Health Care

AbbVie Wins U.S. Trial in Lawsuit Over AndroGel’s Risks

By: Andrew Homer *| Staff Writer

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One out of four middle-aged men over 30 years of age suffer from low testosterone levels (“Low T”). The number of middle-aged men who are prescribed hormone treatment to increase testosterone levels have ballooned since 2001 and began to deflate after 2013.

This rise in Low T treatment might be due to the marketing strategies of the manufacturers of these hormone treatments. Or at least, that is one of the arguments made by the plaintiff in a case recently decided in Notle v. AbbVie, Inc., et al.

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Spring 2018 Symposium: Intellectual Property & Medical Technology: From Creation to Commercialization

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The Wake Forest Journal of Business and Intellectual Property Law present its Spring Symposium:

Intellectual Property and Medical Technology: From Creation to Commercialization 

The Symposium is being held, today, Friday, February 2, 2018, from 8:30 am – 4:00 pm at the Wake Forest Innovation Quarter (Biotech Place). This year’s event will look at medical patents, bioethics and the intellectual property implications of medical technology.

MORNING SESSION

Overview of Regenerative Medicine, Role of Law, & Bioethics

Keynote Speakers: Julie Watson and Dr. John D. Jackson

Julie Watson, Chief Legal Counsel for the Institute for Regenerative Medicine at the Wake Forest School of Medicine, opened the Wake Forest Journal of Business and Intellectual Property Law Symposium by introducing the first speaker of the day, Dr. John D. Jackson. Dr. Jackson, an associate professor at the Institute since 2010, began the day’s events by explaining the technical components of the Institute.

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A General Overview of the Journal of Business and Intellectual Property Law’s Symposium: “Intellectual Property and Medical Technology: From Creation to Commercialization”

By Justfixingawrongnumber (Own work) [CC0], via Wikimedia Commons

By Justfixingawrongnumber (Own work) [CC0], via Wikimedia Commons

The Wake Forest Journal of Business and Intellectual Property Law will be hosting its spring symposium,  “Intellectual Property and Medical Technology: From Creation to Commercialization,” beginning at 8:30 a.m. this Friday, February 2, 2018, in the Wake Forest Biotech Place Atrium at Wake Forest Innovation Quarter. Medical patents, the intersection of bioethics and the law, and the venture capitalist-side of regenerative medicine are among some of the topics to be discussed at this year’s symposium. This blog post is meant to provide a brief overview of bioethics and venture capitalists of medical devices.

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Big Wins for Johnson & Johnson Are Giving Plaintiffs a Lot to “Talc” About

By: Emily Marcum *| Staff Writer

By Austin Kirk (https://www.flickr.com/photos/aukirk/12795954293/) [CC BY 2.0 (http://creativecommons.org/licenses/by/2.0) or Public domain], via Wikimedia Commons

By Austin Kirk (https://www.flickr.com/photos/aukirk/12795954293/) [CC BY 2.0 (http://creativecommons.org/licenses/by/2.0) or Public domain], via Wikimedia Commons

Over two-thousand lawsuits are currently pending in state and federal court alleging that Johnson & Johnson failed to warn women about the potential cancer risks associated with its popular talc-based baby powder product. Around 5,000 women claim that they developed ovarian cancer from using the Johnson & Johnson powder containing talc. Talcum powder is made from the mineral, talc, which is mostly made up of three elements magnesium, silicon, hydrogen, and oxygen. In its natural form, some talc can contain asbestos, a known cancer-causing agent. As a result, the United States has ensured since the 1970s that all talcum products used in consumer products are asbestos-free. The American Cancer Society has talc containing asbestos listed as a carcinogen. However, the studies regarding the asbestos-free talc contained in the Johnson & Johnson baby powder and other consumer products remains inconclusive. The American Cancer Society urges consumers that are concerned about talcum powder to avoid or limit their use of consumer products that contain it.

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FDA Knocking Off Drug Prices by Encouraging Knock-Offs

By: Whitney Hosey *| Staff Writer

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Traditionally, the Federal Drug Administration’s (FDA) role in pharmaceuticals is to ensure that products are safe and effective. Now, in response to public backlash against increasing complex drug prices, the FDA is taking a more active approach to drug prices and accessibility. The FDA is authorized to deal with matters which concern public health, however, it is expanding that definition to include increased access to more affordable life-saving drugs, in the form of generic versions of the existing medications. While the FDA is not engaging in price fixing, the new measures released in October 2017 will, according to FDA Commissioner Scott Gottlieb, help increase competition in the market by encouraging companies to invest in making generic versions of these medications.

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Round Two: FDA Approves Pfizer’s Previously Withdrawn Cancer Drug

By: Gabriela Mejias *| Staff Writer

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By The U.S. Food and Drug Administration (Inspecting a Drug Manufacturer (FDA034)) [Public domain], via Wikimedia Commons

The FDA recently approved a new version of a previously withdrawn drug for the treatment of acute myeloid leukemia. Mylotarg, produced by Pfizer, Inc., was voluntarily withdrawn from the market in 2010 after studies showed the drug failed to provide clinical benefits and carried certain safety concerns, such as a high number of deaths.

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DOJ Joins High-Profile Lawsuit Against UnitedHealth Alleging Medicare Fraud

By: Hailey Cleek *| Guest Writer

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The U.S. Department of Justice (DOJ) is a party to a high-profile case, brought under the False Claims Act, involving one of the largest health insurers in the United States, UnitedHealth Group (UHG). False Claims Act cases allow private individuals or the federal government to file a lawsuit against those individuals or businesses that have defrauded the federal government. Congress strengthened the Act in 1986 by increasing incentives for whistleblowers to file lawsuits. Federal prosecutors said that they want to consolidate their case with another whistleblower lawsuit that alleges UHG, and customers of its subsidiary for data and analytics received billions of dollars in government overpayments.

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The Growing and Changing Business of “Impact Investing” in Private Group Homes for Disabled Adults

By: Anna-Bryce Flowe*| Staff Writer 

https://pixabay.com/en/integration-home-at-home-welcome-1777543/Throughout history, families with disabled children have grappled with how to provide adequate housing for their mentally disabled children as these children, and their caretakers, grow older. Often, families turn to the state and federal governments for funding assistance, like Medicaid, and/or state-funded housing options. Over time, the government’s approach to providing said housing assistance has changed. Asylums, which were funded by most state housing boards in the early part of the twentieth century, were initially popular for providing cheap housing and hospital-like care to anyone who seemed mentally inapt in any way. Continue reading »

Will Nursing Home Residents Get Their Day in Court

By: Doriyon Glass*| Staff Writer 

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Centers for Medicare and Medicaid Services (CMS) is an agency within the Health and Human Services Department.  CMS is the federal agency that controls over $1 trillion in Medicare and Medicaid funding.  In September, the agency promulgated Part 483 to Title 42 of the Code of Federal Regulations, the Requirements for States and Long-Term Care Facilities.  These regulations cover many regulatory requirements for long term care facilities and make new compliance obligations for providers. Continue reading »

An Executive Order Responds to a Lack of Paid-Sick Leave in America and Gives Government Workers Something to Celebrate

By: Charity Barger*| Staff Writer 

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In America today, many households are dual-career households, meaning both parents have jobs outside of the home.  However, there is no federal legal requirement that businesses provide paid sick leave to their employees, although some companies are required to offer unpaid sick leave under the Family and Medical Leave Act.  In fact, the United States is the only wealthy nation that does not require a minimum of paid sick leave. Continue reading »