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Today is Ash Wednesday and begins the 40 days (not counting Sundays) of Lent. Lent comes from the Anglo Saxon word for Spring. For Christians, the 40 day period represents the time Jesus sojourned in the wilderness, resisting the temptation of Satan, and preparing his final ministry. Lent is a time for repentance, fasting, and preparing for the coming of Easter. Many Christians, even minimally-observant ones, follow the tradition of giving up something for Lent. In that spirit, we offer our list of what we will forego between now and April 21.

1. When the other side finishes deposing our company witness, no more will we smugly say “our questions are reserved for trial,” and pack up our things. It is smarter to do some sort of redirect exam. Yes, we hate to show the other side our hand, but what if our hand – the witness – disappears? Or he/she becomes hostile or evasive? We have geared up for trial too many times wishing we had a decent deposition direct exam of our witness because, for whatever reason, it had become impossible or inconvenient or imprudent to bring that witness to trial. Occasionally, we felt a bit steamed about prior counsel’s decisions not to do a redirect at the deposition. But see point 3 below.

2. From now on, or at least for the next six weeks, we will keep our smart phone and iPad more than six feet from the bed. Consulting the buzzing, too-well-lit device in the middle of the night ruins sleep and peace of mind. Whatever it is, it’ll keep.

3. However much we might disagree with former counsel’s decisions, we will not complain about them. We might try to alter or remedy them, but there is no sense in mere grousing. When a client invites you to parachute into a trial, it is an honor and a delight. You get all the good bits of doing a trial, but very little of the drudgery. Better just to take what was given to you, say thank you, and put on the best show at trial you can. By the way, it is possible that those decisions you now bemoan might have been perfectly justified under the circumstances at the time. We promise to shut up and do the work.

4. Adios, sports talk radio. We can probably slog through the early mud season sans this air-wave festival of carping by loud-mouth know-nothings. Who deserves blame for the Sixers’ latest loss after building a double-digit lead? Who will the Patriots face in the next Super Bowl? Who should bat after Bryce Harper? Who cares? The opinions shared by sports-talk blowhards would not pass the Daubert test in even the most lenient jurisdictions. Plus, the radio hosts recycle the same trio of topics every hour, so even a medium length car-ride of this nonsense will leave you bitter and lobotomized. Did we mention that we live in Philadelphia?

5. We will take a time-out on trying to discern or characterize the motives of our adversaries. It is fine to challenge the other side’s arguments, but imputing motives to one’s opponent is pointless, lacks foundation, and annoys the judge. Is there a more overused word in legal briefing than “disingenuous”? When lawyers deploy that word, they are essentially saying that the other side cannot sincerely believe what they are saying. But the court will not decide the issue based upon who is more sincere. If the argument is weak, show why it is weak. So much of law and life is brought to ruin by misunderstandings about the other side’s motives. There is a reason why philosophers have puzzled over the problem of other people’s minds. Even if Descartes proved that he exists and that God exists, he could not prove that other people’s minds are like ours. Other people could be robots. Or simpletons. Or predatory plaintiff lawyers. Or oafish writers. It doesn’t matter. It is not actionable. Moreover, since we actually do believe (on faith) that other people’s minds aren’t so different from our own, we see no reason to turn bad assumptions into nasty words and thereby hurt others’ feelings.

6. We will stop griping to our kids about how they never return our calls, emails, or texts. Obviously, they were raised badly and it is too late to do anything about it. (And yet, when money or free vacations are on offer, the Drug and Device Daughter and Son suddenly become robustly responsive.) Make no mistake, though; on April 22, our litany of recriminations on this subject shall recommence.

7. It will be hard, but we will halt, at least temporarily, our stereotyping of jurisdictions. Every once in a while, good opinions do emerge from California and Missouri. And, conversely, sometimes the Good Place turns out to be a Very Bad Place. Of course, Madison County is always a Very Bad Place … oops, there we go again.

8. We will give Amazon, EBay, and Costco a rest for a while. Our house is full of unnecessary purchases. We have enough batteries to power a 767. That three pound jar of salsa will go bad before it is even a quarter consumed. Sure, it’s nice to be greeted by one of those smiley boxes on the porch at the end of the day, but how many tactical flashlights do we need? (At least we’ve got the batteries.) EBay might be the worst. Someday, those not-responding heirs will have to throw out the Flintstones lunchbox, Gillette safety razor from the year we were born, and Oddjob action figure. Serves them right; they should have answered our texts

9. For at least the next 40 days, we will leave off certain arguments we keep trotting out and losing. Perhaps we need to make a record, but we are starting to worry about injury to our credibility. Will we tell you what those arguments are? No, we will not. Do you think we are crazy?

10. Bacon. No, wait a minute, speaking of crazy, that would be crazy torture. Desserts? But what about crème brulee? We really, really love crème brulee. Hmmm. This last one’s a toughie. Okay, got it: for Lent this year, we are giving up brussels sprouts. (Unless they are adorned with bacon.)

 

It’s hard to escape the suspicion that blue states are more pro-plaintiff and red states are more pro-defense, though that is not a hard and fast rule. There are parts of Alabama and Texas where it is hard for an out of state corporate defendant to get a fair shake. Delaware and West Virginia also do not fit neatly into the blue/plaintiff-red/defense model.

