Photo of Stephen McConnell

When we were on a jury last month we were warned not to consult any outside sources.  And we didn’t.  When we were in high school last century and studied the works of Eliot, Lawrence, Joyce, Waugh, and (another) Eliot, we were instructed not to consider extraneous issues, such as biography or social conditions.  Our teachers were still in the grip of the New Criticism and, therefore, so were we. 

 

But we found today’s case, Lynch v. State, 2018 Conn. Super. LEXIS 851 (Conn. Superior Ct. April 17, 2018), tough sledding without doing some research beyond the four corners of the opinion.  The case is about a plaintiff who was inseminated by a sperm bank donor, came down with a cytomegalovirus (CMV), and gave birth to children with serious injuries.   What we learned courtesy of the internet is that CMV is fairly common and usually doesn’t cause terrible maladies.  The problem is that if a CMV-negative woman gets infected with CMV during pregnancy, there is a possibility of birth defects.  That is what happened here.  The plaintiff had been CMV negative.  That is something she knew and her doctor knew, but the sperm bank did not know it.  The sperm donor tested as CMV-positive, though he no longer actively suffered from CMV.  The sperm bank accurately disclosed the CMV-positive status of the sperm.  What the sperm bank did not do was tell the plaintiff that if she was CMV-negative, then CMV-positive sperm could pose a risk.  But, presumably, the plaintiff’s doctor would know that.  We know it from reading a Wikipedia article.  We never attended medical school, not even for ten seconds.  Call us a semi-learned, blogging defense hack.

 

The sperm bank moved for summary judgment, arguing that it did not owe the plaintiff a duty of care because a sperm bank does not have a duty to inquire into its clients’ CMV status, nor is it obligated to engage in an informed consent discussion with clients regarding the clients’ CMV status.  The Connecticut court agreed with the sperm bank and dismissed the case.  How is this a drug or device case?  It isn’t, but the scope of duty to warn and the relevance of the learned intermediary doctrine both poke their way into this case, and that is enough for us to stand up and take notice.    

 

Pursuant to the regulations, sperm banks are required to test their donors for certain diseases, including CMV. But the regulations do not impose on sperm banks an obligation to discuss the implication of the tests they run with the purchasers.  The evidence here showed that the sperm bank fulfilled its obligation to test for the sperm donor’s CMV status and to report the results accurately.  The results indicated that the donor was fully recovered and immunized from the virus, and that he was not actively infected with CMV at the time of the donation. Due to these test results, the defendants reported that the donor was CMV-positive.  The evidence did not show any knowledge on the part of the sperm bank that the plaintiff was CMV-negative.  The only duty the sperm bank had to the plaintiff was to conduct the required testing on the donor and to report the results of the tests, which it did.

 

The Connecticut court analogized to the duties that a pharmacy owes to its customers.  A previous Connecticut court applied the learned intermediary doctrine to pharmacists. Yay for the Nutmeg State. The court held that imposing a general duty on pharmacies and pharmacists to investigate and evaluate all of the medications that their customers’ physicians prescribed would impose a burden outside the scope of their normal duties, as the main job of pharmacists is to dispense the medications that their customers’ physicians prescribe. The learned intermediary doctrine makes sense in the pharmacist context given the fact that physicians have more knowledge than pharmacists about their patients’ needs and proclivities. Holding otherwise would put pharmacists between the physician-patient relationship.  The sperm bank is like a pharmacist.  (That’s a sentence we never thought we would write, but there it is.) The plaintiff’s doctor testified that he would typically advise CMV-negative patients to choose CMV-negative sperm. (The opinion does not make clear why that did not happen here.)  The court reasoned that holding that the sperm bank “had a duty to inform the plaintiff parents about the risks that CMV posed would also put the sperm bank in the middle of the physician-patient relationship.” 

 

Most of the Lynch opinion contains a discussion of the scope of duty.  There is a lot about foreseeability. (It throws us back to first year in law school, when we sat in the last row, next to the guy who always added to the seating chart a space for “Garth, the Most Savage Troll of All.”  Only one teacher ever had the temerity to call upon Garth.)  Even beyond foreseeability, the court asked whether the sperm bank might have assumed a duty to the plaintiff because either its failure to exercise care increased the risk of harm or the harm was suffered because of the plaintiff’s reliance upon the defendant’s undertaking. No and no.  First, the information that the sperm bank made available on its website about sperm CMV status did not appear to increase the risk of the type of harm that the plaintiff allegedly suffered. Although the website did arguably give some medical advice by saying that the risk of acquiring CMV from donor sperm is low, the website also informed its customers that this is a medical issue that clients should discuss with their physician. This language “clearly suggests that the sperm bank’s customers should not rely on the information provided on the website and that they should ask their physicians about CMV.”  Back to the learned intermediary.  Second, there is no evidence that the plaintiff relied on this information when selecting the donor’s sperm. The plaintiff testified that she did not discuss her or her donor’s CMV status with any representative from the defendant sperm bank, and there is no indication that she saw the page on the website that allegedly created a duty.  The Lynch court went back to the pharmacy example.  It is possible for a pharmacy or pharmacist to assume a duty when they have “specific knowledge of potential harm to specific persons in particular cases.”  But here, “this exception is not applicable because the defendant sperm bank had no knowledge of the plaintiff mother’s CMV status.” 

 

Applicable federal regulations did not help the plaintiff’s case.  Test results will show that a donor is CMV-positive even if the donor had contracted and then subsequently recovered from the virus. FDA regulations provide that a sperm donor who is actively infected with CMV is ineligible to donate. Here, the sperm bank tested the donor and determined that he was CMV-positive, but that he had fully recovered from the virus and was not actively infected with it at the time of his donation.  There was no violation of the regulations.

 

Finally, there was the usual argument from a plaintiff that summary judgment should be denied until discovery is complete.  But a party requesting more time to conduct discovery bears the burden of establishing a valid reason why the motion should be denied, including some indication as to what steps the party has taken to secure facts necessary to defeat the motion. That burden was not met here.  Thus, the court granted the defendant summary judgment.

Last week at the DRI conference in New York an especially talented lawyer delivered an especially interesting address.  Everything about the speech was riveting and splendid, until she deployed the word “fulsome” in the increasingly popular, albeit wrong, fashion, as a synonym for full or complete. About twenty heads spun around to look at us with glee, knowing we had recently railed against this misuse.  How is “fulsome” superior to the simpler, correct words?  The interesting, specific meaning of fulsome is being diluted by foolish pomposity.  Still, the message conveyed to us by this event was not so much about the increasing misuse of “fulsome” but more about our increasing reputation for crankiness.  It is a curse.  When someone hands us a draft for editing, we must pass through it at least twice. Only after clearing away the grammatical wreckage can we review for substance.  It is undeniably a weakness on our part. A misplaced “only” will throw us off and make us want to drop the draft in the trash bin.  It would be wrong to say we “only threw three fits over confusions between ‘uninterested’ and ‘disinterested’ yesterday.”  That “only” belongs next to the word it is modifying, which is “three,” not “threw.” When someone writes that the court “found” something, if the reference is to a legal holding rather than a finding of fact, we reach for the red pen and mutter about the decline of the West.  The Third Circuit “held,” not “found,” that Levine preemption is a fact issue. Of course, the pernicious thing about the Third Circuit’s Fosamax ruling is that it transformed what should be a holding into a finding.  You have probably heard all this before.

 

Are we fretting too much over silly mistakes?  Maybe.  Are we being more than a bit pompous?  Maybe.  Nobody’s perfect.  There are probably no fewer than five dopey mistakes in this post. 

 

Mistakes are not always a big deal.  That is the lesson of a recent Third Circuit ruling in Estate of Goldberg v. Nimoityn et al., No. 17-2870 (3d Cir. April 13, 2018) (not precedential).  The case was a wrongful death med-mal case.  The plaintiff claimed that the doctors and hospital erred in delaying placement of a feeding tube.  The defendants hired an expert witness doctor who opined that the delay in placing the feeding tube was appropriate.  But in that expert’s report there was a mistaken assumption that pneumonia was a factor prompting delay on a certain date when, in fact, the pneumonia diagnosis did not occur until a later date.  At trial, the defense counsel fronted the error with the expert and elicited the expert’s testimony that the mistake was a typo and did not, in any event, affect his ultimate opinion that the delay in placing the feeding tube made sense.  The plaintiff lawyer objected and explained at sidebar that the fronting of the mistake and the explanation by the expert should be precluded because such testimony wandered beyond the scope of the expert report.  The plaintiff lawyer had been salivating over the mistake.  He told the court that he had considered raising the issue before trial.  But surprise seemed more appetizing.  It would no doubt make for a devastating cross.  The problem was that the defense lawyer had surprised the plaintiff by ruining the surprise.  The district court permitted the defense expert to ruin the surprise, reasoning that the ultimate opinion was the same and there was no material surprise.  The case went to the jury, which returned a verdict for the defense.  The plaintiff asked for a new trial, again arguing that the defense expert should not have been allowed to fix his mistake and, furthermore, that the expert’s attribution of the mistake to a typo was perjury.  The district court agreed that the typo explanation was “disingenuous at best,” but continued to believe that there was no prejudicial surprise.  The district court denied the motion for a new trial.  The plaintiff appealed to the Third Circuit.

