What Happened In The MassTorts World Last Week? 2020-Jul-13
Cook Medical Asks Court To Drop Fraud IVC Filter Claims
Cook Medical Inc. has filed a motion seeking the dismissal of fraud claims brought by plaintiffs in the IVC filter multidistrict litigation, stating that the cases failed to plead all the elements necessary to establish fraudulent concealment.
According to a motion filed on June 19 in the U.S. District Court for the Southern District of Indiana, Cook asserted that "plaintiffs' pleading of fraudulent concealment is indefinite and non-specific, and it provides none of the detail necessary to state a claim sufficient to toll the statute of limitations."
The MDL includes 27 such cases against Cook and others that were filed in federal court in 11 different states. Each lawsuit claims that the company and others associated with the filters' manufacturing and sales knew about the defects in Cook's inferior vena cava filters yet hid them from the patients and doctors. The plaintiffs have also alleged that this coverup, in turn, delayed them from filing suit.
Three cases involving Cook Medical went for trial in the MDL, of which the first one ended in a jury verdict in Cook's favor in November 2017. The second was tossed in March 2018 as time-barred, and the latest was sent back to trial by U.S. District Judge Richard L. Young in January over "hearsay" evidence that incorrectly influenced the jury, reversing a $3 million verdict awarded to the plaintiff.
An Inferior vena cava filter (IVC filter), earlier popularly known as Greenfield filter, is a medical device implanted in the inferior vena cava just below the kidneys to capture blood clots, preventing them from reaching the heart and lungs, thereby, safeguarding against life-threatening pulmonary emboli (PE). IVC filters were cleared for use through the 510(k) process since 1976 however, in 2010 the FDA issued a device safety communication after reviewing more than 900 adverse events related to the devices over a period of five-years C.R. Bard, Inc. and Bard Peripheral Vascular, Inc. (collectively, Bard) and Cook Incorporated, Cook Medical LLC, and William Cook Europe ApS (collectively, Cook) are the main manufacturers of retrievable IVC filters. Other manufacturers include Argon Medical Devices, Cordis Corporation, Rex Medical, Johnson & Johnson, ALN, B. Braun Medical, and Rafael Medical.
Nearly 7,000 cases are pending against Cook, which is centralized under MDL No. 2570 in the Southern District of Indiana and assigned to District Judge Richard L. Young and Magistrate Judge Tim A. Baker for coordinated or consolidated pretrial proceedings.
JPML To Hear Arguments Over Covidien Mesh Consolidation
On June 26, the JMPL issued a Notice Of Hearing Session, indicating that a panel of federal judges will be hearing oral arguments this month over the consolidation of Covidien hernia mesh lawsuits, which is favored by the manufacturers but opposed by some plaintiffs.
Last month, the manufacturer of Covidien hernia mesh products filed a Motion For Transfer with the U.S. Judicial Panel on Multidistrict Litigation (JPML), asking to establish fifth multidistrict litigation (MDL), following a rise in the number of lawsuits over the products. The motion indicated that at least 12 cases are pending in nine different federal district courts.
According to the notice issued, a videoconference has been scheduled for July 30 to hear oral arguments for and against the consolidation of the lawsuits.
Covidien Parietex is manufactured and sold by a subsidiary of Medtronic, Inc. Plaintiffs using the device have alleged that design defects associated with Covidien Parietex and other products resulted in painful and debilitating complications, leading to revision surgery for removal of the product.
The consolidation is supported by some plaintiffs, whereas some are against the move, stating it is premature to predict the rise in the number of claims or indicating establishing an MDL would unnecessarily delay proceedings that have already proceeded significantly through discovery.
The mesh products named in the lawsuits contain polypropylene material, which can easily break, shrink or wear off. This often leads to device migration, organ perforation, infection, and several other complications. Lawsuits allege the defective design of the hernia mesh often required the patients to undergo additional correction surgeries.
The MDL, if formed, would join similarly centralized proceedings over Atrium C-Qur, Ethicon Physiomesh, Bard Polypropylene Mesh, and Kugel Patches.
Concerns Raised Over Invokana And Similar Drugs Warnings
The consumer rights advocacy group, Public Citizen, filed a petition with the U.S. Food & Drug Administration (FDA) on June 24, asking to add stronger warning labels for commonly used type 2 diabetes drugs known as SGLT2 inhibitors like Invokana, Farxiga, Jardiance, and other similar drugs, which have been linked to serious and potentially life-threatening cases of diabetic ketoacidosis.
