The Food, Drug, and Cosmetic Act (“FDCA”) was enacted in 1938 to regulate, among other things, the drug and medical device industry in order to ensure the safe and effective design, manufacture, sale and labeling of such products.  Due in large part to the growing cost of health care, in 1984, Congress passed the Drug Price Competition and Patent Term Restoration Act, commonly referred to as the Hatch-Waxman Act, which was instrumental in bringing generic drugs into mainstream production. 

One of the main goals of the Hatch-Waxman Act is to provide individuals with ready access to more affordable generic drugs.  Further, the government’s interest in providing affordable health care to the majority of Americans remains a top priority as evidenced by the Obama Administration’s recent hard push for health care reform.  Generic drugs play a key role in accomplishing these important goals.  Notably, “seven in ten prescriptions filled in this country are now for generic drugs.” Mensing v. Wyeth, 588 F.3d 603, 607 (8th Cir.2009).

So, if the legislative and the executive branches understand the importance of affordable health care, why is the judiciary rendering decisions that appear to ignore these public policy considerations?  In light of the regulatory provisions set forth in the FDCA and the Hatch-Waxman Act, and given today’s paramount concern over the rising cost of health care, coupled with the integral role that generic drug manufacturers play in accomplishing that goal, it seems wholly inconsistent that the judiciary would undermine these ideals by finding claims against generic drug manufacturers are not preempted.  While such a conclusion seems counterintuitive, the majority view appears to be leaning in the direction of no preemption.  More and more courts are holding that generic manufacturers have a duty to avail themselves of the Changes Being Effected (“CBE”) process notwithstanding the “same as” requirement for Abbreviated New Drug Application (“ANDA”) approval set forth in the Code of Federal Regulations (“CFR”), and decisions to the contrary are getting reversed.

In Wyeth v. Levine, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009), the United States Supreme Court squarely addressed the issue of federal preemption in the context of FDA approval of a New Drug Application (“NDA”), concluding that state law tort claims are not preempted by the FDA approval process.  It makes sense that the Supreme Court would hold that reference listed drug manufacturers are not immune from tort actions because they have an ongoing duty to monitor the effects of their products on human health and disclose known risks through the CBE process.  See Wyeth v. Levine, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009).  Since Congress places the onus on the manufacturer to monitor the market and not the FDA, the Supreme Court reasoned that state tort actions are one of the best ways to ensure adequate monitoring of the safety and efficacy of prescription medications.  However, Levine did not address whether the same would be true of a generic drug manufacturer, nor did it discuss whether the CBE process was open to manufacturers of generic drugs.

Among the first courts to address Levine in the context of a generic manufacturer was the United States District Court for the Northern District of Illinois in Stacel v. Teva Pharmaceuticals, USA, et al., 2009 WL 73274 (N.D.Ill. 03/16/09).  See also Schrock v. Wyeth, Inc., 601 F.Supp.2d 1262 (W.D.Okla. 2009), which was decided 5 days before Stacel.  In that case, the plaintiff, Melanie Stacel, sued Teva when she allegedly developed drug-induced lupus as a result of ingesting minocycline, a generic form of the reference listed drug, Minocin®.  Specifically, she alleged that Teva had information showing that minocycline may cause lupus, but did not disclose this in its package insert.  Teva filed a motion to dismiss arguing, among other theories, that her state law claims are preempted under the FDCA and the Hatch-Waxman Act. 

As part of its analysis, the court recognized that there are three forms of federal preemption:  (1) explicit preemption, which is stated in the statute itself; (2) implied field preemption, which can be inferred either from a scheme of federal regulation so pervasive as to make reasonable the inference that Congress left no room for state regulation, or where an Act of Congress touches a field in which the federal interest is so dominant that the federal system will be assumed to preclude enforcement of state laws on the same subject; and (3) implied conflict preemption, where state law is preempted to the extent that it actually conflicts with federal law.  Id., quoting English v. Gen. Elec. Co., 496 U.S. 72, 78, 110 S.Ct. 2270, 110 L.Ed.2d 65 (1990).  In other words, preemption exists where it is impossible for a private party to comply with both state and federal requirements, “. . . or where state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.”  Id., quoting English. 