 

The plaintiff’s main argument on appeal was that the district court erred in failing to exclude the defense expert’s testimony under Federal Rule of Civil Procedure 37(c) (Failure to disclose, to supplement an earlier response, or to admit).  The defense expert never supplemented his expert report.  The expert’s repair of the mistake in his report landed like a sandbag on plaintiff counsel’s head.  So the argument goes.  The Third Circuit reviewed the district court’s decision to admit the expert’s testimony  under the abuse of discretion standard.  The issues were whether the plaintiff was surprised/prejudiced, whether there was an opportunity to cure any prejudice,  and whether the defense exhibited any bad faith.  The plaintiff lawyer acknowledged that he knew about the mistake, so the surprise element was frail.  He was more frustrated than surprised. Further, the plaintiff lawyer did have the opportunity to cross-examine the expert and force him to admit that one of the major bases for his original opinion was a pneumonia diagnosis that did not actually exist.  The point was scored, albeit with less drama than the plaintiff lawyer desired.  The point is that any prejudice was largely cured.  Finally, there was no evidence that the defense acted in bad faith by failing to supplement the report.  The mere passage of two years time between issuance of the expert report and the trial testimony did not, by itself, establish a nefarious plan.

 

The Third Circuit also agreed with the district court that the defense expert’s reference to a typo was implausible, but not clearly perjurious.  The plaintiff expert had, after all, admitted the key fact that the pneumonia diagnosis did not yet exist when he thought it had.  The expert got an important fact wrong and confessed as much.  The opinion does not mention whether the plaintiff lawyer had more than a little fun at cross-examination with the typo whopper.  He certainly could have.  As has been said more than once, and as we seem to be hearing every day now, the cover-up is often worse than the original offense.  Be that as it may, there was no reason to order a new trial just so that the impeachment could have played put just the way the plaintiff lawyer wanted.          

 

There is a certain amount of cleverness in the plaintiff’s argument.  But clever is not the same as right.  One additional fact that makes us sure the Third Circuit is right in Nimoityn is that the Third Circuit was affirming a decision by district court Judge McHugh.  Before he became a judge, Gerald McHugh was one of the preeminent litigators in Philadelphia.  We never were in a case with him, and that is probably a good thing, because McHugh probably would have been on the other side of the v, and even more probably would have beaten our brains out.  We’ve been in the Penn Inn of Court with Judge McHugh for many years, and his contributions during the question periods have been invariably insightful.  Judge McHugh possesses a superabundance of intelligence, integrity, and – well – judgment.  He does not make many mistakes.  (We cannot think of any.)  He did not make one here, and the Third Circuit did not make one in affirming his ruling.

 

 

If  clients get sued by someone where physical or financial injury seems remote, unclear, or speculative, consider raising the defense of lack of standing.  Courts are for resolving actual disputes among parties.  As we said a little more than a month ago in another post on standing, courts are not debate halls.  The standing issue was front and center in the recent case of Center for Responsible Science v. Gottlieb, 2018 WL 1997266 (D.D.C. April 27, 2018).  Because the plaintiffs lacked standing, the case was dismissed.

The plaintiffs were three individuals and one organization, the Center for Responsible Science (CRS).  They sued over the FDA’s rejection of their Citizen Petition, which demanded that three specific warnings be added to standard informed consent forms for clinical trials.  The proposed warnings would have told trial participants that (1) animal tests might not be predictive of human safety, (2) some participants in clinical trials for investigative drugs died or were seriously injured, and (3) the drugs in the trial might end up proving to be unsafe or ineffective in humans. The FDA denied the Petition because the additional language applied only to drugs, whereas the standard informed consent forms apply to all clinical trials.

Who were the plaintiffs?  How were they harmed by the FDA’s denial of the Petition?  The three individuals included two people who had previously participated in clinical trials, though it seems nothing bad happened to those two.  The third individual lost a son as a result of his participation in a clinical trial.  The organization, CRS, is a non-profit, non-member organization that promotes advances in regulatory science and advocates better results for patients.

Did the individuals have standing?  No, they did not.  The lawsuit sought injunctive relief, so past harm was irrelevant.  The problem for the individuals was that they could not establish future harm traceable to the FDA’s denial of the Petition.  Any future injury would stem from lack of information, but these individuals clearly had the information (that animal tests are not completely predictive of human safety/efficacy, and that clinical trials pose the risk of death/injury).  Oddly, just by bringing the lawsuit, the plaintiffs demonstrated their lack of standing.  You might put this ruling down to sophistry, but the logic is inescapable.

Does the organization have standing?  Not here, not based on the allegations in the complaint.  An organization can bring a lawsuit on behalf of itself or its members.  But remember that CRS does not have members.  So we are thrown back onto organizational standing, the law concerning which is, as the court admits, “not a model of clarity.”  An organization must show the same things an individual must show: injury, causation, and redressability.  The injury must be concrete and demonstrable.  There must be a consequent drain on the organization’s resources.  A setback to the organization’s social interests will not suffice.  Here, CRS alleged standing “because the interests at stake are germane to [its] purposes, and FDA’s response will require further extensive advocacy work on [its] part, placing a significant train on its limited resources, causing a diversion of its resources, and the frustration of its mission.”  The court held that these allegations, plus others, were too conclusory and vague.  You might chalk this conclusion up to TwIqbal, but it is actually a tougher test for plaintiffs to meet because lack of standing is a Rule 12(b)(1) motion that goes to the court’s subject matter jurisdiction.  Thus, the plaintiff’s factual allegations will be subject to “closer scrutiny.”  CRS’s allegations could not survive such closer scrutiny, but the court permitted CRS to amend the complaint to show programmatic, concrete harms that truly would be above and beyond the organization’s day-to-day advocacy mission.

We will not speculate as to whether CRS can satisfy this test on the next go around.  We leave speculation to plaintiffs.

Last week we attended our law firm’s partner retreat.  In between circuits on the lazy river, there was talk of synergies, branding, cross-selling, diversity, technology, and, mostly, collaboration.  You know – the usual stuff.  That last point, collaboration, is really the predicate for all of the others.  Collaboration today has a positive connotation of people working together to achieve a desirable result.  Collaboration came into the room with a much uglier aroma during the Second World War, of course.  See the 1969 film, The Sorrow and the Pity, for more on that sad story.  The nasty words today are collusion and conspiracy.  One is a specific criminal offense, while the other is mere invective.  But enough said about politics and criminal law.  In any event, a retreat is a perfectly fine place to discuss collaboration.  It is an opportunity for colleagues from all over the map to converge in a convivial setting to get to know each other,  trust each other, respect each other, and commit to work more closely with each other.  Luckily for us, as huge and global as our firm is, we do collaboration exceedingly well.  In fact, the very last thing that happened at the retreat was that a conference room of alpha lawyers punched into our phones real-time, word-one descriptions of the firm.  The results were instantaneously collected to create a word cloud.  Do you know what word ended up front and center and in the biggest font?  Collaboration.  So, yay.

 

Around the banquet table and around the pool there was a lot of talk about collaboration.  Law is a team sport.  It is much more like football or basketball than golf or tennis.  And yet, there is a lot of golf and tennis played at retreats, and no basketball or football.  A paradox?  Not really.  Even our golf and tennis games typically involve two-person teams – sort of like trial teams in the courtroom.   Collaboration is by no means limited to the partnership, even if the term partnership is peculiarly evocative of collaboration.  Tomorrow’s partners are today’s associates and counsel.  Unless we develop their talents and permit them to flourish, the law partnership’s institutional survival is a frail thing.  When we were laboring in our mid-associate years, there was a partner who was especially supportive.  He was generous with advice and generous with praise.  He used to say, “I need you to succeed, because you’ll be paying my pension someday.”  That was back in the days of defined benefit plans, which hardly exist anymore.  Nowadays, in the you’re-on-your-own economy,  we save up for our own retirements, so institutional survival perhaps does not seem as vital as it once was.  Surely, there is a cost to that transformation.  But forget about retirement – every law firm exists on a razor’s edge of intellectual supply and demand.  What Samuel Goldwyn said about movie studios is also true for law firms: it’s scary to think that the assets go home every night.  Without constant renewal from young lawyers who bring competence, commitment, and creativity, a law firm won’t live to see the next quarter. Further, the people who do so many of the things that keep the operations humming are the non-lawyers.  They are just as important and professional as the folks with J.D.s.  They often have the most to say about whether we will have a good or bad day.  And if we want to have an in-depth debate about whether the latest Star Wars movie made sense, we are far more likely to check in with some of our friends in IT than with other Life Sciences lawyers.  The constant collaboration animating our firm makes us better at what we do and happier about our lives. 

 

So far we have been talking about internal collaboration.  But it is more and more the case that mass tort lawsuits force firms to collaborate with others to mount vigorous and effective defenses of their clients.  Sometimes one client will assemble a virtual law firm, doling out different tasks to different firms.  (Pity the firm charged with responsibility for overseeing electronically stored information.  Talk about no-win propositions!) Sometimes codefendants need to align to thwart the predations of plaintiffs who seek to exploit potential fissures and induce the defendants to point fingers at each other, thereby doing much of the plaintiffs’ work for them.  Again, we count ourselves lucky to work in a firm that enjoys both the reputation and reality of playing nicely in the sandbox with others.   Sharp elbows simply aren’t a part of our culture.  There is no reason to horn in on others’ work, and certainly no reason to trash the effort of colleagues, even when they are competitors in the marketplace.  For one, that sort of backbiting does not work.  Clients hate it.  It reminds us of how our elementary school teachers used to tell us that they could see everything that happens in the classroom, every passed note, spitball, and droopy eyelid.  Naturally we doubted that at the time.  But then 20 years later we became a high school teacher and – what do you know – it was totally true that everything in the classroom was laid out in front of us with deep focus and clarity.  It’s the same with clients.  They see how their law firms cooperate or collide.  They hear every snide complaint, and it drives them crazy.  We once knew of two partners who would call the client to complain, not only about how other firms were allegedly shirking their responsibilities, but also about how much better they were than their ‘partners’ at the same firm.  Nice.  Guess what the client did?  She called up another partner at the firm and asked why he bothered to work with partners who were so insecure and disruptive, and also asked why the client should continue to employ a firm that brought too much chaos to the party. Good questions.   

