This post is from the non-Reed Smith side of the blog.

Search for Medtronic on this blog and you’re going to find preemption cases. Lots of preemption cases. Mostly preemption victories for the defense. An overwhelming body of preemption law has been made by Medtronic. They’ve certainly led the charge. So, if we say today’s post is a Medtronic case about a spinal implant, you’re likely thinking more preemption. While that wouldn’t be a bad thing, even here at the DDL blog we can get a little tired of beating the preemption drum (don’t let Bexis know). Everyone once and a while we like to sing a different tune.

After all, if you never flipped over to the B-side, you may have missed some really good music. We’ll now pause to explain B-sides to the iPod generation who may be completely unfamiliar with the old 45-rpm single. The single was meant to showcase an album’s prospective hit on its A-side with an additional song on the B-side. The B-sides were typically throw away tracks. But sometimes, an equally good, and some may argue better, song could be found by flipping the single over. For example, ‘I Am the Walrus’ was on the B-side of the Beatles ‘Hello Goodbye’ (that was a John v. Paul thing). Pearl Jam’s ‘Yellow Ledbetter’ was the B-side of ‘Jeremy’ until radio DJs made it a hit on its own. U2 originally only released ‘The Sweetest Thing’ as the B-side to ‘Where the Streets Have No Name.’ And, perhaps one of the best songs of all time (says this blogger and Sir Paul McCartney) – ‘God Only Knows’ was a B-side. To be fair it was the B-side to the Beach Boys ‘Wouldn’t It Be Nice?’ so isn’t that really like two A-sides?

In the case we’re bringing you today, Medtronic had previously won a motion to dismiss plaintiff’s fraud and consumer protection claims on the grounds of preemption (among other reasons). See our post here.  So, you’ve already heard the A-side.  But following that decision, plaintiff’s design defect and manufacturing defect claims under the Louisiana Products Liability Act (LPLA) remained. So Medtronic moved for summary judgement. As to design defect, plaintiff had to concede that it had no evidence of an alternative design, so that claim was dismissed with prejudice. See Lyles v. Medtronic Sofamor Danek, USA, 2016 U.S. Dist. LEXIS 38550, at *15 (W.D.La. Mar. 23, 2016). On manufacturing defect, plaintiff alleged res ipsa loquitur — welcome to the B-side of this record.  The district court granted summary judgment. See id. at *21-23. Plaintiff appealed. But the Fifth Circuit said the district court got it right.  Like the Stones got it right with ‘You Can’t Always Get What You Want’ on the flip side of ‘Honky Tonk Women’.

Plaintiff had multiple medical device components implanted in his spine to treat his spinal stenosis and cervical cord compression. Lyles v. Medtronic Sofamor Danek, USA, 2017 U.S. App. LEXIS 17534, at *3 (5th Cir. Sept. 11, 2017). X-rays taken within the first day of surgery showed something amiss with one of the implanted plates (experts disagree regarding whether the plate was broken or just misaligned). Id. at *3-4. Plaintiff sought additional treatment and underwent a second surgery, but the plate was not explanted and remains in plaintiff’s spine. Id. at *4-5.

To maintain a manufacturing defect claim under the LPLA, plaintiff has to prove that at the time the medical device left the manufacturer’s control, it materially deviated from its specifications or from other identical products from the same manufacturer. Id. at *9. Plaintiff offered no proof of either the device’s specifications or how the device used in his surgery deviated from those specifications. He relied instead on res ipsa loquitur – arguing that the only reasonable inference that would explain the device breaking was that there was a defect in how it was made. Id. at *10.

The Fifth Circuit does a nice job of explaining both how the doctrine is to be applied sparingly and then discussing those rare situations in which a plaintiff has been allowed and not allowed to use it in the products liability context. See id. at *10-13. In sum, “where there are other potential causes of injury, a plaintiff’s inability to exclude all known potential causes other than a manufacturing defect preclude his reliance on the doctrine.” Id. at *13.

In his opposition to defendant’s motion for summary judgment, plaintiff relied exclusively on two things – the short time between implant and breakage and his expert’s conclusion that he had no other reason for the breakage other than a defect. Id. at *13-15. What plaintiff failed to do was address any of the “multiple potential explanations,” offered by the defendant. Id. at *14. Putting aside for a minute that plaintiff can’t make an argument on appeal that he didn’t make below, his new argument to the Fifth Circuit was that there was no evidence for defendant’s alternative explanations. But plaintiff lost sight of his burden of proof:

[T]o succeed on the theory of res ipsa loquitur, [plaintiff] has the burden of producing evidence excluding other reasonable explanations. Though [plaintiff] argues that there is no evidence for any other cause for the [device’s] breakage, there is no evidence for a manufacturing defect either, which is why he is invoking res ipsa loquitur. The other reasonable explanations for the [device’s] breakage posited by [defendant] are equally as likely as a manufacturing defect. It is [plaintiff] who has the burden to adduce evidence excluding them.

