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En Banc Re-Argument of Haskell v. Harris To Be Live Streamed, Mon., Dec. 9!

At 2:00 pm on Monday, December 9, an en banc panel (11 judges) of the United States Court of Appeals for the Ninth Circuit will argue, again, the constitutionality of California’s law requiring arrestees to provide DNA immediately for CODIS profiling.  The district court judge upheld the law and a 2-1 decision of the appellate panel affirmed.  The court granted rehearing en banc and heard the case argued in early September 2012 – eight weeks before the Supreme Court granted cert in Maryland v. King.

The Ninth Circuit then put the case on holding pending the Supreme Court decision.  When that decision came down, it ordered supplemental briefs about the meaning of Maryland v. King for this case.  It then ordered this re-argument.

Back in June, I put up a long post on the possible ways the court could distinguish California’s law from the Maryland law upheld by the Supreme Court, and followed it with a few shorter ones, here, here, and sort of,  here.  On Monday we’ll all have a chance to see what the en banc panel thinks – at least as far as their questions can show that.

To watch, go here shortly before 2:00 pm on Monday, December 9; click on Haskell v. Harris; and hope it works.  Should be fun!

Hank Greely

To Inform Policy on Consumer Genomic Tests, Go Empirical

By Roland Nadler, 2L, Stanford Law School, Student Fellow, CLB

As many of our readers will know, last week the Food and Drug Administration let the regulatory hammer fall on 23andMe, last of the major direct-to-consumer personal genomics firms (at least, the last one dealing in single-nucleotide polymorphism analysis).  As Hank Greely detailed in this space previously, the company seems to have exhausted the agency’s patience by engaging in an advertising blitz while maintaining a baffling radio silence vis–à–vis its regulator for six months. The move has touched off some truly stimulating debate in the law and biosciences communities; our local NPR, for instance, hosted a lively Forum segment featuring some familiar voices.

There is certainly plenty to debate.  On the more formal legal side of things, commentators have been trading arguments regarding whether FDA can properly exercise jurisdiction over these sorts of direct-to-consumer tests in the first place, an issue which boils down in large part to whether it is correct to say that the product is “intended” for diagnostic use.  But looming perhaps larger is the policy debate: should we be regulating this sort of personal genomic service, and if so, how aggressively?  As the above-linked radio segment makes clear, the ongoing sparring over this question pits “health exceptionalists” — who believe that a certain level of paternalism is quite justified when it comes to health and medicine, where expertise can be a matter of life and death — against more libertarian–leaning individualists, who counter that consumers are perfectly capable of using their genomic information sensibly, that the market will provide adequate resources and guidance to help them do so, and that, anyhow, no government has the right to stand between individuals and (companies offering them) information about their own bodies.

Read the rest of this entry »

My Comments on the HHS Notice of Proposed Rulemaking to Overturn Flynn v. Holder

A few minutes ago, on the last day on which comments would be accepted, I submitted the comments below to the Department of Health and Human Services in connection with its Notice of Proposed Rulemaking to amend its regulations under the National Organ Transplant Act.  That amendment would, in effect, reverse the Ninth Circuit’s decision that hematopoietic stem cells removed from a donor’s blood through apheresis were not “bone marrow” or any other organ covered by the Act, and its criminalization of any compensation for the organ or tissue donor.   I oppose the regulatory change, as should not surprise anyone who read my earlier post after the Ninth Circuit decision, here (along with Professor Alex Capron’s different view, here, and my response to him).

My comments follow.

Read the rest of this entry »

The FDA Drops an Anvil on 23andMe – Now What? (slightly revised Wed. night)

On Friday, November 22, the FDA sent a nastygram to 23andMe, the only remaining substantial pillar of the “direct to consumer” (DTC) genomic testing industry. The letter, available here, is well worth reading in its entirety, but, in brief, it told 23andMe, in no uncertain terms, to stop marketing its “Saliva Collection Kit and Personal Genome Service” (“the PGS”) on the ground that it was an unapproved and uncleared “device” under the Federal Food, Drug, and Cosmetics Act.  It noted that the PGS, because of its lack of approval or clearance, was both adulterated and misbranded under the Act; the distribution of adulterated or misbranded devices is a federal crime.

