Author: JGL Law

The Department of Justice is claiming the healthcare giant filed false medicare claims in California. Click below for the full article.  

The university has yet another lawsuit on its hands. Former student athletes are claiming their coaches pushed them into phony classes. Click below for the full article. 

When a patient is injured or dies as a result of inappropriate medical treatment, it is known as medical negligence. In medical negligence cases, it’s important to provide your attorney with a list of specific items to better help them investigate the claim. 

The first set of items your attorney will need is any background information related to your case. Your attorney will need a chronological list of key events that led to your injury, as well as a list of any people who were there at the time. It’s also important to include a list of any people who spoke to the health care provider. 

You should also include a statement that will inform your attorney about how and when you first knew that you may have received inappropriate medical treatment. 

Next, you will need to provide information about the healthcare provider itself. Make sure you include the names of all doctors and hospitals involved in your care, on top of the name of the doctor or doctors’ professional practice(s). 

After you provide all of the background information and information about the healthcare provider, it’s time to give your attorney some information about yourself. 

The most important set of items to provide is your medical history. It doesn’t have to be too extensive, but make sure you briefly describe it. Include a list of any medications you take, along with a statement of what you were told by the doctor or hospital about your treatment at the time of the injury. 

It’s important to include a copy of all medical records, both from the treating doctor and from the hospital. These records should include the entire medical chart, and not just the summary. 

There are two special cases that would require more records: birth injury and death. 

In a birth injury case, it’s important to provide both your prenatal records and any records from other pregnancies and deliveries. Include your labor and delivery records, the fetal monitor strip, the baby’s newborn records and the pediatrician’s records. It’s also important to provide any reports of radiology studies, such as MRI or CAT scans, as well as any records relating to any testing done on the child. 

In a death case, it is important to include a copy of the autopsy report. 

It’s a lot of information to include, but all of it will help your attorney investigate the case. However, if you cannot obtain any of the records, your attorney can do that for you. 

 

Senior Counsel Eleanor Hunt attended the J. Franklyn Bourne Bar Association Inc. Women’s Committee Scholarship Tea on April 23.

The tea honored the new women judges of color in both Prince George’s County and Montgomery County. All proceeds from ticket sales went toward book scholarship for law students in the Washington DC metropolitan area who are also women of color.

 

 

Some basic considerations when thinking of reporting health care fraud

Most employees never imagine reporting their employers. No one takes a job with their sights set on clandestinely gathering evidence for a government health care fraud investigation. But, anyone working in the health care field long enough knows that fraud is still rampant and it sometimes causes real patient harm. So, how does a loyal employee turn whistleblower, and what should you do if you find yourself in this position?

What is the False Claims Act and what does a whistleblower do?  The Federal False Claims Act dates back to the Civil War and is also referred to as “Lincoln’s Law” as it was signed by President Lincoln. While it lay dormant for decades, it was strengthened by both Presidents Reagan and Obama. The current law provides for civil liability to anyone who knowingly presents or causes to be presented a false claim, uses a false record, conspires to commit these acts, or conceals or avoids an obligation to pay the Government. 31 U.S.C. § 3729. The Act carries significant penalties of between $5,000 and $10,000 per claim plus three times the amount of the damages sustained by the Government. 

The False Claims Act is one of the only vehicles that allows a private person to bring a claim on behalf of the Government – to do some of the Government’s work for it. Though this is not the whistleblower’s claim, if a case is successful, a whistleblower is entitled to receive between 15%-25% of the proceeds of a settlement. While this has been described as a “bounty” by some, it is much more. For, the successful whistleblower has intimate knowledge of the fraud, the scheme and the ways in which the defendant attempts to cover it up. The whistleblower has gathered evidence and taken personal risk to bring the fraud to light. He or she works closely with the Government to investigate, map out the fraud, and drive the defendant to the negotiation table or to trial. For his or her efforts, the Government will then pay the successful whistleblower between 15% – 25% of the total recovery. If a case goes forward without the Government’s participation (“non-intervention”), the percentage increases to between 25% – 30% of the ultimate recovery. 31 U.S.C. § 3730(d). 

