When two generic companies manufacturing valsartan recalled hundreds of lots of the blood-pressure medicine last July, Alembic Pharmaceuticals was unaffected by the recall and saw the perfect opportunity to increase prices.
Teva Pharmaceutical and Prinston Pharmaceutical recalled the medications after testing indicated traces of carcinogens in their medications. Making a smart move, Alembic tripled the price of 17 of its own valsartan formulations. According to the data from a healthcare analytics firm, the price hikes ranged from 329% to 469%. The Wall Street Journal stated the prices for McCleods Pharmaceuticals’ valsartan products surged as much as 305%. The price hikes affected those consumers who have prescription drug coverage, as they would get high co-pays and premiums next year when insurance companies respond to the price hikes. It is also bad news for those without coverage, as they will not be able to afford costlier medications, and they might compromise on their ongoing treatment altogether by controlling the medication.
Several individuals have already filed valsartan lawsuits seeking fair compensation for their cancer allegedly caused due to N-Nitrosodimethylamine (NDMA) or N-nitrosodiethylamine (NDEA) contamination in the blood pressure drug. The U.S. Judicial Panel on Multidistrict Litigation last week heard oral arguments on the motion, to centralize product liability claims linked to valsartan recall before a single federal judge for coordinated discovery and other pretrial proceedings.
In a complaint filed by Bobby Jo Robichaux in the U.S. District Court for the Eastern District of Louisiana, she suffered an allergic reaction in July 2018, after being injected with various gadolinium-based contrast agents during a lumbar spine MRI and CT scan of her abdomen and pelvis.
In her complaint, Robichaux named GE Healthcare, Bayer, Tyco Healthcare, Mallinckrodt, Inc., and Bracco Diagnostics as defendants who manufactures gadolinium-based contrast dyes such as Omniscan, Magnevist, Gadavist, MultiHance, Dotarem, ProHance, OptiMARK, Eovist, and Ablavar. The plaintiff was re-admitted to the hospital numerous times owing to the continued complications from the IV dye. The lawsuit stated, “upon information and belief, the GBCAs produced by Manufacturing Defendants and used by Petitioner is defective in its design or formulation in that it is not reasonably fit, suitable, or safe for its intended purpose and/or its foreseeable risks exceeded the benefits associated with its design and formulation.” The Louisiana woman claimed that she suffered severe, disabling and disfiguring injuries as side-effects of the IV injection.
The lawsuit filed by Robichaux will join the growing number of gadolinium contrast dye lawsuits filed in several state courts nationwide, and the litigation is expected to expand in the coming months.
Johnson & Johnson and its DePuy Orthopaedics unit are about to resolve a large number of lawsuits targeted at their metal-on-metal Pinnacle hip implants.
Plaintiff lawyer Mark Lanier told that the consumers and the company had agreed on a settlement term to resolve the long-running hip implant litigation which holds more than 10,000 lawsuits. Though the settlement plan has not reached the final stage, it can be expected by the end of this year. Last month, J&J agreed to settle deceptive marketing claims filed by 46 U.S. states over the defective nature of the implants. The defendants denied admitting liability of misconduct linked to the claims filed. Metal-on-metal hip implants were reported to cause a build-up of metal ions in the blood resulting in groin pain, allergic reactions, and tissue death. The settlement talks caused a federal jury overlooking the case of five Texas plaintiffs, to dismiss the jury in the ongoing trial.
More than 10,400 Pinnacle hip implant lawsuits are consolidated as a part of multidistrict litigation (MDL 3:11-MD-02244, In Re: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation) overlooked by U.S. District Judge Ed Kinkeade since 2011 in the Northern District of Texas. Similar lawsuits are filed against other hip device manufacturers in the U.S. involving defendants Zimmer, Stryker, Biomet, Wright, and Smith & Nephew.
U.S. District Judge F. Dennis Saylor denied GlaxoSmithKline PLC’s request to dismiss hundreds of birth defect lawsuits filed by women, who used Zofran as an anti-nausea medication during their pregnancy.
The federal judge stated that the question of fact about whether GSK fully revealed the material data about Zofran to the FDA, and the agency would have rejected a request for a stricter warning label, was yet to be resolved by the jury. GSK claimed that the FDA conducted an extensive review of Zofran and a warning label for the alleged birth defects was not backed up by science. The company argued that the claims filed by the women were barred under federal preemption. In his decision, Judge Saylor told it was unclear if GSK had complied with the FDA's letter of regulations and whether GSK had presented expert backing for its argument about the data's authenticity.
