The whole business of discovery in civil litigation is dreary and depressing.  In a mass tort, a defendant can rack up defense verdicts yet still incur discovery costs that exceed the damage amounts sustained by defendants found liable in other torts. Little wonder that the mass of defense lawyers in mass torts lead lives of quiet desperation. At least, that’s true for the poor drudges who must review documents for responsiveness and privilege.

We’ve been thinking about Henry David Thoreau.  An anniversary is almost here.  Walden was published on August 9, 1854.  Thoreau built a cabin near the shore of Walden Pond and began living in it on July 4, 1845, “alone in the woods, a mile from any neighbor.” It was a declaration of independence.  He lived there for two years, two months, and two days.  The book took eight years to write, and there is much more artifice in it than straight nature reporting.  Whatever you think about American exceptionalism, Thoreau exemplified many traits that, for better or worse, seem at the core of the American ethos:  embrace of self-reliance and ecological preservation, and stand-offishness with respect to politics and society.  We wondered whether Thoreau wrote anything about discovery.   Our well-worn volume of Walden contains an index, but we found no reference to “discovery.”  Nor was there a word about document requests.  The best we could do was the famous passage in the “What I Lived For” chapter that explains the project at hand:  “I went to the woods because I wished to live deliberately, to front only the essential facts of life, and see if I could not learn what it had to teach, and not, when I came to die, discover that I had not lived.” There’s that word “discover,” but we suspect Henry had something else on his mind.

Thoreau never had the misfortune to encounter Federal Rules of Civil Procedure 26, etc.  Had he, he might have drafted an interrogatory about discovery:  “whether it is necessary that it be as bad as it is, whether it cannot be improved as well as not.” Most of what we do in civil litigation is discovery, and most of that is a waste of time.  Such time wasting would have mightily irked Henry:  “As if you could kill time without injuring eternity.”  From Thoreau’s revelatory prose we now turn to a judicial opinion that makes those of us who spend time opposing discovery want to retreat to the woods.

Today’s case is In re: Genentech Herceptin (Trastuzumab) Marketing and Sales Practices Litigation, 2017 WL 9939631 (N.D. Okla. May 8, 2018). The defendants wanted to argue preemption, and the plaintiffs engaged in what has become the typical response of insisting on wide-ranging discovery to test the preemption defense.  “Wide-ranging” is an understatement.  From the court’s description, it seems that the plaintiffs wanted pretty much everything.  The defendants countered with something less than everything.  And so we end up with cross discovery motions.  The plaintiffs filed a motion to compel while the defendants filed a motion for a protective order regarding all unanswered preemption discovery requested by the plaintiffs.  The court granted every one of the plaintiffs’ motions to compel discovery responses, and denied every one of the defendants’ motions for protective order.  The opinion is a sadness machine.  That machine is fueled by two all-too-common judicial impulses: (1) letting plaintiffs conduct any discovery they want, and (2) hostility to the preemption defense.  Why, it is almost as if the court was unhappy with the defendants for even raising the preemption defense.

At least the court was convinced that the preemption issue should be decided prior to class or merits discovery.  But the court entertained what it called “a more realistic view of the discovery required for resolution of the preemption motion.” “Realistic” turns out to mean exceedingly broad.  According to the court, the defendants’ preemption motion “relies upon evidence regarding its communications with FDA and its manufacturing process, both of which Plaintiffs are entitled to explore before responding to the motion.”  Consequently, the “preemption defense opened doors in discovery that may well have stayed closed if the only issue was breach of a state-law warranty.”  Open doors are bad.  They let in all sorts of unwanted things – traffic noises, heat, peddlers and, bugs, to name a few.  And bad ideas.

