What Happened In The MassTorts World Last Week? 2020-Dec-28

Study Links Zantac Problems To Degradation Of Ranitidine

A study was published this month in the medical journal Organic Process Research & Development in which U.K. researchers working with Zantac manufacturer GlaxoSmithKline (GSK) suggested that the degradation of the active pharmaceutical ingredient ranitidine results in the formation of the cancer-causing chemical N-nitrosodimethylamine (NDMA).

Ranitidine hydrochloride is a drug sold under the name of Zantac, used to treat and prevent ulcers in the stomach and intestine. Earlier this year, the FDA requested manufacturers to discontinue all versions of Zantac from the market after finding that the cancer-causing chemical NDMA levels in the drug exceeded the set daily acceptable limit.

According to the latest study, the researchers conducted a root cause analysis and confirmed that the heat produced by the human body’s digestive processes aids in the transformation of the ranitidine molecule into the toxic chemical. The researchers further found that the impurities did not play any role in Zantac NDMA contamination.

The analysis was done using suitably isotopically labeled ranitidine hydrochloride, which revealed that the factors that influence the transformation were heat, humidity, and the crystal morphology of ranitidine hydrochloride with the material that exhibits a columnar habit showing a slower rate of degradation.

The manufacturer of the heartburn drug is facing more than 500 Zantac lawsuits, which were centralized under MDL No: 2924 in the Southern District of Florida for coordinated discovery and pretrial proceedings.

U.S. District Judge Robin L. Rosenberg, overseeing the Zantac litigation, is expected to establish a bellwether program that will set aside a small set of representative cases to be prepared for a series of early trials, unlikely to begin until at least 2022.

In October, Judge Rosenberg issued a pretrial order that outlined the information and reports that will be made available to the parties, which are extracted from census forms submitted as of September 30.

The court established the census in April to gather more information about all filed and unfiled claims. The census will enable the parties and the court to have a robust and timely understanding of the scope and size of the litigation and to facilitate early case management decisions.

Valsartan MDL Judge Denies Defendants' Preemption Motion

On December 18, U.S. District Judge Robert B. Kugler, overseeing the valsartan multidistrict litigation docket (MDL), denied three dismissal motions filed by the defendants stating that claims by buyers and users of the drug are not preempted by federal law.

The order was signed on Thursday and filed the next day, in which the New Jersey federal judge noted that it would be one in a series of the number of claims and arguments put forth in the motions to dismiss, and each would address different claims and arguments.

The manufacturers are facing allegations, which include that generic valsartan pills were distributed for years with cancer-causing impurities, including NDMA and NDEA, which appear to be a by-product of the drug manufacturing process. Several lawsuits have been filed in recent months by individuals who indicated that they were left with different types of cancer, including liver cancer, kidney cancer, gastric cancer, pancreatic cancer, and other injuries following exposure to NDMA or NDEA.

The defendants involved in the litigation filed a motion to dismiss three master complaints, arguing preemption under the Food Drug and Cosmetic Act (FDCA) and the Drug Supply Chain Security Act (DSCSA). The motion further contended that the claims were subsumed by the state's own product liabilities laws and also stated that certain claims, including unjust enrichment and punitive damages, were insufficiently alleged. The defendants also asked to dismiss or put a stay on those claims, which are linked to pending FDA investigations and regulatory actions until the same is finished by the federal agency.

The defendants include wholesalers AmerisourceBergen and Cardinal Health Inc.; pharmacies, CVS, and Walgreens; and the manufacturers, which include Teva Pharmaceuticals USA Inc. and Mylan Pharmaceuticals Inc.

Judge Kugler, through the order, indicated that manufacturers, wholesalers, and pharmacies couldn’t escape the lawsuits that claimed them for selling a blood pressure medication contaminated with a carcinogen. The order did not indicate when further opinion on the motions to dismiss will be issued.

Court Appoints Special Masters For Valsartan Settlement

Last week, U.S. District Judge Robert B. Kugler, overseeing the valsartan multidistrict litigation docket (MDL), along with rejecting defendants' preemption motion, announced the appointment of Special Masters to work with the parties to resolve lawsuits brought against the recalled versions of the hypertension drug

Valsartan belongs to a class of drugs called Angiotensin II Receptor Antagonist and is used to treat high blood pressure (Hypertension), and Congestive heart failure.

Diovan (Valsartan) was manufactured by Novartis International AG and was approved by the FDA on August 14, 2002. Diovan lost its patent in September 2014. The launch of the generic drug had been on hold since patent expiry due to regulatory problems with the FDA. In 2014, a US-based Ohm Laboratories (Ohm), a subsidiary of Ranbaxy Laboratories, was the first to get the approval from FDA for generic Valsartan. Thereafter, many generic versions of Valsartan came into the market via many other pharma companies.

