Regular readers of this blog know that we have a pretty jaded view of many MDLs. Obviously consolidation makes sense, at least on paper, in terms of efficiency and the best use of scarce court resources.  But, in practice, many MDLs promote a litigation “mob mentality,” in which the merits of individual cases are not important at the outset and, in the world of “settlement inventories” and “mass settlements,” may never draw the scrutiny of the judge or anyone else.   Though we continue to hope that “Lone Pine” orders will burgeon and raise the standards for plaintiffs seeking to fly under the radar and await settlement, many MDLs remain “safe havens” for plaintiffs who can’t satisfy the burden of proving their claims.

And a recent decision from the hip implant MDL does nothing to disturb this reality. In that MDL, a longstanding “Explant Preservation Order” requires preservation of hip implant devices removed from plaintiffs during explant surgeries.  The order requires plaintiffs to “make good faith efforts to ensure that [medical facilities] preserve” explanted devices and provides options for plaintiffs’ counsel to claim devices within 60 days of explant or, in the alternative, for the devices to be sent to the defendants.  It  requires all parties to handle explanted devices in accordance with a written protocol or consistent  with “methods and practices accepted by those in the field of inspection and testing of orthopedic devices,” to notify each other of devices in their possession before the date of the order, and to make devices available to each other after inspection and testing.   All of this, obviously, ensures that the critical evidence in this product liability MDL is preserved and handled in a fair and consistent manner.

In Marquis v. Biomet, Inc., et al., 2017 U.S. Dist. LEXIS 28465 (N.D. Ind.  Mar. 1, 2017), the defendants moved for summary judgment against six plaintiffs.  Five of these plaintiffs had had their devices explanted before they filed suit, or after they filed suit but before their cases were transferred into the MDL, and did not know what happened to their devices after they were explanted.  The sixth plaintiff had several revision surgeries.  During the first, the femoral head of her hip implant was replaced, and she asked for the explanted femoral head.   She explained, “I figured I paid for it.  I wanted it.”  She kept the femoral head in her closet, didn’t disclose on her fact sheet that she had kept it, and didn’t tell anyone she had it until her deposition.  The devices explanted during her subsequent surgeries were not preserved.

Continue Reading Hip Implant MDL Denies Summary Judgment on Claims of Plaintiffs Who Failed to Preserve Explanted Devices

Recently someone asked the listserv for members of the Product Liability Advisory Council (“PLAC”) whether a plaintiff’s demand for the videotaping of a defense expert’s non-destructive examination of the components of an explanted medical device can be resisted. It seemed like an interesting question, and we like PLAC, so we decided to look for product liability cases where such demands had been made – recognizing, of course, that just as the other side might want to demand this of us, we might also wish, in certain cases, to require the same of the other side.

The brief answer to the question posed is “yes, it can be resisted.”

Continue Reading Videotaping Opposing Expert Product Examinations

Not too long ago (March 28, and April 2) we read with interest a couple of articles on 360 that brought back unpleasant memories.  The articles discussed congressional inquiries to the FDA (including “pointed questioning” of FDA Commissioner Margaret Hamburg) about undisclosed (to the public, anyway) meetings between “FDA officials” and the plaintiff’s bar concerning its current extremely controversial proposal to change its generic drug regulations in an effort to eliminate preemption of product liability claims involving such drugs.  Because 360 requires a subscription, we’ve hunted around on the Internet and found the same matter discussed here.

We’re not sure at the moment whether the FDA provided equal access to those with opposing views, but we wouldn’t be surprised if it didn’t.  Why not?  Because we’ve seen this all before.  Back in 1997, shortly after Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), and long before Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), courts were just beginning to draw the distinction between 510k clearance and FDA pre-market approval that the Supreme Court ultimately found critical in Riegel.  Then as now, from our perspective, anyway, it appears(ed) the FDA suffered what is sometimes called “agency capture” by pro-plaintiff elements.  So then as now, the FDA did what the other side wanted and issued a proposal to change its regulations designed to thwart preemption in product liability litigation.  That proposed rule was published at 60 Fed. Reg. 65384 (FDA Dec. 12, 1997).  Less than a year later, however, the FDA was forced to withdraw its proposal to gut preemption.


