Last weekend we returned to Utah, one of the most beautiful states in the USA.  Over the years we had taken in the polite delights of Salt Lake City, the powderpuff snow of Park City, and the cinematic enthusiasms of the Sundance Festival.  This time was different.  It was an occasion to explore Zion National Park, where wind, water, and time have carved splendor out of the rocks.  The apricot-colored natural amphitheaters put on quite a show in February.  Mule deer didn’t mind us at all as they chomped on rough, stubborn grass, mere feet away from us and a frozen waterfall. We drove through a mile-long tunnel with occasional natural ‘windows’ allowing light in from the canyons.  Every sublime inch of the place, every cactus skirted by snow, every stone arch, every smiling hiker, every helpful ranger, supplied further proof that the National Park system truly is America’s best idea.  If Yellowstone, Yosemite, and Grand Canyon do not already clinch the argument, Zion silences the debate with one long shadow cast from the Court of the Patriarch peaks or one gurgling note from the demure but insistent Virgin River.

It was good to get back to Utah.

Today’s post also gets back to Utah.  Three weeks ago we reported on a federal court decision in Burlingame v. Wright Medical Group, Inc., (D. Utah), a product liability personal injury case involving a hip implant.  The defendant filed a motion for summary judgment.  The solitary vexing issue was whether comment k to section 402A of the Restatement (Second) of Torts applies to medical devices so as to shield them strict liability design defect.  Utah law governed, and it is absolutely clear that Utah law applied comment k across the board to prescription drugs. But what about medical devices?  Our take on that question is to wonder why devices and drugs should be any different.  The need for a prescription should be enough to establish the “unavoidably unsafe” element of comment k, so the issue should be clear.

That’s apparently what the defendant in Burlingame thought, too, as it argued that the federal court had all the case law it needed to apply comment k and dismiss the strict liability claim.  The plaintiff  also was content with existing law, but in a different way, as the plaintiff argued that the federal court could conclude that medical devices fell outside of comment k.  Neither party asked the court to certify the question to the Utah Supreme Court, but that is what happened. It not only happened sua sponte, it happened over both sides’ objections.  That is what we reported on three weeks ago.

But it is not the end of the story.   The federal court then invited the parties to try to agree on what issues should go to the Utah Supreme Court.  Well, inasmuch as neither party wanted to add the Utah Supreme Court to the festivities, should anyone really be surprised that the parties could not agree? The federal court certainly seemed surprised, and more than a little disappointed.   In a new opinion, Burlingame v. Wright Medical Group, Inc., 2018 U.S. Dist. LEXIS 25637 (D. Utah Feb. 15, 2018), the federal court blasts the parties for submitting one-sided, self-serving position papers.  Isn’t that a little like Captain Renault in Casablanca declaring how shocked he is that gambling has been going on at Rick’s Cafe?  Anyway, the federal judge grabbed a pen and crafted the following questions for the Utah Supreme Court to enjoy and resolve:

1.  Under Utah law, does the unavoidably unsafe exception to strict liability in design defect recognized in Comment K to section 402(A) of the Restatement (Second) of Torts apply to implanted medical devices?

2.  If the answer to Question 1 is in the affirmative, does the exception apply to all implanted devices, or does the exception apply only to some devices on a case-by-case basis?

3.  If the exception applies on a case-by-case basis, what is the proper analysis to determine whether the exception applies?

4.  If the answer to Question 1 is in the affirmative, does the exception require a showing that such devices were cleared for market approval through the FDA’s premarket approval process as opposed to the 510(k) clearance process?

Dear reader, we hope you do not think it presumptuous if we draft answers on behalf of the Utah Supreme Court:

1.  Yes, comment k applies to medical devices.  The number of courts that have distinguished between drugs and devices with respect to application of comment k is truly miniscule.  And the reasoning is … unimpressive. Why would Utah want to join such a dreadful, dull minority? But the correct adjective is “prescription,” not “implanted.”  Sure, any implanted device will require a prescription, but there are plenty of other medical devices that fit the unavoidably unsafe bill without being implants.  Ever heard of medical lasers?  Why some plaintiffs or courts fixate on implantation is beyond us.  The permanence of the thing shouldn’t matter.  Prescription drugs don’t stay in the system permanently.  If the court wants to stay parallel (not our favorite word in the DDL universe, but stay with us a moment) with drug comment k case law, the issue is whether or not a doctor’s prescription is required.

