The RGLZ Report

May is Motorcycle Safety Awareness Month

May is Motorcycle Awareness Month

We urge everyone to share the road and be alert, and we’re especially reminding motorcyclists to make yourselves visible, to use DOT-compliant motorcycle helmets, and to always ride sober.

How to choose the right helmet before you hit the road.Watch this Video from the NHTSA: https://www.youtube.com/watch?v=uB0ZY55ty7Q&feature=youtu.be

Motorcycle Safety

If you ride a motorcycle, you already know how exciting it can be. You love cruising the open road. But riding a motorcycle can also be challenging as well as dangerous. 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.

Tips to Prevent Slip and Fall Injuries

PREVENTING SLIP AND FALL INJURIES IN THE WINTER

The Centers for Disease Control and Prevention reports that about 1 million Americans are injured, and 17,000 people die, as a result of slip and fall injuries every year.

Winter tends to be the worst weather for work related slip and fall injuries. OSHA and National Oceanic and Atmospheric Administration (NOAA) are working together on a public education effort aimed at improving the way people prepare for and respond to severe weather.
Continue reading

First Steps After A Construction Accident

industrial concept with tools and equipment, selective focus on nearest

New York has special provisions to address the unique dangers faced by construction workers. Workers at construction sites are routinely subject to dangerous conditions and potentially serious injury. When a worker is injured, he/she is covered by workers’ compensation. But that is often not sufficient to cover the severe injuries that occur at construction sites. Furthermore, construction sites are usually occupied by numerous employers (contractors, subcontractors) at a time. Often, one of these third parties will be the cause of an injury to a non-employee who is working for someone else on the site. Continue reading

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

The RGLZ Street Team And Motorcycle Mike ESQ Wrap Up The Summer Season

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In addition to fighting for people’s rights, RGLZ Personal Injury Law supports our local communities in many other ways. In the last few weeks, we have sponsored two local events that proved to be a great way to reconnect with the public, reaffirm our services, and give back to the communities that turn to RGLZ when they need help or just legal advice.

On September 18th, Accompsett Middle School held it’s second annual Color Run. RGLZ was a proud sponsor of the event, which supported a variety of cultural arts programs in the community. The Color Run was a 4k paint race that has no winners, but excited runners are showered with colored powder at stations along the run. Over 225 people participated and it proved to be successful in raising funds to help the children rediscover art.

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The next week, Motorcycle Mike Esq was out in support of the Nassau County Cruise to The Show, and also sponsored this 7th annual parade and car show, which was a great send-off for an awesome summer. It was a fun-filled 2-day event at Eisenhower Park, with over 1200 show cars, vendors, and even a free concert featuring Eddie Money! Motorcycle Mike gained a lot of exposure at the show, along with connecting with the community.

It was a busy and productive September for the “RGLZ Street Team”, and we can’t wait to come up with even more new ways to conduct positive outreach. Stay tuned, as we transition into the colder months of the year, and if you see us out and about, come over and say hi!

Click to check out our photo album from both events!

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

RGLZ’s Newest Attorney: Mary Ann Risavich-Birgeles

IMG_3935RGLZ Personal Injury Law is happy to welcome our newest associate Mary Ann Risavich-Birgeles on board as of May 2016. She is the first new attorney on staff since Christopher Glass joined the team in 2012. Mary Ann studied American History and Political Science at University of Pennsylvania, before moving on to the William and Mary School of Law where she received her law degree with an additional recognition for public service.

Mary Ann has previously done work for the New York State Attorney General’s Office in the area of consumer fraud, as well as the Suffolk County Attorney’s Office. She is a member of the Womens’ Bar Association of New York, the American Association of Justice, the New York State Trial Lawyers’ Association, as well as both the Suffolk County and New York State Bar Associations.

Ms. Risavich-Birgeles will predominantly work on cases in the personal injury, nursing home abuse, and medical malpractice fields; adding even more strength to RGLZ’s already considerable talents in those practice areas.

The entire firm is excited to have her on board, and we can’t wait to see her take on the sort of serious cases that RGLZ is known for. We’re confident that she will flourish in her new role, and only reinforce RGLZ’s sterling reputation for excellence both inside and outside of the courtroom.