E Cigarette Hazards

Electronic Cigarettes or vapor cigarettes are devices made from metal tubes which contain a cartridge filled with nicotine laced liquid. The liquid is vaporized by a battery powered heating element.  E Cigarettes mimic cigarettes and come in a variety of flavors.  Manufacturers of e cigarettes falsely claim they are a less dangerous alternative to smoking cigarettes and an alternative smoking cessation device.

In a 2009 analysis of certain electronic cigarettes, the FDA found that e cigarette cartridges contain carcinogens including nitrosamines and toxic chemicals such as diethylene glycol.  The FDA has major concerns about the safety of e cigarettes for the smoker and non-smoke

“If you are around somebody who is using an e cigarette you are breathing in aerosol of exhaled nicotine, ultra-fine particles, volatile organic compounds and other toxins,” reports Dr. Stanton Glantz, Director of the Center for Tobacco Control Research and Education, University of Southern California, San Francisco.  The vapor inhaled and exhaled is not pure water vapor and can lead to major health risks.

Americans for Non-Smokers Rights are concerned that e cigarettes are being falsely marketed as something that smokers can use in the workplace and public places where smoking of tobacco is prohibited.  Others fear deceptive marketing practices and believe false claims of e cigarettes as a “safe alternative to smoking tobacco” are tempting teens to addiction.  The variety of flavors they come in are an added temptation to teens.

Currently, e cigarettes are unregulated and manufacturers are not required to disclose the ingredients in e cigarette liquid, nor the substances present in the aerosol.  The FDA aims to regulate them as tobacco products after a U.S. Court of Appeals decided that the FDA cannot regulate them as a drug delivery device, which is how nicotine replacement products are regulated.   In September 2010 the FDA sent warning letters to 5 retailers advising that their practices are in violation of the FDA and Cosmetic Act.

As of April 2015, 354 municipalities and 3 states include e cigarettes as products that are prohibited from use in smoke free environments.  Cities and states can enact laws that regulate when and where they can be used as well as laws that regulate sales to minors or where product can be sold.  City and state law makers must address these issues.

Click here to contact us to schedule a free consultation to see if you have a case.

At Hudson & Castle, we approach each case ethically, honorably, and skillfully, beginning with a free consultation, continuing with the convenience of flexible appointments, and finally, charging you nothing unless we win or settle. We also handle cases on behalf of our clients who are Delaware residents but have been injured in nearby Pennsylvania. Please call Hudson & Castle at 302-428-8800 (Monday-Friday, 8:30am- 5:00pm, ET) or contact us, and we will get back to you shortly to discuss your case.  

The Civil Justice System: Supporting Women’s Health

The civil justice system plays a key role in women’s health that many people are unaware of.  Access to the civil justice system makes women’s health safer and helps keep corporate misconduct in check when regulators of medical devices have been unwilling to rank the health of women above financial profit.  Corporations have rushed products to market without properly conducting safety studies and concealing known safety issues in exchange for profit.

In addition, women historically have underrepresented in Phase I clinical drug trials.  According to an investigative study published in Women’s Health Issues in 2009, “Although the last US Food and Drug Administration (FDA) study (published in 2001) showed that women’s participation may have been statistically large enough to determine whether the drug was effective in women, the rate of women’s participation throughout the whole process of testing a drug was variable, with women clearly underrepresented in most trials.  By 2002, studies indicated that only 24% to 25% of subjects in many phase 1 and 2 clinical trials were women.”  As a result, women have suffered disproportionately from the effects of dangerous and defective drugs and medical devices.  Recently in the news lawsuits are being filed against manufacturers of NuvaRing and Essure, both contraceptive methods used by woman and marketed by doctors.

Following are some historical examples of known abuses against women:

  • Hormone Replacement Therapy – With the knowledge that breast cancer is the second most deadliest form of cancer affecting women, pharmaceutical companies, since 1942, have marketed estrogen supplements as HRT even with known links to breast cancer, heart attacks and blood clots.
  • The Dalkon Shield – The manufacturer, A.H. Robbins knew the contraceptive caused fatal infections but it wasn’t until 1980 that, after lawsuits, the company finally agreed to issue a letter to doctors recommending the removal of the device.
  • Surgical Mesh – These devices cause organ perforation, infection and many more side effects. Many versions went to market without FDA approval and at least 70,000 women have vaginal mesh implants each year.  Johnson & Johnson stopped selling it’s product in 2012 after facing 4,000 lawsuits from injured women.
  • Deputy Artificial Hips – Introduced in 2015 by Johnson & Johnson, the ASR XL Acetabular hip replacement system immediately began attracting attention. Doctors reported the device shed large portions of metallic debris and caused infection, fractures, dislocations, necrosis and nerve damage.  The device stayed on the market for 5 years until sales were halted in 2010.  Johnson & Johnson payed over $4 billion to settle thousands of cases.

Click here to contact us to schedule a free consultation to see if you have a case.

At Hudson & Castle, we approach each case ethically, honorably, and skillfully, beginning with a free consultation, continuing with the convenience of flexible appointments, and finally, charging you nothing unless we win or settle. We also handle cases on behalf of our clients who are Delaware residents but have been injured in nearby Pennsylvania. Please call Hudson & Castle at 302-428-8800 (Monday-Friday, 8:30am- 5:00pm, ET) or contact us, and we will get back to you shortly to discuss your case.  

