Back in October we posted about the Eastern District of Pennsylvania decision McLaughlin v. Bayer Corp, 2016 U.S. Dist. LEXIS 37516 (EDPA Mar. 22, 2016) saying that while we liked the ultimate result – tossing out most of plaintiffs’ claims – some pieces of the decision weren’t as strong as we would have liked. Well, McLaughlin’s back and it’s still not a slam dunk, but plaintiffs’ don’t have too much left of their cases either.

As a reminder, this is actually a decision in 5 cases each alleging injury from plaintiffs’ use of a Class III, PMA contraceptive device, Essure. McLaughlin v. Bayer Corp., 2017 WL 697047, at *1 (E.D.Pa. Feb. 21, 2017). Several of plaintiffs’ original causes of action were dismissed with prejudice, but they were given an opportunity to amend to try to salvage their claims for negligent training, negligent risk management, breach of express warranty, fraudulent misrepresentation, and negligent manufacture. Negligent misrepresentation and failure to warn premised on failure to report survived the first motion to dismiss.

The decision methodically goes through each cause of action.

Negligent Training: In its first decision, the court opined it was possible to state a parallel claim for negligent training, but since plaintiffs failed to specify how defendant’s training deviated from federal training requirements or how those deviations caused plaintiffs injuries, the claim had to be dismissed as insufficiently pled. Id. at *3. In the amended complaint, plaintiffs alleged 6 such failures by defendant. As to 3, the court couldn’t find any federal directive that required defendant to do what plaintiffs alleged it failed to do. So, as to those 3 allegations, the claim was dismissed as expressly preempted. Id. at *4-5. As to the remaining 3 alleged violations, defendant challenged them on causation grounds but was unsuccessful. The court found the complaint sufficiently alleged that because defendant failed to properly train the doctors, the doctors in turn did not properly place the device causing it to migrate and cause plaintiffs’ injuries. Id. at *5. The complaint, however, lacked any specific allegations about the actual doctors who performed plaintiffs’ surgeries. The court didn’t find that fatal at the pleadings stage – that was for discovery. Id. at *6. But if you look at what the 3 bases for the failure train claim are, they appear to all be things plaintiffs could have asked their doctors about before filing these lawsuits. Did the doctor successfully complete 5 preceptorings? Did the doctor read and understand the training manual? Did the doctor successfully complete the simulator training? If the answers to those 3 questions are yes in each case – this claim is over.

Continue Reading PMA Preemption Revisited in Pennsylvania

Kentucky –sure, it gets pretty sticky in the summer, and the bluegrass isn’t really blue, and Wildcats fans – well, they’re a breed of their own. But give us the bourbon, the chicken, and the Derby and we’ll be singing “My Old Kentucky Home” and “Coal Miner’s Daughter” with the rest of the Kentucky natives.

DeMoss v. Eli Lilly & Co., 2017 U.S. Dist. LEXIS 19142 (W.D. Ken. Feb. 10, 2017) is a bit like the commonwealth it’s from — we like some pieces and others we could certainly do without. The case involves an anti-clotting drug which plaintiff alleges led to her husband’s fatal internal bleeding. Plaintiff asserted claims for design, manufacturing, and failure to warn defects under both strict liability and negligence; breach of implied warranties; negligent misrepresentation; and violation of the Kentucky Consumer Protection Act. Id. at *5. On the defendant’s motion to dismiss, all claims except design defect and failure to warn were dismissed without prejudice.

On strict liability, Kentucky has adopted comment k’s exception for unavoidably unsafe products such as prescription drugs and devices, but has not adopted it across the board. Rather, applicability of comment k is determined on a case-by-case basis using a risk-utility test. Id. at *6-7. So, at the pleadings stage, the court was unwilling to toss out plaintiff’s strict liability claim as a matter of law finding the inquiry too fact dependent. Id. at *8. This approach kicks a comment k analysis to the summary judgment stage.