Here, the court opened the door very wide indeed.  For example, the plaintiffs wanted all correspondence between the manufacturer and the FDA relating to product labeling – both pre and post approval.  They also asked for all Establishment Inspection Reports, FDA Form 483s, and Warning Letters issued by the FDA relating to the labeling.  That scope might make sense if the defendants were raising Wyeth v. Levine “clear evidence” preemption.  But they weren’t.  Rather, the defendants argued that the proper inquiry is whether they could “independently do under federal law what state law requires” and whether they could, as a matter of law, “make a unilateral label change that would satisfy the state-law obligation alleged in Plaintiffs’ Complaint.”  That’s Mensing/Bartlett.  That’s different.  That’s straightforward.  That’s binary. The defendants quite logically argued that they were “not raising a Wyeth-type preemption defense and that Plaintiffs ‘have no need for discovery relating to an argument [they] will never make.’”   The defendants also argued that even under the Wyeth changes-being-effected analysis, the plaintiffs could not possibly unearth any “newly-discovered information” that would prompt a labeling change, because it was clear that the FDA knew the relevant information.  End of story.  End of inquiry.  End of discovery.

The defendants were being very Thoreauvian.  They wanted to “simplify, simplify.”  But the court, perversely, was having none of it.  Here is what the court said:  “This Court – and not Defendant – will ultimately decide how to apply Supreme Court law to the evidence presented. Plaintiffs are entitled to advocate for the Wyeth standard, and their requested discovery is relevant to the impossibility preemption analysis in Wyeth.”

And here we must digress.  We are reminded of a story about a legendary D.C. Circuit judge who had stayed on the bench a bit too long.  His practice for oral argument was to consult index cards filled with questions written up by his clerks.  By “ consult,” we mean that he would read off the questions, word for word.  At one argument, he read off a question and managed to stump a polished advocate.  Said polished advocate was stumped because the question had absolutely nothing to do with the case.  Awkward silence. Then the clerk ran up to the side of the bench and whispered frantically, “ That’s the next case, the next case.”  The elderly judge was having none of it.  He sputtered, “ We’re not getting to the next case until this lawyer answers my question!”

In the In re Herceptin case, it is as if the judge was listening to a different case – certainly a different argument.  No wonder, then, that the discovery analysis is so wrong.  Granting the discovery requests would require search of “an extensive regulatory database containing over four million documents.”  The defendants argued proportionality, but the court finds “this proportional to the needs of the case, considering the importance of the issues raised in this multi-district litigation action, the substantial amount in controversy, Defendant’s access to relevant information, Defendant’s resources, and the importance of the discovery in resolving the issues.” So now, in addition to the court’s laissez-faire (or is it les bon temps rouler?) attitude toward discovery, evident disaffection with preemption (at one point, the court bemoans how the plaintiffs “will be deprived of resolution of their state-law claims if the [preemption] defense is successful”), and misconstruction of the defense arguments, we get that other discovery bugaboo about how an MDL  can make even the most extravagant plaintiff discovery request seem proportional.  There is good authority to the contrary (see here, for example), but you won’t see it cited by this court.

Thus, the plaintiffs walk off with a clean sweep win.  They will get communications occurring prior to FDA approval relating to the “Chemistry, Manufacturing and Controls” because such information could be relevant to an obstacle preemption defense that the defendants are not raising.  The plaintiffs will get discovery on the approval process for the purpose of exploring whether FDA “weighed the competing interests relevant to the particular requirement in question, reached an unambiguous conclusion about how those competing interests should be resolved … and implemented a conclusion via a specific mandate …”  Hmm.  That “unambiguous” bit sounds like the Third Circuit’s Fosamax analysis that is sure to be trashed by SCOTUS next year.  To be clear, it is hard to blame the plaintiffs for their approach.  They smartly asked for as much as the court would give them, which turned out to be the whole kit and caboodle.

But wait.  There’s more.  The plaintiffs will not only get everything under the sun involving the product labeling, but will also get all documents and communications touching on the mass, volume or density of the medicine available in a vial.  Naturally, inevitably, ineluctably, the court rejected the defendants’ argument that, “even if additional documents exist, they would be cumulative and would not meaningfully alter the preemption analysis.”  Why?  Here is the court’s answer:  “If one document certainly exists saying ‘ x,’ – which is relevant to overcoming a preemption defense – it is not overly speculative that other similar documents exist in Defendant’s files.” Huh?  That’s like saying that no evidence could ever be cumulative. If there is some evidence of something, we must collect all such evidence.

