Author: Gracious Legal Services

Legal Drafting

Legal drafting is an art which involves preparation of legal documents that are reduced into writing including the substance of underlying law, negotiating skills, arguments, and strategies for client’s representation and ability to close a transaction. It is an essential part of legal writing, where a legal issue or problem is analyzed with regards to the binding legal text and then duties, rights, and liabilities of a person or a legal entity are crafted. Understanding of legal context, specific area of law and knowledge of the language used by the courts and attorneys are important while drafting any legal document, including but not limited to, contract, agreement, demand letter, settlement letter, motion, response to the motion, mediation brief, complaint, appellate brief, etc.

While drafting a legal document, one must keep in mind a few things, like, organizing of thoughts before writing, use of clear and simple language, avoid unnecessary words and lengthy sentences, appropriate use of legalese, scope of amendments in future, anticipation of the impact on the interpretation, precise and concise matters, details of events or documents in a chronological order, etc.

A legal professional who drafts a legal document should always focus on his audience while drafting and should be aware of the need to enhance his professional drafting skills. Drafting of any complex legal document has to be done with immense care to make it flawless and with all the efforts to facilitate strong arguments in favor of the concerned party and places heavy reliance on the authority.

Litigation Overview

Litigation is the process of dispute settlement among the parties to a lawsuit. Parties involved in a lawsuit can be individuals, business entities, non-profit organizations, or State. In the process of litigation, Plaintiff is a party which initiates the legal proceeding against the other, Defendant with relevant allegations of fact which gives rise to cause of action, statement of damages claimed and prayer for relief. Such matters are heard before a court of competent jurisdiction brought by the parties to the lawsuit for dispute resolution. The rules of civil and criminal procedure govern the process of dispute resolution in the adversarial system of law or common law countries.

In the modern era, the process of litigation initiates the moment anyone takes steps to enforce or defend his legal rights by sending a legal notice or a demand letter by the attorney on behalf of his client asking the other party to compensate the aggrieved party for injuries or damages sustained by him. Nowadays pre-suit litigation activities are involved to save time and avoid the cost and inconvenience of a lawsuit in a legal proceeding.

In case the dispute has not been settled by initial negotiations then the aggrieved party goes for filing a formal lawsuit. However, there are serious consequences that can be faced by the litigants if not complied with the law of limitation or procedural laws, since the court of law does not allow a suit to be admitted if it is barred by limitation or if adequate procedural laws are not followed.

In general, there are different phases in a litigation process, i.e., pleading, discovery, trial, resolution of the dispute, appeal, and enforcement. However, at times litigation still continues after a verdict is rendered. Even when the jury’s verdict is accepted by both the parties, motions, hearings, and orders are necessary to properly close a case. Litigation does not end with the trial. It’s an ongoing process which can be quick and to the point or can stretch for years.

Pedestrian hit by vehicle dies. $4.5M. Los Angeles County.


Pedestrian struck by company vehicle in a crosswalk.

The Case

  • Case Name: Tran v. TNT USA, INC.
  • Court and Case Number: Los Angeles Superior Court / BC645566
  • Date of Verdict or Judgment: Friday, August 31, 2018
  • Date Action was Filed: Wednesday, January 04, 2017
  • Type of Action: Vehicles – vs. Pedestrian, Wrongful Death
  • Judge or Arbitrator(s): Hon. Charles Palmer
  • Plaintiffs:
    Bihn Tran
    Lawrence Chan
    Ken Tran
  • Defendants:
    TNT USA, Inc., employer of defendant driver.
    Noe Astorga, defendant driver.
  • Type of Result: Jury Verdict

The Result

  • Gross Verdict or Award: $4,528,391.91

The Attorneys

  • Attorney for the Plaintiff:

    The Vartazarian Firm by Steven Vartazarian and Matthew Whibley, Sherman Oaks.

    Daniels Law by Bill Daniels, Sherman Oaks.

  • Attorney for the Defendant:

    Kirk & Myers by Jeffrey Cabot Myers and Brandon M. Corday, Los Angeles.