Defendant also argued that plaintiff’s pleading of strict liability design defect was insufficient under TwIqbal. The court disagreed finding that plaintiff’s allegation that the drug carried “an unreasonably high bleeding risk without any reversal agent” and that plaintiff’s husband died as a result of that injury, was more than just regurgitating the basic elements of a design defect claim. Id. at *9. And on the issue of pleading an alternative design, the court allows a different drug to serve as the alternative design. Id. There isn’t much discussion of this and so we hope it’s something that can be more fully explored later in the case – after all, a different drug is a different drug, not an alternative design for the drug at issue. The court similarly found that plaintiff had pleaded enough for her failure to warn claim to survive. Id. at *12. In addition to alleging a failure to adequately warn about the increased risk of bleeding, plaintiff also alleged a failure to adequately test which the court found was not an independent cause of action, but was subsumed in the failure to warn claim. Id. at *15. Based on very similar reasoning, the court allowed both negligent design defect and negligent failure to warn to stand as well. Id. at *13-14.

Strict liability and negligent manufacturing defect claims, however, were both dismissed. Unlike with design defect and failure to warn, plaintiff’s manufacturing defect claims were nothing more than a recitation of the elements of the claim with no specificity or factual support. Id. at *10-11. The complaint fails to allege how the drug taken by plaintiff’s husband deviated from the defendant’s specifications or standard processes or how any such failure caused her husband’s injury. Id. at *11; *13-14 (negligent manufacturing claim dismissed).

Next the court dismissed plaintiff’s breach of implied warranty claim for lack of privity. Id. at *15-16. The same lack of privity was the downfall for plaintiff’s claim for violation of the Kentucky Consumer Protection Act (“KCPA”). Id. at *21. The KCPA, however, has a privity exception when a plaintiff alleges express representations were made. Plaintiff here tried to claim her failure to warn allegations demonstrated express representations that would allow her to fall within the exception. But those allegations did not rise to the level of being “affirmations of fact or promise” that qualify as express representations, so the claim was dismissed. Id. at *23.

On negligent misrepresentation, while plaintiff attempted to argue that she had made out the who, what, where, when and why to satisfy even the heightened pleading standards of Federal Rule 9(b), all of those allegations were about concealing or omitting facts. Under Kentucky law, a claim for negligent misrepresentation “requires an affirmative false statement; a mere omission will not do.” Id. at *20. Essentially, plaintiff wasn’t allowed to re-package her failure to warn claim as an additional negligent misrepresentation claim.

While it’s not a slam dunk (something Wildcats fans are seeing a lot of recently), it’s a much smaller complaint that advances to the next round. Not perfect, but good enough for now.


It’s been two years since we applauded the downfall of Azzarello in Pennsylvania. Two years since the Pennsylvania Supreme Court ruling in Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014). Two years since we opined that we didn’t think Tincher changed Pennsylvania law applicable to prescription medical products much at all. After all, Hahn v. Richter, 673 A.2d 888 excluded prescription medical products entirely from Azzarello strict liability twenty years ago, so Tincher’s reworking of strict liability shouldn’t be of much consequence. And, our prediction has largely held true. We really haven’t mentioned Tincher much since here on the DDL blog, other than to point out the serious flaws in plaintiffs’ attempts to argue that Tincher somehow altered Pennsylvania’s negligence-only standard for prescription medical product litigation and that plaintiffs’ theory had been rejected by the first courts to consider it.

Now, two years later, we have to report that a Pennsylvania federal court used Tincher to allow a strict liability manufacturing defect claim to proceed in a medical device case – in what we view as a misconstruction of both Tincher specifically and Pennsylvania products liability law (especially post-Lance) generally.

The case is Wagner v. Kimberly-Clark Corp., slip op., No. 16-4209 (E.D. Pa. Dec. 1, 2016). During the installation of a feeding tube, a piece of the tube came off in plaintiff’s stomach and she had to undergo several procedures to have to have it removed. Wagner, slip op. at 2-3. Plaintiff’s complaint brings claims for negligence, strict liability, and breach of warranty. Defendant moved to dismiss the latter two claims. Id. at 1. Plaintiff did not oppose dismissal of the breach of warranty claim. Id. at 13. As for strict liability, the court dismissed strict liability design defect and failure to warn on the ground that neither is allowed under Pennsylvania law for prescription medical products. Id. at 6 n.3. But the court was unwilling to find the same was true as to plaintiff’s strict liability manufacturing defect claim.