In denying Teva’s motion and finding no implied conflict preemption, the court relied on its interpretation of the Code of Federal Regulations and the recent Levine decision, which held that failure-to-warn claims are not preempted as to the manufacturer of a referenced listed drug.  The court recognized that Levine is distinguishable because it did not involve a generic manufacturer, yet it nevertheless concluded that the reasoning was analogous with regard to generic manufacturers.

The Stacel court found compelling that Teva could not point to any instances where the FDA had withdrawn an Abbreviated New Drug Application (“ANDA”) because a generic drug manufacturer added to or strengthened its warning label.  Similarly, the Supreme Court in Levine also noted that it could not imagine that the FDA would bring an enforcement action against a generic manufacturer for strengthening its warning pursuant to the CBE process outlined in the CFR.  However, the question is not whether the FDA would bring an enforcement action, but instead, the question is whether Congress and the FDA found some other overriding policy consideration that it deemed to be paramount to the apparently ambiguous CBE regulations.  (While there is a colorful argument that the CBE regulations do in fact apply to generic drug manufacturers, the courts have not found persuasive conduct by the FDA and the United States government indicating that the CBE regulations were not intended to apply to generic manufacturers.  The reasons for their disregard of this expression of intent is unclear.)

As part of the ANDA process, the law requires that the manufacturer of a generic drug show that the labeling is “the same as” (or identical to) that of the reference listed drug; however, Stacel and the line of similarly situated cases hold that a generic manufacturer does in fact have an independent duty to strengthen its labeling through the CBE process, although it acknowledges that this can be done only after the approval process.  The court states that its reasoning conforms with the legislative intent behind these regulatory laws because the purpose of Hatch-Waxman was to provide a conduit by which manufacturers could produce more affordable pharmaceuticals, not to permit them to engage in negligent activities.  More particularly, courts seem to take considerable issue with the fact that a contrary holding would in effect leave an injured plaintiff without any substantive remedy.

Notwithstanding the court’s reasoning, one overriding consideration that seems to have been overlooked is the fact that professionals in the health care industry rely heavily on the consistency of labeling between manufacturers of reference listed drugs and generics.  For instance, in the context of prescription pharma, much of the information relied upon by health care professionals comes from the Physicians Desk Reference (“PDR”).  While the PDR is a commercial publication, it is widely used and often relied upon by physicians when rendering medical treatment.  Some courts have even gone so far as to say that the PDR is a learned treatise and can be relied upon as such for evidentiary purposes at trial.  See Kahanek v. Rogers, 12 S.W.3d 501 (Tex.App. San Antonio 1999). 

The PDR is a compilation of package inserts for reference listed drugs, and often times a number (although typically not all) of commonly prescribed generic equivalents are cross-referenced; however, the package inserts for generic drugs are rarely if ever included in the PDR.  Prescribing physicians typically are less familiar with a generic and write prescriptions based on their knowledge of the reference listed drug, although they typically authorize the administration of a less expensive generic if available.  Of course, the physician’s decision to authorize the use of a generic is premised on the generally accepted notion that the generic is “the same as” the reference listed drug.  If a physician was no longer able to rely on the “same as” presumption, he may be less inclined to authorize the use of a generic, which in turn results in an increased health care cost.  The same reasoning holds true for pharmacists who offer their clients a generic alternative.  Thus, the practical effect of Stacel and other similarly situated decisions on health care reform may be significant.  Surely Congress contemplated this when the legislation was passed, yet this public concern seems to have escaped the judiciary for the time being.

While Stacel may have been among the first to apply Levine to generic drug manufacturers, it certainly isn’t the last.  Recently, both the Fifth and Eighth Circuits have found that state failure-to-warn claims brought against generic drug manufacturers are not preempted by federal law.  See Mensing v. Wyeth, 588 F.3d 603 (8th Cir.2009); and Demahy v. Actavis, Inc., --- F.3d ----, 2010 WL 46513 (5th Cir. 2010).  In Mensing, the court would not say that the Code of Federal Regulations expressly permits a generic manufacturer to avail itself of the CBE process, finding instead that, in that case, it should have at least tried.  Seven weeks later, the Fifth circuit followed suit when it issued its decision in Demahy. 