There are more than 200 complaints against the company that its drug Zofran, approved to treat nausea during chemotherapy procedures, was illegally promoted to treat morning sickness in pregnant women. Zofran multidistrict litigation (MDL No. 2657; In Re: Zofran (Ondansetron) Products Liability Litigation) was formed in October 2015 in the District of Massachusetts for consolidated pretrial proceedings.
In a lawsuit filed on January 30, 2019, in the U.S. District Court for the Western District of Arkansas, Betty Selph claimed that taking generic valsartan medication for treating her high blood pressure caused her colorectal cancer.
In her complaint, the Arkansas woman named various generic valsartan manufacturers and distributors as defendants, such as Zhejiang Huahai Pharmaceutical Co., Prinston Pharmaceutical, Inc., Solco Healthcare, and Aurobindo Pharma USA. Selph started taking the medicine on December 14, 2014, and since then used several generic tablets until August 2018. She was diagnosed with colorectal cancer in September 2018. The blood pressure pills consumed by the plaintiff were manufactured by the above-mentioned defendants and were part of the valsartan recall issued by the U.S. FDA. The federal agency started a number of recalls starting from July 2018 due to the presence of N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) in valsartan. The FDA's review indicated that patients taking valsartan will not realize its cancer side-effect until about four years, which is what happened in Selph's case also. In September 2018, when colorectal cancer was detected in Selph, the FDA discontinued all imports of drug ingredients and medicines manufactured by Zhejiang Huahai Pharmaceuticals (ZHP) in China, which produced many such ingredients that had NDMA as a by-product of manufacturing drawback.
Valsartan lawsuits filed by several individuals claimed they were diagnosed with liver cancer, kidney cancer, lung cancer, and other forms of cancer due to the NDMA or NDEA contaminated valsartan medicine.
In an opinion issued on February 4, 2019, Superior Judge Mary M. Johnston gave a green signal to Delaware Attorney General to pursue claims against drug manufacturers who downplayed the addictive nature of opioids.
According to Judge Johnston's opinion, Attorney General Kathy Jennings’ office supported the state's allegations filed against the drugmakers such as Purdue Pharma L.P. and Endo Pharmaceuticals Inc. However, claims for negligence and consumer fraud against CVS Health Corp. and Walgreens Boots Alliance Inc. were tossed by the Superior Judge finding that the allegations were speculative.The ruling paves way for the next stage in the high-profile lawsuit, which was filed by former Attorney General Matt Denn in January 2018. In a 124-page complaint filed by Denn's office, the pharmacies, opioid manufacturers, and distributors were accused of using deceptive marketing tactics to push opioid sales and permit painkillers for unapproved uses. The lawsuit seeks to reimburse the costs incurred in health care, the criminal justice system, social services, welfare, and education systems.
According to a report issued by the Drug Enforcement Administration (DEA) last November, opioid caused the largest number of deaths last year nationwide. Opioid lawsuits are consolidated into a multidistrict litigation MDL No. 2804 (In Re: National Prescription Opiate Litigation) overlooked by Judge Polster in the Northern District of Ohio.
In an order issued on February 4, Judge Arthur D. Spatt of the U.S. District Court for the Eastern District of New York granted summary judgment to Zimmer Inc. in a case involving its knee replacement system, finding that the plaintiff's injuries were not caused because of inadequate warnings regarding the device.
The federal judge found that the plaintiff, Elizabeth Webb, failed to furnish sufficient evidence asserting that her implanting surgeon would have preferred a different knee replacement system had he been given enhanced warnings about the system's side-effects.The plaintiff underwent a total right knee replacement surgery on March 14, 2011, during which Zimmer's Gender Solutions Natural-Knee Flex System specifically designed for those who have hyperextension of the knee or high posterior tibial slope was used. She raised allegations about the adequacy of Zimmer’s warnings and filed a product liability lawsuit against Zimmer on February 20, 2014.
The Zimmer NexGen knee implant lawsuits were consolidated in 2011, as MDL No. 2272, in Re: Zimmer NexGen Knee Implant Products Liability Litigation, in the U.S. District Court for the Northern District of Illinois before Judge Rebecca R. Pallmeyer. There were reports about the plaintiffs and the defendant agreed to settle this 7-year-old litigation for an undisclosed amount.