2.  The comment k exception should apply to all prescription medical devices.  Across the board.  Case-by-case noodling makes no sense, is a burden on the court, provides no guidance to parties and, all-in-all, is the way of nincompoops.

3.  See, by adopting across-the-board, we’ve already aided judicial economy by freeing you from answering this silly question.

4.  The only thing dumber than drawing a line between implant and no-implant would be to draw a line between preapproval and 510(k).  By the way, the court’s question mucks up the distinction between approval and clearance. More to the point, how does regulatory pathway determine the unavoidably unsafe categorization?  There is no logical connection whatsoever. Either pathway concludes in a determination of safety. You do know about the substantial similarity test, right?  The plaintiffs asked for this horrible question, didn’t they?  (To be fair, this is not the first time a court mixed up the 510(k) vs. PMA issue with comment k.  Last year, we grieved over an 11th Circuit decision that engaged in the selfsame heresy.)

Some of these certification questions strike us as being unsafe, but there is nothing remotely unavoidable about them.

Strict liability is not the same as absolute liability.  We learned that truth in law school, but too many plaintiff lawyers and judges seem to have unlearned it along the way.  The key separator between strict liability and absolute liability is comment k to section 402A of the Restatement (Second) of Torts (1965), which observes that “[t]here are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use.”  Think of dynamite, for example.  More pertinent to our practice area, comment k included prescription drugs and vaccines among its examples.  But it did not mention medical devices.  That is probably because comment k antedated anything approximating the degree of regulation of medical devices we enjoy today.  In any event, we are left with this question: does comment k apply to medical devices?  If so, which ones?

This is not the first time that we have faced this issue.  Back in 2011, we authored a magnum opus called “Comment k, Some of the Way.”  To this day, it is one of our most widely read posts.  The question keeps cropping up, as product liability plaintiffs keep trying to minimize the scope of comment k.  One simple way of bifurcating judicial treatment of comment k is “across-the-board” versus “case-by-case,” but that misses some nuances.  In 2015, in a post charmingly entitled “How Does a Bad Idea Get Implanted?” we blasted the commonplace California plaintiff argument that comment k applied to medical devices only if they were implantable.  As we demonstrated, that argument lacked sense and support, and the real issue should be whether the medical device required a doctor’s prescription. Tongue depressors come with neither prescriptions nor comment k protection, but, say, medical lasers should come with both.  In 2017, we revisited the issue to look beyond California, finding cases in other jurisdictions applying comment k to medical devices. It is an important issue, and it keeps surfacing.  Here is another post where we scrutinized the contours of comment k. So, is it unusual for courts to apply comment k to medical devices?  Not at all.  Take a look at our favorite reference book, Beck/Vale, Drug and Medical Device Product Liability Deskbook, section 2.02[2] and footnote 14.  There are literally hundreds of cases that have applied comment k to medical devices, in the same way they apply it to prescription drugs. 

Recently, the scope of comment k surfaced in Burningham v. Wright Med. Grp., Inc., 2018 U.S. Dist. LEXIS 10726 (D. Utah Jan. 23, 2018).  In that case, the plaintiff alleged injuries from an implanted hip device.  The design defect claims were premised on a theory of strict liability.  The defendants argued that the hip implant was an “unavoidably unsafe” product and was, therefore, categorically barred from design defect claims. Utah law controlled and the Utah Supreme Court has adopted the comment k “unavoidably unsafe products” exception to strict products liability.  But while the Utah Supreme Court has explicitly applied comment k to prescription drugs (categorically, not case-by-case), it has thus far been silent on whether comment k reached medical devices.  The defendant in Burningham argued that the doctrine regarding unreasonably unsafe products should apply equally to the medical device at issue.   

