FDA Announces Public Hearing on Off-Label Communications; Registration Deadline October 19, 2016

The FDA recently came under scrutiny regarding their use of off-label promotions. The FDA can restrict the promotion of off-label products, but there is some questions as to what extent the FDA can do that. Certain scientific freedoms come under question when the FDA tries to restrict products that are not truthful and not misleading.

Key Takeaways:

  • The US Food and Drug Administration (FDA) will hold a public hearing to obtain input on manufacturer communications regarding unapproved uses of approved or cleared medical products.
  • FDA has broad authority to proscribe the content of product labeling and impose restrictions on the off-label promotion of drugs, medical devices and other regulated products.
  • How the agency should monitor off-label promotions and what actions it should take with respect to those that are false or misleading or otherwise raise public health issues.

“The US Food and Drug Administration (FDA) will hold a public hearing on November 9 and 10, 2016, to obtain input on manufacturer communications regarding unapproved uses of approved or cleared medical products (off-label promotions).”

http://www.natlawreview.com/article/fda-announces-public-hearing-label-communications-registration-deadline-october-19

FLSA Didn’t Cover Workers

In a summary judgment, a federal court ruled that a couple that performed odd jobs for a small business were not covered Fair Labor Standards Act (FLSA) because the business did not hit a revenue threshold of $500,000 and because the couple’s limited interactions with out of state customers did not constitute interstate commerce. The details in U.S. District Court for the Middle District of Tennessee’s ruling in Davis v. Patel can serve as a roadmap for small businesses looking to head off expensive FLSA litigation.

Key Takeaways:

  • “The court allowed limited discovery as to whether FLSA coverage existed and ordered briefing on that issue; After conducting written discovery, the motel filed for summary judgment.”
  • “While the magistrate judge recommended that the motel’s summary judgment motion be granted, the district court judge held that the Davises’ declarations created a genuine issue of material fact as to the frequency and extent of their front-desk duties.”
  • “With this additional evidence, the district court held that the Davises’ limited contact with interstate travelers did not constitute engaging in interstate commerce for the purposes of the FLSA. The court granted summary judgment in favor of the motel. “

“Precise evidence can prove that the Fair Labor Standards Act (FLSA) does not cover employees if the employer’s revenue is less than $500,000 and the workers didn’t engage in interstate commerce”

https://www.shrm.org/resourcesandtools/legal-and-compliance/employment-law/pages/flsa-did-not-cover-workers.aspx?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+shrm%2Femploymentlawsregulations+%28SHRM+Online+Employment+Laws+and+Regulations+News%29

FCC Issues $11 Million in Total Fines to Three Long Distance Carriers

After reading this information it makes me wonder if I am being charged more for my long distance calls. the way the system is set up they can switch you without you knowng and I feel that should be a decison I should make myself. Some of the companies that deal with this service can charge you outrages rates and you don’t even know what it is for. There should be more explainations done concerning our bill and what we are paying for.

Key Takeaways:

  • The Federal Communications Commission (FCC) had to adopt rules that would protect amateur radio operators from the reach of community association rules, architectural standards, and other private land use restrictions that can interfere with the installation and operation of amateur radio towers and antennas.
  • FCC Issues $11 Million in Total Fines to Three Long Distance Carriers for Cramming, Slamming, Deceptive Marketing, and Truth-In-Billing Violations; Central Telecom Long Distance, Inc., Consumer Telcom, Inc., and U.S. Telecom Long Distance, Inc.
  • FCC to Host Info Session on Communications Technology Transitions ito nform consumers about how the switch from copper networks to new technologies will affect them.

“When customers realized what had occurred and returned to their preferred carriers, these companies continued to charge consumers a recurring monthly fee” and also “failed to clearly and plainly describe the charges included in their customer bills, as required by the FCC’s rules.””

http://www.natlawreview.com/article/fcc-issues-11-million-total-fines-to-three-long-distance-carriers

Invention Harvesting: Best Practices for Turning Aspiration into Action

Being able to read this article has given me more knowledge in how to incorporate my business idea into action. There are many levels that you have to face in the business word. Most businesses is run through technology and if you are not familiar with technology you will be at a lost. If I incorporate the things that are mention in this article, I have a good opportunuty to be successful in my business.

