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Significant economic indicators continue to support the proposition that new business startup activity is on the rise. On August 4, 2016, the Kauffman Foundation released the 2016 Kauffman Index of Startup Activity, its highly respected annual report which focuses on new business creation.
According to the Index, entrepreneurship in the United States rose for the second year in a row in 2015. This a mere two years after the index plunged to its lowest level in two decades.
The foundation noted, in a development of particular significance, that more new businesses are being started out of desire as opposed to need.
The Index contains additional data supporting the positive trend. The foundation noted that job creation numbers issued by the federal Bureau of Labor Statistics show that 889,000 jobs were created by new establishments in the last quarter of 2015 alone – the highest job creation number for new establishments since early 2008.
In addition, the Kauffman Index contains the following key developments:
- The number of new business owners increased by more than 15 percent since 2014, with about 330 out of every 100,000 adults in the nation becoming entrepreneurs for the first time.
- An increase in women-owned business is helping to drive the trend; 260 out of every 100,000 women are now new entrepreneurs, up from 220 out of 100,000 in 2014. The “gender gap” for entrepreneurs decreased from 2014 to 2015.
- Latino entrepreneurship is significantly on the rise, with 21 percent of new entrepreneurs being Latino in 2015, as opposed to only 10 percent in 1996.
The share of startups run by African Americans and Asian Americans has also increased during that period.
- The startup rate is at its highest since early 2008.
- Although the trend is positive, startup activity is still well below pre-2008 recession levels.
“Understanding what is happening to our country’s startups and entrepreneurs is essential to any policymaker hoping to accelerate and expand on the recent progress we have seen in entrepreneurial activity,” said Senator David Vitter (R-LA), chairman of the U.S. Senate Small Business Committee, who wrote the foreword to the current Kauffman Index report.
Here’s to a continuation of the trends reported in the Index. Good news for small business is good news for everyone — as small business drives the American economy.
The 2016 Kauffman Index of Startup Activity can be viewed in full here: http://www.kauffman.org/microsites/kauffman-index/reports/startup-activity.
I am Andrew E. Greenwald, partner at Joseph Greenwald & Laake, and am a former chair of the American Association for Justice Birth Trauma Litigation Group. I have given over 100 lectures to trial lawyers and other groups and have recovered $1 million or more in over 50 cases for victims of medical negligence. I am dedicated to serving victims of medical negligence, and much of my practice is devoted to just that.
People who suffer injuries or death from improper medical treatment can, in many instances, file a lawsuit against a physician, hospital or other provider for medical negligence. Here are some of the basics about medical negligence.
What is medical negligence? Medical negligence occurs when a person is injured or dies as a result of improper medical treatment.
What happens at an initial meeting between a victim of medical negligence and me, an attorney who represents victims? We have a detailed conversation about how the injury occurred and discuss the client’s concerns. I explain what is involved in pursuing a case and provide an initial evaluation. There is no charge for this meeting.
How is a medical malpractice case investigated? The client signs a HIPAA form so that I can get a complete copy of the relevant medical records. After a detailed review, I consult with medical experts in the area of concern. Findings are shared with the client.
How is a medical malpractice case pursued? What happens next? If the case is meritorious, with my client’s consent, a lawsuit or claim is filed. A life care plan of the client’s future needs is prepared. An economist is engaged to assess lost income and project the cost of the client’s future needs. Witnesses are questioned and the court sets a trial date. The parties may agree to mediate.
What is mediation? An independent mediator meets with all parties to try to resolve the case. Each side has an opportunity to present its case to each other and to the mediator. The parties are separated into different conference rooms, and the mediator discusses the case with each side hoping to reach a settlement.
The following is a checklist to help you gather relevant records, history, and other information that your attorney will need.
