Donate   |   Search   |   Contact Us   |   Sign In
Community Search
Drug, Device and Biotechnology Content
Share |


 

 

 

AUGUST 2018


The board has spoken and the 2017-18 DD&B Chair is Michael Walsh and the Vice Chairs are Joseph P.H. Babington, Michael J. Hurvitz, John W. Sinnott, Andrew B. Johnson and Christopher P. DePhillips. We anticipate an aggressive agenda for 2017-18 and look forward to being an important resource for our section members.

 

A word about Montreux: DD&B partnered with Transportation and Class Actions and had a great panel on a unique topic entitled: From Farm to Table or Felon to Table: FSMA - What is it and what it means for foreign suppliers. An Update on Implementation, Compliance, Litigation and Enforcement. The panel addressed domestic and international aspects of the new regulations under the Food Safety Modernization Act.  The speakers put a lot of effort into the program and did a great job presenting a complicated subject in a short period of time.

AMELIA ISLAND WINTER MEETING:

The Drug Device and Biotechnology section will be putting on a panel entitled: Opioids – The Fifth Vital Sign - Summary of Underlying Issues. According to the federal Department of Health and Human Services “[t]he United States is in the midst of a prescription opioid overdose epidemic. In 2014, more than 28,000 people died from opioid overdose, and at least half of those deaths involved a prescription opioid. The epidemic has significant civil and criminal liability implications for manufacturers, distributors, dispensers/formularies, payors, employers, physicians, hospitals and surgery centers. 

Because opioids do not discriminate based on geography or any social demographic and threaten death, the current “epidemic” is unlike anything we have seen before. Unlike other agents or products that have stirred up controversy, here the media and the public attribute moral “culpability” at every level, including academic medical, legislative, manufacturing, distribution, formulary/dispensing, hospital/medical facility, prescribing physician, payor, employer, patient and even family members.  In addition, beyond any medico-ethical or societal justification in looking for a solution, there are significant enforcement and litigation risks associated with these products that are reflected in the steady uptick in state and federal enforcement and private litigation against manufacturers, distributors, dispensers and prescribers of opioid products, including increasing creative theories of liability.  These actions include civil and criminal cases at the state, federal and even in tribal sovereign courts.  This is a trend with no end in sight.


SEPTEMBER WEBINAR The DD&B section will host its first Webinar for 2017 in September 7, 2017.  Click here and register today for the program entitled: Drug Device and Biotech: Shifting Political Winds –what does it mean for FDA regulated industry?

    • Regulatory trends: what was left undone under the Obama Administration and where is FDA heading?
    • Enforcement: recent enforcement and DOJ actions
    • Litigation trends: who is getting sued and what defensive theories are prevailing
    • Hot cases: discussion of some of the recent reported cases and what these cases may mean.

The speakers are

Jessica Davis, Roetzel, Columbus, Ohio
Michael D. Shalhoub, Goldberg Segalla
John W. Sinnott, Irwin Fritchie Urquhart & Moore LLC[1]
Michael Walsh, Strasburger & Price, LLP, Dallas



[1] John I’m happy to discuss regulatory trends. Here is a possible short blurb for that portion:

Regulatory trends—Possible changes in the FDA under President Trump and what they mean for drug, device, and biotechnology companies.

 

 

JULY 2017

 

Montreux Summer 2017:  Reminder that on Wednesday, July 26, 2017 at 7:45 a.m. we will hold the joint DD&B/Transportation/Class Action program entitled: From Farm to Table or Felon to Table: FSMA - What is it and what it means for foreign suppliers. An Update on Implementation, Compliance, Litigation and Enforcement.  This will be a dynamic panel addressing compliance requirements, risk reduction strategies and current enforcement and litigation trends under the new rules.  With a new administration at the helm, it is unclear how the agencies will enforce the new requirements but what is clear is that over 4,000 pages of new rules provide a lot for this multi-section panel to cover.

Please arrive early for the joint program (if that is possible) to discuss any ideas you have for initiatives for the DD&B Section for the next year.


DD&B Webcast: We have made a change to the topic for our webcast scheduled for early September 2017. The topic is: Drug Device and Biotech: Shifting Political Winds –what does it mean for FDA regulated industry? Regulatory trends: what was left undone under the Obama Administration and where is FDA heading?

 

Amelia Island Winter 2018:  The DD&B Section is sponsoring a program topic for the Winter 2018 program on opioids.  Not a day passes that there is not a news headline, new medical journal or other data disseminated concerning opioids.  In fact, the federal Department of Health and Human Services puts it this way: “[t]he United States is in the midst of a prescription opioid overdose epidemic.” Our speakers are leading advocates on these issues and the panel will focus on where we are today, how we got here and where this is headed.

 

JUNE 2017


Welcome Jessica Davis! Jessica recently joined the FDCC ranks and is the newest member of the Drug Device and Biotechnology section.  Even before she joined our section she has been engaged in some issues we are working on and we look forward to her insight and active participation. Jessica’s practice includes defense of medical malpractice, professional negligence, products liability, breach of fiduciary duty, fraud, and premises liability. Her bio is here.  We asked Jessica if she would share additional information and, as you might expect from a fellow FDCC lawyer she said “I would also share with the group that we live in Westerville, Ohio and I am married to my wonderful husband, Scott, and we have 3 beautiful children ages 11, 9 and 7.”

