Today, the Supreme Court heard oral argument in Bowman v. Monsanto, No. 11-796 (2013). The transcript is here. I’ll briefly re-cap the facts: Monsanto’s makes genetically modified soybeans that are resistant to its pesticide, Roundup. It sold those soybean-seeds to Vernon Hugh Bowman, an Indiana farmer–but with a catch. Bowman could plant his crop, save the resulting seeds from the mature plants, and sell those to a grain elevator (a place where seeds are collected for animal feed), but he couldn’t replant them. To do that, he’d need to go back to Monsanto and buy another bag of seed. And Bowman signed a license with Monsanto to that effect. But Bowman had an idea. He, and other farmers, were selling their Monsanto seed to grain elevators. If he planted those seeds and sprayed them with Roundup, he’d have a Monsanto crop on the cheap. He did just that, and Monsanto, believe it or not, sued him. His principal argument in his case was that Monsanto was prevented from suing him under something known as the doctrine of patent exhaustion–the “once I sell it you, you can do whatever you want with it” rule. Neither the trial court nor the Federal Circuit bought it, and so, at 11:27 a.m. this morning, his lawyer found himself at One First St., N.E., staring down nine lawyers clad in black robes. The recap is below, followed by an analysis below the asterisks.
On Not De-Extincting Homo neanderthalensis
Making “to de-extinct” into a verb is probably a bad idea. Trying to de-extinct Neanderthals is probably a worse one.
The idea of bringing species back from extinction has been getting increasing attention recently and will get even more attention soon. I generally support the idea, though with some reservations. One of them is that this shouldn’t be tried with extinct hominids any time soon (if ever).
The Neanderthal possibility kicked off a worldwide teapot tempest in January 2013 when Der Spiegel, a major German magazine, published an interview with George Church, a prominent (and wildly creative) Harvard bioengineer. In a question, the interviewer noted that, in his recent book, Church says “an extremely adventurous human female” could serve as a surrogate mother for a Neanderthal. George has since said that his discussion of the topic was a thought experiment that escaped containment, which, on reading the whole Spiegel interview (here) seems mainly right (qualified by the fact that Church, whom I know, is not always averse to stirring up controversy). I suspect the controversy was largely the result of the British tabloid press, notably a headline (between quotation marks!) in a story in the Telegraph about the Spiegel interview that read “I can create Neanderthal baby, I just need willing woman.” There’s no evidence Church ever said that.
But the controversy does raise the question – if this were possible, should it be tried. I think clearly not – at least for now and a long, long time to come. My reasons are both medical and social. Read the rest of this entry »
Making Available All Clinical Trial Data: A First by GSK
In an announcement last week, which has been described as “a genuine historic milestone”, by Ben Goldacre, author of ‘Bad Pharma’, the British pharmaceutical major GlaxoSmithKline has committed itself to publishing the results of all clinical trials, without holding back any of the results no matter how adverse the results may be to the success of the drug.
In an op-ed in the NYT, a few days before GSK’s announcement, Goldacre, had slammed the pharmaceutical industry for allegedly cherry picking only the best data from the clinical trials for the purposes of publishing, while holding back on information about possible adverse events.. Gouldacre describes how pharmaceutical companies have allegedly been violating the reporting requirements of the Food and Drug Administration Amendments Act of 2007 by not disclosing all data from clinical trials. The lack of access to all such data from all clinical trials, especially trials that demonstrate adverse effects of a drug, seriously impedes, the ability of the medical community to treat patients safely with them. It is hoped that with greater access to clinical trial data the medical community will be better empowered to make the best decision for patients.
So, what made GSK commit itself to this path-breaking move of disclosing all clinical data?
The answer probably lies in the massive $3 billion dollar fine that GSK had to pay to U.S. regulators to settle criminal and civil liability for falsely promoting drugs for off-label uses, bribing doctors etc. By agreeing to publish all clinical data, GSK may not only reduce its liability arising from any future lawsuits alleging suppression of critical clinical trial data, but the company will also gain precious moral ground over its competitors. For a company which has suffered adverse publicity, a move like this may just help restore some of the lost sheen. As per the report in the Guardian, GSK has committed to publishing “CSRs for clinical outcomes trials for all approved medicines dating back to the formation of the company in 2000.” Given that GSK is releasing clinical trial data from more than a decade ago, there is the possibility that the company may be opening itself up to further claims – unless of course it is confident of its track record on safety.
