Health

This Time It’s Personal(ized): Pharmaceutical Companies, Dosing Regimen Patents, and Personalized Medicine

March 20, 2017
Health, Healthcare, Patents

Peter Selness, MJLST Staffer

An area of developing healthcare garnering attention in both the medical community and areas of intellectual property law is that of personalized medicine.   Personalized medicine changes the old one-size-fit-all approach of medication dosing to instead tailor medications to each individual patient based upon their genetic make-up.  This practice promises numerous benefits for patient healthcare, but also has some substantial road blocks to overcome before becoming a reality.  Among the issues facing this field of medicine is the controversy surrounding the patentability of personalized medicine methods.  Several recent cases such as Mayo Collaborative Services v. Prometheus Laboratories and Association for Molecular Pathology v. Myriad Genetics, Inc. have raised serious concerns over whether or not personalized medicine methods are based on patentable subject matter.

This concern was taken one step further in the recent article Decline of Dosage Regimen Patents in Light of Emerging Next-Generation DNA Sequencing Technology and Possible Strategic Responses, which discussed the potential impact this may have on the pharmaceutical industry.  Among the concerns addressed was the impact of not being able to obtain patents on dosing regimens for drugs developed by pharmaceutical companies.  While a pharmaceutical company should have no problem patenting a novel medication it has developed, adding additional patent protection to its patent portfolio surrounding that product, such as patents on dosing regimens, has long been a practice utilized to keep competitors at bay.  Considering the massive investment in research and development required to bring a new drug to market (sometimes billions of dollars), pharmaceutical companies are rightly alarmed by any potential loss of patent protection they may experience on their product.  As the article mentioned, this issue will also surely be compounded by the transition to personalized medicine and integrated healthcare, but it may also be a self-solving problem.

Though the article is concerned with the impact personalized medicine may have on pharmaceutical companies if they no longer can obtain patent protection on dosing regimens, researchers developing personalized medicine methods currently face the same issues.  In order for personalized medicine to have an impact on pharmaceutical companies, it must be a fully developed method that has been integrated into everyday healthcare practices.  For that to happen, researchers must have a fundamental understanding of what specific genes give rise to differences in patients’ responses to medication.  This has proven to be a long and expensive process requiring the systematic sequencing of millions of genes from numerous subpopulations of patients; and all of this work is expensive.  Given that the end result of personalized medicine research is a method of administering medication based on an individual’s genetic make-up, patents on personalized medicine fall victim to the same issue facing pharmaceutical companies’ dosing regimen patents.

Lacking the ability to obtain patent protection on personalized medicine methods, the economic feasibility of research in this area becomes more questionable.  To circumvent this dilemma, those within the field of personalized medicine will most certainly be looking for the same solutions as pharmaceutical companies.  Therefore, one of two results will likely occur, both of which may solve the issues of dosing regimen patentability facing the pharmaceutical companies.  One possibility is that the field of personalized medicine will be unable to economically sustain future research without patent protection and fully integrated healthcare will never become a reality; making this issue disappear for pharmaceutical companies.  The other, more likely, possibility is that in order for research in the field of personalized medicine to continue, those researchers will solve the very dilemma that pharmaceutical companies fear will be brought about by the emergence of integrated healthcare.  Either way, pharmaceutical companies’ dosing regimen patents are so closely tied to the fate of personalized medicine patents that the emergence of integrated healthcare most likely cannot occur in a manner that will be detrimental to pharmaceutical companies’ patent portfolio.

Something to Chew On: The FDA, Food, and a Healthy Dose of Definitions

February 21, 2017
Drug Policy, FDA, Health, Regulatory

MJLST Guest Blogger, Tommy Tobin

[Editor’s Note: This post is #3 in a series on current FDA issues. You can find the previous post here and here.]

Is food medicine? The answer to this simple question is surprisingly complicated.

The name of the Food and Drug Administration (FDA) seems to distinguish between foods and drugs. So too does the Federal Food, Drug, and Cosmetics Act, which helpfully defines “food” as “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.”

