The U.S. Food and Drug Administration (FDA) has announced a final decision to no longer allow distribution or use of the antimicrobial drug enrofloxacin (Baytril) for the purpose of treating bacterial infections in poultry. This ruling, however, does not affect other approved uses of the drug.

This animal drug belongs to a class of drugs known as fluoroquinolones and is marketed under the name Baytril by Bayer Corporation. The drug is in the same “family” as Cipro, the widely used human antibiotic.
The FDA finally made a decision which many infectious disease experts had been calling for and directed its Center for Veterinary Medicine (CVM) to began proceedings to withdraw use of this animal drug in poultry.

The FDA now acknowledges scientific data shows that the use of enrofloxacin in poultry caused resistance to emerge in Campylobacter, a bacterium that causes foodborne illness. Chickens and turkeys normally harbor Campylobacter in their digestive tracts without causing poultry to become ill.

Enrofloxacin does not completely eliminate Campylobacter from the birds’ intestinal tracts, and those Campylobacter bacteria that survive are resistant to fluoroquinolone drugs. These resistant bacteria multiply in the digestive tracts of poultry and persist and spread through transportation and slaughter, and are found on chicken carcasses in slaughter plants and retail poultry meats.

Campylobacter bacteria are a significant cause of foodborne illness in the U.S. Antimicrobial treatment is recommended for people with severe illness as well as the very young, the elderly, and people with certain medical conditions.

Complications of such infections can include reactive arthritis and, more rarely, blood stream infections. Early treatment can mitigate symptoms and may decrease the risk of complications.

Fluoroquinolones used in humans are ineffective if used to treat Campylobacter infections that are resistant to them. This failure can significantly prolong the duration of the infections and may increase the risk of complications. The proportion of Campylobacter infections that are resistant to fluoroquinolones has increased significantly since the use of enrofloxacin in poultry was approved in the U.S.

Bayer Corporation has been given 60 days to appeal the withdrawal. The final order withdrawing approval of the antimicrobial drug enrofloxacin for the purpose of treating bacterial infections in poultry will become effective on September 12, 2005.

The Final Decision can be found at www.fda.gov/oc/antimicrobial/baytril.pdf.

This ruling is seen as a step forward in the battle to stem the tide of antibiotic-resistant bacteria that are rapidly becoming a public health crisis. Critics of the FDA’s inactivity on the matter have praised this first, decisive measure to deal with the problem.

The CPSC and American Suzuki Motor Corp. of Brea, California have announced the voluntary product safety recall of 3,400 Suzuki 2004-2005 TwinPeaks™ All-Terrain Vehicles (ATVs). Customers should stop using the product immediately.

A significant impact to the front wheel of the ATV while the steering is fully turned to either side can result in suspension damage, wear, and an eventual loss of steering control that could result in injury or death.
American Suzuki Motor Corp. has received seven reports of ball joint separation. No injuries have been reported to date.

The recall includes all 2004-2005 Suzuki LT-V700F TwinPeaks™ ATVs. These ATVs are yellow or blue in color and have “TwinPeaks” written on the fuel tank.

The ATVs in question were manufactured in Japan and sold at Suzuki dealerships nationwide from December 2003 to July 2005 for about $7,100.

Consumers should stop using these ATVs immediately. Registered owners have been notified about this recall by mail. Consumers with a recalled ATV should contact their local Suzuki ATV dealer to schedule the free repair.

For additional information call the firm toll-free at (800) 444-5077 between 8:30 a.m. and 5 p.m. PT Monday through Friday, or go to the firm’s Web site at www.suzukicycles.com.

Medical experts and health officials on both sides of the Atlantic are troubled by the emergence and spread of various strains of antibiotic-resistant tuberculosis (TB).

In the UK, the Health Protection Agency (HPA) is currently battling a potentially fatal strain of TB known as isoniazid-resistant TB which first appeared in north London in 2000. Since that time, some 200 cases of the disease have been reported throughout the UK, although London, with 188, is the real “hot spot.”

According to the HPA, “the failure of patients to complete courses of prescribed antibiotics” has facilitated the spread of isoniazid-resistant TB. Since the treatment regimen lasts six months or more, proper treatment of at-risk groups like the homeless and intravenous drug users is quite problematic thereby increasing the likelihood that the strain will continue spreading.

