Category Archives: Reactions

The Eyes Have It: Tighter FDA Regulation of LASIK Surgery

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Lori Andrews by Lori Andrews

What has Tiger Woods got that you don't have?  Ads for LASIK surgery capitalize on his golf swing, his charisma, his fortune–with the subtle implication that you, too, could be a Tiger if only you underwent surgery for nearsightedness.

Over a million people a year undergo LASIK.  But not everyone who submits to the procedure enjoys Tiger's success.  The surgery, laser-assisted in-situ keratomileusis, can pose risks. Some patients who have undergone LASIK complain of double vision, blurriness, and depression.  Last year, the FDA held hearings on the risks, including a report of suicide by a man who had an unsuccessful procedure.

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Chicago Takes A Stand: City Council Committee Unanimously Votes in Support of the BPA-Free Kids Ordinance

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SarahBlennerBy Sarah Blenner, JD, MPH

Bisphenol A (BPA), the controversial, toxic chemical found in many plastic food containers, is once again making headlines.  BPA is an estrogen-mimicking chemical that is used to make polycarbonate plastics.  Hundreds of studies have linked BPA to a variety of adverse health conditions, such as diabetes, insulin dependency, obesity, breast cancer, prostate cancer, hyperactivity, ADHD, autism, early onset of puberty, cardiovascular disease and liver enzyme abnormalities.

In January, Julie Burger argued that “the time to act is now.”  Leading scientists state that the potential health risks of BPA are too significant and the FDA’s determination that BPA is “safe” is simply the chemical industry’s creation of “manufactured doubt.”  With hundreds of studies linking BPA to adverse health conditions, the FDA relied solely on a limited number of studies funded by the chemical industry that showed “no harm.”

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Big Brother Is Watching–FBI, States Expanding Forensic DNA Databases by Millions

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Tim WelchBy Tim Welch

Last month, the FBI drastically changed its policy on whose DNA will be entered into and stored in the largest forensic DNA database in the world.  Previously, the FBI only collected DNA samples from convicts, i.e., people who have been declared guilty by a judge.  The FBI now plans to join 15 states in collecting DNA samples from people who have only been arrested or detained.  Law enforcement officials claim that including people in forensic DNA databases who have either been released without charges or declared not guilty in court will ultimately put more criminals in jail.  But the federal government's decision raises privacy issues as well.

Forensic DNA databases exist at the local, state, and federal level.  When a person is convicted of a crime, his or her DNA code is entered into a computer system, such as the Combined DNA Index System (CODIS), which allows investigators to compare biological specimens collected at crime scenes to DNA profiles of convicted criminals already stored in the database.  Even if no match is found, investigators can cross-check anonymous samples from different crime scenes to hopefully shed light upon unsolved crimes.  Law enforcement officials claim that their forensic DNA databases have helped convict thousands of criminals and have exonerated hundreds of innocent people who were wrongfully convicted.

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Access to Easy Abortions Skew Sex Ratio in China–Leads to Nearly 33 Million More Males than Females Under Age 20

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JulieBergerBy Julie Burger

A study examining China's 2005 census report estimates that there are 33 million more males than females under the age of 20 in China.  The sex ratio started skewing sharply in the late 1980's with the introduction of low cost and portable ultrasounds which would be followed by abortions if the fetus were female.  Then the couple would try, try again until a penis was finally observed on the machine's screen.  Now, the birth sex ratio stands at 124 boys for every 100 girls.  (Worldwide the ratio is 100 girls to 103-107 males.)  While the Chinese government's policy may be that couples cannot be told the sex of their baby before it is born, until the government comes up with a better way to enforce this policy, it is going to get population control from a method it didn't expect–-fewer women left to have babies and generations of men who cannot find spouses.  In addition, rural areas in China have reported increases in crime and instability–thought to be the result of the growing population of unmarried men.

In Re Kubin: Federal Circuit’s Decision Sounds the Death Knell for Gene Patents

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Joshua SarnoffGUEST BLOGGER Joshua D. Sarnoff

The U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) has decided an important case regarding the application of the obviousness requirement to gene patents.  In re Kubin, No.2008-1184 (Fed. Cir. Apr. 3, 2009).  That case upheld the rejection by the U.S. Patent and Trademark Office (USPTO) of typical claims to gene sequences as unpatentable because they were obvious.

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Teaching Law Through Fiction

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Lori Andrews by Lori Andrews

Last weekend, the Association for the Study of Law, Culture, and the Humanities met in Boston.  Along with panels on constitutional theory, human rights, criminal law, and same sex marriage, there were panels on novels and movies–Billy Budd, Twelve Angry Men, Notes from the Underground, even Harry Potter.