What Does Health Care Fraud Look Like? If you have witnessed or have been asked to participate in fraud, you might want to, or feel compelled to, report it. Fraud can take just about any form. Fraudsters can be creative. There are lots of examples of fraud. But, here is a list of some of the most common fraud in the health care space:

• False and off-label marketing and promotion;
• Kickbacks or quid pro quo arrangements (e.g., speaker or writer fees, sham consultant agreements, paid dinners, outings or vacations, paid advertising);
• Upcoding CPT codes, DRGs, RUG rates or HHRG scores to increase reimbursement;
• The fabrication of records or bills;
• Billing for services not provided at all or not provided as billed;
• Billing for services or patients that are ineligible for government reimbursement; and
• Providing unreasonable and unnecessary medical services

Some fraud is blatant, rampant and out in the open. Most fraud, however, is more subtle and takes an insider to detect and uncover it. Basically, any time an employer is directing you to skirt the rules, or when you discover that decisions are being made for monetary reasons instead of in compliance with governing rules and regulations, you might rightfully suspect fraud.

Act Fast. If you are considering reporting fraud and filing under the False Claims Act, you must act fast. This cannot be overstated. The Act has a harsh “first-to-file” rule. Even if your allegations are more detailed and you have more evidence than the person who is first to file, if you are not first, you are entitled to nothing under the Act. 

Maintain All Records. As with any potential litigation, if you are even considering filing a whistleblower lawsuit, you should maintain, and do not purge, your files. If you do end up retaining an attorney to file under the False Claims Act, you will need to turn over all of your evidence to your attorney, who will then turn it over to the Government as required in a detailed Disclosure Statement. However, never try to get documents that you do not normally have access to or to which you are not privy. You can blow a case before it has a chance if you unlawfully obtain documents.

Keep Quiet!  False Claim Act cases, unlike other types of litigation, are filed under seal and are not served on the defendant at first. This means that during the Government’s investigation, the defendant target is unaware that you have filed a case and is unaware that the Government is pursuing a False Claims Act case against it. As soon as you file suit, the Court will issue sealing order, with which you and the Government must abide until it gets lifted, which could take years. This sealing provision is a critical part of the Act that allows the Government to conduct is investigation thoroughly, without detection and without fear that the defendant might destroy or compromise sensitive evidence. Any good whistleblower attorney will tell you to assume the seal is in place even before you file, while you are still putting together your Complaint. This means that you need to keep strict confidentiality about what you are doing and the evidence you are gathering from your friends, family and even from your spouse.

Get Trusted Legal Advice. If you have witnessed activities you think may violate Medicare, Medicaid, or other health care laws or regulations (including private insurance regulations in certain states), you should consult with an experienced whistleblower attorney immediately. These consultations are confidential and are protected from disclosure. Always call or email an attorney from a personal phone or personal email address and never from a work-sponsored computer or hand-held device tied to a company server to ensure the communication remains protected.

An experienced whistleblower attorney will walk through your various options, which may include: (1) filing a case under the False Claims Act or state false claims act equivalents; (2) bringing a retaliation claim under the False Claims Act and/or state laws; (3) negotiating a settlement and severance with the employer; and (4) other options depending on your unique situation.

Trust your gut! Trust your instincts, your training and your experience. If an employer is asking you to perform tasks that you know or feel are outside or contrary to Medicare’s or Medicaid’s rules and regulations, then you are right to question and pushback on these requests. If you are complicit in fraud, then there is a likelihood that someone will report it, whether it is a co-worker, a patient or a competitor. You will then be on the wrong side of the inevitable investigation. Licenses and livelihoods are then on the line. In the most egregious cases, criminal charges can result. It is best to consult with an attorney to know your rights and map out a strategy that works for you. 

The article explains implied certification under the False Claims act. A Supreme Court ruling last summer made some changes all government contractors should know. Click below for the full article 

Attorney Debora Fajer-Smith was given a challenge coin by a select group of her clients, Prince George’s County police officers, and by a member of the Prince George’s Fire Fighters. These coins signify that recipient is valuable to the organization and is so dedicated to be considered “one of them.” 

“ I was humbled and so appreciative by this small gesture with great meaning, coming from my clients” comments Debora Fajer-Smith, of Counsel to Joseph Greenwald & Laake, PA.