23andMe’s initial response, click here, through an unnamed press spokesperson on its blog, was, at least on its face, conciliatory.

We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.

What’s going on – and what does it mean in the long run?

Read the rest of this entry »

Big Changes in the Works for Generic Drug Labeling

On Friday, FDA announced a proposed rule* that, if finalized, will represent a significant change for generic drug companies.  Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FDCA) requires that, to be approved, generic drugs have the “same”** approved labeling as the brand-name drug (known as the reference listed drug, or RLD), and it has long been FDA’s position that this “same labeling” requirement applies throughout the life of the drug.  But the proposed rule announced Friday would change that position by allowing generic drug companies to substantively update their drugs’ labeling, without waiting for the RLD’s labeling to be updated first, to reflect newly acquired information about the drug.  This is big news not just because it would change generic drug companies’ obligations under FDA regulations, but also because of what this change may mean for generic drug companies’ tort liability. Read the rest of this entry »

OK S Ct Answers US S Ct's Questions in Cline v. OK Coalition for Reproductive Justice

in a way that I think means the S Ct will dismiss the case as improvidently granted.

Here’s the Oklahoma order, just out today: order.

Basically, the Court (7 justices concurring in the per curiam, two “not voting” – what’s with that?) held that when the Oklahoma statute required that all “abortion-inducing drugs” be used only according to FDA-approved protocols, the proper statutory construction meant that it included all three drugs that same statute had defined as “abortion-inducing drugs”:  RU-486 (mifepristone), misoprostol, and methetrexate.  The problem is that the FDA approved protocol for using mifepristone requires the use of misoprostol as a second drug. But the FDA approved protocol for using misoprostol does not include its use in causing abortions.

Read the rest of this entry »

The Journal of Law and the Biosciences Is Launched!

The Journal of Law and Biosciences is a peer-reviewed, faculty-edited journal published by Oxford University Press. It will publish three issues a year (in March, July, and November), on-line, on all areas of the intersection of law and the biosciences, from patent law and FDA regulation to cognitive enhancement and genetic selection, with many stops between. The Journal is owned by Duke University, Harvard Law School, and Stanford University.  Its founding three co-editors-in-chief are Nita Farahany at Duke, I. Glenn Cohen at Harvard, and me.  We’re looking for a few good papers of up to 10,000 words.  The Journal will also have a student-written “developments” section.  The Journal is now accepting submissions; here’s the link.

Hank Greely

"Electroceutical" Ads Are Here. What Will Regulators Say?

Post by Roland Nadler

Next time you impulsively pull up YouTube to check out the adorable cat video du jour, you might find your fix delayed by a most unusual advertisement:


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BioSci Fi: Childhood’s End, Arthur C. Clarke, 1953

About a year ago, this blog started a series on “bioscience” fiction:  series  intro.  That series has, thus far, comprised one post, on Robert Heinlein’s short story, Jerry Was a Man (here).  There has been no second.  Until now.

One night earlier this month I just couldn’t face the philosophy book I was trying to use as bedtime reading and wandered over to my science fiction bookcase for something lighter.  My eye fell on Childhood’s End.  My Ballantine Book’s paperback copy (which cost me 75 big cents at the time) is from the 15th printing, in 1970.  I probably hadn’t read the book since then, but I’ve remembered it warmly – really interesting plot and one great line.  Forty-some years later – and 60 years after it was first published – it stands up well, although not entirely as I remember it.

Read the rest of this entry »

Video: Brains on Trial: A Panel Discussion Moderated by Alan Alda

For those of you who missed our Brains on Trial event on October 2nd, video of the panel discussion is now available on YouTube.  The panelists were Silvia Bunge, Hank Greely, Robert Sapolsky, and Anthony Wagner, and the discussion was moderated by Alan Alda.  Check out their interesting discussion of various law and neuroscience issues!