- BACKGROUND INFORMATION
- a chronological list of key events that led to the injury
- a list of persons who were present or who spoke to any of the health care providers
- a statement about how and when you first became aware that there may have been inappropriate treatment
- THE DOCTORS
- the names of all doctors and hospitals involved
- the name of the doctor or doctors’ professional practice(s)
- YOUR MEDICAL HISTORY
- your brief medical history
- a list of all medications prescribed
- a statement of what you were told by the doctor or the hospital about your treatment
- a copy of the medical records from the treating doctor and from the hospital (this should include the entire chart, not just a summary)
- BIRTH INJURY (www.dcbirthinjurylawyer.com)
- your prenatal records
- records from other pregnancies and deliveries
- your labor and delivery records
- the fetal monitor strip
- the baby’s newborn records
- the pediatrician’s records
- reports of any radiology studies such as MRI or CAT scans
- all records relating to any testing done on the child
- DEATH
- a copy of the autopsy report
If you cannot obtain these records, your attorney can obtain them for you.
Jay P. Holland, a principal in the Firm’s Civil Litigation Group and chair of the firm’s Labor, Employment, and Qui Tam Whistleblower practice, was quoted on July 25, 2016, in an article in Law360 concerning the National Basketball Association’s decision to relocate its 2017 All-Star game out of Charlotte, N.C. The NBA took that action in opposition to the state’s new law that restricts transgender people from using the bathroom of their choice.
The NBA’s decision is regarded as an important test case of the ability of a sports league to effect social change. The controversial law prevents municipalities in North Carolina from enacting anti-discrimination measures and forces people to use bathrooms based on the gender listed on their birth certificate.
North Carolina Gov. Pat McCrory has sharply criticized people and groups that he said were outsiders trying to pressure the political leaders of his state into changing the law.
“Left-wing special interest groups have no moral authority to try [to] intimidate the large majority of American parents who agree in common-sense bathroom and shower privacy for our children,” McCrory said in a statement. “American families should be on notice that the selective corporate elite are imposing their political will on communities in which they do business, thus bypassing the democratic and legal process.”
Holland responded to these concerns in a quote that appeared in the Law360 article.
“I find it a little absurd or disingenuous for the governor to say that the NBA is not respecting the democratic process,” Holland said in the article. “They feel that a jurisdiction is acting in a discriminatory fashion, and they are entitled to say: ‘We don’t want to give you our business.’ ”
Holland was also quoted in the article as saying that the state law “puts the NBA in a very difficult and untenable position,” had the All-Star game gone on as planned. “I frankly don’t know how North Carolina intends to enforce the law. Are they going to have bathroom monitors? And even then how are they going to know?”
The full Law360 article can be found at: http://www.law360.com/articles/821106/nba-tests-power-to-effect-change-with-all-star-game-move. (Please be advised that due to Intellectual Property rights full access to these articles may require registration or purchase of a subscription.)
In most contested matters, mediation should be considered as an option in resolving even the most complicated divorces. Mediation is generally less emotionally wrenching for the people involved than a trial, can be substantially less expensive, and helps to keep family secrets out of the public eye when it may be important to do so. When a divorce case reaches the courtroom, the future of the entire family, not just the parents, is at stake. Mediation allows people to resolve issues amongst themselves, not leave those decisions to a stranger – decisions that are likely to affect the lives of the entire family for much if not all of their lives. Whether the issues be financial or parental, there can be serious risks involved in letting a judge decide the ownership of high-valued family assets or parents’ child custody and visitation rights.
The choice of a mediator is therefore a very important one in any divorce that is going to be mediated. One aspect of that choice that should never be overlooked is the importance of selecting a mediator who understands the role that cultural differences can play in a mediation.
Culture, for this purpose, has been defined by social scientists as “the characteristics and knowledge of a particular group of people, defined by everything from language, religion, cuisine, social habits, music and arts.” It includes “shared patterns of behaviors and interactions that are learned by socialization” as well as “a group identity fostered by social patterns unique to the group.”
The culture in which a person has been brought up will affect her behavior in ways that she will not even be aware of. How someone greets another person, what tone of voice she uses, what her expectations are from daily human interactions – all these and more are affected by the subtle, pervasive and undeniable effects of culture. This is human nature – it is all of us, whether in a classroom, at the gym or even in a Starbucks. To assume that this simply goes away during a session or two of mediation is akin to burying one’s head deeply in the sand.
