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January 2018

Submitted by: Francisco Ramos, Jr.

Amelia Island Meeting

The Opioid Dilemma - Pain and Punishment

 

Without regard to race, ethnicity, gender, age, geography, socio-economic or other demographic, the opioid crisis has grown to be the most inclusive health crisis in American history.  And opioids now sit at the top of the agenda for state and federal regulators, legislators, prosecutors and civil litigants.  As the media points blame at every stage of the vertical distribution chain; from manufacturers to distributors, dispensers, hospitals, healthcare providers, employers, and possibly even extending to payors, schools and municipalities, our panel will discuss where we are, how we got here and what steps should be taken towards a solution.  We will peel back the veneer to expose the themes that comprise the claims to ensure that lawyers defending these claims are prepared to construct a cogent and compelling defense.


Planning for 2018

Interview with our member Amanda M. Cialkowski


Tell us a little about yourself and your practice?

I'm a trial lawyer practicing in the areas of product liability, toxic exposures, drug and medical devices and mass torts.  Increasingly, I'm enjoying the role of last minute, drop-in trial counsel, working with other attorneys around the country.  My background in teaching lends itself well to explaining complex concepts in ways jurors can understand.  When I'm not working, I enjoy spending time with my husband and daughters and learning about midcentury modern architecture and furnishings.

At the beginning of a year, what plans do you make generally to advance your clients’ interests in their matters?

I inform my clients of any changes in the law that may impact their business.  This may include preventive advice to change internal policies or practices that help fend off future litigation.  I also start with a close look at the trial calendar for the upcoming year to ensure that clients are aware of upcoming deadlines and anticipated expenses, so they can budget and set reserves.

How do you apply how you plan and prepare for your cases to how you plan your professional career?

In terms of my style as a trial lawyer, I like to prepare by doing a deep dive into the documents, science and facts supporting my case.  That is balanced, however, by the challenge of unexpected drop-in trials.  So I'm learning to take risks and accept some of the uncertainties inherent in that role.  I've been doing the same with my marketing and promotion, accepting invitations to attend and speak at conferences where I am less familiar with the subject matter.  It's a great opportunity to learn and grow.

 

What advice do you have for our members on how they plan for 2018 regarding their cases? Business Development? Their careers?

One goal of mine for 2018 is to focus on clear, frank communication with my clients and colleagues.  I have seen clients' frustrations when they receive evolving stories or evaluations of cases from their counsel.  I think it is important to explain to a client quickly why my view of a case changed and to explain what happened to change that view (i.e., a witness crumbled in a deposition, I discovered a damaging document, etc.).  Those are not usually the most fun conversations, but it is critical to maintaining the client's confidence and helping them understand how to value the risks of litigation.

I also want to focus on providing candid, constructive feedback to my younger colleagues to help them grow as attorneys.  Since trials can be so few and far between, it's important to search for opportunities for roles for younger attorneys so they can develop trial skills.

How do you plan for the new year?  For example, do you create a formal plan? Can you share your ideas with our members?

I do create a written plan each year.  I include conferences I plan to attend, articles I plan to write, any speaking engagements, as well as the names of clients with whom I want to connect in the coming year.  Since many clients create their budgets in January, I make sure to let them know about future conferences that might be of interest to them, so they can include plans to attend in their budgets.  I also think about where my travel will take me and who I can visit while I'm there, including FDCC friends and clients.

How do you stick to your plans? 

Following through is definitely difficult.  Luckily, I have the benefit of a wonderful marketing team who checks in with me periodically throughout the year to see if I'm doing the things I committed to do.  Absent that, setting a reminder on your calendar to review your plan once a quarter or once a month (whatever works for you) is a good way to prompt yourself to take action.

How do you reward yourself when you check off an item for the year’s to do list?

Wine!


Any last thoughts about long term planning for one’s career, business development or case load?

Without exception, the most fulfilling part of my career has been the relationships I've developed with colleagues and clients.  It's a difficult job, the hours can be long, but being yourself and developing friendships makes the work so much more enjoyable.


Planning for 2018

Interview with our member Marie E. Chafe

 

Tell us a little about yourself and your practice?

My practice is focused on product liability litigation, covering a variety of industries such as medical devices, pharmaceuticals, automotive and trucking, marine products, and toxic chemicals.  I have over 20 years of broad litigation experience throughout the state and federal courts of New England.

 

I am an active member of DRI, serving in the leadership of the Product Liability Committee and the Women in the Law Committee, and also am active in the Women’s Bar Association of Massachusetts, currently serving as the organization’s Vice-President of Operations, and the Massachusetts Defense Lawyers Association, as a member of the board of directors.  In addition to those activities, I enjoy writing and speaking about the legal issues and law firm practice.

 

I am lucky to have two terrific daughters (age 13 and 20) and a fabulous husband who give me personal joy and fulfillment, as well as law firm colleagues who are supportive of my organizational involvement.

 

At the beginning of a year, what plans do you make generally to advance your clients’ interests in their matters?

As a new year begins, I try to step back and get a global view of my cases and my clients.  When was the case filed, how long as it been going on, where are we in the discovery process, what additional work needs to be done?  Particularly when I am working on multiple cases for a single client – what overall schedule is coming in the next several months?  How can I prepare a client for what lies ahead?

 

Sometimes I, and perhaps others, get into the “weeds” of litigation that grow from smaller debates and discovery wrangling.  With a fresh perspective, it’s helpful to ask if those individual disputes are helping the ultimate objective for a client.

 

What does your client really want from this litigation?  I’ve had plenty of cases that resolve prior to trial, but I’ve had other clients that stand on principle and fully defend their products and their company reputation.  For each case that I am working on, it helps to ask that question – what does the client want.  If I don’t know, I need to ask and listen to the client’s needs.

 

How do you apply how you plan and prepare for your cases to how you plan your professional career?

In many ways, the approach is the same – take a step back and evaluate big picture.  I have greatly enjoyed my organizational work, but those demands can add up at times.  The New Year is a great time to stop and think.  Am I getting what I want out of this organization and work?  After some thought, I have stepped back from commitments that were no longer a priority (including a recent tough decision about a local organization that I care about).  I try not to lose sight of the fact that there are other, talented folks to take over and bring new life to a role that has worn me out.  It’s time to give them the chance, take a break for myself, and allow myself to focus on something new.

 

What advice do you have for our members on how they plan for 2018 regarding their cases? Business Development? Their careers?