An Indiana federal jury awarded $3 million in the third bellwether case involving Cook Medical's Inferior Vena Cava (IVC) filter injuries, finding that the company's product was the reason for a woman's complications.
The award was granted to Tonya Brand, on Friday, February 1, as the jury found Celect vein filter broke and ruptured her internal organs requiring her to undergo multiple surgeries to get the filter removed. The verdict solely covered liability and compensatory damages; Brand's attorney told the parties are yet to arrive on an agreed punitive damages amount. In 2009, the Celect model of the IVC filter was implanted in Brand during a spinal-fusion surgery. According to the court records, she got the filter removed in October 2015, as she started experiencing severe complications owing to the filter breakage and migration. Brand sued Cook Medical and other associates claiming strict liability and negligent failure to warn, strict liability and negligent design defect, negligent manufacturing, negligence per se, breach of warranty, and loss of consortium. Cook Medical moved for summary judgment on all claims, but U. S. District Judge Richard L. Young tossed most of them, and stated Brand was right in claiming that lack of adequate warnings caused her harm before and after surgeries. Brand failed to respond to the breach of warranty, negligent manufacturing and loss of consortium claims, so the judge granted summary judgment for those bids. This is the third bellwether case in the MDL after, the first one ended in a defense verdict, and the second bellwether case was dismissed in March 2018 as time-barred.
Several Cook IVC filter lawsuits are centralized since October 2014 under MDL No. 2570 (IN RE: Cook Medical, Inc., IVC Filters Marketing, Sales Practices, and Products Liability Litigation), in the Southern District of Indiana.
On Tuesday, January 29, Arkansas federal jury awarded more than $18 million in a lawsuit brought by the family of a mechanic, Ronald Burlie Thomas, who was diagnosed with mesothelioma due to asbestos exposure from automotive brakes, holding Honeywell and Ford Motor Co. responsible for the man's fatal condition.
The deceased man, who worked at a brake shop in the city since the 1970s, was in constant contact with the brakes produced by Bendix Corp. Plaintiff Michael Lyn Thomas claimed that Honeywell and Ford Motor Co. were liable for his father's death linked to asbestos exposure at work. Ronald Thomas was diagnosed with mesothelioma in March 2017 and died the same year in December 2017 at age 72. The 24-day trial concluded with Chief U.S. District Judge Brian Miller ruling partially in favor of the plaintiff after finding that Ford was not responsible for Thomas' disease, but Honeywell was 18.75% liable, while Thomas himself was 5% responsible for the disease. The remaining blame was put on non-parties such as Pneumo Abex LLC, which settled their part during the jury selection. The jury awarded Thomas $5.55 million in damages for pain and suffering, $1 million each for the mental suffering his three children endured, and an additional $10 million in punitive damages against Honeywell. This is one of the largest verdicts against Honeywell recently.
Asbestos exposure has affected thousands of individuals in the U.S. with most of the individuals blaming companies for not taking adequate measures to prevent asbestos exposure hazards. Asbestos fibers from talcum powder is also a prime reason for ovarian cancer in several women who used talc-based products for hygiene purposes.
On Thursday, January 31, Delaware Superior Court Judge Ferris W. Wharton denied Ford Motor Company's request to overturn a $9.1 million asbestos verdict awarded to Paula Knecht, the widow of Larry Knecht, an auto mechanic who died in 2014 owing to mesothelioma. The company's request for a new trial was denied by the Judge who ruled in favor of the widow and disagreed with the company's argument that the damages awarded were excessive.
According to the lawsuit filed by Larry, her husband who owned Knecht Automotive in Los Alamos, New Mexico, was exposed to asbestos from the clutches and brakes in the company which caused his deadly cancer. Knecht’s case headed to trial last year in May when the jury awarded Knecht $1 million in punitive damages and ordered Ford to pay $9.1 million to the plaintiff as the company was found 20% liable for Larry's death. Ford argued that Knecht failed to furnish sufficient evidence in accordance with New Mexico causation standard to prove Ford's conduct directly caused the disease. However, the court found no merit in Ford's argument and considered the evidence provided at the trial sufficient.
Asbestos exposure at workplaces has been a prime reason for an increasing number of mesothelioma lawsuits which are pending in several state and county courts. Talcum powder is another product alleged to cause ovarian cancer and mesothelioma in several individuals across the U.S. over asbestos exposure present in the talc.