SOME OFF THE CUFF OBSERVATIONS OF ZIKA VIRUS ADDENDA

There is no doubt that the Zika virus is a health crisis with a potential for horrific results. As the epidemiological puzzle has not been fully fleshed out, more questions remain then have been answered. For better or worse we also witness heightened media attention and its predilection for catering to hysteria and histrionics.

Histrionics aside, the tragedy visited upon an effected family will be immeasurable. The financial impact on a family for lifelong care will be catastrophic. It is only a matter of time before we see a lawsuit against a person or persons who may have prevented or minimized the damage to a child suffering Zika mediated microcephaly. If you do not believe there is an incentive to file against an offending party for a brain-damaged infant, I caution you with some headlines from 2014.

Georgia Jury Awards $8.4 Million In Action Brought On Behalf Of Infant Who Suffered Hypoxic Ischemic Brain Injury At Birth

Ohio Jury Awards $14.5 Million In Action Arising From Preterm Labor And Baby’s Resulting Brain Hemorrhage

The awareness of the virus, damage and associated costs has, within the ART community, prompted many responses. One, which we address here, is the so-called Zika Virus Addenda. When I look at these Addenda I see some of the best drafting I have been exposed to in years. I would, however, say that while the intention behind the drafting is noble, it is misplaced and will lead to more problems than it solves.

DRAFTING ATTORNEY CENTRIC VIEW

When we speak about the language contained within the Addenda, we fall into an argument of what is, in fact, appropriate direction. Ignoring the words themselves, we look at the aspirational nature of the words. Is the drafter providing us a “Standard of Care” or a “Best Practices” perspective?

“Standard of care” is a legal term with a clear definition. It is the level at which the ordinary, prudent professional having the same training would practice under the same or similar circumstances. Standard of care is not perfection or average. The standard of care is actually a pretty low threshold. The standard of care is what most reasonable professionals under similar circumstances do.  It is not an aspirational standard as the professional is permitted to be wrong or even make an error. The professional is not, however, permitted to be negligent.

“Best practice” refers to professional practices and procedures arising from the evidence discovered through academic research. A “best practices” approach applies the most recent, relevant, and helpful interventions to real world applications. Best practices are an aspirational approach to delivering professional services.

Many experts will opine that “standard of care” means, “best practice.” So any care that deviates from best practice, they contend, is a prima facie failure to meet or exceed the standard of care (and is therefore, malpractice). While this is generally a view within the university or research setting, it is specifically the interpretation that plaintiff experts will proffer in a malpractice trial.

A significant problem arises when our colleagues don’t articulate the difference between the standard of care and “best practices.” This is unfortunate because when we conflate “standard of care” with “best practices,” the perception becomes reality.  It’s important to articulate the difference.

In the reality that is a Zika addenda, a best practices approach to the behaviors demanded of a Surrogate is aspirational and, therefore, unrealistic.

SURROGATE CENTRIC VIEW

As stated earlier, Zika Addenda are well written. Perhaps, however, too well written. They are dense with medical language and terminology. They dictate patterns of behavior which are unrealistic in the real world and which go well beyond anything published by the Centers for Disease Control. They are, for the most part, aspirational and follow a best practices approach to managing risk.

In fact, as the vectors for disease transmission are not all known and are not subject to finite epidemiological pathways, any listing of prohibited behaviors or permitted actions cannot be complete. The Addenda create an illusion that following the aspirational language will prevent a Zika infection. As a practical matter then, Zika Addenda are inescapable traps from which infection will always be attributed to the Gestational Carrier as improper behavior(s).

Plaintiff counsel will draft a Complaint that will, of course, start out with a Breach of Contract count. Following that, expert testimony may provide testimony such to establish that the Addenda language sets a floor for a Count in Negligence Per Se.

(1) She violated clause in the Contract;

(2) The violation proximately caused injury to a Child;

(3) The injury resulted from an occurrence of the nature which the contract language was designed to prevent, i.e., that the failure to conform to the behaviors set out in contract language was inherently negligent; and

(4) The Child suffering the injury was one of the classes of persons for whose protection the language was adopted.

Will these fly? Who can know? Each jurisdiction is different as to the application of novel causes of action. We can be sure, however, the Carrier will be in the suit at least to a Motion To Dismiss.

