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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 hospital? What is it? It’s a big building with patients, but that’s not important right now. Airplane, 1980. It’s also a big building filled with doctors and that is important right now. Those doctors are learned intermediaries between prescription drug and device manufacturers and the patients. A manufacturer’s duty to warn runs to the doctor and it then becomes the doctor’s responsibility to use his/her medical expertise to counsel his/her patient and advise the patient of the risks of the recommended treatment, therapy, drug, device, etc. This is drug and device products liability law 101.

Well, now in Washington, device manufacturers (not sure how this will impact prescription drugs) have another duty to warn – the duty to warn the hospital that purchased the device. See Taylor v. Intuitive Surgical, Inc., 2017 Wash. LEXIS 200 (Wash. S.Ct. Feb. 9, 2017). In a bizarre decision, the Washington Supreme Court creates what we believe is a unique, separate duty by device manufacturers to provide warnings to a hospital. Nowhere in the opinion does the court cite any precedent for this alternative warning claim, because there isn’t any. They also hold that the learned intermediary doctrine does not apply to this unprecedented duty. And then the court also refused to apply a negligence standard to plaintiff’s traditional failure to warn claim under comment k. Surely you can’t be serious. I am serious . . . and don’t call me Shirley.

The device at issue in Taylor was a robotic surgical device used for laparoscopic surgeries, including prostatectomies such as the one performed on plaintiff. Id. at *3. It is a complex medical device for which the manufacturer requires surgeons undergo training, including performing at least two proctored surgeries before being credentialed to use the system and recommends surgeons choose “simple cases” for their initial unproctored procedures. Id. at *4-5. The manufacturer also specifically warned surgeons not to use the device for prostatectomies on obese patients or on patients who had undergone prior lower abdominal surgeries and advised that the patient should be in a steep head down position during the procedure. Plaintiff Taylor was the first unproctored procedure for his surgeon and his surgeon opted to use the device despite plaintiff being obese and having had prior abdominal surgery. The surgeon also did not place plaintiff in the downward position due to his weight. Id. at *5-6. Plaintiff’s surgeon conceded plaintiff was not an optimal candidate for using the device. Id. at *6.

Plaintiff brought suit against the surgeon, the hospital, and the manufacturer, then settled with the surgeon and hospital before trial. At trial against the manufacturer, the jury found the manufacturer was not negligent in providing warnings to the surgeon. Id. at *7-8. As noted above, the warnings seem detailed and clear. On appeal, plaintiff argued that the trial court erred in not instructing the jury that the manufacturer had a duty to warn the purchasing hospital and erred in applying a negligence standard to the failure to warn claim.

Continue Reading Washington State Creates Device Manufacturer Duty to Warn Hospitals

Today’s post is on a short decision from the Court of Appeals of Florida, but it is important. In drug and device litigation, defendants are almost always required to produce the adverse event reports related to the product at issue based on the argument that they go to notice. Beyond notice we take strong issue with their admissibility. Take a look at our AER cheat sheet.  And with so many courts excluding them from evidence, extensive discovery of adverse events is something defendants should push back on. As part of that push back, defendants should never overlook raising the burden of redacting from any adverse event report any information that identifies either the voluntary reporter (physicians, consumers) or the person who used the drug or device (if not one and the same). If you’ve made that argument, you may have had a court question whether redaction is really necessary. The answer is an unequivocal yes.

The FDA requires manufacturers to maintain the confidentiality of this information.

The names and any information that would identify the voluntary reporter or any other person associated with an adverse event involving a human drug, biologic, or medical device product shall not be disclosed by the Food and Drug Administration or by a manufacturer in possession of such reports in response to a request, demand, or order. Information that would identify the voluntary reporter or persons identified in the report includes, but is not limited to, the name, address, institution, or any other information that would lead to the identities of the reporter or persons identified in a report.

21 C.F.R. §20.63(f) (emphasis added). So, whether plaintiffs request them or the court orders their production, the manufacturer is obligated to redact adverse event reports before producing them. So, from a practical standpoint, time must be built into any schedule to allow for this redaction to take place. Further, if plaintiffs’ adverse event request is overly broad, you might have grounds to ask for cost-shifting or at least cost-sharing. May help to refocus plaintiffs on what they really want/need.

Continue Reading Protecting Foreign Adverse Events

Is the lesson learned by at least one plaintiff’s counsel in the In re Yasmin & Yaz Mktg. Sales Practices & Prod. Liab. Litig. We already know mass tort MDLs are a breeding ground for lax plaintiff-side representation. A handful of plaintiffs’ attorneys lead the charge, while the rest file their cases, and then lie in the weeds waiting for settlement. And in a system designed not to pay much attention to the individual cases, at least until the litigation is significantly advanced, missing due dates in an individual case also doesn’t garner much attention. That is until it does.

Today’s case isn’t about preemption, or expert opinions, or off-label use, or even about pleadings standards. What it is about is an individual plaintiff’s counsel being held accountable for not paying attention to MDL orders and for simply doing nothing. We’re just going to tell this one like it is, because we couldn’t even make up facts this absurd.

