Category Archives: Medical Malpractice

Medical Malpractice 3rd Leading Cause of Death

MEDICAL MALPRACTICE IS NOW THE THIRD LEADING CAUSE OF DEATH IN THE UNITED STATES

While President Trump and the newly elected Republican Congress clamor to enact restrictions on victim’s legal rights, including caps on damages, lost in their enthusiasm to protect big business, doctors and hospitals are reports that incidents of medical malpractice are at epidemic levels.    In fact, it was recently reported that deaths from medical errors is now the third leading cause of death in the United States. Continue reading

Mass Tort Report – RGLZ Personal Injury Law

RGLZ Personal Injury Law has always been active in pursuing medical device, drug and mass tort product liability cases, but we are expanding our mass tort practice with the addition to our firm of Tom Valet. Tom was a founding partner of the Rheingold, Valet law firm, where he worked for more than 30 years on mass tort, medical malpractice and product liability cases, for which his firm had a national reputation. Tom now brings that wealth of experience to RGLZ.

RGLZ is currently looking for cases involving the following drugs and devices:

Ethicon Physiomesh, Atrium C-Qur, And Bard Ventralex Surgical Mesh Failures:
There are a variety of mesh products used to surgically treat hernias and other soft-tissue defects, with doctors using these products in more than 1 million operations each year. Many of these mesh products are associated with serious complications including mesh failures and high infection rates. Over the years there have been numerous recalls and litigations involving surgical mesh and the newer designs continue to be associated with serious medical complications, particularly mesh made from polypropylene.

Physiomesh, manufactured by Ethicon, was voluntarily recalled from the worldwide marker last year after reports of significantly higher complication rates causing recurrence and the need for reoperation. In 2012, the FDA issued a warning letter to Atrium after it failed to investigate reports of high infection and failure rates tied to its mesh product, the Atrium C QUR. The Bard Ventralux mesh has also been associated with serious complications including bowel obstruction, bowel perforation and high infection rates. RGLZ is currently representing clients injured by these products and welcomes the referral of clients of yours who have experienced a problem related to the use of hernia mesh products.

Proton Pump Inhibitors:
Proton Pump Inhibitors (PPIs) are drugs prescribed for the treatment of acid-reflux and other gastric-acid disorders of the upper GI tract. They include popularly known drugs such as Nexium, Prilosec, Prevacid and Protonix. For years there have been reports of issues with these drugs related to bone fractures and heart attacks, but new research suggests a link between PPIs and a form of kidney disease known as Acute Interstitial Nephritis. Adverse effects of PPIs appear to be more prevalent with long-term use of these drugs. RGLZ is currently handling a number of PPI cases and welcomes referral of any client of yours who used a PPI and has suffered an injury as a result.

IVC Filter Cases:
Inferior Vena Cava filters are medical devices implanted into a patient’s vena cava, the body’s largest vein which carries blood back to the heart from the lower body. IVC filters are designed to prevent blood clots from reaching the heart and lungs in patients at risk for formation of emboli who cannot be treated with blood thinners.

The devices are designed to be retrievable by the surgeon after short-term use, but in many cases the IVC filters are left in permanently. Retrieval of IVC filters is often not possible because the devices are prone to fracturing, migration and embedment in the wall of the vein. Bard and Cook are the most common brands of IVC filters and MDLs (Multi-District Litigations) have been established for coordination of cases in federal court. RGLZ is participating in the MDLs with a number of IVC filter cases in suit.

Diabetes Drugs:
Drug manufacturers continue to develop and promote new drugs for treatment of Type 2 Diabetes, many of which are associated with serious medical conditions. Invokana and Farxiga are two such drugs, known as SGLT2 Inhibitors, which work to lower the patient’s blood sugar by helping the kidneys remove excess sugar through their urine. Starting in 2015 the FDA required enhanced warnings for Invokana and Farxiga. Previously unreported side effects for which additional warnings are now required include the development of ketoacidosis, a serious condition related to excess acid in the blood, and acute kidney injuries tied to these drugs.

Zofran:
This drug was developed and approved by the FDA for treatment of nausea in chemotherapy patients. The manufacturer, GlaxoSmithKline, however, improperly began promoting the drug off-label for use in pregnant women suffering from severe cases of morning sickness. Virtually no research had been done, however, into the effects of Zofran in pregnancy, and reports soon surfaced of a variety of birth defects believed to be tied to the drug. These birth defects include cleft palette and severe malformations of the heart.

