Workers' Compensation: Food and Drug Administration

Showing posts with label Food and Drug Administration. Show all posts

Tuesday, September 10, 2013

New Concerns on Robotic Surgeries

Today's post was shared by WCBlog and comes from well.blogs.nytimes.com

A technologist with the da Vinci surgical system, which has been criticized in a series of reports.

Mike Spencer/Wilmington Star-News, via Associated PressA technologist with the da Vinci surgical system, which has been criticized in a series of reports.

In early March 2009, Erin Izumi, a woman in her 30s from Tacoma, Wash., underwent robotically assisted surgery to treat endometriosis.
The operation at St. Joseph Medical Center dragged on for nearly 11 hours.
Ten days later, Ms. Izumi was rushed to an emergency room, where doctors discovered that her colon and rectum had been torn during the operation. She was hospitalized for five weeks, undergoing a series of procedures to repair the damage, including a temporary colostomy, according to her attorney Chris Otorowski.

But even though medical device manufacturers and hospitals are required to report every device-related death and serious injury to a database maintained by the Food and Drug Administration within 30 days of learning about an incident, no report about the case was made in 2009. Hospital officials declined to comment, and a spokeswoman for the manufacturer said it became aware of the incident only when Ms. Izumi filed a lawsuit. It disputed the claim and settled the case in May 2012.

That was not the only lapse in reporting problems with robotic surgical equipment, a new study has found.

The equipment, called the da Vinci system, is made by Intuitive Surgical Inc. of Sunnyvale, Calif. It has been on the...

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Friday, June 28, 2013

FDA Closes Down Illegal On-Line Pharmacies

Operation Pangea VI combats online sale and distribution of unapproved prescription medicines

The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 9,600 websites that illegally sell potentially dangerous, unapproved prescription medicines to consumers. These actions include the issuance of regulatory warnings, and seizure of offending websites and $41,104,386 worth of illegal medicines worldwide.

The action occurred as part of the 6th annual International Internet Week of Action (IIWA), a global cooperative effort to combat the online sale and distribution of potentially counterfeit and illegal medical products. As part of this year’s international effort – Operation Pangea VI – the FDA’s Office of Criminal Investigations, in coordination with the United States Attorney's Office for the District of Colorado, seized and shut down 1,677 illegal pharmacy websites. The effort ran from June 18 to June 25, 2013.

Many of these websites appeared to be operating as a part of an organized criminal network

that falsely purported its websites to be “Canadian Pharmacies.” These websites displayed fake licenses and certifications to convince U.S. consumers to purchase drugs they advertised as “brand name” and “FDA approved.” The drugs received as part of Operation Pangea were not from Canada, and were neither brand name nor FDA approved. These websites also used certain major U.S. pharmacy retailer names to trick U.S. consumers into believing an affiliation existed with these retailers.

Tobacco Industry Argues Against New Cigarette Warnings

Big Tobacco continues to argue against the Federal requirement of new dramatic warnings of cigarette packs. Tobacco is the a leading contributing cause for death in the workplace.

Click here to read more from Jurist blog....

"A panel of judges for the US Court of Appeals for the District of Columbia Circuit [official website] heard oral arguments on Tuesday over the constitutionality of newFood and Drug Administration (FDA) [official website] regulations [text] requiring cigarette packaging and advertisements to display more prominent graphic health warning labels [materials]. A federal judge issued a permanent injunction [JURIST report] last month prohibiting the warnings as unconstitutional. The new requirements of graphic image and textual warning labels were imposed by the Family Smoking Prevention and Tobacco Control Act (FSPTCA) [HR 1256 text].

Wednesday, February 15, 2012

NIOSH Alerts Home Healthcare Workers About Latex Allergies

NIOSH (The National Institute for Occupational Health and Safety) has published a booklet to educate Home Healthcare Workers about preventing latex allergies. Latex products are made from natural rubber, and sensitivity can develop after repeated exposure. Limiting exposure to latex can help prevent allergic reactions for both home healthcare workers and their clients.

Once Natural Rubber Latex (NRL) sensitivity occurs, allergic individuals continue to experience symptoms, which have included life-threatening reactions, not only on exposure to NRL in the workplace but also upon receiving or accompanying a family member receiving healthcare services at inpatient as well as office-based settings.