Facts and Background

  • Facts and Background: On October 24, 2016, at approximately 9:06 a.m., defendant’s employee made a left-hand turn at the corner of Main St and 3rd Street in Alhambra, striking Ms. Tien Ahn Chung. Ms. Chung was a pedestrian walking in a marked crosswalk with a green light and walk signal. Her cause of death was a combination of traumatic brain injury and blunt force trauma to her cardiovascular system. Ms. Chung was 69 at the time of her death and survived by three adult children, the plaintiffs in this lawsuit.
  • Plaintiff’s Contentions: Plaintiffs filed suit for negligence and wrongful death against defendant driver and his employer.
  • Defendant’s Contentions: Defendant admitted liability.

Special Damages

  • Special Damages Claimed – Past Medical: $28,391.91
  • Special Damages Claimed – Future Medical: 0
  • Special Damages Claimed – Past Lost Earnings: 0
  • Special Damages Claimed – Future Lost Earnings: 0

Demands and Offers

  • Defendant Final Offer before Trial: $5,000,000


Full Service LPOs vs. Task Specific LPOs

Legal Process Outsourcing (LPO) Industry has emerged with the concept of globalization and is growing rapidly. The reason behind its rapid growth is the increased demand for legal outsourcing services at low cost since the litigation costs are getting ridiculously high day by day and with the bunch of legal proceedings going on, lawyers find it difficult to spend hours in paralegal and other legal support work. Nowadays most of the law firms either large or small, in-house counsels and corporate legal departments consider LPO industry to be helpful and efficient in getting their work done. The industry since its emergence till date faces several challenges, such as, quality, client relationship, security and confidentiality issues, ethical implications, service level agreements, certifications to address the security and confidentiality concerns, etc, and by overcoming all the challenges, the outsourcing industry has emerged as a go-to solution for most of the law firms and corporate entities, irrespective of their size

Based on different types of services provided by LPOs, they are classified into full-service LPOs and task-specific LPOs. Full-Service LPOs provide a full range of LPO services. They are well established as well as large organizations in this industry. One can get all the services done on a single platform rather than dividing tasks into different LPOs who are dealing with specific LPO services. Task-Specific LPOs are those which provide legal outsourcing in a particular field like document review, contract review, and so on. It delivers specific services and not a bunch of legal outsourcing services.

Most of the law firms and in-house counsels prefer full-service LPOs reason being they get all their work done from a single source which saves their time and money. Task-Specific LPOs are good options when one has to avail a specific task. Most of the task-specific LPOs have clients from big law firms and organizations since it might turn costly for small organizations and law firms to avail services from such LPOs. Whereas Full Service LPOs are better options for both large as well as small organizations and facilitates several benefits when compared to task-specific LPOs, such as cost saving, everything on a common platform, time-saving, fits all organizations’ needs, etc.

Benefits of Legal Outsourcing

In recent years the legal outsourcing industry has seen unexpected growth. The reason behind such growth is the benefits that one gets from legal outsourcing, be it in-house counsel, law firms or other organizations. There are several benefits of legal outsourcing to these organizations, such as—

  • Cost savings
  • Better focus on core business activities
  • Dedicated workforce
  • Access to experienced legal professionals with outstanding expertise
  • Save valuable time
  • Exceed client expectations
  • Reduced cost of having regular employees
  • Minimal infrastructural costs
  • Increase in profits
  • Access to quality legal services
  • Gain an edge over competitors
  • Not just for big firms

With the ever-rising cost of litigation to stay competitive, it became imperative to reduce costs which in turn took a toll on the partners’ profits and overall net revenue of the firms. Considering to outsource most of the tasks not only reduced the cost but also increased the overall revenue by handling more volume of work, which otherwise was difficult with the limited number of resources available to do the job. Through outsourcing, they save more than 50 to 60 % of the cost, as Full-Service Legal Process Outsourcing (LPO) companies have the capabilities and resources to offer comprehensive litigation support services, corporate legal services, medico-legal services and paralegal support services which enable lawyers or the designated resource to spend less time on the review. When most of the work is delegated and delivered on time, they get ample time to focus on the core business activities

It also facilitates dedicated workforce with the required expertise in that particular area of law.  The added advantage of legal outsourcing is that the professionals who are hired by these outsourcing companies to perform even the basic secretarial work are also law school graduates with five years of legal education under the common law. These law school graduates are extensively trained to handle almost every single task, so the clients have access to quality legal services delivered to them on time.