Still, when we read a case where a Massachusetts court tries to predict New York tort law, our fears toggle between whether the pro-plaintiff errors will be multiplied linearly or exponentially. Daley v. Mira, Inc., 2019 WL 499775 (D.Mass. Feb. 8, 2019), is pretty bad. Check that; it is really bad.

The plaintiff in Daley alleged that a surgical implant used in an eye operation in 1986 went bad in 2015 (that’s right – 29 years later) resulting in follow-up operations and near total vision loss in one eye. She sued the manufacturer and seller of the implant. She also sued a company that designed and patented the implant. The designer then licensed the product to the aforementioned manufacturer-seller, more than 29 years ago. This much is clear: the patent-holder had no dealings with the plaintiff. So how could it be a proper defendant?

To answer that question it is necessary to look at the plaintiff’s theories of recovery. After some initial skirmishing, it was determined that New York Law governed the tort claims. So goodbye to the claim under Chapter 93A of the Massachusetts General Law. Goodbye, also to the warranty claim, because of the statute of limitations. What was left against the patent-holder? Three other claims remained: negligent pre-market testing, strict product liability, and post-sale failure to warn. The patent-holder moved to dismiss these claims, contending that it would not be held liable under any of these theories under New York Law. That argument was premised largely on the defendant’s status as never having interacted with the plaintiff. You know – standard product liability stuff.

But hold up a moment. The claim of inadequate pre-market testing, based on an alleged failure to make sure the product could not fail after 29 years, is a bit of a reach. There is certainly no indication that the FDA required any of the testing for “long-term effects.” And whatever product testing is necessary is required by the FDA of the company that submitted the device. The court did not ask these questions, or many questions at all in waving this pre-market testing theory along. This ‘what, me worry’ approach may now be responsible for creating a very broad cause of action available to lots of future plaintiffs against lots of fairly remote defendants.

Whether any of these theories should apply to a non-manufacturer/seller is an issue of theoretical majesty. But the Massachusetts court seems to think it is fairly simple. Either the non-manufacturer/seller can be held liable for its own remote role, because New York Law recognizes “that a defendant can owe a duty of care to a third party – even without a contractual or other direct relationship between the defendant and the third party – and, thus, may be liable to the third party for injuries resulting from a breach of that duty,” or it can be dragged into court based on an allegation of concerted action. If that were so, we would see patent holders dragged into product liability litigation all the time – but we don’t.

The result in the Daley case is bad, and it follows ineluctably from the court’s deficient methodology. Here we have a Massachusetts federal court purporting to predict New York law. The opinion is quite short. That brevity is something we ordinarily welcome. But not one of the New York cases cited by the Massachusetts court is at all on point (they do not involve any kind of product, and one ultimately rejected the claimed duty). Absent is the usually rigorous duty analysis undertaken by New York courts. So what we have is something we have griped about many times before – a federal court expanding state law tort doctrine, and here it is doing damage to the law of a different state. (We are not completely discounting the possibility that what is really going on is that a Patriots or Red Sox fan is trying to wreak havoc on New Yorkers. Those two Super Bowl losses to the Giants must still sting. And, recent success notwithstanding, 100 years of losing to the Yankees really smarts.)

Even aside from lacking anything approximating a rigorous legal analysis, the Daley court seems oblivious to the real world implications of the decision. The extension of liability to the patent-holder is particularly dangerous in terms of the chilling effect it would have on the licensing of patents. Must a patent holder undertake extensive testing – including clinical trials – before it can license a patent? How can a patent holder, or anyone for that matter, test whether a medical device might fail after 29 years?

Massachusetts and New York have always had a funny relationship. That is true in all sorts of areas, including historical and cultural. It is possible that Thoreau did not quite get Whitman’s poetry, or got only parts of it (certainly not the sexy bits). Such a misreading might have been unfortunate. But at least it didn’t actually hurt anybody. (Well, maybe it hurt Whitman’s feelings. Come to think of it, we could see a Massachusetts court making that actionable, too.)

Roy Cohn would have turned 92 today, had he not died in 1986, a few weeks after being disbarred in New York. Cohn’s legal career was legendary. He was on the team that prosecuted the Rosenberg spy trial. He worked closely with Senator Joseph McCarthy. His clients included mafia figures, the owners of Studio 54, and the owner of the New York Yankees. (It is that last one that makes us most queasy.) Cohn mentored the current POTUS, teaching him always to be nice. Just kidding. Cohn actually told Trump that when someone hits you, hit back even harder. Lesson learned, apparently. Cohn is a character in Angels in America. That is quite a resume. Why are we thinking of Cohn today? Why, indeed.

We personally know two lawyers who managed to get in really hot ethical water. One was disbarred, while the other was fired from his firm. Both ghost-wrote affidavits that were later disavowed by the named affiants. [Practice pointer: do not write false affidavits.] Today’s case, Webb v. Zimmer, Inc., 2019 WL 438361 (EDNY Feb. 4, 2019), involves another sketchy affidavit – a “sham” affidavit in the parlance – and the revelation of the sham led to dismissal of a product liability case. The plaintiff claimed injuries from failure of knee flex-system implant. There were various legal claims, but eventually the only claim left was for failure to warn. Then came the dispositive motions.

