took a few spins on a robot that went through simulated movements. In a legal suit brought against DePuy for a different hip implant last year, the mechanical test did not include the full range of motion of which a human being is capable.

If we assume that a new product truly is "substantially equivalent" to previous products and if the new product has the same safety and effectiveness-regardless of any new materials or technologies-then the 510(k) system might work just fine. But that's presuming the device's manufacturer put the product through enough testing to determine independently that the device could withstand the same circumstances as other products.

What's more, products are allowed to be "substantially equivalent" to products that are themselves "substantially equivalent" to other products, which are in turn "substantially equivalent" to still other products. It's a dangerous game of telephone, particularly when you recall that it is permissible to combine two or more products and claim your new device is "substantially equivalent" to all of them.

The DePuy ASR system was approved because it claimed to be substantially equivalent to threeproducts which themselves claimed to be substantially equivalent to other products. None of the products in the chain was ever subjected to clinical trials before being brought to market.

Many people note that the 501(k) process amounts to an enormous loophole, through which many companies bring under-tested products to market. With better testing, the DePuy hip recall might have been avoided altogether.

The DePuy ASR XL Acetabular system was approved through this FDA loophole, despite the fact that it had a materially different design than its predecessors. But it was designed to treat the same problem, so it must have been all right. It was made of a metal ball and a metal socket - but other hip implants had successful metal-on-metal designs, so it must have been all right. And it was designed to allow the bone to grow directly onto the implant - but still other hip implants had used this tactic successfully, so it must have been all right.

Except that, when put all together, it just wasn't.

On August 4, 2010, the FDA issued two reports that recommend sweeping changes to the 510(k) process and procedures. We can only hope they include actually testing the products to which the FDA affixes its seal of approval.

By Megan Breckenridge, Staff Writer
SULLO & SULLO, LLP
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HOUSTON — Apparently, “’Till death do us part,” was merely a suggestion for two of television’s most visible stars, who have elected to divorce after eight short months of matrimony.
Mad Men actress Elizabeth Moss—who plays Peggy in the popular AMC series—filed for divorce from Saturday Night Live comedian Fred Armisen in Los Angeles on Monday, September 20. However, Entertainment Tonight reported that Moss listed June 26 as the date of the couple’s separation, only eight months after they were married in an intimate ceremony in Long Island City.

By Megan Breckenridge, Staff Writer
SULLO & SULLO, LLP
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HOUSTON — Stars in the United States have long enjoyed our nation’s brand of “celebrity justice”, but overseas their status is often overlooked. Case in point: The Japanese government’s recent refusal to allow Paris Hilton into the country after pleading guilty to misdemeanor drug charges in Las Vegas.
Hilton joined the ranks of such pop icons as Paul McCartney and the Rolling Stones when she was delayed by immigration authorities at Narita International Airport and officially denied entry into Japan. Her trip came just two days after she plead guilty to drug possession and obstructing an officer; and was sentenced to one year of probation, a $2,000 fine, 200 hours of community service and completion of a substance-abuse program. Japan has strict immigration laws that bar entry to those convicted of drug offenses, although exceptions are occasionally granted.
The 29-year-old celebrity socialite was supposed to promote her fashion and fragrance lines at a news conference on the morning of Wednesday, September 22, in Tokyo. She arrived Tuesday evening but was stopped at the airport and spent the night at a hotel there after being questioned by officials.
Tokyo was the first stop on Hilton’s planned Asia tour, during which she was to visit Kuala Lumpur, Malaysia, and open a new retail store in Jakarta, Indonesia. She was forced to cancel all of her appearances, which she has said she will make up at a later date.
Hilton’s trip was scheduled before her arrest last month in Las Vegas, when an officer found a small amount of cocaine in her purse. She was given a one-year suspended sentence, the terms of which stipulate that if she is arrested for anything besides a minor traffic violation in Vegas within the next year, she will have to serve a full year in prison. The conditions did not, however, restrict her travel overseas.
Japan has taken a hard line with famous figures in the past, including rock legends, The Rolling Stones, who struggled for years to gain entry to the country because of drug convictions among the group’s members. Former Beatle Paul McCartney was also deported in January 1980, when he was arrested at Narita airport for marijuana possession while touring with his band, Wings.
Kazuo Kashihara, an immigration official at Narita International Airport, said if Hilton had applied for an entry permit in advance of her arrival, there might have been a chance for Japan’s minister to consider an exception in her case. Instead, “She just showed up the day after [pleading guilty],” he said.
According to a statement issued by Hilton’s publicist, Dawn Miller, “Paris is very disappointed and fought hard to keep her business commitments and see her fans, but she is forced to postpone her commitments in Asia. Paris understands and respects the rules and laws of the immigration authorities in Japan and fully wishes to cooperate with them.”
Drug charges can affect every aspect of your life, including business relationships and your ability to earn a living. If you or someone you know are facing accusations of this nature, please contact the experienced team at Sullo & Sullo, LLP. Call us at 713.839.9026 or visit our website at www.sullolaw.com for a free legal consultation today.

By Megan Breckenridge, Staff Writer
SULLO & SULLO, LLP
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