The Burningham case has traveled a circuitous path through the judicial system.  It was filed in California state court, then became part of a coordinated proceeding, then was released from that proceeding, then was moved by consent to the federal court in Utah.  Meanwhile, there is a federal MDL in Georgia dealing with design defect claims against these same hip implants.  Not so long ago, we authored a screed against a decision in that litigation involving what we saw as a complete misreading of Utah law on … wait for it .. comment k.  The Georgia federal court did not apply comment k to the medical devices and, just for good measure, completely mangled Utah law on design defect.  We were disappointed. Then the Eleventh Circuit affirmed the horrible result and wretched reasoning.  We were disappointed again.

So we have some history with this topic.

You will not be surprised to hear that we agree with the defense argument that Utah law should and would include hip implant medical devices as “unavoidably unsafe” products warranting comment k protection. The Burningham court stated that the defendant pointed “to decisions from courts in Oklahoma, Washington, California, and Pennsylvania, which do apply the doctrine to implanted medical devices.”  Yikes – there’s that unnecessary/wrong restriction to implanted devices, but since the devices in Burningham definitely were implanted one can see why the defendant in that case would take the most conservative approach.  If the federal court was going to try to predict which way the Utah Supreme Court would go, the broader reading of comment k, which would include medical devices, would probably prevail. But because the “question of whether the categorical exception applies to implanted medical devices is a question of first impression for Utah courts,” the federal court sua sponte (on its own) decided to issue an order certifying the issue to the Utah Supreme Court.  Our bet is that the defense will persuade the Utah court to extend comment k to medical devices.  Just don’t dig in too hard on the question of implantation.  Leave us room later to argue that comment k should apply to all prescription medical devices, please-and-thank-you.

Meanwhile the federal court was in a perfectly fine position to dismiss the misrepresentation and breach of warranty claims for lack of reliance.  The complaint supplied conclusory allegations of generalized reliance, but never listed any factual allegations that the plaintiff or his doctors “actually read or saw Defendant’s misrepresentations” and the complaint contained “no allegation that the Defendants’ express warranties were ever communicated to Plaintiffs or Mr. Burningham‘s physicians.”  The complaint could not “withstand the Twombly/Iqbal analysis.”  So much for those claims, and now it is up to the Utah Supreme Court to read comment k correctly and pave the way for dismissal of the strict liability claims. 

 

One of the wonders of parenthood is its ability to deliver interludes so sublime in their exquisite simplicity that they provoke smiles long after they end. Such was an evening last week when we journeyed to New York to celebrate the birthday of the Drug and Device Law Rock Climber, now a waxing college senior completing a summer internship at an insanely cool company in Lower Manhattan.  We were treated to a tour of the office and to the comments that colleagues and mentors reserve for interns’ mothers.  We had perfect saltimbocca at a beloved Italian bistro.  We saw Waitress (again – we love this show).  We stayed overnight on the Climber’s couch, joined at some point by a four-pound Chihuahua.  And we relished every moment with this child-now-adult.  We were awash in happiness for the entire train ride home.

We were also happy (yet another suspect segue) with the court’s evidentiary rulings in today’s case, but decidedly not with the case’s very sad facts—an all-too-frequent dichotomy in our line of work. Because we spend vast amounts of our professional time struggling to achieve the exclusion of plaintiffs’ causation experts, we are always pleased to read a Daubert opinion that layers tidy analytical segments to reach a satisfying conclusion that correctly applies the Rules of Evidence and controlling case law.

In Smith v. Terumo Cardiovascular Systems Corp., et al., 2017 U.S. Dist. LEXIS 108205 (D. Utah July 12, 2017), the plaintiff’s decedent underwent open-heart surgery in which a heart-lung machine was used to circulate oxygenated blood through the patient’s body while his heart was being repaired.  At some point during the surgery, the machine stopped working for approximately ten minutes.  The plaintiff’s decedent never left the hospital after the surgery.  Eleven months later, he suffered a heart attack and died.

The plaintiff sued the hospital and the heart-lung machine’s manufacturer, asserting the usual claims. She hired a cardiologist as her causation expert, and he opined that the malfunction of the heart-lung machine caused the decedent to suffer physical and mental deterioration and ultimately caused his heart attack and his death.  The defendants moved to exclude the expert’s testimony, arguing that: 1) his causation opinions were unhelpful and unreliable; 2) he was not qualified to opine on neurological injuries; and 3) he should not be allowed “to provide a narrative of events that can and should be provided by other witnesses and records.” Smith, 2017 U.S. Dist. LEXIS 108205 at *5 (citation omitted).