In September of 1997, the Food and Drug Administration (FDA) issued a final rule requiring cautionary statements in the labeling of all medical devices that contain natural rubber likely to come in contact with humans. The rule provides that such products must contain the following cautionary statement in bold print: "Caution: This product contains natural rubber latex which may cause allergic reactions." Additionally, the FDA issued a final ruling that the labeling of medical devices that contain natural rubber, likely to come in contact with humans, shall not contain the term "hypoallergenic".

Over the last few years, there has been a significant increase in the number of workers' compensation claims filed against employers on behalf of individuals who have suffered latex allergic reactions. Scientists and government officials estimate that about 950,000 U.S. health care workers have developed an allergic sensitivity to latex.
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For over 3 decades the Law Offices of Jon L. Gelman 1.973.696.7900 jon@gelmans.com have been representing injured workers and their families who have suffered occupational accidents and illnesses.

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Tuesday, June 21, 2011

Sun Exposure, Prevention and Workers Compensation

The first day of summer brings attention to working outside, sun exposure and the risk of skin cancer. Workers Compensation coverage offers a unique opportunity to provide affirmative action to prevent, detect and treat high risk workers before the disease takes a fatal course.

While working outside has the connotation of working in a clean air and healthy environment, the reality is quite the opposite. With a reduction of the world's ozone layer, workers exposed to the sun are at an increase risk of developing skin cancer at an even shorter exposure time.

The US Food and Drug Administration (FDA) just published recommendations for sunscreens. This initial first step will most likely expand the government's roll in getting skin cancer under control. In the meantime, exposed and diagnosed workers must rely upon the workers' compensation programs for treatment and benefits as a result of occupational induced skin cancer resulting from the occupational exposure to the the sun.

Workers' Compensation insurance companies and employers would do well to heed the government's recommendations and take affirmative action to protect employees and provide medical evaluations for medical monitoring and surveillance. That action may include: avoiding exposure to the sun, seek regulation medical monitoring and mandating the use of sunscreens in the workplace. The risk of sun exposure is well known and employers should be encourage to protect workers from such obvious and deadly common place exposures.

Saturday, June 11, 2011

Formaldehyde Is A Cancer Causing Agent Reports US Government

The U.S. Department of Health and Human Services announced today that eight substances have been added to its Report on Carcinogens, a science-based document that identifies chemicals and biological agents that may put people at increased risk for cancer. Formaldehyde has been reportedly used in hair straightening products causing potential danger to hair salon workers and users of the products.

The industrial chemical formaldehyde and a botanical known as aristolochic acids are listed as known human carcinogens. Six other substances — captafol, cobalt-tungsten carbide (in powder or hard metal form), certain inhalable glass wool fibers, o-nitrotoluene, riddelliine, and styrene — are added as substances that are reasonably anticipated to be human carcinogens. With these additions, the 12th Report on Carcinogens now includes 240 listings. It is available at http://ntp.niehs.nih.gov/go/roc12.

"Reducing exposure to cancer-causing agents is something we all want, and the Report on Carcinogens provides important information on substances that pose a cancer risk," said Linda Birnbaum, Ph.D., director of both the National Institute of Environmental Health Sciences (NIEHS) and the National Toxicology Program (NTP). "The NTP is pleased to be able to compile this report."

John Bucher, Ph.D., associate director of the NTP added, "This report underscores the critical connection between our nation's health and what's in our environment."

The Report on Carcinogens is a congressionally mandated document that is prepared for the HHS Secretary by the NTP. The report identifies agents, substances, mixtures, or exposures in two categories: known to be a human carcinogen and reasonably anticipated to be a human carcinogen. A listing in the Report on Carcinogens does not by itself mean that a substance will cause cancer. Many factors, including the amount and duration of exposure, and an individual's susceptibility to a substance, affect whether a person will develop cancer.

Once a substance is nominated by the public or private sector and selected for consideration, it undergoes an extensive evaluation with numerous opportunities for scientific and public input. There were at least six opportunities for public input on each substance. The NTP used established criteria to evaluate the scientific evidence on each candidate substance under review. The NTP drew upon the scientific expertise of several federal agencies, including the National Institutes of Health, Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease Registry, U.S. Food and Drug Administration, U.S. Environmental Protection Agency, U.S. Consumer Product Safety Commission, and Occupational Safety and Health Administration.