Since the essence of a divorce mediation is to bring about agreement among human beings, not to create legal precedents, it is a deeply personal process. Personal traits that are affected by culture are present in every moment of the mediation. The mediator, in helping the parties achieve agreement, must be aware of these cultural facts and the differences that will arise from them.
In the highly diverse nation that we live in, there will inevitably be cultural differences between people. They can reflect differences between the parties themselves, or, more subtly, they can express a divergence between the culture of one party to the divorce and the expectations that a mediator may have – again, expectations that spring from the mediator’s own cultural experiences.
A mediator must be attuned to these differences if he wishes to achieve a fair and equitable result for the parties. There are many possible examples. In some cultures, interrupting someone is not considered rude, as it generally is in the United States. A mediator who does not understand that might well disdain or disregard a person who interrupts during the mediation, failing to realize that the person is not being difficult but is expressing a cultural style.
One frequently overlooked example of a cultural difference that may have immediate effect on the tone of discussions is eye contact. There are cultures in which constant eye contact is considered an important sign of thoughtfulness and attention. If eye contact wavers, an individual may see that as a sign of fatigue or inattention. If a mediator tends to look away and not keep eye contact, the person may view the mediator unfavorably. The mediator needs to be aware of these feelings.
Similarly, cultural artifacts and metaphors that are obvious to the majority of Americans may not be understood by people from a different culture. A mediator, for example, should be wary of using sports metaphors like “we’re only in the first inning,” since many people from other countries or cultures may not know the rules of baseball. They may feel that the mediator is using language to exclude them.
One thinker has even suggested that to attempt to mediate a case without fully understanding cultural diversity can verge on the unethical. At the very least, cultural awareness is crucial in bringing about a resolution that is fair to all.
Handling vacuum extraction cases requires an understanding of the use of the instrument and the consequences of its misuse. After discussing the warnings to physicians and midwives, the American College of Obstetrics and Gynecology and other literature, practical information and suggestions, including deposition excerpts, for representing those who may be injured will follow.
TECHNICAL BULLETINS
In February 1991, ACOG issued a Technical Bulletin[i] 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 that 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[ii] was superceded by another one issued in August 1994[iii], 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.[iv]
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.[v] The contraindications,[vi] 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.[vii]
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.” In addition, “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.” When should operative vaginal delivery be avoided? ACOG indicates, “most authorities consider vacuum extraction inappropriate in pregnancies before 34 weeks of gestation because of the risk of fetal intraventricular hemorrhage. Suffice it to say, vacuums may also be responsible for retinal hemorrhages and hyperbillirubinemia.”[viii]
THE MANUFACTURERS
Dow Corning, in its literature dealing with the SILASTIC® Obstetrical Vacuum Cup, under general indications states:
The indications for the use of the 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.”[ix]
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.[x]
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.[xi]
SOME OF THE LITERATURE
In Shoulder Dystocia and Birth Injury, Prevention and Treatment,[xii] 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.[xiii] Trauma, in turn, is a causative agent in cerebral venous thrombosis.[xiv] Also, by way of example, venous sinus thrombosis has been associated with cranial trauma and instrumental delivery.[xv]
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,”[xvi] 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.[xvii]
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.”[xviii]
There, the reviewing physicians state:
In summary, the use of vacuum extraction may produce ventricle stress on the fetal cranium in the occipitofrontal diameter, causing tentorial hemorrhages . . . In two of these patients, the hemorrhagic complications were associated with diffuse hypoxic-ischemic injury or cerebral infarction.[xix]
It has also been noted that:
Tentorial tears have been associated with mechanical injury to the fetal cranium and are thought to be related to the sheering forces on the tentorium resulting in rupture of the deep venous system or laceration of the inferior surface of the cerebellum. Although the pathophysiology is not clearly understood, the vacuum extractor may produce stress on the fetal cranium in the occipital frontal diameter, with tension on the tentorium. The tentorium may then rupture, causing intracranial hemorrhage.[xx]
In his chapter on cephalopelvic disproportion, in the Manual of Clinical Problems in Obstetrics and Gynecology (1994), Dr. Sibai states that:
The association of documented CPD with abnormal patterns of progress, in the form of arrest of dilatation or descent, is an indication for cesarean birth without any further trial of labor . . . Once CPD is diagnosed, cesarean delivery is the treatment of choice.
