Category: Defective Products

E-Cig Makers Have 60 Days to Reduce Youth Sales

By Emily Cox
e-cig
flickr/Kingssummers

The FDA issued a historic ultimatum Wednesday to crack down on e-cigarette use among minors, sending out more than 1,300 warning letters and fines to retailers who sold to underage customers and giving five e-cig manufacturers 60 days to develop adequate plans to keep their products out of the hands of children.

The actions are in response to a nationwide undercover investigation of physical and online stores over this summer into what the FDA is calling an “epidemic” of minors using e-cig products. According to a statement the agency released Wednesday, products from Vuse, Blu, Juul, MarkTen XL, and Logic accounted for the vast majority of illegal sales. The five manufacturers account for 97 percent of the U.S. e-cig market.

Part of the measure’s focus is on e-liquids that have designs and flavors that are inherently appealing to children, like candy or cookies. The FDA indicated that it will monitor and take immediate action against companies that continue to sell nicotine and tobacco products that could be appealing to children. The FDA has looked to e-cigarettes as a way to help adults stop smoking. However, FDA Commissioner Scott Gottlieb said that the agency didn’t expect the widespread teen use.

“We didn’t foresee the extent of what’s now become one of our biggest challenges,” Gottlieb said in a statement. “We didn’t predict what I now believe is an epidemic of e-cigarette use among teenagers.”

The FDA indicates e-cigarettes are the most commonly used tobacco product among minors during the past several years. More than 2 million middle and high school students used e-cigarettes within the past year.

FDA Warns E-Cig Makers to Change Policies

In its letters to the five manufacturers, the FDA put the companies on notice that they had 60 days to submit plans to address youth access and use of their products. The regulatory body suggested that these plans may include: stopping sales to retailers that the FDA fined for selling to minors; eliminating online sales or providing evidence that these sales aren’t going to minors; revising marketing practices; developing or improving internal programs to monitor retailers; or removing flavored products from the market pending FDA authorization.

Should the companies fail to comply, the FDA said it will consider revisiting its current policy that allows the products to remain on store shelves without a marketing order.

This effort is part of measures the FDA announced in July 2017 to make cigarettes less addictive, while encouraging the development of products that deliver nicotine in less harmful ways.

“Smoking remains the number one preventable cause of death in America, killing nearly half a million people a year,” Gottlieb said. “If we aren’t successful in more sharply reducing the rate of addiction to tobacco, then we’ll continue to see this needless death and disease.”

Gottlieb went on to say that e-cigarettes represent an opportunity for smokers to move away from smoking traditional combustible cigarettes, attributing the harmful effects of cigarettes to burning them. However, he did warn that nicotine itself is harmful, especially to children whose brains are still developing, saying that the FDA still needs a stronger regulatory process for e-cigarettes.

E-Cig Company Response

CEO for JUUL Labs Kevin Burns said the company intends to work proactively with the FDA regarding its request and remains committed to preventing minors from accessing its products.

“Our mission is to improve the lives of adult smokers by providing them with a true alternative to combustible cigarettes,” he said. “Appropriate flavors play an important role in helping adult smokers switch. By working together, we believe we can help adult smokers while preventing access to minors, and we will continue to engage with the FDA to fulfill our mission.”

Blu manufacturer Fontem Ventures released a statement, indicating the company supports the FDA’s initiative to keep e-cigs out of the hands of minors, adding that it also welcomes the opportunity to demonstrate its youth access prevention policies. These include an online verification process that monitors transactions for fraudulent activity and post-market surveillance.

A Logic spokesperson said the company received the FDA’s request and will continue working with the agency to prove it only markets its products to adults.

 

Cigarettes and Asbestos Caused Fatal Cancer

By Emily Cox
kool cigarettes
flickr/Tim Vrtiska

During Friday’s opening statements, a Boston jury heard that RJ Reynolds and Phillip Morris cigarettes coupled with exposure to an auto parts company’s asbestos-laden brakes caused a man to develop fatal lung cancer.