Continue Reading Pennsylvania Federal Court Uses Tincher to Find Claim for Strict Liability Manufacturing Defect in Medical Device Case

Drug and device cases regularly involve plaintiffs who have suffered serious injuries, the type that engender sympathy, even from defense attorneys. It’s understandable that a plaintiff who suffered such trauma would turn to the courts for redress. But bad experiences do not make a viable drug or device claim. Drugs and devices have inherent risks, so the law requires more than injury due to those risks for a viable products liability claim. Generally, the injury must result from a defect of some sort, such as a design, manufacturing or warning defect. If a plaintiff doesn’t allege such a defect, the court must dismiss the claim, no matter how traumatic the plaintiff’s injury.

Smith v. Pride Mobility Products Corp., 2016 U.S. Dist. LEXIS 149955 (N.D. Cal. Oct. 28, 2016), illustrates this. The plaintiff was wheelchair-bound and claimed that, while attending a Renaissance Fair, the power to her wheelchair gave out as she was trying to climb a steep hill. Ultimately, the wheelchair went into a free-wheel fall at a sharp angle down the hill, throwing plaintiff from the wheelchair to the ground. Plaintiff claimed serious injury to her neck and knee, permanent disability to one of her toes, whiplash and serious psychological and emotional distress resulting from the event and her injuries.

These allegations no doubt suggest great trauma for the plaintiff. But do they state a claim? The initial consideration for a court is not the severity of the injuries or the trauma that led to them but whether the plaintiff’s allegations are sufficient to state a viable products liability claim. Here, the Smith court did its job. It reviewed plaintiff’s allegations dispassionately and determined that plaintiff had not made the type of allegations necessary to state a manufacturing defect claim:

In order to allege a strict products liability claim under a manufacturing-defect theory, a plaintiff “must identify/explain how the [product] either deviated from [the company’s] intended result/design or how the [product] deviated from other seemingly identical” models of the product.

Here, Plaintiff states that the wheelchair started “freewheeling down [a] hill” after Plaintiff placed the wheelchair in reverse on a hill and that the wheelchair “was either defective or . . . deliberately designed to” freewheel in such a manner. The complaint does not state how the wheelchair that Plaintiff purchased is different from the design of the wheelchair that Defendant intended or from other identical models of the wheelchair. Rather, “Plaintiff[] make[s] only conclusory allegations” that the product is defective, which is insufficient to allege a manufacturing defect claim.

Id. at *25-26 (citations omitted).

Continue Reading Bad Experiences and Serious Injury Do Not Make a Drug and Device Law Claim

A couple of weeks ago we reported on our visit to the Women’s Health Litigation Conference. One of the conference panels discussed the most interesting ongoing litigations involving women’s health products. Essure, a permanent contraception implant, was among those products. The standard claim is that the Essure implant can cause women to suffer pelvic pain, blood clots, and various other injuries. A plaintiff lawyer at the conference recounted (from a certain point of view) the Essure development and medical stories, concluding that Essure would be a “slam dunk … if not for the fact that it is a PMA product.”

Aye, there’s the rub. Essure is, indeed, a medical device that went through, and passed, the FDA’s rigorous Pre-Market Approval process. PMA approval means that almost all product liability theories are preempted by federal law. If state law, including jury verdicts, would impose any requirement different from, or in addition to, the FDCA, then such state law must yield. Consequently, tort claims against PMA products are difficult to sustain. Still, difficult is not the same as impossible. Plaintiff lawyers have tried all sorts of clever ways to circumvent PMA preemption. But clever is not the same as correct. Good for courts that can tell the difference.

Such a court issued the opinion in Norman v. Bayer Corp., 2016 U.S. Dist. LEXIS 96993 (D. Conn. July 26, 2016). As is typical, the complaint in that case covered the product liability waterfront, with claims for strict liability, negligent failure to warn, negligent training, negligent manufacturing, negligent misrepresentation, negligence per se, and breach of warranty. As is typical, the complaint devoted most of its girth to the generic development and medical stories alluded to above. In the 29 pages of the Norman complaint, “only four short paragraphs” related to the plaintiff and her experience with the product.