While it is not difficult to swallow the concept of chewing gum being food, the broad legal definition of “food” is somewhat circular and does not provide much guidance by itself.  Indeed, the definition of “drug” under the same law notes that drugs are, in relevant part, “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”

Setting the table for further discussion, it should be noted that foods and drugs face different regulatory burdens. For example, drugs face pre-market approval. As for foods, the FDA does not have sole regulatory oversight over food products, which it shares with approximately 14 other federal agencies. The Government Accountability Office labeled the patchwork of federal food safety oversight as a “high risk issue” noting that it had caused “inconsistent oversight, ineffective coordination, and inefficient use of resources.”

Knowing whether an item is a drug or a food dictates whether it is regulated appropriately and even which laws apply to the item. From the definitions, it would seem that foods are categorically not drugs. Yet, sometimes foods do function as medicine. For example, the Harvard Food Law & Policy Clinic argues that “for critically and chronically ill people, food is medicine.” Part of the Clinic’s work has advocated for expanded medically-tailored food and nutrition interventions to improve health outcomes and reduce overall health care costs for high-risk, high-need populations. Even outside of high-risk populations, it is likely many of us provide self-care through food, such as sipping chicken soup for colds or the flu.

Adding more food for thought, there are several terms that blur the lines between the categories of “food” and “drug.” The FDA notes that “terms like ‘functional foods’ or ‘nutraceuticals’ are widely used in the marketplace” but are not explicitly defined in the Food, Drug, and Cosmetic Act. While one could devote a book to the regulation of nutraceuticals and functional foods (and some have done so), it is sufficient here to note that nutraceuticals and functional foods have their own definitions in the relevant, non-regulatory literature. According to an article in the aptly-titled scholarly journal Nutrients, a nutraceutical is “food (or part of a food) that provides medical or health benefits, including the prevention and/or treatment of a disease” and functional foods are “food products that have an added positive health benefit” (internal citations omitted). Notably, each definition expressly notes that these items are foods, not drugs. Put another way, an apple a day may keep doctors away, but apples enriched with antioxidants may be a functional food that merits a price premium from consumers.

The terms have largely arisen out of marketing practice, and a combination of the words “nutrition” and “pharmaceutical.” Entire publications have devoted themselves to the news and scholarly analysis of these products, including Nutraceuticals World and the Journal of Functional Foods. One recent article examined whether Jelly Belly, the jelly bean purveyor, could support its claims that its Sports Beans were “clinically-proven” to maximize sports performance.

Further blurring the line between foods and drugs, a “medical food” is defined under a statute that has “drug” in the name, but the product is not actually a “drug.” A “medical food” is defined under the Orphan Drug Act, as “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” Pursuant to the above definition, the FDA has declared that medical foods must be taken only under the supervision of a physician. According to a recent FDA Guidance Document, medical foods are explicitly not drugs and are not subject to the requirements that apply to drugs. As an example, one medical food, Deplin, is an orange pill that advertises itself as a “prescription medical food” specifically designed to meet the “clinical dietary management of depression and schizophrenia.”

In the supermarket, consumers may stroll from the pharmacy aisles to the food aisles, seeing pharmaceuticals one moment and nutraceuticals the next. With consumers willing to pay a price premium for healthy foods, including functional foods, foods that make claims to reduce disease and promote good health are likely here to stay.

En-Chantix: Smoking Cessation & Involuntary Intoxication

February 13, 2017
Criminal Law, FDA, Health

MJLST Guest Blogger, Tommy Tobin

[Editor’s Note: This post is #2 in a series on current FDA issues. You can find the previous post here.]

Smoking cessation is a difficult process. To assist patients in the process, many physicians are turning to Chantix (Varenicline), which is advertised as the nation’s #1 prescribed prescription anti-smoking medication. Health professionals have lauded the product as a useful adjunct to other methods of smoking cessation treatment and over 10 million Americans have received prescriptions for the drug.

After the introduction of Chantix into the market, reports of adverse events, including potentially serious neuropsychiatric effects, prompted the FDA to issue a black box warning in 2009 for the drug. In 2014, McClatchy reported that Pfizer, Chantix’s manufacturer, had paid at least $299 million to settle civil claims regarding the drug and its alleged neuropsychiatric effects. In December 2016, the FDA approved the removal of this black box warning. While these events certainly are of interest to drug manufacturers and regulators, they also have surprising implications for criminal law.