Medical malpractice cases also exist against Obstetricians who prescribed this drug to their patients off-label despite the lack of research into its effects when used during pregnancy. RGLZ is currently handling a case involving a baby born with severe heart defects and other serious medical issues related to the use of this drug.

3M Bair Hugger:
This medical device is a forced-air blanket used during surgery to maintain the patient’s body temperature. The system, however, recirculates air contaminated with bacteria, causing infections in the patient. Patients undergoing knee or hip replacement are at particular risk of deep joint infections, which are extremely difficult to treat.

Metal-on-Metal Hip Replacements:
Suits for defective and recalled artificial hips have been ongoing for years now, with several major settlements of litigations involving DePuy and Stryker hips. RGLZ is investigating any case involving metal-on-metal hips, including DePuy ASR Systems which were recalled in 2010, DePuy Pinnacle hips, and Stryker Rejuvinate hips which were recalled in 2012. Other metal-on-metal hips in litigation include those manufactured by Zimmer, Wright and Biomet.

Defective Carbon Fiber Bicycles:
High-end bicycle manufacturers charge a premium for bicycle frames made from carbon fiber, which are touted as being stronger and lighter than metal bike frames. Unknown to most consumers, however, is that despite their branding, these frames are not manufactured in Europe or the United States. Rather, they are made in China, with limited quality control. These defective carbon fiber frames can crack while riding, causing crashes and falls that have resulted in serious injuries and death.

Essure Birth Control Device:
The Essure Birth Control device is a metal coil inserted into a woman’s fallopian tube to provide permanent sterilization. The device, however, has been reported to be associated with a variety of complications, including perforation of the fallopian tube or uterus and migration into the abdomen or pelvis. Tom Valet handled one of the first cases involving this device, in which he successfully sued the implanting doctor who failed to recognize that the Essure device had migrated out of the fallopian tube and perforated his client’s uterus.

Defective St. Jude ICD / CRT-D Devices

Defective St. Jude ICD / CRT-D Devices

assura-ellipseSt. Jude Medical Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices – Early Battery Depletion

If you are a New York user of a St. Jude Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D), you need to be aware of a major defect in the device’s battery that can lead to injury or death at worst, and necessitate immediate replacement of the device at best.

Due to conductive lithium deposits in the battery, it can possibly deplete rapidly enough to lose all power within a 24-hour window. This renders the device completely inoperable. Under normal circumstances, a user of one of these devices would have a significant warning as to a nearly depleted battery, and would be able to plan a replacement far in advance. The potential of a catastrophic and sudden device failure presents a situation where the typical “Elective Replacement Indicator” (ERI) signal may only come 24 hours before the device ceases to function, and many are forced to have their devices replaced immediately.

This defect is not acceptable for such a medical device, as it puts patients’ health at grave risk. Failure of the device to operate can and has led to serious injuries to users of the devices, as well as forcing premature procedures to replace the devices. If you, a family member, or someone you know has been put in this situation, or currently has one of these devices, we implore you to call us. We can help recover money for injuries or other complications stemming from these defective medical devices. We can be reached at 800-734-9445, or via email at Info@RGLZlaw.com.

Relevant FDA Notices

FDA Safety Communications
FDA MedWatch Safety Alert

Winning the Battle Over Medical Record Copying Costs: The Federal HI-Tech Act

The federal Health Information Technology for Economic and Clinical Health Act (the HI-TECH Act) was passed in 2009 to promote the adoption of electronic medical records.  The Act encompasses many subjects, but some of its provisions can be used to substantially reduce the cost of obtaining electronic copies of medical records.  The Act applies to any medical provider who maintains electronic medical records, and requires a digital copy of the records be supplied at cost upon request.[i]  In practice, this results in a significant reduction in the cost of purchasing medical records.