 

One of our colleagues at the retreat told us about a trial last year that ended in a hung jury.  The result ended up not being so bad, as it was followed by a favorable settlement not long afterwards.  But our co-counsel saw the result as a cue to second-guess several trial decisions, such as doing a short opening statement, deciding not to call an expert witness they had worked up, and deploying ‘only’ 37 slides in the closing.  We know it was bad form for the other law firm to engage in such self-indulgent revisionism, but even beyond that, knowing nothing about the case, we suspect that the criticisms were unfounded.   As we mentioned in our post two weeks ago about our recent jury duty, we harbor deep doubts that overlong presentations with superabundant graphics are the best way to pierce a jury’s confusion and indifference.  The older we get, the more convinced we are that simpler and shorter are better.  (We’d dance a jig if depositions were shortened from seven hours to five,  if opening statements were capped at 30 minutes and closings at an hour, and if legal briefs were limited to 20 pages.  But we digress.)  And then we heard that the hypercritical colleague from another firm espoused more “fulsome” presentations.  That did it.  Now arose our antediluvian, pedantic hatred for the use of “fulsome” as a faux benign synonym for “full” or “complete,” when it really means “excessively flattering.”  By “really means” we mean that “fulsome” should be confined to its proper 1663 denotation.  Do not fight us on this one.  Consult the OED or Fowler’s.  Garner is mostly on our side here, though he calls “fulsome” a “skunked term” because the loose sense is now so common.  We don’t like skunks.  The philistine encroachments of the latter part of the last century and the early jabberings of this one do not persuade us.  Hmmm.  Perhaps there are limits to our own ability to collaborate.   And please do not get us started on the current fashion of beginning almost every answer with the word “So,” no matter how nonsensical. 

 

By the way, while we are talking about collaboration among law firms, we ought to acknowledge that this blog has always been a collaborative effort among lawyers from different, often competing, law firms.  It is possible that this fact makes the Drug and Device Law blog unique among Big Law blogs.      

 

Just before we left for the retreat, we got a call from a client who asked us to parachute in and do a product liability trial for them.  There was a catch.  The case had been worked up by another firm, discovery was closing in a week, and the other firm would file all the summary judgment papers and handle the experts.  All we would do is work up motions in limine, prepare for trial, and then do our parts of the trial.  Was that okay?  Ha! – that wasn’t just okay, that sounded splendid.  We couldn’t stop ourselves from telling the client that it sounded like just about the most perfect assignment we could ever get.  We were getting in on the fun bits.  Not only would we gladly take on this assignment, but we would offer gratis a profound promise:  not once would we utter a word of complaint about what had been done in the case before our arrival.  No mutterings about ‘why didn’t they depose the mother?’ ‘why didn’t they hire a better expert?’ ‘why didn’t they file a motion based on x?’ etc.  We are betting the other firm had its reasons for doing what it did.  Whatever.  What’s the use in whining?  Let’s treat this case as an exemplar for all litigation which is, in turn, an exemplar for the whole world.  Let’s take what’s given to us with gratitude and make the best of it.   We’re happy to join the team.  Maybe it took us a while to realize it, but practicing law can be a joy, but not so much when it is a solo activity.  The success and joy of it lies in collaboration.

 

 

The first year law school class we most anticipated was Constitutional Law.  Then disappointment greeted us when we learned that the first year course covered only broad institutional topics such as judicial review and separation of powers.  The sexy bits – First Amendment, Fourth Amendment, Equal Protection, and Due Process – were reserved for higher level courses.  Con Law I threatened to be a snooze-fest.  No worries.  Our teacher, Cass Sunstein, kept the class lively and made a compelling case that the institutional architecture of the Constitution was, in fact, the primary source of civil rights.  The Bill of Rights  might get asked to the prom, but checks and balances, jurisdictional doctrines, and even the lonely, oft-forgotten Tenth Amendment are lovely, lifelong companions.  And consider the commerce clause.  (U.S. Const. art. I, section 8, cl. 3.)  You might remember reading how there was enormous controversy as to whether the commerce clause could support enactment of the 1964 Civil Rights Act.  How could Congress regulate the dealings of a little BBQ restaurant in Birmingham or a motel in Atlanta? SCOTUS decided that the commerce clause could support such federal intervention.  And yet, if that is so, what couldn’t the commerce clause support?  Our courts are still wrestling with that question.  Remember the challenges to the Affordable Care Act?    

 

There is a flip side to the endlessly elastic, expansive commerce clause: say hello to the dormant commerce clause, which is like the crazy uncle who falls asleep on the couch and wakes up at odd moments to utter something  loud and inconvenient.  The dormant commerce clause perks up every once in a while to announce that a state’s effort to regulate commerce has gone too far.  James Madison originally harbored doubts that states could impose shipping tonnage duties, given that the commerce clause invested such powers in a unitary, federal authority.  In the judicial context, Chief Justice Marshall first alluded to the dormant commerce clause in Gibbons v. Ogden, 22 U.S. 1 (1824).  The notion is that implicit in the power of Congress to regulate commerce is a corollary constraint on the power of states to enact legislation that interferes with or burdens interstate commerce.  A state cannot regulate commerce occurring wholly outside its borders.  A state law violates the dormant commerce clause’s extraterritoriality principle if it either expressly applies to out-of-state commerce or if it has that practical effect, regardless of the legislature’s intent.

 

When we were in law school, the big dormant commerce clause case was City of Philadelphia v. New Jersey, 437 U.S. 617 ((1978), in which SCOTUS held that New Jersey could not exclude Philly’s garbage.  (Insert your favorite Jersey jokes here.)  To a certain extent, the dormant commerce clause came to be thought of as primarily prohibiting a state from discriminating against commerce from another state.  But there is more to the dormant commerce clause than a nondiscrimination principle.  Think of Kassel v. Consolidated Freightways Corp., 450 U.S. 662 (1981), where SCOTUS struck down Iowa’s law against double/tandem tractor trailers as constituting an unreasonable burden on interstate commerce.  There wasn’t discrimination against commerce from another state, but the rule would have had a deleterious affect on trucks rolling through Iowa and other states.

 

All that being said, Justices Scalia and Thomas essentially decried the dormant commerce clause doctrine as a judicial fraud.  That was and remains a minority position.  We certainly do not think the dormant commerce clause is a fraud, and we have hosted a couple of excellent guest posts on this blog about whether the dormant commerce clause might stop states from using their corporation registration statutes to extend personal jurisdiction over companies that played no actual in-state role in the matter being litigated.  See here and here for example.

  

Todays case, Ass’n for Accessible Meds v. Frosh, 2018 U.S. App. LEXIS 9265, 2018 WL 1770978 (4th Cir. April 13, 2018), involves an interesting application of the dormant commerce clause.  It applied to drugs, so we aren’t wandering too far afield.  Maryland enacted a statute (the Act) concerning “Public Health – Essential Off Patent or Generic Drugs – Price Gouging – Prohibition” that regulated drug pricing both inside and outside Maryland.  The Act prohibited manufacturers and wholesale distributors from charging an “unconscionable” price even on initial, upstream sales of drugs that occurred outside Maryland.   A prescription drug manufacturer trade association filed a lawsuit challenging the Act on the grounds that it violated the dormant commerce clause and was unconstitutionally vague.  The district court denied the plaintiff’s motion for a preliminary injunction, and the matter went up to the Fourth Circuit.  The appellate court held that the district court got it wrong, that the antigouging Act’s reach beyond Maryland’s borders was a violation of the dormant commerce clause, and that judgment should be entered in favor of the plaintiff.  Adios, antigouging Act.

 

Only one member of the plaintiff trade association was a drug manufacturer actually based in Maryland.  Drug manufacturers typically sell their products to wholesale pharmaceutical distributors – not one of which was based in Maryland.    Thus, very few of the sales regulated by the Act took place within Maryland’s borders.  In defending the Act, Maryland was forced to acknowledge that it intended to reach the series of upstream, wholesale transactions, not merely the downstream sales to Maryland consumers.  Maryland argued that the effects on upstream, out-of-Maryland sales were indirect effects that could not implicate the dormant commerce clause.  But it is hard to see how such outside-Maryland effects were indirect when they were fully intended by the legislature.  Moreover, the Act explicitly prohibited a manufacturer’s use of a defense that it did not directly sell to a consumer in Maryland.    The inescapable fact is that the Act was a price control on sales outside Maryland.  The Fourth Circuit held that Maryland cannot impose its price preferences outside its borders, even if it thinks it has to do so to create lower prices for consumers within its borders. 

 

Further, the Fourth Circuit considered how the Act might interact with the legitimate regulatory regimes of other states.  Different states could subject prescription drug manufacturers to conflicting requirements with respect to wholesale pricing.  The commerce clause protects against inconsistent legislation arising from the projection of one state regulatory regime onto the jurisdiction of another state. None of this was intended by the Fourth Circuit to say that states cannot enact legislation to secure lower prescription drug prices.  (There was a vigorous dissent in the case, which was longer than the majority opinion and which excoriated the majority for blessing price gouging).  The issue is how a state goes about regulating prices within its borders.  If it tries to do so by  regulating external transactions, it runs afoul of the dormant commerce clause.

 

We cannot read the Frosh case without daydreaming about how its logic applies to the sorts of cases we deal with every day.  We know from preemption precedents that jury verdicts can be treated as a species of state legislation.  When juries are permitted to rewrite product labels and Instructions for Use, how are they not imposing extraterritorial effects?  How are they not setting up prescription drug and device manufacturers to face inconsistent regulatory regimes?  How are they not interfering with interstate commerce?  Perhaps you think that we are extending the logic of the dormant commerce clause too far, but at least, unlike the crazy-quilt of jury verdicts we read about every day, it is logic.