Incentives and other programs that encourage and reward those who adhere to the lengthy treatment routine are being utilized. These include giving out food vouchers, social service support, and accommodation assistance.

Between 1987 and 2003, London has seen TB cases double to 2,745 thereby accounting for 45%   
of all cases in England and Wales. Sir William Stewart, Chairman of the HPA, states: “The bugs are cleverer than we are. They grow, multiply and mutate more quickly than we can deal with them.

Antibiotics, though still hugely important, are no longer the saviors that they were thought to be in the 1950s.” The overuse by the medical and veterinary professions has contributed to the appearance and spread of new strains of antibiotic-resistant bacteria in hospitals and beyond.

Thus, the problem has become a global one with respect to a number of bacteria in general and TB in particular. In the U.S., for example, the groups that were once at greatest risk of developing multi-drug resistant tuberculosis (TB) included HIV patients, prisoners, and the homeless.

Today, however, it is more likely that new cases of the resistant form of the potentially deadly disease will be brought into the country by immigrants who have traveled from areas where there is a “raging pandemic” of TB.

As pointed out above, drug-resistant TB arises when ineffective drugs are prescribed or infected patients stop taking their medication too soon thereby allowing mutant strains of the TB bacteria to multiply.

Once this type of mutant strain arises it is capable of person-to-person transmission. Whereas multidrug-resistant TB had been resistant to 2 or 3 drugs in the past, today’s strains are resistant to 6 to 11 drugs.
A report in the June 8 issue of the Journal of the American Medical Association (JAMA) also reveals that California has the largest concentration of drug-resistant TB cases in the U.S. with 37 in 2004. California has gone from about 20% of the nations total cases in 2001 to an estimated 33% at present.

According to the JAMA report by Dr. Reuben Granich of the Centers for Disease Control and Prevention (CDC), most of California’s multidrug-resistant cases of TB involve people born outside of the United States.

Dr. Granich believes that the key to controlling the problem lies in caring for immigrants and enhancing TB care overseas and not in closing the borders.

Although the overall number of cases of multidrug-resistant cases of TB has declined by 76% since outbreaks in 1993, California’s total number of cases has “stagnated.” The California Department of Health is concerned with the problem of imported multidrug-resistant TB since immigrants are often poor, frightened, and prone to move frequently.

The 37 California cases in 2004 cost $8.72 million in direct medical costs and contact tracing when you include the 120 people who developed latent infections from them. Normal TB cases can usually be treated in 6 months with about $2,000 of standard antibiotics.

Cases of multidrug-resistant TB can take anywhere from 18 to 36 months to treat. The cost of the often toxic, second-line drugs required can be between $28,000 and $1.2 million per patient.   

Last week, a pet distribution center in Ohio, which sends hamsters, gerbils, and mice (“pocket pets”) to stores throughout the east coast of the U.S., was linked to the infected hamster that caused the deaths of three organ transplant recipients in Rhode Island and Massachusetts.

Now that four more infected hamsters have been found at Mid-South Distributors of Ohio, 4,000 small pets that have been quarantined there will be destroyed according to the Ohio Department of Agriculture.

An investigation by the Centers for Disease Control and Prevention (CDC) first linked Mid-South to the original infected hamster where subsequent testing revealed the presence of the other sick animals.

As we first reported on May 25, health officials linked the deaths of at least six transplant patients to a viral infection known as LCMV (lymphocytic choriomeningitis virus). The virus is carried by approximately 5% of all rodents and is usually spread to humans through contact with infected animals or their feces or urine.
About 2% of the general population has antibodies to the virus which means that those individuals have been exposed at some point in their lives. LCMV usually causes few problems for healthy people.

The results can be quite different (and deadly), however, for those whose immune systems have been compromised by diseases like cancer or AIDS or as a result of taking immune-suppressing drugs designed to prevent organ rejection.  

Two kidneys, a liver, and two lungs taken from a donor in Rhode Island, who died of a stroke, were transplanted into four patients in Massachusetts and Rhode Island. Three of the recipients died within weeks of receiving the organs. Tests revealed that a hamster owned by the donor was infected with LCMV.

In December 2003, three organ recipients died in Wisconsin under similar circumstances. Unfortunately, the Wisconsin deaths were not regarded as a public health threat at the time since there was apparently no evidence that the virus was spread from person-to-person. Thus, no public statement was made about the occurrences.