Montreux Summer 2017:  On Wednesday, July 26, 2017 at 7:45 a.m. we will hold the joint DD&B/Transportation/Class Action program entitled: From Farm to Table or Felon to Table: FSMA - What is it and what it means for foreign suppliers. An Update on Implementation, Compliance, Litigation and Enforcement.  This will be a dynamic panel addressing compliance requirements, risk reduction strategies and current enforcement and litigation trends under the new rules.  With a new administration at the helm, it is unclear how the agencies will enforce the new requirements but what is clear is that over 4,000 pages of new rules provide a lot for this multi-section panel to cover.

A First for the FDA: On June 8, 2017 the FDA requested removal of a prescription opioid. According to the FDA, “[t]his is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.” DD&B Opioid Webcast We expect to have our webcast scheduled for early September 2017.  Liability issues surrounding this class of products continue to evolve involving claims by states, cities, municipalities and Tribal Nations against multiple industry sectors.  Our panel will outline where we are today, how we got here and what to expect going forward. The so-called “opioid epidemic” has unique enforcement and litigation risks throughout the vertical supply chain.

Winter 2018 The DD&B Section is working on a program topic for the Winter 2018 program.  We don’t want to steal any thunder from the Winter program planning folks by announcing anything prematurely but, if you are interested in working on a topic that is certain to change at least a few lives, please let one of the section leadership know and we will get you involved.

 

MAY 2017


Montreux Summer 2017:  On Wednesday, July 26, 2017 at 7:45 a.m. we will hold the joint DD&B/Transportation/Class Actions entitled: From Farm to Table or Felon to Table: FSMA - What is it and what it means for foreign suppliers. An Update on Implementation, Compliance, Litigation and Enforcement.  We will have a dynamic panel to address the new compliance requirements for the rules being implemented and enforced beginning 2016-17.  With a new administration at the helm, it is unclear how the agencies will enforce the new requirements but what is clear is that over 4,000 pages of new rules provide a lot for this multi-section panel to cover.

DD&B Webcast: We are closer to having a date for the webcast on opioids entitled: Opioids – and the Fifth Vital Sign.  This liability issues surrounding this product continue to evolve and our panel will have representatives of industry and FDCC lawyers to outline where we are today, how we got here and what to expect going forward. The so-called “opioid epidemic” has unique enforcement and litigation risks, some of which are playing out in the courts and agencies today and some which are simmering beneath the surface.

On May 9, 2017 the Senate confirmed President Trump’s appointment of Scott Gottlieb, M.D. by a vote of 57 to 42. There are a number of initiatives FDA has underway that might, at long last, see some positive progress.  Not the least of which is FDA’s docket on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products” aka off-label promotion.

 

 

 

 

APRIL 2017


Charleston Winter 2017
: For those unable to attend the Charleston meeting, the Drug Device and Biotech Section had an outstanding panel on off-label promotion that Michael Hurvitz moderated and included FDCC member and former DD&B Chair, Marisa Trasatti, and Jonathan Kahan of Hogan Lovells. The topic and speakers brought us up to date on the more challenging aspects of compliance, enforcement and private litigation related to new uses for medical products. This is a hot topic in our practice area and will remain on the front burner for the foreseeable future.  Among the things to follow include, the effective date for the FDA final rule on Intended Use is extended until March 2018 and April 19, 2017 is the deadline to submit written comments to the FDA on the docket for Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.”


Montreux Summer 2017:  DD&B is running a joint program with Transportation and Class Actions entitled: FSMA - What is it and what does it mean for foreign suppliers? An Update on Implementation, Compliance, Litigation and Enforcement.  We have a dynamic panel of speakers and industry representatives to address the new compliance requirements for the rules being implemented and enforced beginning 2016-17. With a new administration at the helm, it is unclear how the agencies will enforce the new requirements. What is clear is that over 4,000 pages of new rules provide a lot for this multi-section panel to cover.

DD&B Webcast: We are in the final planning stages for a webcast on opioids entitled: Opioids – and the Fifth Vital Sign.  This program will have representatives of industry and FDCC lawyers and will outline where we are today,  how we got here and what to expect going forward. The so-called “opioid epidemic” has unique enforcement and litigation risks, some of which are playing out in the courts and agencies today and some which are simmering beneath the surface.

The AMA and the Plaintiff’s Bar:
  In response to the recent DD&B request for members to submit important issues for the DD&B section members to consider, Tim Pratt forwarded letters to the ABA from the House Committee on the Judiciary and the ABA’s response  Both are attached here.

As you can see from the letter we attach to this newsletter, the Judiciary Committee expressed the concern raised in the recent American Medical Association resolution supporting a legislative or regulatory remedy to “[t]he onslaught of attorney ads” that has resulted in “some patients …stopping prescribed medications without speaking to a physician.” The ABA’s response reads like a plaintiffs brief. First, the ABA claims that drugs injure and kill many people each year. Second, the ABA takes the position that it is barred by the First Amendment from imposing rules regulating lawyer advertisements. Third, the ABA already regulates “false and misleading ads” and the attorney advertising is not false or misleading. If the one-sided and fallacious analysis of the First Amendment didn’t convince you of the ABA’s plaintiff oriented agenda, this third issue certainly should.

This is an important issue for the DD&B industry as these ads are directly focusing on our clients. As leaders in the defense bar, we might give serious consideration to lending our voice in response. Please respond to the Section Chair and Vice Chairs with any thoughts, suggestions or recommendations.

more Calendar
Featured Members
Melinda S. KollrossDefense Counsel, Clausen Miller PC, Chicago, IL
J. Eric MilesDefense Counsel North, Pursell & Ramos, PLC, Nashville, TN

Special Thanks

Membership Software Powered by YourMembership  ::  Legal