First came the Daubert motions. What makes the Webb case so interesting is how the implanting physician (designated as an expert by the plaintiff) signed an affidavit that was fully at odds with what he actually believed. The plaintiff used that affidavit to fend off the defendant’s Daubert motion, but struck out when attempting to use it again, this time to fend off summary judgment. The defendant obtained the right to re-depose the implanter, who promptly contradicted everything in his affidavit. It turns out that the surgeon did not write, or even read, the affidavit, which he admitted contained “inaccuracies, errors, and imprecise language.”

Would you like an example? Of course you would. The implanter offered the following opinion in the affidavit: “I reviewed the Package Inserts and find them to be inadequate because they provide a false sense of security to the treating surgeons.” Well, that’s not good for the defendant, is it? But at his second deposition, the implanter contradicted much of what he stated in this paragraph. He did not review either the package inserts or the surgical technique pamphlet prior to reading or signing the affidavit. He also testified that he was unaware of anything that the defendant “failed to do in terms of researching this product” and was “unaware of the existence of clinical data for any problems related to the Plaintiff.”

Want more contradictions? Here they come. In his affidavit, the implanter proffered the opinions that (1) the failures that occurred with the product were foreseeable; and (2) he should have been warned about it. But the implanter testified in his second deposition that he did not have enough information to testify that the failures that occurred in the plaintiff’s case were foreseeable. Further, the affidavit says that the defendant should have warned or contraindicated the use of the knee system “by advising that it was not tested in patients with hyperextension or high posterior tibial slope.” By contrast (you could see this coming by now, right?), here is what the doctor said at his deposition: “Q. But you don’t know, without evidence or whether there’s a problem with articular surface dissociation, that a warning was appropriate? A. Yeah, that’s true.”

Faced with a collection of contradictions that would have made Emerson or Whitman or Mao blush, the court refused to allow the plaintiff to utilize the implanter’s affidavit “to escape summary judgment only to permit him to modify or contradict himself at trial.” The implanter was also “prohibited from testifying as an expert on these matters.”

The implanter went on to bury the plaintiff on the learned intermediary doctrine. Even aside from the contradictions, the evidence showed that the implanter “chose to use the Product for all his primary implants based on his comfort with the Product rather than any of [the defendant’s] marketing materials or warnings contained in the package inserts.” Moreover, the doctor continued to use the knee implant system long after the plaintiff was forced to undergo multiple revision surgeries and “[t]o this day … remains confident in the product.”
The defendant got out of the case. As far as we can tell, nobody was sanctioned for the sham affidavit, and we find that darned near amazing. Why did the doctor contradict himself so badly? The Drug and Device Law Daughter has shared with us the Reddit theory about people occupying alternate dimensions or timelines. Maybe this doctor traipsed between different timelines. We are just about prepared to believe it.

We’ve written several times (here, for example) about the Biomaterials Access Assurance Act (BAAA), 21 U.S.C. section 1604 et seq., and how it issues a get-out-of-litigation-free card to suppliers of raw materials and components. Today’s case, Connell v. Lima Corp. et al., 2019 WL 403855 (D. Idaho Jan. 30, 2019), supplies another illustration of the BAAA’s power. The plaintiffs sued for injuries after a hip prosthesis fractured. The defendants initially included the manufacturer and a supplier of component parts. The plaintiffs settled with the manufacturer and then directed their fire at the supplier. Big mistake. The remaining defendant moved for summary judgment, arguing that because all it had done was supply the stem and neck parts of the manufacturer’s hip system, all claims against it were preempted by the BAAA.

The plaintiff attempted to evade this rather clear preemption by recharacterizing the parts supplier as the actual manufacturer, and the (now-settled-out) manufacturer as a mere distributor. But, as John Adams said, facts are stubborn things. The actual, settled-out manufacturer had submitted the 510(k) application to the FDA, listing itself as the manufacturer of the “hip system,” which was made up of component parts. Moreover, the settled-out manufacturer – not the component parts supplier – had its name on the front of the IFU and the surgical technique brochure. The Supply Agreement between the manufacturer and the parts supplier also shed light on who was what. Importantly, when the settled-out manufacturer had received the component parts from the defendant supplier, those parts were not yet ready for implantation into a human being.

The plaintiffs’ product liability claims would not have been pre-empted by the BAAA if the remaining defendant acted (1) as manufacturer of the implant; (2) as seller of the implant; or (3) furnished raw materials or component parts for the implant that failed to meet applicable contractual requirements or specifications. But the answer was No, No, and No. The court considered whether there might be some basis to treat the parts supplier as a manufacturer of the implant. Under the BAAA, this exclusion applies only in three situations: first, if the parts supplier registered or was required to register with the Secretary of Health and Human Services and included or was required to include the implant on a list of devices filed with the Secretary; second, if the parts supplier was subject to a declaration issued by the Secretary that stated the company was required to so register and list the implant but filed to do so; and third, if the supplier was related by common ownership or control to the manufacturer. Again, three strikes and the plaintiffs were out. and that meant that the supplier defendant was out of the case. BAAA preemption applied and the parts supplier was dismissed.