Continue Reading Federal Court Dismisses Essure Complaint

Today’s decision is that simple. Actually, it’s that simple and it’s that surprising that plaintiffs tried to side-step this golden rule of complex drug/device products liability litigation. You must have expert testimony.

In Chatman v. Zimmer, Inc., 2016 U.S. Dist. LEXIS 78657 (S.D. Miss. Jun. 16, 2016), plaintiff alleged she suffered injury as a result of implantation and subsequent failure of her knee implant.  The device was implanted in 2006 and in 2013 plaintiff started experiencing pain that led to revision surgery. Id. at *2. Rather than producing an expert to opine regarding product defect or medical causation, plaintiff informed the court she would be relying on “her own accounting of the events, records from her treating physicians, and a recall notice.” Id. at *3. We don’t need to know anything else. There is no way any of those three sources could satisfy the requirement that plaintiff produce expert testimony as to the alleged defect.

The court first threw out the recall notice because it pertained to a different knee replacement device than that implanted in plaintiff. Plaintiff apparently cited to cases involving commercial products to argue the admissibility of substantially similar circumstances. But this wasn’t similar circumstances, it was an entirely different product. Therefore, the recall is irrelevant. Id. at *5.

So plaintiff is down to “her own accounting” and her “medical records.” Plaintiff’s “own accounting” cannot establish product defect or medical causation. Plaintiff did not appear to be either a biomedical engineer or an orthopedic surgeon. The fact that her knee implant eventually failed after seven years and that she experienced pain are facts – but they have no connection to liability without expert testimony on defect and cause.

Continue Reading No Experts, No Case

Some plaintiffs seem to think that if they allege any problems about anything in the manufacturing process of a prescription medical product, then it falls under the rubric of “manufacturing defect.” They’re wrong, of course.  “Manufacturing defect” − as we’ve discussed before − has a precise and universally adopted meaning.  It is some kind of error in the manufacturing process for a product that results in a unit that fails to meet the manufacturer’s own design specifications.  As the Third Restatement puts it:

[A] manufacturing defect [exists] when the product departs from its intended design, even though all possible care was exercised in the preparation and marketing of the product.

Restatement (Third) of Torts, Products Liability §2(a) (1998). Or, as the California Supreme Court held, before the Third Restatement existed:

A manufacturing defect is one which results from an error in the production process. The product comes off the assembly line in a substandard condition: in some way it differs from the manufacturer’s intended result or from other ostensibly identical units of the same product line.

Finn v. G. D. Searle & Co., 677 P.2d 1147, 1163 (Cal. 1984) (citation and quotation marks omitted).

An allegation of some more global problem with a product’s manufacturing process, which results in some purported “defect” in all of the defendant’s products, isn’t a manufacturing defect claim at all, and courts have recognized this. In a batch of essentially identical opinions, out of Connecticut, one court addressed allegations that attacked the manufacturing method by which the defendant fashioned the exterior surface of an implant.  E.g., Johannsen v. Zimmer, Inc., 2005 WL 756509, at *5 (D. Conn. March 31, 2005).  This claimed problem, because it allegedly involved how the defendant manufactured all of its implants, didn’t involve a manufacturing defect:

Summary judgment is granted on the alleged defect in the manufacturing process. There is nothing in the record to support the contention that [defendant’s] manufacturing efforts were substandard in any respect. . . .  Plaintiff relies heavily on claims that the choice of manufacturing process − the decision to engage in grit-blasting and precoating − created a defect, but this is not evidence of a manufacturing defect; rather, it is possible evidence of a design defect.  A product can be manufactured correctly, according to all designs and regulations, and yet be defective-but the defect would not be the result of a manufacturing failure.

Id. at *8 (emphasis added). Accord Fuentes-Weed v. Zimmer, Inc., 2005 WL 756533, at *8 (D. Conn. March 31, 2005); Lopes v. Zimmer, Inc., 2005 WL 756535, at *8 (D. Conn. March 31, 2005); Dunn v. Zimmer, Inc., 2005 WL 756538, at *8 (D. Conn. March. 31, 2005); Vino v. Zimmer, Inc., 2005 WL 756540, at *9 (D. Conn. March 31, 2005).