It remains to be seen whether these commitments translate into firm action on the ground but assuming that things go according to plan, GSK’s action will be a vindication of the efforts by drug regulators and the medical community to force pharmaceutical companies to disclose more information.
Prashant Reddy Thikkavarapu, CLB Student Fellow, Stanford Law School LLM candidate
Outbreaks and Duties
Last month, in Seebold v. Prison Health Services, Inc., the Supreme Court of Pennsylvania ruled that prison doctors were not negligent in failing to warn corrections officers about an outbreak of the “superbug“ methicillin-resistant staphylococcus aureus (MRSA) among twelve inmates. (One of the corrections officers apparently contracted MRSA.) On its face, the ruling seems absurd. Prison doctors are clearly those most knowledgeable about inmates’ medical conditions; shouldn’t they be required to warn prison officials about the dangers of coming into contact with infected inmates? But–and as Seebold makes clear–unpacking that question simply raises a host of numerous and particularly difficult problems. What is a physician’s duty during an outbreak? And to whom? And when? And does it matter if the outbreak occurred in a prison? Seebold provides at least some of the answers. Read the rest of this entry »
CLB Workshop Mini-Podcasts
Podcast No. 6
It’s official–podcast no. 6 is out. You can check it out here:
In it, we discuss:
1. Genetic Testing, Race & Family Law
2. The Myth of Anonymity in Genetic Donation; and
3. Bringing Back(?) the Neanderthal
Enjoy! And thanks, as always, to our producer, sound engineer, comic foil, David LM Preston.
The Drug Labeling Experts–They’re Not Who You Think
Currently, Novartis is defending several fairly large and complex products liability cases involving two of its cancer-related drugs, Aredia and Zometa. The core of the allegations centers on those drugs’ putative connections with osteonecrosis of the jaw (ONJ)–a condition as painful as it sounds. One theory of liability hinges on whether the drugs’ labels properly warned patients of the risk of ONJ. In theory, had the labels properly described the risk of ONJ, physicians prescribing those drugs would have warned their patients of that risk, and Novartis wouldn’t be liable.
Complex trials often come down to expert witnesses, the scientist, for example, who can testify that the contamination in the water caused the plaintiffs’ cancer. And Novartis’s case will likely be no different. Both sides will almost certainly provide testimony about whether the drugs actually caused, or heightened the risk for, ONJ, what ONJ is, and what physicians would have done had they known about the drugs’ alleged risks. But a relatively dry, pretrial order in one of these cases raises the interesting question: Who’s a drug-labeling expert? And it seems it’s not who you’d think. Read the rest of this entry »
Podcast Bonanza
As some of you may know, we podcast a lot over here at CLB, about once a month. With that said, we have not one but four special installments of podcasts for you, all graciously hosted by Stanford Talks. The first is our December podcast, where we discuss the In re Frito-Lay All Natural Litigation case, developments in genetic testing, and U.S. v. Caronia. You can listen straight from the blog here:
Our second is a special, blockbuster Supreme Court special. There we discuss five major law and biosciences cases currently pending before the Court: Bowman v. Monsanto, Mutual Pharmaceutical v. Bartlett, FTC v. Watson, Maryland v. King, and Association for Molecular Pathology v. Myriad Genetics.
In addition, as part of our Law and Biosciences workshop, Hank has been hosting mini-podcasts with our speakers about their papers. This month, we have Peter Lee at UC Davis School of Law and Robert Merges, currently visiting Stanford Law School, but the Wilson Sonsini Goodrich & Rosati Professor of Law and Faculty Director, Berkeley Center for Law & Technology at the UC Berkeley School of Law.
Mini-Podcast with Peter Lee
Mini-Podcast with Peter Lee
Mini-Podcast with Robert Merges
Mini-Podcast with Robert Merges
Here at CLB, we simply couldn’t produce our podcasts without the assistance of David L.M. Preston, our sound engineer, music director, and friend. Thanks, David!