"The strength of this report lies in the rigorous scientific review process," said Ruth Lunn, Dr.P.H., director of the NTP Office of the Report on Carcinogens. "We could not have completed this report without the significant input we received from the public, industry, academia, and other government agencies."

Friday, May 20, 2011

Nail Salon Workers at Risk for Occupational Exposures

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Nail salon workers are at risk for exposures to hazardous chemicals at work reports a recently published study. The report in the American Journal of Public Health concludes that workers at nail salons may be at higher risk of exposure to chemical toxins that may be harmful to their health.

Researchers set out to measure personal and area concentrations of solvents among Vietnamese women working in various California nail salons through a community-based participatory research study. Researchers collected data from 80 Vietnamese female nail salon workers from 20 different nail salons. They measured work-shift concentrations of toluene, ethyl acetate and isopropyl acetate and found that measured levels of these solvents were higher than recommended guidelines to prevent frequently reported health symptoms frequently reported. One-third of workers reported that they experienced certain health symptoms such as irritations, headaches, nausea and breathing problems after entering the workforce. Irritations of the nose, throat, lungs, skin and eyes were the most common symptoms, reported by 26.5 percent of workers.

“Our findings underscored the need for more attention to preventive public health strategies for his workforce. Recommendations to promote worker health and safety include policy changes to update occupational exposure limits that take into account various chronic health conditions, better regulatory oversight of chemicals in cosmetic products, and more research focused on the health of understudied and vulnerable worker populations,” said the study’s authors.

The Campaign for Safe Cosmetics and several other lobbying groups are supporting the passage of The Safe Cosmetics Act. The pending legislation calls full labeling of salon and cosmetic products and a phase out of those hazardous products that contain products that cause cancer or birth defects. It would allow the US Food and Drug Administration regulatory powers over the manufacture of cosmetics. The proposed legislation would require all ingredients to be listed on the product labels.

Concern has not only been expressed recently by nail salon workers, but various government agencies have issued health alerts concerning the presence of formaldehyde in hair straightening products. The State of New York was the latest to issue a health warning for those who use or are exposed to hair straightening products.

Thursday, May 19, 2011

NY State Issues Health Alert for Hair Straightening Products and Formaldehyde

The Department of Health of the State of New York has issued a health alert advisory to workers and consumers about a group of hair straightening products known as "Brazilian Keratin Treatment" (BKT) that may contain formaldehyde.

The warning advises those exposed that:

Exposure to formaldehyde can cause irritation of the eyes, nose, throat, and skin.
People with asthma or other respiratory diseases may be more sensitive than others to the effects of breathing formaldehyde.
Formaldehyde is classified as a probable human carcinogen (cancer-causing chemical).
The Department tested some products, and cautions that others in the market may also contain also formaldehyde.

A list of 22 products containing formaldehyde include:

BioIonic Kera Smooth Anti Frizz
Brazilian Blowout Solution
Brazilian Blowout Acai Professional Smoothing solution
Brazilian Gloss Keratin Smoothing Gloss
Cadiveu Brazilian Thermal Reconstruction
Coppola Keratin Complex Smoothing Therapy, Natural Keratin Smoothing Treatment
Coppola Keratin Complex Smoothing Therapy, Natural Keratin Smoothing Treatment, Light Wave
Coppola Keratin Express Brazilian Smoothing Treatment
Coppola Keratin Complex Smoothing Therapy
Global Keratin Functional Keratin Hair Taming System Light Wave Chocolate
Global Keratin Taming System Strawberry
Global Keratin Taming System with Juvexin Strawberry Resistant
Global Keratin Taming System with Juvexin Strawberry Light Wave
IBS Beauty IStraight Keratin Advanced Keratin Treatment
JKS International Smoothing Treatment
Kera Green Keratin and Protein Hair
Marcia Teixeira Advanced Brazilian Keratin Treatment
Marcia Teixeira Brazilian Keratin Treatment
Marcia Teixeira Chocolate, extreme de-frizzing treatment
Pravana Naturceuticals Keratin Fusion
Pro-Collagen RX Keratin Treatment
QOD GOLD Solution

Oregon OSHA (health and safety program), Health Canada and the European Directorate-General of Health and Consumer Affairs did the testing and found formaldehyde in each of the products they tested. They also conducted air tests during application of one of the products in two salons and found that formaldehyde had been released into the air.