Explaining that , “to be helpful, [the expert’s] opinion . . . that the . . . surgery and related complications had any causal . . . relationship to Mr. Smith’s injuries and ultimate death must be based on a ‘valid scientific connection,’ the court held that that the expert’s own deposition testimony demonstrated that his opinion would not be helpful to a jury. To wit, in his deposition, the expert admitted that he could not testify with certainty that there was a connection “between the surgery, the ten-minute lack of flow, and the heart attack that caused” the decedent’s death. Id. at *10-11 (citations omitted).   Instead, he could only go as far as concluding that “the events that happened at the time of surgery simply made it more likely” that the decedent would die as the result of a heart attack, although the decedent’s own risk factors –hypertension, smoking, diabetes, family history – were generally considered to be “the main contributors” to the development of the plaque that narrowed the decedent’s arteries and caused his myocardial infarction.  As such, the expert concluded, “[While] I think that what happened . . . played a role in his having a heart attack and made it less likely that he would survive a heart attack, but I cannot say that it caused his heart attack.Id. at *11-12 (emphasis in original, citation omitted).

While this is refreshing (and uncommon) candor for a plaintiff’s expert, it is obviously not “helpful” to the establishment of causation. Moreover, the court held, even if the testimony had been helpful, it was not reliable, because the expert did not “provide a basis to conclude that the relationship [was] causal and not merely corollary,” leaving too large a gap between his premise and conclusion, and because he failed to account for obvious alternative explanations for the decedent’s death.   Id. at *15-16.

The expert also concluded, contrary to the results of the decedent’s autopsy, that the decedent had suffered an earlier heart attack, around the time of the surgery, before the one that ultimately killed him eleven months later. The court held that this opinion was also inadmissible because the expert’s diagnostic methods were not generally accepted.  As such, the court concluded, “To allow the jury to hear [the expert’s] opinion on this point would be to allow the jury to hear conclusions based on inferior diagnostic metrics.  This will not be permitted.” Id. at *20.

Next, the court addressed the expert’s opinion that the decedent “suffered an injury to the brain due to prolonged lack of oxygenated blood flow to the brain.” Id. at *20-21.  The court held that the expert lacked the “knowledge, skill, training, or education that would qualify him to diagnose neurologic injuries.” Id. at 21 (internal punctuation and citation omitted).  Moreover, the opinion lacked any scientific basis, as the autopsy revealed no sign of hypoxic encephalopathy.   The court concluded, “[The expert] is not being as careful as he would be in his regular professional work outside his paid litigation consulting.  A jury has no use for [this type of speculation], especially from someone whose expertise lies elsewhere.” Id. at *24.

The court did not exclude the expert’s entire report, permitting him to testify that the decedent’s heart was injured during his surgery and to indicate what he relied upon to form his opinions. It held, however, that the expert would not be permitted “to give a general narrative of Mr. Smith’s health before, during, and after the surgery.” Id.

We like this opinion. It draws the correct lines, and it does so in clear and logical fashion.  It also reinforces the oft-apparent conclusion that plaintiffs’ lawyers disserve their clients when they hire the wrong people, and pay them to say the wrong things, in their quests for big settlement paychecks.   We will continue to keep you posted on judges who properly bar the courtroom doors against such experts, and those who don’t.

A funny thing happened on the way to a defense verdict last year—after the jury decided that the defendant’s product was not defective, the MDL judge told the jurors that perhaps they did not “fully understand” and instructed them to try again. So the jury went back into the jury room, and having been duly admonished by the court, the jury changed its mind and returned a verdict for the plaintiff.  We commented fully on the proceedings here, and while we will not repeat all the gory details, trust us, the proceedings were odd.

The Eleventh Circuit has now affirmed the plaintiff’s verdict, and the defendant has valid reasons to be unhappy. Not only did the Eleventh Circuit place its stamp of approval on the do-over verdict, it applied a hopelessly muddled view of comment k.