You guessed it.  The FDA was exposed as having had improper, one-sided contact with the plaintiffs’ bar concerning its 1997 anti-preemption proposal.  As the FDA ultimately admitted:

FDA has decided to withdraw the rulemaking to amend its regulations regarding preemption of State and local requirements applicable to medical devices.  FDA is taking this action because . . . [c]oncerns have been raised by industry and congressional representatives that the agency did not share its thinking on its interpretation of [the relevant provisions], even though an early draft of the proposed rule was shared during the spring of 1997 with attorneys for Public Citizen Litigation Group, who represented Lohr in the Lohr case. The remedy under FDA’s regulations for disclosure of a draft regulation is ordinarily to issue a notice in the Federal Register. . . .  Such a contemporaneous notice was not, however, provided in this case.

Because of the great policy significance of these preemption issues, the concern that Congress was not aware of the agency’s thinking during [its] deliberations, and the potential interplay between the [relevant] device provisions and device preemption, the agency believes that it is imperative for all interested parties to have confidence that the agency is addressing their concerns in an impartial manner.  Therefore, the agency is taking the unusual step of withdrawing the proposed rule.

63 Fed. Reg. 39789, 39789 (FDA July 24, 1998) (emphasis added).  Déjà vu all over again?

If it turns out that the FDA was meeting with the plaintiffs’ side, but not with the defense/industry side (a point that is not yet clear), then we have an example of history repeating itself – the FDA would yet again have exhibited institutional favoritism towards the plaintiffs’ bar with respect to a proposed regulatory change intended to adversely affect defense positions on preemption.  One would hope that, should such favoritism turn out to have occurred, the current FDA would have the good sense to do what the FDA did back in 1998, when the Agency’s impartiality was similarly subject to question.  Thus, if the FDA has indeed been meeting with plaintiffs’ lobbyists, but not their defense/industry counterparts, then the pending proposal to do away with generic preemption should be withdrawn – never again to see the light of day.

Whenever the other side starts cranking out the crocodile tears about the FDA being a supposed “puppet” of industry, just remember that we’re not the ones that have been caught – now, it looks like twice – with our hands stuck in the FDA preemption cookie jar.

We are only a couple of days away from the 50th anniversary of The Beatles’ arrival in America.  The DDL heirs say they are sick of hearing about it, but for those of us who sat in front of a black and white tv on February 9, 1964 as Ed Sullivan introduced the Fab Four, yeah, yeah, yeah, it was a really big deal.  To quote another great British artist, “Bliss was it in that dawn to be alive/But to be young was very Heaven!”  To the vexation of family and friends, hardly a hard day or night goes by when we don’t subject them to a Beatles song.  When you think of it, the legal biz provides many moments that call to mind a Beatles song. Plaintiff moaning and groaning?  “Misery.” Challenges to confidentiality designations? “Do You Want to Know a Secret.”  Those little slippery floor cases we handled early in our career?  “If I Fell.”   Impeaching a contradictory plaintiff?  “She Said, She said.”  A certain prolific plaintiff expert on the witness stand?  “Fool on the Hill.”  The opposing closing argument?  “Twist and Shout.”  An example of a troublesome local rule?  How about “No Reply”?  Plaintiff lawyers and their high-minded principles?  “Money, That’s What I Want.”  Also, “Baby, You’re a Rich Man.”  Worst of all, when case developments bring us low:  “I’m Down,” and, of course, “I’m a Loser.”

It seems like only yesterday when we mined some goodies from an unpublished case.  (It was last week  – just seven, not eight, days ago.)  Today we have an unpublished case with useful points here, there, and everywhere.  Even if it is not, strictly speaking, a drug or device case, it’s not across the universe either.  In Ross v. American Red Cross, 2014 U.S. App. LEXIS 1827 (6th Cir. Jan. 27, 2014), the plaintiff claimed that a Red Cross phlebotomist improperly inserted a needle into her left arm during a blood donation, injured a nerve, and failed to provide appropriate follow-up care, causing the plaintiff to develop something called “complex regional pain syndrome” (CRPS).  (That is an all too suggestive acronym, and the phrase sounds like something we’d get after a fried-feeding frenzy at a meat-and-three down South.  The facts also sound weirdly reminiscent of the dreaded Levine case.) Not a good day in the life.  Following a nine-day trial, a jury found that the plaintiff failed to prove that the Red Cross was negligent and that its negligence proximately caused the alleged injury.  Help – that verdict must have hurt as much as the needle.   The plaintiff filed an appeal on several grounds.  We will take a magical mystery tour through the plaintiff’s arguments and why the Sixth Circuit rejected them.  Curiously, each one of those grounds made us think of a Beatles song — don’t ask me why.