Under the HI-TECH Act, an individual patient may request the digital record.  In addition, any other person who has authority to act for the patient “under applicable law” can make the request.[ii]  Although this language suggests the patient’s attorney should be able to send the request for electronic records as the patient’s “authorized representative,” that would be wrong.  The agency which enforces the HI-TECH Act, the federal Office of Civil Rights (OCR), has consistently taken the position that the Act will only apply if the request for medical records is in a writing signed by the individual and is authored by the individual; i.e. – the patient (or authorized estate representative).  The OCR takes the position that third-party requests for medical records (i.e. – attorney requests) are governed by state laws, which vary from state to state.[iii]  In New York, the state law is Public Health Law Section 18, which provides that the fees shall be cost-based but in no event in excess of $0.75 a page.

To invoke the Act, therefore, the medical record request must be in a writing signed by the patient.  The attorney can prepare the medical record request for the client’s signature.  The letter from the patient requesting the medical records can be forwarded to the health care provider from the attorney’s office, again, as long as the request is in a writing signed by the patient.  The regulations provide that the client (the individual) can require that the medical records be mailed to a third party designated by the patient (i.e. – the attorney’s office).[iv]  It is also important to note that a HIPAA authorization is not required as part of a HI-TECH Act request for electronic records.[v]

Upon receipt of a request for electronic records under the HI-TECH Act, the health care provider must act on the patient’s request no later than 30 days from receipt.[vi]  Recall, that under the New York’s Public Health Law Section 18, the time limit to produce the records is a “reasonable” time.  If the provider cannot comply within 30 days, it/he/she can extend the time by a one- time extension of an additional 30 days, but must provide a written explanation for the delay.[vii]  Although a medical provider may insist on payment of a copying fee, the records must be sent within the allotted time frame, regardless of whether payment has been made in full.[viii]

While there is no private right of action under the HI-TECH Act, the OCR can investigate complaints and levy fines for violations.   Generally speaking, no penalties will be imposed if the failure to comply is corrected within 30 days after the medical provider knew that the failure to comply occurred.  The Office of Civil Rights may provide “technical assistance” to the provider during this 30-day period to resolve the dispute without penalty.[ix]  Translated roughly, that means that the OCR can contact the provider and work out a resolution. If your client’s request for medical records is made consistent with the parameters discussed above, and you nonetheless receive a bill from the hospital or the copying company for $0.75 a page, your recourse is to make a complaint to the Office of Civil Rights.  The process is relatively painless and can be done online in a few minutes time at the OCR website.[x]  OCR normally will only accept complaints that are filed within 180 days of when you knew, or should have known, that the alleged violation of the statute occurred.

The HI-TECH Act, when invoked correctly, should significantly reduce the cost of obtaining your client’s medical records.  Remember, however, the key to triggering the statute is to have your client demand an electronic copy of the record in a writing signed by the client.

1 42 U.S.C. 17935(e)(1),(2); 45 C.F.R. 164.524
2 45 C.F.R. 164.502(g)(1),(2)&(4)
3 OCR Decision Letters, obtainable only through FOIL request
4 See http:\\www.hhs.gov\hipaa\for-professionals/privacy/guidance/access/index.html ;
45 CFR Sec. 164.524
5 CFR Section 164.524
6 45 C.F.R. 164.524(a)(2)(i-iv); 45 C.F.R. 165.524 (b)(2)(i)(A).
7 45 C.F.R. 164.524(b)(2)(ii)(A)&(B)
8 See OCR Decision, Reference Number 16-225898, dated February 4, 2016, obtainable only through FOIL request.
9 See OCR decision letters, obtainable only through FOIL request.
10 www.hhs.gov/hipaa/filing-a-complaint/complaint-process/index.html

Are You Paying Too Much for Subpoenaed Medical Records?

Any lawyer who routinely purchases medical records as part of their practice is familiar with the ubiquitous $0.75 charge per page.  However, does Public Health Law Section 17 and 18’s provision, requiring medical records be furnished to patients at a maximum of $0.75 per page, apply in the context of subpoenaed medical records?  A reading of CPLR §8001 suggests the answer is no. Continue reading

A Guide to Pressure Sore Cases: Part Three

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Typical interventions to prevent the development of a pressure sore for an at risk resident include routine turning and positioning to off load pressure points, maintaining adequate nutrition and hydration, employing pressure relief devices such as a pressure relief mattress or pads or heel protectors, and providing appropriate skin cleaning and skin care. Many of these interventions are provided by the certified nurse assistants, who work under the supervision of the facility nurses. The facility should maintain some form of a CNA accountability record which documents on each shift whether the interventions required by the Plan of Care are actually being performed. Pressure sore litigation is often waged in and around the CNA accountability record. Large gaps in documenting daily care, such as the turning and positioning of the immobile resident, provide plaintiffs’ experts with a ready explanation as to why the pressure sore developed or failed to heal. Conversely, a well -documented chart of daily interventions support the facility’s argument of “clinical unavoidability.”