The case is Christiansen v. Wright Medical Technology, Inc., No. 16-12162, 2017 WL 1046088 (11th Cir. Mar. 20, 2017).  The plaintiff alleged that a defect in the defendant’s metal-on-metal hip replacement device caused him an injury, and he asserted product liability claims governed by Utah law. Id. at *1.  As luck would have it, the case was selected as a “bellwether” trial case in the Conserve Hip Implant MDL, and after a trial that lasted about a week, the jury returned a verdict finding that the product was not defectively designed. Id. The jury also found that the defendant had made negligent misrepresentations and awarded compensatory and punitive damages. Id.

Under Utah law, this is a defense verdict. The Utah Products Liability Statute covers all claims for injuries allegedly caused by defective products, and it requires proof of a product defect.  As a result, once the jury found that the product was not defective, nothing else mattered.  The defendant won.  The court, however, ruled that the verdict was “inconsistent” because the jury found no defect on the one hand, but also found negligent misrepresentation on the other. Id. That is why the court re-instructed the jury, resulting in the second verdict finding a product defect. Id.

The Eleventh Circuit affirmed this result, and its opinion relies on the assumption that the first verdict was “inconsistent.” Id. at **5-7.  But what inconsistency?  The jury made two core findings—no defect and negligent misrepresentation.  Maybe the evidence supported those findings and maybe it did not, but it is very possible for a defendant to make a misrepresentation and also sell a product that is free from design defects.  (There were no manufacturing or warning-based defect claims, in case you were wondering.)  The finding of no defect makes the misrepresentation finding meaningless under Utah law.  They are not “inconsistent.”  The former just deprives the latter of any legal consequence.

For whatever reason, the district judge saw an “inconsistency,” and the Eleventh Circuit deferred. The Eleventh Circuit tries to explain the proceedings in the district court, but in the end, it really did not explain why the initial verdict called for further deliberation.  It seems to have taken that for granted.

There is a second problem with the Eleventh Circuit’s opinion—it declined to apply Utah’s adoption of Comment k and gave a reason that simply does not hold up. Comment k to section 402A of the Restatement (Second) or Torts provides protection against strict liability claims involving “unavoidably unsafe products.”  Nearly all states have adopted some version of Comment k—some apply it on a case-by-case basis; some treat it as an affirmative defense; some apply Comment k as a matter of law in all cases involving prescription medical products, recognizing that all drugs and medical devices have both benefits and risks.

Utah has adopted Comment k, but has placed the burden on the defendant to prove certain elements to invoke Comment k as a defense. However, in cases involving prescription medical products, the Utah Supreme Court has “rejected the case-by-case approach and adopted Comment k as a categorical bar against strict liability.” Id. at **7-8 (quoting Grundberg v. Upjohn Co., 813 P.2d 89 (Utah 1991)).  Comment k therefore applies in Utah across the board, and the Defendant justifiably argued to the Eleventh Circuit that Comment k applied and that it should result in a judgment for the defense.

The Eleventh Circuit “predicted” Utah law differently. According to the Eleventh Circuit, the Utah Supreme Court applied Comment k to prescription drugs because they are FDA approved. Id. at *8.  It therefore held that the Utah Supreme Court would not apply comment k categorically to medical devices. Id. at **8-9.  It further held that, even if Comment k applied to “FDA-approved medical devices,” the defendant had not carried its burden of proving that the product was FDA approved. Id. at **8-9.

There is so much wrong with this holding. To start, with the Utah Supreme Court having decided that Comment k applies to prescription drugs, there is no basis on which to predict that Utah law would be different for prescription medical devices.  The rationale for applying Comment k is the same—no matter how you design a drug or medical device, there will always be risks. (See here for our research post on comment k, including a 50-state survey.)  In addition, the Eleventh Circuit’s fixation on FDA approval to distinguish prescription drugs from prescription medical devices ignores that the FDA regulates medical devices, too.  It also ignores that drugs are approved for marketing in different ways—some through full-blown new drug applications, some under pre-NDA rules, some through a showing of substantial equivalence, etc.  Comment K applies to all of them, and the Utah Supreme Court has never drawn a distinction.  There is no reason to believe it would draw a distinction between drugs and medical devices because of their respective regulatory pathways either.