Continue Reading The Difference Between Manufacturing and Design Defects

You’ve probably heard James Carville’s description of Pennsylvania as Pittsburgh on one end, Philadelphia on the other, and Alabama in-between.  Let’s put aside that last bit, which manages simultaneously to insult both Alabama and middle Pennsylvania, and focus on the rivalry between Pittsburgh and our fair city, Philly.  Those two municipalities are separated by a lot more than 305 miles.  Pittsburgh invented Big Steel, while we invented, you know, freedom.  People in Pittsburgh eat huge sandwiches containing French fries, while we fill ours with meat and cheese-whiz, leaving the fries on the side.  Our sports fans are more devoted – think Invincible or Silver Linings Playbook.  Lincoln Financial Field had its own Eagles jail.  (Granted, Pittsburgh’s teams, unlike ours, actually win with some frequency.  Congrats to the Penguins, we say through gritted teeth.)  A short road trip from Philly gets one to NYC, the Shore, the Poconos, or DC.  Not bad, right?  If you drive for a couple of hours out of Pittsburgh, you can be in … West Virginia.  (Oh no – time for more Mountaineer hate mail.)  Our city’s name is on some great movies – e.g., Philadelphia, The Philadelphia Story.  Philly was the setting for many essential flicks.  There’s Witness, Dressed to Kill (that great early scene is in the Philly Art Museum, though you’re supposed to think it’s the Met), Trading Places, Twelve Monkeys, The Sixth Sense, etc.  We could go on and on.  (Go ahead, dare us.)  Ever heard of Rocky?  By contrast, when has cinematic greatness touched Pittsburgh?  Wonder BoysThe Fish that Saved PittsburghGroundhog Day?  (And that last one is a stretch.)  Two of the greatest American painters, Eakins and Cassatt, lived in the Philly area.  We’ll take either one of them over Warhol.  (Yes, yes – it has been pointed out to us that Cassatt was born in Pittsburgh.  But she high-tailed it out of there at a young age.  She grew up in a nice area near Philly.  At least we think it’s nice.  We live in that area now.  Our street is named Cassatt – though named after her father, not her.)  Our music is better.  We’ll take Joan Jett over Christina Aguilera, Teddy Pendergrass over Stephen Foster, Gamble/Huff over Wiz Khalifa, and Pink over Pink Panther (i.e., Henry Mancini, composer of the theme song).  In a recent poll, the Philly accent was listed as one of America’s ugliest.  But guess who ‘won’ as ugliest of all?  Pittsburgh, the heewme of the Yinzers.

But if we had to defend a drug or device client, we’d probably rather be in Pittsburgh.  We do not remember anybody ever calling Pittsburgh a judicial heck-hole.  Jurors there seem to have a Midwestern-sort of sanity, unlike our jurors, who flip million dollar verdicts around like they were nickels.  Moreover, the judges out there seem to get it right.  They follow the rules, rather than bend them in an effort to accommodate sympathetic plaintiffs or friendly plaintiff lawyers.  Have you ever heard of Pittsburgh litigation tourism?  Neither have we.  A recent example of Western Pennsylvanian common sense arrived in the form of the decision in Carson v. Atrium Medical Corp., 2016 U.S. Dist. LEXIS 74743 (W.D. Pa June 8, 2016).  In Carson, the plaintiff had undergone a hernia repair involving a polypropylene mesh implant.  The plaintiff suffered from complications and additional surgical procedures.  Her complaint included the usual panoply of claims – strict liability, negligence, and breach of warranties. Pennsylvania law governed, and that turned out to be a bit of a problem for the plaintiff once the defendants filed a motion to dismiss.