Challenge coins range from 1.5 to 2 inches in diameter and they come in a variety of shapes, finishes and designs. From traditional circular coins with an insignia, to more unusual coins such as arrowhead shaped coins, gold plated coins and coins with enamel highlights and cut-outs.

Challenge coins have a special history, and originate in the military. Historically, they served as a way for members of a particular unit or rank to prove that they belonged to that given unit, almost like an ID. Now, challenge coins are also awarded to non-military members. For example, the U.S. President and U.S. Vice-president also receive challenge coins to give out during their term.

Debora Fajer-Smith is the chair of the Workers’ Compensation and Insurance Group at Joseph, Greenwald & Laake and she has over 30 years of experience in this field. She has traveled as a citizen ambassador, and is a firm believer in giving back to the community. And it is because of her commitment to representing those involved in occupational injuries and to improving her community, that she was honored here by public safety clients fire and police. Congratulations Debora! Keep up the great work!

Cases that involve victims of brain damage can be very challenging, emotional and complicated. I believe to be successful in court, attorneys must be aware of any potential challenges he/she may face. A specific example of this is using infection as a cause of brain damage. 

Was there a fever before the brain damage was realized? Have you analyzed the mother’s screen? Was chorioamnionitis confirmed before the birth of the victim? These are just some of the questions to answer prior to building a case of brain damage caused by infection. 

Here is a checklist:

1.        Culture Results
2.        Respiratory Course
3.        Question of Meningitis 
                       a.    CSF
                       b.    Amount of days on antibiotics
4.      Mother’s screen
5.      Amount of time before a membrane rupture
6.      Fever
7.      Chorioamnionitis 
8.      Culture from ET tube
9.      Rash
10.    Jaundice
11.    Microcephaly
12.    Intercranial Calcifications at birth
13.    Hearing loss
14.    Asymmetrical growth
15.    Retardation
16.    Igg, Igm
17.    Time of year
18.    Diagnosis entertained 
19.    Placental pathology
                      a.  Infection in the placenta defined? 
                      b. Chronic villitis
20.    Alternative to explain injury

Jay sat down with Amanda Ciccatelli to discuss a recent ruling issued by the 7th US Circuit Court of Appeals. Click below for the full article. 

 

Jay Holland weighs in by saying the $13 million in reported settlements for O’Reilly’s accusers was “more than enough [for 21st Century Fox] to say enough is enough.” Click below for the full article. 

Andrew Greenwald has been named one of the nation’s best attorneys by Super Lawyers Magazine for the 12th straight year. Only 5% of attorneys receive this honor.  

As a founding member of Joseph, Greenwald & Laake, Andrew Greenwald has a reputation for being an unwavering and effective advocate who has obtained millions of dollars in recoveries for his clients. Andrew has extensive experience in representing victims of medical negligence.

Click the image below for more on Andrew. 

INSTRUMENTAL DELIVERIES

An Important Discussion About Vacuum Deliveries All Effected Families Should Read       

“It has been repeatedly shown that under modern conditions, caesarian section, although not devoid of risk, offers better results to both mother and child than does a difficult instrumental delivery.”[1]

            On May 21, 1998, the FDA issued a public health advisory entitled, “Need For Caution When Using Vacuum Assisted Delivery Devices.”[2]  The Advisory stated that:

Vacuum assisted delivery devices may cause serious or fatal complications . . .

 

The Advisory went on to say that:

While no instrumental delivery is risk free, we are concerned that some health care professionals who use vacuum assisted delivery devices, or those who care for these infants following delivery, may not be aware that the device may produce life-threatening complications.

 

            The FDA noted that it had received over the past four years reports of twelve (12) deaths and nine (9) serious injuries among newborns on whom vacuum assisted delivery devices were used.  The types of complications that the FDA discussed were subgaleal hematomas[3] and intracranial hemorrhages. 