Sometimes the nursing home chart has missing parts, or worse, material alterations between the chart obtained before the litigation and the chart produced during the litigation. On an alarming number of occasions we have discovered fabrications in the notes, including the addition of turning and positioning entries which were not recorded in the earlier version of the chart, and even the administration of medications to a resident a day after his death.

The most damning pieces of evidence in the pressure ulcer case are the photographs of the ulcers themselves. Graphic photographs of the deep sores exposing, for example, the vertebrae in the sacrum are a compelling adjunct to the resident’s family’s testimony concerning pain and suffering. In every pressure sore case the family should be instructed to take multiple photographs of the ulcer, or a professional photographer should be dispatched to the hospital or facility for that purpose. If the resident has died, funeral directors will often permit a photographer to document the sores while the body is being prepared. Unfortunately, autopsies are rarely performed on elderly residents who expire in the hospital or nursing home from presumed natural causes. The nursing home and hospital charts should be scoured for any evidence that the facility took photographs to document wound care progression, and careful note should be made of any differences in the description of the pressure sore between the nursing home and the subsequent treating hospital. Once a pressure ulcer is identified, it should be measured by location, size and depth. It is not unusual to discover that a pressure sore is described by the nursing home staff as a Stage III on the day the resident is transferred to the hospital for definitive care, and a few hours later described as a Stage IV by the hospital emergency room personnel.

As the preamble to the New York regulations reminds us, the infirmed elderly are among the most vulnerable in the population. A large percentage of that population is at risk for developing pressure sores. Unless clinically unavoidable, pressure sores should not occur in a skilled nursing facility. Litigation of bed sore cases is one method of promoting enforcement of existing standards of care and improving quality of care throughout the industry. The practitioner would be well advised to seriously consider obtaining the nursing home chart when the family complains that a loved one has developed serious bed sores in the nursing home.

A Guide to Pressure Sore Cases: Part One

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Pressure ulcers are among the most common injuries suffered by nursing home residents. They can be painful and debilitating, and are horrifying to the resident’s family and to jurors alike. Practitioners should have a basic understanding of the law protecting nursing home residents who develop bed sores and be able to make a preliminary determination as to whether a bed sore case should be investigated further.

Nursing home residents are protected by a complex web of federal and state regulations which govern almost every aspect of nursing home care. On the federal level, in 1987, the U.S. Congress enacted a far reaching set of reforms to nursing home regulations to improve nursing home quality.The legislation expanded state and federal responsibilities for nursing home supervision and increased sanctions for noncompliance. The stated purpose of the reforms was to ensure that each nursing home resident receives care which enables the resident to “attain the highest practical physical, mental and psychosocial well-being.” The regulations, collected at 42 C.F.R. Part 483, set forth detailed standards for resident’s rights, the quality of resident’s care, proper maintenance of the facility and other facility practices.

States license nursing homes and also have the authority to enact their own set of nursing home regulations to complement federal oversight. The statutory authority of the New York State Commissioner of Health to regulate nursing homes is set forth in Public Health Law Section 2803. Public Health Law Section 2803-C(3)(e) expressly states that each nursing home patient has the right to adequate and appropriate medical care. Detailed New York State regulations governing the quality of care in nursing homes are set forth in 10 N.Y.C.R.R. Part 415. The New York regulations largely track their federal counterpart, although they are not identical. Both sets of regulations must be referenced in any nursing home neglect case.

New York also protects nursing home residents with a private statutory right of action under Public Health Law Section 2801-d. PHL 2801-d is perhaps the single most powerful tool in the practitioner’s arsenal. PHL 2801-d creates a private right of action for the nursing home resident who suffers any deprivation of a right or benefit conferred by statute, regulation or the nursing home contract. A prima facie PHL 2801-d case is made out when the resident proves the nursing home violated any one of the myriad state or federal regulations protecting residents and demonstrates that the violation caused the resident’s injury. Under the statute, the burden then shifts to the nursing home to prove that “the facility exercised all care reasonably necessary to prevent and limit the deprivation and injury … to the patient.” A prima facie case for the resident under PHL 2801-d can be easier to prove than a traditional negligence claim (in which the plaintiff must establish the facility acted unreasonably), or a medical malpractice claim (in which the plaintiff must establish departures from accepted standards of care). Significantly, PHL 2801-d also provides for minimum statutory damages, punitive damages when willful or reckless disregard of the resident’s rights can be proved and, in the discretion of the court, attorney fees to the prevailing resident’s attorney.

