Search We the Jury

Lately, we’ve seen some plaintiffs add gag order requests to their complement of in limine motions in advance of significant trials. Those of us who participated in the Bone Screw litigation remember plaintiffs attempting – and failing − to prevent the defendants from communicating with their customers (implanting physicians) about that litigation.  Unfortunately, no order resulted.  The first gag order relating to advertising involving civil litigation was entered at about the same time as our Bone Screw brouhaha in a securities-related case. Koch v. Koch Industries, Inc., 2 F. Supp.2d 1409 (D. Kan. 1998).  The court gagged both sides equally, and only after both sides agreed.  Id. at 1415 (“plaintiffs also ask the court to enter an order prohibiting the defendants from advertising” [and] “defendants apparently agree that the court should preclude both sides . . . from advertising”).

Advertisements published or to be published by the parties in this case, whether selling products or ostensibly serving the public interest, seemingly carry messages directed at swaying public sentiment to that party’s side in this case. In short, this case will tried in the courthouse; any attempt to try this matter in the media ends now.  In reaching this decision, the court has considered less restrictive means of preventing unfair prejudice attributable to pretrial publicity.  Unfortunately, the court can devise no content-based restriction that will be fairly and equally applied to the parties.  In light of the parties’ respective requests for restraint, a total ban on advertising is not only simple and expedient, but seems most equitable.

Id. See also Pfahler v. Swimm, 2008 WL 323244, at *2 (D. Colo. Feb. 4, 2008) (rejecting plaintiffs’ request for civil gag order).  Moreover, no matter what the parties might have been trying to communicate to potential jurors in Koch (there had also been a rather questionable opinion “poll” taken by one of the parties), we’re sure that they weren’t discussions of life saving medical products – or even corporate feel-good advertising of the sort seen while watching “Meet the Press” and other similar Sunday talk shows.Continue Reading In Limine Gag Orders – Can We Play, Too?

Samples, samples, samples. We dare you to make it through your local supermarket or bulk supply store without finding at least one table set up asking you to sample the latest offerings from peanut butter to frozen breakfast sandwiches; from hummus to pre-made meatballs; and don’t forget the cheese. And it’s usually more than one. By the time you’re done shopping you can have eaten an entire meal – from salsa to cheesecake. Shopping alone, this doesn’t really present much of an obstacle. Shopping with children, however, and it adds a whole new dimension. Children want to try every sample. In sample size, children love almost everything they taste. So, you then get to listen to “please, please, please” for ten aisles. “I loved it.” “I promise I’ll eat every last frozen pierogi you buy.” In occasional moments of weakness, you say yes. To nobody’s surprise, however, you’re throwing away a nearly full bag of pierogis that you found wedge in the back corner of your freezer 10 months later. Because, what tasted so good in a sample size, simply didn’t have enough flavor to desire an entrée-sized portion.

That’s sort of how we feel about today’s decision, overall it tosses out most of plaintiffs’ claims – we like those samples. But, the decision is long and when you get down to digesting all of it – some of it is a bit hard to swallow.

The case is McLaughlin v. Bayer Corp, 2016 U.S. Dist. LEXIS 37516 (EDPA Mar. 22, 2016). It’s actually five cases with identical complaints all alleging injury from plaintiffs’ use of Bayer’s contraceptive device, Essure. The device is a Class III, PMA device, so Riegel express preemption and Buckman implied preemption are both viable defenses and both were raised by the defendant in response to each of plaintiffs’ twelve claims. That’s part of the problem. Plaintiffs raised novel claims to try to avoid preemption. In fact, none of the specific theories that were allowed to survive preemption have ever actually been recognized by Pennsylvania. So, we’re sure you’re expecting an Erie discussion – but Erie isn’t even mentioned in the decision. Fortunately, TwIqbal was also successfully used by the defense, so plaintiffs really do have to go back to the drawing board on their claims. We hope that after the claims are both stripped down and beefed up, the court will see it left some really indigestible morsels on the table. We’ll take the claims in the order the court did.Continue Reading A Federal Pennsylvania Decision That We Like in Small Bites

We recently read an interesting new empirical study that confirms what we’ve long suspected − that so-called “no-injury” class actions, those that allege that a product was “worth less” than it should have been due to some inchoate, unmanifested defect, are a litigation boondoggle, benefiting nobody but the lawyers who bring them.

The study is Joanna M. Shepherd, “An Empirical Survey of No-Injury Class Actions,” available through the Social Science Research Network, here. Ms. Shepherd, a professor at the Emory University School of Law, started with all class action settlements between 2005 and 2015 that could be located on Lexis or Westlaw – 2158 cases. She applied four criteria for identifying “no-injury” classes:

  1. the plaintiffs suffered no actual or imminent concrete harm giving rise to an injury in fact;
  2. the only harm alleged was a technical statutory violation (primarily of the Fair Debt Collection Practices Act, the Telephone Consumer Protection Act, the Fair Credit Reporting Act, and the Electronic Funds Transfer Act);
  3. if any out-of-pocket economic loss was negligible or infinitesimal; or
  4. the recovery sought was unrelated to compensating plaintiffs for economic or other harm.