CLB Podcast: October 2013

Hey CLB Podcast Listeners: Our new October 2013 podcast is up!  In this edition, we discuss the law enforcement purposes exception to the Genetic Information Nondiscrimination Act (GINA); the risk of liver injury associated with acetaminophen and FDA regulation of the drug, and; concussions and the future of football.  Enjoy!

U.S. v. Harkonen: Should Scientists Worry About Being Prosecuted for How They Interpret Their Research Results?

U.S. v. Harkonen — a case in which Dr. Scott Harkonen, former CEO of InterMune, was convicted of wire fraud based on a press release that discussed clinical trial results for one of InterMune’s drugs – has caused concern that Dr. Harkonen’s conviction means scientists could be subject to prosecution for (mis)interpreting their research results (see here, here, and here).  Dr. Harkonen and others who have voiced these concerns make compelling points—specifically, that scientific debate about the interpretation of research results is commonplace, this debate is critical for medical research, and it must not be chilled.  But are they right to argue that, if the Supreme Court declines to grant Dr. Harkonen’s petition for cert or otherwise allows his conviction to stand, Dr. Harkonen’s conviction puts such scientific debate at risk?  I think the answer is, probably, “no.” Read the rest of this entry »

SCOTUS Bioscience Cert Watch!

OT 2012 in the Supreme Court featured a total of five (maybe, five-and-a-half) bioscience cases: Bowman v. Monsanto (seed patenting); Mutual Pharma v. Bartlett (generic drug tort liability); FTC v. Actavis (pay-to-delay drug settlements); Maryland v. King(DNA collection of arrestees); and AMP v. Myriad Genetics (gene patenting). You can hear CLB’s podcast wrap-up of those decisions here.

But as Autumn comes and the leaves turn and Fall–well, in places other than evergreen Stanford, California–the Supreme Court is busy working on a new list of cases to hear for OT 2013. (At least until Friday, when it runs out of money.) And so–even though it’s ridiculously early to start counting these things–we thought it would be a good feature for CLB to update you on any bioscience cases the Court is slated to hear this term. All (maybe) three of them:

On. Oct. 16, the Court will hear Kansas v. Cheever, a criminal case slated to address whether a defense that focused on the neurological effects of the defendant’s habitual methamphetamine use counted as a “mental disease or defect” that allowed the trial court to order a psychiatric evaluation, otherwise in contravention of the Fifth Amendment’s protection against self incrimination. In other words–does, as a legal matter, smokin’ dat ice make you insane in the membrane?

On Nov. 12, the Court will hear a criminal case, Burrage v. United States, on whether one can be convicted for “distributing heroin causing death,” under 21 U.S.C. § 841,  if the cause of death was listed as “mixed drug intoxication.” This may seem like a run-of-the-mill criminal procedure issue on just how “proximate,” i.e., reasonably foreseeable, proximate cause needs to be. But, as noted by the government, the coroner’s report in the underlying criminal trial focused on the particular pharmacologic breakdown of heroin in the victim’s bloodstream. See Gov’t Br. at 4. If the coroner was wrong–or if the coroner’s opinion was uncertain–that may favor the petitioner-defendant. Frankly, it’s unclear how much this will play into the Court’s decision, but it’s something to watch out for.

Date uncertain: Cline v. Oklahoma Coalition for Reproductive Justice, on whether a state statute can condition the use of an abortifacient on-label, even if typical medical practice is to use it off-label, is still winding its way through the Oklahoma Supreme Court. Hank’s post about that case can be found here–with a correction here.

That’s it so far! We’ll keep you posted. You know, if the Supreme Court can get paid and get back to work any time soon.