 

 

 

 

 

 

Last week we served on a jury in a medical malpractice verdict.  To put it mildly, we were surprised that we made it through the peremptory gauntlet.  The verdict?  It was an enlightening and edifying experience.

 

The Selection

 

The fifth time was the charm.  On four prior occasions, we had marched to the county courthouse.  On four prior occasions, we were thanked and excused.  That is hardly a surprise.  As a former prosecutor and current defender of Fortune 100 companies, we offer lots of litigants a lot to dislike.  But this time was different.

 

Chester County, Pennsylvania is almost a hundred years older than the country. It has a historic courthouse.  That courthouse is splendid.  It is also cramped.  The jury assembly room was formerly located in its basement.  It was not an entirely wonderful place to await one’s service.  But the county put up a gigantic Justice Center ten years ago.  It is a gorgeous facility.  The hallways are wide and well lit.  The restrooms are large and clean.  The courtrooms are big, modern, and majestic without being intimidating. Even better are the people who run things in the courthouse.  Right from the start, as you pass through the metal detector and get wanded by Sheriff’s Deputies, everyone is polite and professional.  A fellow juror commented at the end of the case how all of the courthouse workers were quick to smile.  In particular, the folks who run the jury assembly room were relentlessly pleasant.  Jury service can seem like a bother, but it wasn’t such a big bother in beautiful, wise, fair-minded Chester County.

 

Approximately a hundred of us gathered in the assembly room.  By 9 am we were told that only one panel was required that day.  Fifty-six of us, including your correspondent, were chosen randomly, handed numbered 10×14 cards, and herded upstairs to a courtroom.  We weren’t worried.  It would be interesting to see more of the process before we were inevitably shown the exit. We were juror #14.  That meant that we were seated in the jury box, which had comfy chairs.  Jurors 15-56 squeezed themselves into pews.  Voir dire began.

 

We had completed a simple, one page questionnaire.  We disclosed our residence, marital status, and employment.  That was pretty much it.  We saw none of the attitudinal questions that litter the long-form questionnaires typical in mass tort cases.  The Judge – a calm, dignified man who commanded respect and affection from us throughout the case – briefly described the nature of the case.  A widow was bringing a wrongful death action because her husband died shortly after a medical operation at Paoli Hospital.  She alleged that the doctor might have performed the surgery well enough, but he did not pay attention to signs of an internal hemorrhage, thus permitting her husband to bleed to death two days after the surgery.  The parties and lawyers were introduced.  Then the plaintiff lawyer asked a series of general questions about experience with medical and legal issues.  Jurors raised their numbered cards to answer in the affirmative, their numbers were noted, and then there were individual follow-ups at sidebar.

 

The sidebars took a while.  Apparently, a big percentage of people in Chester County have had run-ins with the medical profession.  We were one of only two lawyers in the group.  The other did insurance and malpractice law, so she was a sure goner. We thought we were, too.   When we were called up to sidebar, we initiated the conversation with a jaunty “Good morning your Honor, and good morning counsel.”  It just came out naturally.  The defense lawyer said, “Oh that’s right, you’re a lawyer.”  When we described where we worked, the Judge smirked that he had never heard of our ‘little firm.’  The plaintiff lawyer asked if we mostly worked on MDLs.  Why, yes, that’s exactly right.   The Judge asked if we could be fair.  Yes, of course.  And then we were sent back to seat #14.

 

The sidebar sessions were halted after juror #30. The court had apparently calculated that it had enough jurors, taking into account whatever challenges for cause had been sustained and the number of peremptory challenges each side had.  Net of those, there would be 14 jurors (12 + 2 alternates).  Goodbye jurors 31-56.  Then the lawyers passed a piece of paper back and forth, each exchange interrupted by much pondering and furrowed brows. As far as we could tell, there were no jury consultants involved.  These lawyers were relying on experience and instinct in choosing which jurors to bounce.  Not for a moment did we think the plaintiff would allow us to remain on the jury.  Eventually, the piece of paper was handed to the court clerk.  He and the Judge scrutinized it and made some notations.  They were figuring out who was on the jury.  Then the clerk called out numbers, instructing those jurors to gather their effects and go home.  “Juror number 2, you may go.”  “Juror number 4, you may go.”  Etc.  “Juror, number 11 you may go.”  That made sense – Juror 11 was the other lawyer. Then we heard it.  “Juror number 14 -“ we bent down to collect our brief-bag.  “-please move to seat 2.”  Wait.  What?

 

Stunned, we plopped down in our new seat.  Soon, others filled the empty seats in the box.  A member of the Court’s tip staff (that is what court bailiffs are called in Pennsylvania – the plural is “tip-staves”) administered the oath to us. Then we went to the jury room and awkwardly introduced ourselves to each other.  The jury was split evenly between men and women.  Two of the women were nurses, and one was studying to prepare medical transcriptions.  The jurors seemed smart, nice, and conscientious.  We got along. We took turns bringing pastries in each morning.

 

Did we mention that Chester County has a reputation as a horrible place for plaintiffs in civil lawsuits?

 

The Case

 

Each side presented an opening statement.  Each lasted 20-25 minutes.  Each employed zero graphics (we do not know whether that was by choice or by order of the Court).  Despite the lack of graphics (or maybe because of it?) the opening statements were crystal clear and easy to follow.  The decedent’s hemoglobin level was 14.5 before the operation, which is about average.  The surgery was uneventful.  There were no complications.  Only about 75 cc of blood were lost, making this a relatively ‘dry’ operation.  There was no issue about whether the surgery was performed negligently.  Instead, the malpractice issue pertained to the post-op standard of care.

 

The decedent’s hemoglobin fell to 11.6 after the surgery, which is not unexpected.  Then it fell to 10 the next day, and 8.8 the morning of post-op day 2.  The decedent vomited a couple of times and fainted once, but his vital signs seemed stable.  There were some blips on the cardio strip, though nothing terribly alarming. A significant point of contention was whether observations of increasing abdominal firmness should have prompted investigation for internal bleeding.  The defendant doctor interpreted the distended abdomen, along with the absence of a bowel movement, to manifest an ileus – a problem with the bowels, but not anything to do with a possible bleed. The defendant doctor visited the decedent mid-day of post-op day 2, recommended ambulation, and headed back to his office.  About a half an hour after that, the plaintiff took a walk up and down the hallway, per instructions.  He returned to his room, collapsed, coded and died.

 

The plaintiff called the defendant doctor as the first witness.  It was an interesting beginning to the case.  In a way, it is like our mass tort cases where the plaintiff lawyer begins by torturing a company witness with reptile questions and insinuations of document spoliation.  In this case, the doctor held his own well, emphasizing the stable vital signs and the unforeseeability of the sudden collapse. He mostly agreed with the plaintiff lawyer’s questions.  There was no unseemly fencing.  But there was an interesting admission: the doctor testified that during his last visit to the decedent, he at least considered the possibility of bleeding.  But the doctor said he didn’t observe any reason to follow up on that thought.  Perhaps later in the day, depending on what he learned, he might enter orders to address that possibility.

 

The next witness was the county pathologist.  She performed the autopsy.  Her testimony came in via video.  She was credible and wasn’t being paid by anyone.  She found approximately 900cc of blood near the surgery site.  She also found that several of the decedent’s arteries were moderately blocked and that the left side of his heart was mildly enlarged, probably from years of hypertension.  Her conclusion was that the blood loss, in conjunction with pre-existing heart disease, had caused the sudden death.

 

The plaintiff presented two more video depositions.  One was of a causation witness, who agreed that blood loss contributed to the death, and the other was a standard-of-care witness, who opined that as soon as the hemoglobin continued to fall the day after the surgery there should have been intervention, such as a CT scan or transfusion.  The standard of care witness hit the required points, but he displayed some shortcomings.  He came from clear across the country and possessed no experience with the type of robotic surgery at issue in the trial.  Moreover, his initial report attributed the death to a heart attack.  One problem with that – there was no heart attack.  Also, this expert suggested that the decedent’s vomit should have been tested for blood because it was brown.  Two problems with that – the pathologist found no sign of blood loss in the upper GI system, and the plaintiff expert weirdly denied that vomit often is brown.  The defense lawyer enjoyed that last answer.  He paused and turned to look at the jurors, holding the moment nicely.

 

We were also treated to testimony from an expert economist, who laid out uncontroversial earnings and valuation numbers.  One set of numbers assumed retirement at 62 (the decedent was 60 years old when he died), and the other assumed retirement at 66.  The bottom-line difference between the two assumptions was over a million dollars.  There was some dispute as to which scenario applied, because the decedent’s brother reported a conversation in which the decedent mentioned the possibility of retiring early, but the decedent’s widow (who was also executrix of the state) was adamant that she and the decedent had planned for only her to retire early, with the decedent working at least to age 66.

 

The widow was the last plaintiff witness, and she presented very well.  She maintained complete dignity through her grief, and painted a picture of her late husband as an impressive, intelligent, fundamentally good man.  He had spent decades in the military, and then carved out a strong career as a Human Resources executive in corporate America.  The jury liked the plaintiff.  We felt terrible about what had happened to her and her husband.

 

The defense case was short and to the point.  A local critical care expert testified via video that an already diseased heart, not the bleeding, caused the death.  The plaintiff’s cross-examination scored some points. We learned that this expert had done a fair amount of testifying for the defense lawyer.  It also became clear that this expert was not much of an expert in the relevant fields.  So much for that.

 

But then another local expert doctor came into the courtroom with formidable credentials.  He testified forcefully that there was no reason to intervene until the hemoglobin level dropped below certain levels, 8.0 for someone with heart disease, and 7.0 otherwise.  Dropping hemoglobin levels could be consistent with hemodilution from administration of IV’s. The absence of disruptions in vital signs was significant.  The various accounts of the decedent’s abdomen and its softness, tenderness, or firmness were not so significant.  Further, transfusions carry their own risks.  That is why doctors must follow well-established standards before intervening.  On cross-examination, we learned that this expert’s price tag was also impressive.  He earned $6000 from reviewing records and another $5000 for the in-court testimony. More than once in the case, the plaintiff lawyer referred to the $11,000 man.  Sure.  Sometimes you get what you pay for.