What if your anti-smoking drug led you to commit a violent crime? Could you convince a jury that the anti-smoking pill made you do it? That is precisely the question posed by some criminal defendants across the country.

Involuntary intoxication can be an affirmative defense for criminal offenses, and this defense is recognized as a complete defense. As a complete defense, the court recognizes that the defendant committed the action alleged but absolves the accused of criminal responsibility due to the circumstances surrounding the commission of the crime.  While standards for this defense vary, criminal defendants alleging such a defense generally claim that they were intoxicated and that this intoxication was not the result of their voluntary action. Many courts apply the same standard as in an insanity defense, which asks whether the intoxicated defendant became unable to distinguish right from wrong.

In one high-profile case, an American soldier repeatedly stabbed and brutally murdered another soldier at Fort Benning, Georgia. The defendant in this case, United States v. MacDonald, was taking Chantix and claimed that he should have been afforded an involuntary intoxication instruction at trial. The US Court of Appeals for the Armed Forces ruled that the lower court had a sua sponte duty to instruct on the defense of involuntary intoxication, finding that it was error to fail to provide a separate and distinct involuntary intoxication instruction in such a case. The MacDonald defendant was granted a rehearing, whereupon his sentence was decreased from life without parole to 45 years with credit for time served pursuant to a plea deal. The case went up on appeal on January 27, 2017 and was affirmed.

In another case, a Maryland man invoked Chantix when he was accused of attempting to kill his wife. As reported in the Washington Post, the man shot his wife and tried to get a second shot off but the gun malfunctioned. At trial, he claimed that Chantix caused an internal imbalance of chemicals, resulting in involuntary intoxication. The judge agreed and ordered that he be released. The local paper reported that a small protest followed the Maryland order, with protestors carrying signs that read “Abusers blame victims, Judges blame Chantix.”

When defendants allege a so-called “Chantix defense,” it is far from a sure thing. Providing a court with evidence in addition to conclusory allegations may improve the chances of a favorable finding.  For example, a Florida man argued with his father and shortly thereafter killed him. Subsequent to the murder, the man called 911 attempting to blame a non-existent intruder. According to the court, the “Chantix defense” was considered but ultimately rejected by the defense counsel. After trial, the man brought a prisoner litigation action. In rejecting the suit, the court concluded, inter alia, that “even if a reasonable juror could find that Chantix rage exists,” the prisoner had presented no evidence that he was so affected.

As noted in the Washington Post, involuntary intoxication is not a new defense but it is being invoked with increasing success nationwide. While the FDA recently removed Chantix’s black box warning, the “Chantix defense” demonstrates the fascinating interplay between FDA law and criminal law. It remains to be seen just how much the defense bar will incorporate this defense into clients’ strategies.

En-Chantix: Smoking Cessation & Involuntary Intoxication

February 13, 2017
Criminal Law, FDA, Health

MJLST Guest Blogger, Tommy Tobin

[Editor’s Note: This post is #2 in a series on current FDA issues. You can find the previous post here.]

Smoking cessation is a difficult process. To assist patients in the process, many physicians are turning to Chantix (Varenicline), which is advertised as the nation’s #1 prescribed prescription anti-smoking medication. Health professionals have lauded the product as a useful adjunct to other methods of smoking cessation treatment and over 10 million Americans have received prescriptions for the drug.

After the introduction of Chantix into the market, reports of adverse events, including potentially serious neuropsychiatric effects, prompted the FDA to issue a black box warning in 2009 for the drug. In 2014, McClatchy reported that Pfizer, Chantix’s manufacturer, had paid at least $299 million to settle civil claims regarding the drug and its alleged neuropsychiatric effects. In December 2016, the FDA approved the removal of this black box warning. While these events certainly are of interest to drug manufacturers and regulators, they also have surprising implications for criminal law.

What if your anti-smoking drug led you to commit a violent crime? Could you convince a jury that the anti-smoking pill made you do it? That is precisely the question posed by some criminal defendants across the country.