The doctors in the New England cases did not learn about the Wisconsin deaths until it was too late to save at least one of the latest victims. It was not until one of the doctors, Dr. Staci Fischer, contacted the CDC that the connection to LCVM and the organ donor’s infected hamster was made. Dr. Fischer believes that had she had the information earlier; “it would have made a difference for our other patient.”

Although such events are extremely rare, the CDC, the Food and Drug Administration (FDA), state health officials, and medical experts immediately began an investigation into the deadly occurrences and started asking doctors and hospitals to carefully monitor all organ transplant patients and blood transfusion recipients for any unusual illnesses. They also recommended careful testing of all donated organs and blood.

No commercial test exists for LCMV and it is not one of the viruses for which tests are routinely performed on organs.

Dr. Terry L. Sanderfer has a lucrative practice specializing in weight-reduction surgery. Unfortunately, he has also been sued more than 20 times for gastric-bypass surgeries gone wrong.

In fact, according to public records and the doctor’s own accounting, 13 of his gastric-bypass patients have died from complications stemming from surgeries he performed.

Now, the Medical Board of California is seeking to revoke Sanderfer’s medical license for a host of reasons including delayed treatment or failing to act promptly after problems arose, failure to adequately evaluate patients before and after surgery, keeping incomplete or illegible records, and abandoning the care of his patients.

These charges are in connection with the treatment if 11 gastric-bypass patients, including six who died following surgery.

Dr. Sanderfer performs surgeries at Corona Regional Medical Center, Riverside Community Hospital, and Parkview Community Hospital. Over $1.2 million has been paid to settle three medical malpractice claims against Sanderfer.

The CPSC, in cooperation with three companies, has announced a voluntary recall of 1,800,000 children’s folding chairs as a result of serious risks to children’s fingers, including amputation. Consumers should stop using all of these products immediately.

Recall #1

522,000 Kid’s Folding Chairs manufactured in China and distributed by Fourstar Group Inc., of Hopkinton, Massachusetts.

The chair’s safety lock can fail, allowing the chair to collapse or fold unexpectedly. Children’s fingers can become caught or entrapped in the hinge and slot areas of the chair, posing a pinch or cut hazard. This can cause severe lacerations and finger tip amputations to children’s fingers.

CPSC and Fourstar Group are aware of three incidents involving children. One resulted in a laceration to the finger and three finger fractures, the second incident resulted in a fracture and laceration to the fingers, and the third incident resulted in a pinched finger.

The recalled kid’s folding chairs are made of metal tubing with a vinyl padded seat and seat back. They were sold in red, blue, yellow, green, pink, and lavender solid colors. They also come in pink with “Princess” printed in red on the seat and seat back along with stars, crowns and hearts, or in blue with pictures of basketballs, soccer balls, footballs, football helmets, and rollerblades.

The recalled chairs were sold individually or as part of a set consisting of a table and two chairs. Each chair is about 22-inches high, 13.5-inches wide, and about 11.5-inches deep. “MANUFACTURED BY FOURSTAR GROUP INC.” OR “IMPORTED BY FOURSTAR INTERNATIONAL TRADING COMPANY” is written on a label located underneath the seat of the chairs.

The chairs were sold at discount and grocery stores nationwide from July 2003 through July 2005 for about $5 individually or about $25 for a set.

Consumers should stop using the chairs immediately, and contact Fourstar for instructions on how to receive a free repair kit to replace the locking pin.

Consumers should call Fourstar Group toll-free at (866) 290-6191 between 9 a.m. and 4 p.m. ET Monday through Friday. Consumers can also visit the firm’s Web site at www.fsgrecall.com

Recall #2

1,100,000 Children’s Folding Chairs manufactured in China for Idea Nuova Inc., of New York, New York.
The chair’s safety lock can fail, allowing the chair to collapse or fold unexpectedly. Children’s fingers can become caught or entrapped in the hinge and slot areas of the chair, posing a pinch or cut hazard. This can cause severe lacerations and finger tip amputations to children’s fingers.

CPSC and Idea Nuova are aware of five incidents involving children. In one incident, there was a finger tip amputation, the second incident involved a finger tip amputation and a laceration, and the third incident involved a finger fracture and a laceration. There were no injuries reported in the other two incidents.