Happy birthday, Bob Marley. (We mean the transcendent reggae singer, not the Maine comedian.) Now let’s get together and feel alright about another good personal jurisdiction decision, In re Pradaxa, No. CJC-16-004863 (Cal. Super. Ct. Jan. 31, 2019). The case strikes a blow against California litigation tourism. There were some awful decisions out of California on this topic in the past. Call this new decision a redemption song.

A bunch of non-California residents claimed injuries from Pradaxa, and sued a number of corporate defendants associated with the medicine’s manufacture and sale. But none of those corporate defendants was incorporated in California, nor did they own, lease, or maintain any property in the Golden State. The defendants challenged personal jurisdiction. The plaintiffs did not even argue that there was general personal jurisdiction over the defendants. The Bauman case thoroughly foreclosed that notion. Instead, the issue was whether the SCOTUS BMS decision left any room for jammin’ the out of state defendants into a California court via specific personal jurisdiction.

Remember, the plaintiffs took the medicine outside California. So what bases could the plaintiffs lively up themselves to show that their claims related to or arose out of the defendants’ contacts with California? The plaintiffs did what some other plaintiffs have done by exploiting the existence of an in-state clinical trial of the drug. If the mere existence of clinical trials does the trick, then the SCOTUS BMS case is a dead letter for pharma companies, since clinical trials often take place in big (and plaintiff-friendly) states. That would be a crazy baldhead result, given that BMS itself involved a pharma defendant. The Pradaxa court was too smart for that. It looked to the qualitative and quantitative nature of the clinical trial in California, and concluded that, in the grand scheme of things, questions relating to 32 in-state clinical trial sites in one massive clinical trial were “too attenuated to support the exercise of specific jurisdiction.” All non-resident Pradaxa plaintiffs were consequently dismissed from the California mass tort for lack of specific personal jurisdiction under BMS. Their exodus is our freedom time.

Since it is a sure thing that forum-shopping plaintiff lawyers will continue to pursue the clinical trial angle, you should pay heed to the factors the California court considered in finding the clinical trial insufficient to establish specific jurisdiction: (1) the forum state was not overrepresented in the trial, and (2) the alleged problems with the trial did not relate to the claimed inadequacies in the warnings. The plaintiffs made much of the fact that there had to be corrections made to label with respect to the adverse event reports out of the California clinical trial, but the “negligible changes in the data” could not support claims. (E.g., the hazard ratio for a life-threatening bleed went from 0.80 to 0.81.). The court was not impressed by the plaintiffs’ argument.

But we are impressed by the rigor and clarity of the court’s reasoning. If corporate defendants can earn such a good and sensible result in San Francisco, we all have cause for optimism. Hallelujah. Don’t worry about a thing. Could you be loved? Every little thing is gonna be alright. And never give up. We offer congratulations, gratitude, and a tip of the cyber hat to Eric Hudson at Butler Snow, who argued and won the motion.

By the way, speaking of congratulations, and speaking of never giving up, today is the birthday of another pop star. In fact, according to an MTV Europe poll in 2008, he is the “Best Act Ever.” We won’t tell you who he is; you’ll have to click on the link at the end. Of course, since we’re telling you to click on a link, you might have some idea what awaits you. Feeling dread? Don’t. Embrace the wonderful, sheer inanity of the Best Act Ever.

Last week business took us to South Florida. Thank you business, as it was 50 degrees warmer in Miami than it was in our frigid Philly suburb. We always love the Sunshine State, but we especially love it in January and February. We love it, even though Florida is the target of many barbs about how it is the home of much News of the Weird. Adam Carolla has his “Florida or Germany” game, where contestants must decide which of those two places is the residence of some recent report of human craziness. An episode of John Oliver’s Last Week Tonight show hardly seems complete without a reference to a Florida outrage.

But sometimes Florida gets it right. The Southern District of Florida got personal jurisdiction right in Goldstein v. Johnson & Johnson, No. 18-20341 (S.D. Fla. Jan. 21, 2019). The plaintiff claimed that Levaquin caused him to suffer an aortic heart tear, valve, which necessitated open heart surgery. He sued defendants who arguably had something to do with making and selling the product, but also – possibly out of a desire to include and harass a bigger player — sued a defendant, J&J, that did not actually have anything to do with making or selling the product. J&J was a holding company. It did not have any relevant contacts with Florida. Consequently, J&J moved to dismiss the case against it for lack of personal jurisdiction.

To support its motion to dismiss, J&J submitted an affidavit from a corporate employee who could speak to organization structure. The affidavit stated that J&J (a) is a New Jersey corporation with its principal place of business in New Jersey; (b) is a holding company for J&J subsidiaries, all of whom operate independently of J&J; and (c) is neither registered nor qualified to do business in Florida; (d) does not ship any products into Florida; and (e) does not design, manufacture, market or distribute any product at all. This affidavit did such a good job of undermining potential jurisdiction over J&J that it shifted the burden to the plaintiff to show personal jurisdiction.

