Articles by mjlst

Dinner for Two? Federal Regulations Indicate a Newfound Love for the Pediatric Medical Device Market

February 8, 2017
FDA, Healthcare, Medical Devices, Regulatory

Angela Fralish, MJLST Invited Blogger

In December 2016, President Obama signed the 21st Century Cures Act which includes Subtitle L “Priority Review for Breakthrough Devices” and Subtitle M “Medical Device Regulatory Process Improvement.” Subtitle L addresses efficiency in medical device development by allowing inventors to request an expedited review for inventions that target disease, and for which there is no alternative device is currently on the market. Subtitle M requires FDA staff to be trained in least burdensome concept reviews and allocates $500 million to speed up commercialization.

This Act presents growth opportunities for the pediatric medical device market which often lacks device development due to time and expense. Under the Cures Act, if the device targets a childhood disease and there is no alternative, this new regulation requires a priority review determination within 60 days from the FDA Secretary. Additionally, there are now $500 million supporting implementation of the priority review.

Currently, pediatric devices can take up to 10 years and $94 million to develop. Market incentives often drive device innovation and the market for children is small. Consequently, most developments are not initiated for profit, but for personal interest in children’s health.

For example, despite using an expedited review process under a humanitarian device exemption, an implantable rib to prevent thoracic collapse took 13 years just to get FDA approval to begin the commercialization process. The pediatric medical device market is viewed by some as a crisis and the 21st Century Cures Act has the potential to improve kids’ health.

For lawyers, scientists and engineers, an increase in device development leads to an increase in demand for regulatory, design, reimbursement and scientific technology experts. Lawyers can make a major difference in getting devices from bench-to-bedside. On the other side of the fence is demand for the same to protect consumers from manufacturers taking advantage of the Cures Act. In fact, some tort lawyers directly oppose the Cures Act for fear of watered-down processes for safety in devices.

However, regardless of one’s stance on the issue, it’s a good time to show some legal love to the kiddos in need of growth in the pediatric medical device market.

Split Ends: WEN Hair Care & the FDA’s Regulation of Cosmetics

February 7, 2017
Class Action, FDA, Regulatory

MJLST Guest Blogger, Tommy Tobin

[Editor’s Note: The LawSci Forum is pleased to announce a new series on current issues in FDA law. This post is #1 in the series, with more in the coming weeks.]

We have all been tempted by late-night television infomercials and their promises. If the product works, our lives become more convenient; if it doesn’t, we’re only out a few dollars and the product will gather dust. For thousands across America, one product that promised a hair-care revolution left them scratching, itching, and balding.

The Food & Drug Administration (FDA) is investigating over 20,000 incidents of adverse events resulting from WEN by Chaz Dean. Los Angeles-based stylist Chaz Dean is the face of the WEN brand, endorsed by Brooke Shields, Alyssa Milano, and other celebrities. Sold on QVC, infomercials, and elsewhere, WEN is unlike most shampoos. It is marketed as a “revolutionary way to cleanse and hydrate the hair” without water.

There’s another way that WEN is unlike most shampoos: using WEN all too often results in large clumps of hair falling off one’s head. The FDA has received complaints of baldness in addition to hair loss, itching, and rashes after consumers tried WEN products. In July 2016, the FDA issued a Safety Alert to warn the public about potential results of using this hair care product. In that warning, the FDA noted that this was the largest number of reports ever received for a hair cleansing product.

Unsurprisingly, litigation has ensued. One California case has resulted in a preliminary class action settlement of over $26 million. Filed in the Central District of California, the suit alleges that the plaintiffs, and their similarly-situated class members, suffered hair loss and scalp irritation, among other injuries. One class representative allegedly lost one-third of her hair after she used WEN’s Sweet Almond Milk kit. In addition, plaintiffs claimed that the WEN was falsely advertised as safe and failed to warn users of potential harm.

