Category: Judicial Opinions

New Developments in the Guatemala STD Experiments Case

Holly Fernandez Lynch Leave a comment

In the late 1940s, US government scientists, in collaboration with Guatemalan counterparts, were involved in a horrible array of experiments on human subjects in which a variety of vulnerable groups in Guatemala were intentionally infected with syphilis, gonorrhea, and chancroid and left without treatment. [For more on how they ended up in Guatemala and the ethics of intentional infection studies, see my work here and here.] The experiments were done without consent and without scientific rigor, violating both contemporaneous and modern ethical standards.  They were not uncovered, however, until a few years ago when a historian discovered the files in the midst of doing archival research on one of the scientists, who had also been involved in the Tuskegee syphilis study in the US.

Since her discovery, the US and Guatemalan governments have both issued apologies and reports condemning the studies (here and here), and the US pledged a relatively small amount of money to support the Guatemalan government’s efforts to improve surveillance and control of H.I.V. and other sexually transmitted diseases in that country. However, individual compensation to the victims of the experiments and their families has not been forthcoming; the victims calls for a voluntary compensation program to be established have gone unheeded, and they have also been unable to prevail in court, for a variety of jurisdictional and technical reasons.

As Glenn Cohen and I argued following the victims’ first court loss in 2012, compensation is a moral imperative.  We expressed support for a voluntary compensation program, but in its absence, alternative mechanisms of justice are essential.  Therefore, we were heartened to hear that a petition for the victims was just filed in the Inter-American Commission on Human Rights in Washington, D.C., by the Office of Human Rights for the Archdiocese of Guatemala, represented by the UC Irvine School of Law International Human Rights Clinic and The City Project of Los Angeles.  The petition claims violations of the rights to life, health, freedom from torture, and crimes against humanity under both the American Declaration of the Rights and Duties of Man, and the American Convention on Human Rights, as well as the denial of a right to a remedy for human rights violations.

There are still a number of hurdles ahead, not the least of which is determining which individuals would actually be entitled to compensation, as the record keeping in the initial experiments was so poor and so much time has passed.  But we are heartened that advocates are still pressing forward for these victims and hope that justice, though certainly delayed, will not continue to be denied.

More information on the petition is available here.

“Crisis Pregnancy Center Fighting for Right to Create More Crisis Pregnancies”

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IUD in hand
Flickr/Creative Commons—+mara

By Gregory M. Lipper

That’s how Tara Murtha describes the lawsuit brought by Real Alternatives and its three (male) employees seeking to enjoin application of the Affordable Care Act’s contraceptive-coverage regulations. This lawsuit is different than the ones currently before the Supreme Court: Real Alternatives is not a religious organization, and its employees argue that the mere availability of contraceptive coverage in their own plans violates their rights under RFRA—even though nobody is making them use that coverage.

The plaintiffs are represented by Alliance Defending Freedom, a Religious Right legal organization that has also represented many of the for-profit corporations and nonprofit religious organizations bringing free-exercise challenges to the coverage regulations and accommodation. Unlike most of ADF’s other clients in these cases, Real Alternatives acknowledges that its opposition to the coverage regulations arises purely from its opposition to the use of birth control; there is no claimed religious basis for this opposition.

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Texas, Self-Induced Abortion, and an Ode to Justice Powell

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Flickr/Creative Commons—Edson Chilundo
Flickr/Creative Commons—Edson Chilundo

By Gregory M. Lipper

With the Supreme Court ready to review the constitutionality of restrictions on abortion providers in Texas, new research from the Texas Policy Evaluation Project suggests that between 100,000–240,000 Texas women ages 18 to 49 have attempted to terminate a pregnancy on their own (that is, without help from a licensed medical professional). According to the authors, “the populations we found to be most familiar with abortion self-induction are among those that have been most directly affected by the closure of abortion clinics in the state.” As a result, the study predicts, “abortion self-induction will increase as clinic-based care becomes more difficult to access.”