Planning for anything takes time and energy.  Think of the effort you put into developing your last vacation, a recent golf/spa/movie/dinner outing with friends, even organizing family gatherings or personal errands.

 

Have we put that much time and energy into planning the “business” of our careers recently?  It’s tough – we’re busy with a lot of other stuff!  Plus, lawyers don’t get a lot of business training in law school.  Where do you even start; how do you keep it going?

 

I have gained a lot of insight and support from being a part of law practice committees and signing-up for law practice blogs.  A local bar organization’s law firm management committee is a great connection point.  One blog that I particularly enjoy is Attorney at Work although there are others.  One e-mail a day that gives me new ideas about business development, digital marketing, case management, and a whole host of law firm management topics.  Or pick-up a good book on legal careers, business development, and management.  The FDCC website is full of great content too!  Some time every week on these issues pays off.

 

How do you plan for the new year?  For example, do you create a formal plan? Can you share your ideas with our members?

I confess that I don’t always come up with a formal plan (and I say this as the former chair of the Business Development Committee of my local bar association).  I have lists and task outlines that help me keep an eye on different aspects of my practice.  On my computer screen desktop, I’ve had the same document that I’ve just called “Important Stuff” for many, many years.  It’s saved to a spot right in the center of the screen.  With my addition of a second screen a few years ago, I often keep the Important Stuff document open on the side screen.  It’s a reminder of long-term issues that need to be tackled – often in small doses and over time.  It’s not a weekend project.

 

There is no magic pill for business development plans.  There’s a lot said about building relationships, but it’s really true.  What does that mean?  Don’t stay at your desk everyday – get involved in organizations and groups that interest you.  Stay in touch with people you meet and ask them about business and career issues.  They are just as interested in it as you are.

 

How do you stick to your plans? 

Well, I try hard!  There are always work commitments, family activities, and person responsibilities that get in the way.  On the substantive work issues, I definitely take the time to stop and evaluate progress along the way.  That’s particularly true at the start of a New Year.  I also set aside a little time on a monthly basis to re-think about how a case is progressing.

 

As for the personal/career issues, I set-up a pretty general annual goal and focus on creating tasks that can be accomplished on a weekly or monthly basis.  For me, it’s about developing manageable goals that keep me going.

 

How do you reward yourself when you check off an item for the year’s to do list?

Chocolate!  Just kidding….mostly.  I have not developed a reward system for the checks on my to-do list.  But, this question is giving me some great, new ideas.

 

 



 

December 2017

Submitted by: Francisco Ramos, Jr.

 

 

The Opioid Dilemma - Pain and Punishment

Michael Walsh, Strasburger & Price LLP, Michael.Walsh@strasburger.com

 

Without regard to race, ethnicity, gender, age, geography, socio-economic or other demographic, the opioid crisis has grown to be the most inclusive health crisis in American history.  And opioids now sit at the top of the agenda for state and federal regulators, legislators, prosecutors and civil litigants.  As the media points blame at every stage of the vertical distribution chain; from manufacturers to distributors, dispensers, hospitals, healthcare providers, employers, and possibly even extending to payors, schools and municipalities, our panel will discuss where we are, how we got here and what steps should be taken towards a solution.  We will peel back the veneer to expose the themes that comprise the claims to ensure that lawyers defending these claims are prepared to construct a cogent and compelling defense.

 

 

An interview with one of our section membersMarisa Trasatti

 

The following is an interview with an FDCC member, Marisa Trasatti, who shares her experience of moving from one firm to another as outside general counsel to a medical device company, and issues to consider when doing so

 

What are some of the unintended issues that tag along with being outside general counsel for a company, when considering joining a large national practice law firm?  You started at one firm on June 9, 2017, and began at the next one on August 31, 2017 due to a conflict with a client for which you serve as General Counsel (“GC”).  What lessons did you learn from this? 

 

There are at least two (2) takeaways from this experience:

 

1.

I am outside General Counsel to a dermatological laser company, Sciton, Inc., in Palo Alto, CA.  This made me an appealing lateral hire,  however, it is also brought a heightened need to vet conflicts even heavier than if I had been simply outside defense counsel.  No piece of general  counsel’s workload is transferable and therefore, no conflict is waivable.  Therefore,  on the front end, any firm considering a lateral hire who has one foot in the general counsel role and one foot in private practice, must consider actual conflicts, as well as future conflicts with:  competitors, outsider investors and other interested individuals in the company such as Key Opinion Leaders, physician users, etc., secondary market or used device sellers, and most importantly, how the current work of the GC fits within the overall existing practice areas of the firm such that cross-claims and third-party issues do not rear their ugly heads.   Keeping in mind that general counsel may oversee outside local counsel depending upon the company’s insurance scenario (SIR versus deductible), this adds yet another layer of vetting. 

 

The best way to avoid a dilemma like the one that I experienced? Ask the lateral to present a “kill” list of company names, general types of companies that are adverse to the GC’s company, and perhaps individual names which must be flagged for actual or potential conflict purposes going forward.  The GC’s company may have exiting contracts to do business with these entities  or may just be aggressively positioned against these entities in the industry such that having proprietary information on a joint server (or even with a  Chinese wall in place) poses a conflict.  Additionally, the list should include “friends” of the company to which the law firm can never be adverse.  As far as the law firm is concerned, a broader “ask” to the law firm’s lawyers must be attempted to assure there are no existing clients in the same or similar industry as the GC’s client.  If there are such clients, then it is imperative that both sides know such relationship(s).

 

2.

Second, and probably most importantly, this experience demonstrated first-hand how strong of a bond that Federation members enjoy.  It is THAT BOND which made my relatively speedy transition possible, and also cordial.  Federation lawyers rallied to re-home me provided their genuine support, professionalism, and collegiality.  While our spiral wound roster provided a critical initial source of guidance for steering the ship, the personal touches from our members were unparalleled.  FDCC is the best organization-BAR NONE—and  in my opinion, no other professional organization can offer stronger friendship bonds amongst its members.  Admissions Committee, you are hitting it out of the ball park as far as selecting members…please keep it up.  FDCC leadership, thank you for teaching us fellowship and civility.

 

Did you reach out to FDCC members for help?  Absolutely and they also reached out to me daily throughout the months of July and August.   Rather than call those FDCC members out by name, the real learning here is that we stick together.  Countless lawyers around the country, including the one interviewing me, went out of their way to call, text, and email to assure the transition was progressing and progressing hastily.  That is the Federation way.  An unwaivable conflict gave way to an unwavering bond that all FDCC lawyers share.    

