Source: http://www.cclfirm.com/blog/category/598/
Timestamp: 2019-04-21 13:13:13+00:00

Document:
Today, CCL filed a brief on behalf of Juanita Nye, opposing the petition for certiorari filed by BNSF Railway Co., which seeks to avoid its liability in the death of Ms. Nye's husband at a railway crossing in Oklahoma.
Jeffrey Nye, a 51-year-old eighth-grade science teacher and sports coach, was killed when a BNSF train hit his car. Vegetation overgrowth hid the approaching train, which also failed to sound its horn to warn motorists at the crossing. The vegetation also obscured the railroad crossing sign. A passenger in the vehicle who was injured but survived reported that Mr. Nye yelled "train" just as his car began to cross the tracks and the train first became visible.
BNSF asserted that it cannot be sued for inadequate signage, known as crossbucks, because the signs were funded as part of a federal program that preempts state causes of action on those grounds. However, it failed to produce evidence that the particular crossbucks at issue were part of the federal funding project. Instead, evidence established that, at the time the federal project was completed, only one crossbuck had been erected and that the current crossbucks were different on each side of the track, both facts are inconsistent with any claim of federal funding and compliance with the specifications of the program, which require two crossbucks that would be identical. The trial court found the evidence sufficiently in dispute that it denied BNSF summary judgment and held that the issue was ripe for the jury's decision.
The jury found liability and implicitly decided the factual issue of funding against BNSF. It appealed to the Oklahoma Supreme Court, which upheld the verdict. That court determined that BNSF's appeal was little more than an attempt to re-try the case in the supreme court by arguing all facts were matters of law for the court's, rather than the jury's determination.
Before the U.S. Supreme Court, BNSF argues that Oklahoma imposed a more stringent standard of proof to support preemption than federal courts do and that intervention is necessary to permit railroads to claim preemption on the basis of unrebutted circumstantial evidence because records from 30 years ago are too scattered and fragmented. CCL's brief demonstrates that the Oklahoma Supreme Court's decision is consistent with both prior U.S. Supreme Court decisions and with other federal courts. BNSF's claimed circuit split simply does not exist. Moreover, the facts overwhelmingly support Ms. Nye's claim that federal funding was not involved with these particular crossbucks and that liability exists even without the sign issue because of the overgrown vegetation and the failure of the train to sound its horn.
BNSF will have an opportunity to write a reply brief, and the Supreme Court is likely to take the matter up at its April 5 conference.
The Minnesota Court of Appeals today held that claims on behalf of a 17-year-old girl who died when her medical implant failed were not preempted by the federal 1976 Medical Device Amendments.
In Jones v. Medtronic, Inc., the court ruled that the trial court had mistakenly dismissed claims for manufacturing defects, failure to warn, and breach of express and implied warranty as preempted. Instead, the court held that the liability action paralleled federal requirements and therefore could proceed.
Kaitlyn Jones suffered from congenital severe cerebral palsy with spastic quadriplegia. She was implanted with a Medtronic SynchroMed(R) II device to deliver periodic, controlled doses of medication to control her muscle spasticity. Due to undisclosed cycles of overinfusion and underinfusion caused by malfunctions, the medication was not delivered, resulting in Kaitlyn's death.
Accepting Medtronic's argument that the complaint filed on her behalf lacked sufficient specificity to constitute a parallel claim, the trial court dismissed the case. CCL President Robert S. Peck represented the plaintiffs on appeal, arguing that violations of federal regulations identified by the Food & Drug Administration in warning letters, recalls of the device, and a lawsuit seeking to enjoin its further use replicated product liability actions under Minnesota law. Citation of these federal violations in the complaint with the parallel elements of Minnesota law provided fair notice of the basis of Medtronic's liability, he said in briefs and the February 1 oral argument before the court. The Court of Appeals unanimously agreed.
On March 12, 2018, CCL filed a letter with supplemental authority in the Minnesota Court of Appeals in Jones v. Medtronic, Inc., No. A17-1124. The case, which CCL President Robert S. Peck argued on February 1, involves a Medtronic implanted medical device that failed, killing the 17-year-old young woman whose life literally depended on it. The trial court had found the plaintiff's cause of action expressly and impliedly preempted because the allegations of manufacturing defects and other problems with the device did not point to specific violations of the application for approval submitted to the Food and Drug Administration, as well as because the claims of federal violations were supposedly attempts to enforce FDA requirements, an authority that the FDA holds exclusively. Peck, however, argued that the FDA's citation of Medtronic for numerous violations of federal regulations that were tied to the precise failures that Kaitlyn Jones experienced were sufficient to plead a parallel claim, particularly when Medtronic's application was not available to anyone but the FDA and Medtronic until a court ordered it produced in discovery.
The March 12 letter advised the Court of a decision of the U.S. Court of Appeals for the Eleventh Circuit, Godelia v. Doe I, 881 F.3d 1309 (11th Cir. 2018), which was rendered after oral argument. In Godelia, the Eleventh Circuit explained a previous decision it had rendered, which the Jones trial court had relied upon to require greater specificity in the complaint. Godelia made clear that, in a case very similar to the Jones case, that specificity is not required. Instead, it issued a decision that tracked the argument Peck made in the Minnesota Court of Appeals.