Outsourcing can play vital a role in gaining an edge over competitors, as your in-house resources have a considerable amount of bandwidth to stay client-focused, offer better customer service experience and exceed client expectations. Outsourcing per say is not just for big law firms or corporations. Solo, Small and Medium law firms and organizations are the biggest benefactors of Outsourcing. It is often seen that a lot of firms either have a higher volume of work with fewer resources to deliver or wish to attain more business, but do not have the required resources to deliver. In either case, Outsourcing is the savior, as your outsourcing partners will have the required resources and the expertise to relieve you of the concern “who is going to handle my work”, rather you have the flexibility and assurance to go out there and the market for more business.



Factors supporting LPO trend

Legal Process Outsourcing (LPO) is the industry which carries out legal work at reduced cost, outsourced by law firms, in-house legal departments and various other organizations. LPO is the fastest growing industry which has provided alternative career option to lawyers, offering them better salaries, working conditions and work-life balance. It attracts the legal professionals because of various factors, such as, exposure to the corporate culture, openness, transparency, inclusivity, etc. Apart from benefiting the legal professionals, it also benefits the legal industry. With the increasing number of litigation work the litigation cost has increased dramatically and it drives corporate legal budget too high and with legal outsourcing the costs involved is reduced. The best part is the quality of work is not compromised.

There are various factors which support legal process outsourcing, these are—

  • Globalization
  • Internet and its growth
  • IT tools
  • Data security
  • Economic changes
  • Rising cost of legal services

The concept of globalization has opened the gate for outsourcing industries as it helps in developing and operating business on international scale. It has also facilitated economic interdependence of different states’ economy across the globe by increasing economic integration. The rapid growth of internet and its usage has also supported the legal outsourcing industry in its extension since the work done requires internet access as all the legal documents are accessed and processed via internet. Legal outsourcing is a combination of legal work and use of information technology as different IT tools help in carrying out legal outsourcing, such as, case management tools, litigation tools, etc. Data security has always been a major concern in legal outsourcing industry as legal professionals work on highly confidential data. However, with the compliance of advanced data security standards this industry works more efficiently, as a matter of fact it is much safer, considering the various studies conducted which prove that majority of the data leaks happen in-house or through ex-employees

There were other challenges too faced by this industry, such as, quality and ethical implications, however, with the growth and maturity of the business these concerns have also been tackled and handled efficiently by adopting the culture of professional ethics. With these supportive factors and many more LPO industry has grown bigger and includes various litigation support services, paralegal, IP, corporate legal services and other services, such as, legal research, medico-legal services, legal billing, etc.

football cup

NFL Concussion Settlement Pays Out Over $502M In Claims

The special master overseeing the National Football League’s concussion settlement on Monday said that more than half a billion dollars in claims have been awarded in the past year and a half, exceeding what the NFL originally estimated it would pay out over 10 years.

According to a report posted online by the special master, as of Monday 521 claims worth a total of $502 million have been awarded to retired NFL players or their families since the settlement went into effect in January 2017. In a news release, Monday, class co-lead counsel Seeger Weiss LLP said the NFL had estimated $404 million in payouts over the first 10 years of the settlement in a report submitted during the settlement approval process.

In a video released online Monday, class co-counsel Christopher Seeger called the fact such a large amount has been paid “highly significant.”

“On the one hand, it’s the sad testament to the fact that there are a lot of sick players who need this relief badly,” he said. “On the positive side, they’re finally getting it.”

He predicted the NFL will ultimately pay more than $1.5 billion over the 60-year term of the settlement.

Counsel for the NFL did not immediately respond to requests for comment Tuesday.

In April 2015, the court approved an uncapped settlement ending multidistrict litigation between the National Football League and about 5,000 former players seeking damages for concussions and degenerative neurological conditions resulting from their playing days.

More than 1,900 claims have been submitted, according to the report. The report said 531 claims have been denied and that additional documentation has been requested for 375 more.

Earlier this month, U.S. District Judge Anita Brody declined a request by the NFL to appoint a special investigator to examine the claims. The league had argued an “extraordinary number of potentially fraudulent claims” have been submitted, but Judge Brody said the current screening process is working properly, although she said would appoint an investigator if the claims administrator or special master asked.

According to the report, of the claims awarded, 67 totaling more than $84.5 million were for deceased former players found to have chronic traumatic encephalopathy, a degenerative brain condition that can only be diagnosed post-mortem. The settlement paid 157 claims totaling more than $78.1 million for Alzheimer’s disease claims and 186 claims exceeding $193 million for players claiming various degrees of cognitive impairment.

The Seeger Weiss news release also said as part of the settlement more than 6,000 baseline neurological exams have been performed on ex-players to evaluate them for brain injury.