This data reinforces that efforts to ban, restrict, or otherwise interfere with efforts to obtain legal abortion don’t stop abortion—they often push women to obtain abortion by other means that are far more dangerous.

Those consequences, as it turns out, are what led one conservative Supreme Court Justice, Lewis Powell, to support abortion rights. Justice Powell was no right-to-privacy diehard; he infamously cast the deciding vote upholding the Georgia sodomy ban in Bowers v. Hardwick. But when it came to reproductive freedom, Justice Powell joined the majority opinion in Roe v. Wade and continued to support abortion rights while sitting on the Court.

According to Justice Powell’s biographer, an incident from earlier in his career reinforced that if women lacked access to legal abortion, the result would be unsafe, off-the-books procedures:

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RFRA Jumps The Shark: The 8th Circuit Strikes Down the Contraception Accommodation (Part 2)

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Lego_SharkJump
Flickr/Creative Commons – Bill Ward

By Gregory M. Lipper

Thomas Jefferson famously said that “[i]t does me no injury for my neighbour to say there are twenty gods, or no god. It neither picks my pocket nor breaks my leg.” Note what Jefferson did not say: “my neighbor is entitled to pick my pocket and break my leg, so long as the government can refill my pocket and pay for a cast on my leg.”

But the latter formulation seemed to influence last week’s Eighth Circuit ruling that the Religious Freedom Restoration Act (RFRA) bars the government from implementing an accommodation for employers with religious objections to including contraception in their health plans. In my previous post, I explained why the Eighth Circuit reduced RFRA’s substantial-burden requirement to a mere formality, potentially subjecting any and every federal law or regulation to strict scrutiny. Once things get to strict scrutiny, the Eighth Circuit goes even further, suggesting that a federal regulation cannot be sustained if the government could, in theory, provide the benefit or service itself.

The Eighth Circuit first applied this approach to the process by which employers obtain the religious exemption. Under the current rules, an objecting organization need only send a written notice to the government and identify its insurance provider or third-party administrator; the government then works with the insurance provider or third-party administrator to arrange for the employees to receive the contraceptive coverage to which they are entitled by law.

The Eighth Circuit, however, reasoned that there is a less-restrictive alternative to requiring this information, since the government could identify the necessary insurance providers and third-party administrators on its own—well, maybe: “Even if the [third-party administrators] are not known, the government has not shown at this stage of the proceedings that the inconvenience of identifying the [third-party administrators] likely would create an administrative problem of sufficient magnitude to make its entire scheme unworkable.” According to the Eighth Circuit, then, no disclosure requirement can be sustained unless the government can prove that it would be unable to discover the information after its own investigation.

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Texas, Abortion, and the Supreme Court – Part II

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[cross-posted at Prawfsblawg]

By Jessie Hill

In this second post on the certiorari petition in Whole Women’s Health v. Cole, I want to consider the likelihood that the Supreme Court will take this case, and if it does, what it is likely to do with it.

I think it’s a very good bet that the Supreme Court will decide to hear this case this Term, perhaps in conjunction with one of the other cases that deals with admitting privileges laws – either Currier v. Jackson Women’s Health Organization, another admitting privileges case, in which the Fifth Circuit actually enjoined an admitting-privileges requirement that would have shut down the last remaining abortion clinic in Mississippi, or Planned Parenthood v. Van Hollen, in which the Seventh Circuit enjoined an admitting-privileges law. However, both of those cases are still at the preliminary-injunction stage, unlike Whole Women’s Health, which was rushed to trial on an expedited schedule. Still, SCOTUS has been holding onto the petition in Jackson Women’s Health Organization since the spring and may well decide to consolidate it with Whole Women’s Health. (No petition has yet been filed in Van Hollen, as that case is back in front of the district court and scheduled for trial.)

There are a lot of reasons for the Court to grant cert in at least one of these cases.