 

The defense case concluded with a pair of fact witnesses.  An attending nurse seemed a bit nervous and genuinely shaken up by the sudden death.  She also seemed surprised by it.  Aside from the patient’s vomiting, the vital signs were not troubling.  Finally, the defendant doctor retook the stand.  First logically, and then passionately, he laid out his thinking as to why his patient did not appear to any reasonable eyes to be in danger.  He elaborated on the hemodilution theory.  He then held up well under a spirited cross-examination.

 

The lawyers conducting the direct and cross examinations mostly sat as they did so.  Very few graphics were employed.  It was all low-key.  We could not resist in our own mind the temptation to grade the performances of the lawyers.  We thought they were quite good.  They all seemed competent and relaxed.  They probably found themselves in court far more often than big-shot, national mass tort lawyers do.  There were no histrionics.  Everybody seemed to get along.  If we had any critique, it was that the editing of the video depositions was a bit clumsy.  Such videos are hard enough to endure, but when we had to sit through useless introductions by the videographer, you could hear the restless seat-shifting  in the jury box.  But that’s a minor quibble.  Both cases came in smoothly.

 

The closing arguments by the lawyers were as short as the opening statements, and mostly made points that were by now well inscribed in the juror’s heads. The lawyers agreed that the three questions the jury had to answer were: 1.  Did the doctor fall below the standard of care?  That is, was he negligent?  If we answered that question No, we were done.  2.  Was the negligence the cause of death?  3.  What were the appropriate damages?

 

The plaintiff lawyer addressed all three questions.  The doctor had a duty to take care of his patient and prevent harm.  The declining hemoglobin levels and firm abdomen should have prompted some form of intervention.  The independent county coroner had determined that the bleeding contributed to the death, and that simply made sense.  Finally, the plaintiff’s expert accountant was essentially unchallenged. That testimony established the economic damages.  Pain and suffering was up to us.

 

The defense lawyer did not address damages at all.  Rather, he devoted the bulk of his argument to showing how attentive the doctor was, how stable the patient’s vital signs were, how hemodilution could well account for the hemoglobin declines, and how the defense expert on standard of care had articulated the relevant standards that precluded any premature intervention.  On causation, the defense lawyer argued that the county coroner did not have access to all the relevant information, and that the defense causation expert offered a more complete picture that supported potential alternate causation.

 

After standard jury instructions (that even this lawyer has to admit were less  than pellucid on wrongful death vs. survival actions), the case was given to us.  The tip-staff personnel escorted us down the hall.

 

The Deliberations

 

The Judge ordered that juror #1 would be the foreperson.  Lucky choice.  Our foreperson was a quiet, calm fellow with no obvious agenda. He suggested that we take an initial vote.  6-6 on question 1 – negligence.  Gasps around the room.  One or two jurors muttered that there was no way they could be stuck in the courthouse all week.   It was around 11:30 am, so we ordered our first free lunch during our jury service and started sharing our perspectives.  It was immediately clear that the two nurses and the medical transcription student were locked into pro-defense positions.  They led the charge for their side and banged home that the vital signs were stable and the hemoglobin levels never descended below the magical number, whether that was 8.0 or 7.0.  The plaintiffy-leaners wished that the doctor had done something more to look into possible bleeding.  Everyone seemed to agree with the independent pathologist that bleeding played a causal role.  The difference was the extent to which this hindsight colored the assessment of standard of care.

 

We argued the salient points in a civil fashion for a couple of hours.  There weren’t many detours.  Several jurors commented that there was no evidence that the doctor intentionally did a poor job.  He certainly did not mean to visit any harm on his patient.  All well and good, but that plainly was not the issue.  The nurses were particularly active in the deliberations.  After we asked for certain medical records to be sent to us (interestingly, the Court refused to send us any testimony we requested), the nurses took the lead in translating them and telling us how they fit into the patient’s care.  As you might guess, the nurses were especially attentive to the nurse’s testimony.  The defense lawyer had done something clever at the end of his direct examination of the nurse.  He asked her what her opinion was regarding standard of care.  The plaintiff lawyer properly objected.   The nurse, after all, was not being tendered as an expert.  The Judge sustained the objection.  But the nurses on the jury construed all this to mean that the nurse thought the defendant doctor had not botched anything.  Other jurors pointed out that this was improper speculation, and the point never arose again.  But there it was.

 

At 3:30 pm we re-voted.  Still 6-6.  We went around the table and concluded we were deadlocked.  We sent a note to the Judge.  While waiting for a response, more than one juror wished aloud that the parties would settle.  It was a hard case and we hated the possibility of getting things wrong.  Then we were sent to the courtroom.  The Judge smiled at us, told us to get a good night’s sleep, change our clothes, and come back the next morning.  In truth, this was what we expected.   In a sense, we were merely making a record, so that if we reported a deadlock the next day, it would be more likely we would be dismissed.  Yes, sometimes jurors think strategically about these things.

 

When we arrived the next morning, we learned that one person had changed his vote from plaintiff to defense.  It was now 7-5.  Then the debate continued.  We asked for more medical records, which we got.  We asked for more testimony, which we did not get.  We were told that it was “unavailable.”  Huh?  Whatever.  We asked for an easel, which the tip-staff brought us with a rueful grin.  One of the nurses had nice, legible handwriting, so she became the easel artist.  We created a chronology that was better and more useful than anything we saw in the case.  It clarified our thinking.  But it did not change any minds.  At this point, one of the defense jurors suggested that we go around the table and have each juror try to state the strongest positions favoring the other side.  What a good idea!  But one of the nurses and the medical transcription student said that they could not engage in that exercise, as they saw no sense in the plaintiff position.  Ouch.  Still ,we never became Twelve Angry Men (and Women).

 

Several times the medical transcription student bemoaned the impossibility of our task.  How could we all, as non-doctors, evaluate the standard of care of a doctor?  Some of us grew frustrated with this dithering.  Applying her reasoning, maybe there shouldn’t be med-mal cases at all.  It seemed a useless, maybe even nihilistic, point.  And yet, it led to the breakthrough in deliberations.  We realized that our discussions on standard of care had involved grabbing hold of various bits of evidence and then asking how they fed into the analysis.  That is, our analysis. But, in truth, the way for non-expert, non-doctor jurors to answer the standard of care question was to look to the expert testimony on that specific point.  There were two expert witnesses, one from each side, who had directly addressed standard of care.  We then made a chart comparing those two experts.  The plaintiff expert said that as soon as the hemoglobin dropped to 10, the treating doctor needed to act.  The defense expert said that as long as the vital signs were stable and the hemoglobin stayed above 8.0 (relying upon a JAMA article), watchful waiting was all that was necessary.  We agreed that the plaintiff expert had some credibility problems, in terms of creds, experience, demeanor, and answering some questions in a way that made little sense, whereas the defense expert was consistently impressive, consistently forthright, and consistently, well, consistent.  A couple of the defense jurors looked at each other and grumbled that sometimes one has to render a decision one might not like.  Three flipped.  Now it was 10-2 for the defense.  We had a verdict.  The foreperson knocked on the door for the tip-staff.  A few minutes later, we walked back into the jury box.  Our faces were blank.  The foreperson read the verdict.  There was no visible reaction from the parties.  There was no request to poll the jury.  The Judge thanked us for our service.  He said that someday we might wonder whether we had done the right thing, but we should be assured that we had done the right thing, because we had gone about the process the right way.

 

And that was it.  The entire case began with jury selection on a Thursday and ended with a verdict just after lunch the following Wednesday.  Some jurors exclaimed at how long the whole thing took.  Hmmm.  They should try being a juror on one of our MDL trials.

 

Lessons Learned

 

Let’s be honest: as a litigator, we had always thought it would be useful to serve on a jury.  It would be a window into a process that had always seemed like a scary black box.  But we never thought we had a chance.  We continue to be amazed that a plaintiff lawyer would fail to exercise a peremptory challenge against us.  But here’s the thing: that plaintiff lawyer was not wrong.  Without getting into the specifics, let’s just say that this particular defense-hack-turned juror gave the plaintiff side a very fair hearing.  The jurors who really clobbered the plaintiff’s case were the three who had medical experience.  So let that be the first lesson.  Medical knowledge on the jury, whether real or pretended, can exercise an extraordinary influence.

 

Other lessons might not exactly arrive as newsflashes for most of our readers:

 

  • The quality of experts can be outcome-determinative.  The moneys paid had no impact on us, but the credentials, consistency, confidence, and reliance on authority all did.  It also helped for the expert to be local.
  • Sympathy played no role.  Maybe we were a hardhearted bunch, but our genuine respect for the plaintiff and her decedent played no role in rendering a verdict.  We all expressed sorrow afterwards, but that was it.
  • Use graphics judiciously.  Clear examinations and clear explanations can go a long way.  Two or three good graphics on important issues (especially timelines) can register more impact than 30 numbing PowerPoint slides.
  • There was very little snarkiness or overreaching in the case, which is all to the good, because the jury did not like even a hint of either.
  • The most important lesson is that jurors really try to do the right thing.  Permit us a moment of civic boosterism.  We already were coming around to the notion that Chester County, with its covered bridges, sad Wyeth landscapes, trout-filled streams, glorious Revolutionary War history, proximity to Philly, preeminent public schools, and low crime, was just about the perfect place to live.  It also might be the perfect place to try a case.

 

We recently read an editorial in The New York Times advocating lawsuits as a means of regulating an industry. Politicians are gripped by paralysis – so the argument goes – thus we must entrust the issue to litigators, smart judges, and good-hearted jurors.  After all, hadn’t years of product liability litigation resulted in safer products?