Spoliation – “I Should Have Known Better”   (This is the second song in the movie, A Hard Day’s Night.  John takes the lead in a scene on a train, while a gaggle of schoolgirls paw at the Beatles.  One of those screaming schoolgirls was Patti Boyd, a real Savoy truffle, who later became Mrs. George Harrison and, still later,  Mrs. Eric Clapton.)

The plaintiff argued that the district court abused its discretion by denying her motion for spoliation sanctions against the Red Cross.  The Red Cross phlebotomist who stuck the plaintiff had to complete a “Donor Reaction/Injury Record” (“DRIR”), which is used by the Red Cross to document possible complications from a blood donation.  In addition, the Red Cross is required to document donor complications pursuant to a consent degree reached by the Red Cross and the United States in another lawsuit. That earlier case traveled a long and winding road when the United States filed a complaint for permanent injunctive relief on behalf of the FDA alleging that the Red Cross violated the FDCA.  The Consent Decree required the Red Cross to follow certain policies and procedures regarding blood safety.  The plaintiff in Ross requested the DRIR containing information related to her injury.  The Red Cross produced a copy of the DRIR as it existed on September 19, 2008, which included notes from the plaintiff’s blood donation and her communications with the Red Cross the following week.  But the Red Cross did not provide a version reflecting later communications between the plaintiff and the Red Cross.  That version was apparently lost.  The circumstances of that loss seem innocent. We won’t assume that everybody’s got something to hide.  Between September 2008 and earl 2009, the Red Cross transferred functions related to donor support from the regional Red Cross offices to centralized offices.  Somehow during that transfer process, the DRIR concerning the plaintiff was inadvertently misplaced and the Red Cross could not locate it no matter how hard they searched.  Stuff happens.  More important, the Red Cross claimed that it was unaware of a possible lawsuit by the plaintiff until after the document was lost.

Predictably, the plaintiff moved for spoliation sanctions.  She sought an order prohibiting the Red Cross from introducing evidence that it provided proper aftercare, as well as an instruction allowing the jury to infer negligence by the Red Cross due to its spoliation of evidence.   Those are, of course, serious sanctions.  They would be a ticket to ride straight to a plaintiff verdict.  But slow down.  Spoliation is the intentional destruction of evidence that is presumed to be unfavorable to the party responsible for its destruction.  The court held that the plaintiff did not establish either of those requirements.  There was no evidence that the Red Cross was notified of a potential lawsuit until at least two months after the DRIR was misplaced.  Moreover, the evidence showed that the Red Cross was not a bad boy.  It lost the documents inadvertently.  It did not destroy them in bad faith.  Further, even if the missing DRIR could have been relevant to the negligent aftercare claim, its absence did not unduly hinder the plaintiff’s case because the parties to the conversations documented in the DRIR were available to testify.

Disqualifying a Turncoat Expert – “The Night Before” (You can hear only bits of this song in the Help movie.  Paul wonders why a girl isn’t as nice to him as she was … well, you know.)

The plaintiff argued that the district court abused its discretion by disqualifying one of her proffered expert witnesses, the Red Cross’s former in-house counsel, and by excluding his expert report and testimony. Just stating the issue so straightforwardly we cannot help but conclude that you can’t do that.  The court agreed.  During discovery, the plaintiff disclosed her intent to call as an expert witness someone who had been a Red Cross deputy general counsel and interim general counsel from 2001 to 2006.  During that time, he handled a variety of legal matters and oversaw all litigation involving the Red Cross, including donor-injury lawsuits.  He was also the lead counsel in negotiations that culminated in the amendments to the Consent Decree.  One more thing: he signed a confidentiality agreement with Red Cross.  The plaintiff planned to have this turncoat expert witness offer opinions that (1) phlebotomy and venipuncture should be classified as inherently dangerous activities; (2) the Red Cross’s failure to maintain a log of needlestick injuries and to document the plaintiff’s injury violated the Needlestick Safety and Prevent Act of 2001 and constituted negligence per se; and (3) the failure to draw the plaintiff’s blood properly and to provide appropriate follow-up care was evidence of the Red Cross’s violation of the Consent Decree’s training requirements. Coupling the substance of that testimony with the positions this expert had held with the Red Cross, that would come together as really strong stuff.  No wonder the Red Cross hated every little thing about this expert’s retention by the plaintiff.