           

            In Childbirth FDA Patient Safety News, June 2002, Problems After Vacuum -Assisted Childbirth, it is noted:

But the FDA has received reports of much more serious complications, including subgaleal hematoma and intracranial hemorrhage.  And although these are rare, they can be fatal.[4]

 

            Subgaleal hematoma (injury to the scalp with subsequent bleeding into the potential space between the galea aponeurotica and the pericranium[5]) may be life threatening because “damage to the emissary veins may cause bleeding and result in a large proportion of the baby’s blood volume accumulating in this space.”[6]  The relationship between subgaleal hematomas and vacuum extractors had been published in the medical literature before the FDA warning of 1998, evidenced in a 1995 article in The Journal of Family Practice which states, “The major reported risk factor for subgaleal hematoma is use of a vacuum extractor to assist with the delivery of the infant.”[7] 

 

            The Committee felt that the decrease in the use of the vacuum device resulting from the Advisory might result in a higher cesarean section delivery rate or the increased use of forceps by some who have not had adequate training.

           

                        The FDA has recommended that in cases where vacuums were used, the caregivers of the newborn are to be instructed to watch for several days for possible problems as set forth above, and recommend that the fact that a vacuum was used be clearly listed in the patient’s chart.[8]

TECHNICAL BULLETINS

            In February 1991, ACOG issued a Technical Bulletin[9] dealing with operative vaginal delivery.  Under the heading of “Clinical Management” the Bulletin stated:

The indications, preparation of the patient, definitions, and prerequisites for vacuum extraction delivery are the same as for forceps deliveries.

 

            Additionally, the ACOG Bulletin stated:

Relative contraindications for vacuum extraction include prematurity, suspected macrosomia, suspected fetal coagulation defect, fetal scalp blood sampling, and a non-vertex presentation.

 

            Noting at that time the literature for the safety of the soft cup vacuum was sparse, the following criteria were suggested:

Descent of the fetal head must occur with each push-pull effort and delivery should be completed or almost completed in three pulls.  The fetal head should be completely delivered within fifteen minutes after the cup is first applied. 

 

            The Bulletin ends with:

As with forceps procedures, there must be a willingness to abandon attempts at vacuum extraction if progress does not proceed easily.

 

            This Technical Bulletin[10] was superceded by another one issued in August 1994[11], which reaffirmed that:

. .indications, preparation of the patient, definitions, and pre-requisites for vacuum extraction are essentially the same as for forceps delivery.

 

            One significant change in the Technical Bulletin appears on page four:

There is a lack of consensus regarding the number of pulls required to effect delivery, the maximum number of cup detachments that can be tolerated, and the total duration of the procedure.  These issues have not been subjected to rigorous scientific study and should be based on the judgment of the operator or supervisor and clinical circumstances.  As a general guideline, progress in descent should accompany each traction attempt.

 

            Again, ACOG stated:

As with forceps procedures, there should be a willingness to abandon attempts at vacuum extraction if satisfactory progress is not made.[12]

 

            Since the indications for vacuum extraction are essentially the same as for forceps delivery, the cervix should be completely dilated, the membranes should be ruptured, and the fetal head should be engaged. With regard to the determination of station, significant caput formation can lead an obstetrician to misjudge where the bony part of the head actually is located.[13]  The contraindications,[14] therefore, include:

• CPD  (Cephalo-Pelvic Disproportion)
• Face or brow presentation
• Breech presentation
• Unengaged fetal head
• Premature infant
• Incompletely dilated cervix

 

Dr. Robert H. Hayashi, in his chapter on ventouse delivery, notes that:

Caution should be used if a vacuum extractor is used on a fetus who has had fetal scalp blood samplings performed earlier in labor, since there has been one report of an exsanguination of an infant when ventouse delivery followed fetal blood sampling.[15]

 

            ACOG Practice Bulletin Number 17, entitled “Operative Vaginal Delivery” and dated June 2000 indicates “the incidence of intracranial hemorrhage is highest among infants delivered by caesarian following a failed vacuum or forceps delivery.”  They go on to say, “… an operative vaginal delivery should not be attempted when the probability of success is very low. Persistent efforts to obtain a vaginal delivery using different instruments may increase the potential for maternal and fetal injury and often indicates cephalo pelvic disproportion.”  ACOG indicates, “most authorities consider vacuum extraction inappropriate in pregnancies before 34 weeks of gestation because of the risk of fetal intraventricular hemorrhage.  Vacuums may also be responsible for retinal hemorrhages and hyperbillirubinemia.”[16]

           

Dow Corning lists in its literature that the indications for the use of its SILASTIC® Obstetrical Vacuum Cup are made much the same as the forceps operations.