And it turns out that the plaintiff had nothing. At least, the plaintiff had no facts. The plaintiff submitted no counter-affidavit. All that the plaintiff had was a whole lot of jaw-boning about how J&J’s “ubiquitous brand name and various products bearing the J&J logo distributed throughout Florida warrant the assertion of personal jurisdiction over J&J.” That’s not a legal argument; that’s wishful thinking. It smacks more of demagoguery than analysis. The bad news for the plaintiff is that the court preferred analysis. In deciding whether J&J is “at home” in Florida (the way it is in New Jersey), the court focused on J&J’s lack of any “offices, employees, bank accounts, or other assets” within the state. Under the Bauman framework, there was no basis to assert general jurisdiction over J&J.

What about specific jurisdiction? The plaintiff still had nothing. J&J did not do any business in, nor ship any products into, Florida. As mentioned above, J&J did not design, manufacture, market, or sell any product whatsoever because it is a “mere holding company.” It functions as an entirely distinct entity from its subsidiaries. The plaintiff did not dispute any of these crucial facts. Instead, the plaintiff was content to argue that because J&J’s “product brand name on multiple products” is distributed in Florida, J&J should expect to be “hailed into court in this state.” Wrong. No case supports that argument. The Goldstein court identified no basis to assert specific jurisdiction over J&J.

Inevitably, the plaintiff’s back-up argument was to request jurisdictional discovery. But it was a half-hearted request, embedded within a footnote of its opposition brief, and that sort of subterranean maneuver does not constitute a “formal motion or other showing as to scope of any proposed jurisdictional discovery request.” In any event, the plaintiff failed to specify with sufficient particularity what jurisdictional discovery could reveal, even if the court granted the plaintiff’s request.

J&J was dismissed from the case, and the plaintiff’s request for jurisdictional discovery was denied.

We are usually sorry to depart Florida, but we doubt J&J grieved over its departure from the Goldstein case.

Happy birthday, Hans Mattson. Did you, dear reader, forget? No worries. Mattson was born in Sweden in 1832, played a key role in Swedish settlement in Minnesota, served in the U.S. Civil War, and was consul to India. It’s been a long time since he blew out any candles, so your oversight will offend nobody. But Mattson’s birthday reminds us of how much we like Minnesota, with its pleasant people, strange accents, Bob Dylan, Kevin McHale, law school classmate Senator Amy Klobuchar, Prince, Morris Day, and pro football team that is often good, but never good enough.

Last March, we reported on a Minnesota trial court decision that was more than good enough. The court excluded a plaintiff expert’s opinion because it was not generally accepted. We liked that opinion. It turns out that the Minnesota appellate court did, too, and today we will share that affirmance with you. The case is In re: 3M Bair Hugger Litigation, 2019 WL 178498 (Minn. Ct. App. Jan. 14, 2019). This is the Bair Hugger litigation, which has a backstory straight out of Dostoyevsky or the most tawdry soap opera. The Bair Hugger is a forced-air warming device (FAWD) used to maintain patients’ normal body temperature during surgery. The inventor of the device ran into some legal problems and left the company. He then invented a rival device, which he charmingly called the Hot Dogger, and proceeded to compete with his former product. His notion of competition was a bit brutal. He did not simply claim that the Hot Dogger was better than the Bair Hugger. Instead, he claimed that the Bair Hugger increased the risk of surgical-site infection (SSI). The FDA investigated the claims that the Bair Hugger increased the risk of bacterial contamination and rejected them.

Then the inventor (whose name is Augustine) funded a study purporting to find an association between the Bair Hugger and increased SSIs. One of the study’s authors, a former employee of Augustine, testified that “[t]he study does not establish a causal basis” and characterized it as marketing rather than research. In 2017, the FDA sent a Safety Alert to healthcare providers “reminding [them] that using thermoregulation devices during surgery, including [FAWDs], ha[s] been demonstrated to result in less bleeding, faster recovery times, and decreased risk of infection for patients”; advising them that “[a]fter a thorough review of available data, [the FDA was] unable to identify a consistently reported association between the use of [FAWDs] and [SSIs]”; and recommending “the use of thermoregulating devices (including [FAWDs]) for surgical procedures. This is all very good news for the Bair Hugger and very bad news for its competitors.

Did Augustine confess error? He did not. Did Augustine take this setback lying down? He did not. He supported lawsuits against the Bair Hugger. Those lawsuits depended on medical experts who linked the Bair Huggers to infections, even though said experts had never previously studied the efficacy of FAWDs or published peer-reviewed articles relevant to the claims in this litigation and none of whom claimed that their general-causation opinions were generally accepted within the relevant scientific community. The Bair Hugger folks quite rightly moved to preclude these threadbare opinions. The trial court excluded the testimony of appellants’ experts and consequently granted responded summary judgment with respect to general causation. That is the opinion we reported on last year and that is the opinion upheld by the court of appeals. Oddly, the last word of the appellate opinion is the usual “Affirmed.” Having watched Fargo at least ten times, we would have thought the court would have concluded with a “You betcha!”