The usage of Diovan had no evidence of any adversity in its entire span, but the FDA did find that the generic versions of Valsartan were causing issues. The most serious issue reported was that it had the presence of an impurity called N-Nitrosodimethylamine (NDMA), which was believed to be formed as a byproduct through a chemical reaction. Not only was this an impurity, but a concern was also raised when it was detected that NDMA is carcinogenic and can lead to cancer in people consuming this drug for the long term.

The letter dated December 18 stated that the court appointed Hon. Gregory M. Sleet (retired) and Hon. Lawrence F. Stengel (retired) as Special Masters for Settlement in the litigation. The counsels involved in the litigation have seven days to raise any objections pursuant to the Code of Judicial Conduct.

Judge Sleet served as Chief Judge of the United States District Court for the District of Delaware and is currently with JAMS, formerly known as Judicial Arbitration and Mediation Services, Inc., in Philadelphia. Judge Stengel served as Chief Judge of the United States District Court for the Eastern District of Pennsylvania and is currently with Saxton & Stump in Lancaster, PA.

Valsartan is used to treat high blood pressure (hypertension) and Congestive heart failure (CHF). In July 2018, the U.S. Food and Drug Administration (FDA) issued a press release indicating that some generic valsartan might contain an impurity known as N-nitrosodimethylamine (NDMA), which is a probable human carcinogen, and announced a massive recall. Several former users of the drug who were diagnosed with cancer filed lawsuits against manufacturers, wholesalers, and pharmacies claiming the pill for their cancer.

Currently, at least 650 cases are pending in the litigation docket, each raising similar allegations that long-term exposure to recalled valsartan drug results in stomach cancer, liver cancer, esophageal cancer, prostate cancer, pancreatic cancer, and other injuries. The lawsuits are consolidated under MDL No. 2875 in the United States District Court, District of New Jersey, presided by Judge Robert B. Kugler, U.S.D.J and Hon. Joel Schneider, U.S.M.J.

Biomet Files Motion To Reverse A $21M November Verdict

Last Friday, Biomet Inc. filed a motion in the U.S. District Court for the Eastern District of Missouri, asking a federal judge to overturn the $21 million verdict awarded to a woman and her husband last month over claims alleging that the company’s metal-on-metal M2a Magnum hip implant system was defectively designed.

The defendant, in the motion, noted that the plaintiffs' win could not be sustained as the jury's decision in the company's favor on the strict liability design defect claim "necessarily disposed" of the negligent design claim that was in favor of the plaintiffs. The defendant argued that the court should reverse the verdict as the elements, design defect, and causation on which the jury based its rejection was common in both the claims.

The company also mentioned another Missouri case involving Auto Handling Corp. in which the court had recognized that claims of strict liability and negligent failure to warn were "inextricably bound together" and had required reversal and retrial of the jury verdict on both the claims.

According to the lawsuit filed by the couple, the woman got both her hips replaced in early 2008 with Biomet's M2a-Magnum hip implant. She started experiencing problems in 2010 and went for revision surgery in March 2011 in her left hip.

The jury awarded a compensatory damages verdict to the plaintiffs on October 22, and after a break, the punitive damages phase concluded on November 18. The jury awarded $20 million to the woman and $1 million to her husband along with post-judgment interest and costs of the action and refused to impose punitive damages against the company.

In the same month, the company also lost in a case considered "virtually identical" to this trial. The case involved an Iowa woman who was awarded a $3.55 million verdict for a similar claim alleging the company's hip implant.

Zimmer Holdings is an Indiana-based orthopedics company involved in providing hip and knee solutions including joint and skeletal replacement systems and surgical tools as well as biologics designed to assist in joint replacement surgeries. In April 2014, Zimmer and Biomet announced to come together to provide joint replacement, bone repair, and dental implant solutions. In June 2015, they started out as Zimmer Biomet and began offering solutions to the musculoskeletal healthcare industry. The hip and knee implants were intended to relieve pain, provide good quality of life to the patients. However, Zimmer lawsuits filed by several individuals claimed the metal-on-metal articulation used in the system resulted in Metallosis, because of the metal grounding on metal as it leads to toxic metal shards being released into the patient's surrounding tissues and bone.

In August 2018, Zimmer Biomet revealed it received a warning letter from the FDA over quality violations at a plant in its home base of Warsaw, Ind. during an inspection done in 2016. The violation was documented in Form 483.