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A Circuit Split on Contraceptives Coverage

Holly Fernandez Lynch Leave a comment

Perhaps foreshadowed by the dissent in the 10th Circuit that I wrote about here, the 8th Circuit has now officially launched a circuit split regarding the legal validity of the accommodation that allows modified compliance/objection to the contraceptives coverage mandate.  Unlike the seven other circuits to have considered the question since Hobby Lobby, the 8th Circuit yesterday issued opinions upholding preliminary injunctions in two cases (here and here), thereby preventing the mandate+accommodation from being enforced against the objecting non-profits.

First, the 8th Circuit determined that the accommodation still substantially burdens objectors’ religious beliefs because it imposes significant financial penalties if they refuse to comply with a requirement that they view as violative of those religious beliefs. As I explained previously, I do think the court was right to focus on the monetary consequences of objection, rather than assuming that merely filing the required paperwork for an accommodation does not or cannot actually make objectors complicit in the way they claim it does.

Like SCOTUS in Hobby Lobby, the 8th Circuit then went on to assume that the contraceptives coverage mandate advances a compelling government interest, which is the next step in the analysis under the Religious Freedom Restoration Act once the substantial burden test is met.  So far, so good.  But that’s the end of my agreement.

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Texas, Abortion, and the Supreme Court

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[cross-posted at Prawfsblawg]

By Jessie Hill

Several Texas abortion providers have filed a petition for certiorari in Whole Women’s Health v. Cole, asking the U.S. Supreme Court to decide on the constitutionality of a Texas state law requiring abortion providers to have admitting privileges at a local hospital and requiring all abortion clinics to qualify as ambulatory surgical centers (ASCs), including requirements that are more demanding than those that apply to other, similar facilities that do not provide abortions. Here is my brief analysis of the legal issues in that case. (Note that this analysis is only of the “undue-burden” issues; there is also a res judicata issue in that case, which I will not analyze.)

The plaintiffs in Whole Women’s Health claim that the admitting-privileges and ASC requirements are unconstitutional because, under the standard identified in Planned Parenthood v. Casey, they impose an undue burden on the right to abortion. There are basically two ways in which these requirements can be seen to impose an undue burden.

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Hell Hath No Fury Like An ACA Opponent Scorned

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IMG_0888
Flickr Creative Commons/Tabitha Kaylee Hawk

By Gregory M. Lipper

Over the weekend, Ted Cruz again lamented the role played by John Roberts in rejecting the plaintiffs’ arguments in King v. Burwell, the recent attempts to undermine the Affordable Care Act in the Supreme Court. After Chief Justice Roberts wrote the Supreme Court’s 6–3 opinion in the case, the emerging narrative in some conservative circles is that Roberts and his (apparently illegitimate) judicial restraint is to blame. Cruz said that “if [Edith] Jones and [Michael] Luttig had been on the court instead of Souter and Roberts, then the marriage laws in every state would still be on the books and Obamacare would not been law.” Apparently, the same Chief Justice who invalidated a key provision of the Voting Rights Act, went out of his way to reach the First Amendment question in Citizens United, and joined aggressive decisions targeting contraceptive coverage and labor unions is actually a passive Obama apologist who should never have been nominated.

That, I suppose, is one lesson to be learned. Another is that the King lawsuit was so obviously frivolous and nakedly political that even arch-conservative and Affordable Care Act skeptic John Roberts felt constrained to reject it.

Let’s review: in King v. Burwell, the plaintiffs argued that four words in the Affordable Care Act should be read in isolation to prevent the federal government from offering subsidies to those who lived in states that refused to create their own healthcare exchanges. They pressed this argument even though such a reading would have rendered the federal exchanges entirely illusory, stripped millions of Americans of health insurance, and produced the very death spiral the Act was supposed to prevent.

Commentators noted that the plaintiffs’ argument was reminiscent of “an old Amelia Bedelia story” and that it depended on the “Moops doctrine.” And those were the nice reviews. Others described the case as “cynically manufactured,” “mean-spirited,” and a “political challenge … dressed up in legal garb.” The plaintiffs’ counsel didn’t help matters by speaking about the companion case in rather political terms.