Notwithstanding this line of cases, not all courts have gone so far as to extend Levine to generic manufacturers.  District courts are divided on this issue both across the country in some cases within the same state.  For instance, to date, among the post-Levine courts to address this issue, the Northern District of California, Western District of Kentucky and Southern District of Florida are among those in favor of preemption, see Gaeta v. Perrigo Pharm. Co., --- F.Supp.2d ----, 2009 WL 4250690 (N.D.Cal. Nov.24, 2009); Smith v. Wyeth, 2009 WL 425032 (W.D.Ky. Feb.20, 2009); Morris v. Wyeth, 642 F.Supp.2d 677 (W.D.Ky.2009); Wilson v. Pliva, 640 F.Supp.2d 879 (W.D.Ky.2009); and Masterson v. Apotex Corp., 2008 WL 3262690 (S.D.Fla. Aug.7, 2008), while the Northern District of Florida, New Hampshire and the Northern District of Illinois are against it, see Munroe v. Barr Labs., Inc., --- F.Supp. ---, 2009 WL 4047949 (N.D.Fla. 2009); Bartlett v. Mutual Pharm. Co., ---F.Supp. ---, 2009 WL 3126305 (D.N.H. 2009); and Stacel v. Teva Pharm., 620 F.Supp.2d 899 (N.D.Ill.2009).  Note, however, that the Kentucky decisions are currently on appeal to the Sixth Circuit, so this decision will be an important one to watch.

While both the United States and the FDA have expressed a contrary intent to this kind of broad-based application (see, for example, the FDA’s preamble to the proposed rule change relating to CBE submissions that was published in January 2008; see also Brief of the United States in support of Wyeth in Levine, 2008 WL 2308907), the prevailing trend is to find that tort actions against a generic drug manufacturer based on a failure-to-warn theory of liability are not preempted.  In the absence of a United States Supreme Court ruling or Congressional act directly aimed and correcting this inequity in the law, the majority rule will allow such claims to survive.

Lauren Fajoni Bartlett is a senior associate in the New Orleans, Louisiana, firm of Leake & Andersson, LLP.  She specializes in the areas of products liability, commercial litigation, insurance law, construction law and appellate advocacy.  She currently serves as the newsletter editor for the DRI Technology Committee, she is the vice-chair for the Technology Subcommittee for the Young Lawyer’s Section of DRI, and she also serves as the Young Lawyer representative to the DRI Insurance Law Committee.

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A few years ago, when I was expecting my first child, I attended a settlement conference in federal court. While the magistrate and I were waiting for the other side to respond to my most recent offer, we started talking about the challenges women in this profession face when it comes to balancing work and family.  She began reminiscing about when she was a younger lawyer and how demanding our profession can be on working mothers.  She shared with me a story about how she actually participated in a telephone mediation and settled a case while at the hospital delivering her first child.  Of course, being a bit younger and not yet realizing how incredible the demands placed on women in this profession can be, I thought she was nuts.  (Of course, I didn’t tell her that!)  I told myself that will never be me.  I figured whatever was on my desk on that glorious day could wait until I returned to work, or in case of an emergency someone else in the firm could handle it in my absence.  A few very short months later I found myself scheduling my delivery around an important hearing date “that only I could handle” and placing calls to the hospital’s technical support office to find out if the hospital had wireless rooms.  If not, I would need a room where my wireless card would be able to get a signal.  You can imagine the chuckle I got from that request!  When my efforts proved unsuccessful, I had to come up with a “Plan B” and fast.  So, I cleared a few days on my calendar, “scheduled” my delivery and began working remotely the following Monday.  If you think I’m crazy, then you probably haven’t had kids yet.  If you are laughing out loud, then my guess is you’re a mom and you probably did the same thing!

For those of you who have not yet endeavored to find that “balance” between work and family, you’re probably saying that’ll never be you.  I know I did.  But, for those of you who are fighting the good fight, you can probably empathize with my plight and you’re thinking back on your own war stories!  How do we do it?  It’s really quite simple – lack of options.  The good news is that we are venturing down this path at a time when we have so many tools at our disposal that make striking a balance possible.  The reason I decided to write this article is to provide some information about a few useful tools, and also to encourage you to take advantage of the tools we all now take for granted in order to relieve some of the stresses that face working women today. 