There are other problems with the Addenda that the Carrier will have to address during Motion Practice.

  1. These Addenda are adhesion contracts. Generally, adhesion contracts create a power imbalance where the drafting party controls all contract terms. These Addenda are dense with medical terminology and medical direction, bordering upon the practice of medicine. Gestational Carriers may not fully read such dense documents nor understand the burden placed upon their behaviors.

Even if a Carrier reads and understands the Addendum, there is no room for negotiation. Should the Carriers find a term unfavorable, often, their only option is to match elsewhere. And, with Zika found in all but 5 states, the possibility for re-matching will be slight. Even if re-matching was possible, the Carrier may have to reimburse the IPs for their expenses leading up to her exit from the match. As a result, Carriers will most likely continue with the match and Addendum, stuck with an oppressive agreement.

  1. These Addenda are unconscionable. Unconscionability is generally recognized to include inequality of bargaining power which results in no real negotiation and ‘an absence of meaningful choice” together with contract terms which are overly harsh or one-sided. The fact that a Carrier either signs or goes back into the market demonstrates a certain inequality and, with terms that are overly oppressive, the Addenda fall squarely into being unconscionable. Unconscionable contract are unenforceable.

What can we glean from these thoughts? If a Carrier agrees to execute the Addendum and is infected, she is going to be sued. Carriers are generally uncollectible but an angry Parent may chose to “send a message” regardless.

Adding insult to injury, Carriers will most likely be unable to find $10,000 as a minimal deposit to hire counsel. I would expect the majority of these cases would end up with default judgments and a subsequent bankruptcy. As these cases would, most likely, not be appealed, we would not be fortunate enough to have appellate direction that could help stave off subsequent similar lawsuits.

REVIEWING ATTORNEY CENTRIC VIEW

A Reviewing Attorney will be putting their malpractice carrier on notice should the Carrier, their Client, is sued. Why? Simply stated, the Reviewing Attorney placed the client into a position where breach of contract is indefensible. Thus, the Carrier will file a third party complaint against the attorney alleging legal malpractice for permitting her execute the Addendum. Further, and depending upon the jurisdiction, there may be a concurrent ethical violation.

Interestingly enough, the Carrier must prove that but for the malpractice, there would not have been a Zika Addenda, or had the Addenda been drafted differently, she would not have been found to be in breach. So we revisit the standard of care vs. best practices once again. It would be perverse indeed if the Carrier/defendant argues standard of care while the Carrier/third party plaintiff argues best practices. That is most likely how we would see such litigation play out.M

Actress Sherri Shepherd Loses Appeal; Must Pay Child Support

A Pennsylvania court ruled that actress Sherri Shepherd has to pay child support for her child born of a surrogacy prior to her divorce. This is the first court ruling in Pennsylvania making surrogacy agreements binding. Shepherd appealed that ruling since she tried to void the surrogacy agreement when she filed for divorce. The court has denied that appeal and has upheld the lower court’s ruling.

sherri_shepherdThis decision is an important one not just for Pennsylvania, but for all states, because it reiterates and confirms the importance of upholding the validity and legality of parentage via surrogacy. By treating the child support issue as they would have had the child not been born by way of assisted reproduction, the court is sending the message that a parent of a child born via surrogacy is that child’s parent in all respects.

The result here brings attention to the fact that not only should individuals consider having a child via surrogacy carefully, the attorneys and professionals helping them through the surrogacy journey should take the time to make sure the individuals are aware of this responsibility. It is one of the many conversations that should take place before anyone takes this journey.

This is a positive step for the acceptance of parentage via surrogacy in our society, legitimizing this right to procreate.

Is Egg Freezing Right for You?

There is no denying that egg freezing is a controversial topic. This has been much discussed in the Assisted Reproductive Technology (ART) world for some time now and with Apple and Facebook offering egg-freezing benefits for employees, the topic is under more scrutiny than ever. As a 27-year-old female ART attorney, this is of interest to me for more reasons than one. It is intriguing from a legal point of view, but it’s also a conversation about medical advances, social politics, business strategy, and moral interpretation. Our societal history divides women into two camps, those who have their career and those who have their children. What about the women who want the best of both worlds? Do we have to choose? Is egg freezing the solution?

