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Decision Anticipated

Justices

Justices

The Supreme Court of the US is expected to release its decision on the case of Obergefell v. Hodges very soon. This case, as summarized on the SCOTUSBlog, asks:

1) Does the Fourteenth Amendment require a state to license a marriage between two people of the same sex? 2) Does the Fourteenth Amendment require a state to recognize a marriage between two people of the same sex when their marriage was lawfully licensed and performed out-of-state?

It does so in order to decide, specifically, if James Obergefell, who married his partner of 20 years, John Arthur, can be listed as a spouse on Mr. Arthur’s death certificate (Arthur died of ALS). The two were married in Maryland, but were residents of Ohio, where same sex marriage is not recognized.

For a description of the case in plain English, visit the SCOTUS Blog.

The decision is expected late this month.

 
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Posted by on June 23, 2015 in Uncategorized

 

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Science on Trial – Science in the Media

Amongst the many interesting topics that Paul Offit’s Autism’s False Prophets brings up are how science is perceived in the media, received by the public, and judged in the courtroom.

For reference, Offit brings up the fiasco of the 1990s lawsuits against the makers of silicone implants.

Kristin E. Schleiter writes an excellent paper about the history of silicone implants and the litigation that followed them in Silicone Breast Implant Litigation in the AMA Journal of Ethics.

Breast implants, she says, were first introduced in the 1960s. In 1976, the FDA was granted the power to regulate them as medical devices, but did not specifically do so until 1988. Prior to that, in 1984, Maria Stern won [the first case against an implant manufacturer totaling] “$211,000 in compensatory damages and $1.5 million in punitive damages from silicone breast implant manufacturer Dow Corning after claiming that her breast implants caused autoimmune disease.” This was the first, but not last case to bring implants to court. In the 1990s public opinion was against the makers of breast implants and thousands of suits were filed against their makers.

A natural progression

A natural progression

-Schleiter’s paper goes through a list of important individual and class action cases that I don’t feel the need to repeat here, however it is a fascinating read.

In the midst of these lawsuits, the attorney, “John O’Connor, relied on PR and sympathy to win [his case representing client, Pamela Johnson]. O’Connor hired a public relations firm that gave interviews to Phil Donahue and 60 Minutes, and the trial was broadcast in its entirety on Court TV. At trial, O’Connor set up a rebuttable presumption, asking the jury to hold MEC liable unless the company could prove that they knew their implants were safe at the time they marketed them. “

That is, it doesn’t matter whether the implants caused damage, but instead, whether the company, MEC, could prove them to be safe.

In the wake of litigation, studies began appearing showing the lack of any connection between breast implants and negative health outcomes.

Schleiter provides a list of papers reviewing the safety or danger linked to implants consolidated here:

  •  Plastic and Reconstructive Surgery published a study that found no increase in the incidence of breast cancer in women who had received breast implants
  • The New England Journal of Medicine soon followed with a study that concluded that breast implants did not substantially increase a woman’s risk for breast cancer
  • In 1994- New England Journal of Medicine published a study by Mayo Clinic epidemiologists that found no increased risk of connective tissue disease in women with silicone gel breast implants
  • In 1995, the Journal followed with yet another study—this one larger and more refined—that found no association between implants and connective tissue disorders.
  • In 1997, the American Academy of Neurology reviewed existing silicone gel breast implant studies and concluded that there was no link between the implants and neurological disorders
  • Also in 1997 Journal of the National Cancer Institute published a review of studies and concluded that breast implants did not cause breast cancer

However, billions of dollars had already been awarded or settled upon and Dow Corning was forced into Bankruptcy.

With respect to Offit’s book, the question arises, “How should science be settled in court?” It’s tempting to say that the cases should prompt investigations that statistically determine the culpability of, in this case, breast implant manufacturers. But that leads directly to one of the core problems that raised the specter of a MMR / Autism connection. Andrew Wakefield’s paper was intended to do just that – provide scientific evidence to help determine a case. In that case, the British government provided $30M to a law firm in order to fund their investigation. But that’s not proper either. To begin with an outcome in mind, i.e. “MMR shots cause autism” and then try to uncover evidence to support that idea is putting the cart in front of the horse. It’s OK to ask, “Does MMR vaccination cause autism?” and then look for the answer, but starting with the answer in mind – No.

For those in my Pathophysiology class, consider, as you read these next chapters, how these questions should be answered. If you were in the position to outline how cases involving questions of science / healthcare should be handled in court, how would you do it? Are these questions any different from the other questions that courts have to address?