 

What assistance did they provide?  They offered overwhelming support including phoning friends in Maryland;  taking lead on joint FDCC projects;  offering their staff to assist on projects and case assignments as a stop gap; setting  up conference calls with their office managers to run through the practicalities of hanging out my own shingle.  I have no  doubt that the Federation is THE SINGLE BIGGEST REASON that this worked out the way it did, with long standing friendships preserved and new bonds forged.

 

 

Tips for Young Lawyers – How to Find the Right Expert

 

            As a young lawyer, you may be asked to track down prospective experts.  There are many places to look. Before embarking on your search, ask yourself what type of expert you are looking for:

 

Should the expert have a national reputation?

 

Should he or she be published?

 

Should he or she be a professor or instructor?

 

Should he or she have led a relevant professional association?

 

How many years of experience should he or she have?

 

What educational background are you looking for?

 

Do you need a professional expert?

Do you prefer someone with little testifying experience?

How much experience should he or she have in handling depositions?

 

How experienced should he or she be at testifying at trial?

 

How aggressive do you expect opposing counsel will be cross-examining him or her?

 

What skeletons in his or her closet are you willing to work with?

 

How much is your client willing to pay?

 

What technical issues will the expert need to tackle?

 

How broad a range of expertise are you looking for?

 

When looking for an expert, consider the following sources to mine for one:

 

1.    Google search. Go online and search for the topic that you will need the expert to testify upon.

 

2.    Google Scholar. Look up experts who have written on your topics.

 

3.    Local Universities. Look up the faculty lists for local universities.

 

4.    The Ivies. Look up the faculty lists for the premier universities.

 

5.    Expert Referral Services. Study the lists of experts available on expert referral services.

 

6.    Bar Association lists. Plaintiff and Defense Bar associations often provide lists of experts used and approved by their members.

 

7.    Colleagues. Send an e-mail to colleagues requesting recommendations. Create a circle of other attorneys who ask one another for expert referrals. Make sure to make recommendations when you can, just as you will be asking for recommendations.

 

8.    Professional Associations. Look for the professional associations that cater to the type of expert you are looking for. See who is heading or has previously led those organizations. The ones who have held leadership positions generally are more active in their field.

 

9.    Verdicts. Do a search of jury verdicts to see which experts’ names come up, particularly experts who appear repeatedly. What are the verdicts associated with their testimony? In the cases they testified, were the results generally favorable for their clients?

 

When searching for an expert, remember that your goal is to find one that will resonate with the jury (even though most cases settle long before trial). Since your jurors are local, consider a local expert. Search through the faculty list at the local university, and search for someone who is published (demonstrates he's an expert), who teaches (shows that he is comfortable in front of others, teaching them about his expertise, as he will need to do with a jury) and has real world experience relevant to the issue central to your case. Being from Miami, an expert from the University of Miami or Florida International University may have a greater influence on a jury than someone from the Ivy Leagues. Often the expert you are looking for is in your own backyard.

 

When you have crafted your list of potential experts, take the time to pick up the phone and call them. Yes, you call them. Not a paralegal or a legal secretary. You. Who you hire as an expert can make or break your case, so take the time to become acquainted and comfortable with your choice. Before speaking with him, though, ask his office for a copy of his curriculum vitae. Review his C.V. closely, looking for the following:

 

1.             Is he published? Are any of his texts or articles relevant to the issues in your case? If so, you need to review them. You can't have your expert taking a position in your case contrary to his prior writings. If his publications undermine your case theme, consider another expert.

 

2.             If you're retaining a doctor, did he have to leave the country for medical school?

 

3.             Has he ever held any leadership positions where he was elevated by his peers?

 

4.             Has he received any honors or awards?

 

5.             Does he hold any teaching positions? Is he still active in academia? Professors are accustomed to teaching and your expert will have to teach the jury about your case.

 

6.             When's the last activity on his C.V.? If it's been years since he's written or spoken on a panel, he may not be up on the latest trends.

 

7.             Does anything in the C.V. not feel right? Intuition is powerful. Ask the expert about your concerns. More and more, we read about heads of companies, coaches, and experts fibbing on their resumes, assuming no one will ever find out. Assume your opposing counsel will find out. Even if no one ever has, assume your opposing counsel will be the first. If anything causes you to raise an eyebrow – a degree from a certain university, a speaking engagement, an award – take the time to independently verify it.

 

In addition to reviewing his curriculum vitae, find everything you can about the expert online. Do a search of the following:

·      Google

·      Google Scholar

·      Westlaw

·      Expert’s website

·      Expert’s blog

·      Linkedin

·      Facebook

·      Online articles

·      Online comments on blogs or message boards

·      Prior appellate opinions

·      Prior affidavits filed by expert

·      Online versions of his CV (compare to his current CV)

·      Licensing boards

·      Professional Associations

·      Pacer

·      Prior Depositions

 

Conduct the same investigation you would conduct on the other side’s expert. Be assured, that once you disclose your expert, opposing counsel will do everything within his power to find the dirt on your expert. Find it first. Investigate any chinks in the expert’s armor. You want to learn about them now, before you retain him, rather than hearing it for the first time at his deposition, or worse, at trial.

 

After you have reviewed the C.V. and done your online research, you are ready to interview the expert. There are two types of questions - the ones about his expertise and the ones about the skeletons in his closet. The ones about his expertise include:

 

1.    How long have you practiced in ___ field?

 

 2.    What are your general opinions about topic ____?

 

3.    So far, our case is based on _____themes? What do you think about those themes?

 

4.    We anticipate the other side will rely on ______ themes? What do you think about those themes?

 

5.    The facts of the case are ____. Based on those facts, what was our client’s responsibilities? What were the opposing party’s responsibilities?

 

6.    What are the applicable standards?

 

7.    How familiar are you with the issues involved in our case?

 

8.    How much do you charge?

 

9.    How much do you anticipate charging in this case?

 

These questions are directed to gain an appreciation about the expert’s expertise - how broad and deep it is and how applicable it is to your case – and to gain an appreciation regarding what his role will be in your case.

 

If you’re comfortable with his expertise, then ask him the tough questions. You owe yourself and your client the duty to ask your prospective expert these questions. Be upfront with him. Let him know that you ask all your prospective experts some tough questions. You do not mean to offend him and he should not be offended. Let him know that you, someone you know or someone you read about had a bad experience with a seemingly qualified expert and because of that experience, you go through a thorough list of questions just to avoid any surprises. Your questions will help you find out the following that the expert neglected to tell you:

 

“I am a convicted felon.” Yes, your expert may have a criminal past. He may have been guilty of crimes that undermine his credibility. Ask him if he’s ever been convicted, arraigned or arrested. And then do your online background search to confirm his answers.