Involuntary intoxication can be an affirmative defense for criminal offenses, and this defense is recognized as a complete defense. As a complete defense, the court recognizes that the defendant committed the action alleged but absolves the accused of criminal responsibility due to the circumstances surrounding the commission of the crime.  While standards for this defense vary, criminal defendants alleging such a defense generally claim that they were intoxicated and that this intoxication was not the result of their voluntary action. Many courts apply the same standard as in an insanity defense, which asks whether the intoxicated defendant became unable to distinguish right from wrong.

In one high-profile case, an American soldier repeatedly stabbed and brutally murdered another soldier at Fort Benning, Georgia. The defendant in this case, United States v. MacDonald, was taking Chantix and claimed that he should have been afforded an involuntary intoxication instruction at trial. The US Court of Appeals for the Armed Forces ruled that the lower court had a sua sponte duty to instruct on the defense of involuntary intoxication, finding that it was error to fail to provide a separate and distinct involuntary intoxication instruction in such a case. The MacDonald defendant was granted a rehearing, whereupon his sentence was decreased from life without parole to 45 years with credit for time served pursuant to a plea deal. The case went up on appeal on January 27, 2017 and was affirmed.

In another case, a Maryland man invoked Chantix when he was accused of attempting to kill his wife. As reported in the Washington Post, the man shot his wife and tried to get a second shot off but the gun malfunctioned. At trial, he claimed that Chantix caused an internal imbalance of chemicals, resulting in involuntary intoxication. The judge agreed and ordered that he be released. The local paper reported that a small protest followed the Maryland order, with protestors carrying signs that read “Abusers blame victims, Judges blame Chantix.”

When defendants allege a so-called “Chantix defense,” it is far from a sure thing. Providing a court with evidence in addition to conclusory allegations may improve the chances of a favorable finding.  For example, a Florida man argued with his father and shortly thereafter killed him. Subsequent to the murder, the man called 911 attempting to blame a non-existent intruder. According to the court, the “Chantix defense” was considered but ultimately rejected by the defense counsel. After trial, the man brought a prisoner litigation action. In rejecting the suit, the court concluded, inter alia, that “even if a reasonable juror could find that Chantix rage exists,” the prisoner had presented no evidence that he was so affected.

As noted in the Washington Post, involuntary intoxication is not a new defense but it is being invoked with increasing success nationwide. While the FDA recently removed Chantix’s black box warning, the “Chantix defense” demonstrates the fascinating interplay between FDA law and criminal law. It remains to be seen just how much the defense bar will incorporate this defense into clients’ strategies.

Evaluating an FDA ban on Use of Human-Used Antibiotics in Animals

February 9, 2017
Drug Policy, FDA, Health, Regulatory

Nathan Vanderlaan, MJLST Staffer

Over the past several years, antibiotic resistance in humans has become one of the leading health concerns in the United States. Many heads are turning towards the U.S. farming industry, and the antibiotic consumption by animals as a leading culprit. Today, about 80% of all antibiotic consumption in the United States is attributable to animal consumption. Many argue that unless the government takes stronger regulatory stances on the animal consumption of antibiotics, an inability to effectively fight a number of illnesses due to antibiotic resistance will be on the horizon.

In her article “Slowing Antibiotic Resistance by Decreasing Antibiotic Use in Animals,” Jennifer Nomura argues that the FDA should implement a total ban on the use of antibiotics in animals that are also used therapeutically in humans. Currently, the FDA has taken the position that there is no definitive proof that antibiotic use in animals leads to greater resistance in humans. As such, they intend to allow producers to continue to use antibiotics used to treat humans in farming practices until a scientific correlation between resistance and farm use is established. Nomura advocates that the FDA transition from this “wait-and-see” policy and enter the realm of stiff antibiotic regulation. She argues that the FDA is under such an obligation based on their duty to minimize risks to human health. However, this duty may suggest that the FDA should not rush into a total ban on antibiotics also used in human health.

An all-out ban on such antibiotics may in fact have a more detrimental impact on human health. The potential that a ban would lead to increased incidence of disease cannot be underscored. While Nomura suggest that disease may be kept down due to improved farming practices, the reality of creating the infrastructure to promote such practices may not be feasible for a country with such high meat production. And although several countries have been successful in making the transition from these kinds of antibiotics, their success may not be entirely indicative of the success a large country like the U.S. will have. If the incidence of disease goes up after a ban, consumers will likely suffer medically and financially, and these risks cannot impulsively be set aside.

