U.S. District Judge Robin Rosenberg, of the Southern District of Florida, issued an order on July 9, granting part permission to the plaintiffs in the Tasigna lawsuit to pursue claims against Novartis; however, he barred them from pursuing punitive damages in one claim.
The ruling allows product liability case filed by Dennis and Lori McWilliams to proceed, involving allegations that the Tasigna manufacturer failed to provide adequate warning about the drug’s side effects like constricting and hardening of arteries, which caused McWilliams to develop a stroke. Judge Rosenberg refused to dismiss the case based on preemption. To prove a preemption claim, the defendants are supposed to present that the state failure-to-warn laws conflict with the drug's federal approval. The Court ruling indicates that Novartis failed to prove that the FDA would have disapproved of a stronger label warning for Tasigna. However, the Court supports the defendant in denying punitive damages to the plaintiffs due to the New Jersey law which prohibits awarding punitive damages if the drug is approved by the FDA.
Plaintiffs filed a motion on July 13 to allow partial reconsideration of the summary judgment requesting to allow pursuing punitive damages. The motion stated, “Under New Jersey law, punitive damages are available ‘where the product manufacturer knowingly withheld or misrepresented [material and relevant] information required to be submitted under the agency’s regulation. Plaintiffs have shown that Novartis not only withheld from the FDA material information related to atherosclerosis-related conditions associated with Tasigna but that it knowingly made material misrepresentations to the FDA.”
A Court trial is scheduled for September 17, 2018, and a status conference for August 15, 2018. Growing number of Tasigna lawsuits claim it causes atherosclerosis (hardening of the arteries), which can develop a stroke, heart attack, or can even lead to death.
A lawsuit filed by Terrence Smith, in the New Jersey Supreme Court against Ethicon Prolene manufacturer Johnson & Johnson and its subsidiary Ethicon, alleges that the hernia patch led to a series of complications ever since it was implanted.
The complaint filed by Smith on July 5 indicates, he was implanted with a 4.5 cm by 10 cm patch of the Ethicon Prolene Hernia System February 2007, for correcting a right inguinal hernia. Surgeons discovered that the Prolene Hernia Mesh got attached to the inguinal canal floor and encircled his spermatic cord as well as iliac inguinal nerve. The condition worsened as he developed severe pain, inflammation, nausea, extreme weight loss, and the need for additional surgeries. Eventually, he underwent revision surgery to remove the hernia patch in December 2009. The lawsuit states Johnson & Johnson and Ethicon did not conduct proper clinical trials for their Ethicon multi-layered hernia mesh product line, which includes the Prolene Hernia System, as well as the recalled Physiomesh product.
Hernia Mesh Lawsuits were consolidated in June 2017 for pretrial proceedings in the Northern District of Georgia as a part of multidistrict litigation (MDL No. 2782; In Re: Ethicon Physiomesh Flexible composite Hernia Mesh Products Liability Litigation) presided over by Judge Richard Story.
Colgate-Palmolive recently announced to settle a lawsuit filed by a 67-year-old man, Paul Garcia, who claims asbestos in Colgate's talcum powder caused his mesothelioma. This confidential settlement saved the case from going to trial in California Superior Court in Los Angeles.
Late last year another lawsuit which was set for trial in New Jersey Superior Court was settled for an undisclosed amount and back in 2015, a plaintiff who developed mesothelioma due to Colgate's talc-based product was awarded $13 million as damages. However, Colgate-Palmolive continues to deny the presence of asbestos in their talcum products and has not yet admitted liability in any of the cases against them.
In a response filed on July 11, Zimmer Biomet expressed opposition to a motion filed by the plaintiffs to consolidate Zimmer hip lawsuits over the Versys, M/L Taper and M/L Taper with Kinectiv Technology stating creation of a formal MDL is unwarranted. The plaintiffs requested for Judge Donovan Frank to overlook the cases in Minnesota District Court.
The hip implant manufacturer stated in the response that, “Just 20 federal lawsuits properly within the scope of Plaintiffs’ proposed MDL have been identified for transfer and Plaintiffs provide no reason to suggest that the pace of filings will increase." Zimmer insists if the JPML does decide to consolidate the hip component lawsuits, it should be overlooked by Judge Sarah Evans Barker in the Southern District of Indiana.
Zimmer lawsuits filed across the nation claim that the Zimmer M/L Taper Hip Prosthesis and Zimmer VerSys Hip femoral head are defectively designed and unreasonably dangerous when paired together, with a tendency to corrode and leave metal pieces that perforate into the tissue and blood resulting in the implants failing and needing to be removed. Zimmer Durom Hip Cup lawsuits were centralized on June 9, 2010, in the U.S District of New Jersey before Judge Susan D. Wigenton as a multidistrict litigation, MDL No. 2158 (In Re: Zimmer Durom Hip Cup Products Liability Litigation).
Following numerous reports on the risk of hypoglycemic (low blood sugar) coma associated with the antibiotic class fluoroquinolones, the U.S. FDA announced the Fluoroquinolones makers must include a strong label warning to alert patients. About 13 patients succumbed to death due to hypoglycemia between October 1987 and April 2017 while under fluoroquinolone medication.
Some of the patients were treated for relatively uncomplicated infections or were under post-surgery treatment. Few others who took the drug became disabled. The FDA specified the blood glucose disturbances subsection of the product label must reflect hypoglycemia risk. The patients are required to inform doctors if they are already under a diabetes treatment since the fluoroquinolone related hypoglycemia is mostly seen in diabetic and older patients. In addition to hypoglycemia, the FDA also ordered that all drugs like levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox) belonging to the same class to have uniform label warnings about the mental health side effects which include Disturbances inattention, Disorientation, Agitation, Nervousness, Memory impairment and Delirium.