Egg Freezing

 

Egg freezing preserves your fertility. Freezing eggs can give a woman the time she needs to focus on her career and achieve a level of success harder to attain otherwise. After all, statistics overwhelmingly demonstrate that most managerial and leadership positions are still held by men and childrearing and family building can negatively affect that opportunity for many women. Not to mention, some companies are now offering egg-freezing coverage for their employees so cost may not be as big of an issue.

 

Medically, this is also helpful for women whose health will impact their ability to produce eggs in the future. Women with cancer, for example, who have an expectation of chemotherapy, can freeze their eggs before treatment to retain the option of having a genetic child. The American Society of Reproductive Medicine (ASRM) considers egg-freezing an invaluable option for cancer patients. (see the ASRM Ethic Committee’s report on the effect of chemotherapy on fertility here.) This is an option for women with a strong family history of early menopause or premature ovarian failure.

 

Freezing eggs also provides one the ability to donate eggs to a woman who never had or has lost her ability to produce her own eggs. Egg donation is becoming increasingly popular and that is a direct result of the cryopreservation techniques for eggs used today. Unfertilized egg cryopreservation removes the necessity of a sperm contributor, medical costs, and medical risks associated with a fresh embryo transfer. Additionally, speaking from an ethical or perhaps religious perspective, some women rather freeze their eggs and not their embryos. They would argue the fertilized egg is a person and no longer just a gamete. Egg freezing allows preservation before “personhood” is achieved.

 

Conversely, there are many reasons to be skeptical of this technique and manner of preserving ones fertility. For starters, there is not a lot of research on the health or mental status of the resulting children. While ASRM removed the “experimental” label from egg freezing in 2012, they are not proponents of the technique for elective use. ASRM states there is “still not enough known about the egg freezing procedure’s safety, efficacy, cost-effectiveness, and emotional risks” and cautioned that it may “give women false hope”. The American College of Obstetricians and Gynecologists reported, “There are not yet sufficient data to recommend oocyte cryopreservation for the sole purpose of circumventing reproductive aging in healthy women.”

 

Additionally, as a clinic in California explains, there is the concern that not all eggs will survive the thawing process anyways and no guarantee that the woman will have a live birth from it. The age at which the egg is retrieved for cryopreservation is a large factor in the quality of the thawed egg. A Belgian bioethics report states “women tend to cryopreserve oocytes at an age that is suboptimal … in their late thirties – when both oocyte quantity and quality have already considerably diminished and success rates for eventually establishing a pregnancy are thus limited”. (See ASRM about diminishing egg quality here.)

 

In addition to not really being an insurance policy to having children later, there are also many health risks involved as well. New Republic states that some women have reported becoming infertile or experience early menopause after exposure to the drugs or have had retrievals that leave behind damaging scar tissue. The process is not by any means like retrieving sperm from a man; egg retrieval is a very intensive procedure and requires medication on top of an invasive surgery. Normally, a woman’s body produces one egg per cycle but, to freeze, a woman’s ovaries are stimulated to produce anywhere from 5-30 eggs (although 10-15 is common) for the retrieval. This stimulation can sometimes lead to Ovarian Hyper Stimulation Symptom and although the risk of it can be lowered there is always a risk. There can also be ovarian torsion and mental effects post treatment like depression and post traumatic stress disorder.

 

Lastly, the cost is huge down side to this procedure. Aside from paying approximately $500-$1000/month for storing the frozen eggs, there are costs associated with the procedure itself (approximately $10,000.00), the medications involved pre-retrieval and post-retrieval, the IVF procedure later on to become pregnant from the thawed eggs (approximately $5,000.00), and quite possibly the cost of having a surrogate carry the child if the woman cannot.

 

Overall, there are many things to think about when considering egg freezing but in the end, this is a woman’s individual choice. We are all different and only we can decide what our journey will be. What is important is that we do our research before making this decision. Informed medical consent is far from being everything necessary to know about this process and education on the matter is key. Don’t let comments like “take control of your biological clock” fool you; instead consider the facts and ask yourself, am I doing this because I have the luxury to, or because I need to? What am I giving up? Is this reproductive path a choice or a last resort?