The New York State Department of Health is monitoring the situation and they are in contact with other states about their experiences with these products. Through this fact sheet, they are taking the precautionary step of alerting salon workers and consumers about the hazards. At this time, they know that 51 companies market a total of 156 products. Over 100 of those are widely distributed in New York. This year alone, seven new products have come on the market. At this time they have no reliable way, at this time, to know which ones contain formaldehyde. The U.S. Food and Drug Administration (FDA), responsible for regulating cosmetic products, is gathering reports from consumers and salon professionals about eye irritation, breathing problems and headaches.

Many other agencies have issued health alerts and taken action. The Oregon Department of Consumer Business Services and the Connecticut Department of Public Health issued alerts on the release of formaldehyde from these products. The Attorney General of the State of California filed a lawsuit against a California-based manufacturer of one of these products (Brazilian Blowout's Acai Professional Smoothing Solution) alleging that the manufacturer failed to warn users about the presence of formaldehyde, as required by California regulations. Health Canada issued an advisory about the release of formaldehyde from the Brazilian Blowout product. Health Canada also received complaints of burning eyes, nose and throat, breathing difficulties and a report of hair loss. The European Directorate-General of Health and Consumer Affairs banned the sale of some products and recalled others.

New York State advises that the following action should be taken if a consumer or professional is concerned about these products: First, consider not having your hair treated with the products.

Seek medical attention, if you are experiencing health problems.
Consumers and salon professionals are urged to report adverse experiences to FDA in either of the following ways:
Report to the nearest FDA district office. The phone number for the New York State Complaint Coordinator is (866) 446-9055.
Report online to FDA's MedWatch adverse event reporting system. You also may call Medwatch at (800) 332-1088 to request a reporting form by mail.

For over 3 decades the Law Offices of Jon L. Gelman 1.973.696.7900 jon@gelmans.com have been representing injured workers and their families who have suffered work related accidents and injuries.

Monday, May 16, 2011

FDA Orders Surveillance of Hip Implants

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Hip replacements are utilized through the workers' compensation medical delivery system in an effort to cure and relieve medical conditions arising out of employment injuries and exposures. The US Food and Drug Administration (FDA) has recently announced that it is widening its roll in monitoring the hip implants. This follows a recent recall of defective hip implants.

"The FDA is continuing to gather and review all available information about currently marketed metal-on-metal hip systems, including information related to adverse events that may be associated with increase levels of cobalt and chromium in the bloodstream. To that end, on May 6, 2011 the FDA issued orders for postmarket surveillance studies to manufacturers of metal-on-metal hip systems. The FDA sent 145 orders to 21 manufacturers. Manufacturers will be required to submit a research protocol to the FDA that addresses specific safety issues related to these devices. Data from the studies conducted will enable the agency to better understand these devices and their safety profiles.

Tuesday, April 19, 2011

Dangerous Formaldehyde Based Hair Straighteners Reportedly in Widespread Use

A recent report published by the Environmental Working Group (EWG) reports, that formaldehyde based hair straighteners, used in many hair salons, are health hazards. The products are allegedly being used without disclosure of the potential health dangers of human exposure. Formaldehyde is a known carcinogen, a cancer causing agent, as well as an allergen.

EWR reports:

"For the past four years, some celebrities and fashionistas with $250 to $600 to drop at a hair salon have raved about “Brazilian-style keratin” hair straighteners purported to transform frizzy, unmanageable hair into flat, silky-smooth locks.

"In fact, those chemical concoctions are loaded with formaldehyde, which numerous prestigious health bodies, most recently, a National Academy of Sciences panel, have labeled a human carcinogen. Formaldehyde is also a potent allergen. It is especially hazardous when it reverts to its natural state, a gas, and is inhaled. Formaldehyde-based hair straighteners present a particular danger to salon workers who apply blow driers and 450-degree flatirons to chemical-coated hair.

"Some salon clients and personnel have suffered severe allergic reactions, massive hair loss, neck and face rashes, blistered scalps and other serious health problems, according to an Environmental Working Group review of 47 previously unpublished “adverse event” reports filed with the U.S. Food and Drug Administration and obtained under the Freedom of Information Act.

