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.

 

A recent case in the Southern District of New York debunks two myths that we see all the time. Myth number one:  A medical device is defective if it fails.  Myth number two:  A plaintiff can prove causation on a failure-to-warn claim by asserting that he or she would not have consented to the procedure if his or her doctor had told her about some risk.  Plaintiffs often assert these positions.  Neither is true.  And the magistrate judge’s report and recommendation granting summary judgment in Tomaselli v. Zimmer Inc., No. 14-CV-04474, 2017 U.S. Dist. LEXIS 9874 (S.D.N.Y. Jan. 20, 2017), does a really nifty job explaining why.

In Tomaselli, the plaintiff was treated with a hip repair device—a Greater Trochanter Reattachment device, or GTR.  A GTR is not like the ball-and-socket total hip replacement devices that have generated so much litigation and with which so many of our readers are familiar.  A GTR consists of a plate and two 1.8 millimeter cables that are surgically implanted to reinforce the top of a patient’s femur—the trochanter—in the event of a fracture. Id. at **1-2.

The plaintiff later complained of hip pain, and imaging revealed that one of the cables broke. Id. at *5.  It is not clear whether the broken cable made any difference:  The cable stayed in place, and removing it would not have alleviated the pain. Id. The evidence also suggests that the pain was not substantial:  The plaintiff went for long periods of time between doctor’s appointments; she was able to exercise and engage in daily activities; and she testified that stretching and taking a few steps would relieve any pain. Id. at *6.  The plaintiff sued the device’s manufacturer and distributor anyway, alleging a variety of product liability claims.

The defendants moved for summary judgment under New York law, and the magistrate recommended granting their motion on every claim. The magistrate’s report and recommendation is particularly interesting on the two issues that we foreshadowed above—failure to warn and product defect.

Continue Reading Hip Case Breaks the Right Way in New York

We don’t write a lot on the various pelvic mesh MDLs in West Virginia because we are so heavily involved in two of them. But the MDL court entered an order last week on design defect and alternative design that we consider to be a real gem.  The case is Mullins v. Ethicon, Inc., No. 2:12-cv-02952, 2016 WL 7197441 (S.D. W. Va. Dec. 9, 2016), and we recommend it to all of you.  We say that not only because the district court held that West Virginia law requires that each plaintiff must prove a feasible alternative design—which is the correct result—but also because the order is particularly well reasoned.

Not every state requires proof of a feasible alternative design, but it is nevertheless a basic product liability concept. It is a particularly good fit when dealing with products that always bear risks—such as implanted medical devices.  The Restatement (Third) of Torts, Product Liability § 2 is as good a place as any to start, as it bakes alternative design right into the definition of a design defect:  “A product . . . (b) is defective in design when the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design by the seller or other distributor, or a predecessor in the commercial chain of distribution, and the omission of the alternative design renders the product not reasonably safe.”  (emphasis added).

Take the obvious example of a machine with sharp spinning parts. The same machine with a protective guard may be a safer alternative design.  Or it might not.  The point is that the plaintiff has to prove it.  Take also the example we discussed in Bexis’ aptly named post “On Alternative Design.”  That case involved hernia mesh, not pelvic mesh, and the plaintiffs’ claims failed because, among other reasons, they had failed to prove that a mesh of a different design would have been any safer.  Consider hormone-based contraceptives.  Cholesterol drugs.  We could go on and on.  All these products bear known and unavoidable risks, and those risks should not be labeled “defects” and result in potential liability unless the plaintiff can prove an alternate design would feasibly mitigate them.  And, no, it is not sufficient to say that the feasible alternative is to use a different product or not use any product at all.  As we observed in the aforementioned post, that would convert strict liability into absolute liability.  As we asked in yet another post on this topic, are motorcycles defective because full-sized automobiles are generally safer?  You get the point.

Continue Reading A Gem on Alternative Design from a Pelvic Mesh MDL

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

Bexis, who took some lumps in probably the worst Wisconsin product liability decision ever (he filed PLAC’s amicus brief in Thomas v. Mallett, 701 N.W.2d 523 (Wis. 2005)), just read what we believe is the best Wisconsin law decision ever – at least in the drug/medical device sandbox that we inhabit. The decision is In re Zimmer Nexgen Knee Implant Products Liability Litigation, 2016 WL 6135685 (N.D. Ill. Oct. 21, 2016) (since the caption is a mouthful, we’ll call it “ZNKI“).

Here’s why ZNKI is favorable on Wisconsin legal issues.