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.[xxi]
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.”[xxii]
CONCLUSION OF THE VACUUM EXTRACTION DANGERS & CONSEQUENCES BLOG SERIES
In handling vacuum injury cases, 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.”[xxiii]
To learn more about Andrew Greenwald’s experience with medical malpractice and how he can help victims of medical malpractice, you can visit www.dcbirthinjurylawyer.com.
[i] ACOG Technical Bulletin Number 152, (November 1991).
[ii] Id.
[iii] ACOG Technical Bulletin Number 196, Operative Vaginal Delivery (August 1994).
[iv] Id.
[v] ACOG Technical Bulletin Number 196, page 2.
[vi] RESNICK CREASY, ET AL., MATERNAL FETAL MEDICINE, (4th Ed., 1999).
[vii] D.K. JAMES, HIGH RISK PREGNANCY MANAGEMENT OPTIONS, 1147, (1994).
[viii] ACOG Practice Bulletin Number 17, Operative Vaginal Delivery
[ix] Dow Corning Silastic Brand Obstetrical Vacuum Cup package insert, March 1989.
[x] Operational Guidelines for Use of the MITYVAC® Obstetrical Vacuum Extraction System, March 1997.
[xi] Id.
[xii] JAMES A. O’LEARY, M.D., SHOULDER DYSTOCIA AND BIRTH INJURY, PREVENTION AND TREATMENT (1992).
[xiii] See Hickey and McKenna, Skull Fracture Caused By Vacuum Extraction, 88 Obstetrics & Gynecology, (October 1996).
[xiv] See BERG, NEUROLOGIC ASPECTS OF PEDIATRICS, 333-34 (1992); PELLOCK & MYER, NEUROLOGIC EMERGENCIES IN INFANCY AND CHILDHOOD, 377 (1993).
[xv] See Hanigan, et. al., Neonatal Cerebral Venous Thrombosis, 14 Pediatric Neuroscience, 177 (1998).
[xvi] Aldo Vacca, M.D., Birth by Vacuum Extraction: Neonatal Outcome, 32 Journal of Pediatrics, Child Health, 204 (1996).
[xvii] ALDO VACCA, M.D., HANDBOOK OF VACUUM EXTRACTION IN OBSTETRIC PRACTICE, 72, (1992).
[xviii] Tentorial Hemorrhage Associated with Vacuum Extraction, 85 Pediatrics 534 (April 1990). See also SWAIMAN & ASHWAL, PEDIATRIC NEUROLOGY, 2, 1174 which states “Risk factors are age related. Dehydration is especially common in neonates as well as birth trauma including vacuum extraction.”
[xix] Tentorial Hemorrhage Associated with Vacuum Extraction, 85 Pediatrics 537 (April 1990); See also Lucas, Michael J., The Role of Vacuum Extraction in Modern Obstetrics, 37 Clinical Obstetrics and Gynecology, 794 (December 1994).
[xx] D.K. JAMES, HIGH RISK PREGNANCY MANAGEMENT OPTIONS, 1150, 1994.
[xxi] MALCOLM I. LEVENE, ET AL., FETAL AND NEONATAL NEUROLOGY AND NEUROSURGERY, (1995).
[xxii] ROBERT K. CREASY, MANAGEMENT OF LABOR AND DELIVERY, (1997).
[xxiii] ACOG Technical Bulletin Number 152, November 1991.
Andrew Greenwald’s 2 Part Blog Series “Vacuum Extration Dangers and Consequences” begins here.
Part 1 Of Blog Series: Vacuum Delivery Warnings & Possible Consequences
Handling vacuum extraction cases requires an understanding of the use of the instrument and the consequences of its misuse. After discussing the warnings to physicians and midwives, the American College of Obstetrics and Gynecology and other literature, practical information and suggestions, including deposition excerpts, for representing those who may be injured will follow.