Robert Terenzio, Esq., To Speak at AARTA Conference

Charleston Assisted Reproduction Technology Conference

Robert T. Terenzio will be speaking in Charleston on November 10, 2013, with other legal experts on the subject of Assisted Reproduction Technology.

Orlando, FL, November 05, 2013 –(PR.com)– Ethics, contracts and procedure will be among the many Third Party Reproduction topics to be discussed at the Mills House, Charleston, South Carolina, on Sunday afternoon, November 10, 2013.

Robert T. Terenzio, a Florida attorney with over 10 years of experience in this area of the Law, will be speaking with other legal experts on some of the ethical, contractual and procedural aspects of ART. The presentation will include information on the ethical and legal precedents to drafting ART contracts so that intended parents may expand their families in a legally secure, predicable manner.

This presentation is one part of a multi-day, comprehensive program organized by AAARTA, an organization promoting best legal practices within the assisted reproduction area.

About Robert T. Terenzio, Esq.
A graduate of Quinnipiac University School of Law in Connecticut, and a member of the American Bar Association, Assisted Reproduction Technology Committee, Robert T. Terenzio has extensive medical and legal education at the post-graduate level. Robert who is known as a dynamic speaker, has addressed professional and lay groups, both domestic and international on these topics. For more information, visit www.robertterenzio.com.

The Truth About IVF & Multiples

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About a month ago now, an anonymous father shared his disappointment and unhappiness at the upcoming birth of his twins via IVF on his Babble.com blog post for the world to see. See the CNN article here. He explained that he and his wife were “pissed. And terrified, and angry, and guilty, and regretful.” To say that they were upset at the prospect of having two healthy babies is an understatement. One commentator wrote, “…there are thousands of parents out there who would love to take them in. I’m not sure if I should feel [pity] or disgust.” Yet others sympathized with him at the hardship that raising twins will bring but nevertheless emphasizing the blessing it is in the end.

It is important to note that while IVF increases the chance of multiples, it is not as likely as one might believe. Today, increased success rates allow for the implantation of fewer embryos, which therefore result in less multiple births. However, like many of those who showed their support for the Babble Blogger parents, there is a misconception that persons using IVF will likely get pregnant with an unusually high number of children. Just last week I was at the beauty salon and two of the nail technicians were talking about how “dangerous” IVF was because you could get pregnant with EIGHT children. This idea has stuck in people’s minds due to the media coverage and popularization of people like Nadya Suleman (“Octomom”) and shows like John & Kate Plus Eight on TLC.

The truth is that although IVF has an increased chance of multiples, recent technology and practice limits it primarily to singletons or twins. Earlier this year, The Society for Assisted Reproductive Technology [SART] released it’s latest data which confirms that the number of live births resulting from IVF are going up, while the chances of having multiples is consistently going down.  SART’s national statistics show that for women between the ages of 35 and 37 undergoing IVF and using fresh embryos, 26.7% of them had live births resulting in twins, while only 1.3% of them had live births resulting in triplets or more. Those numbers go down to 14.9% and .7% for women ages 41 to 42 and with on-going medicals trials improving the success rates, the numbers continue to decrease. See Fertility and Sterility 100.3 (2013): 697-703 abstract here.

These same outcomes are reflected internationally as well. The European Society of Human Reproduction and Embryology reports that in 2010 the average number of embryos transferred per cycle was 1.75. Furthermore, a more recent trend is to only implant one embryo per transfer, this technique is referred to as a single embryo transfer or SET for short. The use of SETs is reflected in Europe’s low rates of multiple births. For example, Sweden has the lowest multiple delivery rates in the world right now and 73.3% of all transfers performed there were single embryo transfers. Due to higher success rates, this is a trend that is picking up speed in the United States as well.

Ultimately, just like a natural method of conceiving, it is hard to know for sure how many embryos will take before they actually do, but technology today gives us a really good idea. When you begin your journey, you and your doctor should have gone through all of the possible outcomes and make sure you are fully informed before making your decision. In the end, with the information available to you and the informed consent from your physician, the possibility of multiples should never be a complete surprise. Keep in mind however, that with single embryo transfers becoming more of the norm and technology advancing more and more everyday, that possibility is lower than you might expect.