The recalled children’s folding chairs are made of metal tubing with a vinyl padded seat and seat back. They were sold with the following designs: “Monkey Moods” a monkey with stars, “Rock n Roll” with a monkey playing a guitar, “Princess” with pink flowers and a crown, “Sport” with a football, basketball and soccer ball, “Training Camp” with frogs, “Rainbow Angel” with clouds, rainbows and stars, Spiderman®, and Disney® Princess.
The recalled chairs were sold as part of a set consisting of a table and two chairs. Each chair is about 22-inches high, 13 inches wide, and about 11 inches deep. “Idea Nuova Inc.” or “I.N.I.” is printed on a label located underneath the seat of the chairs.

The chairs were sold at discount department and toy stores nationwide from September 2004 through June 2005 for between $15 and $25 per set.

Consumers should stop using these chairs immediately, and contact Idea Nuova for instructions on how to receive a free repair kit to replace the locking pin.

Consumers should call Idea Nuova toll-free at 866-772-1666 between 9 a.m. and 4 p.m. ET Monday through Friday. Consumers can also e-mail Idea Nuova at www.repair@ideanuova.com

Recall #3

CPSC, Meco Corp. Announce Recall of Children’s Folding Chairs

175,000 Juvenile Folding Chairs manufactured in China for Meco Corp., of Greeneville, Tennessee.
Children’s fingers can become caught or entrapped in the hinge and slot areas of the chair, posing a pinch or cut hazard.

In 2004, Meco recalled red-colored children’s folding chairs because paint on the chair contained excessive lead levels, posing a lead poisoning hazard to young children.

CPSC and Meco are aware of three incidents. Two resulted in pinched fingers and there was one laceration to a child’s finger.

The recalled children’s folding chairs have safety locks under the seat. The chairs are made of metal tubing with a vinyl padded seat and seat back. They were sold in red, blue, yellow and green colors as a part of a set consisting of a table and four chairs. Each chair is about 22-inches high, 10-inches wide, and about 11-inches deep. “Meco” or “Samsonite” is printed on the label underneath the seat bottom.

The chairs were sold at furniture and wholesale club stores nationwide from July 2003 through May 2005 for between $25 and $40.

Consumers should immediately stop using the chairs and contact Meco for instructions on receiving a refund.
Consumers should call Meco at (800) 251-7558 between 8 a.m. and 6 p.m. ET Monday through Friday or e-mail Meco’s customer service at csr@meco.net Consumers can also visit the company’s Web site at www.meco.net

Claiming that Reynolds American Inc. violated state consumer-protection laws prohibiting unfair and deceptive advertising, the Vermont Attorney General has sued the tobacco giant regarding its marketing campaign for Eclipse brand cigarettes.

The lawsuit is the result of a multi-state investigation into whether enough scientific evidence exists to support the claim that Eclipse is safer than regular cigarettes. Specifically, Reynolds American claims that Eclipse (introduced in 2003) “may present less risk of cancer, chronic bronchitis, and possibly emphysema.”

The claim is also made that eclipse is the “nest best choice” after quitting for health-conscious smokers because it “responds to concerns about certain smoking related-related illnesses…including cancer.”

The Attorney General’s position is that the scientific evidence does not support these claims of a “less harmful” cigarette and, thus, the marketing campaign is in violation of the terms of the 1998 settlement wherein the tobacco industry was prohibited from misrepresenting facts about the health risks associated with tobacco use.

Reynolds American has taken the position that there is “adequate scientific evidence to defend the claims we make on Eclipse.” The company cites chemical testing and animal studies to support its position. Most experts, however, remain unconvinced that any of the “gimmicks” being used to market “less harmful” or “healthier” cigarettes are supported by any scientific proof at all.

In fact, it appears that just the opposite may be true as the debate over these reduced-harm cigarettes grows.

As newsinferno.com reported only this week, a new study conducted at the Roswell Park Cancer Institute in Buffalo, New York, and published in the August issue of the American Journal of Preventative Medicine has found a significant percentage of smokers mistakenly believe cigarettes marketed as “less harmful” are safer than regular cigarettes.

While these researchers and others before them have found no credible evidence that any cigarette advertised as “less harmful” is any safer than traditional brands, too few smokers seem to know that.

Of the 2,000 adult smokers surveyed, only 39% had heard of these “less harmful” cigarettes and even fewer (27%) could actually name a brand. Finally, 25% actually believed they were not as dangerous as regular cigarettes. Those over 55 were more likely to have heard of these products.