The individual case is Dzik v. Bayer Corp., 2017 U.S. App. LEXIS 684 (7th Cir. Jan. 13, 2017). Plaintiff filed her suit alleging that she suffered a blood clot from her use of Yasmin, a birth control pill. Id. at *2. Discovery, however, revealed that plaintiff had not filled a Yasmin prescription for 10 months before her alleged injury. Plaintiff’s counsel suggested that plaintiff had been given samples shortly before her injury. In May 2014, defense counsel requested plaintiff produced additional medical records or even an affidavit from the prescribing doctor to substantiate use at the time of injury. Id. That requested was ignored for 15 months.

During those many months, defendant began settling the pending cases. As for non-settling plaintiffs the court entered an order (sometime in the summer of 2015) splitting them into two groups – those likely to settle and those likely not to. Pursuant to the order, if a plaintiff thought her case was likely to settle with a little more negotiation, plaintiff should so notify defendant and if defendant agreed, the case was stayed for 60-90 days to facilitate settlement. Id. at *3. For all other cases, defendant had to notify plaintiff that her case was in the non-settling group and if plaintiff didn’t timely object to that classification, plaintiff had 120 days to serve a Plaintiff Fact Sheet and certain pharmacy and medical records, and a report from an expert on causation. Id. If a plaintiff failed to comply, defendant could move for dismissal and dismissal with prejudice was automatic for any plaintiff who did not respond to the motion to dismiss within 14 days.

Continue Reading You Can Hide But You Can’t Run

Some bloggers on this site have openly admitted to being swayed by the length of an opinion in choosing whether to blog about it. Shorter decision, shorter post. Less words, less work. In all honesty, a 56-page summary judgment opinion does tend to elicit a slight groan or at least an audible sigh. But sometimes, if you can manage to push through, you find that 16,000 words can be summed up very succinctly – preemption, preemption, preemption.

That’s not to say that the 15,999 other words in Babayev v. Medtronic, Inc., 2017 WL 90403 (E.D.N.Y. Jan. 5, 2017) are not important or interesting but there is a lot of case specific detail and a fairly lengthy recitation of preemption law, including the division among the circuits and within the Second Circuit as to the scope of implied preemption in the context of parallel violation claims. Id. at *14-20. We’ve covered this history in significant detail and anyone with even a passing familiarity with our blog knows well our feeling that the Eighth Circuit’s interpretation of the interplay between Riegel and Buckman gets it right – that there is only “a narrow gap through which a plaintiff’s state-law claim must fit if it is to escape express or implied preemption.” In re Medtronic, Inc., Sprint Fidelis Leads Products Liab. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010). Babayev goes on to lay out the split in the circuits on the issue of whether Current Good Manufacturing Practices (CGMPs) are specific FDA regulations on which a parallel violation claim can be based. Babayev, at *22-23. Again, we align with the Eighth Circuit’s conclusion that CGMPs, which apply to all devices, not just PMA-devices, are too general to give rise to a parallel violation claim. Rather, a parallel claim that survives preemption must be based on an alleged violation of a PMA, device-specific requirement. Id. at *22.   While Babayev doesn’t go quite as far as the Eighth Circuit, it went far enough to reach the right result here – the federal violations alleged by plaintiff aren’t specific enough to warrant surviving preemption.

Babayev involved an implanted neurostimulator. Following surgery, a technician employed by the manufacturer assisted in testing the device and making sure it was functioning. As plaintiff prepared to leave the hospital he connected the device as instructed and received a shock that caused him to spasm and jump. Plaintiff did not fall. Id. at *6. The device was disconnected and plaintiff was sent home. He returned to the hospital in pain and the leads were removed. Over one week later it was discovered that plaintiff had a fractured hip which he alleged he suffered during the shock incident. Id. at *6-7.

Continue Reading Lengthy Decision, Simple Conclusion – Preemption Win Across the Board

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

We use products with warranties every day. There are warranties on frying pans, on light bulbs, on computers. We once saw a warranty on a pair of nail clippers that cost $1.49 that allowed the owner to send them in for repair or replacement as long as you included $3.00 for return shipping. What a bustling warranty department that company must have had. Generally speaking, we don’t pay much attention to warranties unless they are on big ticket items. If something goes wrong with your car, you’re scrambling to see whether it’s covered by a warranty. If a light bulb that’s supposed to last five years burns out in three, you most likely just toss it out and screw in a new one. You probably forgot how long it’s been since you last changed it anyway (speaking for this blogger at least).

Medical devices such as implantable spinal neurostimulators (guess what today’s case is about) don’t come with warranties of the kind alluded to above. You’re not going to see a provision on the labeling that says should this device break or malfunction within 3 years of implant, just send it back for a new one. There are many reasons for this, the most obvious of which is the device is inside someone’s body. Returning the device it isn’t always an option, because revision surgeries aren’t always the best option. Moreover, most product warranties talk about normal wear and tear or under normal conditions. There is no such thing as “normal” or “typical” when you are talking about inside the human body. There are simply too many unknowns for medical device manufacturers to guarantee their products.

