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.  

Medicare’s Stringent Requirements For Post Hospital Care

AARP reported in an article dated October, 2012 that an elderly patient, Jean Arnua, spent five days in the hospital for a fractured spine following an emergency room visit.  Neither she nor her family was aware that Jean had never been “formally” admitted to the hospital.  The stay was recorded as “observation” and not “in patient” by the hospital.  Once discharged, the family wanted to place Jean in a Skilled Nursing Facility for post hospital rehabilitation care.  This is when they discovered she was never fully admitted to the hospital.  The financial consequences were staggering.

Medicare will only pay for post hospital care in a Skilled Nursing Facility after the patient has been an “in patient” at a hospital for three consecutive days.  They will pay for the full twenty days in a Skilled Nursing Facility if the patient meets this requirement.  If they do not, the patient is financially responsible for the entire bill at the Skilled Nursing Facility.

Another example is Amau, an 84 year old widow, who received a bill for $3,900 from a Skilled Nursing Facility for a two week stay.  Medicare did not cover her stay because she did not meet the three day “in patient” hospital stay requirement.

Are elderly patients being financially exploited?  Experts believe hospitals are using the observation status in order to protect themselves against new policies that penalize hospitals for unnecessary admissions and frequent readmissions of the same patient.  Medicare is auditing hospitals where they believe the hospital is admitting patients unnecessarily.  Elderly patient are caught in the crossfire between hospital administration and Medicare policies.  Due to these policies, elderly patients have suffered negative health consequences and substantial financial loss.

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.  

ANESTHESIOLOGIST TRASHES SEDATED PATIENT AND PAYS FOR IT!

The Washington Post recently reported that a Vienna, Virginia man pressed the “record” button on his smartphone prior to the start of his colonoscopy with the intention of recording post-op instructions the doctor would give him following the procedure. The man’s phone, which was left in his pants, was placed beneath the surgical table and therefore recorded the conversation between the medical staff during the procedure in its entirety.

After he awoke from the general anesthesia and recovered enough to safely drive home, he hit the “play” button on his phone and listened to much more than post-op instructions from his doctor. He was shocked to find that the surgical team had mocked and insulted him throughout the procedure. While the patient was sedated, the female anesthesiologist was recorded as saying to him, “After five minutes of talking to you in pre-op, I wanted to punch you in the face and man you up a little bit.” When an assistant noted that the patient had looked queasy while watching a needle administered to his arm, the anesthesiologist was recorded as saying, “Well, why are you looking then, retard?” There were also disparaging comments made about a rash on his genitals, suggesting he had syphilis or tuberculosis.

In addition to these unwarranted remarks, the doctor, in order to avoid the patient after the colonoscopy, instructed an assistant to lie to the patient after he awoke from the anesthesia.  The assistant was to tell the patient that the doctor had already discussed the findings with him, but the patient just couldn’t remember. If that was not enough, a false diagnosis of hemorrhoids was entered into the patient’s chart even though none was detected.   Why would he do this? Evidently, the doctor felt, “People are into their medical problems. They need to have medical problems.”

The patient rightly sued the two doctors and their practices for defamation and medical malpractice and after a three-day trial,  a Fairfax County jury awarded him $500,000.

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.  

Res Ipsa Loquitur

Res Ipsa Loquitur is a legal term which in Latin means “the thing speaks for itself.” It is a doctrine of law that one is presumed to be negligent if he/she/it had exclusive control of whatever caused the injury even though there is not specific evidence of an act of negligence. An example would be a foreign object left within a patient who underwent surgery or a surgeon who operates on the wrong limb or organ.

Medical malpractice lawsuits are usually based upon a claim that a medical provider was negligent and the doctors actions fell below an accepted standard of care. Establishing that a doctor’s actions fell below the accepted standard of care requires the expert testimony of another health care provider in the same field of medicine as the defendant.

What if the patient was unconscious when the negligent act occurred and there is insufficient documentation regarding the health care provider’s actions during the medical procedure or surgery, such as in the above examples? It would be very difficult to prove negligence even with the assistance of a medical expert. In cases such as these, medical malpractice attorneys rely on the legal doctrine of res ipsa loquitur, as it allows for the admission of circumstantial evidence to infer negligence.  Once res ipsa loquitur is established, the medical practitioner is then presumed negligent and the burden of proof shifts from the plaintiff to the practitioner to prove otherwise. The plaintiff, or patient, need not prove who committed the improper act. The court instructs the jury to infer that the health care provider was negligent.

Laws differ from state to state regarding the law of res ipsa loquitur in medical malpractice cases. To ensure the proper applicability of res ipsa loquitur, it is advisable to retain a qualified medical malpractice attorney who will consider your possible case and your state’s statutes.

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.  

