Today’s case, Knudsen v. Ethicon, Inc., 2021 WL 390825 (M.D. Fla. 2021), involves product-liability claims against a surgical-mesh manufacturer. In a short decision, the court dismissed manufacturing-defect and implied-warranty claims as inadequately pleaded under Michigan law. Although not fully developed, the court’s reasons for dismissing the claims exhibit both insight into manufacturing-defect claims and
We’ll be hitting all the Presidents’ Day sales today, but something tells me we’ll be disappointed because we won’t be able to buy, beg, borrow, or steal a new one. So we keep trying.
With plaintiffs desperate to find some way to continue pursuing aggravated, aggregated product liability litigation in their favorite venues after Daimler …
Way back in 2007 we said this: “We really don’t see the purpose in a separate cause of action for breach of implied warranty in a case involving a prescription medical product. Warranty claims are for ham sandwiches and lawn chairs, where the term “merchantable” has some coherent meaning. . . . Except in unusual situations, where there’s physical contamination or a counterfeit product, an implied warranty of merchantability makes no sense and adds nothing except a different statute of limitations.” We still feel the same way. Fortunately, so do a lot of courts.
In some states breach of implied warranty claims have been merged with other warning-based theories of liability (like in New Jersey where all products claims other than breach of express warranty have been subsumed under the Products Liability Act). In states where a breach of implied warranty claim remains as an independent cause of action, some courts have ruled that such claims are not allowed in the context of prescription drugs and devices. The reasons vary but most often include application of the learned intermediary doctrine (see post here) or the unavoidably unsafe product doctrine.
And while at a quick glance, Alabama appears to be one of the states that generally doesn’t recognize a cause of action for breach of implied warranty of merchantability for inherently dangerous products – the law on the issue has become muddled over time. So, in Collins v. Novartis Pharma. Corp., slip op., No. 2:08-cv-438-MHT-PWG (M.D. Ala. Jan. 14, 2015), the court tried to sort it all out.
OK, we made that up. It is not true at all. A complete lie, much like “The Dallas Cowboys are America’s Team.” Or “Eating turkey makes you sleepy because of its high tryptophan content.” Or “The pilgrims left England because of their desire to wear stylish hats.” Or “Lawyer advertising for drug and device cases serves an important role in improving medical care.” If you did your duty as an American yesterday and gorged yourself on an assortment of turkey, stuffing, tubers, cranberry compotes, pie, and football, then you may be feeling somewhat bloated today. You have many options to address that feeling, including taking a walk outside before returning to leftovers and more football. Reading this post about a recent express preemption decision will not help with indigestion, but it should not hurt either.
The opinion in Hesik v. Boston Scientific Corp., No. 1:12-cv-00014-JMC, 2014 U.S. Dist. LEXIS 156563 (D.S.C. Nov. 4, 2014), carved up the product liability claims asserted in connection with a Class III device, specifically a cardiac defibrillator. As our readers know, the Medical Device Amendments of 1976 served up express preemption for Class III devices—basically, those approved though a Pre-Market Application—as to state law requirements that are “different from, or in addition to” the FDA requirements. 21 U.S.C. §360k(a). This has been interpreted by the Supreme Court to bar product liability actions premised on claims that do not impose “parallel” duties on manufacturers. Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); our numerous posts on the subject. A parallel claim is a “narrow exception to the rule of preemption” into which some courts strain to stuff plaintiff’s claims. We sometime post on how it grinds us that courts, particularly federal courts sitting in diversity, extend existing state law to allow a claim that would be predicted on non-compliance with an FDA requirement such that imposing liability would not add to the federal requirements on the manufacturer. Like here.
We do not have that situation in Hesik, which (drum)sticks with South Carolina law as is. We do have a few twists on the typical arguments we see in cases like this, including that plaintiff had the giblets to move for summary judgment himself.
We were surprised by the article in the New York Times this weekend about how the Supreme Court revises some of its opinions years later. Those changes are picked up in some reporters, but not others. Some of those changes are relatively minor (e.g., Justice Scalia correcting his statement of what the EPA’s position was on a particular issue) but others are not. The article sent us into a reverie of wishful thinking about ‘correcting’ the Wyeth v. Levine opinion to take into account the non-automatic nature of Changes Being Effected, or to excise Riegel’s frolic and detour on parallel claim exceptions, or to foreclose the Solicitor General’s new, crabbed interpretation of FDA preemption applying only to device-specific actions. But why stop at Supreme Court opinions? Looking back over the years, we can think of many things we said and wrote that we’d now like to edit. That wedding toast where the ex-girlfriend, rather than the bride, was saluted would be fixed. And now in our dotage we finally realized the correct answer to the question of whether “this makes me look fat.” It reminds us of the classic definition of a gaffe: telling the truth at the wrong place and time.