Id. at *15-16. The issue isn’t whether there is evidence to support the other reasonable explanations, but rather what evidence plaintiff has adduced to exclude the other reasonable explanations. Id. at *18.

Further, plaintiff didn’t offer any evidence that any alleged defect existed when the device left the manufacturer’s control. Prior to plaintiff’s surgery, the device was stored at the hospital and any number of people had access to it. Id. at *16-17. The Fifth Circuit concluded that even if the district court had been wrong in not applying res ipsa loquitur, which it wasn’t, plaintiff’s manufacturing defect failed on this ground as well. Id. at *17.

Res ipsa loquitur is definitely a B-side to preemption but don’t overlook the B-sides or you might miss out on a winner.

It’s a fairly well known double standard. If you ask your child why he or she did that rotten, terrible, awful thing and he or she responds “just because” – that’s never good enough. When a parent is faced with the question “why,” however, “because I said so” is a fairly standard, albeit a bit of a crutch, response. If your child happens to have a litigator as a parent, the lesson that “just because” won’t cut it is learned very early. Litigators like to practice their cross-examination skills. Litigator-parents get that opportunity when faced with broken windows, missed curfews, and dented bumpers. DDL Blog litigator-parents not only cross-examine, we TwIqbal (actually seems to work well as a verb). We want supporting facts and they better be sufficient to “nudge” whatever explanation is being offered “across the line from conceivable to plausible.” Ashcroft v. Iqbal, 556 U.S. 662, 680 (2009).

That’s exactly what the judge was looking for in Staub v. Zimmer, Inc., 2017 U.S. Dist. LEXIS 89109 (W.D. Wash. Jun. 9, 2017). Try as he might, however, he couldn’t find it. Plaintiff filed suit in Washington state alleging injury from the implantation of a prosthetic hip. Id. at *1. Following removal to federal court, defendant moved to dismiss.

In Washington, all products liability claims are subsumed under the Washington Product Liability Act (“WPLA”). Id. at *4. The WPLA allows a plaintiff to seek recovery for defective design; failure to warn; defective manufacture; or breach of express or implied warranty. Id. at *4-5. While a plaintiff does not have to specify in the complaint which precise theories he or she is pursuing, the complaint has to “contain sufficient non-conclusory factual allegations to support at least one avenue of relief.” Id. at *5. So, the court combed the Staub complaint to see if it met that basic requirement.

First, the court could find no indication anywhere in the complaint that plaintiff was alleging either failure to warn or breach of warranty. Id. at *5-6. The court was unwilling to read into the complaint claims that plaintiff appears to have failed to assert. As an aside the court pointed out that should plaintiff wish to pursue a failure to warn claim, it may be barred by the learned intermediary doctrine. Id. at *6n3. Perhaps a little foreshadowing?

The WPLA recognizes both the risk utility test and the consumer expectations test as bases for a design defect claim. So plaintiff’s complaint better have support for at least one of these theories. Plaintiff Staub, however, failed to adequately plead either. On risk utility, plaintiff only alleged that the product was “not reasonably safe.” Id. at *7. On consumer expectations, plaintiff only alleged that the device “failed to meet consumer expectations of safety.” Id. at *8. These are the pleading equivalent of “just because.” Parroting back the words of the elements of the claim do not suffice. Nowhere did plaintiff allege how a design element led to his alleged injury, whether there was a feasible alternative design, or how the product didn’t meet expectations. Id. at *7-8.

On his manufacturing claim, plaintiff failed to allege any facts showing that the device at issue deviated in any way from the intended design. Id. at *9. Once again, a bare bones allegation that the product was “defective and unreasonably dangerous” was far from satisfactory. Id. Plaintiff apparently made some attempt to save his manufacturing defect claim by alluding to the fact that the product had been voluntarily recalled. But without any allegations connecting the recall to plaintiff’s alleged injuries, the recall alone offers no support. Id. at *10n5.

Plaintiff is getting a do-over; he has 20 days to file an amended complaint. It’s sort of like, go to your room and when you come back you better having something better than “just because.”