The issue turned on application of Minn. R. Evid. 702, which governs expert testimony. When you see “702” and “experts,” you might think of Federal Rule of Evidence 702 and the Daubert requirements. But Minnesota does not follow Daubert. Rather, Minnesota calls itself a “Frye-Mack state.” Frye is the old “general acceptance” theory trotted out a long time ago and which now finds itself ousted from the federal courts and most state courts. But the Frye theory is alive and well in the land of ten thousand lakes. The key Minnesota case is called Mack. Get it? Under the Frye-Mack test, if an expert’s opinion involves a “novel scientific theory,” the proponent must establish “that the underlying scientific evidence is generally accepted in the relevant scientific community.” The Minnesota appellate court reviewed de novo whether the underlying scientific evidence was generally accepted in the relevant scientific community. (Federal appellate courts reviewing Daubert decisions usually employ a less rigorous abuse of discretion standard.)
The appellants tried to escape the Frye-Mack general acceptance test by arguing that the science used here was not “novel” within the meaning of Minn. R. Evid. 702. Nice try. But the court held that Minn. R. Evid. 702 pertains to “novel scientific theory,” not novel science. The fact that air and particulate movement is not a new science does not mean that appellants’ premise, i.e., that FAWDs increase the risk of SSIs, is not a novel scientific theory. So much for that first line of attack. (This “novel scientific theory” issue is quite different from a typical Daubert analysis.)

Now on to the main feature.

The appellants repeated their argument from below that Minn. R. Evid. 702 does not require a showing that “proof of the expert’s ultimate opinion” is generally accepted; instead, it requires only a “showing that the tools employed by the expert[s] in reaching their opinion [i.e., the experts’ methodologies] have gained general acceptance.” The appellate court agreed with the trial court that Minn. R. Evid. 702 is not restricted to novel methodologies; it refers to “opinion or evidence involv[ing] novel scientific theory” for which “the underlying scientific evidence is generally accepted.”

The appellate court deferred to the assessment of the relevant scientific community rejecting appellants’ novel scientific theory (that’s the swell, easy thing about the Frye test – it is really about deferring to scientific consensus) and concluded that there is no demonstrated causal relationship between FAWDs and increased risk of SSI. Accordingly, the appellate court affirmed the district court’s decision to exclude appellants’ experts’ evidence. It also affirmed the trial court’s summary judgment as to general causation. It occurs to us that the holding that regardless of methodology, your result is crazy and therefor excludable, indicates that a properly enforced “general acceptance” based exclusionary rule can be as good as, or even better than, Daubert.

In any event, this Bair Hugger opinion is useful and nice. Minnesota nice.

We recently gave a talk on things in MDLs that drive us crazy. Discovery is front and center. The asymmetry of discovery is a huge source of unfairness. If plaintiffs have their way, all discovery would be about company conduct, and we’d never get to find out if those 8,000 plaintiffs used the product or suffered an injury. Mere details. And don’t get us started on a plaintiffs’ insistence that we “certify” that our discovery is complete. That certification is both an insult and a departure from the Rules. Plaintiff lawyers might seek such certification in any case, but they definitely will seek it in an MDL, where discovery is most difficult, one-sided, and expensive.

Okay, now you went and got us started. Federal Rule of Civil Procedure 26(g)(1) requires that “every discovery request, response, or objection must be signed by at least one attorney of record … [to certify] that to the best of the person’s knowledge, information, and belief formed after a reasonable inquiry (A) with respect to disclosure, it is complete and correct as of the time it is made …” Although some enterprising plaintiff lawyers have argued that this language should mean parties are required to certify that discovery responses are complete, this Rule is limited to disclosures required by Rule 26(a)(1) – not discovery responses.

The comments to subsection (g)(l) tell us that Rule 26(g) “imposes an affirmative duty to engage in pretrial discovery in a responsible manner that is consistent with the spirit and the purposes of Rules 26-37.” Fed. R. Civ. P. 26(g) advisory committee’s note. Additionally, “the signature certifies that the lawyer has made a reasonable effort to assure that the client has provided all the information and documents available to him that are responsive to the discovery demand.” Id. Although there is a duty to make a reasonable inquiry to ensure that discovery responses are complete, there is no duty to certify complete discovery. United States v. Fresenius Medical Care Holdings, Inc., No. 1:10-CV-1614-AT, 2014 WL 11517841, at *5-6 (N.D. Ga. May 13, 2014). The “complete and correct” language applies only to initial disclosures required by Rule 26(a) (l). Moore v. Publicis Groupe, 287 F.R.D. 182, 188 (S.D.N.Y. 2012).

In Moore, the plaintiff relied on Rule 26(g)(l )(A) to argue that the defendant’s counsel was required to certify that the client’s document production was complete and correct at the time it was made. Id. The court disagreed, pointing out that Rule 26(g)(l)(A) specifically applies “with respect to disclosure” and that Rule 26(g)(l)(B) applies to discovery responses and does not call for certification. Id. The court acknowledged that “[i]n large-data cases … no lawyer using any search method could honestly certify that its production is ‘complete.”‘ Id. True enough.

Similarly, in Fresenius, the plaintiff argued that the defendant’s counsel was required to certify complete document production and that the court must impose sanctions under Rule 26(g)(3) for providing a certification that violates the Rule. Fresenius, 2014 WL 11517841, at *5-6. Looking at the language of Rule 26(g)(l), the court stated that there is no certification requirement for complete document production. Id. at *6.