Finally, the Eleventh Circuit held that Comment k would not help the defendant in any event because the defendant did not prove that the product was approved by the FDA. This is wrong.  Utah’s version of Comment k requires the defendant to prove certain elements, but FDA approval is not one of them.  Neither the Utah pattern jury instruction nor the instruction given by the district court called for the defendant to prove FDA approval.  Yet, the Eleventh Circuit based its opinion on this purported failure of proof.

We can’t help but consider the possibility that this plaintiff’s judgment had more staying power because it came out of an MDL “bellwether” trial. Maybe.  Maybe not.  It seems to us that if you assume that “bellwether” verdicts actually help the parties value other cases, a defense verdict is as useful as a plaintiff’s verdict.  Both have dollar amounts attached to them, and the number attached to the defense verdict is zero, plus the defendant’s costs.  That should have been the result in Christiansen.

We aren’t going to mince words today. We don’t like Christiansen v. Wright Medical Technology Inc., MDL 2329, 2016 U.S. Dist. LEXIS 46409 (N.D. Ga. Apr. 5, 2016). It is an opinion on post-trial motions in a case that went to trial in the Conserve Hip Implant Products Liability Litigation. It’s a beautiful spring day here in the Mid-Atlantic and we hope that’s true where you are. If it is, and if anything in this post makes you interested in the greater details and nuances of the decision, we recommend taking it outside, sitting under a tree, and enjoying some fresh air. You should at least have pleasant surroundings while you try to get through it. It’s long, and tedious, and frankly, muddled. So, we are going to try to focus in on the key parts – so that we might also try to get out and enjoy some of this fine weather.

Christiansen is a hip implant case. It went to trial on 5 theories of liability: strict liability design defect, negligent design defect, fraudulent misrepresentation, fraudulent concealment, and negligent misrepresentation. Id. at *2-3. Apparently the court had dismissed plaintiff’s failure to warn claim on summary judgment. Id. at *69 n.18. The jury ultimately returned a verdict finding the hip implant was defectively designed and caused plaintiff’s injuries and awarded $550,000 in compensatory damages. The jury also found in favor of the defendant on the fraudulent misrepresentation and concealment claims, but awarded another $450,000 to plaintiff on his negligent misrepresentation claim and $10 million in punitives. Id. at *18.

But that wasn’t the jury’s first verdict. It’s first verdict, delivered days earlier, answered the first question on the Verdict Form – do you find the hip implant was defectively designed – in the negative. Id. at *6. While that should have been the end of the inquiry, the jury didn’t understand the instruction to not go any further and they kept answering the verdict form. So, they went on to find that defendant had made negligent misrepresentations and awarded plaintiff $662,500 in compensatory damages and $2.5 million in punitives. Id. at *7.

Continue Reading Georgia MDL Court Muddles Utah Law

We have no personal anecdote to share, no movie to discuss, no holiday theme to weave in, and no (self-described) clever theme for our post.  It is a beautiful fall day where we have a relative lull in our slate of depositions, briefs, and arguments, so we will get right to it.  Last month, we had trouble making sense of a long Daubert and summary judgment order in a metal-on-metal hip implant bellwether case.  This month, we think that the evidentiary rulings in the same case make more sense.  Christiansen v. Wright Med. Tech. Inc., MDL No. 2329, 1:13-cv-297-WSD, 2015 U.S. Dist. LEXIS 6704750 (N.D. Ga. Nov. 2, 2015).  Except for this:  neither side filed timely motions in limine, they submitted a joint “Position Statement” on evidentiary issues, and the court issued rulings complete with limiting instructions.  That was awfully generous of the court, as most judges will not rule on what evidence can come in absent a timely motion or objection.  It may be too simplistic to say that plaintiff lawyers in drug and device product liability cases prefer the rules of evidence to be fast and loose, allowing them to spin a narrative that riles up the baser instincts in the jury, whereas defense counsel in such cases prefer that evidence be focused on the issues that the jury will be asked to decide.  In any event, knowing what evidence will be coming in on what issues allows both sides to prepare their respective case so that the jury can hear something coherent.  The Federal Rules of Evidence give trial judges a fair amount of latitude to maximize the chance that the jury will understand the evidence presented and how it fits with what they are asked to decide.  The Christiansen rulings do a pretty good job of that.