Plaintiff Joanna Summerlin’s council kicked off the trial before Middlesex County Superior Court Judge Heidi Brieger by telling the jury that the plaintiff’s late husband, Louis Summerlin, became addicted to cigarettes during a time when tobacco companies knew, and actively concealed, that their products caused cancer. The combination of smoking and exposure to Hampden Automoive Corp.’s brakes multiplied both products’ cancer-causing effects.

During their opening statements, the tobacco companies’ attorneys countered that Summerlin, by his own admission, chose to smoke because he enjoyed it and that he could quit smoking when he had proper motivation.

Summerlin’s lawyer described how his client’s husband, who died in 2015 at age 73, began smoking cigarettes when he was a teenager, outlining how he didn’t initially take to cigarettes until he tried a menthol brand, saying the cigarettes’ additives gave a cooling, numbing sensation that “made it easier for teenagers like Mr. Summerlin to become initiated as smokers.”

The attorney went on the detail internal documents that show Brown & Williamson, the company responsible for Kool cigarettes that has since merged with Reynolds, clearly knew smoking caused lung cancer in the years Summerlin became addicted. Summerlin also smoked Philip Morris Marlboro Menthols.

According to the lawyer, Summerlin became deeply addicted to cigarettes, lighting one up each day “before his feet hit the floor,” adding that years before Summerlin filed his lawsuit, his primary care doctor noted that the man “cannot stop. He has tried all aids to stop smoking.”

Cigarettes and Asbestos Exposure Contributed to Cancer

Although Summerlin quit smoking in 2009, his lung cancer diagnosis “shattered” his life with his wife. The couple’s attorney indicated that the jury would see a videotaped deposition testimony from Summerlin, who originally filed the lawsuit in the months before his death.

The lawyer also emphasized Hampden’s role, telling the jury that Summerlin worked as an auto mechanic for 25 years, being continually exposed to asbestos-containing Hampden brake linings. He asserted that the company could and should have easily discovered the asbestos exposure risks when it was distributing its products. He went on to say that asbestos and cigarettes caused Summerlin’s lethal disease.

“The two interact, there’s a synergy. The more asbestos you’re exposed to, the greater your risk for developing lung cancer from smoking; the more smoking, the greater your risk for developing lung cancer from asbestos,” he said.

During his opening statement, a Phillip Morris’ lawyer told the jury that the plaintiff’s attorneys would not present any evidence, including Summerlin’s own testimony, that shows tobacco companies influenced his decision with their fraudulent information or any other information they disseminated.

According to the defendants’ attorney, Summerlin was a “smart and strong-willed person,” who enjoyed smoking and chose to do so for years after warning labels began appearing on cigarettes and even after he had decided to quit for a short time when he felt cigarettes were affecting his stamina.

The lawyer also pointed out that Summerlin didn’t smoke Philip Morris cigarettes until the 1980s when he tried a coworker’s Marlboro Menthol. At this point, cigarette packs had warning labels, including one saying smoking causes lung cancer.

Defendant attorneys focused on Summerlin’s “personal choice” to begin smoking, and to keep smoking, despite knowing the risks.

 

Gadolinium Brain Depositions Linked to Hyperintensity Spots

By Emily Cox
gadolinium brain
flickr/Jon Olav Eikenes

Canadian researchers have found that gadolinium brain deposits from MRI contrast agents, such as Omniscan and Mangevist, can cause bright spots in non-enhanced MRI scans later, contributing to the growing body of evidence that the body may retain toxic metal from contrast dyes for dangerous periods of time.

The American Journal of Neuroradiology published the study in its August edition. Researchers indicate that gadolinium brain depositions from previous injections can cause hypersensitivity to appear on later scans even when these scans do not use gadolinium-based contrast agents (GBCA). The findings suggest a dose-dependent relationship, strongly indicating a causal link.

The new study comes as concerns continue to mount that gadolinium can build up in the brain and other organs, causing health problems later, which are now increasingly being referred to collectively as gadolinium deposition disease (GDD).

Researchers studied more than 200 subjects with secondary-progressive multiple sclerosis (MS) who were participating in a multicenter clinical trial. They analyzed data on 80 subjects who received nine linear GBCA injections over approximately a two-year period, as well as 115 who only received three such injections over the same timeframe.