In conclusion, while lawyers should make a reasonable effort to ensure that a client has provided all the information and documents available that are responsive to the discovery demand, there is no requirement to certify complete document production. Such certification finds no support in the law. Let’s call such certification what it truly is: a sanctions trap.

A little over a year ago, we reported on a decision by Judge Rufe (E.D. Pa.) dismissing an Avandia heart attack case on the grounds of the learned intermediary rule (Utah law). All of the plaintiff’s claims boiled down to an alleged failure to warn, and that was a problem for the plaintiff, as the plaintiff’s proposed enhanced warning ended up being discredited by the science after the case was filed. Thus, even though the prescriber had stopped prescribing the product for a period of time after some adverse data came out, by the time of the prescriber’s deposition he testified that he felt comfortable with his decision to prescribe the medicine to the plaintiff. That evidence prompted the district court to bid adieu to the claims. Our defense hack hearts were gladdened by this result.

Those defense hack hearts are even more gladdened by the Third Circuit’s recent affirmance of the district court’s decision. In re: Avandia Marketing, Sales Practices and Products Liability Litigation (Siddoway), 2018 WL 6828423 (3d Cir. Dec. 28, 2018). The Third Circuit did not see fit to publish the affirmance in the West Reporter, but we see fit to publicize it.

As the Third Circuit reminds us, the plaintiff’s claims in Siddoway drew a causal link between prescriptions for Avandia prescribed in 2001 and 2002 and the plaintiff’s two heart attacks in 2003. The case hinges on what the prescribing doctor would have done, with regard to prescribing Avandia, if he had seen the warning the plaintiff preferred. The prescriber testified that he stopped prescribing the drug after learning of a 2007 meta-analysis of 42 clinical trials by Dr. Steven Nissen – a familiar name to many of us — that associated Avandia with an increased risk of heart attack. The prescriber testified that he would have “thought twice” and would have been “much more thoughtful” about prescribing Avandia and would not have prescribed the drug to the plaintiff “in the middle of all these heart attacks” if he knew this information in early 2003.

That testimony is mildly interesting, but does not really mean much because (a) the undisputed record shows that the actual prescription occurred one year before the plaintiff’s heart attacks, not “in the middle” of them, and (b) for the prescriber to say he would have been “much more thoughtful” and would have “thought twice” about prescribing Avandia if he knew in early 2003 the risk information that arose in 2007 does not cut it. The Third Circuit concluded that “the vague and highly speculative nature” of the prescriber’s testimony “suggests no concrete action and it is tied to hypothetical knowledge in 2003.” That is an important ruling, because it is exactly that sort of general, speculative, might’ve-thought-more stuff that plaintiff attorneys usually elicit from prescribers. The plaintiff lawyers then pack up their papers and smugly climb aboard their private jets, sure that they have staved off summary judgment. But they have not (or should not have) staved off summary judgment. Rather, they have walked right into it.

And then there is the inconvenient (for the plaintiff) fact that the prescriber in Siddoway also testified that if he had also known in 2001 and 2002 about the exculpatory information available in 2015, the time of his deposition, when the Food and Drug Administration removed the link between Avandia and an elevated risk of heart attack, he would have made the same choice to prescribe the drug to Siddoway. As we wrote a little more than a year ago, the result in Siddoway seemed “inevitable.” The Third Circuit saw it the same way.

It is now 2019, but we are still finding bits of leftover 2018 business on our desk and in our emails. Towards the end of last year, we encountered an avalanche of good rulings from the Southern District of Indiana in the Cook IVC filters litigation. Here is one we found hidden in the toe of our Christmas stocking: In re Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Product Liability Litigation, 2018 WL 6617375 (S.D. Ind. Dec. 18, 2018). It is nice enough; it is not as if we are going to drive to the mall and return it. But there are some parts to it that we don’t love so much. Those parts are like ugly socks that we deposit in the bottom of a drawer and hope never to see again.

The plaintiff moved in limine to preclude evidence of 510(k) clearance of the medical device. The primary basis for such preclusion was Federal Rule of Evidence 402 – lack of relevance because the 510(k) process does not provide a reasonable assurance of the device’s safety and efficacy. That’s the argument, anyway. Prior to the pelvic mesh litigation, that argument was a sure loser. But, sadly, a couple of the pelvic mesh courts have swallowed this bogus argument hook, line and stinker. (Then again, we know of at least one recent non-mesh decision that rejected the no-510(k) argument, and we were so pleased that we deemed that decision one of the ten best of last year.)

As we have shown in a previous walk-through of this issue, the exclusion of 510(k) clearance is based on an over- or misreading of the SCOTUS Lohr decision, where the High Court contrasted the less rigorous 510(k) process with the Pre-Market Approval process. Lohr included loose language about how 510(k) clearance was limited to substantial equivalence with a predicate, rather than an independent demonstration of safety and efficacy. But SCOTUS itself subsequently reeled in that loose language in Buckman, recognizing that substantial equivalence was, in fact, a way of establishing safety. Moreover, the FDA itself subsequently tinkered with the 510(k) process and its characterization of it so as to make clear that 510(k) clearance is about safety. It is not as if the FDA would clear products it does not believe are safe. So where are we, or where should we be, when it comes to 510(k) clearance? Such clearance might not be enough to preempt a state law tort, but it is still relevant to legitimate defenses and should, therefore, be admissible.