First, as our longstanding 50-state survey on the learned intermediary rule points out, Wisconsin is one of nine states in which only federal courts predicting state law have had occasion to adopt the learned intermediary rule.  Looking more closely at these nine, Wisconsin is one of only two states (South Dakota being the other) where only federal district courts have reached this holding.  What isn’t there, but is discussed in ZNKI, is that some courts have (without much reasoning) refused to predict Wisconsin’s adherence to the rule.  Refusing to dodge the issue, ZNKI forthrightly examines both Wisconsin precedent and the general state of the law and concludes that Wisconsin would join the nationwide learned intermediary consensus:

[F]ederal courts applying Wisconsin law have reached different conclusions about the doctrine’s applicability.  The vast majority of states, however, do employ some version of the doctrine.  In addition, this court’s research suggests that those courts that have declined to apply the doctrine under Wisconsin law have done so in cases involving prescription drugs, not medical devices, and those courts offer no reason to believe that the Wisconsin Supreme Court would not adopt this majority rule if presented with the issue.

In the context of . . . surgery, a patient must rely on the experience and judgment of his or her surgeon, who selects the appropriate implant and educates the patient about the particular risks − based on the patient’s particular circumstances and physiology. . . .  Given that context, and given the widespread acceptance of the doctrine throughout the country, the court believes it is likely that the Wisconsin Supreme Court would apply the learned intermediary doctrine in this case.

ZNKI, 2016 WL 6135685, at *19-20 (numerous citations omitted).  As we’ve pointed out recently, the learned intermediary rule is, if anything, enjoying a renaissance, with thirteen straight state high court adoptions since the infamous Karl case (since overruled by statute) was the only supreme court to go the other way.

Continue Reading Probably the Best Wisconsin Law Decision We’ve Ever Seen

The Third Circuit just confirmed what we all knew had to be true in device litigation: pointing to the failure of another device in another patient or to a supposedly better label for a different device is not nearly enough to get to trial on design defect or failure to warn claims. That’s precisely what the Zimmer hip-implant plaintiff tried in Kline v. Zimmer Holdings, Inc., 2016 WL 5864886 (3d Cir. Oct. 7, 2016), and the Third Circuit rejected it.

To support his design defect claim, the plaintiff submitted an affidavit from his treating doctor discussing a different patient who also had a failure of a Zimmer hip implant. But the occurrence of two purported failures does not clear the way to trial. In fact, the court only had to scratch the surface of the affidavit to see its problems. The other patient’s product was a different Zimmer product. The circumstances of the other patient, the implant and its failure were different. There was no evidence as to what caused the other device’s failure. And the other patient’s implant failed after the device had already been implanted in plaintiff. These facts so solidly established the irrelevance of the affidavit that the Third Circuit held it inadmissible. The plaintiff also tried a host of design defect theories from his experts that were just that—theories—but with, as the Third Circuit held, no “record evidence showing any of these design choices were unreasonable.” It then upheld summary judgment against plaintiff’s design defect claims.

The Third Circuit was equally unimpressed with plaintiff’s failure-to-warn evidence. That evidence consisted of pointing to another product’s label, which included a contraindication for patients at a certain weight or BMI, something that the label for the Zimmer product did not have. But that was the extent of plaintiff’s evidence. He did not show that the other device was similar to the Zimmer device. He did not show that the other device’s contraindication was reasonable or why. And he did not show that the risk of fracture in the Zimmer device with patients at such a weight or BMI was high enough to warrant a contraindication. It seems that plaintiff thought that, like pointing to another patient who experienced a failure of a different device, pointing to a contraindication in a different device’s label would get him to trial. It did not. The Third Circuit upheld summary judgment against plaintiff on his failure to warn claim.

Not surprisingly, pointing to the mere existence of other products’ failures or labeling isn’t nearly enough to prove a plaintiff’s claims. We all knew that. To the extent we had any doubts, the Third Circuit just dispelled them.

We’ve often thought that tort reform should be a major goal of those interested in preserving women’s reproductive choice. Every prescription medicine has risks, which is why the FDA requires a prescription in the first place, and prescription contraceptives are no exception. But ever since the very first birth control pills, back in the 1960s, the other side of the “v.” has consistently attacked every innovation in contraceptive technology and attempted to drive it off the market. It’s happened over and over again – with IUDs, Norplant, OrthoEvra, Yasmin, NuvaRing, Mirena, Essure. Except for the Dalkon Shield IUD forty years ago (and occasional idiosyncratic manufacturing errors), all these products were (or are being) ultimately vindicated, and the FDA continues to consider their designs to be both safe and effective. Unfortunately their users have had to pay a significant tort tax in order to continue exercising their personal choice of contraceptive method.