Jacob S. Sherkow

Supreme Court Bioscience Wrap-Up Podcast

Hey CLB Podcast listeners: we’ve yet another podcast up for August 2013. Here, Hank and I wrap-up the five bioscience cases from the past Supreme Court term: Bowman v. Monsanto (seed patenting); Mutual Pharma v. Bartlett (generic drug tort liability); FTC v. Actavis (pay-to-delay drug settlements); Maryland v. King (DNA collection of arrestees); and AMP v. Myriad Genetics.


Jake Sherkow

Breaking News – FDA Issues Final Guidance on Mobile Medical Applications

Today FDA issued a final guidance document describing its policy on regulating mobile medical applications, an issue in which there has been a great deal of interest from Congress, industry, and the public (see, e.g., here and here). Read the rest of this entry »

CLB Podcast! August 2013

Hey CLB Podcast listeners: we’ve got our new podcast up for August 2013. In this edition, we welcome our new fellow, Patti Zettler, discuss whether blood is “property” for purposes of the federal rules, rehash Haskell v. Harris, talk about getting high–legally–in New Zealand, and knock-down the research egg-donation ban in California. Enjoy!

The California Aftermaths of Maryland v. King, Revisited

In June, after the U.S. Supreme Court decision in Maryland v. King on the constitutionality of mandatory collection of DNA from arrestees, I posted a long entry on how that case might, in ways more complicated that immediately obvious, play out in ongoing litigation about California’s statute.  Sequels.  Then I made a small post when the Ninth Circuit ordered supplemental briefing of its en banc case on this topic, Haskell v. HarrisAftermath Begins.  And one more on a particularly odd California trial court case affected by the decision.  Farce

Today, two weeks after receiving the last of the supplemental briefs,  the Ninth Circuit ordered a re-argument of the Haskell case before the en banc court on December 9.  Reargument.

This should be interesting!

By the way, on July 10, 2013, the California Supreme Court sent the state court case, People v. Buza, back to the intermediate appellate court for reconsideration in light of Maryland v. King:  “The above-entitled matter is transferred to the Court of Appeal, First Appellate District, Division Two, with directions to vacate its decision and to reconsider the cause in light of Maryland v. King (2013) __ U.S. __ [133 S.Ct. 1958, 186 L.Ed.2d 1]”

Hank Greely

Breaking News – CAFC Reverses Dt Ct Decision Not To Issue a Preliminary Injunction to Sequenom in an NIPT Patent Case

Friday afternoon, August 9, 2013, the Court of Appeals for the Federal Circuit, the appellate court for all patent cases, reversed an important patent decision by Judge Susan Y. Illston of the Northern District of California.  The four companies that offer non-invasive prenatal genetic diagnosis in the United States (Sequenom, Ariosa, Verinata, and Natera) are all suing each other in that district court for patent infringement.  Judge Illston had denied Sequnom’s motion for a preliminary injunction, which would have prevented Ariosa from offering its service in the U.S. at least until the case was finally resolved at trial or by settlement.  She did so for a variety of reasons, including some that boded extremely poorly for Sequenom’s chances of succeeding on the merits.

The CAFC has now reversed, in a unanimous opinion written by Judge Rader and joined by Judges Dyk and Reyna.  (You can download that opinion here.)   They vacated the lower court’s decision and remanded it for Judge Illston to “try again.”  They did NOT order that issue a preliminary injunction, let alone issue one themselves.  They did “correct her” about almost every reason she gave for denying the preliminary injunction.  Although there are still a few arguments open to Ariosa (and Judge Illston), the chances that Sequenom will be granted a preliminary injunction just got a lot greater.

The court first disagreed with the way Judge Illston had construed Sequenom’s patent claims. This is important because the way she construed them, Sequenom’s chances of success on the merits were small.  They aren’t now.  The court said “Even under the ostensibly more relaxed standard, the district court erred in its claim construction. As a consequence, the district court erred in finding a substantial question of noninfringement.”

The claim had talked about paternally inherited DNA, when the actual method looks at DNA inherited from both parents.  The lower court said the claim was limited to things that only found DNA known in advance to be paternally inherited – i.e., to a method that would only “read” the paternal DNA. The CAFC disagreed.