In addition to what she could offer from her ten experts and apparently friendly implanting surgeon, plaintiff wanted to offer “fact” testimony from four other orthopedic surgeons who had not treated her and were not designated as experts.  We can think of three basic plausible ways, but maybe objectionable depending on the facts, that these non-treating surgeons could be fact witnesses:  1) they could have something to say about their personal involvement in designing the product at issue; 2) they could have some interaction with the manufacturer before the plaintiff’s implant that allegedly provided notice of the risk of the injury that plaintiff claims (“metallosis” per the prior decision); or 3) they could have done some study on the risks and/or benefits of the product that they will talk about.  No, plaintiff wanted them to talk about whether the product was defective under Utah’s consumer expectations test—with an orthopedic surgeon being the consumer for this prescription device—and what the manufacture told them about the device.

Continue Reading Evening Things Out Some With Trial Evidence Rulings In A Bellwether Case

We have not posted for a while—that day job can really get in the way sometimes—so we agreed to tackle the ridiculously long decision in Christiansen v. Wright Med. Tech. Inc., MDL No. 2329, 1:13-cv-297-WSD, 2015 U.S. Dist. LEXIS 115601 (N.D. Ga. Aug. 31, 2015), as a bit of penance.  This act may be appropriate given the recent Day of Atonement and, much like long Yom Kippur services during a fast, the decision drags on, repeats itself, has some highs and lows, and maybe induces some confusion and a touch of a headache.  While we are not looking for a scapegoat, some of the reasoning for why the issues were presented how they were presented and why they were decided is lost on the reader, at least this reader.  (Much like the original meaning of Azazel, to where/whom the original scapegoat was to be sent by Aaron.  Or maybe not at all like that.)  As a combination Daubert and summary judgment order on a bellwether case from an MDL for a product, a metal-on-metal hip implant, for which there is considerable litigation on similar products made by other manufacturers, there will likely to attempts to extend various parts of this decision to other cases.  So, we will resort to the dreaded use of subheadings in discussing it.

Background

Plaintiff had a left hip replacement in 1995 with a device that used a ceramic femoral ball, a polyethylene liner, and a metal acetabular shell.  In 2006, plaintiff had her right hip replaced with the defendant’s product, which utilized a ball and cup each made of cobalt-chromium with no liner.  In 2012, plaintiff started experiencing pain in her right hip and, within a week, had a revision surgery where the defendant’s product was explanted (and presumably something else was implanted).  All three surgeries were done by Dr. Lynn Rasmussen, who happened to have been consulting with defendant on designing hip implants in between the second and third surgeries.  In doing the third surgery, Dr. Rasmussen observed what he called “metallosis” (sometimes “metalosis” in the records and briefs), but did not send any explanted tissue or material for pathological evaluation.  Plaintiff sued under a range of product liability theories based on the risk of “metallosis.”  Thereafter, plaintiff named at least ten experts to weigh in on causation and defect in some form or other, most of whom relied to some degree on Dr. Rasmussen’s characterization of what he saw—and defendant filed a bunch of Daubert motions.  Plaintiff filed a “motion for partial summary judgment” that preemption and the learned intermediary doctrine did not apply to her claims and, at the court’s request, the defendant filed a motion for summary judgment on all the claims that plaintiff did not drop.  An affiliated defendant also filed for summary judgment on different grounds.  There were some other motions we are ignoring, but everything was addressed in one big decision.