Whether the claim involved is the older marketing ploy of reduced toxin exposure, “light” (or “ultra-light) or “low tar” or the newer approach of “less harmful,” herbal, or “smoke-free,” the same percentage of those surveyed believed there to be less danger involved.

Over 50% of those surveyed were already smoking “light” or “ultra-light” brands.

The researchers stated that because smokers are “confused” by advertising claims, those companies marketing any cigarette in this questionable category “should be required to demonstrate convincingly that smokers will not be confused or misled by the marketing claims.”

The results of this survey, however, should not surprise anyone familiar with the history of cigarette advertising since the tobacco industry has always led the public to believe that smoking “light” or “low tar” versions of cigarettes is less harmful because health risks are minimized.

Studies have indicated that this is not really the case at all. There are a number of factors which show that the information provided by the tobacco industry is indeed misleading.

•  A report published by the National Cancer Institute found that people who switched to low-tar cigarettes actually smoked more in order to get the same total amount of nicotine. For the most part, the ratio between tar and nicotine remains the same in all cigarettes and, therefore, the risk for the smoker exposing his or her lungs to the carcinogenic ingredients remains the same. The same report found that smokers of these “mild” brands inhale eight times more nicotine than the amount listed on the packet. “The [report] clearly demonstrates that people who switch to ‘low-tar’ or ‘light’ cigarettes…are likely to inhale the same amount of cancer-causing toxins,” says Scott Leischow, Ph.D., Chief of the NCI Tobacco Control Research Branch. “Scientific research does not show that changes in cigarette design and manufacturing over the last 50 years have benefited public health.”

• According to an analysis in Tobacco Control, a British Medical Association publication, many tobacco companies recognized that low tar products were as dangerous as regular cigarettes, yet continued to market them as “healthier” alternatives. The industry believed that, with all the evidence linking tobacco with lung cancer, smokers would be encouraged to quit and thus they devised “low tar” and “light” products in order to reassure them that smoking was not as bad as they originally thought.

• Cigarettes that are branded as “hi-fi” or “high filtration” imply that they are somehow able to reduce health risks associated with smoking. This filtering ploy has been described in industry documents as “an effective advertising gimmick” which was merely cosmetic, offering “the image of health reassurance.”

•  While some test results related to “low tar/light” cigarettes seemed to illustrate they are a healthier alternative to full-flavor cigarettes, the test results themselves are subject to question. The tobacco industry designed cigarettes specifically so that the Federal Trade Commission tests, which have used smoking machines since the 1960s to determine the levels of smoke toxicity, would find that these “light” and “low-tar” cigarettes yield less tar when smoked. In actuality, they still deliver full doses of tar and nicotine to actual smokers.

• Although low-tar cigarettes are frequently made with porous paper and more loosely packed tobacco in an effort to reduce tar intake, research has shown that smokers will still receive the maximum levels of tar because they will usually take more (and deeper) puffs or smoke more total cigarettes per day. Some of these cigarettes also have small holes in the filters designed to dilute the tar and nicotine with air. Reports show, however, that many people will consciously or unconsciously cover these holes with their mouths while smoking thus receiving the same amounts of tar and nicotine as in regular cigarettes.

• In a study conducted in 2002 by the American Journal of Preventative Medicine, less than 10% of smokers nationwide knew that one light cigarette could deliver the same amount of tar as one regular cigarette.

•  William Farone, a former employee of Phillip Morris, the nation’s largest cigarette manufacturer, has testified that the company increased the tar in one “low-tar” brand, Cambridge Lights, from 0 to 12 mg. over a seven-year period. The company never told consumers that the tar content had gradually been increased. Smokers of that brand as well as smokers who bought Marlboro Lights subsequently sued Phillip Morris on the grounds that the label “lights” was deceptive regarding tar and nicotine levels. (The lawsuit was for the refund of money they paid for the cigarettes as opposed to one for personal injuries). A spokesman for Phillip Morris said that the company did not want the terms “light” and “low-tar” banned from cigarette packs but would support greater regulation of their use.

Clearly, a significant number of smokers are being taken in by the tobacco industry’s unsubstantiated and misleading advertising campaigns with respect to various “less harmful” cigarettes. Once that happens, people will be less likely to attempt to quit. They may even be encouraged to take up smoking again after successfully quitting. It would seem that the multi-state governmental investigation and the Vermont Attorney General agree. 