Tales of the Trial: From Asylum to Refuge – Part 2

In Part two of Tales of the Trial, Charles Rappaport regales us with the closing half of “From Asylum to Refuge”. Find out how the young man makes his way out of the asylum, and how Charles helps turn his life around. If you missed part one, click here.

 

Tales of the Trial: From Asylum to Refuge – Part 1

In Tales of the Trial, follow Chuck Rappaport as he recounts the most influential and impactful cases of his career as a renowned personal injury attorney. In this episode, hear the story of a young man whose mental illness threatens to deprive him of his future, and leads to a very dark place.

 

Emergency Medical Services & Surprise Bills Law

written by Michael Glass

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An increasingly problematic issue patients are facing lately in the medical field is the unpleasant surprise of a stratospheric bill after treatment in the emergency room or the hospital, when they were under the impression that their health insurance was covering those bills fully. In recent years, more and more doctors and hospitals are insisting payment on (and even suing their patients for) the difference between what they charge for their services, and what the patient’s insurance carrier is willing to pay.

For example, one of our clients recently had an orthopedist assigned to her in the emergency room of a local hospital to treat a badly fractured ankle. The orthopedist kept her overnight in the hospital, and performed surgery the next morning. She was well insured, and her insurance paid his bill; which should have been the end of things. But a few weeks later our client received a medical charge from his office in the amount of $27,000.00. At no time during his treatment of her, did he indicate that there would be charges over and above what her health insurance paid for.

Thankfully, help has arrived. On April 1, 2015 New York’s newly minted Emergency Room Medical Services and Surprise Bill became law in the State of New York. The law requires new disclosures from healthcare providers regarding their insurance plan participation and adds new rules for health plans regarding reimbursement for out-of-network services.

One of the most important parts of the law requires physicians, diagnostic and treatment centers and health centers to disclose the insurance plans they accept and the names of the hospitals with which the doctor or provider is affiliated. More important, doctors and facilities have to provide the amount or estimated amount of the charges for the service being performed before the provision of non-emergency services. Upon receiving a request for the amount of the charges, the estimated amount that will be billed, absent unforeseen medical circumstances, must be disclosed in writing.

One particular nasty problem we’ve seen, was that the diligent patient who made certain that the surgeon was on his or her insurance plan could, nonetheless, be surprised by an out of network service provider who provided ancillary services for the surgery or procedure, such as anesthesiology, pathology, laboratory services, or radiology services. Or even an assistant surgeon who participated in the surgery. Now, physicians must disclose to patients the name, practice name, address and phone number of any of these providers at the time that the physician decides he is going to use those additional providers.

With respect to hospitals, the law demands that the hospital post on its website a list of the hospital’s standard charges for items and services provided, and remind patients that physician services provided in the hospital may not be included in the hospital bill, and the hospital must also tell patients that a particular physician may not participate in the same healthcare plan as the hospital.

Under the new law, the patient’s insurance company or HMO also has to make certain disclosures relating to out-of-network reimbursement. Specifically, they have to note on their website information that will permit patients to determine anticipated out-of-pocket costs for out-of-network healthcare services.

Other aspects of the bill specifically hamstring physicians who would otherwise “surprise bill” patients for non-emergency services. For example, if a physician know a patient is insured and accepts an assignment of benefits from a patient’s insurance company, even if that physician is not in the patient’s insurance network, the physician cannot bill the patient for more than the amount that the patient would have paid if the service was provided in-network. Physicians may bill an insured patient if no assignment of benefits was made, but the patient may take the bill to binding arbitration before owing any amount.

The new law addresses important loopholes, which previously permitted physicians and healthcare providers to surprise bill patients for thousands of dollars of unanticipated medical charges. If you have any questions regarding the new law, contact RGLZ Personal Injury Law at 1-800-734-9445.