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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.
Our own Senior Counsel Eleanor Hunt has recently been featured in the television show “Your Future Your Finances” with Brian Kuhn. Click on each of the following links to see how she shares her expertise regarding Estate & Family Planning.
Jeffrey Mills was the Director of Food and Nutritional Services for the District of Columbia Public Schools (DCPS) from 2010 to 2013. DCPS used Chartwells, a contractor, to provide its food and food services for students in DCPS. Mills saw enormous problems with Chartwells, including overbilling and, even worse, providing spoiled food to students. His complaints to DCPS officials were ignored. And when DCPS terminated his employment, he alleged that he was terminated in retaliation for blowing the whistle on Chartwells. Mills sued not only for retaliation but also for fraud against the DC government, under the qui tam provisions of the District of Columbia False Claims Act. DC Code Ann § 2-381.03. Chartwells settled with Mills for $450,000.00 for his retaliation claim, and settled with DC for $19,000,000.00, 30% of which could go to Mills, and the rest to DC to compensate it for the overbilling and spoiled food. https://www.washingtonpost.com/local/education/dc-schools-food-vendor-pays-19-million-to-settle-whistleblower-lawsuit/2015/06/05/bae8dd3c-0b96-11e5-9e39-0db921c47b93_story.html.
Prior to the recent enactment of the Maryland False Claims Act, a private whistleblower action, like the Chartwells case, to benefit the taxpayers in Maryland with respect to fraud involving Maryland government contracts, could not be filed. There was no mechanism . . . until now.
The Maryland False Claims Act (Maryland FCA) went into effect June 1, 2015. Prior to the 2015 enactment, Maryland recognized limited false claim protections through the False Health Claims Act of 2010, which addressed cases of Medicaid and other health care related fraud. The Maryland False Claims Act models the Federal False Claims Act (FCA), 31 U.S.C. §§ 3729-3733, and now covers fraud relating to all state programs involving state funding and/or state contracts. The Act encompasses both qui tam provisions brought on behalf of the government, and anti-retaliation provisions to protect whistleblowers.
The new Maryland FCA generally prohibits the knowing submission of false claims for payment or approval by the state government. MD Code, General Provisions § 8-102 (b)(1)-(9). A court must award damages, at a minimum, in the amount of actual damages the government incurred as a result of the violation (MD Code, General Provisions § 8-102 (c)(1)-(2)), but may award up to three times the amount of damages that the government sustained as a result of the violation. This differs from the federal FCA which mandates treble damages.
The Maryland FCA also imposes civil penalties of up to $10,000.00 per false claim. So, if we were to take the Chartwells case for example, with each bill sent for each delivery, the defendant may be fined up to $10,000.00 per bill. The fines can add up exponentially at that rate. Unlike the Federal FCA, the Maryland FCA contains a list of factors that must be considered in assessing fines and damages. These factors include the number, nature and severity of the violations, and whether the company is a repeat offender. Significantly, there is the potential for personal liability for individual wrongdoers under the Maryland FCA. There is no hiding behind the corporate veil. MD Code, General Provisions § 8-102 (d).
Like the federal FCA, the Maryland FCA includes both individual retaliation claims, and qui tam claims which are private attorney general actions brought on behalf of the State. Through qui tam actions, individuals work with private attorneys to file complaints under seal, and then serve those complaints upon the Office of the Attorney General (OAG). Pursuant to MD Code, General Provisions § 8-104 (a)(1)(7) and § 8-104 (b)(3), the State will decline to intervene in those cases that do not pass its screening and investigative process. In regard to the Maryland FCA, State intervention is the “whole ballgame.” Unfortunately, unlike under the Federal FCA, an individual may not proceed to litigate a claim after the State declines intervention, at which point the Court must dismiss the case. Under the Federal FCA, a relator can litigate even if the Department of Justice declines to intervene.
The Maryland FCA incentivizes individuals to come forward by awarding between fifteen and twenty-five percent of the damages recovered to the whistleblower, plus an award of statutory attorney’s fees and expenses.
The Statute of Limitations to bring a qui tam action requires that the case be filed within the later of either six years after the date on which the violation occurred or three years after the date the individual bringing the civil action knew or should have known of the material facts regarding the fraud (no later than 10 years after the violation occurred) (Md Gen Provis § 8-108).