Niedner v. Ortho-McNeil Pharmaceutical, Inc., ___ N.E.3d ___, 2016 WL 5106479 (Mass. App. Sept. 21, 2016), is both an example of the plaintiff’s bar’s ongoing attempt to deprive women of reproductive choice and an exemplar of how to beat such efforts. Niedner involved a time-release contraceptive patch:

The patch prevents pregnancy by transferring synthetic forms of the hormones estrogen and progestin through the skin. Unlike oral birth control pills, which must be taken at the same time each day, the patch is applied to the skin once per week for three weeks, followed by a fourth patch-free week.

Id. at *1. The decedent decided to use this product in preference to both condoms and daily birth control pills.  Id.

Risks.

It is a well-known scientific fact that any hormonal contraceptive places its user at an increased risk of stroke, myocardial infarction, and blood clots generally. This product was no exception:

[The prescribing physician] informed [the decedent minor and her mother] of the risks associated with using the patch, including that all hormonal contraceptives come with a risk of suffering blood clots. When the prescription was filled by [the] pharmacy, the package included an insert prepared by . . . the manufacturer[], as well as a leaflet from the pharmacy, both of which set forth the risks associated with use of the patch, including the risks of stroke, heart attack, and blood clots.

Id. Unfortunately, after three months use the decedent suffered a fatal “massive bilateral pulmonary embolus.”  Id.

Continue Reading Massachusetts Rebuffs Latest Plaintiff Attack on Reproductive Choice

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

If you’re even remotely interested in the topic of preemption in Pre-Market Approved (PMA) medical devices that were used in an off-label manner, simply search this blog for our Infuse cases. There are dozens and almost all are complete victories for the defense. What occasionally survives are fraud or misrepresentation claims, although they have a tough time meeting the heightened pleading standard of Rule 9(b), or failure to warn claims where a court recognizes failure to submit adverse events to the FDA as parallel to a state law duty to warn physicians. As you’ll easily see from our prior writings, we don’t understand that parallelism at all.

The most recent Infuse victory strikes a blow at each and every attempt by plaintiffs to circumvent, dodge, sidestep, and elude preemption and pleadings standards. And with each by-pass blocked, plaintiffs’ claims had nowhere to go.

As a quick refresher, Infuse is a medical device used to stimulate bone growth in spinal fusion surgeries. It is a multi-component device that received FDA PMA approval for use in single-level, anterior, lumbar surgeries. Aaron v. Medtronic, Inc., — F. Supp.3d –, 2016 WL 5242957, *1-2 (W.D. Ohio Sep. 22, 2016). Aaron is actually a consolidation of the claims of several hundred plaintiffs who alleged they were injured by their surgeon’s use of the Infuse device in an off-label manner. Specifically, they allege the device was either implanted without all of its component parts, implanted posteriorly, implanted at multiple levels, or implanted in their cervical or thoracic spines. Id. at *2. Plaintiffs’ causes of action are fraud/misrepresentation, strict liability failure to warn, strict liability design defect, negligence, and breach of express and implied warranties. Id. Defendants moved to dismiss all claims on several grounds, including most predominantly preemption.

Before getting to the substantive analysis, the court had to consider what pleadings standard to apply. Wait. Isn’t it TwIqbal? What’s the issue? The answer is the Seventh Circuit decision in Bausch v. Stryker. The Aaron plaintiffs alleged that they did not need to plead the specific federal law or regulations that defendant allegedly violated because medical device products liability cases should have a “more permissive” review standard. Id. at *3. Plaintiffs got that idea from Bausch which held that particularity in pleading the specific FDA regulations violated was not necessary due to much of the “critical information” being kept confidential. Id. at *3-4. Many courts disagree with Bausch, including the Sixth Circuit which held in a non-medical device case that a “natural imbalance of information” does not warrant lowering Rule 8’s pleading standards. Id. at *4. The discovery process cannot be used to find sufficient factual support for plaintiffs’ pleadings after the fact. So, Aaron applies TwIqbal, not some watered down version (although the court does state that some of plaintiffs’ claims might not have withstood application of that lesser standard).

Continue Reading Another Slam Dunk Infuse Win – Preemption and More

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

Choice of law doesn’t get too much attention here at the DDL blog. That is due in some part to the fact that there really isn’t a defense-oriented position to take on it. Which state’s law should apply is a very case-specific analysis and in any given case, you might come out differently. It really depends on which state’s law is more favorable to your legal arguments in a particular scenario. The second reason it probably doesn’t get much attention from us is that in most personal injury, products liability cases, plaintiff’s home state’s law governs – the law where the injury occurred.

But what about when a plaintiff lives in one state but seeks medical treatment in another. Not to be considered disparaging of the many excellent healthcare facilities in southern New Jersey (where this blogger resides), but when you live a stone’s throw from some of the leading specialists in the country who happen to be across the state line in Philadelphia, you take that ride across the Ben Franklin Bridge. That’s not an unusual situation, making the choice of law question of interest.