Seeger Weiss and Anapol Weiss LLP are co-lead class counsel in the litigation.

The NFL is represented by Brad Karp, Theodore Wells Jr., Bruce Birenboim, Richard Tarlowe and Sarah Istel of Paul Weiss Rifkind Wharton & Garrison LLP, and Sean Fahey of Pepper Hamilton LLP.

The case is In re National Football League Players’ Concussion Injury Litigation, case number 2:12-and-02323, in the U.S. District Court for the Eastern District of Pennsylvania.


newyork university

NYU Becomes Latest School To Beat ERISA Class Action

New York University defeated an Employee Retirement Income Security Act class action on Tuesday when a federal judge rejected workers’ claims that the school’s two employee retirement plans were mismanaged to the tune of $358 million in losses.

U.S. District Judge Katherine B. Forrest’s opinion and order tossed allegations that an NYU committee wasted workers’ retirement savings by retaining two recordkeepers for the plans instead of one and keeping a pair of supposedly lagging investment funds on the plans’ lineups.

Those claims, which accused NYU of breaching its ERISA-imposed duty to make prudent decisions for over 20,000 plan participants, weren’t supported by the facts, Judge Forrest said Tuesday, two months after hearing both sides’ arguments during an eight-day bench trial.

“While there were deficiencies in the committee’s processes — including that several members displayed a concerning lack of knowledge relevant to the committee’s mandate — plaintiffs have not proven that the committee acted imprudently or that the plans suffered losses as a result,” Judge Forrest wrote.

During the trial’s closing arguments, Judge Forrest had repeatedly interrupted NYU’s counsel to question whether the school’s retirement committee members knew what they were doing.

After reviewing all the evidence in the case, however, Judge Forrest said she found the committee had a prudent process in place for evaluating the plans’ investments and monitoring the recordkeepers.

The class had assumed that dropping one of the plan’s two recordkeepers would reduce the plan’s fees, but the evidence didn’t support that assumption, or the assumption that a single recordkeeper would have been better than two, Judge Forrest said.

Evidence also failed to support the class’ assertion that NYU’s committee slacked when negotiating with the Teachers Insurance and Annuity Association, formerly TIAA-CREF, for lower plan fees, Judge Forrest said.

“While plaintiffs assert that the committee did not negotiate fee reductions zealously enough, the record reflects a number of serious — and successful — efforts by the committee to reduce recordkeeping fees,” Judge Forrest wrote. “As of 2018, both plans’ fees for the TIAA assets decreased substantially.”

The class also fell short when attempting to prove the committee acted imprudently by keeping the TIAA Real Estate Account and the CREF Stock Account on the plans’ investment lineups, the court said.

Analyses of the funds’ performance show that both “performed as well as would have been expected” during the class period, Judge Forrest wrote. Furthermore, evidence showed the class actively engaged with both funds over the years, considering the appropriateness of benchmarks used to measure fund performance and, in the case of the real estate account, asking the Teachers Insurance and Annuity Association to explain the strategy of the fund.

One of the class’s experts, Gerald Buetow, had argued that both funds underperformed, but the judge said he used improper benchmarks and, in the TIAA fund’s case, failed to account for the fund’s cash holdings.

In the case of the CREF Stock Account, Judge Forrest wrote, “Buetow incorrectly used [a] benchmark … that was not in place until mid-2011 to cover a period prior to mid-2011.”

“In fact, the benchmark Buetow used was his own creation,” Judge Forrest said.

NYU spokesman John H. Beckman said Tuesday that the school “maintained from the time the plaintiffs first publicized this case that it was baseless, and the judge’s finding supports that.”

“The simple fact is that NYU is and always has been a careful, conscientious steward of the retirement plans for its employees and retirees, and the plaintiffs failed to meet their burden of proof to suggest otherwise,” Beckman said in a statement.

Judge Forrest’s opinion and order capped off the first trial against an elite university since a series of ERISA class actions were filed against them beginning in 2016.

Many of those suits, which all alleged colleges’ retirement plans flouted ERISA by charging high fees and offering underperforming investment options, came from the Midwestern law firm Schlichter Bogard & Denton LLP, which became known among benefits lawyers after partner Jerry Schlichter prevailed in a series of lawsuits against corporations over their 401(k) plan fees in the 2000s.