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Induced Infringement in Patent Law and the Doctor-Patient Relationship

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By Rachel Sachs

Regular readers of this blog will recall that I often think and write about the interaction between the induced infringement doctrine in patent law and medical method patents of various kinds (previous blog posts are here and here).  Until the recent en banc decision in Akamai v. Limelight, courts had been extremely reluctant to attribute the actions of multiple parties to a single actor for purposes of assigning infringement liability.  These cases have largely involved business method or software patents, but I had hypothesized in prior work that this analysis would extend to medical method patents, making them difficult to enforce.

Last week, Judge Tanya Walton Pratt of the U.S. District Court for the Southern District of Indiana provided evidence for the opposite proposition.  Eli Lilly had sued a set of generic drug companies for patent infringement, arguing that they had induced physicians to infringe a set of method-of-treatment claims involving a chemotherapy drug.  The problem for Lilly was that its claims require action by both physicians and patients, who must take certain other medications, including folic acid, before the physician administers the chemotherapy drug.  Judge Pratt was tasked with determining whether the actions of the patient in preparing for their chemotherapy could be attributed to the physician.  She ruled that because the physician “directs or controls the patient’s administration of folic acid,” “the performance of all the claimed steps … can be attributed to a single person, i.e. the physician.”  As a result, the generic companies could be held liable for infringement.

One problem with Judge Pratt’s ruling is that it fails to confront the single Federal Circuit opinion to have considered and rejected this argument.  McKesson Technologies, Inc. v. Epic Systems Corporation dealt with a patent on electronic communication between physicians and their patients.  In that case, the Federal Circuit had occasion to consider how the doctor-patient relationship fits into the induced infringement paradigm.  Judge Linn’s opinion concluded that “[a] doctor-patient relationship does not by itself give rise to an agency relationship or impose on patients a contractual obligation such that the voluntary actions of patients can be said to represent the vicarious actions of their doctors,” declining to attribute the patients’ actions to their physicians for purposes of assigning liability.

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Akamai v. Limelight: Implications for Medical Method Patents (Redux)

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By Rachel Sachs

Yesterday, the Court of Appeals for the Federal Circuit issued a unanimous en banc ruling in Akamai v. Limelight, altering the reach of patent liability for induced infringement of a method claim under 35 U.S.C. § 271(b).  This is the second time the en banc court has considered Akamai.  Three years ago, in a splintered decision, a majority of the court had ruled that liability for induced infringement was possible where no single entity had performed all the steps of a claim, but where those steps were divided between two or more parties, one of whom had induced the other(s) to infringe.  In 2014, the Supreme Court reversed, essentially reinstating this single entity rule, and after a panel opinion largely adopting the Supreme Court’s reasoning, a unanimous en banc court has now broadened – at least somewhat – the scope of divided infringement liability, relative to the Supreme Court’s decision.

More specifically, the Federal Circuit concluded that an entity may be held liable for others’ performance of steps of a method claim “in two sets of circumstances: (1) where that entity directs or controls others’ performance, and (2) where the actors form a joint enterprise.”  Noting the court’s prior holdings that these circumstances are met where there is an agency relationship between the relevant actors or there are explicit contractual duties to perform the steps of the method claims, the en banc court added another such circumstance in which liability may be found: “when an alleged infringer conditions participation in an activity or receipt of a benefit upon performance of a step or steps of a patented method and establishes the manner or timing of that performance.”  Because this third condition was present in the case under consideration, the Federal Circuit deemed Limelight liable for infringement.

Exactly thirteen months ago, after the Supreme Court’s decision but before the Federal Circuit had considered the case on remand, I had blogged here about the case’s potential implications for diagnostic method patents.  (For those interested in this field, I then wrote a longer article about diagnostic technologies more broadly, which features a more detailed explanation of this issue.) Essentially, my argument was that the increasing restrictions the courts have placed on patentable subject matter under 35 U.S.C. § 101 would interact with these new divided infringement rules.

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