The 7th U.S. Circuit Court of Appeals upheld a summary judgment motion granted to C.R. Bard in a hernia mesh lawsuit filed by the estate of Georgia Bowersock who died in October 2006 allegedly due to the defective design of the mesh.
The three-judge panel found that the plaintiff's experts were unable to establish that the hernia mesh implanted in her was the reason for her death. In October 2006, Bowersock was taken to the emergency room with abdominal-wall abscess and later experienced a heart attack at the end of the month. In the lawsuit filed against Bard and Davol, the cause of her death was mentioned to be pneumonia however, Bowersock’s estate alleged that the hernia patch was defective in nature and was the reason for her death. The medical expert, Dr. Stephen Ferzoco, retained by the estate for this case, stated, the memory ring within the patch, which enables the patch to stick to the abdominal wall was buckled, rubbed up against the bowel causing a break, then sealed up before the discovery of the mesh in the bowel. One of the experts, Dr. William Hyman, admitted he did not examine or view Bowersock’s patch.
The district court granted the defendants' motion to dismiss all expert findings that Ferzoco’s statement failed to qualify the Evidence Rule 702’s reliability threshold and Dr. Hyman was not qualified to have an opinion on medical causation. The Southern District Court entered summary judgment, which was appealed by the estate, but the decision was upheld by the 7th Circuit excluding the expert testimony and relying on Dr. Ferzoco’s testimony. The multidistrict litigation has been formed in the Northern District of Georgia, overlooked by U.S. District Judge Richard Story for coordinated pretrial proceedings.
An analysis published on January 14, 2019, in the peer-reviewed journal, Environmental Sciences Europe, challenges the 2017 decision of the U.S. Environmental Protection Agency’s (EPA) to tag glyphosate as safe to use and non-carcinogenic.
Glyphosate is an active ingredient found in weed-killer Roundup, which is the most widely used herbicide manufactured by Monsanto. In March 2015, the World Health Organization’s International Agency for Research on Cancer (IARC) indicated that glyphosate was a probable carcinogen to humans after an independent review linked the herbicide to an increased risk of non-Hodgkin’s lymphoma (NHL). Monsanto vehemently denied that glyphosate causes cancer and the EPA declared in 2017 that there was no clear evidence that glyphosate causes cancer in humans. The EPA and IARC followed fundamentally different approaches in their glyphosate review. IARC's investigation was based on studies focused on the distribution of real-world exposures and genotoxicity risk in humans, while the EPA relied on studies presented by Monsanto and other agribusinesses. The EPA's own Office of Research and Development was apprehensive about the way glyphosate review was handled by the agency. During the trial procedures, the plaintiff's attorneys presented internal emails and other documents as proof that Monsanto influenced the EPA glyphosate review.
Monsanto faces more than 10,000 Roundup lawsuits in several state courts in the U.S., which are consolidated before Judge Vince Chhabria in the U.S. District Court, Northern District of California as a part of the multidistrict litigation (MDL No. 2741; In re: Roundup Products Liability Litigation).
The government shutdown in the U.S. which started on December 22, 2018, has largely affected the drug and medical device approval process due to a shortage of staff at the U.S. Food and Drug Administration (FDA).
Madris Tomes, CEO of Device Events, told due to the shutdown, there is little or no resources to monitor death and serious injury reports coming into the FDA. The FDA receives approximately 65,000 reports per month just for device adverse events. Also, there has been no warning letters posted by the FDA ever since the shutdown started. Those letters are published after the agency determines a manufacturer significantly violated FDA regulations and are crucial in informing the general public and health care centers about the harmful nature of a drug or device. The FDA posted 19 warning letter in November 2018, but only one in December before the shutdown. Though new drug approvals would take a pause, drug companies are proceeding with the clinical trials.
A letter to the FDA by a group of 34 Democratic senators implied that as soon as the shutdown ends, the agency would be flooded with applications for new drug and device approvals. They wrote this would complicate and slow down the approval process more as there will be a degree of urgency in reviewing a large number of applications. The senators asked the FDA Commissioner Scott Gottlieb to respond to about eight questions about how the agency was planning to handle the financial demands of the shutdown while taking care of the safety and oversight.
The U.S. Centers for Disease Control and Prevention (CDC) recently reported that around 9% of rural residents received an opioid prescription in recent years as compared to 5% of urban residents. The reports were published in the latest edition of the CDC's Morbidity and Mortality Weekly Report using national electronic health record (EHR) data from 2014 to 2017.