Nonetheless, the FDA must take notice of the growing problem of antibiotic resistance. Resistance is giving rise to “super-bugs” and leading to more unpreventable deaths every year. While steps must be taken to address these growing concerns, any action taken by the FDA should not be hasty. Instead of an outright ban on all antibiotics used for humans as well, the FDA should do a full risk analysis regarding the impact giving these drugs to animals poses to humans. Then the FDA should conduct an individual analysis of the highest risk antibiotics being used, tackle these antibiotics first, and then slowly transition away from the use of certain antibiotics once it is determined such a transition will not threaten the health of humans or the nations live stock.

Would Monetary Compensation Incentivize You to Register as an Organ Donor?

January 31, 2017
Ethics, Health, Public Health

Na An, MJLST Article Editor

In the United States, the number of patients on the waitlist for receiving organ donations is much greater than the limited number of supplies.  One person is added to the list every 10 minutes, while only 3 in 1,000 people die in a way that allows for organ donation.  As deceased individuals constitute about two thirds of organ donors, 22 patients die waiting for a transplant every day.  The organ shortage also devastates the qualify of life for more than 100,000 people, and costs national economy tens of billions of dollars every year.  It incentivizes international organized black markets and human trafficking.  The organ shortage has multiple reasons, chief among which is people’s unwillingness to register as donors.  Study has shown that 95% of U.S. adults support organ donation; yet, only 48% of them actually signed up as donors.  Additionally, hospital procedures and customs often allow a family’s objection to undermine the wish of an intended donor.

Currently, the organ donation system is regulated by state law, federal law, government agencies, and hospital procedures.  Each state maintains its own donor registry, mostly linked to the driver’s licensing process, and state laws vary in their donation education program.  The National Organ Transplant Act (Act) instituted the Organ Procurement and Transplantation Network (OPTN) to match donated organs with recipients on the waitlist.  The Act also prohibits the sale of organs.  While the legislatures and courts remain silent, hospital procedures dictate.  For example, hospitals will almost never retrieve organs without the family consent even when doing so would be against the wish of the deceased.  Complicating the issue further is the inherent human rights of the donor, his/her family, and the recipient.

Confronting these issues, Stephanie Zwerner, in her article “A Small Price to Pay: Incentivizing Cadaveric Organ Donation with Posthumous Payments,” proposed a national donor registry and incentivization system.  First, a national donor registry will replace state registries, and eliminate the interstate discrepancies and inefficiencies.  The national registry can be consolidated with OPTN for effective administration.  To improve the validity of donor intent documentation, the article proposed donor registration through health insurance application, registration to vote, or income tax reporting.  Unlike “check-the-box” in driver licensing, everyone will be given a chance to fully consider their decisions.  Families and hospitals would be more willing to respect the wishes of intended donors.

To further incentivize registration, the article proposed a single lump sum payment to the donor’s estate financed by the recipient’s health insurance provider upon the event of an executed cadaveric organ donation.  Monetary compensation for organ donation has been a controversial topic.  Not only it is illegal under federal statute, it has also been considered as the “commodification of human body parts” and an intrinsic evil.  It decreases respect for life and human body, and can lead to exploitation of people in dire economic circumstances.  Acknowledging these negative consequences, the author presented several benefits: increasing donations while decreasing familial objections, saving lives, relieving people on the waitlist for many years of suffering, reducing black markets and the economic burden on national economy.  Considering that one donor could potential save eight lives, the article argues that the benefits outweigh the negative implications.