The court applied the standard  two-step inquiry to determine whether disqualification is proper.  First, the court asked whether the adversary had a confidential relationship with the expert. Second, the court asked whether the adversary disclosed confidential information to the expert that is relevant to the current litigation. Here, the plaintiff’s expert witness clearly had a confidential relationship with the Red Cross.  He had been entrusted with confidential information relating directly to the matters on which he intended to provide expert testimony against Red Cross.  For example, the expert witness provided privileged advice during the negotiation of the Consent Decree identified in his report – the very same Consent Decree he intended to opine that the Red Cross violated in this case.  Additionally, the expert witness oversaw all litigation involving the Red Cross, including donor-injury cases, at least one of which involved CRPS.  Finally, the plaintiff’s expert witness had “provided privileged advice regarding the Red Cross’s compliance with FDA blood regulations.”  The district court not only held that these facts favored the plaintiff expert’s disqualification, they made his participation in the case “unseemly.”  For the Sixth Circuit, the question was not whether the plaintiff’s expert would necessarily use or reveal confidential information but, rather, whether the expert actually obtained  confidential information from the Red Cross when it was objectively reasonable for the Red Cross to believe it had a confidential or fiduciary relationship with him.  That was an easy Yes, and so was disqualification.  Hello, Goodbye.

Denial of Leave to Amend the Complaint – “Not a Second Time” (This song was on the With the Beatles album – a slightly butchered version was called Meet the Beatles in the USA.  The music critic of the London Times compared it to Mahler’s “Song of the Earth.”  John thought that was funny.)

The plaintiff left no doubt that she wished she could amend her complaint.  She wanted to amend it before trial, and then she wanted to amend it after trial to conform to alleged proof.  The plaintiff sought to add a claim alleging that the Red Cross is strictly liable for her injuries because venipuncture and phlebotomy are inherently dangerous activities.  When a plaintiff moves to amend the complaint after the deadline established by a scheduling order (as happened here), the plaintiff first must show good cause under Fed. R. Civ. P. Rule 16(b) for failure earlier to seek leave to amend and the district court must evaluate prejudice to the nonmoving party. The district court held that the plaintiff could not demonstrate good cause to extend the deadline to amend the complaint because her proposed amendments were not based on any newly discovered facts.  As so often happens, the plaintiff suggested that her failure to comply with the scheduling order should be excused because she obtained new counsel more than a year after the deadline to amend the pleadings.  I’ve got a feeling that argument almost never works.  It didn’t work here.  The court held that the substitution of new counsel does not justify failure to comply with a scheduling order. Additionally, the Red Cross argued that it would have suffered prejudice if the case scheduled were modified to allow the plaintiff to add new claims because it would have had only one month to depose the new expert witnesses and two months to identify its own expert witnesses after the addition of new claims.

So much for the effort to amend before trial.  But the plaintiff would not let it be.  Now for the effort to amend after trial.  You can’t do that, either.  Rule 15(b) provides that when an issue not raised by the pleadings is tried by the parties’ express or implied consent, it must be treated in all respects as if raised in the pleadings. A party may move—at any time, even after judgment—to amend the pleadings to conform them to the evidence and to raise an unpleaded issue.  Rule 15(b) is designed to allow parties to a civil action to get to the heart of a matter and not have relevant issues obscured by pleading niceties.  At the same time, the rule was not designed to allow parties to wait and change theories in mid-stream. The district court observed that the plaintiff’s argument for amending the complaint to add issues purportedly tried by consent was “based not so much on what evidence she presented on these claims but on the defense that the Red Cross pursued at trial.”  The district court had refused to instruct the jury on the defenses of assumption of risk and comparative negligence, meaning that these defenses were never before the jury for consideration.  As mentioned above, the district court had expressly denied the plaintiff’s attempt to amend the complaint to add a strict liability claim prior to trial.  The court concluded that in light of the earlier ruling that the plaintiff could not amend her complaint to add a strict liability claim, “it would defy logic for the Court to now find that the Red Cross consented to try a strict liability claim at trial.”   Sounds right to us.

Excluding Evidence of Settlements and the Consent Decree – “We Can Work it Out” (This was the A side of a single released at the end of 1965.  The B side was “Day Tripper.”  The Beatles believed in giving their listeners value.  In fact, they thought it cheating to issue singles and then include them on albums.  Anyway, “We Can Work it Out” is a classically optimistic, sensible Paul song, and its application to settlement issues is self-evident.)

