Update on Sperm Bank Product Liability Lawsuit

A belated update on a story from a year and a half ago concerning a lawsuit brought against a sperm bank under product liability laws after a child conceived with that sperm developed Fragile X syndrome.

Under the laws being tested, it seemed all that needed to be shown was that injury (in this case, genetic disease) occurred as a result of using the product (in this case, sperm), not that negligence or lack of testing was a factor. At the time, I wondered whether genetic disease even qualified as "injury" since the alternative to injury is not being born at all. It turns out the courts had the same consideration.

A few months after the initial ruling by a judge that the case could go forward, the judge reversed his decision - a reversal that was upheld by a federal appeals court, on the basis that the situation basically amounts to a "wrongful life" case:

"Simply put, a cause of action brought on behalf of an infant seeking recovery for wrongful life demands a calculation of damages dependant upon a comparison between the Hobson's choice of life in an impaired state and nonexistence," Barry wrote. "This comparison the law is not equipped to make."

Barry, who was joined by Judges Theodore A. McKee and Morton I. Greenberg, quoted from Becker v. Schwartz, a 1978 decision of New York's highest court, that said: "Whether it is better never to have been born at all than to have been born with even gross deficiencies is a mystery more properly to be left to the philosophers and the theologians."

In addition to "wrongful life" considerations, the decision also points out other ways that treating genetic disease as injury is problematic.

The difficulties that B.D. now faces and will face are surely tragic, but New York law, which controls here, states that she “like any other [child], does not have a protected right to be born free of genetic defects.” To find the contrary would invite litigation for any number of claimed injuries and, even more problematic, require courts to identify certain traits below some arbitrarily established marker of perfection as “injuries.”

So kids, it looks like you can't sue your parents after all.

Direct-to-Consumer Genetic Testing Takes a Blow

That entire genomes can be sequenced, and the prices of those services continue to drop, is pretty exciting stuff. It also presents some unique opportunities for science education, explaining what results mean and how they should be interpreted. Of course, like with any new technology, there are opportunities for abuse and potential need for regulation, for example genetic discrimination by insurance companies, fears of which resulted in the Genetic Information Non-discrimination Act (GINA).

US Congress has been having hearings on direct-to-consumer genetic testing, and part of the fallout was this video:



The recordings were part of a government investigation and some of that is pretty damning. Or at least a very strong case for properly trained customer service representatives. It also underlines a need for proper pre- and post-test counseling.

Daniel MacArthur at Genomes Unzipped has a more in depth look at the full hearing proceedings, but puts things into perspective:

But overall, the document is obscenely one-sided. It conflates responsible companies offering scientifically valid products with small-time con artists. It ignores the remarkable effort that has been expended on creating intuitive interfaces that allow consumers to grasp complex risk predictions far more easily than anything you’ve seen in a GP’s practice. It ignores the remarkable technical accuracy of the companies’ products, which measure hundreds of thousands of genetic markers with an accuracy over 99.99%. It ignores the fact that the vast majority of personal genomics customers are satisfied with the experience, to the point that reporters seeking to present negative experiences need to exaggerate to do so.

Personal genomics is finally here

Want to get your genome sequenced? No problem, all you need is $50,000 .... or you could wait 12 years and, if it follows Moore's law, it should cost under a $1000. Still pretty impressive:

" Illumina, Inc. today announced that it has delivered Hermann Hauser’s genome sequence. Dr. Hauser, Partner, Amadeus Capital Partners Ltd, is the first consumer to purchase Illumina’s individual genome sequencing service working with his physician, Michael Nova, MD, of Pathway Genomics. The genome was completed in Illumina’s CLIA-certified and College of American Pathologists (CAP) accredited laboratory using the Genome Analyzer technology. Over 110 billion base calls were generated, delivering over 30X coverage of the genome. Data analysis showed 300K novel SNPs in the genome that have not been documented elsewhere."

Kids! Sue your parents for defective genes!