In a release which follows on the heels of a July 8 announcement by the U.S. FDA that it was approving updated labeling for Viagra, Cialis, and Levitra to reflect the possible link between these Erectile Dysfunction medications and sudden vision loss, Health Canada issued a similar Advisory yesterday.

All  of this began on May 27, when the FDA disclosed that, since 1998, it has received some 43 reports of non-arteritic anterior ischemic optic neuropathy (NAION), a type of blindness, in men taking impotence drugs (38 involving Viagra, 4 for Cialis, and 1 for Levitra).

To be sure, NAION is a very rare condition and the FDA was quick to point out that a definite link between the drugs and the condition has not been established. Yet, the possibility that such a serious side-effect exists was enough to raise the issue of whether the FDA should require a warning these drugs to carry a warning with respect to NAION.

On July 8, the FDA approved updated labeling for Cialis, Levitra and Viagra to reflect a small number of post-marketing reports of sudden vision loss, attributed to NAION .

The FDA advised patients to stop taking these medicines, and call a doctor or healthcare provider immediately if they experience sudden or decreased vision loss in one or both eyes.

Further, patients taking or considering taking these products should inform their health care professionals if they have ever had severe loss of vision, which might reflect a prior episode of NAION. Such patients are at an increased risk of developing NAION again.

The FDA stated that: “At this time, it is not possible to determine whether these oral medicines for erectile dysfunction were the cause of the loss of eyesight or whether the problem is related to other factors such as high blood pressure or diabetes, or to a combination of these problems.” The manufactures contend their drugs are safe and not the cause of these problems.

 The new labeling information is available along with additional information for healthcare providers and consumers online at:

Viagra (http://www.fda.gov/cder/consumerinfo/viagra/vIAGRA.htm)
Levitra (http://www.fda.gov/cder/drug/infopage/vardenafil/default.htm)
Cialis (http://www.fda.gov/cder/drug/infopage/cialis/default.htm)
The Advisory from Health Canada follows:

“Health Canada is advising individuals who use the drugs Viagra, Cialis and Levitra to consult their physicians and seek immediate medical attention if they experience sudden vision loss or vision-related problems while taking these drugs. Viagra, Cialis and Levitra are drugs used to treat impotence and erectile dysfunction in men.
The specific type of vision loss, called nonarteritic anterior ischemic optic neuropathy (NAION), occurs when blood flow to the optic nerve is blocked. It causes sudden and painless loss of vision in one or both eyes. Those who experience one episode are at a greater risk of experiencing a second episode affecting the other eye. Vision loss may be partial or complete. While in some cases the condition may improve over time, it can also be irreversible.

 Risk factors for NAION include:

•    age greater than 50 years
•    heart disease
•    high blood pressure
•    high cholesterol
•    diabetes
•    smoking
•    certain pre-existing eye problems

An article in the March 2005 issue of the Journal of Neuro-Ophthalmology discussed 14 cases of NAION that occurred in patients using Viagra. All these patients had other risk factors for NAION, including high blood pressure, high cholesterol or diabetes. Health Canada is currently reviewing two Canadian reports of vision problems in patients using Viagra that may be consistent with NAION, but it has not yet been confirmed that these problems are related to the use of the medications above. It is difficult to determine whether the use of Viagra, Cialis or Levitra is causing NAION, as individuals who have erectile problems often have high blood pressure, diabetes or other conditions that put them at increased risk.

Health Canada continues to monitor these drugs and has requested additional safety information from all three manufacturers - Pfizer (Viagra), Eli Lilly (Cialis), and Bayer AG/GlaxoSmithKline (Levitra). Changes to the product information for health care professionals and patients are anticipated, and the information will be communicated to the public after all the safety data has been thoroughly assessed.

While Health Canada’s assessment of the safety data on this issue continues, the Department is advising Canadians of this information now to address any concerns.”

On July 13, the Food and Drug Administration (FDA) issued an extensive warning to Richard L. Ernst, President and CEO of Hitachi Medical Systems America, Inc. of Twinsburg, Ohio.

