News

Minnesota Star-Tribune Reports on CCL Victory in Jones v. Medtronic

March 29th, 2018

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

CCL Wins Medical Device Preemption Appeal

March 26th, 2018

     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.

CCL Files Supplemental Authority in Medical Device Preemption Case

March 12th, 2018

     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.

Ending Johnson & Johnson’s Bid to Avoid Liability, U.S. Supreme Court Denies Certiorari in Children’s Motrin Case

January 19th, 2016

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.

CCL Attorney Defends Interests of More than 1,000 Plaintiffs Against Attorneys for 4 Major Drug Companies Before 2 Judges

September 11th, 2015

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 Attorney Discusses Favorable Preemption Implications of Pro-Pharma First Amendment Ruling

August 12th, 2015

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 Petitions Minnesota Supreme Court to Review Medtronic Infuse Suits

May 20th, 2015

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.

CCL Distinguishes “Handmade” Claims Involving Tito’s Vodka from those Made by Maker’s Mark Bourbon

May 20th, 2015

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.

Supreme Court Denies Review of Petitions for Certiorari Opposed by CCL

May 18th, 2015

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.

CCL’s Andre M. Mura Successfully Opposes Wal-Mart’s Motion to Dismiss In Deceptive Food Labeling Suit

April 24th, 2015

 

In a case argued by CCL’s Andre M. Mura, a federal district court in Florida refused to dismiss a class action complaint seeking damages for deceptive food labeling. The case concerns Wal-Mart’s Great Value “100% Cranberry Pomegranate” juice blend, which contains far less cranberry or pomegranate juice than labeling suggests. Wal-Mart argued that the suit was preempted because its labeling complied with federal law, and it sought dismissal because, it said, plaintiffs lacked standing. The district court here agreed with plaintiffs that their suit is not preempted and that they have standing to sue. The 37-page ruling, issued on April 23, is highly detailed in its analysis of preemption in this context, and is a great precedent for plaintiffs.

Plaintiffs are also represented by Tim Howard of Howard & Associates, PA of Tallahassee, Florida.