Social and Legal Concerns as America Expands into the Brain-Computer Interface

January 31, 2017
Criminal Law, Health, New Technology

Daniel Baum, MJLST Staffer

A great deal of science and technology has been emerging in the field of the brain-computer interface, the connection between the human brain and machines. In addition to forming effective prosthetics and helping doctors repair brain damages, technology in the brain-computer interface has recently allowed a man to operate a prosthetic hand and an electric wheelchair with his mind using only a microelectrode array surgically implanted into his arm’s nerve fibers. The professor who developed the implant also experimented on himself, and made himself able to see in the dark: with an implant into the median nerve of his wrist, he could use the electric feedback from an ultrasonic range-finding sensor mounted on his hat to guide himself around a room blindfolded. Since this technology is still in its experimental stages, American law does not have much to say about human enhancements. Already, dangerous medical devices can lead to confusing and unfair trials, and it’s easy to imagine courtrooms getting even more confusing and unfair as medical devices progress into the brain-computer interface. This technology is close enough that the implementation of legal changes now could help this emerging technology develop in ways that will balance minimizing harm with utilizing its enormous potential to make people better.

Current laws impose no affirmative duty on manufacturers to allow pacemaker users access to their own data, and the top five manufacturers do not allow patients to access the data produced by their own pacemakers at all. As we begin to view machines as extensions of ourselves, in order to maintain our personal autonomy, we will need to be able to control who accesses the data we produce. This calls for an already necessary legal change: a right to access and control access to the data generated by objects that are effectively extensions of ourselves.

As this technology moves from healing disabled humans to giving normal people supernormal powers, its use will become much more widely pursued—“the disabled may prove more abled; we may all want their prostheses.” If other job applicants are capable of so much more because of their built-in brain-computer interface technology, employers may discriminate against natural, unenhanced humans. To protect people who cannot or who choose not to install machinery in the brain-computer interface, for financial, medical, ethical, religious, or any reasons, an independent statutory scheme with the purpose of eliminating discrimination both for and against individuals with brain-computer interface devices would not disturb the currently established disability protocols in the Americans with Disabilities Act and could be amended to account for each new form of machinery.

Another frightening concern arises once these enhancements become capable of connecting to the internet: if someone hacks into somebody else’s machinery and makes that person damage something or someone, who will be criminally and civilly liable for the damage? Since American law does not have much to say about human enhancements, no defense has been defined for the person who was hacked into and forced to cause harm. The person whose body actually committed the act could try pleading the affirmative defense of duress—that is, the defendant was compelled to commit the crime against his or her will or judgment—but the U.S. Supreme Court held in 2014 in Rosemond v. United States that “circumstances that traditionally would support a necessity or duress defense” require proof that the defendant “could have walked away.” The hacker took away the defendant’s control of his or her own body, making it impossible for the defendant to have walked away. To solve this problem, states that recognize the defense of insanity could amend their statutes to allow defendants who were mentally unable to control their own bodies due to hacking to plead the affirmative defense of insanity. States that conform to the Federal Rules of Criminal Procedure would then order the defendant to be mentally examined by an expert who could determine and tell the court to what extent the defendant was in control of his or her own mind and body at the time of the crime. The defendant could them implead the hacker to shift the liability for committing the crime. However, since the insanity defense is a mental health defense and brain-computer interface devices aren’t necessarily related to mental health, states may want to define a new affirmative defense for being hacked into that follows a similar procedure but that better fits the situation and that doesn’t carry the stigma of mental disorder.

New machinery in the brain-computer interface is exciting and will allow us both to heal physical and mental damages and to develop supernormal powers. Legal changes now could help this emerging technology develop in ways that will balance minimizing harms like invasions of privacy, discrimination, and hacking with utilizing its enormous potential to make people better.

Ensuring a Fair Trial in Medical Device Cases

January 21, 2017
FDA, Health, Medical Devices

Frank Griffin, M.D., J.D., Adjunct Professor, University of Arkansas School of Law

Dangerous medical devices have been in the news, and the Institute of Medicine—upon the FDA’s request—made recommendations to make device approval pathways safer, but little has changed.  Orthopaedic device companies use the pathway that the Institute of Medicine called “flawed” to gain approval of 88% of their devices—resulting in an 11.5 times higher recall rate than if a more rigorous pathway to approval were chosen.  Predictably, patients are often harmed by recalled devices (and likely other devices that are not officially recalled), but harmed patients may have no choice but to suffer the “overwhelming misfortune” (envisioned in Escola) of shouldering the burden of the companies’ design choices in the current unnecessarily prejudicial legal environment.