A private right of action for illegal retaliation could be pursued in addition to or separate from the qui tam complaint. The retaliation claim belongs to the individual and there is no need for State intervention to proceed. Like the Federal FCA, the Maryland FCA prohibits retaliatory actions under Md. Gen Provis § 8-107, when the employee’s (or contractor’s) protected conduct was a substantial factor in the employer’s decision to terminate the employee or pursue other adverse actions. So, if retaliatory action is taken by the employer – like it was against Mills in the Chartwells case – the employee may file a civil action to seek relief, including an injunction to stop an ongoing violation; reinstatement to seniority status; reinstatement of fringe benefits; two times lost wages including interest; payment of reasonable costs and attorney’s fees; punitive damages; and civil penalties.
The Maryland FCA does provide some advantages over the federal law. For example, the Federal FCA does not specifically provide for injunctive relief, punitive damages, or civil penalties, for retaliation claims. Retaliatory actions fall under Maryland’s general three year statute of limitation requiring filing from the date of retaliation. Md. Code Ann., Cts & Jud. Proc., § 5-101.
Maryland Courts have had little opportunity to interpret the Maryland FCA. Thus, as a general rule, practitioners and courts should look to the Federal FCA and related federal decisions for guidance.
And a final note, Mills likely and sadly could not have brought his particular claim in Maryland because Maryland, in contrast to DC, prohibits governmental employees from being relators. MD Code, General Provisions § 8-106(b). That is unfortunately a loss to the citizens and taxpayers in Maryland. Perhaps we will learn from our neighbors and ultimately broaden the scope of the law.
Full citations:
MD Code, General Provisions, § 8-101 – § 8-111 Maryland False Claims Act, 2015 Maryland Laws Ch. 165 (S.B. 374)
Jay P. Holland is a shareholder in the law firm of Joseph, Greenwald & Laake, P.A., and Co-Chair of Labor and Employment Section of the Prince George’s County Bar Association.
On March 21, 2016, the American Bar Association formally announced its opposition to a proposed bill in Congress that would limit the amount of noneconomic damages that can be awarded by judges and juries in medical liability cases in state courts across the nation. In a letter to the chairman and ranking minority member of the House Judiciary Committee, the ABA said that the bill, which would cap those damages at $250,000, violates principles of federalism and would deprive many deserving people of the chance to receive compensation for their injuries.
First, the ABA noted that for more than 200 years, “the authority to determine medical liability law has rested in the states” and that each state has always had autonomy to write its own laws on the subject. “Congress should not substitute its judgment” now for the varying systems that the states have evolved, the letter said. The bill, known as the Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016, would do just that, according to the letter.
In addition, the ABA letter emphasized that “research has shown that caps diminish access to the courts for low-wage earners, like the elderly, children, and women; if economic damages are minor and noneconomic damages are capped, attorneys are less likely to represent these potential plaintiffs.” In other words, the bill would have the effect of denying many people access to the courts.
The letter noted that “patients who reside in communities around the country should not be told that, due to an arbitrary limit set by members of Congress in Washington, DC, they will be deprived of the compensation determined by a fair and impartial jury.” Courts already have the power to set aside excessive verdicts, and that is the correct solution to the problem of excessive verdicts, if a problem arises.
We wholeheartedly agree with the ABA’s position. A recent study (may 2016 British Journal of Medicine) showed that medical error is the third leading cause of death in the United States, just behind heart disease and cancer! Clearly medical negligence can have devastating and permanent consequences. Many times the only recourse for someone who is seriously injured as a result of an avoidable medical injury is the pursuit of a court case. Additionally medical negligence suits expose medical errors, thereby forcing Healthcare Provider providers and their insurers to enact measures that improve the quality of health care.
By driving down the size of awards, this bill would act as a deterrent to bringing medical negligence suits given their high cost. If the verdicts go down and the costs remain the same less victims will have access to the Courts. This, after all is the real intent behind the bill.
Thus this bill will harm those who are injured and would make the nation and its courts less fair and less just. It would also harm the ability to expose medical errors and this hinder the improvement of the quality of health care.
The American Institute of Family Law Attorneys has recognized the exceptional performance of Maryland’s Family Law Attorney Jeffrey N. Greenblatt as 3 Years 10 Best Family Law Attorney for Client Satisfaction.
The American Institute of Family Law Attorneys is a third-party attorney rating organization that publishes an annual list of the Top 10 Family Law Attorneys in each state. Attorneys who are selected to the “10 Best” list must pass AIOFLA’s rigorous selection process, which is based on client and/or peer nominations, thorough research, and AIOFLA’s independent evaluation. AIOFLA’s annual list was created to be used as a resource for clients during the attorney selection process.
One of the most significant aspects of the selection process involves attorneys’ relationships and reputation among his or her clients. As clients should be an attorney’s top priority, AIOFLA places the utmost emphasis on selecting lawyers who have achieved significant success in the field of Family Law without sacrificing the service and support they provide. Selection criteria therefore focus on attorneys who demonstrate the highest standards of Client Satisfaction.