Previous expert studies revealed that doctor prescription was the root cause of the opioid epidemic; in most cases, there was no legitimate need for painkillers. The prescriptions related to opioids declined after the CDC released new prescription guidelines for opioids in 2016. According to the guidelines, doctors must reduce unnecessary prescription. However, there was still a gap between prescribing rates among rural patients and urban patients even when prescribing rates declined in March 2017. Researchers warn that doctors are putting patients at risk for addiction and overdose by unwanted prescription.
Drug overdose deaths continue to mount in the U.S. and contribute to 70% of all drug overdose deaths. More than 1,600 opioid lawsuits, filed by opioid affected individuals, 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. The first bellwether trial in the litigation has been set for September 2019, involving lawsuits filed by Cleveland and the Ohio counties of Cuyahoga and Summit.
The widow of a factory worker who died of pleural mesothelioma due to exposure to asbestos while working in a chemical company was awarded $2.38 million in compensatory damages on Tuesday by a New Jersey state court jury. The second stage of the trial will determine the punitive damages to be paid by the defendants and is expected to begin on January 23, 2019.
Thomasina Fowler’s husband, Willis Edenfield, was a manufacturing plant worker at an industrial site in Bloomfield, New Jersey, managed by the now-defunct National Starch and other companies from 1954 until 1994. He was in frequent contact with asbestos-containing materials over the years. Defense lawyers for Union Carbide asserted that there was no evidence to confirm asbestos exposure led to Edenfield’s mesothelioma and that the only witness who testified told that he saw Edenfield working with another brand of asbestos. The Middlesex County jury held Union Carbide responsible for Edenfield’s death which occurred in 2011. In 2015, Judge Ana Viscomi granted summary judgment considering that none of Edenfield's co-workers found him using Union Carbide's asbestos products. The appeals court reversed Judge Viscomi's decision and stated the plaintiff presented evidence Union Carbide supplied over 40,000 pounds of asbestos to the facility over a 12 year period while the decedent was working at Bloomfield.
Asbestos exposure at workplaces has been the major reason for a growing number of mesothelioma lawsuits in the country. 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.
Johnson & Johnson and its DePuy Orthopaedics unit agreed on Tuesday, January 22, to pay $120 million to resolve defective hip implant claims filed by 46 U.S. states over the company's metal-on-metal (MoM) hip implant complications.
Attorney general of the 46 states asserted that DePuy was engaged in unfair and deceptive marketing practices while extensively promoting ASR XL and Pinnacle Ultamet hip implants as safe to use. According to a statement by New York Attorney General Letitia James, DePuy must maintain a post-market surveillance program and update procedures to monitor complaints about their hip implant devices. Back in 2010, DePuy announced a voluntary recall of 93,000 of its ASR hip implants due to reports that 12% of them failed within five years. The company paid at least $2.47 billion to settle thousands of lawsuits filed by patients who got the device removed.
There are more than 10,400 lawsuits filed against the company in the U.S. over its Pinnacle hip replacement system. The consolidated lawsuits in the multidistrict litigation (MDL 3:11-MD-02244, In Re: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation) are 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.
According to a recent complaint filed on January 17, 2019, by a Louisiana man, Wayne Sistrunk in the U.S. District Court for the District of New Jersey, AstraZeneca, Merck, and Procter & Gamble failed to provide an adequate warning regarding gastric cancer as a potential side-effect linked to the proton pump inhibitors (PPI) medication.
In the lawsuit filed, Sistrunk indicated that he started consuming Nexium medication since 2004 and switched to an over-the-counter version of Prilosec later and used one of the heartburn drugs till 2016. It was only in January 2018 that he was diagnosed with stomach cancer alleged to be a side effect of the PPI medications. The lawsuit blamed the manufacturers for not taking any action or provide warnings to the medical fraternity and consumers even after receiving numerous reports indicating that the drug might cause stomach cancer.
Sistrunk’s lawsuit would be centralized as a part of the federal multidistrict litigation (MDL No. 2789; In Re: Proton-Pump Inhibitor Products Liability Litigation [No. II]) in the District of New Jersey where currently more than 2,600 Nexium, Prilosec, Prevacid, Protonix, and other PPI lawsuits are pending before Judge Claire C. Cecchi. Most of these lawsuits claim that PPI drugs are prone to cause kidney malfunction, kidney acute interstitial nephritis, and other renal disorders.