We’ve all had cases where plaintiffs try to use their prescribers and treaters as their experts on everything from failure to warn and causation to design defect and company conduct. Even on the medical aspects of the case, a treater needs to offer more than just an unsupported general conclusion in order to withstand scrutiny under Daubert. But, when a surgeon or an orthopedist, for example, starts to offer opinions on product defects; when he or she has sufficiently wandered away from the parameters of their general expertise; the bar needs to be set even higher. Or, at least the proffered opinion needs to be even more carefully scrutinized. And certainly something more than — gee, I’ve never seen this before – is required.

But – gee, I’ve never seen this before – is all plaintiffs had to offer in Whybark v. Synthes, Inc., 2017 U.S. Dist. LEXIS 67988 (W.D. Ken. May 4, 2017). And that’s why defendants were awarded summary judgment. The case involves a bone screw (a product dear to Bexis and me). Plaintiff had one implanted in his foot to correct an osteoarthritis issue. Id. at *1. Two months after surgery, x-rays revealed that the plaintiff’s bones had not yet fully healed. X-rays taken four months after surgery show the bone still not completely healed and also that the bone screw had fractured. Id.

Kentucky products liability actions are governed by the Kentucky Product Liability Act which allows three potential claims: defective design, defective manufacture, and failure to warn. Id. at *4-5. Plaintiffs abandoned both their design defect and their failure to warn claims. On design defect, the only evidence in the case was that plaintiff’s surgeon testified the product was safe and effective. Id. at *5. Nor did plaintiffs challenge that the package insert contained an adequate warning about the risk of screw fracture. Id. at *6.

Plaintiffs instead decided to place their sole focus on manufacturing defect. The court begins its analysis of the claim by determining that indeed plaintiffs needed expert testimony to support it. Knowledge of the design and manufacture of bone screws is “far outside the realm of common experience” of lay jurors. Id. at *7.   But the only expert proffered by plaintiffs was the implanting surgeon. The surgeon’s only testimony regarding defect was that “he suspected the breakage of the [defendant’s] screw was due to a manufacturing defect because he had never seen a bone screw break after surgery.” Id. at *2. While it’s reassuring to know that the doctor has had such a good track record, that tells us absolutely nothing about whether this particular screw contained a manufacturing defect.

But even before getting to the substance or basis for his opinion, the surgeon’s testimony failed Daubert because he was unqualified on manufacturing issues. The first point was obvious, he had no training, education or experience in manufacturing, metallurgy, or biomedical engineering. Id. at *12. Beyond that though, plaintiff could offer no reason for why the doctor’s clinical experience and personal knowledge of bone screws qualified him to offer an expert opinion on manufacturing defect. Id. The treater/prescriber’s testimony is generally admissible as to care, treatment, prognosis – things he observed, concluded, or formed an opinion on in the course and scope of treatment. Id. This is another reason to challenge a treater/prescriber’s testimony on causation, if not supported by an independent expert report that withstands Daubert. While causation is in the realm of the doctor’s expertise, if it’s not something he opined on during care and treatment, he shouldn’t be allowed to opine on it at trial.

Even though clearly not qualified, the court went on to assess the reliability of plaintiff’s surgeon’s opinion. Here, the doctor failed to state his opinion, such as it was, to a reasonable degree of medical certainty. Id. at *13. That is because he couldn’t. He had done no research. Reviewed no company or manufacturing documents. He could cite no principles to support his conclusion. Id. at *14-15. But, he was well aware that “it is generally accepted in the medical community that bone screws can fracture secondary to fatigue when subject to loads caused by non-union [non-healing].” Id. at *14. So, even though he’d never seen it before, he knew it could happen. As if that wasn’t enough to take the wind from his sails, he also testified that he would “absolutely” defer to a metallurgist on the issue of defect. Id. at *15. As luck would have it, defendants had a metallurgist and he opined that the screw met industry standards and contained no manufacturing defects. Id. at *2.

Finally, plaintiffs attempted to argue res ipsa loquitur – they didn’t need an expert because the circumstantial evidence justified an inference that the screw would not have fractured absent some defect. Id. at *17. But that theory only works if plaintiffs can eliminate “all other reasonable explanations for the accident;” in this case the fracture. But they can’t because plaintiff’s own surgeon and sole expert witness conceded that the non-healing of the bone may have caused the screw to fracture. Id.

This case appears to have been a loser for plaintiffs from the outset. Relying on the treater as a defect expert just sealed its fate. The defense relies on prescribers as learned intermediaries and we don’t go after them unless really forced to. If they step this far outside their expertise, we’re sort of forced to.

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