"EWG’s comprehensive survey of 45 manufacturers of hair-straightening products has found that:

15 of 16 companies claim little to no formaldehyde but tests show their products contain substantial amounts – These include Brazilian Blowout, Cadiveu and other top brands. The hair straightener company Goleshlee admits on its website that its product contains formaldehyde but omits the toxic chemical from its online ingredient list.

Fumes in salon air – Tests of salon air conducted in 2010 found powerful formaldehyde fumes. Other tests have found that hair straighteners contain up to 11.8 percent formaldehyde. When vapors reach significant levels, and when products contain a formaldehyde solution of more than 1 percent, federal law requires salons to provide medical monitoring for workers with symptoms, quick-drench showers for immediate use if solution touches skin and emergency eyewash stations.

Most top salons deny risks – Only three of Elle magazine’s 41 top-rated salons surveyed by EWG do not offer hair-straightening services because of health dangers. Nine salons claimed they used products free or nearly free of toxic chemicals. Yet test results compiled by EWG show the products are laden with formaldehyde. The salons’ claims usually echoed the manufacturers’ own misstatements about the chemistry and safety of the products. Among salons offering formaldehyde hair straighteners are the Andy Lecompte salon in Los Angeles, Whittenmore House Salon in New York and Metodo Rossano Ferretti Hair and Spa in Miami."

Recently the US Occupational and Health Administration issued a "Hazard Alert" to salon workers and owners over the dangers of the us of hair straighteners. The EWG has petitioned the US Food and Drug Administration (FDA) to also take action citing allegedly hazardous products. The exhibit accompanying the petition reviews multiple products including:

The EWR reports on the following products:

R and L Soft-Liss Professional Line

KeraGreen Keratin and Protein Hair System by LBD

Tahe Thermo Keratin Hair Treatment

Silkening Technologies Pro Collagen Rx Keratin Treatment

Brazilian Gloss Brazilian Keratin Treatment

Keratin Express Formula

Marcia Teixeira Brazilian Keratin Treatment

IBS i-Straight System

Coppola Keratin Keratin Complex Smoothing Therapy

Brazilian Blowout Açai Professional Smoothing (“Original”) Solution

Cadiveu Brazilian Keratin Smoothing Formula

Global Keratin (“GKHair”) Products

QOD

Since the FDA does not have the authority to issue a recall, EWR recommends, among other safety issues that need to addressed, that companies voluntarily recall their hair straightening products.

Thursday, March 10, 2011

Another Hernia Patch Recall by FDA

Image via WikipediaThe US Food and Drug Administration (FDA) issued another hernia and abdominal patch recall. The FDA on March 4, 2011 issued a Class 1 Recall Notice for Davol's XenMatric Surgical Graft.

The FDA indicated that the recall was issued because “Testing cannot confirm that all units of XenMatrix Surgical Graft are within FDA requirements for endotoxin levels. Several lots have been found to have elevated endotoxin levels. Endotoxins (pyrogens) are substances found in certain bacteria that, at elevated levels, can cause serious illness which can be fatal.”

This product was manufactured from June 1, 2010 through October 31, 2010 and distributed from July 1, 1010 through October 31, 2010. For more information, please see the FDA’s safety alert.

Litigation is pending against Davol, Inc. is pending in both federal and state court on behalf of patients who suffered serious injuries or complications related to the company’s Composix® Kugel® Mesh hernia repair patch.

Friday, August 27, 2010

Hip Implants Recalled Due to Failure

Johnson and Johnson has recalled 2 Hip Implants because of failure. The two implants were made by the DePuy Orthopaedics unit of Johnson and Johnson. The decision to withdrawn the products was based upon the fact that many patients require a second hip replacement because of product failure.

DePuy release a statement today that they two products being recalled were: the ASR XL Acetabular System, a hip socket used in traditional hip replacement, and the ASR Hip Resurfacing System, a partial hip replacement that involves placing a metal cap on the ball of the femur, a method intended to preserve more bone. There about 93,000 of the defective appliances that have been implanted worldwide.

For over two years the US Food and Drug Administration (FDA) has been besieged with complaints about the failure of the devices and painful surgery to replace them.

The office of Jon L. Gelman has advocated for consumer rights and has helped those who have unfortunately received defective medical devices. Please call 1-973-696-7900 or e-mail for further information.

Workers' Compensation and Joint Replacement

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