Well, … no.  Data doesn’t  show that litigation leads to safer products.  Fewer products, probably.  More expensive products, definitely.  But litigation is a perfectly awful way to impose safety regulations on an industry.  Say what you will about politicians, but at least they are somewhat representative of people’s will.  Say what you will about regulators, but at least they possess some expertise.  If there is paralysis in the halls of a legislature or government agency, that paralysis reflects a lack of consensus, a clash of passions, or a genuine conflict in the science.  Litigation is an eccentric means of ruling on general issues – it is off-center.  The peculiarities of one lawyer’s eloquence, or one judge’s bent for social engineering or twelve jurors’ emotions can produce a verdict with profoundly puzzling and profoundly enormous implications.  It is a rotten way to lay out general safety rules.  (Mind you, we are not talking about constitutional issues that may require judicial intervention.)  The various say-sos of jurors or even judges can be unpredictable, unbalanced, and inconsistent.  Lawsuits are not designed to determine safety science or policy.  Instead, they resolve disputes between parties.

Enter the judicial doctrine of standing. You cannot pursue a lawsuit merely because you are sure you have the right idea of How It’s Got to Be.  Rather, you must be actually injured in fact.  Injured sensibilities are not enough.  Not every Nosy Nellie qualifies as a plaintiff.  The doctrine of standing means that lawsuits pertain to actual disputes.  Courtrooms are not debating societies.  If there are judges anywhere in the land, say, in Brooklyn or Boston or Los Angeles or anywhere else who think they have a great idea about how to regulate consumer products, great; write a letter or comment to a legislator or regulator, but don’t glom onto a lawsuit as a way of playing the role of Philosopher King.  Maybe the judiciary is not always the “least dangerous branch,” but limiting doctrines such as standing are intended to make it so.

Standing is the key issue in today’s case, Debernardis v. IQ Formulations, LLC, 2018 U.S. Dist. LEXIS 52445 (S.D. Fla. March 29, 2018).  Debernardis was a purported class action alleging that certain dietary supplements contained a stimulant that was unlawful and, therefore, rendered the supplements “adulterated” or “misbranded.”  The plaintiffs parsed the FDCA regulations to justify this allegation.  While the FDCA does not provide for a private right of action, there are a number of state consumer protection laws that incorporate FDCA labelling provisions and provide a mechanism for private suits.  Accordingly, the plaintiffs in Debernardis contended that the makers of the supplements had violated Florida, Illinois, and New York deceptive practices acts and other laws.  The plaintiffs alleged that they suffered economic injury because they would not have purchased the supplements had they known that one of its ingredients had not been approved by the FDA. Importantly, the plaintiffs did not allege that they had suffered any physical harm or that the supplements did not work as advertised.

The defendants moved to dismiss the class complaint, arguing, inter alia, that the plaintiffs lacked standing to bring the action.  The Debernardis court began with an overview of the standing requirement, describing the actual injury requirement, as well as the need for plaintiffs to demonstrate “a causal connection between the injury and the conduct complained of.”  As we argued in a recent post, it is remarkable how many cases come down to the issue of causation.  The Debernardis court also mentioned the requirement that plaintiffs must show “a likelihood that a court ruling in [the plaintiff’s] favor would remedy [his] injury.”  These standing requirements are in no way relaxed for class actions.  The named plaintiffs still must still allege that they personally have been injured such as to satisfy the test for standing.
We are pleased to report that the key standing cases cited by the defendants in Debernardis were three cases residing within the Third Circuit.   One in particular, Hubert v. Gen. Nutrition Corp., 2017 WL 3971912 (W.D. Pa. Sept. 8, 2017), was very similar to Debernardis and arrived at a dismissal for want of standing.  In Hubert, the plaintiffs offered only a “threadbare allegation” that they paid more for supplements than they would have if the supplements had been accurately labeled.  Without supporting factual allegations, such conclusory statements did not establish injury in fact.  Moreover, the Hubert court rejected a benefit-of-the-bargain theory because the plaintiffs alleged no adverse health consequences nor that the supplements failed to perform as advertised.  Exactly the same weaknesses bedeviled the Debernardis complaint.  No actual, concrete injury was set forth in the complaint.  (The plaintiffs in Debernardis relied on two cases from the Eleventh Circuit. That circuit was the winner of a big, fat No-Prize from us last year, as it generated the most cases in our Bottom Ten list.  In any event, the Eleventh Circuit cases had some meat to their price differential theories – something wholly lacking in Debernardis.)
The Debernardis court confronted the issue of standing squarely and concluded that the plaintiffs did not have it:  “The broad claim that they would not have purchased the Supplements at all had they known that [the defendant] had failed to follow the FDA’s approval procedure regarding an ingredient is insufficient to confer standing.” Similar reasoning might apply to some of the drug and device cases we encounter.

The major sporting event this time of the year is the NCAA basketball tournament.  Our money is on Villanova University, because that is where we sent a lot of our money over the last four years, funding the education of the Drug and Device Law Son.  Even if we didn’t have a Villanova graduate in the family, we’d probably root for that school, because it is just down the road from where we live, it runs an athletic program that manages to be both excellent and clean, and we know many extremely fine people associated with the University.  Our money is also on Jalen Brunson as the tournament Most Valuable Player (MVP).  [That being said, there is a lot to like in all of the Final Four teams.  In particular, the amazing run of Loyola of Chicago, with chaplain Sister Jean, is a  great sports Cinderella tale.  Plus, the smartest guy in our law school class went to Loyola-Chicago, and is probably right now bragging to his students at USC Law about the inevitability of the Ramblers cutting down the nets at the end.]

 

If we had to pick an MVP for the area of law in which we practice, we’d choose causation.  It is a powerful concept we learned back in our first year of law school, and it probably plays a bigger role in deciding cases than anything else, including duty, breach, damages, or Bexis’s beloved preemption.  Even when dealing with statutes that do their best to erode such tried and true defenses as reliance, causation can ride in to save the day for our clients.  If no other defense seems available, do not give up on causation.  It poses fundamental questions of “so what?” “what if?” “but for?” “why?” and “huh?” — and there are lots of plaintiffs who can never answer those questions satisfactorily.

 

Today’s case, United States v. Chin, 2018 WL 1399297 (D. Mass. March 20, 2018), is a criminal case, which (1) might seem a bit far afield from the heartland of what we – and here the royal “we” encompasses most of our readers as well as ourselves – do, (2) explains why today’s post was penned by this particular ink-stained wretch, as ex-AUSAs are always quick to glom onto any case where the first listed party is the United States of America, and (3) turns on the all-powerful notion of causation.  The defendant was convicted for mail fraud racketeering (RICO), conspiracy, and violations of the federal Food, Drug, and Cosmetic Act.  The underlying conduct involved the notorious national spinal meningitis epidemic traced to defective doses of injectable methylprednisolone acetate manufactured by the New England Compounding Center (NECC). The defendant was a supervising pharmacist at NECC.  Now it was time for sentencing.  The government sought $82 million in restitution to be paid to the families of the deceased and the survivors.   

 

The court observed that “[r]eality casts a cold light on the $82 million request.”  The defendant was destitute and would never-ever be in a position to pay even a small fraction of the amount sought.  The government conceded at oral argument that “any restitution award would be no more than a symbolic gesture.”  Indeed.  This selfsame scenario played out in many courts when we represented the United States.  The statutes and sentencing guidelines made restitution a component of sentencing, and the standard presentence report would include a recommendation of restitution. But the standard joke in our office was that we would go out onto the roof of the courthouse and shoot off fireworks if a defendant ever actually paid any restitution. As the government said in Chin, an order of restitution amounts to a mere gesture.

 

Nevertheless, courts take restitution seriously, as they should.  Restitution is required by the Mandatory Victim Restitution Act (MVRA), 18 U.S.C. section 3663A(c)(1)(A)(ii).  Restitution is paid to victims, so the Chin court begins with the MVRA’s definition of “victim”: “a person directly and proximately harmed as a result of the commission of an offense.”  When we see words such as “directly,” “proximately,” and “as a result of” we think causation.  So did the Chin court.  “Directly” and “proximately” signal efforts to cabin the causation concept in some reasonable, predictable fashion.  Any law school graduate can think back to the ancient Palsgraf v. Long Island R.R., (1928) case, where New York’s high court (per future SCOTUS Justice Cardozo) tried to limit proximate cause via the requirement of foreseeability.  Then again, we are also all familiar with how courts over the intervening years have stretched foreseeability to the breaking point, so much so that, as we have said with respect to some decisions, on even a not-so-clear day some judges can foresee forever.   But the Chin court actually drew a pretty tight circle around causation.  It held that “a loss for restitution purposes must be causally tied to the underlying offense of conviction, in Chin’s case, mail fraud and racketeering conspiracy based on predicate acts of mail fraud.”  The government’s calculation of an $82 million restitution award was based on a tabulation of the medical expenses, costs for physical and occupational therapy, lost income, burial expenses, and other expenditures compiled by patients who were injected with  the contaminated drugs.  But NECC “made no representations to end-users and patients for the purposes of obtaining property (money); rather, it made those misrepresentations … to the hospitals and clinics that purchased the drugs.”  The government suggested at oral argument that the word “sterile” on the syringes in question, if seen by a patient prior to injection, would potentially constitute a misrepresentation for mail fraud purposes, there is  no evidence in the record to suggest that this ever occurred. 

 

Moreover, in an interesting way, the learned intermediary relationship played a role in cutting off causation in the Chin case.  To the extent that patients may have implicitly relied on NECC’s representations by relying on their doctors as learned intermediaries, this additional layer of insulation between NECC and the patient further renders any such reliance “too attenuated” to satisfy the “direct causation” standard of the MVRA.  Consequently, the Chin court calculated the total restitution award as the loss suffered by the hospitals and clinics that purchased lots of degraded or defective drugs during the life of the racketeering enterprise.