Continue Reading Making Sense of the Daubert and Summary Judgment Orders in A Metal-on-Metal Hip Implant Bellwether Case

Today the World Cup takes another day off before it starts its semifinals to determine who will play for the Trophy on Sunday.  I know this only because other people have told me.  Left to my own predilections, I’d know none of it.  But other people’s interest and intense enthusiasm for these games has swept me into rooms where I’ve actually watched them.  And in so doing I’ve learned a few things about soccer.  The most important is that soccer players fall – much more than your average human.  They are extraordinary fallers.  And they never have a mundane fall.  All their falls are big productions.  Players drop all over the field, grab legs, rock in fetal positions, writhe in pain, and wince and wince some more.  Priests administer last rights to players doomed with shin injuries.  Soccer players are the eggshell plaintiffs of the sport world.  You should never walk in a crowded hallway full of soccer players.  You’ll be Godzilla going down Broadway.  A few unintentional shoulder brushes later and you’ll leave behind you a mass of human carnage the likes of which you have never seen before.
And, now, if a soccer player from Utah – say, someone who plays for Real Salt Lake – buys a non-prescription pain reliever at a pharmacy to help him with his life-threatening shin bruise, he may be able to sue the pharmacist for any bad advice that he’s given about the drug.  A federal court in Utah recently held that pharmacists can be sued for professional malpractice or negligence based on advice offered on the suitability of a non-prescription drug.  Whiting v. Rite Aid Pharmacy, 2014 U.S. Dist. LEXIS 87354 (D. Ut. June 24, 2014).
Before this decision, the state courts of Utah hadn’t authorized such an action.  Ordinarily, we’d be very critical of a federal court finding a state cause of action for the very first time.  But we won’t spend time on that today, mostly because the effect of this decision is limited.  This particular pharmacist offered (allegedly) affirmative advice on the suitability of the drug and, more important, offered it about a non-prescription drug, meaning that the interaction did not implicate the learned intermediary doctrine or a patient’s relationship with a prescribing doctor.  And there’s no question that Utah follows the learned intermediary doctrine in prescription drug cases.  The Whiting court itself recognized this.  Id. at *12-13.  It also recognized, as we’ve told you before, that in such cases there is no cause of action for failure to warn against a pharmacist.  It would invade the relationship between a patient and her or his doctor, and it would sidestep or vitiate the learned intermediary doctrine.  As such, the Whiting court made clear that its decision was not applicable to litigation involving prescription drugs.
Now, the main reason that we care about this decision is removal to federal court and diversity jurisdiction.  Plaintiffs in a state-court action often list a local pharmacy as a defendant in that action with the purpose (we believe) of defeating diversity between the plaintiff and the manufacturer defendant so that the defendant cannot remove the case to federal court.  But if the pharmacy is fraudulently joined (meaning, usually, that there is no viable claim against it), the defendant can still remove the case.  The Whiting decision changes none of that in cases involving prescription drugs and medical devices.  Local pharmacies remain improper defendants in such cases in Utah courts.  In fact, even in non-prescription drug litigation, the plaintiff must still allege that the pharmacist made affirmative representations about the suitability or safety of the drug.  And if the plaintiff’s doctor actually recommended that the plaintiff take the non-prescription drug, there may be an argument, under that scenario, that a claim against a local pharmacist does in fact invade the physician-patient relationship and is improper.
In short, the effect of Whiting outside of pharmacy-only litigation is limited.  But that’s probably not bad news for soccer players in Utah.  We doubt that they really needed the pain relievers.

We’ve blogged before about the split among Utah courts about whether Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), preempts the fraud on the FDA exception to Utah’s statutory bar (Utah Code Ann. §78B-8-203) against punitive damages where the product complies with FDA standards.

The first case, Grange v. Mylan Laboratories, 2008 WL 4813311 (D. Utah Oct. 31, 2008), got it rightBuckman‘s rationale extends to any state-law assertion of fraud on the FDA that could bring about submission to the FDA of unnecessary and unwanted information due to fear of later tort liability.

Indeed, since punitive damages can (and often do) exceed compensatory damages in their amounts, allowing punitive damages based on fraud on the FDA is even more likely to bring about the prophylactic conduct that Buckman decried than the claim in Buckman itself – particularly since punitive damages are frankly intended to “deter” the conduct they punish – and thus create precisely what Buckman held was unacceptable.

The next case, Lake-Allen v. Johnson & Johnson, 2009 WL 2252189 (D. Utah July 27, 2009), botched the issue, for some reason asserting that Buckman involved express preemption.  We criticized this patently wrong result here.

Continue Reading Utah Preemption Split Deepens