In Finnerty v. Howmedica Osteonics Corp., 2016 U.S. Dist. LEXIS 123071, *2 (D. Nev. Sep. 12, 2016), plaintiff, a resident of Nevada, sought medical treatment from an orthopedic oncologist located in California. Plaintiff had cancer in his left leg that required either amputation of the leg or a total knee replacement. Plaintiff opted for the replacement and defendant’s modular replacement device was implanted. Id. At the time of surgery, plaintiff was “clinically obese.” Id. The surgery took place in March 2005 and plaintiff had no complications until 2011 – over 6 years later. Id. at *2-3. In August 2011, plaintiff started working as a shuttle driver for a car rental company. The job required him to lift luggage, weighing up to 80 pounds, on a repetitive basis. Id. at *3. In December 2011, while lifting luggage, plaintiff heard a “pop” in his left knee. During revision surgery, it was discovered that the implanted device had fractured. Id. Plaintiff continued to suffer complications and eventually his left leg was amputated.

Plaintiff sued the device manufacturer alleging failure to warn, negligence, strict liability design defect, manufacturing defect, and breach of express and implied warranty. Id. Defendant moved for summary judgment on all counts.

Continue Reading An Interesting Choice of Law Question

As the calendar turns from August to September, it is time once again to concede the strength of the Southeastern Conference.  You probably think we are referring to college football or basketball, in which teams from Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Mississippi, Missouri, South Carolina, Tennessee, and Texas prevail with grinding monotony.  [We have a feeling that OJ’s old college squad, USC, will have an ugly time of it against Alabama in the ostensibly neutral site of Jerry World this weekend.]  But, no, we are talking about product liability law.  [For the moment, we are pretending that the Weeks innovator liability abomination in Alabama never happened.  Moreover, the Alabama legislature eventually cleaned up that mess.]  Today we are focusing on the safer alternative requirement in design defect cases.  It occurs to us that some very good cases on this issue come out of the SEC.  In the beginning of the year, we discussed a Mississippi case, Mealer v. 3M, where the court dismissed a case on the ground that an elastomeric respirator was not a safer alternative to a cheap paper respirator mask.  They were two entirely different products, fundamentally different in terms of operation, longevity, and expense.   Consumers might have all sorts of important reasons, aside from safety, to choose one over the other.

[Readers who are especially nerdy or possess especially good memories might point out that in July we bemoaned a Louisiana opinion permitting a plaintiff to suggest that other drugs could constitute a safer alternative to the drug at issue.  To our mind, different drugs, which consist of different molecules with entirely different risk-benefit profiles, are separate products and cannot be treated as a safer alternative that can shame other drugs out of existence.  Under the plaintiff’s (and, unfortunately, the Louisiana court’s) theory, jury verdicts might drive all drugs that treat, say, diabetes, out of the market except one.  And even that one would not be safe from attack.  Or, to veer away from drugs and devices, we might as well shut down Harley-Davidson, since motorcycles are less safe than other modes of motorized transportation.   Live to ride, ride to live?  Not anymore.  But don’t worry too much.  You can still sing “Born to be Wild” on your Hydra Glide.  The recent Louisiana error stands as an aberration.  As Bexis pointed out in a magnum opus blogpost that strolled down bone screw memory lane back in 2013, Louisiana has quite a lot of good safer alternative decisions.]

Today’s case, Hosford v. BRK Brands, Inc., 2016 Ala. LEXIS 91 (Ala. August 19, 2016), sees the Alabama Supreme Court apply an even stricter test in pouring out a plaintiffs’ case on the ground that the proposed safer alternative was a separate product altogether.  The facts of Hosford are grim.  A four-year-old girl died in a fire that destroyed her family’s mobile home in May 2011.  The fire began in a faulty electrical outlet in the girl’s bedroom.  Her family sued the manufacturer of the smoke alarms in their mobile home.  The theory was that the smoke alarms were defectively designed because they relied solely on ionization technology which, the plaintiffs alleged, failed to give adequate warning to allow an escape in the event of a slow smoldering fire.  There are dual sensor smoke alarms on the market that employ both ionization and photoelectric technology.  According to the plaintiffs, such alarms would have roused the family in time to save the little girl.  After the plaintiffs presented their case at trial, the defendant moved for judgment as a matter of law.  The trial court mostly granted that motion, and only one claim went to the jury.  The jury ultimately returned a verdict in favor of the defendant.

Continue Reading Alabama Supreme Court Imposes Tough Standard on Safer Alternative Design