WARNING
On May 21, 1998, the FDA issued a public health advisory entitled, “Need For Caution When Using Vacuum Assisted Delivery Devices.”[i] 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[ii] 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.[iii]
Subgaleal hematoma (injury to the scalp with subsequent bleeding into the potential space between the galea aponeurotica and the pericranium[iv]) 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.”[v] 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.”[vi]
In 1998, the Food and Drug Administration User Facility Reporting Bulletin[vii] discussed the FDA warning of May 21, 1998, and pointed to findings that would indicate a potential problem from the vacuum, including cerebral irritation, convulsions, lethargy, apnea, bulging fontanels, poor feeding, increased irritability, bradycardia and shock. It further pointed out that these symptoms were sometimes delayed until hours after birth. When a vacuum was used, it was important for those taking care of the newborn to watch for abnormal signs. Other signs that may be present at delivery from the use of a vacuum would include swelling, pallor, increased respiration rate and tachycardia.[viii] These might not be noticeable until hours after birth.
The Safe Medical Device Act of 1990 requires facilities to report deaths, serious illnesses and injuries to the FDA, as well as to the device’s manufacturer. This is done by using the Mandatory Reporting Form 3500A. There have been certain adverse reactions reported from the use of the vacuum extractor.
In September of 1998, ACOG issued a committee opinion. Among other things, the ACOG Committee On Obstetric Practices, stated that:
. . . As with any other obstetric procedure, obstetric care clinicians using vacuum-assisted delivery devices to effect operative vaginal deliveries should be appropriately trained and familiar with the indications and contra-indications for the use of the device, as well as with its proper application and traction procedure.[ix]
The Committee expressed concerns regarding the implications of the FDA Advisory, specifically given the decline in forceps use in the United States. They 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.
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.[x]
Diane Dwyer, BSN and Sonia Swayze, RNC in Nursing 2000, elaborated on the FDA warning by stating: “Intracranial hemorrhage may be subdural, subarachnoid, intraventricular, or, intraparenchymal. Signs and symptoms, which may not appear for several hours, include convulsions, lethargy, obtundation, tachypnea, a bulging fontanel, poor feeding, increasing irritability, tachycardia and shock.”[xi]
The FDA has recommended that in cases where vacuums were used, the caregivers of the newborn 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.[xii]
It is therefore 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. When doing discovery in these cases, inquiries should be made of the health care professionals who were in the delivery room and those who took care of the newborn. This should include whether or not they were familiar with the FDA warning and if so, how it had been implemented.
To learn more about Andrew Greenwald’s experience with medical malpractice and how he can help victims of medical malpractice, you can visit www.dcbirthinjurylawyer.com.
[i] FDA Public Health Advisory: Need For CAUTION When Using Vacuum Assisted Delivery Devices, May 21, 1998.
[ii] See, P. Govaert, P. VanHaesebrouck, et al., Vacuum Extraction, Bone Injury and Neonatal Subgaleal Bleeding, 151 Eur J. Pediatr. 532-535. (1992).
[iii] FDA Patient Safety News, Problems after Vacuum-Assisted Childbirth, 5, June 2002
[iv] Sue Ann Smith, M.D., et al., Subgaleal Hematoma: The Need for Increased Awareness of Risk, 41 The Journal of Family Practice, 569-574 (1995).
[v] ALDO VACCA, HANDBOOK OF VACUUM DELIVERY IN OBSTETRICK PRACTICE, 114, (2003).
[vi] Sue Ann Smith, M.D., supra at 569.
[vii] Sheila Murdock, Ph.D., FDA Cautions Users of Vacuum Assisted Delivery Devices, FDA User Facility Reporting Bulletin, 24, (Summer 1998).
[viii] Id.
[ix] ACOG Committee on Obstetric Practice Opinion, Number 208, September 1998.
[x] FDA Patient Safety News, Problems after Vacuum-Assisted Childbirth, 5, June 2002
[xi] Diane Dwyer, BSN, et al., Device Safety: Problems After Vacuum-Assisted Childbirth, 32 Nursing, 74 (2002).
[xii] FDA Patient Safety News, Problems after Vacuum-Assisted Childbirth, 5, (June 2002).