 

• Appropriate presentation and attitude.  It may be safer not to use the cup in brow or face presentations.
• No demonstrable clinical cephalopelvic disproportion.
• Adequate dilatation and effacement of the cervix.
• Ruptured membrane.
• Engagement of the head.

 

Dow specifically states under contraindications:

• Deliveries requiring unusual amounts of traction
• There must be no disproportion between the parturient canal and the presenting fetal part
• The SILASTIC® Obstetrical Vacuum Cup must never be applied to overcome an absolute mechanical obstacle

 

The manufacturer also advises, “Always pull in synchronization with the contractions- this is one of the most important principles and rules in the application of the vacuum cup.”[17]

The operational guidelines for the use of the MITYVAC® list as contraindications for the use of the vacuum an unengaged presenting part, a breech face/brow presentation or transverse lie, and cephalopelvic disproportion.[18] 

 

In the Operational Guidelines for use of The Mityvac Obstetrical Vacuum Extraction System, published in March, 1997, the manufacturer warns:

CAUTION

INCORRECT USE OF THIS DEVICE COULD POSSIBLY CAUSE:

MATERNAL SOFT TISSUE INJURIES:  VAGINAL, CERVICEAL [sic], UTERINE, BLADDER AND RECTUM.  FETAL BRUISES, CONTUSIONS, LACERATIONS, FRACTURES, INTRACRANIAL HEMORRHAGE, CEPHALHEMATOMA, SUBDURAL HEMATOMA, SUBGALEAL HEMATOMA, PARENCHYMAL HEMATOMA AND RETINAL HEMORRHAGE.[19]

 

 

In Shoulder Dystocia and Birth Injury, Prevention and Treatment,[20] Dr. James O’Leary warns that “both the perturbations of difficult high or mid-forceps delivery or a vacuum extraction of a head wedged within an inadequate tight, bony birth canal, present grave danger of fetal, skull and brain injury. . .”

            As a general proposition, the use of vacuum extractors has been directly linked with cranial trauma, including skull fractures.[21]  Trauma, in turn, is a causative agent in cerebral venous thrombosis.[22]  Also, by way of example, venous sinus thrombosis has been associated with cranial trauma and instrumental delivery.[23]

            Moreover, the body of medical literature contains several studies and articles indicating that vacuum extractors can cause dangerous and life threatening effects as a result of the pressure applied to the area of the venous sinuses.  To cite only a few examples, Dr. Aldo Vacca’s paper entitled “Birth by Vacuum Extraction: Neonatal Outcome,”[24] indicates that use of vacuum extractors has caused the incidence of subgaleal hemorrhage to increase “considerably.”  Dr. Vacca writes:

Intracranial hemorrhage should always be considered in the differential diagnosis if the baby exhibits abnormal neonatal behavior after difficult vacuum extraction so that early diagnosis may lead promptly to more effective treatment.[25]

 

            Dr. Vacca has also published a comprehensive work concerning use of the vacuum extractor entitled, Handbook of Vacuum Extraction in Obstetric Practice (1992).  In the section entitled “Effects of Vacuum Extraction on the Infant,” Dr. Vacca warns:

[D]amage to the falx or tentorium and to their venous sinuses may occur when compression on the head is excessive as may happen when vacuum extraction is attempted in the presence of severe molding.

 

            Vacuum extraction is also correlated with tentorial hemorrhage and mental retardation by the physicians in “Tentorial Hemorrhage Associated with Vacuum Extraction.”[26] 

           

Vacuum extraction has also been associated with the development of dural tears.  The application of the vacuum cup to the vertex with longitudinal traction exerts vertical stresses on the tentorium with tearing and hemorrhage similar to that seen with forceps delivery.[27]

            While the incidence of intracerebral hemorrhage with vacuum extraction is small, it is increased in situations involving pre-term delivery, and therefore, “…pre-term delivery is a relative contraindication for the use of the vacuum extractor.”[28]

            The prenatal record usually has a place on it for the obstetrician to note whether or not the mother’s pelvis is adequate for a normal vaginal delivery.  As there are various different types of pelvises, it would also be important for the doctor to note what type of pelvis the mother has. 