The plaintiff argued that the district court abused it discretion by granting the Red Cross’s pretrial motion in limine to exclude evidence and argument relating to settlements, consent decrees, or judgments involving the Red Cross, governmental agency inquiries, investigations, involving the Red Cross, any adverse determination letters (ADLs) issued to the Red Cross by the FDA and other lawsuits filed against the Red Cross. It’s all too much.  The Consent Decree was especially high on the plaintiff’s wish list, but the district court observed that evidence of the Consent Decree was irrelevant because it “does not inform the key issue of whether the Red Cross was negligent in attempting to draw blood on September 12, 2008, or in its ‘aftercare’ following needlestick injury.”  The plaintiff sought to use the ADLs to demonstrate that the Red Cross must have violated the rules in her case because it did so in other cases.  How many times have we heard that before?  The district court held that even if this information were probative of a fact at issue in the case before it, the probative value was substantially outweighed by the risk of unfair prejudice because “[t]here is a substantial risk that the jury, looking at the Red Cross’s unrelated violations in other regions and at other times, would draw an improper conclusion regarding the Red Cross’s conduct in this case.”  Rather than get back to relevant evidence, the plaintiff argued that she intended to use the lawsuits as evidence of “foreseeability and proximate causation.”  The court basically said Nice Try.  There was no dispute that the Red Cross owed the plaintiff a duty of care, rendering foreseeability of the injury “a collateral issue, at best.”  Moreover, the plaintiff never explained how another lawsuit would inform the issue of whether the needle stick proximately caused the onset of injuries in this particular case.

Res Ipsa Loquitur – “Because”  (In law school we constantly argued with a roommate about whether early or late Beatles music was better.  We were devoted to the early stuff, and you still won’t convince us that anything exceeds A Hard Day’s Night – which was, by the way, the first album where all the songs were composed by The Beatles.  Our roommate thought that pop music reached its height in Abbey Road, which included “Because,” “Maxwell’s Hammer,” “Octopus’s Garden,” a few other light ditties, and the sublime McCartney suite on side 2. Hmmm.  Just saying “side 2″ kind of dates us, doesn’t it?  Anyway, more people agree with the roommate than with us.)

The Res ipsa loquitur  doctrine (meaning, the thing speaks for itself) provides that the plaintiff, in certain circumstances, does not need to prove negligence.  Rather, the theory is that sometimes something happens that is so helter skelter that it could not happen unless somebody screwed up bad.  The plaintiff in Ross argued that the district court abused its discretion by failing to give the jury a res ipsa loquitur instruction. Essentially, the plaintiff’s position was that nobody would sustain the CRPS injury she sustained unless the phlebotomist stuck her wrong.  But it wasn’t as simple as fixing a hole.  The expert proof at trial was conflicting as to whether the plaintiff in fact sustained a nerve injury or CRPS, whether the phlebotomist was negligent, and whether any injury to the plaintiff was caused by the phlebotomist’s negligence.  The defendant’s expert testified that nerve injury can occur even when a phlebotomy is properly performed, and plaintiff’s expert said that a needlestick can cause the alleged injuries in the absence of negligence. Those disputes made the Ross case very different from the classic res ipsa case that  involves a sponge or surgical instrument left in the body during a surgical procedure.  Because it was equally probable that the plaintiff’s injury was not attributable to negligence, the case did not warrant a res ipsa instruction.

Negligent Aftercare – “Getting Better” (The general public seems to think that The Beatles reached their height in Sergeant Pepper’s Lonely Hearts Club Band.  That LP always gets major points for supposedly being such a great ‘concept’ album.  We find ourselves agreeing with John, who said that Pepper is considered a concept album only because The Beatles called it one.  There is nothing especially great or essential about whatever the concept is thought to be. Look:  Pepper is a wonderful album.  But we’ll always favor Rubber Soul – which we were constantly stealing from our sister — Revolver, and, yes, Hard Day’s Night.  Anyway, “Getting Better” is a catchy song, with Paul singing in his lilty way about how he had to believe that things were getting better, while John muttered in the background that things “couldn’t get much worse.”  That’s the Lennon-McCartney synthesis in a nutshell.)

The plaintiff did not manage to point to evidence presented at trial supporting her negligent aftercare claim.  Nor did she point to evidence indicating what the appropriate standard is for follow-up care, how the Red Cross failed to meet it, or how such alleged failure led her to develop CRPS.  The issue was not one of ordinary negligence.  Rather, the question was whether the follow-care provided by the Red Cross caused or exacerbated the plaintiff’s CRPS.  This is not something where the court could simply tell the jury to think for yourself.  The Sixth Circuit agreed with the district court that expert testimony was necessary to explain how the Red Cross’s actions contributed to the plaintiff’s condition.  There was no such expert testimony, so the claim, and the appeal, went nowhere,  man.

The Sixth Circuit supplies the word we love to see after a defense verdict:  “affirm.”  The end.