On July 5, 2016, partner Timothy F. Maloney won a major victory in the Maryland Court of Appeals, when the state’s highest court ruled unanimously that adults who serve alcohol to minors in Maryland can be held civilly liable for deaths or injuries that result from the minors’ driving in a drunken or impaired condition.
This was the first time that the court had held adults responsible to third parties who were killed or injured as a result of the actions of impaired underage drivers.
“Underage persons are not solely responsible for drinking alcohol on an adult’s property because they are not competent to handle the effects of this potentially dangerous substance,” the court wrote.
The court based its analysis on a 1996 Maryland statute that makes it unlawful for adults to “knowingly and willfully” allow a person under 21 to drink inside a home. One question before the court was whether the existence of that law implied that a violation of it by an adult who allows drinking will result in liability in a civil lawsuit, a doctrine called “social host liability.”
The court, in an opinion written by Judge Sally D. Adkins, held that “there exists a limited form of social host liability sounding in negligence—based on the strong public policy reflected in [the statute] but that it only exists when the adults in question act knowingly and willfully, as required by the statute.”
The decision came in two separate cases that both posed the issue of liability. In one case, Linda Stapf permitted 17-year-old Steven Dankos to drink with friends at a party in her garage in 2009. Another young man, who was drunk, left the house in his pickup truck and crashed it, killing Steven. Steven’s mother sued Stapf, saying that Stapf, as the adult who was aware of the alcohol consumption, was legally responsible for Steven’s death.
In the other case, Manal Kiriakos was walking her dog in 2011 when an SUV driven by 18-year-old Shetmiyah Robinson struck her. Kiriakos was severely injured and sued Brandon Phillips, an adult at whose home Robinson had been drinking.
Maryland now joins 31 other states that impose civil liability against people who knowingly permit minors to drink alcohol.
Under Maryland law, people and establishments that serve alcohol to adults are generally not legally responsible for deaths and injuries that result from drunken driving. But the court found that because of the 1996 statute and because people under 21 lack full adult capacity to make decisions about drinking and driving, people who serve alcohol to minors should be civilly liable.
Tim Maloney said regarding the case, “This is a wake-up call to the so-called cool parents who on Friday nights have their kids’ friends over and allow them to drink in their basements. This has been an epidemic in some communities when these kids go out and get behind the wheel and someone pays the price.”
Eleanor Hunt, senior counsel at the Firm, recently discussed wills, trusts, and related estate-planning topics on “Your Future Your Finances,” a television show that aired in Montgomery County, Md., on MMC Channel 16.
Hunt, who represents clients in the areas of family law and estate planning, told the show’s moderator, Brian Kuhn, that a basic estate plan for most individuals consists of three documents – a will, a financial power of attorney, and an advance medical directive.
Hunt noted that although these documents are very important for people to have, a surprisingly large number of people fail to have them prepared. She pointed to the recent passing of Prince, who died without a will, as an example of a celebrity who did not take care of these key matters.
She said that perhaps some people feel that it’s taboo to talk about death and that some people have the idea that preparing these documents might hasten their death. She also said that many people “are misinformed about a will and about what protection it provides.” If people, on their own, try to express their advance wishes about their property or their medical treatment without following the legal formalities set forth in the Maryland law, and without the guidance of a knowledgeable attorney, then third parties such as financial institutions and hospitals may not adhere to their wishes, let alone the courts in Maryland and elsewhere.
Hunt also said that in many cases, a trust, which transfers ownership of property to a trustee who holds the property for the beneficiary, can function as an alternative to a will in disposing of property after death. She said that a trust will avoid the probate process that occurs when there is a will and that it can be a speedier, more efficient process. In addition, a trust is well adapted to a situation when a person owns real property in a state other than his or her residence. If that person dies with a will, there would need to be an ancillary probate proceeding opened in that other state.
Finally, Hunt said, another advantage of a trust, from some people’s perspective, is that it never becomes public. After a will is admitted to probate, it becomes public record.
The video of Hunt’s interview can be found at https://youtu.be/i9Leh-zneb4 and https://youtu.be/Yd-Qz9OO66o.