Shepherd Empirical Study at 1. After applying those criteria, Professor Shepherd included only cases about which information existed on both attorneys’ fees and settlement funds. Id. This culling produced 432 class actions that could be studied.Continue Reading Empirical Study Confirms That No-Injury Class Actions only Benefit Lawyers

This post does not come from the Reed Smith side of the blog.

After two grueling months, the second bellwether trial in the Pinnacle Hip Implant MDL has gone to the jury.  The last time that happened—in 2014—the jury came back with a defense verdict.  It was a resounding and, to some, upset victory for the defense in a plaintiff-selected case in a Texas court against Texas plaintiffs’ lawyers.

But that was then.Continue Reading Trouble in Texas?: The Latest Pinnacle Hip Implant Trial Goes to the Jury

Two of our favorite themes in the drug and device world intersected a few weeks ago in the Third Circuit—class actions and “no injury” lawsuits.  We don’t see many drug and device class actions these days, which we view as one of the more notable accomplishments of the drug and device defense bar over the last 20 years.  In fact, it is difficult to understand why anyone ever thought that personal injury class actions would be a good idea in the first place.  Personal injury cases are different—everything from the patients, to the doctors, to the information available, to the products used, and the injuries alleged.  Those facts leave you with a Hobson’s choice:  Either you take all the individual factors into account, in which case you have defeated the whole point of a class action; or you gloss over it all and pretend everyone is the same, which violates the rules and is downright unfair to everyone involved.  Either way, class actions don’t work.

“No injury” lawsuits are similarly vexing.  They generally come in two forms—medical monitoring lawsuits, where the plaintiff has experienced no drug or device complication but wants the defendant to pay for future medical care anyway, and lawsuits alleging only some form of economic loss. At the risk of oversimplifying, we generally view these cases with a “no harm, no foul” attitude.  It particularly grabs our attention when “no injury” claims are brought as class actions.  You might call it a mashup of bad ideas, which adds up to a really bad idea.  Sort of like Kim Kardashian marrying Kanye West.  Or Donald Trump using Twitter.  Or the upcoming Superman v. Batman movie.  (Actually, that would be two good ideas adding up to a really bad idea, but we digress.)Continue Reading Third Circuit Shuts Down “No Injury” Pharma Class Action

Sometimes it takes an outsider to point out  something that should be blindly obvious.  In this case, that role was performed by a couple of our colleagues earlier this month at the annual ACI Drug and Medical Device Litigation Conference.  They both told us how useful they found the new – adopted in 2015 − Pennsylvania Suggested Standard (Civil) Jury Instructions (“Pa. SSJI Civ.”) on the learned intermediary rule in prescription drug and medical device litigation.  So we thought we’d introduce them to you.  Here they are:

23.00 (Civ) Duty to Warn − Reasonable Care

In the case of prescription [drugs] [medical devices], the manufacturer has an obligation to exercise reasonable care to inform the plaintiff’s prescribing physician about the risks of its product.  Such a manufacturer has a duty to warn about risks of its products that are not generally known, if the manufacturer knew or reasonably should have known about the risks of its product.

23.10 (Civ) Duty to Warn Physicians, Not Patients − Learned Intermediary Rule

A drug or medical device manufacturer only has a duty to warn the [prescribing] [implanting] physician about the dangers of its [drugs] [medical devices].

It does not have a duty to warn patients directly.

If you find that the defendant adequately warned the plaintiff’s [prescribing] [implanting] physician, even if the physician did not transmit that information to the plaintiff, you must find for the defendant on the failure-to-warn claim.

23.20 (Civ) Different Warning

The plaintiff has the burden of proving both of the following:

  1. that the defendant did not adequately warn the [prescribing] [implanting] physician about the risks of its [drug] [medical device], and
  2. that the [prescribing] [implanting] physician would not have [prescribed] [implanted] the [drug] [medical device] if a different warning had been provided.

23.30 (Civ) Physician’s Knowledge − Other Sources

A pharmaceutical or medical device manufacturer that fails to adequately warn the [prescribing] [implanting] physician about the risks of its [drug] [medical device] is not liable if the physician was aware of the risks from medical literature or other reliable sources.

If you find that the plaintiff’s [prescribing] [implanting] physician already knew about the risks of the defendant’s [drug] [medical device] when he or she decided to [prescribe] [implant] it [to] [in] the plaintiff, then you must find for the defendant on the negligent failure-to-warn claim.Continue Reading Introducing the New Pennsylvania Learned Intermediary Jury Instructions

April might be the cruelest month according to T.S. Eliot, but the last month hasn’t been very kind to plaintiffs’ expert Nicholas Jewell, Ph.D.  As we posted recently, at the beginning of December, Prof. Jewell was booted from the Zoloft MDL.  See generally In re Zoloft (Sertraline Hydrocloride) Products Liability Litigation, 2015 WL 7776911 (E.D. Pa. Dec. 2, 2015).  Only two weeks earlier, however, he was also given the bum’s rush in In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, ___ F. Supp.3d ___, 2015 WL 7422613 (D.S.C. Nov. 20, 2015).  His being shown the door in two MDLs in two weeks is pretty impressive defense work.  Anybody out there in a position to turn this brace into a hat trick?