The warning followed an inspection of Hitachi’s medical device manufacturing facilities in Twinsburg by an FDA investigator on March 16-18 and 24 and April 8, 11 and 12, 2005 with respect to the magnetic resonance imaging (MRI) systems manufactured by Hitachi Medical, Tokyo, Japan which are medical devices as defined in section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act).

The above inspection revealed that Hitachi’s devices are misbranded in that the company failed to furnish material or information required under the Act and the Medical Device Reporting (MDR) Regulation.

Specifically, Hitachi had received complaints relating to four separate events for which it failed to submit an MDR to the FDA within 30 days of receiving information that the devices may have caused or contributed to a death or serious injury.

For example:

•    One complaint documents an event involving a patient being scanned in Hitachi’s AIUS MRl device. During the scan, the system flashed an "unrecoverable error" message and continued to scan after the error message. The patient complained of heat on the right side of the head. The technologist noticed that the head coil had come unlatched on the right side of the patient. On 7/2/04, your firm received a letter from the patient complaining of daily headaches since the MRI scan in the area where the burns occurred. This event suggested that the device failed to perform as intended and may have caused or contributed to a serious injury. An MDR should have been submitted to FDA for this event.

•    Two other complaints involved a patient being scanned in one of Hitachi’s AIRIS MRI devices. Both patients sent letters to Hitachi complaining of permanent tinnitus since being scanned. One of those patients had never experienced tinnitus prior to the MRI scan and so advised Hitachi in a letter and faxed to the company on 10/18/2002. The other patient had seen several otolaryngologists as well as a neuro-otologist regarding the tinnitus which still remains and the company was also advised of this in a letter of 11/20/02. Since the MRI may have caused or contributed to the tinnitus, MDRs should have been submitted to FDA for these two events.

•    In another case, a patient being scanned in one of Hitachi’s AIRIS MRI devices of the MRI being too loud and was given an additional set of earplugs. After the exam, the patient claimed to have suffered hearing loss due to the noise in the MRI. The patient saw an audiologist the next day who confirmed the patient had suffered some hearing loss and had tinnitus and fullness in the right ear. The audiologist indicated the vibrations in the machine contributed to the problem. Again, an MDR should have been submitted to FDA for this event.

Although Hitachi claimed to have filed the above complaints (as well as an additional complaint that was not reviewed by the FDA investigator) as MDR events, the FDA found the company’s MDR procedure to be inadequate because it does not address several of the factors included in the definition of caused or contributed as defined in the MDR Regulation.

The warning letter also found Hitachi’s Altaire MRI systems were misbranded within the meaning of the Act in that a report of correction or removal was not submitted to FDA as required by the Act.

The Correction and Removal Regulation requires manufacturers and importers to promptly report to FDA, within 10 working days, any correction or removal of a device to reduce a risk to health. The FDA found three corrections and removals that Hitachi did not report to the agency.

•    On December 17, 2004, Hitachi created a work instruction to visit all sites that owned an Altaire MRI and to inspect and tighten all gradient coils due to safety concerns. Hitachi created this work instruction because it had received a complaint that an Altaire MRI caught fire due to arching between connections.

•    On November 18, 2004, Hitachi released field service instructions for all service representatives to visit each site that had an Altaire MRI and to inspect each compressor. According to the instructions, if the compressor contained a Type A absorber, it needed to be replaced, because these absorbers contained bad welds and were from an unauthorized supplier. Hitachi created these field instructions, because on October 18, 2004, it had received a complaint that an absorber unit on the helium compressor had cracked at the seam, and that the pressure released resulted in "an explosive force that bent the compressor covers and popped the screw heads making them "projectile."

•    On April 20, 2004, Hitachi issued a Software Release Bulletin instructing the service representatives to install a software upgrade to all Altaire/AIRIS MRI systems. This upgrade fixed the problem of images from one patient’s study being co-mingled with another patient’s study. Hitachi became aware of the co-mingling problem when it received complaints from two different customers stating that images from one patient’s study were co-mingled with another patient’s study. Both complaints also stated that the images were captured under one patient file.

The FDA warning noted that regulations require manufacturers and importers to promptly report to FDA any correction or removal of a device if the correction or removal was initiated to reduce a risk to health. The FDA concluded that because Hitachi’s actions met the definition of a "correction" in the regulations and because they were initiated to reduce a risk to health, Hitachi’s failure to report them until the issue was raised by the FDA investigator violated the applicable regulation.