In Daubert v. Merrell Dow Pharmaceuticals, the United States Supreme Court provided a framework for judges’ gatekeeper role in assessing the reliability and relevancy of scientific expert testimony to be heard by the jury.  Unfortunately, judges may be overwhelmed and unintentionally unfair in handling a task that some judges from the beginning considered “daunting” complaining they were “no match” for the experts they face.  Since Daubert, in limine challenges have increased, “primarily driven by a significant increase in the number of in limine challenges raised against plaintiff expert witnesses.”

However, there is hope for the overwhelmed judge sorting through the pretrial in limine motions regarding scientific experts in complex orthopaedic cases.  As explored in depth in my recent article to allow for a fair trial, judges should place defense experts and epidemiology studies under greater scrutiny, while being more willing to admit the few experts available to plaintiffs in these often-novel cases.  In addition, courts should require all experts to file conflict of interest disclosure forms under penalty of perjury similar to those used in the orthopaedic journals to assist with assessment of reliability—given that an overwhelming (>97%) majority of experts with stock options, consulting contracts, employment contracts or royalties report positive outcomes in their studies, and also considering that studies are generally reproducible only when <25% of the data comes from developers.  On the plaintiffs’ side, judges should be more open to allowing experience experts and experts who do their research in preparation for trial—because in these novel cases, no other non-industry experts may exist to expose problems.

My article—“Prejudicial Interpretation of Expert Reliability on the ‘Cutting Edge’ Enables the Orthopaedic Implant Industry’s Bodily Eminent Domain Claim”—highlights information of which courts, attorneys, doctors, and patients should be aware.  The article provides ways that the court may stand on equal ground with experts in these complex cases to fairly assess reliability and to do its part to create a safer and more effective medical device market that does not unnecessarily “take” Americans’ health.

A New Year! A New You!: Update Your Look on Regenerative Healing Law

January 2, 2017
Bioethics, FDA, Health, Patents

Angela Fralish, MJLST Invited Blogger

Stephen Breyer, Associate Justice for the Supreme Court remarked that in this age of science, we must build legal foundations that are sound in science as well as in law, because a judge is not a scientist and a courtroom is not a scientific laboratory. Further, our decisions should reflect a proper scientific and technical understanding so that the law can respond to the needs of the public.

Human regenerative healing from embryonic stem cell research has sparked many debates on the public’s needs. On one hand, this research has the ability to relieve great suffering and even death, but on the other hand, it is accompanied by the using and destroying of human life. Moral controversy is a dark cloud looming over any courthouse looking to rule on the science of regenerative healing.

Legislative measures have ebbed and flowed with presidencies. Presidents Clinton, Bush and Obama have used executive orders to either expand or reduce federal funding of regenerative healing. President-Elect Trump’s policy is unknown. According to an NPR article issued in November 2016, “his campaign said little about research and development in general, or health research in particular.” This will be an important point in the near future as a Swedish scientist broke taboo in September of this year by altering healthy human embryos. Further, the NIH plans to lift the ban on regeneration in chimeras in early 2017. As it stands, the federal perspective towards future regenerative healing technology remains unclear.

The most recent executive response has been the Cures Act signed on December 13th of last year by President Obama. Sections 3033-3036 support an expedited FDA review of regenerative therapies and demand an update to regulatory law. Practically speaking, this means that clinical trials will be shortened to get the product on the market faster. While some worry this change will compromise ethics, others worry about the United States ability to keep up with a global market. Dr. Brenda Canine quotes, “If concerted long-term investments in research are not made, America will lose an entire generation of young scientists.”

One established principle in regenerative healing is ownership rights under intellectual property law. Challenges have been made on the grounds that researchers are attempting to patent “life,” but courts have allowed ownership rights to certain cell lines. Dr. Nicholas Zachariades wrote in his article titled Stem Cells: Intellectual Property Issues in Regenerative Medicine that “with respect to the stem cells and their use in the field of regenerative medicine, the U.S. Patent and Trademark Office has recognized inventions involving stem cells as patent-eligible subject matter.” He cites to Consumer Watchdog v. Wisconsin Alumni Research Foundation (WARF)  where the plaintiff sued WARF for the patent being too broad, but lost because they lacked standing. WARF maintains a valid patent for “in vitro cell culture.”