 
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Posted by on February 15, 2015 in Uncategorized

 

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Congratulations Sarah Koenig

logoOn January 13, 1999, a girl named Hae Min Lee, a senior at Woodlawn High School in Baltimore County, Maryland, disappeared.

So begins the serial podcast – a spinoff from This American Life featuring Sarah Koenig researching, editing and performing long form journalism which she and her staff have spent a year investigating.

Adnan Syed has been serving a life sentence for the murder of his former girlfriend, Hae.

The podcast succeeds in several ways: It is the gripping product of intense investigation and reflection; It questions what it is to be accused and sentenced (without ever fully committing to whether this is sentence is correct or not); and it illustrates how the prosecution of minor offences by the police and fundamental religious values within a family can lead to unpredictable and undesirable ends.

First, the purpose of serial is to present one single story from beginning to end over the course of a full ‘season’. In doing this, much more time is spent on a single question than almost any other form of journalism. Each week focuses on a different element of the story from the history of the case, interviews with the witnesses who were called (and some not called) in the case, an exhaustive exploration of cellphone records, and even one episode devoted entirely to the inconsistencies of the case.

Second, it asks what is it to be accused and convicted of a crime that you did not commit (giving Mr. Syed the benefit of the doubt in this question)? What does it do to a life? How much or how little evidence is needed to convict? What factors (other than the facts of a case) may play into a jury’s decision?

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A note from the victim, written just before the crime.

Mr. Syed speaks about how it hurts to have lost the trust of his friends and community. He explains how he has never known independence in his life after leaving school to go directly to jail. He discusses his experience in jail – how it was or was not as he expected, what he does all day, and how he maintains relationships with those on the outside.

Thirdly, it is plain (to me) that much of the trouble that the different players of this story get into is due to their initial unwillingness to expose relatively minor illicit dealings to the police or to keep parents in the dark with respect to relationships outside of their own cultural group (Mr. Syed is of Pakistani Muslim descent and his family has prohibited him from dating girls outside of this religious community.

And, lastly, on a more personal level, this story brings memories of a case in which I sat on the jury for earlier this year. Was our judgment correct? Were we biased against the defendant? Did we have sufficient information to make the decision we made? It was painful to weigh the lack of ‘hard’ evidence against an abundance of ‘circumstantial’ evidence. Yet we were instructed by the court to consider both types of evidence as equivalent (an instruction that literally wound up settling our decision more than any other single fact).

How would I feel if I was the one on trial? Wouldn’t I be irate if I learned that I had been convicted on the basis of such a simple instruction? Is justice really blind? Was this instruction about evidence reasonable?

All during the trial, it was plain to the jury that it was the incompetence of the defendant’s lawyer that really made the case for the prosecution. Would he have been convicted if he had a better lawyer?

I’ve been mulling over all of these questions – bouncing from the case of Adnan Syed, to the one I served on. For all this, I think Serial has been incredibly successful.

 
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Posted by on December 19, 2014 in Uncategorized

 

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Unaltered genes are a product of nature and not patentable

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See this Jim? It’s not patentable.

The Supreme Court of the United States released its ruling on the ‘Association for Medical Pathology v. Myriad Genetics, Inc.’ case today. Briefly, they ruled that Myriad’s patent is invalid as they merely discovered a natural entity. Because they did not alter the material in any way vital to their industry or possess a methods claim associated with this material, their patent fails because  “laws of nature [or] natural phenomena …lie beyond the domain of patent protection” according to precedent set under United States Code. 

Wait – you mean the USC clearly states that they couldn’t patent this stuff?  Well, no.

USC Title 35 Part II Chapter 10 Section 101

“Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor…”

The applicable precedent case is Mayo v. Prometheus___566 U.S. In that case, Prometheus had a patented clinical diagnostic kit that Mayo Collaborative Services (a nonprofit affiliated with the Mayo Clinic) used for some time until they developed their own version of the kit. (A pretty close precedent). In this case, the court ruled that, “Because methods for making such determinations were well known in the art, this step simply tells doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists in the field. Such activity is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law.”

My Interpretation

From these rulings it appears that in order to become a patentable entity a gene must be novelly transformed in some manner that makes it functionally distinct from the naturally occurring entity, or that the method for interrogating the gene involves some novel method beyond what is previously known art. 

 
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Posted by on June 13, 2013 in Uncategorized

 

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