 

“I am a person of interest in a federal investigation.” It is easy enough to find out if an expert is a convicted felon. But what if he is a yet-to-be-convicted-felon? Just ask him. And by the way, do Google searches for your experts, and check the websites for the local papers where they reside to see if they have received any negative press.

 

“I had a substance abuse issue.” Experts are human like the rest of us. They too can succumb to the temptations of alcohol and drugs. If it has affected their professional life, such concerns may have been flagged by their licensing board.

 

“I lied on my curriculum vitae.” Yes, sometimes experts fudge their resumes. And yes, they are naïve, or arrogant or just plain dumb enough to think no one will find out. If your expert lied on his resume, his credibility is shot. Who is going to believe what he says about whether a given product is defective, when he lied about what degrees he earned or what course work he took? If there is anything that raises any red flags on his CV, ask him about it. And ask him the ultimate question, “Are there any issues on your CV I should be concerned about?”

 

“My professional license was suspended.” “So Mr. X, has your license ever been suspended, revoked, curtailed or been the subject of an investigation?” Just ask. Also, he may belong to a board, organization or association that keeps track of such suspensions and makes them available to the public. Take the time to look and confront the expert with what you find.

 

“I collapse like a deck of cards at trial.” There are experts, and then there are experts. There are those experts who look great on paper, but when they take the stand they wilt like a dandelion. You need to ask them how often they have testified at trial and the verdicts in those cases. Then ask for the attorneys who retained them in those cases and ask them how the expert performed on the stand.

 

“I have a bit of a temper.” Some experts are prima donnas. Some have short fuses. Some are temperamental. Some are impossible to get a hold of. You need to spend some time with your expert and gauge his personality. Is he going to be easy to work with or does he have an ego, personality or character flaw with which you will have to contend. Ask for references of other lawyers who have retained him and ask them how easy (or difficult) this expert was to work with.

 

“My opinions have changed.” Your expert may have already addressed the very issue central to your case in a prior case. In fact, he may have once held an opinion that is just the opposite of his opinion in your case. You need to ask him whether his opinions have changed or evolved and ask for the names of the cases where he tackled the same issue and get his report or deposition from that matter. Odds are opposing counsel is going to get his hands on that report or deposition.

 

“My opinions have been disqualified.” Find out if he has ever been the subject of a Daubert challenge, and if so, whether the challenge proved successful. Has a court ever limited or struck his opinions? Has a court ever stated he was unqualified? Has his opinions ever been the subject of a written opinion? Make sure to do a Westlaw search to see if any appellate decisions have criticized the expert.

 

“I don’t think you’re going to like that article I wrote.” You hire experts because they are leaders in their fields. As experts, they often have been published and have taken positions in the articles they have written. You need to ensure those positions are not contrary to yours. Ask him what articles he has written on your topic, review them and make sure they support, not undermine, your case.

 

“I cost a fortune.” On the front end, find out what the expert is going to cost. In fact, ask what he generally charges for cases such as yours. Be up front regarding what records you want him to review, what testing you want him to perform, whether you need a report and when you need it. After you’re honest with him about what you want, press him to be honest with you about what his final bill will be. Clients hate big expert bills, and juries are suspicious of them.

 

This is not an exhaustive list of tough topics. Some other tough questions to ask include:

1.    Have you filed for foreclosure?

2.    Have you filed for bankruptcy?

3.    Have you ever been sued by a client?

4.    Have you ever sued a client?

5.    Have you ever been accused of sexual harassment? Discrimination?

6.    Have you ever been fired?

 

Your expert is there to help your case, not undermine it, and nothing undermines your case more than an expert with a secret that affects his credentials or credibility. Take the time to ask the hard questions. You will be surprised how often you will come across an expert who is not what he seems to be and who can hurt your case with who he really is. A little legwork can help you avoid retaining such an expert and retain the right one for you, your client and your case.

 

After you speak with the expert and are prepared to take the next step, ask for two to four references, other attorneys (both plaintiff and defense) who have retained his services. Call them, and ask them:

1.             Is he easy to work with?

2.             Is he arrogant?

3.             Does he have any pet peeves?

4.             How responsive is he? How responsive is his office?

5.             How good of a witness is he at deposition? At trial?

6.             How much was his total charge to you in your case?

7.             Does he have any skeletons in his closet?

8.             Where is he subject to impeachment?

9.             Any issues with any of his licenses or certifications?

10.          What did you like about him? What didn't you like about him?

11.          Would you use him again?

12.          Anything else you remember about him?

Track down prior depositions the expert has given, as well as prior trial testimony, and review it. How does he come across? What skeletons came out? What flaws were exposed? How did his opinions hold up under cross-examination? If your expert is hesitant to direct you to prior testimony, that may be a red flag.

           

The right expert can make your case.  The wrong can break it.  There is no such thing as too much due diligence when deciding upon an expert.

 

 


 

November 2017

Submitted by: Francisco Ramos, Jr.

 

Amelia Island Meeting

 

The Opioid Dilemma - Pain and Punishment

 

Without regard to race, ethnicity, gender, age, geography, socio-economic or other demographic, the opioid crisis has grown to be the most inclusive health crisis in American history.  And opioids now sit at the top of the agenda for state and federal regulators, legislators, prosecutors and civil litigants.  As the media points blame at every stage of the vertical distribution chain; from manufacturers to distributors, dispensers, hospitals, healthcare providers, employers, and possibly even extending to payors, schools and municipalities, our panel will discuss where we are, how we got here and what steps should be taken towards a solution.  We will peel back the veneer to expose the themes that comprise the claims to ensure that lawyers defending these claims are prepared to construct a cogent and compelling defense.

 

 

10 TIPS FOR DEFENDING DRUG AND MEDICAL DEVICE CASES

By: *Michael Bonasso, Lindsey M. Saad, and Elizabeth L. Taylor

 

 Drug and medical device cases are much like other serious product litigation, with certain nuisances depending on the product in issue. With drug and medical device cases, you will find yourself working with skilled and knowledgeable in-house counsel. These individuals will help guide the course of the litigation and are invaluable resources on the product and the company. We include the below ten tips and areas to think about when defending a drug and medical device case.