Prof. Jewell is a statistician, not a medical doctor.  Lipitor, 2015 WL 7422613, at *14 (“Prof. Jewell is a statistician, not a medical doctor or medical professional.  He has no expertise in diabetes, has never treated participants of any kind, and is not a clinician.”).  As in Zoloft, the Lipitor plaintiffs called him in to second-guess the statistical bona fides of studies involving the drug and condition (diabetes) in question.  As we discussed in detail in the Zoloft post, Prof. Jewell started with the “a priori opinion” needed by his plaintiff-side paymasters and “t[ook] a results-driven approach . . ., molding his methodology and selectively relying upon data so as to confirm his preconceived opinion.”  Zoloft, 2015 WL 7776911, at *16.  Thus, it’s no surprise at all that he committed the same statistical sins in Lipitor:

The Court finds that Prof. Jewell’s analysis of the [statistical] data was results driven, that Prof. Jewell’s methodology and selection of relevant evidence changed based on the results they produced, and that Prof. Jewell chose to ignore and exclude from his report his own analyses that did not support his ultimate opinions.  It is apparent to the Court that rather than conducting statistical analyses of the data and then drawing a conclusion from these various analyses, Prof. Jewell formed an opinion first, sought statistical evidence that would support his opinion and ignored his own analyses and methods that produced contrary results.

Lipitor, 2015 WL 7422613, at *18.Continue Reading Bookends – Prof. Jewell’s Opinions Also Excluded in Lipitor MDL, and More

Albert Einstein famously defined insanity as “doing the same thing over and over again and expecting different results.”  We thought of that definition when we read Shepherd v. Vintage Pharmaceuticals, LLC, ___ F. Supp.3d ___, 2015 WL 6956767 (N.D. Ga. Nov. 4, 2015).  Shepherd is – was – a personal injury class action.  No personal injury class action has survived a contested appeal anywhere in the federal court system since the Supreme Court put the kibosh on such things with its decisions in Amchem Products, Inc. v. Windsor, 521 U.S. 591 (1997), and Ortiz v. Fibreboard Corp., 527 U.S. 815 (1999).  That includes several dozen decisions involving prescription medical products, which are listed in our federal class action denial cheat sheet.

Shepherd was decided a month ago – an eternity in blog time – but whatever reason, the decision fell through the cracks and was not picked up by the services. In fact, we first learned about it from a story in the Legal Intelligencer (local Philly legal newspaper; behind a paywall) about a bunch of these plaintiffs abandoning ship following denial of class certification and becoming litigation tourists in Philadelphia. We have a PACER account and know how to use it, so before the day was out we had located the opinion and sent it to Westlaw.

As a class action, the pleaded facts were rather (or perhaps typically) overreaching.  The manufacturer defendant, exercising extreme caution, recalled “eight different oral contraceptive products” all packaged by the same entity, after one improperly packaged blister pack was returned by a pharmacist in Iowa.  2015 WL 6956767, at *1.  “Of the 507,966 blister packs that were returned in the recall, only 53 were improperly packaged in the reverse order.”  Id. at *2.  Plaintiffs claimed that 113 women became pregnant because of the error, but never proved a single case.  Id. at *2.  As the court pointedly observed, “[t]he Iowa package is the only known defective package received by a consumer.”  Id. at *1.Continue Reading Definition of Insanity – Expecting Certification of a Personal Injury Class Action

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

As drug and device lawyers we live in a comment k dominated world.  When we say comment k on this blog, everyone knows what we mean.  We aren’t talking about a scientific discovery regarding potassium.  We aren’t reviewing a new flavor of k-cup for the Keurig.  We aren’t posting about breakfast cereals.  And we definitely are not passing comment on the Kardashians, Kobe, Keanu, or K-Fed.

But just in case you need a refresher, here is the comment k that concerns us:

Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. . . . Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. . . .  The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.

Restatement (Second) of Torts §402A, comment k (1965)  (emphasis added).  As you can see from the highlighted language, comment k recognizes that some products – drugs and medical devices in particular – are “unavoidably unsafe” and therefore not defective if properly prepared and accompanied by an adequate warning.  Most courts to have considered the issue have interpreted comment k to mean that manufacturers do not face strict liability for properly manufactured prescription drugs that are accompanied by adequate warnings.  That is true in Washington.  Young v. Key Pharmaceuticals, Inc., 922 P.2d 59, 63 (Wash. 1996) (under comment k, a prescription drug manufacturer is liable “only if it failed to warn of a defect of which it either knew or should have known . . . it is liable in negligence and not in strict liability”).Continue Reading No Error With Comment k Jury Instruction

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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