But that doesn’t stop plaintiffs from including express warranty claims in their complaints. Typically the allegations in express warranty claims in drug and device cases are general statements that the manufacturer’s labeling and advertising represented that the product would be safe, effective, fit, proper, etc. When pressed for the actual representations that constitute the express warranty or for proof of reliance on such statements – well, that’s when plaintiffs’ express warranty claims often fall away. That’s because they don’t exist. And, that’s usually the focus of our discussion on express warranty. Occasionally, however, plaintiffs come armed with a little more specificity.

Continue Reading Express Warranty Claim Preempted

One doesn’t see many new PMA preemption issues raised, but we found a case that does just that – Vincent v. Medtronic, Inc., 2016 WL 7374271 (N.D. Ill. Dec. 20, 2016). We are used to seeing plaintiffs try to use off-label use to circumvent PMA preemption. Just check out any of our Infuse posts to see how badly that has worked out for plaintiffs. They largely unsuccessfully have argued that if a product is used off-label, it is used for a purpose for which its PMA approval does not apply and therefore, the PMA requirements likewise don’t apply which plaintiffs contend means preemption should not apply. The courts have disagreed.

In Vincent, plaintiffs tried a similar end run around preemption. Plaintiff underwent surgical implantation of a pacemaker on February 12, 2004. The pacemaker lead used in the surgery was a Class III, PMA medical device. Shortly before plaintiff’s surgery, Medtronic had submitted the lead for supplemental pre-market approval. The approval was granted on March 10, 2004. Id. at *1. Ten years later, plaintiff had to undergo explant surgery due to a fractured lead and then filed a products liability suit. Id. at *2. In addition to standard claims based on failure to warn and design defect, plaintiff alleged that the lead had not received FDA approval at the time of the initial procedure, which was not disclosed to plaintiff or his surgeon. Id.

Continue Reading A Twist on PMA Preemption

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

People supplement a lot of things. You can supplement your diet with a multivitamin. You can supplement your income with a part-time side job. On the DDL Blog, we are always supplementing our scorecards and cheat sheets. Generally speaking, supplement is a pretty common word and has a fairly universally accepted definition. A supplement is an add-on. Something you do to make something more complete. Does the food you eat contain vitamins and minerals? Sure. But that multivitamin adds to it. It’s a boost.

In litigation too, we do a lot of supplementing. In fact, we are required to do so. Federal Rule 26(e) requires a party to supplement its discovery responses if it “learns that in some material respect the disclosure or response is incomplete or incorrect.” This duty to supplement extends to expert reports as well. Fed.R.Civ.P. 26(e)(2). But what does it mean to “supplement” an expert report? And when does supplementing to make a correction or completion go too far?

Plaintiffs got the answer to that question in U.S. ex. rel. Brown v. Celgene Corp., 2016 U.S. Dist. LEXIS 156826 (C.D. Cal. Aug. 23, 2016). Plaintiff-Relators brought a False Claims Act and Medicare Anti-Kickback Statute case against defendant alleging it illegally marketed Thalomid and Revlimid off-label and paid kick-backs to physicians for prescribing off-label. Id. at *6. The court set a deadline for the expert reports and relators timely served a report from their damages expert. Shortly thereafter, however, relators sought leave to supplement that expert report based on late produced Medicare data. Id. at *6-8. Relators wanted to time to analyze the data and supplement the report with that analysis. Relators also represented that while the supplement would be based on new data, the opinions were not expected to differ significantly. Id. at *8. The court granted the leave requested. Defendant was likewise given an opportunity to amend its expert reports in rebuttal and relators’ expert was deposed after his supplemental report was served. Id. at *11.

Continue Reading Plaintiffs Learn Supplementing Isn’t a Second Bite at the Apple

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

“He who knows others is wise; he who knows himself is enlightened.” — Lao Tzu

This may not be exactly what the court in Moore v. C.R. Bard, Inc., 2016 U.S. Dist. LEXIS 156923 (E.D. Tenn. Nov. 14, 2016) had in mind when it authored its recent opinion dismissing the complaint in this case, but the decision brought these ancient philosophical words to our mind. Of course, if we are talking about self-knowledge advice, we might be more partial to Ann Lander’s “Know yourself. Don’t accept your dog’s admiration as conclusive evidence that you are wonderful.” But, we trust you get the point. You better know yourself first before you start worrying about what you don’t know about others.

Plaintiffs tend to put the cart before the horse on this issue. When faced with a motion to dismiss for failure to state a claim, plaintiffs focus intently on what they claim they don’t know yet or can’t possibly know – but never seem interested in all of the things that they should know before filing a lawsuit. That’s a big part of where plaintiffs fell short in Moore.

During surgery to repair a hernia, two mesh products were implanted in plaintiff – one Bard product and one Ethicon product. Id. at *2-3. Plaintiff alleged that both products were made of polypropylene; that both defendants failed to adequately warn about the risks of their products; and that following surgery plaintiff’s condition worsened which he alleges is due to one or both of the mesh products. Id. at *3-4. And, that is all plaintiff alleged.

Continue Reading Excellent TwIqbal Decision — Plaintiffs Need to Look for Some Enlightenment