Two of the firm’s university targets, the University of Pennsylvania and Northwestern University, beat the lawsuits at the motion-to-dismiss stage, while a school sued by Schneider Wallace Cottrell Konecky Wotkyns LLP, the University of Chicago, opted to settle for $6.5 million.

That leaves 15 universities — the Massachusetts Institute of Technology, Yale, Duke, Vanderbilt, Johns Hopkins, Emory, Cornell, the University of Southern California, Columbia, Princeton, Washington University in St. Louis, Brown, Georgetown, the George Washington University and the University of Rochester — left facing suits at the district court level.

Schlichter Bogard has appealed the suit against Penn to the Third Circuit and asked an Illinois federal judge to reconsider his verdict in the suit against Northwestern.

On Tuesday, Schlichter said he plans to appeal the NYU decision.

“We respectfully continue to believe that retirement plan participants at universities that operate as nonprofits have the same rights and protections under the law to build their retirement savings as workers at for-profit companies,” Schlichter said in a statement to Law360. “We also continue to believe, from the unanimous ruling by the U.S. Supreme Courtin Tibble v. Edison, that placing high priced retail funds in the NYU multibillion-dollar plans is a fiduciary breach and the fees charged were excessive. We will continue to pursue this case in order to make the NYU employees and retirees financially whole.”

Counsel for NYU did not immediately respond to requests for comment Tuesday.

The class is represented by Jerome J. Schlichter, Heather Lea, Joel Rohlf and Ethan Hatch of Schlichter Bogard & Denton LLP.

NYU is represented by Mark Muedeking, Ian C. Taylor, Jennifer K. Squillario, Harry Rudo and Evan D. Parness of DLA Piper.

The case is Sacerdote et al. v. New York University, case number 1:16-cv-06284, in U.S. District Court for the Southern District of New York.



Ex-University of Arizona student files lawsuit in connection with fraternity hazing incident

A former University of Arizona student is suing the Arizona Board of Regents and Alpha Sigma Phi fraternity in connection with a hazing incident last year that left the young man seriously injured.

The UA removed its chapter of Alpha Sigma Phi in April 2017 after an investigation by the school found that its members engaged in hazing, assault and provided alcohol to minors, according to a letter from the Dean of Students Office.

During a fraternity event on the night of March 22 and the morning of March 23, 2017, Alpha Sigma Phi members were blindfolded, physically assaulted and forced to drink excessive amounts of alcohol, the letter says.

At least one student was arrested at the time, and in January 2018, two former members of the fraternity were indicted on felony assault charges in connection with hazing, court records show.

Cody William Ward is facing a charge of aggravated assault with serious injury in connection with the March 22 incident, and Brandon Sellers is facing a charge of aggravated assault causing temporary or substantial disfigurement, stemming from incidents that took place from Jan. 15 through Feb. 7, 2017. The case is ongoing, with status conferences scheduled in August, according to Pima County Superior Court records.

The lawsuit, filed by former Alpha Sigma Phi pledge Brett Barr, says the UA, the Arizona Board of Regents and Alpha Sigma Phi acted negligently. The lawsuit also accuses the fraternity of negligent supervision, battery and intentional infliction of emotional distress. Ward and Sellens are also named as defendants in the lawsuit.

Barr was a UA freshman and Alpha Sigma Phi pledge at the time of the incident and did not return to school afterward because he feared for his safety, according to the lawsuit.

After the incident, Barr required emergency medical attention and was found to have head trauma, a lacerated spleen, sepsis, cigarette burns on his arms, abdominal pain, nausea and vomiting, the lawsuit says.

Barr also suffered from severe emotional distress, mental anguish, anxiety, depression and a fear of retaliation by other fraternity members, the lawsuit says.

Gordy Heminger, president, and CEO of Alpha Sigma Phi told the Star that Ward was permanently expelled. Heminger also said the fraternity is pursuing damages against Ward for his actions that led to the closure of the chapter.

“We hope the court system, criminal and civil, will hold this individual fully responsible for his actions, and Alpha Sigma Phi pledges its full support to that effort,” Heminger said.

Alpha Sigma Phi’s national organization has made it clear that members who haze will be removed from the fraternity and the organization will do whatever it can to ensure they are held accountable through the university conduct process and the court system, Heminger said.

The UA has been removed as a defendant in the case since the Arizona Board of Regents is the governing body that represents the school.