We congratulate Jeffrey N. Greenblatt on this achievement and we are honored to have him as a 3 Years AIOFLA Member.
You can contact Jeffrey N. Greenblatt directly at: 240 399-7894 or jgreenblatt@jgllaw.com.
Estates and Trusts attorney Paul Riekhof recently penned an article for Law 360 discussing the many complexities of estate taxation and evaluation in the wake of music icon Prince’s death. The article titled Prince’s Estate and the Countless Challenges Ahead discusses the many details that will need to be uncovered and decided before his estate can be valued and ultimately awarded.
The fact that Prince may not have had a formal will or estate plan in place will lead to countless inquiries and questions about the value of his many assets, both current and future. Riekhof discusses how the estate will have to go through both federal and state estate taxation processes and the probate administration process before being divided up between his many siblings and potential heirs. He then points out that before any assets can be distributed to his heirs, the estate will have to satisfy its estate tax obligations- which could be significant.
Riekhof continues on to explain the many complexities that may come into play as the estate determines the fair market value of his current and future assets and their potential tax implications for his heirs for years to come.
For more information on estate planning, estate tax planning, probate, trust administration, business planning, guardianships or estate litigation matters for individuals, families or businesses contact Paul Riekhof at priekhof@jgllaw.com or direct at 240-399-7899.
A study published in the British Journal of Medicine published on May 3, 2016 found that the third leading cause of death in the United States is medical error resulting in 251,000 deaths annually. Medical error is just behind Heart disease (611,000 deaths annually) and cancer (585,000 deaths annually). After medical error, the next largest cause of death in the United States is chronic respiratory disease (149,000 deaths annually).
The study author defined medical error as:
… an unintended act (either of omission or commission) or one that does not achieve its intended outcome, the failure of a planned action to be completed as intended (an error of execution), the use of a wrong plan to achieve an aim (an error of planning), or a deviation from the process of care that may or may not cause harm to the patient.
The study author, a surgical oncologist at Johns Hopkins, claims that when death certificates are signed, causes of death that are not associated with an ICD code (International Classification of Disease) are not captured. As a result, when death certificates are studied nationwide, medical errors as defined above and which include things that can directly result in patient harm and death such as communication breakdowns, diagnostic errors, poor judgement or inadequate skill are neither counted or analyzed.
The study argues for better data in order to better measure the problem, design safer systems, and reduce the frequency of error as a cause of patient harm.
As a medical malpractice lawyer, the study’s findings were not surprising. We are often asked to review cases with fatal outcomes where the death certificate makes no mention of medical mistakes. As lawyers, we are forced to overcome misleading death certificates and prove that our clients’ loved one died from an avoidable medical mistake.
The fact that the third leading cause of death is medical error is shocking. If this number is even partially accurate, it constitutes dramatic evidence that huge numbers of medical mistakes are unrecognized each year not only by the medical community, but by patients or their families as well. A quarter of a million deaths annually from medical error means that most of the deaths could have been avoided with better systems, education, training, technical competence and/or attention to detail. It should be noted that the quarter of a million medical errors cited in the study refer only to deaths. This shocking number does not include the other victims of medical error who may have been maimed or crippled.
While the study author’s point is that the method of coding causes of death used to compile national statistics needs to include methodology for acknowledging medical error, there is another conclusion that can be drawn as well.
At present, it is the plaintiff lawyers, representing families of the victims of medical error who are primarily responsible for uncovering these medical errors and bringing them to light. The current tort system provides a significant benefit, not only to the patients and their families, but to the medical community as well. Medical malpractice suits often result in improvements imposed by insurance companies and hospitals once the mistakes are recognized. This in turn improves the overall quality of healthcare if for no other reason than to avoid making additional payments to other victims in the future.
Perhaps the most shocking aspect of medical error being the third leading cause of death in the United States is that the medical establishment and the corporations that insure it continue to press for additional relief from lawsuits by seeking more and more limits on the ability of patients to bring lawsuits and obtain just compensation for their injuries. They do so by insisting that they need protection from the “frivolous” lawsuit. A quarter of a million annual deaths suggests otherwise. With appalling numbers like these, is it any wonder that the medical establishment seeks additional protection to avoid paying the victims of their errors?
The continued effort to throw up roadblocks for patients and their lawyers’ who attempt to uncover these medical mistakes by imposing limits on jury awards and attorney fees flies in the face of logic and this new and shocking statistic. With medical error as the third leading cause of death the United States, it is abundantly clear why the medical establishment and the insurance companies are so motivated to keep medical errors private and ultimately uncompensated.