While many of us take for granted things like remote access and wi-fi service (these days, most coffee houses offer free wi-fi), we so often forget to take advantage of this kind of widely available technology especially on those “class outside” kind of days that you just hate to waste indoors.  Let’s face it, between the billable hours, the non-stop telephone calls, emails and constant intrusions at the office, and lest we forget the perfectly timed telephone call from your child’s school informing you that your little one is sick just as you are finally sitting down to draft that motion for summary judgment that’s been hanging over your head, there is just no time to stop and smell the roses.  So, we have to improvise.  You can’t take a day off – that’s not even an option – but you can, you should and you must somehow figure out how to strike a balance.  Here is what I suggest:  take your laptop, go down to your favorite coffee house, grab a latte, sit outside, logon to your remote access and get to work writing that motion.  The phone isn’t ringing (don’t forward your phone – opt to call in and get your messages instead), there are no interruptions, and you get to relax and enjoy a little quiet time.  It’s not perfect – personally, I’d rather be reading Cosmo or enjoying a spa day – but we have to take our indulgences where we can. 

Since my kids turned my life upside down, I have become fairly tech savvy out of necessity more than anything else.  Back in the day, things like remote access, laptop computers and wi-fi access either didn’t exist or weren’t readily available.  Fortunately, though, times have changed.  A lot.  From “basic” technology to the uber-chic PDAs that have since come to rule our lives, we can now practice law anywhere that has an Internet connection.  Most of us are used to grabbing the laptop and heading to the coffee house so we can work on Saturday or Sunday afternoon, but what’s stopping you from doing the same thing on a random Tuesday when the weather is perfect and you are a little stir crazy because you have worked through yet another weekend?  Between the hectic schedule that befalls us during the week and the impossible demands that are placed on us over the weekend, it is so easy to forget about us.  I’ve long since given up on reading a good book from start to finish – at least for now – but, by taking advantage of the technology that is placed at our fingertips, it’s possible to bill for that little bit of ‘me time’ that we all so desperately need. 

But, enough about ‘me time’ (such as it is); let’s talk about firm time.  As wives and mothers, we have to be prepared for anything.  What do you do when you are in charge of a major case, you’re a mom, you have a mega-conference with the client, a multitude of experts and probably several local counsel, and your child wakes up with a fever and can’t go to school?  You’ve spent countless hours setting up the conference and it can’t be moved, but you have to stay home and play mom, too.  What seems like an impossible situation is really quite simple to resolve.  Internet conferencing is a great way to collaborate, and with a little pre-planning (for just such an emergency) it can be done with very little effort: simply set up the conference initially as an Internet conference.  That way, you get to impress the participants with your modern approach to conferencing, you might even save the client a few bucks since you’re collaborating online instead of over-the-phone (which is never bad), and you have just made yourself very flexible in the event that a family emergency happens to come up just as your conference is about to start.  So, Internet conferencing is not only practical as a business practice, but it allows you to cope relatively easily with what can (and probably will) occur at some point in your career. 

Internet conferencing is the way to coordinate these kinds of larger scale meetings because they are so difficult to coordinate and even more difficult to reschedule.  You simply can’t afford to have something go wrong at the last minute, and for less than about $500 a year you can set up an Internet conference account that will allow you to share documents, make on-screen revisions and/or comment on shared documents, engage in a multi-party real time collaboration and even record the conversation for future reference.  Better yet, Internet conferencing gives you the flexibility to chair the meeting as easily from your home as from your office and no one is the wiser.  Further, regardless of the infinite number of extraneous circumstances that can present themselves on a given day, Internet conferencing is a phenomenal tool that can be used to maximize the productivity level of these kinds of collaborations.

If you would like to learn more about Internet audio and video conferencing, I highly recommend that you visit some of the websites that offer these services.  For instance, Citrix (a common remote access service provider) offers an online meeting service that incorporates all of these items in one fairly easy-to-use program.  One such website is located at www.gotomeeting.com (Citrix), and you may also want to check out www.webex.com (Cisco Communications) or IBM’s Lotus system, which can be viewed at www.webdialogs.com.  Internet conferencing offers countless advantages over standard conference calling, and it allows you to participate, with documents in hand, from anywhere.  So, whether you’re geared up and ready to chair the meeting in the office or you have to nurture a sick child while simultaneously spearheading a major defense brainstorming session, Internet conferencing can offer an easy and flexible way to fulfill the many, and often times conflicting, roles that we have to fill on any given day. 

