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Medtronic Core Valve-Related Recall is Deemed A Class I

Medtronic’s recall of its EnVeo R loading system for the CoreValve Evolut transcather aortic valve device has been designated as Class 1 by the U.S. Food and Drug Administration (FDA). The recall was issued last month due to reports of “particulate being observed in a small number of cases,” Medtronic’s CoreValve was first approved in early 2014 for patients at extreme or high risk of open-heart surgery. The device has also since been approved for “valve-in-valve” (VIV) replacement, where a valve is placed within a failing artificial heart valve.

Medtronic received eight complaints associated with this issue, according to a recall letter posted on the website of Germany’s Federal Institute for Drugs and Medical Devices. The particulate was observed during the valve loading procedure in six cases, and observed in the packaged kits in the other two cases. Medtronic notified customers of the recall in an urgent field safety notice, which stated that a blood clot could arise if particulate matter is mistakenly deployed while the Evolut device is being implanted. More Medtronic Core Valve-Related Recall is Deemed A Class I

Staten Island Hospitals Barely Miss Making the List of Hospitals Penalized by Medicare

SI Hospitals Barely Miss the Medicare Penalized List

SI Hospitals Miss Making the List of Penalized Hospitals

Staten Island’s two hospitals narrowly missed making the list of the New York hospitals being penalized by Medicare for having high rates of patient infections, complications and other injuries.

Staten Island University Hospital (SIUH), which has sites in Ocean Breeze and Prince’s Bay, and Richmond University Medical Center (RUMC), West Brighton, escaped the penalties facing 17 other New York hospitals, barely scoring above the cutoff rating to avoid federal Medicare payment cuts, according to a new federal government report viewed by More Staten Island Hospitals Barely Miss Making the List of Hospitals Penalized by Medicare

Mother of Inmate who Died After 21-Hour Restraint Settles Lawsuit Against Southwest Missouri Jail Employees

Mother of Inmate who Died After 21-Hr Restraint Settles

Mother of Inmate who Died After 21-Hr Restraint Settles

The mother of a man who died in a southwest Missouri jail after spending several hours in a restraint chair has settled her lawsuit against Jasper County and other defendants.

Jane Brown of Joplin, Missouri, alleged in the lawsuit that her son, 43-year-old Richard Watson, was strapped into a restraint chair for at least 21 hours without proper food, water or medication. Watson died eight days after he was arrested for an alleged violation of a protection order taken out against him by his stepfather. Jail officials were unable to resuscitate Watson, who had mental and physical health issues, after he was found unresponsive and not breathing. Brown’s lawsuit alleged the chair’s manufacturer advises that no one be left in the restraints for more than two hours, according to the Associated Press (AP). More Mother of Inmate who Died After 21-Hour Restraint Settles Lawsuit Against Southwest Missouri Jail Employees

Veterans Passed Away While on Secret VA Hospital Waiting List

At least 40 U.S. veterans have passed away while waiting for medical appointments at Phoenix Veterans Affairs Health Care system. The dead include a large number of veterans who were on a secret waiting list.

According to a report by the New York Daily News, the list was part of a multifaceted cost-cutting system set up by Veterans Affairs managers in Phoenix in an attempt to conceal the fact that between 1,400 and 1,600 sick veterans had to wait up to 21 months to see a doctor. The details of the scheme were provided a retired top VA doctor and high-level sources. More Veterans Passed Away While on Secret VA Hospital Waiting List

HHS Probes Cardiac Defibrillators Manufactured by Boston Scientific Corp.

This week, the U.S. Department of Health and Human Services (HHS) subpoenaed Boston Scientific Corporation for information relating to the medical device maker’s 2008 launch of two brands of implantable cardiac defibrillators (ICDs) and their performance between 2007 and 2009, as well as the operation of a “Physical Guided Learning Program.”

The defibrillators are sold under the brand names Cognis and Teligen, according to the Wall Street Journal (WSJ). More HHS Probes Cardiac Defibrillators Manufactured by Boston Scientific Corp.

Hospital Sued After Patient is Found Dead After Being Missing for 17 Days

A wrongful death lawsuit has been filed after a patient was found dead at the bottom of an emergency stairwell 17 days after she disappeared from her room. The family of the victim filed the lawsuit against San Francisco, which owns the medical facility.