 

In sum, the Chin case demonstrates the continuing force of the causation requirement. This was a criminal case, and the issue of restitution was at the center.  The Chin court’s analysis of proximate causation is better and tighter than we typically see in civil cases, and we can, ahem, foresee some litigant attempting to distinguish away Chin on those grounds.  But why should there be any difference in the causation analysis?  We intend to have the Chin causation analysis in our pocket the next time we litigate the issue, especially if we are in the sometimes challenging First Circuit.     

 

 

 

All of us – defense lawyers, plaintiff lawyers, and judges – tend to assume that the federal Daubert standard for admissibility of expert testimony is more rigorous than competing standards, particularly the Frye standard, which lingers in a minority of jurisdictions (and not even where it originated).  In simple terms, Frye merely asks whether the expert opinions find general acceptance in the relevant expert community, whereas Daubert digs into the reliability of the particular opinions.  Put another way, Frye makes judges count experts, whereas Daubert makes them become experts.  Maybe that is why there are so many judges that hate Daubert and apply it in name only. When application of the Daubert standard results in exclusion of an expert opinion, it is usually the reliability component, not, say, qualifications, that does the excluding.  Daubert’s reliability component, in turn, contains several components.  Some are highly technical, such as rate of error.  Others are a little easier to understand, such as whether the expert opinions are litigation-driven, whether peer review literature supports the opinions, and – ta da! – whether the opinions find general acceptance in the field.  That is, Daubert incorporates Frye to a certain extent.  But whereas general acceptance is the whole ballgame in Frye, general acceptance is only one among several factors, and is not by itself dispositive.  Consequently, one can dream up a scenario where an expert opinion might get knocked out by the Frye standard but would make it to the jury under Daubert.  Think of an expert opinion that lacks general acceptance but otherwise can lay claim to other indicia of reliability.  You might not find it terribly easy to conjure up such an expert opinion.  After all, how has a reliable opinion not achieved general acceptance?  Is it just too new?  Would you be surprised to learn that the Daubert standard was initially created by courts to liberalize Frye? Be that as it may, the point drilled home by today’s case, In re 3M Bair Hugger Litig., 2018 WL 894021 (Minn. Dist. Ct. Jan. 8, 2018), is that, every once in a while, the old Frye standard really cooks.

 

It appears from the introduction to the state court’s opinion that a hearing on expert admissibility was held jointly before the state and federal courts in the Bair Hugger litigation.  Such state-federal coordination is a welcome dose of efficiency in aggregated litigation.  The plaintiffs and defendants moved to exclude each other’s expert opinions, and the defendants moved for summary judgment with respect to general causation.  The medical device in question was the Bair Hugger, which is used to maintain a patient’s normal body temperature during surgery.  The court pointedly tells us that “[m]ore than thirty years ago, it became generally accepted within the relevant scientific community that maintaining a patient’s normal body temperature (“normothermia”) during surgery led to decreased infection rates, a shorter period of post-operative recovery, and improved healing. This theory remains generally accepted, and various manufacturers compete to market their warming devices.”  Nice job foreshadowing the “general acceptance” issue.  The issue in the litigation was whether the Bair Hugger’s forced-air system of temperature regulation increased the chances of infection.   That was the opinion proffered by the plaintiffs’ three medical experts, and the issue was whether such opinions were generally accepted.  And now we will do a little foreshadowing ourselves:  they weren’t.  Hug the Bair Hugger litigation goodbye.

 

But first you will want a bit of background.  That background is a bit tawdry, and it is hard to think such background did not make it a little bit easier for the court to drop both the plaintiffs’ expert opinions and complaints into the trash bin.  The Bair Hugger had been invented by a fellow named Augustine.  The Bair Hugger became the leading warming device in the world.  Then came bad news.  That inventor was notified by the United States Department of Justice that he was under investigation for Medicare fraud. Augustine resigned from the company.  He later pled guilty, was fined $2 million, and was prohibited from participating in federal health-care programs for five years.  The Bair Hugger device continued to be successful. 

 

Augustine later invented a competing normothermia device, this time employing electric conduction rather than forced air.  He called this new device “the HotDog.” As if the reference to a delicious meat snack was not enough to win over customers, Augustine then did his best to attack his old device.  In 2008, he began to impugn the safety of the Bair Hugger overseas. He issued a press release criticizing forced-air warming systems such as the Bair Hugger. Augustine claimed that such devices increased the risk of surgical infections. The United Kingdom National Institute for Health and Clinical Excellence rejected this claim, concluding that forced-air warming devices were not associated with an increased risk of infection.

 

Then things got even nastier.  Augustine hired a law firm to promote the use of HotDog patient warming, and he agreed to work with the law firm as a “non-testifying expert.” That law firm eventually began to represent individuals in lawsuits to be brought against the Bair Hugger.  But meanwhile, the efforts to besmirch the Bair Hugger’s safety were as unsuccessful in the United States as in the United Kingdom.  The FDA investigated the allegation that the Bair Hugger increased the risk of bacterial contamination. It did not agree with the allegation.  And now we get a wonderful little observation from the Minnesota court that captures so much about what is wrong with mass tort drug/device litigation:  “The FDA exercises a more stringent approach to product safety than state and federal courts…. The FDA will remove drugs from the marketplace upon a lesser showing of harm to the public than the preponderance-of-the-evidence or more-likely-than-not standards used to assess tort liability.”  Just so.  And yet we spend the major portion of the day defending claims against drugs and devices that the FDA chooses to leave on the market.  We think of the Jeremiad: “And still we are not saved.”  (We have a post about the FDA enforcement standards being less than the common law tort “more likely than not” standard.  Where do we have it?  Here.) 

 

Back to our story.  The bad turns ugly.  In 2012, the inventor-turned-competitor-turned-adverse-expert tried “to coerce” a defendant into purchasing his HotDog system by warning that the defendant “would suffer a significant loss of market share and ‘a lot of negative marketing rhetoric’” about the Bair Hugger causing infection if the sale did not occur.  It’s as if the inventor was trying to make the defendant an offer it could not refuse.  But guess what?  The defendant refused. 

 

Then Augustine began to market the HotDog as reducing the rate of surgical infections when compared to forced-air systems. In response, the FDA sent a warning letter to Augustine in 2012, stating that his claim was without clinical support and made without FDA approval. Meanwhile, the Hotdog in-house counsel proposed to prepare a “detailed guide” to sue the Bair Hugger. Even so, Hotdog again proposed a marriage with the Bair Hugger.  Again, the proposal was rejected.  Again, the FDA was forced to respond to the inventor’s attempts to impugn the safety of the Bair Hugger, by issuing a letter endorsing the continuing use of forced-air warming devices and the beneficial effect of such devices on patient safety. 

 

We remember once hearing a jury consultant say that every product liability lawsuit is a romance novel.  The story goes like this: you seduced me, you harmed me, and now you have abandoned me.  Well, this normothermia saga is the weirdest kind of romance novel.  It as if the Hotdog inventor was stalking the Bair Hugger, mixing entreaties of “marry me” with the most hateful invectives and assaults.  Fabio is nowhere in sight.  Even the Lifetime Network would take a pass on this improbable narrative.

 

Naturally, this narrative culminates in mass litigation.  Augustine and his law firm saw 60 cases get filed in Minnesota state court and thousands of cases in federal court.  Those cases rested on a three-legged stool of three iffy general-causation medical expert opinions.  Notably, “[n]one of these experts had studied the efficacy of forced-air warming devices prior to being retained by Plaintiffs. They have not published any peer-reviewed articles relevant to the claims made in this litigation. They do not claim that their general-causation opinions are generally accepted within the relevant scientific community.”  The experts were named Samet, Stonnington, and Jarvis, and odds are that you have encountered at least one of them in the long inglorious history of plaintiff experting.  You will hardly be surprised to hear that the defendants argued that the opinions were not generally accepted within the relevant scientific community and, therefore, were inadmissible under Minnesota law.  There was no mention of Daubert, since Minnesota is not a Daubert state. Don’t worry; Daubert was not needed. 

 

The plaintiffs’ only argument to save the expert opinions was that the general-acceptance requirement does not apply to an expert’s opinion. Rather, the standard applies only to the “methodology” an expert uses to arrive at his or her opinion.  We have to give the plaintiffs credit.  They placed their finger on the key issue in many Frye jurisdictions.  What has to be generally accepted, the bottom-line, ultimate opinion, or the methodological bits utilized to arrive at that opinion? Mind you, it’s not as if separating one from the other is perfectly obvious. The Minnesota court consulted both precedents from its own state as well as a Florida case desperately seized upon by the plaintiffs, and then announced its own bottom-line, ultimate opinion: the opinion itself, not just the methodology, must find general acceptance.  The general-acceptance prong under Minnesota law applies to “opinion or evidence” that “involves novel scientific theory,” and requires that the “underlying scientific evidence” be generally accepted.  The opinion that forced-air warming devices increase the rate of surgical site infections “is undisputedly novel and not generally accepted. Plaintiffs’ attempt to narrowly apply the rule must be rejected.”  The court reasoned that if the plaintiffs’ “interpretation were applied to its extreme, a witness would be able to opine that the earth is flat, or the center of the universe, if the person’s methodology for arriving at those opinions was generally accepted.”  True, and one can be sure that such extreme application will show up before the year is out. Interestingly, the Minnesota court quoted an earlier Minnesota precedent to the effect that the application of the Frye [in Minnesota it is called FryeMack] standard “avoids the problem that many commentators see as inherent in Daubert, namely, that such an approach “takes from scientists and confers upon judges *** the authority to determine what is scientific.”  But when most other courts praise the superiority of Frye, it is whilst they are in the process of waving by junk science.  What is so important and powerful about this decision is that it shows how Frye can be applied to bar junk science at the courthouse steps.  You should definitely have this opinion in your pocket the next time you visit Minnesota.  You should probably use it in any Frye jurisdiction.  You can probably exploit it here in the Commonwealth of Pennsylvania, where we have heard references to “Fraubert.”  Heck, you can probably be clever enough to use this opinion in the right circumstances in a Daubert jurisdiction.   