The defendants even lost an argument that should have been a sure winner – that discovery on “the number of rejected lots is irrelevant because these batches never reached customers.”  Nobody bought those products.  But the court wasn’t buying the argument, because the preemption defense “is not devoted to the substantive claims.”  Well, if a defense is not devoted to substantive claims, it is not really a defense, is it?

The court’s opinion in In re Herceptin leaves us dissatisfied and puzzled.  Near the end of Walden, Thoreau tells us that he “left the woods for as good a reason as I went there.  Perhaps it seemed to me that I had several more lives to live, and could not spare any more time for that one.  It is remarkable how easily and insensibly we fall into a particular route, and make a beaten track for ourselves.”  To our mind, the court’s all-in approach to discovery in Herceptin is an overly-beaten track.  It is certainly insensible.

With one glance at the calendar, regular readers of this blog will have been able to predict the content of these prefatory paragraphs, later to be (tenuously) tied to today’s case. On Monday and Tuesday, as we have for nearly twenty years, we attended the annual Westminster Kennel Club Dog Show, the second-oldest continuous sporting event in the United States (behind only the Kentucky Derby) in Manhattan.  The show draws the best representatives of almost 200 dog breeds, including two breeds eligible to compete this year for the first time: the Nederlandse Kooikerhondje and the Grand Basset Griffon Vendeen.  About 3,000 total entrants are narrowed, during daytime breed judging, to one “best of breed” winner from each breed, then (during the familiar nighttime televised portions) to seven group winners.

The climactic event is the selection of the best-in-show winner from the seven group winners.   (BTW, if you haven’t seen the movie Best in Show, we think it is one of the funniest movies ever made, and, like all good humor, it skates very close to a lot of truths.)  This year, unlike some years, none of the “breeds of our heart” was represented in the final seven, so we watched with excited anticipation but without a favorite.  Not so the sellout crowd.  A pug named Biggie, with a sad human interest backstory (google it), got roars, as did Flynn the Bichon Frise and the Giant Schnauzer that was the top-winning show dog in the country for 2017.  But the crowd favorite was a Sussex Spaniel (a cheerful-looking, low-slung, long-eared spaniel breed with a shiny golden-liver coat) named Bean.  Every time Bean got close to the “bait” – the treats his handler was carrying – he sat up on his haunches and begged.  Needless to say, the crowd swooned.  And we admit that this was insanely cute.  But Bean took it too far, doing his trick right under the judge’s nose, including when was supposed to “free stack” (get himself into a stretched, square stance without his handler placing his feet in the proper positions).

Ultimately, the beautiful little Bichon was Best in Show, and Bean’s begging was for naught, kind of like today’s case (we warned you), a terrific jurisdictional decision out of the consolidated Xarelto litigation in the Superior Court of Los Angeles County, California. In In re Xarelto Cases, 2018 WL 809633 (Cal. Super. Feb, 6, 2018), the plaintiffs sued several manufacturers and a distributor, claiming various injuries and alleging the usual litany of causes of action.  Appearing specially, the (non-resident) manufacturer defendants moved to quash service of the plaintiffs’ summons, arguing that California courts lacked jurisdiction over them.  In response, the plaintiffs served jurisdictional interrogatories and requests for production comprising 113 separate discovery requests, seeking information about marketing and clinical trials allegedly performed by the non-resident defendants in California, including free sample voucher programs, as well as information about the functions the resident distributor defendant performed for the non-resident manufacturers.  The defendants moved for a protective order, alleging that none of the pending jurisdictional discovery was permitted under the United States Supreme Court’s three recent jurisdiction decisions (Bauman, BMS, and BNSF Railway Co. v. Tyrrell, 127 S.Ct. 1549 (2017)), and the plaintiffs countered with a motion to compel responses to the outstanding discovery requests.