“The university took immediate and decisive action upon notification of the injury,” UA’s Dean of Students Kendal Washington White told the Star in an email. “That action included suspending all chapter activities pending the outcome of our investigation.”

Once the UA confirmed that Alpha Sigma Phi had endangered members, including assaulting a pledge, the school withdrew the group’s campus recognition — the most serious sanction the UA can issue against a student organization, White said.

The Board of Regents has denied the allegations, saying Barr’s injuries were “caused by his own contributory negligence and/or assumption of the risk.”

Barr’s attorney, Phoenix lawyer William Fischbach, told the Star he was unable to comment on the pending case, but said the original claim filed with the state asked for $1.2 million in damages.

To sue a public body, a person must first file a claim, allowing the organization 60 days to settle before it can be filed in court.


University Hospitals fertility clinic failure affects more patients than thought

More than three weeks after a “catastrophic failure” at its fertility clinic in Ohio, the University Hospitals Fertility Center is now saying 4,000 frozen eggs and embryos were lost — twice the number the hospital initially reported. Nearly 1,000 patients of the University Hospitals Fertility Center in Cleveland were sent letters Tuesday apologizing once more and acknowledging some of the reasons for the failure to preserve frozen eggs and embryos held in a storage tank. The hospital is now blaming human error for the devastating loss.

In the letter from University Hospitals Fertility Center, patients received the crushing news that it’s unlikely that any of the frozen eggs and embryos are viable. The letter also confirms that the remote alarm system on the tank — which should have alerted an employee to temperature swings — was shut off during the weekend of March 3. It was during that time the temperature in the tank began to rise, destroying the thousands of frozen eggs and embryos.

“We don’t know who turned off the remote alarm nor do we know how long it was off, but it appears to have been off for a period of time,” the letter states. “We are still seeking those answers.”

Despite 11 miscarriages, Wendy and Rick Penniman had two healthy children with the help of University Hospitals Fertility Center. But now, there’s no hope of using their frozen embryos to have a third child.

“It’s devastating, I think, for us, but it’s more devastating because it’s taking something away from our kids,” said Wendy Penniman, 41.

Christina and Marc Ellis wanted to use their two remaining embryos at the center to give their daughter, now 2, a sibling.

“I don’t know if I can go through the whole process again. And what’s the outcome gonna be?” Christina Ellis told NBC News.

Both couples are now suing. So are at least 16 other sets of plaintiffs, all claiming negligence and breach of contract. An investigation has found the manufacturer of this particular storage tank, Custom Biogenic Systems, has a history of problems dating back almost 15 years. In 2003, Rachel Southwood’s husband Andrew had sperm frozen in the UK after he was diagnosed with cancer. The Taunton, England, the couple had one child and hoped they would be able to have another.

“He gave the sample and as far as we were aware, we would potentially be able to have more children,” Southwood said.

But less than a year later, the freezer storing his sperm malfunctioned, rendering the sperm no longer viable. Andrew Southwood eventually died from cancer.

“They simply said that there had been a technical malfunction with the unit that was storing the sperm of my husband,” said Southwood, who was 30 at the time.

In 2003, British regulators warned that freezers made by CBS, a Michigan company, had problems with their automatic filling mechanisms.

“The manufacturer is aware of 21 incidents” in the UK, regulators said.

“The alert was withdrawn,” according to a statement from the UK’s Medicines and Healthcare Products Regulatory Agency to NBC News. “The UK supplier informed MHRA that 95% of the devices in the UK had been returned and upgraded. The other 5% were to be complete by 2006. Therefore, this issue should no longer be affecting the UK. No further reports have been received by MHRA since September 2005.” But two years later, after the warning was first issued, a similar incident occurred in Gainesville, Florida. Up to 60 male patients, many with cancer, lost stored sperm when a tank made by the same manufacturer failed.

Experts estimate that there are 500 clinics that specialize in assisted reproduction around the country, based on a 2015 report about the state of assisted reproduction by the Centers for Disease Control and Prevention. That report included a list of 451 clinics that have provided them with data and 35 others that had not. The lack of reliable data on procedures and clinics in the United States — and possible problems with their frozen eggs and embryos — has contributed to a “regulatory vacuum,” says Dov Fox, director of the Center for Health Law Policy and Bioethics at the University of San Diego.

“There is almost no regulation or oversight of any kind that relates directly to the prevention of mistakes like these,” said Fox, who is working with one of the plaintiffs in the Cleveland case.