 

1.    What to do when a new D&MD CASE lands on your desk

 

First, determine the client’s goal for ultimate resolution of the case. Does the client want to settle the small damages cases or show plaintiffs’ counsel that the cases do not have merit through a strong defense? Is it possible that the case will open the flood gates of related litigation? The client will play a large role in the early development of the plan for the litigation, but will rely heavily on a litigator’s experience to read the “tea leaves” and anticipate the future of the case and litigation on that drug or device.

 

2.    Crucial items to do at the onset of the case

 

Once you have an understanding of the client’s goal for resolution, identifying and retaining quality experts will help flesh out the nuanced defense themes and alert you to any weaknesses. The expert may also help you identify key documents to obtain from the client and regulatory agencies and research to gather on specific topics.

 

3.    Documents to collect

 

If there has been other litigation for related products, obtaining documents already disclosed is an easy first step. This will help you see the strategies that Plaintiffs are attempting to develop in your case. Other categories of documents to consider include: correspondence with the Federal Drug Administration (“FDA”), internal memoranda about the drug or device, emails regarding the development and approval, clinical trial or testing history, and sales representatives’ custodial files.

 

4.    Witnesses to interview or depose

 

Aside from the typical cast of characters in any product liability case, you may consider interviewing or deposing individuals involved with product development (R&D), program directors, and sales representatives (depending on the type of product). It is also important to get an idea of internal defense witnesses that may be deposed. Meet with them if possible and begin an initial prep earlier rather than later.

 

5.    Discovery Plan

 

As part of the discovery plan, evaluating jurisdiction and venue should be at the top of the list. Is personal and subject matter jurisdiction proper? Is this a case where preemption will apply? Can you invoke federal question jurisdiction to remove to federal court if diversity does not exist? Next, it is very helpful to build a history of the product or drug and learn about predecessor products/drug development, design, testing, trials, warnings, marketing and selling of the drug or product at issue. This will dovetail into discovering the approval records, sales history, and complication rates that will help drive the defense of the case.

 

6.    How to keep the case moving forward toward a favorable resolution

 

The more you know about the good and bad of the drug or product you are defending and how the course of discovery is likely to proceed, the better the odds of moving the case in the direction that you want. It is often difficult to anticipate that a key corporate witness may blunder through a deposition, so in those instances, keeping the client timely apprised of new developments will weigh in your favor. Similarly, if you anticipate that certain depositions may go poorly, the timing of settlement negotiations can be critical.

 

7.    What makes a D&MD CASE a candidate for early settlement

 

Obviously, this is a client choice primarily. However, outside counsel might recommend early settlement when there are other similar cases that will make defending the current case difficult. Also, there are times when a case is filed too early in a product or drug’s lifespan to make it easy to defend because more time is needed to develop the overarching themes and defenses. The client may opt to settle an early case, so as to more fully defend a similar case later. Of course, the usual suspects are those cases with limited damages or cases that may be “one off” cases that may never be replicated.

 

8.    Getting ahead in Multi-District Litigation and Class Actions

 

Drug and medical device litigation can present the unique challenge of Multi-District Litigation (“MDL”) or mass tort claims. MDL or other mass cases require finding ways to simplify thousands of claims into common themes for defenses and damages. Early, case-specific strategies also will help guide MDL litigation and assist with evaluating what criteria will result in the ideal “bellwether plaintiff.” In class actions, one way to aggressively handle these cases on the front end for your client is to defeat class certification.  Pre-certification discovery and investigation combined are effective tools to utilize when opposing class cases.

 

9.    Regulatory Activity

 

As with many products, drugs and medical devices are heavily regulated.  The FDA and certain regulatory activity may play a key role in your case themes and defense.  For instance, depending on the claim, certain regulatory activity may be required.  There could be the need to report to the FDA or to get the company regulatory and compliance attorneys involved. Because of the important role the FDA plays not only in the development of these drugs and devices, but also with the approval of the products and whether they can be on the market (which, in return, directly impacts the client’s financial health and future), it is important to evaluate on the front end of the litigation whether any specific regulatory activity is required or ongoing.  

 

10. Items outside counsel can help the client address

 

Outside counsel’s role is not just limited to one case or even litigation in general.  Rather, outside counsel can provide a valuable function to the client in a myriad of other areas outside the specific litigation involved, such as assisting with any public relations issues, dealing with any consultants, and offering guidance regarding communications with company shareholders and board of directors. Outside counsel also can play an important role in helping the client recognize (and thus plan) long term by looking at the big picture – for both the product and the company in general.  We have all heard some variation of the joke that no one ever thinks of the phrases “outside counsel” and “cost savings” in the same sentence, but by helping the client appreciate the potential outcomes, outside counsel can do just that. This can result in the client taking proactive measures to minimize risk and exposure and thus, avoid future lawsuits, saving the client valuable time and money in the long run.

 

Michael Bonasso is managing member of Flaherty Sensabaugh Bonasso PLLC in Charleston, WV. He has extensive experience defending complex litigation cases. In products liability, he represents manufacturers of medical devices, vehicles, industrial and agricultural equipment, recreational equipment, and consumer/commercial tools. He can be reached at mbonasso@flahertylegal.com or (304) 347-4259.

 

Lindsey M. Saad is a member practicing in Flaherty’s Morgantown, WV office. Lindsey has a broad practice that includes defending cases involving drugs and medical devices, long term care, medical malpractice, product liability and complex personal injury and wrongful death claims. She can be reached at lsaad@flahertylegal.com or (304) 225-3052.

 

Elizabeth L. Taylor is a member practicing in Flaherty’s Charleston, WV office. Elizabeth concentrates her practice in civil litigation, particularly in the defense of drug and medical device manufacturers as well as automotive and industrial equipment manufacturers in serious personal injury and wrongful death cases. She can be reached at etaylor@flahertylegal.com or (304) 347-4217.

 

 

An Interview with William Vita about Defending Drug & Medical Device Matters

 

1.    Tell us about yourself and your practice.

 

I have been a trial attorney for 34 years.  I am a partner in a mid-sized law firm in New York.  We regularly practice in all of the jurisdictions in southern New York.  To the extent that I have a specialty, it is complex litigation.  I have been fortunate enough to work on many different types of matters, including:  commercial disputes; asbestos and other mass torts; employment; product liability, including medical devices; multi-district litigation and class actions.  The diversity of cases has made my work much more interesting than it would have been had I only worked on one type of litigation.