Lynne Spalding, 57, was placed in San Francisco General Hospital on September 19, 2013 and was found dead in a hospital emergency stairwell on October 8, 2013, the LA Times reported. According to the lawsuit, an horrific set of errors, allegedly made by the hospital and the San Francisco Sheriff’s Department, which provides security for San Francisco General, was responsible for Spalding’s death. The lawsuit was filed on behalf of Spalding’s son and daughter–both adults–and alleges that Spalding had been diagnosed with episodic confusion, a bladder infection, and a blood infection when she was admitted to the hospital, the LA Times reported. More Hospital Sued After Patient is Found Dead After Being Missing for 17 Days

Jury Awards Woman $1.3 Million for Botched Tummy Tuck Surgery

A jury awarded a Michigan woman $1.3 million in a medical malpractice case after the woman suffered serious injuries fro a “tummy tuck” surgery gone wrong.

On June 4, 2009, Pagan underwent a “tummy tuck” or abdominoplasty, which included liposuction of the abdominal flap, at Dr. Rouchdi Rifai office in Jackson, according to the lawsuit. Complications from the surgery left Pagan, 43, with long-term physical and medical issues as she continues to receive treatment for what has been a big, gaping stomach wound that has never entirely healed, reported. Once an active business owner, Pagan lost her business while her health was failing and now endures pain while trying to do basic household tasks, her lawsuit alleged. More Jury Awards Woman $1.3 Million for Botched Tummy Tuck Surgery

Man Awarded $9.1 Million in Medical Malpractice Case

A Tonawanda, New York man was awarded $9.1 million after alleged medical malpractice resulted in the man having his leg amputated.

Donald R. Schultz, a former City of Tonawanda public safety dispatcher, broke his ankle nearly 10 years ago, but complications led to the eventual amputation of his leg. The State Supreme Court jury awarded Schultz $2 million for past pain and suffering, $2.8 million for past and future medical expenses and loss of wages, and $4 million for future pain and suffering, the Buffalo News reported.  Donald’s former wife was also awarded $350,000 for loss of services.

Schultz, 45, broke his ankle in October 2004 after he fell on steps on his way to work as a public safety dispatcher. He first received treatment from a physician at Excelsior Orthopaedics, which has offices in Amherst, Orchard Park and Niagara Falls, according to the Buffalo News. The jury found that neither the physician nor the Excelsior Orthopaedics were liable for any wrongdoing.

However, Schultz began feeling pain on the side of his foot near his little toe, which is typically connected to an unusual nerve disorder, apparently caused by the ankle fracture, Schultz’s lawyer argued. One year after the surgery, Schultz switched doctors to Dr. Michael A. Parentis. Parentis began performing surgeries on his little toe, eventually amputating it, the Buffalo News reported. Pain continued after the amputation and Schultz soon developed an infection. Parentis then amputated the fourth toe, and after pain continued, amputated the leg below the knee in July 2009.

The suffering did not end there, according to the lawsuits. Following the amputation of his lower leg, Schultz developed another infection, requiring amputation of the remaining leg above the knee in September 2009. When the process was finally over, Parentis had performed 12 surgeries on Schultz.

The jury returned the verdict against Parentis, ruling he was guilty of medical malpractice after a 15-day trial, according to the Buffalo News.

Since the amputation, Schultz has no longer been able to work and was described as his lawyer as being devastated.

Medical Malpractice continues to be a major issue in the U.S. According to an article in the Journal of the American Medical Association (JAMA), more than 225,000 people die each year due to medical malpractice. The article found that nearly half of those deaths occur in the emergency room. Meanwhile, a study conducted by the Harvard Medical School found that five percent of all hospital patients endure some type of injury due to medical malpractice.

Family Awarded $55 Million in Malpractice Case Against Hospital, Surgeon

A Pennsylvania family was awarded $55 million by a jury in one of the largest verdicts in Lehigh County history. The jury ordered St. Luke’s University Hospital and one of its doctors to pay the family the this sum for their medical malpractice case.

The verdict was delivered after a two-week civil trial before Judge J. Brian Johnson. The lawsuit was filed on behalf of Mark Crowell; his wife, Sharon Petrosky Crowell; and their 4-year-old son, Matthew Crowell, The Morning Call reported.

The jury found that that St. Luke’s in Fountain Hill and Dr. Ronald Kriner disregarded signs that Matthew Crowell was losing a substantial amount of oxygen during delivery on Nov. 4, 2009, and was too large for Sharon Crowell to deliver, according to The Morning Call. Lawyers for the family argued that the baby lost additional oxygen when he got stuck during a vaginal delivery in which vacuum extraction was used. Mark Crowell told The Morning Call that his son barely had a pulse when he was born.