The court explained it weighed three factors in deciding whether to permit the jurisdictional discovery: 1) the nature of the jurisdictional facts the plaintiffs sought to discover; 2) whether sufficient methods of investigation were available to the plaintiffs without formal discovery; and 3) the likelihood that the plaintiff could establish the necessary facts. Xarelto, 2018 WL 809633 at *10.  It concluded, “. . . [T]he Court has weighed these factors, and finds that Plaintiff has not made a prima facie case for personal jurisdiction in order to conduct the requested jurisdictional discovery.” Id. (citation omitted).

First, under Bauman, because none of the manufacturer defendants was incorporated or had its principal place of business in California, the courts lacked general jurisdiction.  Second, with respect to specific jurisdiction, noting that the (non-resident) plaintiffs were allegedly injured in their home states, the court held that, under BMS, neither the fact that clinical trials were performed in California nor the fact that the manufacturers hired a resident distributor was sufficient to establish that the plaintiffs’ claims “arose out of” the defendants’ contacts with California.  As such, the court found, “the proposed discovery seeks information on, at best, merely tenuous contact between the Defendants and California.” Id. The court concluded, “Consistent with BMS . . . , the requested discovery will not likely lead to the production of facts establishing jurisdiction over the defendant, based on the allegations of the complaint.  Under these circumstances, the Defendants’ requested protective order is appropriate.” Id. at *11.  That’s right — not a single one of the 113 discovery requests was allowed.

We love this decision. Its correct application of the Supreme Court’s mandates underscores the demise of litigation tourism and emphasizes the futility of plaintiffs’ pervasive and reprehensible joinder of distributors in quest of jurisdiction.  We hope other courts follow suit.  And we’ll keep you posted.

When Congress enacted HIPAA and its Privacy Rule in the mid-1990s, it was a big deal. Healthcare providers surely protected patient privacy in the pre-HIPAA days, but the federal statute gave them a standard set of rules with which to comply and a uniform referent against which to gauge their privacy practices.  All told, HIPAA’s impact has been both pervasive and positive.  Moreover, one of its lasting virtues is that, because the statute created no private right of action, you can’t get sued under HIPAA.

At least not directly. A plaintiff cannot file a complaint outwardly claiming damages for a “HIPAA violation,” but that has not stopped some state courts from permitting negligence claims using HIPAA to define a standard of care.  The latest is Connecticut, whose Supreme Court recently created the new tort of “unauthorized disclosure of confidential information.”

The case is Byrne v. Avery Center for Obstetrics and Gynecology, P.C., 327 Conn. 540 (2018) (to be published in A.3d), and its outcome will give healthcare providers in Connecticut even greater pause when producing medical records in litigation.  In Byrne, the plaintiff/patient instructed the defendant healthcare provider not to release her medical records to her ex-boyfriend, who later filed a paternity action against the plaintiff. Id. at 542.  The defendant healthcare provider then received a third-party subpoena in the paternity action ordering a records custodian to appear and produce the patient’s medical records, which the provider did by mailing records directly to the court a few days later. Id.

This is where Connecticut’s new tort comes in. Alleging that her ex-boyfriend viewed her records in the court file and then harassed her, the patient sued her doctor for breach of contract and negligence in multiple forms. Id. at 543-44.  The trial court ruled initially that the negligence claims were preempted because the plaintiff was using HIPAA as the basis for her claims. Id. at 544-545.  The Connecticut Supreme Court, however, reversed that order in 2014 and held that HIPAA did not preempt the claims.  Given the purpose of HIPAA—i.e., to enact uniform rules—and the transparent nature of the plaintiff’s effort to enforce HIPAA through civil litigation that the statute does not permit, we would have criticized this ruling had we written on it when it came out in 2014.