            Where nurse-midwives are allowed to use vacuum extractors to deliver babies, it is usually done by an agreement with the delivering obstetrician for whom they are employed.  This is subject to various state regulations requiring a definition of the circumstances and manner in which the vacuum can be used.  In Maryland, for example, COMAR 10.27.05.06 provides that:

A. A certified nurse midwife who meets the requirements of Regulation .02 of this chapter may perform the following functions:

(1)        Independent management of clients appropriate to the skill and knowledge of the certified nurse midwife and the nurse midwife’s agreement and protocols;…

 

Hospitals usually have protocols dealing with vacuum extraction.  These discuss various issues, including under what conditions vacuum use should be terminated.  The American College of Nurse-Midwives has published a book on vacuum-assisted birth, in which they discuss, in the sample protocols, what the operative role of the nurse-midwife is in the use of the vacuum extractor, i.e., how the vacuum is to be applied, what steps are to be taken before applying the vacuum, how it is determined where on the fetal head the vacuum is placed and how the vacuum is then used.  Also addressed are the functions of others in the delivery room during the attempted vacuum extraction?[29] 

            Usually a nurse in the delivery room will be responsible for making sure the pressure on the vacuum is appropriate for the use of the instrument.  Questions dealing with how this was determined and how it was maintained are essential.  Nursing issues may also deal with a failure to use the chain of command when inappropriate actions are instituted by the deliverer.

            It is important to understand not only how many times the vacuum has popped-off, but why that has occurred.  Some protocols provide that after two to three pop-offs, vacuum use should be discontinued.[30]  They may also be informative as to how long the vacuum should be used.  See also Operational Guidelines for Use of the MITYVAC® Obstetrical Vacuum Extraction System, March 1997, which states:

DISCONTINUE VACUUM EXTRACTION IF ANY OF THE FOLLOWING EXIST 

1.         Cumulative traction time exceeds 10 minutes.

2.         Extractor cup becomes disengaged three times.[31]

 

            While ACOG does not specifically list in any of the technical bulletins or practice bulletins the amount of pop-offs before the vacuum should be discontinued, a review of the ACOG publication Prolog Obstetrics provides information in this regard.[32]  Instructive of this is the following:

The American College of Obstetricians and Gynecologists recommends that the time of vacuum application be limited, but does not specify what this limit should be.  The University of Mississippi protocol recommends limiting suction pressure, restricting vacuum application to twenty minutes or less and abandoning the procedure after three pop-offs of the applicator.

 

Prolog goes on to state that:

Those such recommendations are level C evidence (recommendations of respected expert).  They highlight the importance the limiting the suction and duration of application with vacuum.  In many cases, when signs predicting failure of vacuum-assisted delivery are present, it is appropriate to proceed with the cesarean delivery or to change the position of the vacuum or to change to forceps.

 

            There are only so many reasons why a vacuum will pop-off.  These would include, among other things, inappropriate placement of the vacuum.

 

            There is also a noted relationship between the use of a vacuum extractor and shoulder dystocia.  The authors in “Shoulder Dystocia and Operative Vaginal Delivery” point out, “… This is not the first study to suggest that the use of the vacuum extractor is more likely to cause shoulder dystocia.”[33]  See also Gosk J, Rutowski R., “Analysis of Risk Factors for Perinatal Brachial Plexus Palsy” (article in Polish).  ACOG recognizes with regard to shoulder dystocia “associated intrapartum factors include labor induction, epidural anesthesia, and operative vaginal delivery (forceps and vacuum-assisted delivery).” [34]

AFTER THE DELIVERY

            It is important to carefully review the newborn records to determine whether or not any abnormal signs were present.  These may include bogginess of the scalp, increased size of the head, pallor and other indications of a baby that was not neurologically intact.  If caught at an appropriate time, an expanding subgaleal hemorrhage can be appropriately treated.  If left unattended, it will lead to the baby’s demise.

 

CONCLUSION

            During delivery, it is important to recognize whether it was appropriate to use the vacuum, whether the vacuum was used appropriately with respect to placement, number of pulls, pop-offs and time.  Also important to discover is whether newborn caregivers were aware of the potential problems from its use.  Always remember the ACOG admonition: “as with forceps procedures, there should be a willingness to abandon attempts at vacuum extraction if satisfactory progress is not made.”[35]