Subjects in the high-exposure group demonstrated increased MRI signal intensity in all deep brain structure regions. The low-exposure group only presented with increased signal intensity in the dentate nucleus.

“Hyperintensity in deep brain structures from gadolinium deposition is related to the number of doses and the type of linear gadolinium-based contrast agent (nonionic greater than ionic) administration,” researchers wrote.

Other Health Concerns Beyond Gadolinium Brain Depositions

Concerns over the safety of MRI gadolinium contrast agents first emerged about ten years ago when they began to be associated with the development of nephrogenic systemic fibrosis (NSF). This is a rare and life-threatening condition that occurs among patients with compromised kidney function, causing their skin to harden and thicken, severely impairing mobility.

Sometimes called gadolinium associated systemic fibrosis, NSF is a painful disorder with no known cure. It often progresses to wheelchair confinement followed by death.

Consequently, in 2007, the FDA stepped in to limit gadolinium contrast doses in many kidney patients and contraindicated it for others, minimizing NSF risks. In September 2010, the FDA acted again to ban the use of Bayer’s Magnevist for patients with kidney problems due to the increased NSF risks.

The agency further required GBCA label changes to warn medical professionals to screen patients to identify those with acute kidney injury or chronic kidney disease before using gadolinium injections.

MRI contrast dye manufacturers are now facing a growing number of individuals without any kidney problems coming forward after developing severe and debilitating health problems linked to gadolinium brain and organ retention. Complications include bone and joint pain, cognitive difficulties, headaches, skin thickening, and other serious injuries.

FDA Further Intervention Regarding Gadolinium Brain Depositions

In September 2017, the FDA’s Medical Imaging Drugs Advisory Committee voted for new MRI contrast agent warnings pertaining to the risk of gadolinium brain depositions. However, the FDA concluded in May that brain gadolinium didn’t appear to pose any significant health threats.

In December 2017, the FDA released a drug safety communication for GBCAs, including Omniscan, OptiMark, Magnevist, Gadavist, and others, with new information about gadolinium retention risks and potential side effects.

The FDA cautioned that medical professionals should consider the fact that the body retains gadolinium when dealing with patients who would be at a higher risk for health problems. These include pregnant women, patients with kidney issues, children, and patients with inflammatory concerns. Regulators also recommend that healthcare professional minimize the repeated use of GBCAs when possible, especially when MRIs are occurring closely together.

 

 

 

Toyota Recalls 1M Vehicles Due to Electrical Fire Risks

By Emily Cox
Toyota Recall
flickr/Mike Mozart

Toyota announced Wednesday that it is recalling around 1 million of its Prius and C-HR compact SUV vehicles due to concerns that an exposed engine wire could short circuit and cause fires.

The Japanese vehicle manufacturer indicates the problem affects 2016-2018 Prius and C-HR models. Owners will be able to take their vehicles to Toyota dealerships to have the faulty wires repaired.

The issue stems from “an engine wire harness which is connected to the hybrid vehicle power control unit,” Toyota said. “A portion of the wire harness could contact the cover at this connection and wear over time, causing an electrical short circuit, which can generate heat.”

“If sufficient heat is generated, there is an increased risk of a vehicle fire,” the company added.

When vehicle owners bring their vehicles to dealerships, the manufacturer indicates that the wire harness will either be “replaced with a new one that includes a protective sleeve” if a “wire core is exposed,” or the dealership will simply apply protective tape to the harness assembly if the core is not exposed.

Toyota estimates that the recall will affect approximately 1 million vehicles. Roughly 800,000 of these, including all the C-HR model compact SUVs, were sold in Japan, Europe, and Australia. The recall will also affect about 192,000 Prius’ sold in the US.

Toyota Continues to Face Serious Problems

Wednesday’s announcement comes on the heels of Toyota announcing that it is recalling nearly 20,000 2012 Avalons for potentially defective seatbelt buckles that could cause the airbag not to deploy correctly.

In August, a jury slammed the company with a $242 million verdict, finding that the defective front seats of a Lexus caused two small children’s serious injuries in a rear-end collision and that Toyota carried most of the blame for their skull fractures and traumatic brain injuries.

A putative class action of owners also sued Toyota in February over claims that certain Prius models have a defect that presents serious risks of stalling while traveling at high speeds, potentially causing accidents.