But that is not today’s story. On remand, the trial court again ruled for the defendant and granted summary judgment on the basis that Connecticut law did not recognize a common law claim for breach of physician confidentiality. Id. at 548.  On appeal, the Connecticut Supreme Court filled that gap:

We conclude that recognizing a cause of action for the breach of the duty of confidentiality in the physician-patient relationship by the disclosure of medical information is not barred by [Connecticut statutes] or HIPAA and that public policy, as viewed in a majority of other jurisdictions that have addressed the issue, supports that recognition.

Id. at 550. So Connecticut patients not only can sue their doctors now for negligently disclosing their medical information, but can do so for responding to a subpoena in a pending legal action.

The core of the opinion examines both federal law and other states’ laws to conclude that the “majority” support the new cause of action. On federal law, the Court held that HIPAA supported a common law claim because Connecticut doctors follow HIPAA anyway and that a state-law tort would support HIPAA:

We further conclude that, to the extent it has become common practice for Connecticut health care providers to follow the procedures required under HIPAA in rendering services to their patients, HIPAA and its implementing regulations may be utilized to inform the standard of care applicable to such claims arising from allegations of negligence in the disclosure of patients’ medical records pursuant to a subpoena.

. . . [N]egligence claims in state courts support at least one of HIPAA’s goals by establishing another disincentive to wrongfully disclose a patient’s health care record.

Id. at *556-57.

As for other states’ laws, the Court surveyed state cases and found eight states that recognized comparable claims (although the one case cited from New York does not really say that) and four that did not. Id. at 557-68.  In following the states that have recognized the tort, the Court cited various sources for the duty, including state licensing statutes, evidentiary rules governing privileged communications, common law “principles of trust,” and the Hippocratic Oath. Id. at 564.

We have a few questions about this new tort. First, it is highly questionable to cite federal law as “supporting” a civil action with HIPAA defining the standard of care.  As even the Connecticut Supreme Court acknowledged, “It is by now well settled that the statutory structure of HIPAA . . . precludes implication of a private right of action.” Id. at 555.  Having recognized this principle on the one hand, the Court should not have invoked HIPAA to support its new private right of action on the other.

Second, it stands out that the Court spent about nine pages discussing the state authorities that support its position, but dismissed the four states that reject the tort in a single paragraph and a single sentence of analysis: “[Connecticut statutes] created a broad physician-patient privilege, and, therefore, the rationale of these jurisdictions that decline to recognize a common-law action for breach of duty of confidentiality is not persuasive in Connecticut.” Id. at 567.  More discussion of the contra authorities would have been helpful, especially considering that Connecticut is not unique in recognizing a physician-patient privilege.

Third, what are healthcare providers supposed to do? The ex-boyfriend served a subpoena, a court-issued document that millions of litigants rely on every day to obtain documents—including medical records.  The Connecticut Supreme Court’s first reaction is to denigrate subpoenas.  Connecticut law allows disclosure of medical records without patient consent only pursuant to “statute or regulation of any state agency or the rules of court.” Id. at 568.  According to the Court, a “subpoena without a court order” is none of those things. Id. That leaves us scratching our heads, because subpoenas in our home state and also in federal court are authorized by statute and/or court rules.  We would be surprised if the law of Connecticut were different.

The Court also placed great weight on the fact that the healthcare provider did not appear in person to produce the records and did not alert the patient/plaintiff or move to quash. Id. at 569-72.  But even though subpoenas routinely order record custodians to “appear” with records, they almost never do.  They make the records available for copying, or they mail them, which is what the healthcare provider did here.  This strikes us as creating a new cause of action on the back of a technicality.  As for the requirement that the provider alert the plaintiff or seek a judicial remedy, the Court cited federal regulations.  So now we are back to enforcing HIPAA.

We sometimes advocate for a high regulation, low litigation approach to product liability, and that approach particularly suits the protection of private information. Healthcare providers take patient privacy seriously, and when pulled involuntarily into litigation, the rules they need to follow ought to be clear.  Connecticut’s new tort does not advance that cause.