 

2.    Drug and Medical Devices cases have a lot of moving parts.  How do you keep everything moving forward toward a favorable resolution?

 

I try to discuss an overall strategy with my clients at an early juncture in each matter.  We try to decide what type of resolution we want to shoot for.  For example, is it a case that is susceptible to summary judgment?  Should the case go to trial?  Is it a case in which my client is a small player among several defendants and therefore we want to take a lower profile?  Can I show plaintiff’s counsel that my client’s device could not have caused the plaintiff’s injuries?  The ultimate desired outcome will determine the path we take to arrive at that goal.

 

3.    What do you do when a new D&MD lands on your desk?

 

I try to work with the client to understand the medical device in question.  Usually that means talking with technical representatives and sometimes engineers about the device, as well as reviewing the client’s manuals and brochures.  Medical devices can be highly technical and often incorporate cutting edge technology.  A defense attorney needs to understand the engineering in order to explain the workings of the device to the court and adversaries and also to properly question witnesses. 

 

4.    What are crucial to do items at the onset of the case?

 

If the case is originally filed in state court, the most important thing is to determine if the case can be removed to federal court.  If the case can be removed, then we ask if the case should be removed to federal court.  In our state court system, litigants do not have the right to depose expert witnesses.  This is usually a crucial factor in determining whether or not to remove the case.  If the case cannot be removed, then it is crucial to check if venue is proper and to check the statutes of limitations, including UCC § 2-725.

 

5.    What documents are you trying to track down?

 

The plaintiff’s medical records are key to understanding how the device interacted with organs or systems within the plaintiff’s body.  It takes time to assemble all of the plaintiff’s medical records and therefore this is a crucial early first step.  Conversations with the client about how the device was approved and how it works, usually determine what type of internal documents we need from the client.  It is helpful to talk with plaintiff’s counsel at a very early stage to determine what the plaintiff’s theory of liability is.  This will help determine which of the client’s documents are relevant to the defense of the matter.

 

6.    Which witnesses do you want to interview or depose?

 

I like to speak with internal witnesses who can explain the device and who will not be rattled by appearing at a deposition.  These conversations can also shape our thinking on whether or not we will want to retain outside expert witnesses to complement our in-house witnesses.  With regard to plaintiff’s witnesses, it is important to review the plaintiff’s disclosures to determine the witnesses that they identify.  The plaintiff should then be questioned about those witnesses during the plaintiff’s deposition.  If it appears that the witnesses may offer helpful testimony, they should be interviewed and/or deposed.  Indeed, even if a witness is likely to offer unhelpful testimony, they should usually be deposed so that the defendant knows exactly what they will say at trial.  This allows the defendant to build its defense accordingly.

 

7.    What makes a D&MD a good candidate for early settlement?

 

I try to talk to plaintiff’s counsel early in the litigation, in a non-adversarial manner, to explain the workings of the device and to candidly discuss the strengths and weakness of the plaintiff’s case.  At that point, we can usually determine whether the plaintiff really wants to pursue an early settlement for a rational and reasonable number.  If that is the case then early settlement will work.  It is also important to accurately assess plaintiff’s damages as early as possible.  If the case is of relatively modest value it may make the most sense, from a business perspective, to resolve the case as soon as possible and thereby save on defense costs. 

 

8.    What does your discovery plan look like?

 

 Our discovery plan is pretty simple.  We serve paper discovery, review the responses and then take the plaintiff’s deposition.  The results of those two things usually dictate the remaining discovery.

 

9.    What’s the role of counsel in helping the client appreciate the potential outcomes?

 

My corporate clients are very experienced and savvy about litigation in general and potential outcomes.  I think outside counsel perform a valuable role in explaining the quirks of the jurisdiction and how that will affect potential outcomes.  In particular, it is important to explain the expected jury pool and how potential jurors are likely to view large corporations.  It is also important to explain the leanings of the judge or judges who will hear the case.

 

William E. Vita is a Partner in the New York law firm of Westerman Ball Ederer Miller Zucker & Sharfstein, LLP  He has also held leadership roles in national bar associations, including the Federation of Defense and Corporate Counsel and the Defense Research Institute.  He is a Fellow of the Litigation Counsel of America, The Trial Lawyer Honorary Society.

 

 

 An interview with Brooks Magratten about Jury Selection

 

Tell us a little about yourself and your practice?

 

 I am a partner in the Providence and Boston offices of Pierce Atwood, LLP.  My practice concentrates on litigation of ERISA, Life, health & disability insurance and annuity claims.

 

What was your first experience picking a jury?  What lessons did you take from it?

 

 I conducted voir dire as an associate in a casualty case. An allegedly defective window casing caused a glass pane to fall on a bar patron’s head, embedding glass shards in his scalp.  I learned to be sincere and straightforward with the venire.  Plaintiff’s counsel oversold his case from the start.  The jury punished the plaintiff in the end.

 

What do you do to prepare for jury selection?

 

 I focus on major themes of the case and design questions to elicit juror reactions to those themes.  Most of my work is in federal court where most judges vet voir dire questions and ask the questions themselves.

 

Do you go into jury selection with a “juror profile” you want to select?

 

 In my experience most assumptions about juror age, gender and occupation turn out to be incorrect.  My principal criteria are 1) education and 2) interest in serving on the jury.  I want jurors who are intellectually curious and who want to serve.

 

Do you rely on jury questionnaires? 

 

 Most judges in my jurisdictions will permit jury questionnaires in more complex cases.  The biggest challenge is crafting questions that will elicit truthful and meaningful responses.  Many jurors do not want to reveal personal information in a written questionnaire where 1) they do not know who will read responses and 2) when or if responses will be destroyed.

 

What rules of the road would you share with our readers about jury selection?

 

 Remember theories of primacy and recency.  Voir dire may be your first impression with the jury.  Be yourself.   Be honest.  Let the jury know you (and your client) are grateful for their involvement.  Do not talk down to the jury or be overly formal.  Speak like you would address a next door neighbor.

 

What pitfalls should you avoid?

 

 See comments above

 

What are your thoughts on jury consultants?

 

 Can be helpful in the large case.  Again, however, in my experience many assumptions about juror age, gender and occupation end up being incorrect.

 

Any last thoughts on jury selection?

 

 See comments above.

 

Brooks Magratten is a partner at Pierce Atwood, LLP, where he is the partner in charge of the firm’s Providence, Rhode Island office.  He concentrates in insurance and financial services litigation.  Brooks is a former Northeast Regional Director on the DRI Board and is a current member of the ADTA Executive Committee.  He is a frequent author and lecturer on ERISA law.