Under the terms of the preliminary settlement, notice will be given to 6 million class members, defined as any American purchaser of WEN hair care products between November 2007 and August 1, 2016. A warning will be added to the product’s packaging telling users to seek immediate medical attention for adverse reactions. While many claimants in the class can submit claims for a $25 payment, those with more extensive damages can submit claims for additional recovery. For example, those that have lost more than 50% of their hair with minimal “hair regrowth” could recover as much as $20,000.

But, wait there’s more! The nature of the allegations against WEN have led many consumers, lawmakers, and even the New York Times to ask whether the FDA should have the authority to recall dangerous cosmetics from the market. Currently, the FDA is not authorized to order recalls of cosmetic products. Instead, such recalls are voluntary efforts by manufacturers or distributors.

A cursory inspection of the FDA’s name reveals that “cosmetics” is nowhere to be found in the title of the Food & Drug Administration. While the FDA notes that cosmetic companies and marketers “have the legal responsibility to ensure the safety of their products,” the WEN case provides an opportunity to reflect on the FDA’s regulatory authority over cosmetic products.  For example, the FDA may order warning statements on cosmetics that present health hazards and work with manufacturers on voluntary recalls. Time will tell whether WEN prompts further action to regulate cosmetic products.

Split Ends: WEN Hair Care & the FDA’s Regulation of Cosmetics

February 7, 2017
Class Action, FDA, Regulatory

MJLST Guest Blogger, Tommy Tobin

[Editor’s Note: The LawSci Forum is pleased to announce a new series on current issues in FDA law. This post is #1 in the series, with more in the coming weeks.]

We have all been tempted by late-night television infomercials and their promises. If the product works, our lives become more convenient; if it doesn’t, we’re only out a few dollars and the product will gather dust. For thousands across America, one product that promised a hair-care revolution left them scratching, itching, and balding.

The Food & Drug Administration (FDA) is investigating over 20,000 incidents of adverse events resulting from WEN by Chaz Dean. Los Angeles-based stylist Chaz Dean is the face of the WEN brand, endorsed by Brooke Shields, Alyssa Milano, and other celebrities. Sold on QVC, infomercials, and elsewhere, WEN is unlike most shampoos. It is marketed as a “revolutionary way to cleanse and hydrate the hair” without water.

There’s another way that WEN is unlike most shampoos: using WEN all too often results in large clumps of hair falling off one’s head. The FDA has received complaints of baldness in addition to hair loss, itching, and rashes after consumers tried WEN products. In July 2016, the FDA issued a Safety Alert to warn the public about potential results of using this hair care product. In that warning, the FDA noted that this was the largest number of reports ever received for a hair cleansing product.

Unsurprisingly, litigation has ensued. One California case has resulted in a preliminary class action settlement of over $26 million. Filed in the Central District of California, the suit alleges that the plaintiffs, and their similarly-situated class members, suffered hair loss and scalp irritation, among other injuries. One class representative allegedly lost one-third of her hair after she used WEN’s Sweet Almond Milk kit. In addition, plaintiffs claimed that the WEN was falsely advertised as safe and failed to warn users of potential harm.

Under the terms of the preliminary settlement, notice will be given to 6 million class members, defined as any American purchaser of WEN hair care products between November 2007 and August 1, 2016. A warning will be added to the product’s packaging telling users to seek immediate medical attention for adverse reactions. While many claimants in the class can submit claims for a $25 payment, those with more extensive damages can submit claims for additional recovery. For example, those that have lost more than 50% of their hair with minimal “hair regrowth” could recover as much as $20,000.

But, wait there’s more! The nature of the allegations against WEN have led many consumers, lawmakers, and even the New York Times to ask whether the FDA should have the authority to recall dangerous cosmetics from the market. Currently, the FDA is not authorized to order recalls of cosmetic products. Instead, such recalls are voluntary efforts by manufacturers or distributors.

