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With the increased use in both tobacco and cannabis vaping products, the Food and Drug Administration is sending out warning letters to companies in these industries about false product claims. Legal departments should play a large role in handling any concerns the FDA brings up with your company.

Agustin Rodriguez, counsel at Troutman Sanders in Richmond, Virginia, said it is important to strike the right tone with the FDA.

"Reach out to the agency contact leads and let them know that the company acknowledges receipt and is taking the letter seriously," Rodriguez said. "The agency typically will have placed a deadline under which the company must respond and the company will want either to meet that deadline or, if it feels it will need more time to respond, it should let the agency know that and request a time frame that it thinks is reasonable."

He also said it's important to hire experienced outside counsel to make sure the investigation can be protected by the attorney-client privilege.

"Ultimately, all this work is intended to put the company in a place where it can credibly respond to the agency and set the right tone for a resolution of the issues raised," Rodriguez said.

Does your legal department have procedures in place to respond to FDA inquiries? If so, let me know by emailing me at [email protected].


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What's Happening

 

In-House Training Leads To Cost Saving

The most cost-effective legal departments are the ones that make an effort to develop talent in-house, according to a survey from Gartner Inc.

The survey found these legal departments spent 2.04% of their in-house budget on training and development. Legal departments with higher costs only spend 1.04% of their budgets on training, according to the report.

The survey also found that the most cost-effective legal departments dedicate 8% more of their budgets to in-house staff salaries, training, information technology and software.

"Legal departments have a tendency to hand off complex work to outside counsel, but organizations can achieve significant cost savings by bringing this work in house," Michael Mayfield, research director in Gartner's legal and compliance practice, said to Corporate Counsel.

However, James Wilber, a principal at Altman Weil Inc., said choosing whether to use outside counsel is more complex than spend.

"Although I have long held that for legal work that can and should be handled internally, it certainly can be managed in a well-managed law department," Wilber said. "That doesn't mean it will be well-managed and necessarily lower cost. There is a lot that goes into it."


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In-House Attorney Out Of Jail

Bryan Schmitt, associate general counsel and director of contracts at Manhattan Associates, was granted $500K bond over a road rage incident that ended in a man's death.

Fulton County Superior Court judge Kevin Farmer granted the bond after a nearly 2½-hour hearing last week. Prosecutors allege Schmitt drove into a garbage can to purposefully vault it into Hamid Jahangard. Jahangard died because as a result of his injuries from the incident.

Schmitt has spent 25 days in jail before the bond hearing. Prosecutors believed he was a flight risk because of the substantial prison term that would go along with a conviction.

However, Farmer said he did not believe Schmitt to be a flight risk. Schmitt must surrender his driver's license and must not go within a half-mile radius of Manhattan Associates, which is near the Jahangard daughters' late mother's home, except between 9 a.m. and 6 p.m. Schmitt is facing charges of murder, felony murder and aggravated assault.

His attorney said Schmitt intends on returning to work once he makes bond.


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What I've Been Reading

When suing accused patent infringers, in-house counsel should consider the venue because of differing results in different venues in cases with similar circumstances, according to a report in Bloomberg Law. The report says the different district courts have contradicting applications of a regular and an established place of business. In some districts the location of the defendant company can be applied to the defendant for the purposes of the venue.

The demand for diversity coming from GCs is paying off, according to a report in The Global Legal Post. The report said more than 90% of Mansfield Rule-participating firms have seen an increase in diverse lawyers making pitches to clients.

Just because a company is big does not mean it is a monopoly, president and CLO of Microsoft Brad Smith told CNBC. However, he did say those corporations do need to be responsible and it's not too late to change business practices. "When you put it in that broad perspective, it's not a day too late but we better not wait until tomorrow," Smith said.


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Don't Miss

Monday, Sept. 23 to Tuesday, Sept. 24 – American Property Casualty Insurance Association will be hosting the National General Counsel Conference at the Sheraton Inner Harbor Hotel in Baltimore. Speakers include Elizabeth Brodeur, corporate counsel and director legal and regulatory compliance at Safety Insurance; Laura Lazarczyk, chief legal officer of Zurich North America; and Claire Howard, general counsel at American Property Casualty Insurance Association.

Wednesday, Sept. 25 to Thursday, Sept. 26 – Corporate Counsel will be hosting its annual General Counsel Conference at the New York Marriott Marquis. Speakers this year include Peter Gyr, global general counsel of wealth management at JP Morgan Wealth Management; Graham Luce, general counsel at BJ's Wholesale Club; and Megan Ryan, general counsel at NuHealth.

Monday, Oct. 14 to Wednesday, Oct. 16  The Minority Corporate Counsel Association will be hosting its Creating Pathways to Diversity Conference in New York at the New York Hilton Midtown. The MCCA will host a Diversity Gala on the last night of the conference at the American Museum of Natural History.


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On The Move

 

 XFL  Mali Friedman was named general counsel of the new professional football league slated to open in February 2020. Most recently she worked as the assistant general counsel at The Golden State Warriors and has worked in-house at the NHL.

 Blue Apron Holdings Inc.  Meredith Deutsch has been named the general counsel and corporate secretary of the online food delivery service. She joins a leadership team that changed after a stock plunge earlier this year led to the Securities and Exchange Commission threatening to delist Blue Apron.

 Nasdaq Inc.  Edward Knight, the company's CLO, has been promoted to vice chairman effective Oct. 1. Knight will be replaced by John Zecca, who previously served as the general counsel of North America for Nasdaq.