 

 

 

 

October 2017


The Opioid Dilemma - Pain and Punishment

Michael Walsh

Strasburger & Price LLP

Michael.Walsh@strasburger.com

 

Without regard to race, ethnicity, gender, age, geography, socio-economic or other demographic, the opioid crisis has grown to be the most inclusive health crisis in American history.  And opioids now sit at the top of the agenda for state and federal regulators, legislators, prosecutors and civil litigants.  As the media points blame at every stage of the vertical distribution chain; from manufacturers to distributors, dispensers, hospitals, healthcare providers, employers, and possibly even extending to payors, schools and municipalities, our panel will discuss where we are, how we got here and what steps should be taken towards a solution.  We will peel back the veneer to expose the themes that comprise the claims to ensure that lawyers defending these claims are prepared to construct a cogent and compelling defense.

 

 

FDCC Members Leads NAWL

Angela Brandt

Larson King LLP

abrandt@larsonking.com

 

Can you tell us a little about yourself and your practice?

 

I grew up in South Dakota thinking I wanted to be a doctor.  At some point during college physics, I realized practicing law may be more aligned with my skillset.  I am now a trial lawyer/litigator at Larson King in St. Paul, Minnesota.  I focus on products liability, employment, and commercial litigation.  Because of my background and the fact my brothers and I recently bought my parents’ farm, I am particularly interested in the agriculture industry.  I’m licensed in Minnesota, North Dakota, South Dakota, and Wisconsin.

 

For our members who don’t know much about NAWL, can you tell us what are the most important items it is tackling this year?

 

NAWL was established in 1899 – before women could vote!  The important items then are the same as now:  advancing women lawyers in the law and protecting women’s rights under the law.  In 2016, NAWL issued the One-Third by 2020 Challenge.  This challenge to the legal profession seeks to increase the representation of women across five areas of the law.  The areas include: Fortune 1000 General Counsels; law firm equity partners; law firm lateral hires, law school deans, and diverse female attorneys (including women of color and LBTQI attorneys).  Our meetings and programming are designed to help women in each of those areas advance in their careers and give tools to the organizations that employ them.  Progress has been slow (see the results of NAWL’s recent survey here: http://www.nawl.org/p/cm/ld/fid=1163  ) and we are hoping to accelerate some movement.

 

What’s your vision this year as President of the organization?

 

My vision for the year is for NAWL to be a place where attorneys with different backgrounds and ideas can come together and find some commonality.  It is when we find the commonality that we connect with one another and figure out how to work together.  I am particularly focused on the NAWL Challenge Club.  An initiative developed a couple years ago with another FDCC member, Alan Bryan of Walmart.  The Challenge Club provides opportunities for high potential female non-equity partners or senior associates to make connections with corporate legal departments seeking to hire more female outside counsel.  The overall goal is to increase the number of female equity partners in law firms.

 

What are your goals?

 

Overall, my goal is to leave NAWL just a little better than where I found it.  I hope to do this first by engaging in strategy work this year to establish ways to attract and strengthen relationships with sponsors and clearly defining NAWL’s ROI to its members.  Furthering the commonality theme, I also hope to find ways to involve more men and diverse lawyers in NAWL.  I believe there are ways for us to craft conversations that allow us to better hear and respect one another when discussing development and advancement of women lawyers.   

 

How can FDCC work with NAWL to help each other accomplish their respective purposes?

 

Perfect question.  I think there is an opportunity for each of the organizations to increase membership by helping the other with visibility.  NAWL can assist FDCC with its goal of increasing diversity in its membership.  There are countless phenomenal lawyers who are members of NAWL.  Likewise, NAWL is always open to more members – of any gender or background.  I have re-joined FDCC’s Diversity Committee and hope to collaborate throughout this year and beyond.

 

How can FDCC members get involved with NAWL?

 

I would be happy to speak with any FDCC member looking to engage with NAWL.  We have a number of events throughout the year.  We have  a number of active committees including our programs, membership, sponsorship, mentorship, and diversity and inclusion.  We also have a number of Affinity Groups that are specific to practice areas.  More information on all of this can be found at NAWL.org

 

 

Working with Local Counsel

Beth A. Bauer

HeplerBroom LLC

Beth.Bauer@heplerbroom.com

Can you tell us a little about yourself and your practice?

 

I have been in private practice at HeplerBroom for 16 years, after a year working as a law clerk for a judge on the Missouri Court of Appeals, Eastern District.  I provide creative solutions to clients’ complex legal problems in some of the most difficult jurisdictions for defendants in the U.S. – St. Louis City and Madison, St. Clair, and Cook Counties in Illinois.  I typically work on “bet the company” litigation in the form of class actions and mass torts, alleging consumer fraud, injury from products (typically pharmaceuticals and medical devices), and damage from environmental impacts.  For the past two to three years, I have worked primarily on mass actions alleging that a major personal care products manufacturer’s talcum powder products cause ovarian cancer.  My husband Brock Bauer is a pharmacist by training and now works as a healthcare consultant, and we have three daughters, Ainsley (14), Ava (10), and Camille (6).  I am an American Heritage Girls troop leader, serve in my church and community through various missions projects and outreach, and spend other “free” time hiking, going on Jeep rides, and cheering for the Blues hockey team.      

 

And you handle matters for clients as local counsel?

 

Although I have been the lead lawyer on complex litigation, I also often partner with other lawyers serving as national counsel for a client facing the same type of lawsuit filed in multiple jurisdictions.  Often, because the jurisdictions where I practice are considered beneficial for plaintiffs, the cases I am involved in are at the forefront of the national litigation.   Thus, I work with national counsel to develop strategies for handling the litigation that will benefit our client throughout the country and not just in my local jurisdictions. 

 

What responsibilities do you have as local counsel?

 

The responsibilities vary by client, national counsel, and type of case, but I try to bring as much value to the team as possible so that my role grows.  As local counsel, I aim to be the most knowledgeable about the judge, jurisdiction, local politics, and law, which is what you would expect a good local counsel to do.   But, I also have much experience working on risky complex cases.  So, my goal in every engagement is to add value to the overall strategy and preparation of a case beyond a typical local counsel.  Once you demonstrate a grasp of the bigger picture and make valuable suggestions that benefit national counsel and the client, often you gain a larger role in the litigation.  Although I often act as local counsel, I have handled everything from acting as someone to file documents prepared by others to presenting key witnesses at trial. 