In January, Toyota announced it was adding several hundred thousand vehicles to the ongoing recall over faulty Takata airbags. The ensuing fallout of which has dragged Takata Corp. into a protracted bankruptcy.

 

High-Risk Heart Devices Receive FDA Approval Despite Scarce Scientific Evidence

By Emily Cox
heart devices
flickr/Christopher Mance

A new study confronts significant issues with medical device approval in the US, underlining more than a dozen instances federal regulators approved heart devices under its “Priority Review” process that were later found to be dangerous and ineffective.

JAMA Internal Medicine published the study August 27. University of California San Francisco School of Medicine researchers found that the FDA relied on studies with little scientific evidence to establish cardiovascular devices were safe or even effective before approving them through its “Priority Review” program.

The report analyzed randomized clinical trials manufacturers performed to provide evidence for premarket approval from the FDA for heart devices. Researchers found that, as devices move through the Priority Review program, the quality and thoroughness of scientific evidence to justify approval of products is not known, let alone evaluated.

The researchers evaluated evidence manufacturers provided federal regulators for 14 high-risk cardiovascular devices that received FDA approval under its Priority Review program between 2007 and 2017. During that time, federal regulators approved a total of 29 devices under the fast-track program. Of these, 14 were high-risk heart devices. Manufacturers used a total of 18 studies to support that these devices were safe and effective.

The findings indicate that none of the 18 studies were double-blind trials. This research benchmark is generally considered essential for high-quality data. At least 13 of the studies used surrogate end points. Furthermore, none of the studies were large-scale, enrolling only an average of 500 patients.

Heart Devices Point to Regulatory Failings

In total, the FDA convened nine safety expert advisory panels to review the effectiveness and safety of the heart devices. Four of these panels found that the devices were safe. However, they did not find the devices were effective in treating the cardiovascular problems at issue. But, regulators pushed the devices through anyway. For 13 of the 14 devices, the FDA asked for post-approval studies for further information.

As of May 23, 2018, there have been two Class I and 13 Class II recalls for six of the heart devices. Earlier this year, Medtronic heart implants, which were among the products covered in the recent report, were recalled because of defects that stopped the devices from providing life-saving shocks.

Study authors warn that the majority of the recalled heart devices received approval based on a single nonrandomized, non-blinded study. They are calling for regulators to make some changes to Priority Review during premarket approval.

“To lower the odds of recall the new program should demand high-quality pre-approval data, larger scale studies, and longer followup,” researchers wrote.

Study Authors Call for Regulatory Changes

The push for high-quality research for approvals stands diametrically opposed to the FDA’s recent efforts to make medical device approvals ever easier and faster. This year the FDA also announced an action plain to spur innovation by further streamlining the premarket and post-market process.

Bringing devices to market faster along with the integration of the premarket and post-market processes only deepens already substantial concerns that patients will pay the ultimate price for devices coming to market through a rushed and ineffective approval process.

Consequently, researchers are calling for the FDA to take action to ensure that post-market studies are completed within a specified time limit. This way, if any problems are revealed, like those that could warrant a recall, the post-market study might help pick up these problems before a significant number of patients are harmed.

 

McAfee Exposes Medical Device Cybersecurity Weaknesses

By Emily Cox
cybersecurity
flick/Fotos GOVBA

McAfee researchers recently hacked into a central patient monitoring station for medical devices to demonstrate potential cybersecurity weaknesses.

The McAfee team performed the demonstration this past month at Defcon, a large annual hacker convention in Las Vegas, Nevada. Researchers simulated a patient whose heartbeat had flatlined to show how they could alter patient vital signs.

While researchers did not perform the demonstration remotely, they warned that it could be done from great distances as long as the hospital’s system is connected to the internet.

The team highlighted the security weakness just ahead of the new McAfee Advance Threat Research Lab’s opening in Oregon. The facility will also be used to demonstrate potential cybersecurity threats to all forms of new technology.

Two years ago, numerous U.S. hospital systems were hacked, infecting their systems with malware that stopped staff from communicating with the computers. The hospitals paid ransom through bitcoin to regain control.