According to the lawsuit, the baby was pale and hypotonic with poor respiratory effort after birth and displayed “seizure-like activity,” The Morning Call reported. Matthew also experienced brain bleeding. After giving birth Sharon Crowell also experienced problems. According to the lawsuit, she was hemorrhaging blood and needed to have emergency surgery.

The lack of oxygen Matthew received has resulted in a vast amount of medical issues for him, many of which may be permanent. According to the family, the boy is severely developmentally delayed, suffers from cerebral palsy, has trouble talking and walking, and still wears diapers, The Morning Call reported. The family said the fetal monitoring showed it should have been a C-section delivery and if the baby had been delivered by C-section, he would have been healthy. The jury ruled that the hospital and Kriner are each 50 percent to blame.

At the time of Matthew’s birth, the family lived in the Lehigh Valley. The family has since moved to Mountain Top, Luzerne County so they could be closer to family and receive more help with the child.

Medical malpractice lawsuits, such as the one won by the Crowell family, continue to be filed across the United States. According to an article published in the Journal of the American Medical Association (JAMA), more than 225,000 people die every year due to medical malpractice. Nearly half of those deaths occur in hospital emergency rooms. Equally alarming was a study conducted by Harvard Medical School that found that more than 1 in 20 patients were harmed due to medical malpractice.

Healthcare Worker Infects Dozens with Hepatitis C, Pleads Guilty

A New Hampshire healthcare worker accused of infecting dozens of hospital patients with Hepatitis C pled guilty on Sunday.

David M. Kwiatkowski, a former healthcare worker at Exeter Hospital in New Hampshire, pled guilty to “diverting and obtaining the controlled substance fentanyl as well as to product tampering,” the Albany Tribune reported. Kwiatkowski’s actions resulted in at least 45 people becoming infected with Hepatitis C, a virus that linked to liver damage, liver failure and cancer of the liver. One of the infected patients died, according to a report issued by the Federal Bureau of Investigation.

Kwiatkowski, 34, was given a 39-year prison sentence and also must pay a $1,600 special assessment and restitution in the amount of nearly $25,000, the Albany Tribune reported. This is believed to be the longest sentence ever received for a crime of this nature.

The defendant worked as a health care technician at multiple medical facilities in Michigan between 2003 and 2007, before transitioning into a roll as a traveling radiology technician. According to the Tribune, he used various placement agencies to find employment at medical facilities in Arizona, Georgia, Kansas, Maryland, New Hampshire, New York and Pennsylvania.

During this time period, he stole syringes containing Fentanyl intended for patients undergoing certain medical procedures. Fentanyl is a strong narcotic used as an anesthetic. Kwiatkowski “replaced the stolen syringes of Fentanyl with syringes that he stole from previous procedures and refilled them with saline, after having injected himself with the Fentanyl intended for his patients,” the Tribune reported.

Kwiatkowski committed the drug diversion and tampering with full knowledge that he tested positive for Hepatitis C. According to the FBI, Kwiatkowski told an interrogator that he was going to kill a lot of people from his actions. Kwiatkowski injected himself using stolen Fentanyl syringes, leading to the contamination of the syringes with his infected blood. He then refilled the tainted syringes with saline and replaced them for use on innocent patients undergoing procedures, the Albany Tribune reported. As a result, those patients were given saline tainted with his strain of the Hepatitis C virus instead of their prescribed doses of Fentanyl.

The defendant’s actions were finally found out in May 2012 after a host of Hepatitis C cases were identified at Exeter Hospital in New Hampshire. The disturbing discovery led to a sizable health investigation headed by the Centers for Disease Control and Prevention (CDC) as well as authorities in all of the states that Kwiatkowski had been employed, the Albany Tribune reported.

After the investigation, the CDC concluded that upwards of 12,000 patients should undergo testing to find out for sure whether or not Kwiatkowski infected them with the Hepatitis C virus. As of Sunday, testing revealed that “32 patients who were treated at Exeter Hospital, six patients who were treated at Hays Medical Center in Kansas, six patients who were treated at Johns Hopkins Hospital in Maryland, and one patient who was treated at the VA Medical Center in Baltimore, Maryland, carry a strain of Hepatitis C that has been genetically linked to defendant’s infection,” according to the Tribune.