 

How do you manage to ensure everyone across the country is rowing in the same direction?

 

I try to help national counsel accomplish this by developing regular and thorough communication with them.  I don’t wait for national counsel to ask me for information, but strive to be pro-active to keep them informed and ask questions about what is occurring in other jurisdictions.  I don’t want to be responsible for an action in my jurisdiction that later hurts the client in another jurisdiction, so I need to stay informed of events nationwide.

 

You work with national counsel throughout the country?

 

Yes, I am honored to have worked with some of the brightest and most accomplished lawyers in our country.  Many of them have been FDCC members.  (The others, I have started proposing for membership.)

 

What are your expectations of national counsel?

 

I expect national counsel to treat my team and I as an extension of their team, thoughtfully consider our advice and input, and give us opportunities to do more than review documents to conform to local practice and file them.  When national counsel views us this way, we all achieve more for the client.     

   

How can I help national counsel? 

 

The greatest help I provide is set out above in my philosophy to elevate the value I bring to any engagement.  Additionally, my firm is equipped to handle large litigation and to try big cases.  We have top talent at every level of lawyer and staff, so I can provide national counsel more than just my expertise.  I have a very creative and accomplished team of lawyers and paralegals that have tried big cases.  We understand the client and national counsel’s concerns and often anticipate their questions and needs. 

  

How can national counsel, without meaning to, hurt you?

 

National counsel can hurt local counsel when they do not give local counsel any credit with clients or fail to keep local counsel informed of developments elsewhere in national litigation.

 

 

Preparing Your Client for Deposition

Tiffany M. Alexander

Tanenbaum Keale LLP

talexander@tktrial.com

 

Tell us a little about yourself and your practice?

 

My trial practice is devoted to the defense of corporations, product manufacturers, suppliers and insurers in complex litigation and personal injury matters. 

 

 

What types of clients do you defend in depositions?

 

I typically defend product designers, engineers and managers as designees or fact witnesses in product liability and negligence matters.

 

What are biggest challenges in preparing a client for her deposition?

 

The testimony of the corporate witness or designee is arguably the most critical aspect of the defense, and offers the best opportunity to educate the jury about the process by which decisions are made in business, not simply litigation. The case may not be won during the deposition, but it certainly can be lost if the witness is unprepared or ill-equipped to handle the examination by opposing counsel.   In cases involving experts and causation-based defenses, it can be very helpful to lay the groundwork for your expert opinions through the testimony of your design engineer.  For example, with the right experience, your witness may discuss (and possibly distinguish) a proposed alternative design in the context of the product development which will help your experts down the line.  

 

What are the pitfalls you try to avoid?

 

Putting up the wrong witness as a designee can have significant consequences for your client and may open the door to additional depositions.  I recommend working with your client early to identify the proper witness(es) based on your defense themes and the product at issue. An ideal designee will be knowledgeable, credible and cooperative.  Once the witness is identified, review and collect prior testimony of ensure you know what is already on the record and maintain a consistent message.   

 

How do you deal with a poor witness or bad facts?

 

Having been faced with both, I’ve found the best way to deal with it is directly.  It is critical that your witness is prepared to deal with or distinguish bad facts from your case, and can do it in a way that is credible and authentic.   Consider key words that the witness should avoid and offer alternatives.  Even a poor witness can be trained given the right amount of time and preparation.  A mock deposition tailored to the issue needing improvement, such as nerves, an inexperienced or “green” witness, and the overly confident witness who thinks they don’t need any help at all, is very useful.  This is sort of a good cop, bad cop approach, but it is effective and helps the witness experience the worst-case scenario before they are on the record. 

 

How much time do you spend with a client?

 

You cannot over-prepare for a deposition of a company witness, so the short answer is:  as long as it takes.  This will depend on the level of experience the witness may have testifying about the product or design allegation at issue, but at a minimum, I recommend 2 preparation sessions before the deposition plus ongoing contact as you both continue to prepare.  I do not recommend meeting your witness for the first time the day before the deposition.  Without the early lead time, you have no opportunity to gather and produce additional documents if need be, and your witness may not have enough time to prepare.

 

What is your process with the client?

 

I always meet with the witness for a preliminary session well in advance of the deposition.    In that first meeting, I get a sense if the witness is comfortable with the topics and defense themes and we discuss and identify any additional documents or information that is needed to support those themes.  If need be, we’ll gather the documents and produce them well in advance of the deposition so as not to open the witness up to a second “bite at the apple” based on surprise.   I then schedule additional preparation sessions as needed leading up to the day of the deposition. 

What do you tell your associates how to prepare clients for depositions?

 

Anyone preparing a company witness should be fluent with the facts, key documents and defense themes in the case before the first meeting.  If experts are involved, it may be useful to schedule a call or webex to discuss their preliminary opinions to help frame the defense themes.  It is also helpful to prepare a detailed prep outline before the first meeting to organize key documents and topics for discussion.  

 

What documents do you show your clients?

 

If the witness is a designee, he or she should review all of the documents produced by the company in the case.  Knowing their time is limited outside of our prep sessions, I collect key documents to discuss in detail during the prep session.  I never show my witness privileged materials or expert work product, and I only give them the most basic facts about the underlying accident to avoid the possibility of expert opinion testimony. 

 

Who gets involved with the prep session?

 

It depends on the witness, but I like to keep attendance at prep sessions limited to enable the witness to focus and minimize distractions.  Ideally, in-house counsel will attend all or part of the prep session, and at the very least, is aware of the intended areas of testimony and defense themes.  Collaboration with other lawyers or company witnesses on common issues or products can be very helpful, but be sure that you discuss the response if that question arises during the deposition.

 

Any other advice?

 

The goal for the extensive preparation is to ensure there are no surprises on deposition day, but that is never a sure thing. Whatever happens, defend your witness without being obstructive and take a break if he or she needs to re-group. You may also want to be armed with a direct examination to rehabilitate your witness if needed, and to ensure that your defense themes are conveyed in the most effective way. 

 

 

 

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?

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

1/22/2018
Webinar - Succession Planning for In-House Counsel

2/14/2018
Webinar - Responding to PR Nightmares

2/25/2018 » 2/28/2018
2018 Winter Meeting - Amelia Island

2/27/2018
Professional Women's Forum 2018

4/6/2018 » 4/8/2018
TechU

4/10/2018
FDCC Europe Regional Meeting

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