“And it’s not just fertility clinics, it’s sperm banks, egg vendors, surrogacy agencies, in all these areas, we don’t know how common the mistakes are, because there is no reporting, no tracking agencies.”

NBC News contacted federal regulatory agencies and organizations that provide accreditation for fertility labs. When NBC News’ Investigative Unit asked who’s ultimately responsible, most said it wasn’t them.

The only government agency that told NBC News it technically could regulate storage tanks is the Food and Drug Administration or FDA. But because freezers in fertility clinics have not been specifically marketed as medical devices, it doesn’t. Members of the assisted reproduction industry say tank failures like the one in Ohio wouldn’t have been prevented with more regulations.

“Autofill tanks still require regular periodic checks by laboratory staff to ensure that they are functioning properly,” said Dr. Alan Penzias, a fertility specialist at Boston IVF, an associate professor of obstetrics, gynecology and reproductive biology at Harvard Medical School, and chairman of the practices committee at the American Society for Reproductive Medicine.

“I spoke with members of my laboratory staff who informed me that this is common knowledge.”

Fear of lawyers may have played a role in stopping wider reporting of previous failures in the US, says Dr. Mark Jutras, lab and medical director at Advanced Reproductive Concepts in Charlotte, North Carolina.

“It is usually institutions who have failures and their lawyers will not allow outside people to analyze the situation to find the root cause of the problem and how it could have been avoided,” said Jutras.

That’s little comfort for the patients who lost their frozen eggs and embryos at University Hospitals Fertility Center.

“Who else has the tanks,” asked Wendy Penniman. “And how many babies are at risk right now while we sit, while we talk?”

The University Hospitals letter told patients the facility had obtained another working storage tank and had planned to move frozen eggs and embryos into that extra tank, but hadn’t started that process when the failure occurred.

The fertility center has offered to pay for treatments for any patients who want them.

The Ellises are considering that. The Penniman declined the offer. CBS provided the following statement:

“Custom Biogenic Systems (CBS) is aware of the incident at University Hospitals Ahuja Center in Beachwood, Ohio and is currently in the process of gathering information.

Our objective is to work diligently to support the investigation into what occurred and be helpful in the search for answers in this difficult situation. We continue to have confidence in our products and our people that serve our customers.”

CBS sent a second statement to NBC News on Tuesday evening. In it, CBS denied that issues with the auto-filling mechanism constituted a “malfunction” or an underlying “technical problem.”

Dr. James Liu, chairman of the department of obstetrics and gynecology at University Hospitals, told NBC News on Tuesday that the fertility center did contact CBS when problems with the tank were discovered several weeks ago.

“They did tell us that this is how we would do preventative maintenance on that particular problem, and that we recognize the problem, and that they were aware of that,” said Liu.

In its letter to patients, the University Hospitals said preventative maintenance was needed because the auto-fill system had “difficulty” and was “not working.”

In its second statement, CBS questioned the hospital’s method for filling the tank with liquid nitrogen during this period.

“The CBS tank is not designed to be filled by liquid nitrogen being poured into the top of the tank.”

In addition, CBS noted something which the hospital conceded in its letter — that the remote alarm system was off. Further, the company points out, “CBS did not design, manufacture, install or monitor any remote alarm system on the unit.”

In a third emailed statement to NBC News, CBS stated its position that the alert issued in 2003 and later withdrawn by regulators in the United Kingdom “involved a prior design of the unit which was discontinued in 2003.”

In that same statement, CBS also alleged that the incident in Florida in 2005 “was caused by human error” — contrary to media reporting at the time, which was affirmed by a University of Florida Health spokesperson in an email to NBC News last week.

CBS’ third statement to NBC News also included additional information about a “local” alarm relating to the temperature in the tank at the time of the incident.

“When the temperature began to rise on Saturday night,” the statement said, “the CBS unit functioned properly by indicating a high-temperature condition and activating a local alarm. CBS is not responsible for the alert not being sent to the UH employee or for staffing of the UH lab, both as referenced in the UH letter.”

In a user’s manual , the manufacturer devotes a whole page to “Recommended Best Practices in the industry for safe sample storage.”

In a section titled, “Why do I need a Secondary or Back-Up Alarm?” the manufacturer also warns, “Your freezer could malfunction. By having a secondary or backup alarm you can minimize the possibility of a loss due to a malfunction.”

Resource: Nbcnews