If your firm has much occasion to deal with these kinds of conferences and you have not yet looked into Internet video conferencing, then I highly recommend sitting down with your tech support team and getting your office set up for this.  Local counsel would be responsible for technical compliance (which is usually nothing more than a one time relatively inexpensive expenditure), and the cost of setting up the experts or other attendees would be nothing more than a relatively minor part of the overall cost of litigation.  Plus, once the case is over, the equipment is returned to the firm for future use, so there is no real economic loss at all. Given what we spend on experts in mass tort litigation, a few hundred dollars spent to get connected is well worth the investment. 

Internet conferencing is a great tool, but mega-conferences such as those described above are hardly everyday occurrences.  So, let’s talk about what technology can do to help you maximize your day-to-day activities.  Let’s face it, while we are not supposed to, we all check our blackberries, iPhones or other PDAs of choice while traveling between destinations.  After all, that’s valuable billable time, right?  That being the case, it should come as no surprise that software exists that enables you to bill from your PDA.  Now that’s just brilliant!  There are a number of office management programs that offer a PDA component, and frequently the programmer offers free PDA downloads so that you or your firm will not incur any additional cost for the upgrade.  (Check out www.seabill.com or www.palmgear.com to get some ideas for your PDA.) By implementing this kind of software onto your PDA, you can capture some of the time you spend getting ready for traveling in your car, which in turn translates into a better bottom line and frees you up to take that extra five minutes at the coffee house enjoying your latte before heading home to the kids. 

That being said, let’s not get too crazy with overusing the PDA while we’re driving.  I mean, we do want to make it to where we’re going, right?  Fortunately, there are voice-to-text services that make it possible to respond to emails that just can’t wait even a few minutes.  After all, we don’t want to get completely distracted from the task at hand.  Most voice-to-text services are either free or relatively inexpensive, and if you are one of those people that spend as much time texting as you do driving, then I highly recommend looking into this.  These services allow you to call a telephone number and have your voicemail transcribed into a text message or email and sent to the recipient.  Of course, if you elect to try this out, you may want to invest in a Bluetooth if you do not already have one.  The Bluetooth makes this undertaking infinitely easier. 

There are a number of websites that offer voice-to-text services, such as www.youmail.com, www.nuance.com and www.jott.com, so if this is a feature that interests you, then I encourage you to check it out!

One of my favorite websites, which incorporates many of the tools I’ve outlined in this article, is Skype (www.skype.com).  This is an amazing service that can drastically reduce your personal and your firm’s long distance bill if used properly.  With Skype, you can set up free Internet conferencing with anyone around the world, participate in free video conferencing and take advantage of numerous other services for minimal cost.  Imagine having an hour long face-to-face conversation with your overseas client for free!  Now, imagine how impressed your client would be to learn that, in these financially trying times, you are looking to conserve resources and minimize costs.  That would undoubtedly endear you to your clients, and it instills confidence in your firm and could even result in more business from that client or through referrals in the future.  One never knows how far a little innovation can go when it comes to developing a competitive edge, which is why it is so important to stay on top of technological advancements and consider how those changes can better serve your practice.  (This would be a good time head to the DRI website and join me as a member of the technology substantive law committee!)

A friend of mine once told me that you can do it all, you just can’t do it all well. Well, with all due respect to my friend, I am not willing to give up so easily.  My single friends say I am the busiest person they know.  Of course, my married friends and I trade war stories and laugh about the insanity of it all.  How do we do it?  As for me, I am constantly looking for ways to maximize my billable day and minimize the amount of ‘dead time’ in any given day.  Make no mistake, though, if it’s a ‘class outside’ kind of day, you can catch me sitting in the courtyard of my favorite coffee house with my laptop plugged in and the sound of new age jazz playing softly in the background! 

