News

     Agreeing with an amicus curiae brief filed by CCL on behalf of the American Association for Justice, the Ninth Circuit held that the Supreme Court cases of Medtronic v. Lohr (1996) and Reigel v. Medtronic (2008) controlled the decision on preemption in this medical device case. 

      The case concerned defective Bard IVC Filters, which are transplanted into a person's body. Bard argued that the two precedents had been impaired and that a subsequent congressional enactment meant that states could not impose liability for failure to warn of known defects. CCL's brief refuted those contentions, and the Ninth Circuit agreed that they had no merit. 

      The case was In re Bard IV Filters Prods. Liab. Litig., No. 18-16349.

     The U.S. Supreme Court denied the railroad's petition for certiorari in BNSF Railroad Co. v. Nye today, marking the end of the case in which CCL served as Supreme Court counsel. 

      The case involved the death of an eighth-grade science teacher after his car was struck by a BNSF train. His widow asserted that the train was negligent because of the railroad's failure to post adequate warning signs of the crossing, its failure to trim vegetation that obscured the line of sight so a driver could see the approaching train, and the train's failure to sound its horn as it approached the crossing, as required by law. An Oklahoma jury found the railroad liable, and that determination was affirmed by the Oklahoma Supreme Court.

      The railroad argued that it could not be held liable for its failure to post adequate warning signs because the signs at the crossing was part of a federally funded program in the 1970s. If that were true, participation in the program preempts claims for inadequate warnings. However, the railroad's evidence of federal funding was weak and rebutted by strong evidence that federal funds were not used at the crossing. The trial court submitted the question on the competing evidence to a jury. The Oklahoma Supreme Court upheld the jury's determination.

     The railroad asked the Supreme Court to revisit the question and lessen the burden of proof that the railroad needed to qualify for preemption, particularly in light of how long ago the railroad crossing sign was said to have been posted. It further asked that the Court hold that the factual determination of federal funding be treated as a legal, rather than jury, question. Alternatively, the railroad asked the Court to seek the opinion of the Solicitor General of the United States on whether the case should be taken, or to hold the case while the Court decided a drug-preemption case that also involved a jury's determination of facts.

     The denial of certiorari today means that the Court did not take up any of the railroad's entreaties, and the case is over. CCL President Robert S. Peck served as counsel of record in writing the brief in opposition to certiorari.

     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.

Appeals court panel revives suit faulting Medtronic drug pump in patient death

     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.

The U.S. Supreme Court today ended pharmaceutical manufacturer Johnson & Johnson’s bid to avoid liability for failing to warn doctors and parents that the appearance of redness, rashes or blisters after taking Children’s Motrin can lead to serious consequences. In 2003, a feverish seven-year-old Sammie Reckis was administered Children’s Mortin by her father. When she received no relief, her pediatrician administered another dose. Sammie was taken to the hospital after blisters began to appear, where yet another dose was given. Blisters soon appeared all over her body, and she was diagnosed with Toxic Epidermal Necrolysis (TEN), a life-threatening skin disorder that is usually fatal. The top layer of her skin began drying and sloughing off in sheets and, to ease her pain, Sammie was placed into a medically induced coma. She suffered heart and liver failure, a stroke, an aneurysm, and a cranial hemorrhage. She is now a tremendously underweight, blind adult. A jury found Johnson & Johnson liable and set compensation for Sammie and her family at $63 million.

Johnson & Johnson, after losing in the Massachusetts Supreme Judicial Court, asked the U.S. Supreme Court to take the case, claiming that the state courts ignored clear evidence that the Food & Drug Administration would have forbidden it from placing a warning about redness, rash and blisters on their label and arguing that the Massachusetts decision conflicted with one from the Chicago-based U.S. Court of Appeals for the Seventh Circuit. In opposition on behalf of the plaintiffs, CCL argued that not only did not clear evidence exist that the FDA would prosecute Johnson & Johnson for providing a warning that would have spared Sammie her nightmare, but that subsequent FDA actions requiring warnings about redness, rashes and blisters on the label supported the plaintiffs. Moreover, the claimed conflict between appellate courts was an imagined one, given that the essential holdings of the two courts were the same.

CCL’s Robert S. Peck served as counsel of record on the Supreme Court brief, where he worked with Michael Bogdanow, Leo Boyle, Brad Henry, and Victoria Santoro of Boston’s Meehan, Boyle, Black & Bogdanow, P.C.

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.

In a very significant ruling regarding the First Amendment rights of pharmaceutical companies, Judge Paul Engelmayer of the Southern District of New York ruled that the FDA may not pursue misbranding charges against a drug company for communicating truthful, nonmisleading information about unapproved “off-label” uses of its products. Amarin Pharma Inc. v. FDA (Aug. 7, 2015). While the pharmaceutical industry was busy celebrating its newfound ability to engage in off-label promotion, CCL Chief Litigation Counsel Lou Bograd commented that they should be careful what they wish for: “The First Amendment Ruling in the Amarin Pharma case is a double-edged sword, with huge implications for preemption doctrine, especially for the impossibility preemption defense to generic drug failure-to-warn claims.” As Bograd told Law360 in its article, “Amarin’s Off-Label Victory Opens Door to More Injury Claims,” “If it’s the case that drug companies have the First Amendment right to make truthful statements about off-label uses, and the FDA cannot prohibit them, then it follows that they would have the First Amendment right to truthfully communicate the risks of their products even if that information isn’t on the label of the brand-name products.”

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.