The Essure System : Evaluating The Contraceptive Device

The Essure System was approved and marketed as a non-incisional approach to permanent birth control by the FDA on November 4, 2002.  The Essure procedure involves placing a small, flexible device called a micro-insert into each of your fallopian tubes.  The inserts are made from polyester fibers and metals (nickel-titanium and stainless steel).  Once the inserts are in place the body tissue grows into the inserts, blocking the fallopian tubes.  Blocking the tubes is intended to prevent sperm from reaching and fertilizing the egg, ultimately preventing pregnancy.

From November of 2002 to present, it is reported that the FDA has received more than 4,000 adverse event reports on Essure and that the original manufacturer has received 16,047 complaints.   Complaints received by the FDA range from symptoms such as naseua, chronic fatigue, hives, abdominal pain, pain during and after intercourse, headaches and abnormal menstrual bleeding to misplaced and protruding coils.  The side effects have been severe enough to warrant surgical removal of the coils or total hysterectomies.

It was reported in April of 2015 that the FDA opened an investigation of the Essure system after allegations that the company falsified and altered medical records during clinical trials, failed to report adverse events, deceived the public and the FDA about the device’s safety and efficacy and used defective materials in manufacturing.  In 2002, Essure was given premarket approval which shielded the manufacturer from product liability and litigation.  If Conceptus violated the conditions of it’s premarket approval, they may lose their protective status.

Click here to contact us to schedule a free consultation to see if you have a case.

At Hudson & Castle, we approach each case ethically, honorably, and skillfully, beginning with a free consultation, continuing with the convenience of flexible appointments, and finally, charging you nothing unless we win or settle. We also handle cases on behalf of our clients who are Delaware residents but have been injured in nearby Pennsylvania. Please call Hudson & Castle at 302-428-8800 (Monday-Friday, 8:30am- 5:00pm, ET) or contact us, and we will get back to you shortly to discuss your case.  

da Vinci Surgical System

The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon’s capabilities and offer a state-of-the-art minimally invasive option for major surgery. The robot typically costs about $1.5 million and issued in more than 1,300 hospitals nationwide.  With the da Vinci Surgical System, surgeons operate through just a few small incisions. The da Vinci System features a magnified 3D high-definition vision system and tiny wristed instruments that bend and rotate far greater than the human wrist. As a result, da Vinci enables your surgeon to operate with enhanced vision, precision and control.

Minimally invasive da Vinci Surgery uses the latest in surgical and robotics technologies.  It is typically used in cancer surgery, hysterectomies and gallbladder removals.  Although it is called a robot, the surgeon is 100% in control of the da Vinci System.  The da Vinci System has brought minimally invasive surgery to more than 2.5 million patients worldwide.

In 2013, the FDA warned the da Vinci manufacturer, Intuitive, about robot safety.  The main warning regarding a potential defect in the robot’s surgical scissors.  According to Bloomberg reports, at this time, the company lost about $6 billion in value.   The company also received waring letters from the FDA criticizing the company’s safety-notification process.  An FDA inspection in April and May of 2013 uncovered a number of deficiencies, including a failure to adequately report device corrections.

Intuitive took corrective actions and in April, 2014 an FDA compliance officer informed them that the company’s corrective actions in response to the FDA’s warnings were adequate.  As of March 31, 2014 da Vinci systems installed throughout the United States rose to 2116.  The number of surgeries rose from roughly 367,000 in 2012 to 422,000 in 2013.

Click here to contact us to schedule a free consultation to see if you have a case.

At Hudson & Castle, we approach each case ethically, honorably, and skillfully, beginning with a free consultation, continuing with the convenience of flexible appointments, and finally, charging you nothing unless we win or settle. We also handle cases on behalf of our clients who are Delaware residents but have been injured in nearby Pennsylvania. Please call Hudson & Castle at 302-428-8800 (Monday-Friday, 8:30am- 5:00pm, ET) or contact us, and we will get back to you shortly to discuss your case.  

Takata Airbag Defect : Products Liability

The Takata airbag defect – a new autotomobile products liability issue has drawn the nation’s attention as multiple deaths and severe injuries have been linked to exploding airbags.

The airbag manufacturers, Honda and Takata, may have known about this problem for a decade but failed to do what was necessary to protect consumers by correcting the defect.

Takata airbag systems, like other systems, contain metal inflators located behind the airbag cushions which emit gas during a collision causing the cushion to fill up and deploy.  In order to generate gas, the vehicles’ electronic control unit sends a signal that ignites propellant that it stored within the inflator.

The metal inflator remains intact normally in properly functioning airbags.  In certain defective Takata airbag systems, the inflator itself may rupture upon deployment and eject sharp metal objects that cause serious harm to the car’s occupants.  Think of it as metal shrapnel.

As of 2015, exploding Takata airbags have been linked to dozens of injuries and as many as five deaths.

The total number of recalled vehicles, according to NHTSA, is approximately 7.8 million. Car manufacturers; such as Honda, Mazda, Toyota and BMW began issuing their first recalls in 2013.

On November 6, 2014, the New York Times published an article which gave credence to the thought that this defect had been swept under the rug by Takata executives.

In addition to the defective airbag, Takata changed from using tetrazole to ammonium nitrate in their airbags as a cost saving measure.  Ammonium nitrate is a compound that “tended to disintegrate on storage under widely varying temperature conditions and could produce irregular ballistics consequence.”

Click here to contact us to schedule a free consultation to see if you have a case.

At Hudson & Castle, we approach each case ethically, honorably, and skillfully, beginning with a free consultation, continuing with the convenience of flexible appointments, and finally, charging you nothing unless we win or settle. We also handle cases on behalf of our clients who are Delaware residents but have been injured in nearby Pennsylvania. Please call Hudson & Castle at 302-428-8800 (Monday-Friday, 8:30am- 5:00pm, ET) or contact us, and we will get back to you shortly to discuss your case.