“Properly understood, this sentence describes the method of isolating and identifying any paternal characteristics by comparison to maternal characteristics, hardly a limitation to only paternal characteristics known in advance.”

The lower court read the claim’s discussion of “amplifying” as referring to amplifying only paternally inherited DNA.  The CAFC again said the lower court was just plain wrong.

Although Judge Illston concluded that Sequenom did not have a high likelihood of prevailing on the merits, she went ahead to analyze the other factors involved in granting a preliminary injunction as if it did have such a high likelihood.  She concluded, on several points, that the equities even then would favor NOT granting the injunction.  The CAFC disagreed on every, or just about every, point.

Although I am not and do not claim to be a patent lawyer, and I suspect I am missing something, As far as I can tell, the CAFC left only one obvious and substantial issue on which Sequenom could lose:  the question of patent-eligible subject matter under Section 101. This is the issue the Supreme Court has recently ruled on, in the Myriad case most recently as to “products of nature” and in the Mayo v. Prometheus case a few years ago as to “laws of nature.”

“The district court also found there was a substantial question over whether the subject matter of the asserted claims was to eligible subject matter. J.A. 16-19. Since the district court’s decision, the Supreme Court decided Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013) (Myriad), which held that product claims directed to isolated DNA segments were not eligible subject matter, but that product claims directed to synthetic cDNA were patent eligible. See id. at 2119-20. Because the district court did not have the benefit of Myriad and also in light of this court’s disagreement with the district court’s claim construction, this court remands for the district court to examine subject matter eligibility in the first instance.”

‘To be clear, this court offers no opinion as to whether there is or is not a substantial question regarding the subject matter eligibility of the asserted claims.”

Do Sequenom’s claims involve products or laws of nature?  Beats me, in part because I haven’t read the claims themselves and in part because I have very little idea of what the Supreme Court means by either phrase.

So, what does this mean?

Well, for starters, I think they are dancing in the streets in San Diego at Sequenom’s headquarters. Good news for them.  But what about for everyone else?

It’s clearly not good news for Ariosa, Natera, and Verinata, though just how bad it is won’t be clear  The companies all use somewhat different technologies and all have their own patents, which they say Sequenom is infringing.  It is way too early to know whether even if an injunction issues against Ariosa (which it may not), the same thing would happen to Natera or Verinata. And, of course, there are other firms providing the service in other countries who might enter the US market – I have no idea what their patent situation is.  Plus there are companies trying to enter  the field that use entirely different methods – CellScape, for example, is not trying to read cell free fetal DNA but to isolate whole, intact fetal cells.

As I said earlier, I am not a patent lawyer.  Apart from the (admittedly important) issue of the patent infringement, as a matter of policy I would prefer a situation without an effective patent monopoly.  If Sequenom, or anyone else, has a patent-enforced monopoly on providing NIPT in the US, the technology will be more expensive, will expand more slowly, will improve more slowly, and will help fewer women than if there is effective competition.  So I’m rooting against Sequenom on this one, as a matter of policy, though I don’t know enough to have a good opinion on the proper outcome as a matter of law.

For the last time in this post, I’ll repeat that I am not a patent lawyer.  I hope some of my readers are.  What do you think about this decision?

Hank Greely

An Update to a 2011 Post About Doctors Using Copyright to Stifle Web Criticism

In July 2011, I posted an item about a clever scheme to stifle criticism of health professionals.  Through the help of a firm called “Medical Justice,” doctors and others could get a form for patients to sign, effectively giving the professional the copyright in anything the patient published about the provider.  The provider, if unhappy with, say, a Yelp review, could then demand of Yelp that the review be pulled, as a copyright infringement. Here’s that post: “If an Outrage Is Clever Enough, Is It Still an Outrage? Or, Kudos to Boalt Hall and Santa Clara Law School.

My SLS colleague Paul Goldstein just pointed out to me the playing out of at least one use of this copyright assignment strategy – the patient fought back and the provider (in this case a dentist) has disappeared!  Here’s a story on it from Ars Technica; a summary follows.