Keeping up with science will continue to be a challenge. While it is against norms to destroy healthy embryos, there is a pressing need for the U.S. to compete in a global market. Hopefully, researchers, lawyers and politicians will eventually find a way to merge ethical, legal and federal funding policies related to stem cell research and regenerative healing into a solid legal foundation.

Drinking the Kool-Aid? Why We Might Want to Talk About Our Road Salt

November 1, 2016
Environment, Health, Public Health

Nick Redmond, MJLST Staffer

Winter is coming. Or—at least according to the 2017 Farmer’s Almanac—“winter is back” after an exceptionally mild 2015–2016 season, and with it comes all of the shoveling, the snow-blowing, and the white walkers de-icing of slippery roads that we missed last year. So what does the most overused Game of Thrones quote and everyone’s least favorite season have to do with Kool-Aid (actually, Flavor-Aid)? Just like the origins of the phrase “drinking the Kool-Aid,” this post has to do with cyanide. More specifically, the ferrocyanide compounds that we use to coat our road salt and that are potentially contaminating our groundwater.

De-icing chemicals are commonly regarded as the most efficient and effective means of keeping our roads safe and free from ice in the winter. De-icing compounds come in many forms, from solids to slurries to sticky beet juice- or cheese brine-based liquids. The most common de-icing chemical is salt, with cities like Minneapolis spending millions of dollars to purchase upwards of 15,000 tons of treated and untreated salt to spray on their roads. In order to keep the solid salt from clumping or “caking” and becoming unusable as it sits around it’s usually treated with chemicals to ensure that it can be spread evenly on roads. Ferrocyanide (a/k/a hexacyanoferrate(II)) and the compounds sodium ferrocyanide and potassium ferrocyanide are yellow chemicals commonly used as anti-caking additives for road salt in Minnesota and other parts of the country, and they can be found in varying concentrations depending on the product, from 0.0003 ppm to 0.33 ppm. To put those numbers in perspective, the CDC warns that cyanide starts to produce harmful effects on humans at 0.05 mg/dL, or 0.5 ppm.

But why are chemicals on our road salt troubling? Road salt keeps ice from forming a bond with the pavement by lowering the freezing point of snow as it falls on the ground. As the salt gets wet it dissolves; it and the chemicals that may be attached to it have to go somewhere, which may be our surface and ground waters or the air if the liquids evaporate. The introduction of these chemicals into groundwater is of particular concern for the 75% of Minnesotans and people like them who rely on groundwater sources for drinking water. The potential for harm arises when ferrocyanide compounds are exposed to light and rapidly decompose, yielding free cyanide (CN and HCN). Further, as waters contaminated with cyanide are chlorinated and introduced to acids they may produce the harmful compound cyanogen chloride, a highly toxic gas that was once considered for use in chemical warfare. Taking into account the enormous amount of salt used and stored each year, even small concentrations may add up over time. And although the EPA has placed cyanide on the Clean Water Act’s list of toxic substances, the fact that road salt is a non-point source means that it’s entirely up to states and municipalities to decide how they want to regulate it.

The good news is that ferrocyanides are among the least toxic cyanide salts, and tend not to release toxic free cyanide. What’s more, the concentrations of ferrocyanide on road salt are generally quite low, are spread out over large areas, and are even further diluted by precipitation, evaporation, and existing ground and surface water. In order to really affect drinking water the ferrocyanide has to (1) not evaporate into the air, (2) make its way through soil and into aquifers, and (3) in large enough concentrations to actually harm humans, something that can be difficult for a large molecule. Despite all of this, however, the fact that Minneapolis alone is dumping more than 15,000 tons of road salt each year, some of it laced with ferrocyanide, should give us pause. That’s the same weight as 15,000 polar bears being released in the city streets every year! Most importantly, these compounds seep into our garden soil, stick to our car tires and our boots, and soak the fur of our pets and wild animals. While cyanide on road salt certainly isn’t a significant public health risk right now, being a part of local conversations to explore and encourage alternatives (and there are a number of alternatives) to prevent future harm might be something to consider.

At the very least think twice about eating snow off the ground (if you weren’t already). Especially the yellow stuff.

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