 

By the way, there was a second argument supporting summary judgment for the defendants. (When you win in the trial court, there is nothing better than provision of alternative grounds by the court.  It makes the appellate adventure so much more pleasant.)  Even if the general-causation opinions of the plaintiffs’ experts were admissible, the plaintiffs “have failed to establish that it is generally accepted that the risk of infection associated with forced-air warming devices is greater than the risk of infection associated with hypothermia during surgery or when compared to other warming devices.”  It is a double whammy.  There was no generally accepted scientific evidence that the risk of infection associated with forced air normothermia devices was greater than that associated with patients who are not warmed during surgery, and there is no scientific evidence that warming devices other than forced air warming devices have a lesser rate of infection.  There is no there there.

 

After an application of Frye so robust as to call to mind former Minnesota Governor Ventura, the court ends by dispensing a couple of other goodies to the defense bar.  First, the court praises the general acceptance test because it “values the primacy of science over litigation-driven opinion by allowing the medical and other scientific communities to abide by those generally accepted practices that promote patient safety, and marginalizes the effect of other opinions and efforts that might be unduly influenced by litigation and/or competition.”  Or, as we’ve said more than once before, law must lag science, not try to lead it.  (Thank you, Judge Posner.)  Second, the court observes that “the history leading to this litigation also demonstrates the importance of the general-acceptance standard when the threat or fear of litigation is used as a competitive tool.”  Amen. But while the abuse of science is especially obvious in this case, it exists in some significant form in most drug or device litigations, whether or not a vengeful inventor or romantic pursuer lurks just offstage.

 

 

With a little luck on our part, by the time you read this we will be vacationing in a sunnier clime.  Our beachfront cottage is an Oddjob’s hat-toss away from where Ian Fleming wrote the James Bond novels.  Mind you, we are not pretending to be serving On Her Majesty’s Secret Service.  If anything, with the secluded location of our holiday, the absurd luxury, and our ever-expanding girth, we are more appropriately cast as a Bond villain.  That suits us just fine.  More than one plaintiff lawyer has called us Dr. No. And more than once, we have reached under our desk, probing for a trap-door button that would plunge an opponent into the piranha pool.



The judge in today’s case, Livingston v. Hoffman-LaRoche Inc., No. 17C-7650-MEA (N.D. Ill. March 7, 2018), pushed the button, holding that there was no personal jurisdiction.  Livingston was yet another Accutane case, with allegations of bowel injury.  We have written frequently on the aggregated forms of this litigation in both the federal and New Jersey court systems.  The Livingston case is different.  To be sure, the Livingston opinion last week was largely an obvious application of the SCOTUS Bauman and BMS cases, but there was a scary threat lurking just off-stage.  More on that later.  Moreover, anything good on jurisdiction from Illinois is noteworthy.

 

The history of the Livingston case is more complicated than the plot of The World is Not Enough.  The case was originally filed in Cook County, Illinois – a fabulous pro-plaintiff jurisdiction.  The case was then removed.  Then it was remanded — nine years ago.  The case sat in state court with little happening.  The generics got out on Pliva v. Mensing in the meantime, but by then the branded defendant could no longer remove the case because of the one-year bar.  Then the plaintiff lawyers did the defense a great favor (not the last) by taking their one dismissal in Illinois, which allowed them to refile within a year.  The plaintiff eventually did refile in Cook County, and the branded defendant removed.  That’s the case in our sights today.  The case was initially assigned to a different judge, but then it got reassigned to the same federal judge who remanded a long time ago.  The defendant would have been entitled to view that as a bad sign.  But it wasn’t.

So much for foreshadowing.  Here are the facts, at least the ones that matter for this decision.  The plaintiff took Accutane to treat his acne in Wisconsin in 1999 and in Ohio in 2004.  In 2005, the plaintiff had a surgical procedure to remove his colon.  The gravamen of the plaintiff’s lawsuit is that Accutane made this surgery necessary.  More specifically, the plaintiff claimed that the product was defectively designed and was accompanied by inadequate warnings.  But we are getting ahead of ourselves.  The plaintiff moved to Illinois in 2007. There, he was prescribed a generic version of the drug that allegedly caused him the earlier harm, and the plaintiff asserted that his Illinois doctor committed malpractice.  It is because the plaintiff lived in Illinois that he filed his lawsuit there, even though the manufacturer of branded Accutane was not “at home” in Illinois and the branded prescription and the alleged injury occurred outside of Illinois.


It is thus no surprise that the branded defendant moved to dismiss for lack of personal jurisdiction.  The plaintiff filed no opposition.  The Livingston court references a reply brief filed by the defendant.  Presumably, that reply brief was one of those short, triumphal papers pointing out that the plaintiff’s silence amounts to a concession, so a ruling for the defendant should be compulsory and easy.  And, in fact, the dismissal for want of personal jurisdiction was compulsory and easy.  We’ve seen a report on this case in one of the major online legal publications, and for some reason that report focused on general jurisdiction.  That aspect of the decision is certainly the least interesting part.  The manufacturer of Accutane was not incorporated in Illinois and did not locate its headquarters there.  To our mind,  Bauman makes that a no-brainer.
No, for us there are two angles to the decision that are much more interesting.  First, the Livingston court followed what seems to be the emerging consensus rule for federal courts faced with simultaneous issues of subject matter jurisdiction (is there diversity?  is there fraudulent joinder?) and personal jurisdiction (can this particular defendant be sued by this particular plaintiff here?).  Plaintiffs would prefer the district court to handle the subject matter jurisdiction issue first, conclude that the defendant had not met the difficult test for fraudulent joinder, and then remand the case to state court without ever getting to personal jurisdiction.  Defendants would prefer the federal court to look at personal jurisdiction, find it does not exist, and then dismiss the case without ever getting to subject matter jurisdiction.  It turns out the defendants are right and the plaintiffs are wrong (you’re not exactly surprised to hear us say this, are you?) for a simple reason — literally a simple reason: the personal jurisdiction issue is simple, and the fraudulent joinder issue is not.  That is what the Livingston court concluded, alluding to the “enormous judicial confusion” engendered by the fraudulent joinder doctrine, while viewing the personal jurisdiction issue as being “straightforward” and not presenting “a complex issue of law.”  As addressed above, the general jurisdiction prong of personal jurisdiction truly was simple here: no incorporation or headquarters means no general jurisdiction.
The specific jurisdiction prong was almost as simple, though we are mindful that some plaintiff lawyers and some courts now seem determined to make it much less simple.  (We recently read of a court from one of the very worst jurisdictions deciding to tackle the subject matter jurisdiction issue first, because the plaintiffs had successfully muddied the personal jurisdiction waters.  We don’t recall the judge’s name.  Perhaps Blofeld?)  As SCOTUS set forth in Walden v. Fiore, to support the exercise of specific personal jurisdiction, “the defendant’s suit-related conduct must create a substantial connection with the forum state.”  Here, the plaintiff’s Accutane prescription and treatment occurred outside of Illinois.  Predictably, the plaintiff alleged that the branded defendant “marketed, distributed, and sold” Accutane all over the United States, including Cook County.  The answer to that is: So what?  That conduct played no role in the plaintiff’s injury.  What about the fact that the plaintiff does currently reside in Illinois?  Again, Walden supplies the refutation: “[T]he plaintiff cannot be the only link between the defendant and the forum.  Rather, it is the defendant’s conduct that must form the necessary connection with the forum state that is the basis for its jurisdiction over him.”  Go back and read the facts of the Walden case, and you will understand how the plaintiff’s residence, absent some connection to the defendant’s conduct, cannot unilaterally establish specific personal jurisdiction.  End of story.  Push the button. Cue the piranhas.



But there is one additional, potentially interesting aspect of this opinion.  The physician who prescribed the generic version of the drug was, in fact, a citizen of Illinois.  Again, the court regarded this as a big fat So-what:  “The claim against the local doctor did not mention the manufacturer of Accutane, involved the generic product only, “comprises different time periods, and entails different injuries.”  Swell.  But we must admit that as we read the final portion of the Livingston opinion, we were haunted by a spectre.  It is very, very nice that the bottom line of Livingston is that the prescription of a generic drug in Illinois did not create personal jurisdiction over the brand defendant. For a moment, though, a terrible dread wormed its way into our brain-pan.  We alluded above to the fact that Illinois is the home of some awful personal jurisdiction opinions.  Illinois has also been crazy-bad on the issue of innovator liability.  One might have feared that an Illinois court might contrive to find a way to merge innovator liability with the “arise out of”/”related to” prong of specific jurisdiction and thereby keep the case in Illinois. If a branded company can be on the hook for injury allegedly caused by a generic, why not require the branded company come to the forum where the generic was consumed.  An utterly crazy syllogism is at work there.  But Illinois is the one jurisdiction batty enough (well, along with California) to throw out all of tort and jurisdictional law on grounds of foreseeability and misplaced judicial compassion.  Such an outrageous opinion would have made the judicial sky fall. Mercifully, that did not happen in the Livingston case.  Indeed, now defendants have a precedent to argue that it never should.


We offer a tip of the cyber-cap to the winning lawyers, a defense all-star team including longtime friend-of-the-blog Michael Imbroscio (Covington), as well as Colleen Hennessey (Peabody), and Sherri Arrigo (Donohue Brown).