Breast Cancer

According to the Center for Disease Control, each year in the United States more than 2000,000 women get breast cancer and more than 40,000 die from the disease.  Other than skin cancer, breast cancer is the most common cancer among American women.  Less than 1 % of breast cancer occurs in men.  Women over the age of 50 are at a greater risk for breast cancer, but about 11% of new cases of breast cancer in the United States occur in women younger than 45 years of age.  Most women who develop breast cancer have no known risk factors and no family history of the disease, though family history does increase your risk for breast cancer.  Symptoms of breast cancer can include changes to the size or shape of your breast, pain in the breast and nipple discharge other than breast milk, including blood.  A new lump in the breast or underarm is a symptom of breast cancer also.  If you have any of these symptoms, contact your doctor immediately.

The United States Preventative Services Task Force recommends a screening mammogram every two years for women 50 to 74 years of age.  Below are other ways you can reduce your risk of breast cancer.

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.  

Uterine Cancer

Uterine fibroids are non-cancerous growths in the uterus. They are very common and can cause symptoms such as heavy or prolonged menstrual bleeding, pelvic cramps and frequent urination.  If these symptoms are severe enough, a woman may opt for treatment or removal of the uterine fibroids via hysterectomy or laparoscopic surgery. Though both of these surgical procedures remove uterine fibroids and require an incision in the lower abdomen, laparoscopic surgery uses smaller incisions and requires that the fibroid or uterine tissue be broken down into smaller pieces prior to removal.  Laparoscopic surgery is marketed as being more cost effective, less invasive than an open abdominal hysterectomy and promises a shorter recovery time for the patient.

Until recently, power morcellators, a surgical tool manufactured by Johnson & Johnson, were used to break up the fibroids and uterine tissue intrauterinely prior to laparoscopic removal. After public debate and an FDA investigation Johnson & Johnson, the manufacturers of the surgical tool, pulled the device from hospitals as early July 2014. At one time it was estimated that only 1 in 10,000 women with uterine fibroids were at risk for actually having uterine sarcoma, but after a high profile case in Boston in 2014, the FDA has said that women undergoing surgery for fibroids have a 1 in 350 risk that the growths are actually cancerous.  The process of using this tool to break up fibroid or uterine tissue before removing it laparoscopically has been found to inadvertently spread unknown malignancies and other disease tissue throughout the body.  Before pulling the tool from hospitals, the FDA estimated that it was being used in 50,000 hysterectomies a year not including use during the removal of fibroids.

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.  

GOVERNMENT INVESTIGATING NURSING HOME CULPABILITY FOR COVID-19 (CORONA VIRUS) INFECTIONS

Update: Genesis in Milford, DE has “Dozens of COVID-19 cases” according to Delaware State News (4/15/20). According to the article, 55 residents and 13 employees have tested positive for the disease. https://delawarestatenews.net/coronavirus/report-dozens-of-covid-19-cases-at-genesis-care-center-in-milford/

The Centers for Medicare and Medicaid (“CMS”) has already begun its investigation of nursing homes for violations related to the handling of COVID-19 (Corona Virus).

We have recognized that nursing homes and assisted living facilities have for years been understaffed: including under-payment of employees or not having enough on the schedule. Their corporate greed has led to injuries to their residents and patients in the past. This has been the perfect storm brewing for some time.

With the onset of COVID-19 (Corona Virus), these issues have come to the forefront of the nation and now the federal government is taking a harder look.

Nursing homes and assisted living facilities are required to have sufficient staff based on a ratio of the acuity of the patients, meaning the level of care required for the patient.  This is known as Eagle’s law.  Essentially, the more care a resident needs according to their individual care plan then the more staff a nursing home is required to have.  If the nursing home has many residents that require a higher level of care then the staffing ratio needs to be lower.  This is because each staff member is able to take care of fewer more complicated residents then they could if the residents were less complicated.

In addition, nursing homes are required to have policies and procedures in place to reduce the risk and spread of infection to their residents.  Having the policies and procedures is not enough.  Nursing homes and their staff must also follow their procedures.

Nursing homes are also required to have supplies on hand to deal with an outbreak of infection if one occurs.

Our history of handling nursing home cases in Delaware has demonstrated time and time again that nursing homes cut corners in order to increase their profit margins.  It is unfortunate that it took COVID-19 (Corona Virus) for a more serious investigation, but it is fortunate that the federal government is now investigating.

Here is an article addressing the issues further: https://www.webmd.com/lung/news/20200410/covid-19-shows-gaps-in-controls-at-nursing-homes?ecd=wnl_spr_041120

If you or a loved one has fallen victim to nursing home abuse or neglect, or became infected with COVID-19 (Corona Virus) while in a nursing home please call us to see if you have a case – (302) 428-8800.

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.