A cursory inspection of the FDA’s name reveals that “cosmetics” is nowhere to be found in the title of the Food & Drug Administration. While the FDA notes that cosmetic companies and marketers “have the legal responsibility to ensure the safety of their products,” the WEN case provides an opportunity to reflect on the FDA’s regulatory authority over cosmetic products.  For example, the FDA may order warning statements on cosmetics that present health hazards and work with manufacturers on voluntary recalls. Time will tell whether WEN prompts further action to regulate cosmetic products.

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.

Confusion Continues After Spokeo

January 27, 2017
Internet, Privacy

Paul Gaus, MJLST Staffer

Many observers hoped the Supreme Court’s decision in Spokeo v. Robins would bring clarity to whether plaintiffs could establish Article III standing for claims based on future harm from date breaches. John Biglow explored the issue prior to the Supreme Court’s decision in his note It Stands to Reason: An Argument for Article III Standing Based on the Threat of Future Harm in Date Breach Litigation. For those optimistic the Supreme Court would expand access to individuals seeking to litigate their privacy interests, they were disappointed.

Spokeo is a people search engine that generates publicly accessible online profiles on individuals (they had also been the subject of previous FTC data privacy enforcement actions). The plaintiff claimed Spokeo disseminated a false report on him, hampering his ability to find employment. Although the Ninth Circuit held the plaintiff suffered “concrete” and “particularized” harm, the Supreme Court disagreed, claiming the Ninth Circuit analysis applied only to the particularization requirement. The Supreme Court remanded the matter back to the Ninth Circuit, casting doubt on whether the plaintiff suffered concrete harm. Spokeo violated the Fair Credit Reporting Act, but the Supreme Court characterized the false report as a bare procedural harm, insufficient for Article III standing.

Already, the Circuits are split on how Spokeo impacted consumer data protection lawsuits. The Eighth Circuit held that a cable company’s failure to destroy personally identifiable information of a former customer was a bare procedural harm akin to Spokeo in Braitberg v. Charter Communications. The Eighth Circuit reached this conclusion despite the defendant’s clear violation of the Cable Act. By contrast, the Eleventh Circuit held a plaintiff did have standing when she failed to receive disclosures of her default debt from her creditor under the Fair Debt Collections Practices Act in Church v. Accretive Health.

Many observers consider Spokeo an adverse result for consumers seeking to litigate their privacy interests. The Supreme Court punting on the issue continued the divergent application of Article III standing and class action privacy suits among the Circuits.

Farm Drainage Revisited: Will Tile-Drain Effluent Be Considered a Point Source and Fall Under Clean Water Act Regulation?

January 26, 2017
Agriculture, Environmental Law

Theodore Harrington, MJLST Managing Editor

For years, nutrients from farming operations have been leaking into the Raccoon and Des Moines Rivers, and ultimately arriving at the mouth of the Mighty Mississippi. These nutrients, most notably nitrate and phosphorus, are the result of both fertilizers and natural crop growth and have deleterious effects on humans and the environment. As these nutrients mix with groundwater just below the surface, a polluted effluent is created. This effluent is then drained through a grid of plastic piping a few feet below the soil.

Nearly two years ago, Des Moines Water Works (DMWW), a public water utility, sued the Drainage Districts in Sac, Buena Vista, and Calhoun Counties to recover monies spent treating the polluted effluent to make it safe for public consumption. Defendants contend that the polluted effluent does not fall under the jurisdiction of the Clean Water Act, and therefore DMWW is the appropriate entity to bear these costs, which approach $7,000 per day!

Where it stands: Summary Judgment briefs were traded in May and June of last year. Since then, oral arguments have been heard by the Iowa Supreme Court since September 14, 2016. (Click HERE to see John Lande arguing for the Board of Water Works and Michael Reck arguing for the counties.) A federal trial in front of Judge Leonard Strand is set for this coming June in the Northern District of Iowa. The trial will come two and a half years after the original filing, and lengthy appeals, possibly to the Supreme Court, are likely to follow. Though it will be years before we have an answer to the question titling this post, the judgment’s consequences will reach beyond individual farms to the heart of the industry.