Where does the S.D. Indiana Cook decision fit on the spectrum? It is probably more to the good (pro-defense) side, but not quite as far as we would like. The fact of FDA 510(k) clearance comes in. That’s good. At least the jury will not be under the misimpression that the company unleashed a product on the populace willy-nilly, with no governmental oversight. But … well there’s a big but. (We knew a fellow defense hack who never missed an opportunity to use that phrase in diet drug litigation to get a cheap laugh).

Interestingly, the S.D. Indiana analysis turned on an interpretation of Georgia’s risk utility test for design defect cases, and Georgia law was also at issue in one of the very bad mesh decisions in this area (that we will not and, for reasons of our existing litigation entanglements, cannot name.) Georgia law incorporates the concept of ‘reasonableness,’ i.e., whether the manufacturer acted reasonably in choosing a particular product design. FDA clearance is relevant to such reasonableness. The S.D. Indiana court held that both the plaintiff and the defendant, through appropriate expert testimony, “will be permitted to tell the jury about the role of the FDA in its oversight of medical device manufacturers, the regulatory clearance process for devices like IVC filters, and [Cook’s] participation in the 510(k) process and its compliance (or lack thereof) with the process.”

What do we think of this ruling? It is both good and bad. It is good (and absolutely correct) that clearance comes in. But it is bad, because it seems to welcome plaintiff ‘expert’ testimony that instructs the jury on the law. Why should an expert be able to tell the jury that the company did not comply with the FDA process? Isn’t the fact of clearance itself proof that there was compliance? Is the plaintiff arguing that the FDA erred when it cleared product? Shouldn’t that be up to the FDA? Given the extensive publicity accompanying any mass tort litigation, wouldn’t the FDA have corrected its error, if there really was error? Or is the plaintiff arguing that the FDA cleared the product only because the company hid data and hoodwinked the FDA? If we are not squarely in Buckman-land, are we not at least Buckman-adjacent? Don’t the selfsame policies of deferring to the FDA apply? In other words, isn’t plaintiff’s anti-clearance position preempted?

Thus there is a part of the S.D. Indiana’s ruling that reeks to our (admittedly oversensitive) noses. The defendant is not permitted to present evidence or argument that the FDA’s 510(k) clearance of the device constitutes a finding by the FDA that the device is safe and effective. As set forth above, that ruling is factually incorrect. By contrast, the plaintiff “may present evidence that the FDA clearance process only requires substantial equivalence to a predicate device, that 501(k) regulations are not safety regulations, that Plaintiff’s filter placement was “off label,” and the like.” Wrong, wrong, and whatever “the like” means, we’re sure that’s wrong, too. The 510(k) process does, indeed, address safety. The notion is that relying on a predicate device that was already approved or cleared is a good proxy for safety. There is plenty of regulatory history showing that by devising the 510(k) process, the FDA was not waving bye-bye to the value of safety. Meanwhile, we will all be treated to a blow-hard plaintiff regulatory expert who will take us on a tour of FDA regulations and company documents to tell a tale of a bad company and an overmatched federal government. Some fun. This expert testimony amounts to a preview of the plaintiff’s closing argument. It is so gruesome that we have heard some defense lawyers say that they would just as soon omit the regulatory story altogether. But that’s defeatism. The right result would be for the fact of 510(k) clearance to come in, and then full-stop. There is no need for expert interpretation or interpolation. So for all the trial judges out there who complain that drug and device trials go on too long, here’s an answer: shut down the expert testimony that purports to teach the jury about the regulatory process “and the like.” Always beware of “the like.” And be on guard against “etc.” and “whatnot” as well.

But let’s get back to the good bits of the S.D. Indiana Cook decision. The defendant will be allowed to offer evidence that the device was never recalled by the FDA, that the FDA never observed any violation of the company’s quality system during its inspection between 2000 and 2014, and that the FDA never took any enforcement action against the company. This evidence is relevant to the defense that the design and development decisions were reasonable and that the product is safe. At least this court had some sense of balance.

The S.D. Indiana decision also dealt with the defendant’s effort to use an expert biomedical engineer to talk about the low rate of complaints. She worked at the FDA for over twenty years in various positions and currently serves as a consultant to companies seeking to obtain FDA approval or clearance of medical devices. The expert cited evidence that the device had a fracture rate of 0.066% and perforation rate of 0.153%. The defense expert calculated the occurrence rate by dividing the total number of complaints received by the company (numerator) by the product’s total sales (the denominator).

The plaintiff challenged this expert testimony because “there is no way to know whether these numbers are accurate. Some patients/hospitals may not report adverse events, and some IVC filters may have been sold to hospitals but not used in patients.” The company responded that it did not intend to offer the complaint/occurrence rates as the actual complication rates for the product. With that limitation, the Cook court held that the defense expert’s testimony was admissible.