Key Takeaways:

  • Invention harvesting involves prompting innovators to conceive of new inventions or reveal inventions already conceived and documenting such inventions so they may be protected via the patenting process.
  • Many companies are aware of the potential benefits of invention harvesting and aspire to begin or expand its use.
  • Invention harvesting is a powerful tool to drive innovation, but its promises are likely to be unfulfilled unless a company takes concrete steps to support and nurture its implementation.

“Significantly, invention harvesting also can be leveraged outside the project context to encourage innovators to invent disruptive technologies to occupy a future, envisioned landscape, and to protect such technologies through the patenting process before others do so.”

http://www.ipwatchdog.com/2016/09/20/invention-harvesting-best-practices/id=72738/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+Ipwatchdog+%28IPWatchdog.com%29

Alpha Corporation Agrees to Plead Guilty in Price-Fixing and Bid-Rigging Conspiracy

Nine million dollars in fines. That’s what the Alpha Corporation (Alpha) is facing for its role in price-fixing and bid-rigging conspiracy involving automotive access mechanisms for installation in cars manufactured and sold in the United States and elsewhere. If you have information in regards to this case please contact Antitrust Division’s Citizen Complaint Center at 1-888-647-3258, visit www.justice.gov/atr/contact/newcase.html or call the FBI’s New York Field Office at 212-384-1000

Key Takeaways:

  • Alpha Corporation (Alpha) has agreed to plead guilty and to pay a $9 million criminal fine for its role in a price-fixing and bid-rigging conspiracy.
  • “Alpha is the 46th corporation to be charged with participating in an anticompetitive scheme involving auto parts,” said Deputy Assistant Attorney General Brent Snyder of the Justice Department’s Antitrust Division.
  • The Antitrust Division charges that Alpha and its co-conspirator engaged in meetings and conversations to discuss and agree upon the bids and price quotations to be submitted to Nissan for the sale of access mechanisms.

“Alpha Corporation (Alpha) has agreed to plead guilty and to pay a $9 million criminal fine for its role in a price-fixing and bid-rigging conspiracy involving automotive access mechanisms for installation in cars manufactured and sold in the United States and elsewhere, the Justice Department announced today.”

https://www.justice.gov/opa/pr/alpha-corporation-agrees-plead-guilty-price-fixing-and-bid-rigging-conspiracy

Using the Affordable Care Act in Defense of Catastrophic Personal Injury Cases

Recently, since the Affordable Care Act has come into effect, Plaintiffs in are using the exaggerated life care plans calculations to support medical damages if a catastrophic injury should take place and go to court. What this doesn’t do is consider the plaintiffs entitlement to health insurance if future medical expenses are paid out of pocket. To fight these, defendants are now relying on certain mandates under the ACA to persuade the courts to combat these inflated claims. Also, now individuals are required to have health insurance and insurance companies can’t deny someone coverage because of a preexisting condition.

Key Takeaways:

  • Plaintiffs often use exaggerated life care plans with significant damage calculations to support their future medical damages in catastrophic injury cases.
  • Texas, like many states, enforces the collateral source rule, which precludes any reduction in a tortfeasor’s liability because of benefits received by the plaintiff from someone else − a collateral source.
  • The ACA potentially provides a basis to further limit a plaintiff’s recovery of future medical expenses, as mandatory insurance under the ACA will cover all costs except the amount of the plaintiff’s premium and annual maximum out-of-pocket cost.