According to the petition filed, the group wants the warnings to indicate that type 1 diabetes patients may face the risks of fatal diabetic ketoacidosis associated with the medications, which are often prescribed “off label” to type 1 diabetic.
Diabetic ketoacidosis (DKA) happens when the blood sugar is very high, and acidic substances called ketones build up to dangerous levels in the body. DKA is a serious complication of type 1 diabetes and less common in type 2 diabetes, but a rise in the risk has been reported in the patients consuming type 2 drugs.
The group indicated that the FDA received 550 reports of diabetic ketoacidosis in patients suffering from type 1 diabetes who were treated with SGLT-2 inhibitors, and it was found that 411 cases resulted in hospitalization, and 68 had life-threatening conditions. It also noted that eight randomized, placebo-controlled clinical studies determined Invokana and other similar drugs increased the risk of diabetic ketoacidosis in type 1 diabetics by a factor of three.
Dr. Sidney Wolfe, founder and senior adviser to Public Citizen’s Health Research Group who drafted the petition, in a press release, said, "For several years, the FDA has become increasingly aware of serious life-threatening diabetic ketoacidosis caused by these drugs when prescribed for Type 1 diabetes patients. It’s long overdue, but the agency must explicitly oppose the use of these drugs for patients with Type 1 diabetes with a prominent boxed warning. Further delay guarantees additional, preventable drug-induced diabetic ketoacidosis for these patients."
Invokana (Canagliflozin) is a drug used for the treatment of type 2 diabetes. It was developed by Mitsubishi Tanabe Pharma and is marketed under license by Janssen, a division of Johnson & Johnson in the United States. The FDA approved Invokana on March 29, 2013, for the treatment of type 2 diabetes. It belongs to the class sodium-glucose cotransporter 2 (SGLT2) inhibitor. Glucose is reabsorbed from urine by the action of SGLT2, which is an enzyme in the kidney tubule; by inhibiting the action of SGLT2, Invokana helps the kidneys get rid of glucose from the bloodstream.
Several Invokana lawsuits were filed in courts nationwide against the manufacturer Johnson & Johnson and its subsidiary Janssen Pharmaceuticals Inc. Most of the lawsuits previously filed alleging that the manufacturer failed to warn about the diabetic ketoacidosis risk have been settled.
First 3M Earplug Bellwether Trial Case Set For April 5, 2021
On June 29, U.S. District Judge Casey Rodgers issued a pretrial order indicating that the first 3M combat earplug bellwether case will go to trial on April 5, 2021.
In March 2020, the court identified a group of 25 cases to be a part of the first bellwether trial pool, known as Group A. The agenda of the group asks for plaintiff depositions in those cases to be completed by July 31, the fact discovery to be completed by October 9, and the challenges to case-specific expert witness testimony by January 8, 2021.
Judge Rodgers also issued another case management order, calling the parties to submit a schedule for bellwether trial cases in Groups B, C, and D by month-end, when the next Case Management Conference will be held on July 29. The order also indicates that the court will schedule a second Science Day before the conference, particularly to discuss the discovery protocol for ototoxic medications and illicit substances.
In April, 3M Company attempted to dismiss the lawsuits filed against it by filing a summary judgment stating that it was relying on the “government contractor defense,” and distributed the earplugs as per the guidelines provided by the military. However, in response, the veterans argued that the company's plea should not be accepted as it is blaming the military for its own mistakes and misdeeds.
In July 2018, the company made a settlement of $9.1 million with the Department of Justice, resolving claims that it defrauded the government by deliberately selling the defective earplugs.
The Combat Arms Earplugs Version 2 (CAEv2) was manufactured by Aearo Technologies, Inc. before being taken over by 3M in 2008. The dual-ended 3M CAEv2 combat earplugs served as a standard form of military hearing protection in foreign conflicts for more than a decade, from 2002 to 2016. The 3M military earplugs are made of green and yellow with a double-ended design. The green end is inserted to block all sound, and the insertion of the yellow end reduces the sound of gunfire and explosives but still allowed the service personnel to be part of a conversation. According to several lawsuits filed, the defective military earplugs cause two primary medical issues, tinnitus and hearing loss, mostly among veterans in the Navy and Air Force. The product was discontinued in 2015.
Currently, more than 150,000 claims are filed by veterans, each raising similar allegations that the hearing loss injuries were caused by defective 3M earplugs that were standard issue by the military between 2003 and 2015. The lawsuits are consolidated under MDL No. 2885 (In Re: 3M Combat Arms Earplug Litigation) in the Northern District of Florida.