Broad Inst. Inc. v. Regents of the Bd. of the Univ. of Cal: PTO to Decide CRISPR Gene Editing Ownership

January 26, 2017
Biotechnology, Patents

Jeffrey Simon, MJLST Staffer

The Broad Institute and the University of California will argue claims related to ownership on Patents relating to CRISPR (clustered regular interspaced short palindromic repeats) gene editing technologies. The arguments will be heard on Dec, 6 by the Patent Trial and Appeals Board.

CRISPR technology utilizes prokaryotic DNA segments to confer immunity to foreign genetic elements. CRISPR editing technology has the potential to alter human DNA sequences by removing existing genes or inserting new ones. Moving forward, CRISPR technology has the potential to develop into a form of gene therapy, whereby the human genome can be edited to fortify one’s immune system against infectious diseases or other hereditary issues. CRISPR technology raises ethical concerns, especially relating to the potential use in altering the genes of human embryos.

Although CRISPR technology has been understood for over a decade, the current case revolves around an improvement using cas9 protein that splices DNA at a specific locus. The Broad Institute asserts that patents filed on behalf of the Massachusetts Institute of Technology and Harvard University Researchers (Broad Institute being the eventual assignee of the patents) maintain priority over those owned by University of California. However, the relevant patents have been asserted pre-AIA. Therefore, priority date will be established by date of the invention rather than under the AIA standard of application date. The Patent Trial and Appeals Board (PTAB) initially maintained that the date of invention was properly asserted prior to the patents upon which the challenge was brought. If the decision of the PTAB is upheld, the University of California patents will invalidate the patents held by MIT and Harvard. It’s important to note that both parties are asserting priority date to a previous University of California patent relating to CRISPR technology. The PTAB may determine that both parties failed to prove priority date ahead of the US Patent Application No. 13/842,859, thus invalidating both parties claims.

The Broad Institute is a research institute associated with MIT and Harvard University. It’s unclear how the decision will affect CRISPR technology moving forward. CRISPR technology has attracted lucrative investments from government agencies and private entities alike. Additionally, since the initial patenting of CRISPR, University of California has licensed out the use of CRISPR technology to numerous firms interested in its applications.

Court’s Remain Unclear About Bitcoin’s Status

January 25, 2017
Economics, Financial Law, New Technology

Paul Gaus, MJLST Staffer

Bitcoin touts itself as an “innovative payment network and a new kind of money.” Also known as “cryptocurrency,” Bitcoin was hatched out of a paper posted online by a mysterious gentleman named Satoshi Nakamoto (he has never been identified). The Bitcoin economy is quite complex, but it is generally based on the principle that Bitcoins are released into networks at a steady pace determined by algorithms.

Although once shrouded in ambiguity, Bitcoins threatened to upend (or “disrupt” in Silicon Valley speak) the payment industry. At their core, Bitcoins are just unique strings of information that users mine and typically store on their desktops. The list of companies that accept Bitcoins is growing and includes cable companies, professional sports teams, and even a fringe American political party. According to its proponents, Bitcoins offer lower transaction costs and increased privacy without inflation that affects fiat currency.

Technologies like Bitcoins do not come without interesting legal implications. One of the oft-cited downsides of Bitcoins is that they can facilitate criminal enterprises. In such cases, courts must address what status Bitcoins have in the current economy. The Southern District of New York recently held that Bitcoins were unequivocally a form of currency for purposes of criminal prosecution. In United States v. Murgio et al., Judge Alison Nathan determined Bitcoins are money because “Bitcoins can be accepted as payment for goods and services or bought directly from an exchange with a bank account . . . and are used as a medium of exchange and a means of payment.” By contrast, the IRS classifies virtual currency as property.
Bitcoins are uncertain, volatile, and complex, but they continue to be accepted as currency and show no signs of fading away. Going forward, the judiciary will need to streamline its treatment of Bitcoins.

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.

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