“As a result of the ACA mandates, individuals are now required to maintain insurance and insurance companies are prohibited from excluding coverage based on a preexisting condition.”

http://www.natlawreview.com/article/using-affordable-care-act-defense-catastrophic-personal-injury-cases

The Art of Negotiation: Client Goals and Settlement Authority

As a young attorney you are trying to figure out how to juggle many new things, one specific tricky skill is the art of negotiation. First you need to find out your clients goals and how much authority you have. One major thing to remember is that every case is different and each clients expectations are different. Some steps are: find out what your client wants and then find out their goals.

Key Takeaways:

  • Another tricky skill for young litigators is negotiation. The first step of successful negotiation is simple, figure out your client’s goals and how much settlement authority you have.
  • Every case is different—the facts, the client, and what the client wants. Some clients want money. Some clients want an intangible.
  • Lawyers decide on strategy. Clients decide on settlement. Never forget that. If you have not been given settlement authority, your client has to make the final decision, not you.

“Before taking any action on your client’s behalf, spend time figuring out what they want. First, if your state has adopted Model Rule 1.2 or has a substantially similar ethics rule, you are required to do so.”

https://lawyerist.com/41818/art-of-negotiation-client-goals-settlement-authority/

Square fights off Alice rejection on payment transfer patent proving financial patents are not dead

This article introduces readers to Square, Inc. a California based company as well as some of its recent patents in light of the SCOTUS ruling in 2014. It not only looks at how the Alice Corporation v. CLS Bank International ruling dramatically altered which concepts or methods regarding financial transfer would be ineligible, but how Square, Inc. has managed to successfully been issued such patents.

Key Takeaways:

  • In late August, San Francisco, CA-based merchant services company Square, Inc. (NYSE:SQ) announced that it had entered into business partnerships with a pair of former competitors.
  • These partnerships are the latest moves Square has made in order to develop a more open system for its transaction services.
  • A great deal of Square’s research and development has focused upon card readers but there seems to be a good deal of R&D investment related to financial transaction cards and magnetic strips.

“A great deal of Square’s research and development has focused upon card readers but there seems to be a good deal of R&D investment related to financial transaction cards and magnetic strips.”

http://www.ipwatchdog.com/2016/09/13/square-alice-payment-transfer-patent/id=72564/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+Ipwatchdog+%28IPWatchdog.com%29

Former Fugitive Handed Three Life Sentences for Kidnapping and Alien Smuggling, Both Resulting in Death

Noe Aranda-Soto a Mexican national and apparently an alien smuggler of illegal aliens from this side of the border to what were supposed to be safe houses around the Houston, Texas area apparently graduated to hostage taking and kidnapping was finally caught and convicted in a Texas court after a long investigation by multiple state and federal authorities. His crime besides those above also escalated to murder. he was convicted for only a few of the many crimes he committed. He was sentenced to three life terms one of which was to begin after his first two ran their course.

Key Takeaways:

  • A Houston man has been sentenced to to three terms of life in prison for alien smuggling, kidnapping, and killing two women.
  • Twenty victims testified regarding the effects of the crimes
  • Aranda-Soto admitted to the crimes, and with his plea, all involved in the crimes committed between 2010 and 2012 have been convicted.

“A former fugitive who was illegally residing in Houston has been sentenced to three terms of life in prison after pleading guilty to engaging in an alien smuggling conspiracy that resulted in two deaths and kidnapping two women, one of whom was killed.”

https://www.justice.gov/opa/pr/former-fugitive-handed-three-life-sentences-kidnapping-and-alien-smuggling-both-resulting

Constitutional and Economic Policy Problems Raised by Inter Partes Review (IPR) Suggest Congress Should Consider Acting

Congress wanted to make a move in making things better for patients. They created the Inner Parties review (IPR) through the Patient trial and appeal board (PTAB) in effort of good cause. Their efforts however in this ideas has been diminished. The IPR was accused of being “rigged” and critics accuse it to be very challenging,. Questions now arise to possibly scrap both the IPR and the PTAB as they seem to do more harm than good in the healthcare system.

Constitutional and Economic Policy Problems Raised by Inter Partes Review (IPR) Suggest Congress Should Consider Acting