Health Care

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

https://pixabay.com/en/skin-dermatology-hospital-2404163/

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 

https://pixabay.com/en/seniors-care-for-the-elderly-1505938/

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 »

ADA Website Compliance: Is Your Website in Violation?

By: Doriyon Glass*| Guest Writer

http://nilambar.net/2016/04/making-theme-accessibility-ready-in-wordpress.htmlI recently attended a Legal Marketing Association (LMA) meeting in Raleigh, North Carolina, and the main topic of discussion was website compliance with the Americans with Disabilities Act (ADA).  The discussion was sparked because it had been the topic of a recent Continuing Legal Education (CLE) presentation.  The presentation focused on law firm websites that were not in compliance with the ADA.  A large number of those attending the meeting and the CLE were not aware this was an issue generally or in the legal profession.  The reason for this lack of awareness may be because Title III of the ADA, which applies to public accommodations like businesses, has traditionally focused on physical spaces. Continue reading »

Business as Usual or Profiteering? A Look at Recent Drug Price Hikes

By: Tyler Hood* | Staff Writer

Healthcare is notoriously expensive, and drugs are no exception. Drugs are notoriously costly, with some costing thousands, or even hundreds of thousands of dollars a year. Recently, we’ve all been inundated with news stories about companies drastically raising the prices of certain drugs. Generally, the most expensive drugs are those still on patent. Pharmaceutical companies sell new drugs for such high prices primarily to recoup research and development costs. In fact, taking into account the cost of failed candidates, a drug company spends approximately $5 billion to bring a drug to market. Once the patents expire, generic versions become available and the prices drop. However, recently developed drugs are not the only ones carrying a huge price tag. In some cases, obscure drugs that have been around a long time are subject to price increases if the market for the drug is small enough.

Photo by Sage Ross, CC by-sa

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The Evolving Standard of Antitrust Analysis in Pharmaceutical Product Hopping

By: John S. Sears* | Summer Guest Writer

Photo provided by taxrebate.org.uk

Is it “pharmaceutical innovation” or “product hopping”?  The distinction is not always clear.  While pharmaceutical innovation brings new and improved pharmaceuticals to patients, the term “product hopping” refers to a tactic by which brand name pharmaceutical companies try to obstruct generic competition by making modest reformulations that offer little or no therapeutic advantages.  Such approaches are contrary to section 2 of the Sherman Act that makes it an offense to “monopolize, or attempt to monopolize … any part of the trade or commerce among the several States.” Continue reading »