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 The EEOC recently issued a letter of determination to Belmont Abbey College, a Roman Catholic college in Belmont, North Carolina, after a number of its employees filed a sexual discrimination complaint when the College elected to revise its health care plan by eliminating contraceptives and other population control measures from its health care plan, finding that Belmont Abbey College had engaged in discriminatory practices by implementing this change in its health care plan.  The college is a private institution, although the materials I’ve read indicate that it did accept public funds.  Nevertheless, the Roman Catholic church has condemned the use of contraceptives, abortion and other population control measures since its inception, so the question then becomes to what extent, if any, can the United States government force a private employer to conform with governmental beliefs even where those beliefs are diametrically opposed to the fundamental religious beliefs held by the private employer?  Under what circumstances can the federal government disregard the fundamental tenets of separation of church and state and dictate to a Roman Catholic institution that it much condone, endorse and in fact pay for its employees to have access to health care options that are the antithesis of the fundamental teachings of the Church?  More importantly, can the United States government force private religious institutions to abandon these fundamental religious principles and adopt those social policies held by the government simply because an institution for higher learning happened to accept governmental funds?  If so, where is the line drawn?  If a Roman Catholic Church accepts FEMA money to repair its facilities after a catastrophic event, does it necessarily give up its sovereignty simply because it accepted government assistance?  If so, does this mean that an individual would, too, under similar circumstances?  


The effect of the Belmont Abbey College determination could have potential catastrophic effects on the separation between religious freedom and state regulation, especially now, when health care reform has taken center stage.  Should the public option force private insurance out of business, which legislators suggest would never happen (we’ll see), will the government be able to force health care policies on individuals in violation of religious freedom?  But, the bigger and more practical issue is whether the government can allocate tax dollars to pay for plans that violate religious freedom?  Can the government force you to pay for another person’s abortion?  In short, yes.

Quite simply, individuals do not have control over how tax dollars are spent.  While anyone has the ability to contact his or her legislator and try to make a change in governmental policy, the fact is that individual citizens have no control over how tax dollars are spent.  See English v. Comm’r of Internal Revenue, T.C. Memo. 1986-409, 1986 WL 21620 (U.S.Tax Ct. 1986).  In English, the plaintiff argued that he could validly withhold tax payments when he disagrees with the manner in which the government is spending tax dollars.  The Tax Court held that, regardless of the sincerity of his beliefs, the plaintiff’s arguments were totally without merit.  

While it comes as no surprise that individuals or private companies have no say so when it comes to telling the government how to spend tax dollars, the question then becomes whether the inverse would be true as well.  If tax payers cannot dictate how the government spends tax payer dollars, can the government control personal liberties when tax payers take government dollars?  

The real answer is that the government can do anything it deems just and proper as long as it can identify some “public purpose” for implementing its plan.  See Maready v. City of Winston-Salem, 467 S.E.2d 615 (NC 1996).  In Maready, a tax payer challenged a municipality’s ability to grant economic development incentives to private businesses, arguing that the statute permitting such expenditures was unconstitutional because it was impermissibly vague and violated the public purpose clause of the North Carolina Constitution.  Unbelievably, the lower court held that the statute was in fact unconstitutional; however, the North Carolina Supreme Court later “corrected” this seemingly just result, finding that the case specific “public purpose” standard was not unconstitutionally vague, and holding that governmental entities could use tax payer monies to subsidize or entice private businesses by offering economic development incentives.  The dissent poignantly contemplated that, 

If it is an acceptable public purpose to spend tax dollars specifically for relocation expenses to benefit the spouses of corporate executives moving to the community in finding new jobs or for parking decks that benefit only the employees of the favored company, then what can a government not do if the end result will entice a company to produce new jobs and raise the tax base? If a potential corporate entity is considering a move to Winston-Salem but will only come if country club memberships are provided for its executives, do we sanction the use of tax revenue to facilitate the move? I would hope not, but under the holding of the majority opinion, I see no grounds for challenging such an expenditure provided that, as a result of such a grant, the company promises to create new jobs, and an increased tax base is projected.

Thus, it seems that while the individual citizens are not permitted to dictate how their tax dollars are spent, the inverse effect of the government’s ability to control individual liberties by loaning taxpayers the very dollars they have paid is unquestionable.  As a result, taxpayers such as Belmont Abbey College and other Roman Catholic tax payers, like the rest of us, will have to shelf their constitutional freedoms, at least in part, in favor of what this year’s government deems to be the greater good regardless of their religious beliefs or any other constitutional concerns they may have.  


 

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