As an initial matter, the court held that the plaintiff’s strict liability claim was barred by Pennsylvania law – specifically, the Torts Restatement Comment k on “unavoidably unsafe products.”  To be sure, while the Pennsylvania Supreme Court has invoked Comment k to shut down strict liability claims against prescription drugs, it has not yet decided whether Comment k applies to medical devices.  But state lower courts and various federal courts have reasoned that the same rationale for Comment k makes sense for devices.  The judge in Carson agreed.  The plaintiff argued that if Comment k were to be applied to devices, it should be limited to products that were “accompanied by proper directions and warning.”  Under that reasoning, a failure to warn claim would get a plaintiff out from under Comment k.    But the Pennsylvania Supreme Court has rejected that exception for prescription drugs, so there was no reason to gin it up for devices.  Maybe some other states have recognized or made up caveats to Comment k’s exclusion of strict liability claims, but the Carson court correctly felt bound by Pennsylvania law, which does not recognize such caveats.  Goodbye, strict liability.

Continue Reading W.D. Penn. Dismisses Most Claims in Hernia Mesh Case

We are determined not to end 2015 on a bad note.  Thus, we turn, as we do with surprising frequency (and as we did last week), to a federal court decision out of Mississippi for a heaping helping of solid legal reasoning.  The case is Estes v. Lanx, Inc., 2015 U.S. Dist. LEXIS 171184 (N.D. Miss. Dec. 23, 2015), and the court got everything right.  The case involves the usual panoply of product liability claims against a spinal fixation system.  After a surgery on the plaintiff in 2011, two pedicle screws fractured.  A revision surgery was performed in 2012. The plaintiff then sued, claiming that the pedicle screws were negligently designed or manufactured, that the defendant breached warranties as to the pedicle screws, and that the defendant had failed to obtain FDA clearance for the
spinal fixation system.

Mississippi has a Products Liability Act (the MPLA) that supplants common law claims, such as negligence or negligent misrepresentation.  We wish every state enacted a product liability act.  In fact, we wish every state enacted the MPLA.  The MPLA requires a design defect claim to suggest a feasible alternative design.  The plaintiff offered no such alternative design, so that theory was dismissed.  The manufacturing defect and failure to warn claims also foundered, though there were wrinkles to those claims, and the court’s ruling on those wrinkles made the decision even better.

Continue Reading N.D. Mississippi Invokes Buckman in Rejecting Plaintiff Efforts to Screw Up Product Liability Law

The Judge in the ObTape device litigation has allowed another manufacturing defect claim to go to trial with no direct evidence that the device implanted in the plaintiff had a manufacturing defect.  See In re Mentor Corp. ObTape Transobturator Sling Prods. Liability Litig., 2015 U.S. Dist. LEXIS 140263 (M.D. Ga. Oct. 15, 2015).  In denying the manufacturer’s motion for summary judgment, the court relied solely on a review conducted by plaintiff’s experts of sample ObTape devices—that is, devices other than the one implanted in the plaintiff.  The experts found that the pore sizes of those other samples were at times outside of the alleged manufacturing requirement of 40 to 100 microns.  Relying solely on this, the court rejected the manufacturer’s argument that plaintiff had not shown a manufacturing defect in the device implanted in her.  The court explained its reasoning, which from our point of view is less than convincing:

One way to prove a manufacturing defect is to test the specific subject product against manufacturing standards.  For example, in BIC Pen Corp., the parties tested the cigarette lighter that caused the plaintiff’s injuries.  346 S.W.3d at 540-41.  But Mentor [the manufacturer of ObTape] did not point the Court to any authority that such testing is the only way to establish a manufacturing defect under Texas law.  Here, Mrs. Sanborn relies on the same evidence as the Phase I Georgia Plaintiffs, whose specific ObTape was not tested, either.  Rather, their experts tested a number of ObTape samples and concluded that a substantial portion of each ObTape tested had pores smaller than 40 microns.  In re Mentor, 711 F. Supp. at 1376.  At this time, the Court remains satisfied that this evidence is sufficient to create a genuine fact dispute on Mrs. Sanborn’s manufacturing defect claim.  Mentor’s summary judgment motion on the manufacturing defect claim is thus denied.  The Court may reconsider this issue when ruling on any motion for judgment as a matter of law that may be presented at trial.

Id. at *8-9.

Continue Reading MDL Judge Allows Manufacturing Defect Claim to Go to Trial with No Direct Evidence of a Defect in the Device Actually Implanted in Plaintiff