The FDA also found Hitachi’s devices are “adulterated” within the meaning of the Act, in that the methods used in, or the facilities or controls used for manufacturing, packing, storage, or installation are not in conformance with the Quality System Regulation (QSR), as specified in the Code of Federal Regulations (CFR). The deviations from the QSR cited by the FDA include, but were not limited to, the following:

•    Failure to ensure that all complaints are evaluated to determine whether the complaint should be filed as a Medical Device Report (MDR). Specifically, 4 of the 25 complaints reviewed by the investigator had not been evaluated to determine if they were medical device reportable events. For example, one complaint stated that a patient was shocked and burned on the top of her head while being scanned in the AIRIS MRI system. The complaint was not evaluated to determine if it was a medical device reportable event.

•    Failure to verify or validate corrective and preventive actions to ensure that the action is effective and does not adversely affect the finished device. For example, a complaint dated 7/7/04, states that service personnel were disabling the internal interlock switch because gantry covers on the Sceptre PET system were coming loose. Additionally, service personnel were using epoxy to fix broken shoulder bolts. There were no verifications or validations performed for these corrective actions, and change control procedures were not followed.

•    Failure to adequately inspect, test, or verify as conforming to specified requirements acceptance activities for incoming components. Specifically, Hitachi performed testing on only the first 4 AIRIS elite MRI Rapid Heat Coils used on the AIRIS elite MRI system. No subsequent incoming testing has been performed by Hitachi on incoming coils and there is no documented rationale or statistical basis for only testing the first 4 coils.

The letter stated that it “is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by the FDA. You also must promptly initiate permanent corrective and preventive action on your quality system.”

The warning also cautioned Hitachi that: “Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, no premarket applications for Class III devices to which the Quality System regulation deficiencies are reasonably related will be approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be granted until the violations related to the subject devices have been corrected.”

Hitachi was instructed to “continue to take prompt action to correct any and all deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.”
Hitachi was given 15 working days in which to notify the FDA of the corrective actions it has taken for the deficiencies which the company has not previously addressed and for which the FDA has found corrective actions to have been inadequate.

The FDA will evaluate the adequacy of Hitachi’s corrective measures and procedures during the next FDA inspection. If Hitachi is unable to complete corrective action within the timeframes specified by the company, Hitachi must state the reason for the delay and the timeframe within which the corrections will be completed.

Federal District Judge Kathleen McDonald (Cleveland) has denied a defense motion that sought to exclude testimony that welding-fume exposure causes Parkinson’s disease.

In permitting the plaintiffs to argue their theory that welding fumes cause this extremely serious neurological disorder, Judge McDonald has opened the door for some 5,000 cases premised on the same theory of liability to now move forward in several state courts as well as in some 4,500 cases which have been aggregated before Judge McDonald under a multidistrict litigation order.

While the ruling does not determine the underlying issue of whether welding fumes do, in fact, cause Parkinson’s disease, it will permit the issue to be submitted to a jury for resolution based on expert medical and scientific proof.  Clearly, that is all the plaintiffs really wanted to accomplish in defeating the defense motion. Now, it is anyone’s guess how a jury will decide once it hears all of the evidence on this particular theory.

Plaintiffs’ attorneys as well as a significant number of highly qualified medical experts believe that the welding process which releases significant amounts of manganese fumes, a metal known to cause neurological problems, does indeed cause Parkinson’s disease.

While there are up to 500,000 welders in the United States alone, exposure to welding fumes poses a risk to millions of workers who regularly work in close proximity to welding operations in a number of major industries including ship and bridge building; heavy construction work on other steel structures like high-rise buildings, automotive fabrication and repair, plastics, and electronics.

The lawsuits are directed at a number of current and former manufacturers of welding materials, companies that distributed welding equipment, and major users of welding services.

Although welding materials come with printed warning and welding operations are required to be done in ventilated areas and only with the use of appropriate breathing equipment, the lawsuits claim that the various defendants were well aware of the significant dangers posed by the practice and did not do enough to warn those exposed to those risks.

So far, plaintiffs have won 9 of 10 cases in which evidence of the connection between welding and Parkinson’s was permitted. The motion to prevent this theory from continuing to be advanced was defendants’ last and only hope of turning the tide in the litigation. Since, under federal rules, the order denying that motion cannot be appealed until the end of the case, the trials will have to proceed with that theory intact.