The Minnesota Court of Appeals has Jones under advisement.
On Friday, September 11, CCL Chief Litigation Counsel Louis M. Bograd argued in the US District Court for the Southern District of California that no federal preemption defense warrants summary judgment against more than 1,000 plaintiffs who have developed pancreatic cancer as a result of their use of incretin mimetic drugs manufactured or distributed by defendants Merck, Eli Lilly, Amylin, and Novo Nordisk as treatment for Type 2 diabetes. The motions were heard in connection with the ongoing MDL proceeding before Judge Battaglia in the District Court and the ongoing JCCP proceeding before Judge Highberger in California state court. Both judges presided over the four-hour hearing, which involved three separate summary judgment motions relating to the affirmative defense of federal preemption. Bograd argued that there was no “clear evidence” that the FDA would have rejected a properly supported Changes Being Effected Supplement to add the risk of pancreatic cancer to the approved labeling for the defendants’ incretin mimetic drugs. Both courts took the motions under advisement and are expected to rule in the coming months.
CCL today asked the Minnesota Supreme Court to review the decision of the Minnesota Court of Appeals in Angeles, et al. v. Medtronic, Inc., a group of six consolidated appeals of suits brought by persons injured as a result of their surgeon’s use of Infuse Bone Graft, a recombinant DNA protein, in their spinal surgeries. The FDA never approved Infuse for use in spinal surgery, except in a limited number of anterior procedures when used in conjunction with the LT-CAGE, a capped device designed to keep the Infuse protein from leaking into the spinal cavity and causing catastrophic bony overgrowth. Medtronic nevertheless aggressively promoted the use of Infuse in other spinal surgeries, without the LT-CAGE leading directly to plaintiffs’ injuries. The Minnesota Court of Appeals dismissed most of plaintiffs’ products liability claims against Medtronic on grounds of preemption and also dismissed plaintiffs’ fraud claims as inadequately pled, because plaintiffs could not identify the precise Medtronic misrepresentations that induced their surgeons to use Infuse in their surgeries.
CCL has now asked the Minnesota Supreme Court to review both of those rulings. CCL argues that plaintiffs’ products liability claims are not preempted both because there are no federal requirements applicable to Infuse when used in spinal surgery without the LT-CAGE, and also because plaintiffs’ state-law claims parallel federal requirements prohibiting the promotion and sale of misbranded and adulterated products. As for plaintiffs’ fraud claims, CCL argues that the Court of Appeals applied a stricter pleading standard than the one that the Minnesota Supreme Court itself adopted in Hardin County Savings Bank v. Housing & Redevelopment Authority of Brainerd, where the Court held that plaintiffs pleading fraud need only “plead facts underlying each element” of their fraud claims. CCL Chief Litigation Counsel Louis Bograd represents plaintiffs, along with GoldenbergLaw PLLC and the Fluegel Law Office, both of Minneapolis, and the Branch Law Firm in Albuquerque, New Mexico.
In response to a request from the U.S. District Court for the Northern District of Florida, CCL today submitted a legal memorandum in Pye v. Fifth Generation, Inc. distinguishing misrepresentation claims brought against the manufacturers of Tito’s Handmade Vodka, based on the product’s claim to be “Handmade,” from similar claims against the makers of Maker’s Mark Bourbon. District Court Judge Robert Hinkle had recently dismissed such claims against Maker’s Mark and asked plaintiffs to explain why the same reasoning shouldn’t lead to dismissal of their claims. In its memorandum, CCL Chief Litigation Counsel Louis Bograd explained that there were important factual distinctions between the two cases, which have already led at least one other court to uphold misrepresentation claims against Tito’s Vodka. In particular, the Maker’s Mark bottle gives content to its claim to be “Handmade” by explaining that it was distilled in small batches under close supervision, assertions that plaintiffs in the Maker’s Mark case had not disputed. By contrast, the Tito’s Vodka label claims suggests that it is “Handmade” because it is “Crafted in an Old Fashioned Pot Still,” but plaintiffs allege that that representation is also false and misleading. Thus, a reasonable consumer may be misled by the claim on Tito’s label to be handmade, even if a consumer of Maker’s Mark cannot be.
This week, the Supreme Court denied a petition for writ of certiorari in Teva Pharmaceuticals, USA v. Hassett, the last in a series of petitions by generic drug companies seeking Supreme Court review of lower court decisions permitting plaintiffs to pursue products liability claims against manufacturers of generic metoclopramide, on the grounds that such claims were preempted under Pliva, Inc. v. Mensing. CCL Chief Litigation Counsel Louis Bograd opposed each of these petitions, asserting that the lower courts properly held that plaintiffs’ claims fell into exceptions from Mensing preemption because, under the facts in each case, it would not have been impossible for the generic manufacturer to have provided stronger warnings about the risks of long-term use of metoclopramide to plaintiffs and their prescribing physicians at the time metoclopramide was prescribed to the plaintiffs. Hassett is the fourth and final pending petition for certiorari in such circumstances that the Supreme Court has declined to hear. In each of these cases, plaintiffs may now proceed with their claims before state courts.

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