In 2010, a man named Robert Lee went to Dr. Stacey Makhnevich, the “Classical Singer Dentist of New York”.  He signed a form she offered him, entitled “Mutual Agreement to Maintain Privacy”, which she had received from Medical Justice.  He ended up very unhappy with the services he received and posted a scathing review on Yelp.  Makhnevich’s staff then filed “take down” notices under the Digital Millenium Copyright Act.  Yelp took the review down.  The dentist’s staff then sent invoices to Lee, claiming copyright damages of $100 a day.

He got in touch with Public Citizen and, with the help of Paul Levy there, in November 2011 he sued both Medical Justice and Dr. Makhnevich.  Medical Justice folded one day after the suit was filed, saying they were “withdrawing” that form.  Now the dentist has disappeared.  Her lawyers went to court to seek permission to drop their representation of her, as she hadn’t been in contact with them for three months and they can’t find her.  A default judgment may loom.

So, apparently, an outrage can be too clever by half and still be an outrage.  And keep an eye open for “the classical singer dentist”of wherever.

A Few Revisions to my Post on Cline v. Oklahoma Coalition for Reproductive Justice

My thanks to a commenter who pointed out a few things about my July 4 post on Cline, found here, that deserve correction or further comment.

First, the Supreme Court apparently does not need to grant cert to certify questions to state courts.  There’s not exactly a lot of clear, written rules on this stuff, but apparently they have certified questions before without granting cert.  Furthermore, the language “Further proceedings in this case are reserved pending receipt of a response” are not unusual in orders where the Supreme Court certifies questions – possibly ubiquitous but at least common.

These points are important  because it makes it at least somewhat more likely the Court (or four of its members) really will decide the Oklahoma case.  After receiving the answers from the Oklahoma Supreme Court, the Court could dismiss as improvidently granted, affirm summarily, reverse summarily, or set the case for full briefing and hearing.  The information about the Court’s practice in certification cases makes me lower, somewhat, my guess about the odds of a DIG.

My commenter took issue with my statement that the Oklahoma court will, in light of the statutory language, inevitably say the act banned even the on-label use of mifepristol because it bans the use off-label use of mifepristone, which is necessary to the on-label use of mifepristol, as well as my statement that the Supreme Court posing the questions “recognized” that the statute was poorly drafted.

After looking again at the State’s reply to the plaintiffs’ response to the petition for certiorari (available through SCOTUS blog), i still would be quite surprised if the Oklahoma Supreme Court doesn’t take the statute at its word and say that its workings effectively ban on-label use of mifepristol.  The state makes a very good effort with arguments from the canons of statutory construction to say that such a silly reading of the statute should be avoided.  I think those pretty good arguments won’t work, though, against a statute whose express language – banning all uses of any abortifacients off-label and expressly calling mifepristone an abortifacient – compels such a result.  Besides, the rest of the statute could still be meaningful if the FDA changed the labeling indications for either drug.

So, “inevitable” was too strong – I (and all of you) should know that nothing is inevitable in judicial construction of statutes, cases, constitutions, etc.  But I still think the Oklahoma Supreme Court is highly likely to construe the statute to ban entirely an FDA approved drug.  That, it seems to me, means the statute will fall as an undue burden, and probably on DIG.  It is conceivable that the U.S. Supreme Court might vacate and remand to the Oklahoma Supreme Court on the ground that its very cursory opinion did not perform the analysis required by Casey,  On the other hand, the trial court was more thorough.

So I’d still bet on the Oklahoma Supreme Court decision not being reversed and probably being DIG’d, but I won’t give quite as high odds.

One last point on timing.  The Oklahoma court has set a briefing schedule that points to an October hearing on the certified questions.  The Oklahoma court probably needs to answer the Supreme Court’s questions no later than early January for this case to be briefed and argued in OT 2013.  It could, of course, DIG it or affirm or reverse summarily in OT 2013 as long as it gets the answers by June.