This story is a bit old, and a bit odd. A 13-year-old girl born with Fragile X syndrome is suing a sperm bank after genetic tests showed the genetic condition was carried on the father's X chromosome. (Weirdness about a girl inheriting an X-linked condition from her father, and a Fragile X male as a sperm donor explained here. The short version is that it's a spectrum, repeat-expansion disease whose severity varies from generation to generation so a mildly affected father could have a more severely affected daughter, though it's rare)

The legal premise is based on product liability law that is usually applied to manufacturer defects such as faulty car brakes

Donovan does not have to show that Idant was negligent, only that the sperm it provided was unsafe and caused injury. "It doesn't matter how much care was taken," says Daniel Thistle, the lawyer representing Donovan, based in Philadelphia, Pennsylvania. Genetic tests have revealed that she inherited the disorder from her biological father.

The idea of sperm as a commodity subject to product liability laws raises some interesting questions. In this age of personal genomes and genetic testing, how much responsibility does a sperm bank have to screen for genetic disorders with every available test? If a child inherits Fragile X the old-fashioned way, could they sue their parents?

Should genetic disease even be considered 'injury' for the purposes of legal liability? This is quite different from suing a car manufacturer after suffering an injury caused by defective brakes. No defective brakes and you make it to your destination without a crash and a broken leg. No 'defective' sperm and you don't exist at all.

Either way, as more and more genetic tests come into existence and screening becomes more available there will be interesting legal issues to navigate. I should have gone to law school!

State of California vs. Personal Genetic Testing

This is a brief follow-up on Rob's 23andMe post. In the comments there, I wondered aloud about counselling services and possible misinterpretation of results.

It turns out the normally progressive State of California is taking those concerns seriously, and recently sent cease and desist orders to 23andMe and 12 other personal genetics companies.

The basis of the order was two-fold. First, the State requires that all such companies must be certified by both the state and federal governments, with the idea being to safeguard privacy and protect consumers from charlatans who might turn around and sell that data to the highest bidder.

Secondly, California law requires that genetic tests be ordered by the patient's doctor. Here, presumably the motivation is make sure someone (the doctor) is going to help properly interpret the results.

[T]he site still provides some probabilities of getting certain diseases. And while none of these sites are going to offer any life-shattering information (e.g. “You will die before you hit 30″), many health care professionals worry that any amount of genetic information could be misinterpreted. What happens when a patient finds out they have a lower-than-average risk of heart failure that leads them to neglect regular checkups? Then again, it’s my information - shouldn’t I be free to (mis)interpret it as I see fit?

23andMe feels they are acting withing current law, and are continuing business as usual, at the risk of a fine of up to $3000 per day.

Is this a case of an over-protective nanny state, or a legitimate consumer protection issue?

23andme

This is kind of older news but I ran into a video of a presentation by 23andme to a tech audience at Google (I think). If you aren't aware 23andme is a personal genome analyzing company. Basically they analyze the SNPs in your genome and give you all the associations with those SNPs. For instance they will tell you your ancestry and what SNPs that you have are associated with particular diseases. There are some pretty interesting questions and an interesting look at the interface of how a costumer of 23andme's services would 'surf their genome.'
I guess that I could have also just found out all this stuff on the 23andme website.
I was actually impressed with what they do. Integration with Facebook ect. The security of the data that they collect was stressed, which would be important to me if I was a customer. Also I liked the point that personalized genetics and medicine has been moving too slow and they might be the solution to this. They also plan to share anonymous data for drug reactions and efficacies based on SNPs. This would probably be very valuable information assuming they get lots of customers.
This perhaps is the big problem with 23andme. The only SNPs looked at and the only genomic data collected at a statistically significant amount will be from customers who can afford the US$1000 price tag. Somehow I don't think my genetic relationship to African goat herders is going to be properly analyzed.

Insurance and the Age of Personal Genetics

In the age of the personal genome, companies like 23andMe are springing up, offering personal genetic profiling and ancestry tracing. While there are questions about the accuracy of their claims, the interpretation of the results (are we about to see a boom in genetic counsellors?) and other ethical and privacy considerations, the US Senate has made a pro-active move in passing a bill banning genetic discrimination. In short, the bill prohibits employers or insurers to use personal genetic information in decision making. Ars technica takes a closer look at the insurance angle, explaining why the bill is a good idea. From the article:

Worse yet, the very concept [of insurance based on genetics] threatens to undermine another of the greatest potential benefits of the genome: personalized medicine. The goal of personalized medicine is to tailor treatments to a the unique genetic defects that have helped foster a disease, be it diabetes or cancer. But, if insurers can deny coverage based on those same genetic traits, the patient may never see the treatment.