Many of the cases we post about here could use a bit of editing. When the blogging team goes over the cases on offer for any given week, the phrase “mixed bag” comes up more often than any other. That shouldn’t be surprising. For every wonderful one-two punch Mensing/anti-Conte case, or every Bausch/Perez train wreck, we get ten cases that are more like what we see regularly in real-life – cases that have a little good and a little bad. We cannot exactly edit those cases, but we can accentuate the positive in our humble reviews. That’s what we will do with Kruszka v. Novartis Pharms. Corp., 2014 U.S. Dist. LEXIS 68439 (D. Minn. May 19, 2014). Kruszka is yet another Aredia-Zometa case where a cancer survivor alleges that the drugs that helped her survive cancer caused osteonecrosis of the jaw (ONJ). Some of the rulings we like better than others. While we cannot edit the opinion, we can certainly highlight the good stuff while mumbling sotto voce about the bad. With the glow of the long holiday weekend not yet worn off, we are reluctant to be the deliverer of evil.
The plaintiff in Kruszka was diagnosed with blood cancer in the form of multiple myeloma in 2000. That cancer resulted in hypercalcemia, a compression fracture in her spine, and lytic lesions in her skull, spine, and bones. Multiple myeloma patients’ survival rate is approximately six months where no treatment is received. Doctors told the plaintiff she could expect to live six weeks without treatment. But she did receive treatment. Her doctor prescribed Aredia to protect against bone damage and treated the plaintiff with chemotherapy. She received both branded and generic bisphosphonates. The good news is that she lived. The bad news is that a couple of years later she was diagnosed with chronic osteomyelitis (infection in the bone). The plaintiff was prescribed a prolonged course of four different antibiotics after her prior treatments were determined to be ”suboptimal.” Dead bone was removed from the jaw area in 2003. A year later, the plaintiff complained of numbness in her jaw, chin, and lip resulting in difficulty swallowing and chewing, a “deformed face” and other issues. The plaintiff alleged that the damage to her face and jaw changed her life dramatically, including her speech, eating, social interactions. She had to give up her church choir. There is no doubt that the plaintiff earned sympathy. She was also, as of November 2013, still alive.
Do you remember way back yesterday when we posted on Daubert rulings from an OTC pediatric ibuprofen SJS case? The rulings were in March but just popped up on Lexis last week. We led in with a discussion of video games as a clever segue to the games some experts play. Really, no glimmer of recognition? Well, the same case had summary judgment rulings that have now been “published,” so we are giving you a double dose. See Newman v. McNeil Consumer Healthcare, No. 10 C 1541, 2013 U.S. Dist. LEXIS 113440 (N.D. Ill. Mar. 29, 2013). As with the expert rulings, there is a mix of good and bad, but the bad gets stuck in our throat. Dispensing with the lame medication jokes, on to the rulings, the good ones first.
Plaintiffs asserted a claim under the Illinois Consumer Fraud Act premised on “standby statements” from 2003 and 2005 concerning separate reports of SJS/TEN in children using defendants’ ibuprofen products. This claim failed both because the statements were not deceptive—an obvious element of the claim—and because the defendants established the applicability of the Act’s regulatory compliance defense. (The Act did not require that the plaintiff rely on the deceptive statement, only that the defendants intended that there be reliance, or there would have been another obvious basis where plaintiffs and their parents surely never saw the statements before using the product.) As anyone who has ever participated in drafting any statements on adverse events knows, the line between saying something that will later be called an admission of causation and saying something that will later be called minimizing is a fine one. The statements at issue described the particular cases as “allegedly associated” with the defendants’ product and noted that SJS and/or TEN, in general, “are associated” or “reported to be associated” with ibuprofen and other medications. The FDA-approved label from 2009, when the plaintiffs used the product, included the warning that “[i]buprofen may cause a severe allergic reaction . . . .” Under these circumstances, the statements were held consistent with the label and not “so misleading or deceptive in the context that federal law itself might not regard [it] as adequate.” Id. at *19 (quoting Bober v. Glaxo Wellcome PLC, 246 F.ed 934, 941 (7th Cir. 2001)). It was very sensible to not read “associated with” as deceptive simply because the label later said “may cause.”
The sensible approach continued in the evaluation of the evidence offered on the regulatory compliance defense—an unnecessary analysis given the lack of an otherwise actionable deceptive statement. Without rehashing the discussion, which overlaps with the Daubert analysis at issue in yesterday’s post, the part that interested us was the use of statements from FDA in light of the inevitable allegations that defendants had underreported adverse events and generally kept FDA in the dark about the SJS risk of ibuprofen. Defendants here were able to rely both on a 2006 denial of a citizen’s petition call for withdrawal of all OTC ibuprofen products—for once, not made by Public Citizen, at least openly—and deposition testimony of an FDA official. The denial included the statement that “we have no evidence that there is additional undisclosed safety information that was withheld by ibuprofen manufacturers” and the FDA official did not suggest that defendants failed to perform any required analysis of adverse events. Id. at **23-26. With this back drop, the plaintiffs’ “slight, at best,” evidence of noncompliance could not be assumed to have “affected . . . FDA’s decision making.” Id. at **26-27. Placing the burden on plaintiffs to come forward with evidence that alleged noncompliance with regulatory requirements somehow invalidated FDA’s authorization of defendants’ statements was predictably fatal to plaintiff’s claim.