Lawsuits filed in several state courts blame the manufacturers Bayer Healthcare Pharmaceuticals, Merck & Co, Johnson & Johnson and others of marketing defective and dangerous drugs. Attorneys handling the cases assert the drug makers were aware of the aortic risks of fluoroquinolones but failed to adequately warn patients and doctors.
A federal judge permitted a Tasigna lawsuit to move forward over claims that the manufacturer Novartis AG failed to warn about the health risks of taking the drug. The lawsuit filed by a Florida man Dennis McWilliam for treating chronic myeloid leukemia (CML) alleges that consuming Tasigna caused him a stroke in 2013.
McWilliam was under Tasigna medication since 2011 and claims Novartis failed to warn doctors and patients about the possible adverse effects of the drug. The drugmaker, however, requested for a summary judgment indicating it could not add a warning label without a proper permission from the U.S. Food & Drug Administration (FDA). Novartis also insisted that the FDA would have rejected such a warning label proposal. But the summary motion request was rejected by U.S. District Judge Robert L. Rosenberg of the Southern District of Florida in an order issued on July 9, 2018, asserting that there was no clear evidence that the FDA would reject the proposal to add a warning label for stroke.
Tasigna was introduced in 2007 to treat chronic myeloid leukemia by blocking proteins that make cancer cells grow. However, a growing number of claims link the use of Tasigna and atherosclerosis (hardening of the arteries), which can lead to stroke, heart attack, or even death.
Following a summary judgment order granted by the U.S. District Judge presiding over C.R.Bard Inferior Vena Cava filter (IVC) lawsuit set for trial, cases scheduled for upcoming bellwether trials have been reshuffled. The lawsuit filed by plaintiff Carol Kruse was slated to begin in September this year; however, it was dismissed since the statute of limitation expired on the claims.
In a case management order issued on July 13, Judge David G. Campbell indicated that Kruse's case would be replaced by a claim brought up by plaintiff Mark Hyde, which was expected to go to trial in November. Jury selection for this case will begin on September 18, 2018. Bard plans to appeal for a summary motion in Hyde's case, challenging a choice of law issue. The Court will address this issue on July 25, 2018. Additional trials are scheduled to begin on November 5, 2018, and February 11, 2019. The exact order of the cases would be confirmed once the parties file a briefing on the matter.
C.R. Bard faces more than 3,500 lawsuits over IVC filter complications like internal injuries due to device breakage and migration. A multidistrict litigation (MDL No.2641; In Re: Bard IVC Filters Products Liability Litigation) was formed for centralized pretrial proceedings in the United States District Court District of Arizona on August 17, 2015.
The Judicial Panel on Multidistrict Litigation (JPML) reassigned Wright Medical Conserve Hip implant cases remaining in the MDL docket to Georgia Federal Judge Thomas W. Thrash Jr. of the U.S. District Court for the Northern District of Georgia. The July 10 order includes 12 cases which were not a part of the master settlement and were filed directly in the MDL.
About 200 pending cases over defective Conserve Hip implants filed across several states were dismissed in June. Lawsuits filed against Wright metal-on-metal hip implant claimed adverse events of device dislocation, severe pain and metal toxicity in the blood due to the faulty design involving Conserve, Dynasty, and Lineage implants. The Wright Conserve multidistrict Litigation (MDL No. 2329) formed in February 2012, in the Northern District of Georgia was overlooked by Judge William S. Duffey. In May 2012, a Judicial Council Coordination Proceeding No. 4710 (JCCP) petition was approved before Los Angeles Superior Court Judge Jane Johnson, consolidating California state-court cases involving Wright Medical hip replacement and revision matters, including Wright Medical’s Conserve, Lineage, and Dynasty hip implants.
Stryker Corporation faces similar allegations of causing internal complications due to the alleged faulty design of Stryker Hip implant device. Stryker Hip Replacement lawsuits are centralized before U.S. District Judge Indira Talwani under MDL No. 2768 – in Re: Stryker LFIT V40 Femoral Head Products Liability Litigation.
U.S. District Judge David G. Campbell presiding over C.R. Bard's inferior vena cava filter (IVC) MDL issued an order on July 9, stating ten mature cases would be remanded back to different federal courts for trial as these were already underway when the MDL was established. The parties are required to file a joint summary proposal about the case developments by July 27.
Judge Campbell also mentioned, "The summary generally should chronicle the MDL proceedings, summarize the key MDL legal and evidentiary rulings that will affect the remanded cases, identify any remaining discovery or other pre-trial issues, and estimate the time needed to resolve such issues and make the cases ready for trial.” Though these ten cases were not considered as "bellwethers", the trials would be closely watched by attorneys involved in the litigation, which may affect the settlement values in other claims. In yet another product liability case filed by Carol Kruse against Bard's IVC blood vessel filter, an Arizona jury ordered a summary judgment, stating the statute of limitation expired on the claims and canceled the bellwether trial which was scheduled for September 2018.
C.R. Bard faces numerous lawsuits over complications related to the IVC filter, stating the device is prone to break and injure internal organs. A multidistrict litigation (MDL No.2641; In Re: Bard IVC Filters Products Liability Litigation) was formed for centralized pretrial proceedings in the United States District Court District of Arizona on August 17, 2015.