Since I was speaking at the session on "Law and Contemporary Fiction," I prepared by reading the novels written by my co-panelists Alafair Burke (Hofstra University School of Law), Kermit Roosevelt (University of Pennsylvania Law School), and Marianne Wesson (University of Colorado Law School).  They were all law professors by day, mystery writers by night.  But unlike CSI or the usual thriller, their books tried to stay true both to the law and the emotions of being a lawyer.   It struck me that their novels could be used to teach subjects as wide-ranging as First Amendment Law, Criminal Procedure, Corporate Law, and Professional Responsibility.  But their books involved more than just a clever use of a legal construct.  They'd captured the ethical challenges that lawyers face, the insane hours, and the feeling in the pit of one's stomach when a life, a business, or a principle of value is on the line. 

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In These Tough Times, Young Children Provide Health Care for Parents and Grandparents

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Tim WelchBy Tim Welch

As the incidence of chronic conditions such as diabetes increases across the nation (in 2007, there were 1.6 million new cases of diabetes diagnosed in people aged 20 years or older), more Americans are requiring long-term medical care.  Couple that with an economic recession that has millions of workers unemployed, without income or insurance, and unable to pay expensive hospital bills, and you have a serious health care crisis.  A recent article published in The New York Times described how the pressures of this crisis are frequently falling on the shoulders of American children.  As parents and grandparents are increasingly unable to foot the bill for medical care, children aged 8-18 are assuming the caregiver role.

According to the article, children across the country are being asked to perform various tasks often becoming of professional nurses, including, but not limited to, "lifting frail bodies off beds or toilets, managing medication [including injections], washing, feeding, dressing, and talking with doctors." 

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Deciding the Fate of Frozen Embryos

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Lori Andrews by Lori Andrews

What do Nadya Suleman and Barack Obama have in common?  The mother of octuplets and the President whose Executive Order allows funding for embryonic stem cell research have raised questions about the fate of frozen human embryos.

Over half a million human embryos are frozen in in vitro fertilization clinics across the country.  After Glenda and Scott Lyons had a child through in vitro fertilization, they decided to donate their 14 excess embryos to two other couples.  This month's Good Housekeeping contains an in-depth report of the couple’s decision and the unique family tree that resulted, with seven biological siblings being raised in three different families. 

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Minnesota Families Sue Minnesota Department of Health, Allege that Newborn Screening Violates Informed Consent for Genetic Testing

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Tim WelchBy Tim Welch

A group of families is suing the Minnesota Department of Health (MDH) for violating a 2006 genetic privacy statute that includes an informed consent provision for collecting genetic information.  The plaintiffs allege that MDH has taken blood samples from their newborn babies without their consent, tested the blood for various disorders, kept the blood samples in storage instead of destroying them, and shared the samples with various private entities and hospitals.  The plaintiffs allege that Minnesota state law (Minn. Stat. §13.386) prohibits MDH from "collecting, storing, using, and disseminating blood and genetic information."  In collecting and testing these blood samples, MDH is complying with another Minnesota law (Minn. Stat. §144.125) that requires the mandatory testing of newborns (called "newborn screening") for certain genetic diseases.

Minnesota is not the only state to require the genetic testing of newborn babies for hereditary diseases.  In fact, all states require testing for phenylketonuria (PKU) and congenital hypothyroidism.  Testing for PKU is generally considered justified, since a newborn diagnosed with PKU must immediately follow a strict diet, or suffer irreparable brain damage.  The number of diseases tested for ranges across the country from 4 to 32.  States decide which diseases to test for based on several criteria, including benefit to the newborn, validity and reliability of the test results, and safety and effectiveness of treatment.

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Wyeth v. Levine: The Supreme Court Gets It Right

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Bruce PatsnerGUEST BLOGGER Bruce Patsner, M.D., J.D.

On March 4, 2009 the United States Supreme Court decided that pharmaceutical companies can be sued in state courts for damages either from use of a drug or a failure to warn about the drug’s potential side effects, even if the Food and Drug Administration (FDA) has approved both the product and its label.  One could not have asked for a more sympathetic plaintiff:  a concert pianist who lost her arm as the direct result of receiving an intravenous injection of an anti-nausea prescription drug (Phenergan) with known potential to rarely cause vascular necrosis, information which FDA deemed too unimportant to include in the approved product label.

The bitterly contested and much-anticipated decision in Wyeth v. Levine was the most important food and drug law case to be decided by the Court in the last decade.  At issue was the question of whether the federal government’s regulation of the safety and efficacy of drugs under the Food, Drug and Cosmetic Act preempts the field and prohibits finding the manufacturer liable under state laws.  The ruling represents a clear win for injured patients and possibly the final nail in the coffin of the recently-minted doctrine of implied federal preemption of state tort claims, at least in the area of food and drug law.  Coming on the heels of the Court’s 8-1 decision last year in Riegel v. Medtronic, Inc., 128 S.Ct. 999 (2008), which forcefully affirmed the express statutory preemption provision for damages claims against manufacturers of certain types of prescription medical devices, the 6-3 vote in Wyeth v. Levine was a relief of sorts and surprising not only in outcome but also because the vote was not really even close.

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