We have all heard that bad facts make bad law. We have also heard that discretion is the better part of valor. Sometimes, faced with bad alleged facts, a bad decision may be the predictable result of a motion to dismiss. We are all for knocking out non-existent claims and making plaintiffs plead properly, but it is important when deciding to file 12(b)(6) to keep an eye on the relief being sought and how that relief would affect the case. Although we do not have any knowledge of the considerations that went into the filing of this motion to dismiss, sitting here with our retrospectoscope, we see Williamson v. Stryker Corp., No. 12 Civ. 7083 (CM), 2013 U.S. Dist. LEXIS 104445 (S.D.N.Y. July 23, 2013), as a predictably bad decision. We also feel a little like the venerable plaintiffs’ expert from whom we first heard the term “retrospectoscope,” smug, in our office, blathering on about something with which we were not involved. Unlike him, however, we will resist the temptation to ascribe motive to why the court ruled as it did, as we believe motive is a subject for juries/readers to decide not for experts/blawgers to opine.
When testing the adequacy of a complaint, the “facts” at issue are those plaintiff chooses to include in the complaint, how she chooses to include them. As such, it is not surprising that the facts analyzed in Williamson seem incomplete to anyone who knows medical device product liability cases. It seems likely that a knee replacement plaintiff with at least four prior failed replacement surgeries, who was told her only treatment options were amputation or surgery with defendants’ product, had something else going on besides her basic allegation that: 1) the product broke not long after an uneventful implant, 2) then she was assured by defendants’ representative that there had been no prior reports of such breaks, 3) then she proceeded to have the broken product explanted and replaced with another of the same product, and 4) then the second implant also broke. The court cannot assume additional facts to help direct its analysis to a different result, though. (Hint, hint.) So, the court analyzed a motion to dismiss every count other than failure to warn and loss of consortium. The central allegations were of “manufacturing defect and/or design defect”:
(1) it relies exclusively on “the fixation in place of the femur and tibia bones”; (2) the knee revision system “is not properly designed or constructed to constrain motion between the femur and tibia bones so as to promote fusion by compression of the bones”; and (3) motion by the bones causes excess force on the device, leading to breakage and injury.
Id. at **6-7. Plus, plaintiff’s review of defendants’ website before the first surgery and discussions with their representatives before the second allegedly created liability under theories of fraud, warranty, negligent misrepresentation, and deceptive business practice. As you might expect from this lead in, defendants’ motion was denied across the board, although the court directed plaintiff to flesh out her fraud and negligent misrepresentation counts.
We saw the news yesterday about DePuy discontinuing two of their lines of hip implants, which have been involved in some litigation. While we are not ignorant of the impact of litigation on business or the impact of discontinuation/withdrawal/recall on litigation, we do hate to see situations where the availability of useful medical products can…
Normally we embrace cases that find that plaintiff has failed to meet the pleading requirements of Twombly and Iqbal. We like when courts ferret out the claims that can’t even get out of the starting gate. And while there is a little bit of that to celebrate in Bergstresser v. Bristol-Myers Squibb Company,…
In a relatively recent case, Currier v. Stryker Corp., 2011 WL 4898501 (E.D. Cal. Oct. 13, 2011), the court stated, with respect to a claim for implied warranty:
Because this is a medical implant case, and the [complaint] alleges that the product was surgically inserted in a hospital, the Court cannot plausibly infer from the [complaint] that Plaintiff relied on anything other than his physician’s skill and judgment in selecting the . . . product, nor that any purchase of the product was based on a warranty from the manufacturer to Plaintiff. The Court cannot plausibly infer that there is a relationship between the Defendants and Plaintiff that would allow Plaintiff to state a breach of warranty claim.
Id. at *4. The court seems to be saying that, in a prescription medical product liability case, there can’t be an implied warranty claim unless the plaintiff, as opposed to the prescribing physician, relied on the alleged warranty. That’s useful. We’re sure that this is to some extent grounded in the general California rule requiring privity in express warranty cases, but we thought we’d take a look and see what else may be out there.
The first place we checked, obviously, is the case that the court cites for the proposition, Adams v. I-Flow Corp., 2010 WL 13399488 (C.D. Cal. March 30, 2010), and sure enough, we find pretty much the same thing. “In the context of prescription medical devices and pharmaceuticals, the transaction is between the manufacturer and the physician, not the patient.” Id. at *4. The complaint was simply “devoid of any facts suggesting that plaintiffs relied upon anything other than their physicians’ skill and judgment in selecting and prescribing the [drugs and devices].” Id.