In at least one instance, when a hospital refused to pay the ransom, administrators had to shut down portions of the facility until they could regain control. Consequently, they had to move some of the patients, impacting care.

America isn’t isolated in its vulnerability to medical device cybersecurity risks. Hackers have broken into health trusts in the U.K. and Germany, as well. In most cases, the hospitals end up paying bitcoin ransoms to protect patients in their care. Some hospitals have even hired law firms to buy bitcoin in case hackers hit them with malware, which is becoming known as ransomware.

FDA Action on Medical Device Cybersecurity

In 2016, the FDA issued new guidance on medical device cybersecurity. The document indicated that manufacturers need to detect and monitor potential cybersecurity vulnerabilities in medical devices, as well as research the level of vulnerabilities and risks to patients and establish a protocol for sharing cybersecurity information among manufacturers to limit hacking risks.

The agency indicated that manufacturers should design medical device software with upgrading capabilities to be able to combat newly discovered vulnerabilities for the device’s entire lifespan. The FDA warned that products that cannot be upgraded will become obsolete quickly and put patients in harm’s way. The agency indicates that these measures will allow manufacturers to ensure medical device safety and effectiveness at all stages of deployment and distribution, as well as encourages continuous quality improvement.

Medical Device Cybersecurity Concerns

Medical cybersecurity concerns have been escalating over the past few years as vulnerabilities to healthcare organizations’ record systems and medical devices continue to surface.

Since 2014, the Department of Homeland Security (DHS) has actively investigated at least two dozed cases of probable cybersecurity flaws in hospital equipment and medical devices. According to DHS, if the medical field does not take preventative actions to strengthen its cybersecurity issues, hackers could exploit these vulnerabilities, and patients will pay the ultimate price.

Department of Health and Human Services (DHHS) manager Jason Lay says the medical field’s vulnerabilities are a significant danger. Lay indicates the possibility of hacks to medical devices are an extraordinarily real possibility, saying that hackers could potentially exploit medical devices to gain access to healthcare organizations’ health record systems.

Furthermore, a demonstration at the 2012 San Francisco RSA security conference showed researchers could hack medical devices like insulin pumps from as far as 300 feet away. Researchers further showed how hackers could take control of insulin devices remotely, overriding them to deliver lethal doses of insulin to patients without any notification.

Since the White House issued Executive Order 13536 in 2013, the FDA has worked on improving the medical field’s cybersecurity. The Order called on the private and public sectors to collectively strengthen the gap in cybersecurity infrastructures. In October 2014, the agency issued its first guidance, recommending medical device manufacturers to include strong anti-hack programs during the design stages of development.

 

 

 

Baby Powder Wrongful Death Lawsuit Says J&J Products at Fault

By Emily Cox
baby powder wrongful death lawsuit
flickr/Dun.can

A new baby powder wrongful death lawsuit indicates that a woman developed fatal ovarian cancer after years of using Johnson & Johnson’s Baby Powder and Shower to Shower products and alleges that J&J consciously concealed life-threatening risk factors associated with its seemingly benign talc-based products.

Her husband, Mark Vetrini, filed the Baby Powder wrongful death complaint August 24 in Delaware Superior Court. He is presenting claims on behalf of himself and the estate of his late wife, Vanessa Vetrini, against J&J, Imerys Talc, Rio Tinto Minerals, Inc., and Valeant Pharmaceuticals.

According to the lawsuit, Vanessa Vetrini used Baby Powder and Shower to Shower around her genital area for feminine hygiene purposes for decades. She received an ovarian cancer diagnosis in January 2012 and died from the disease on June 5, 2016. She was only 42 years old. However, the Baby Powder wrongful death lawsuit asserts that the manufacturers knew about the connection between talcum powder and ovarian cancer for decades but deliberately withheld this information to protect brand image at the expense of human lives. The companies even encouraged women to use the product unsafely to increase use and sales.

“All of the Defendants have been or should have been aware for nearly forty (40) years of independent scientific studies linking the use of their products to the increased risk of ovarian cancer in women when used in the perineal area,” the lawsuit states. “Despite this overwhelming body of evidence all of the Defendants have failed to inform their consumers of this known hazard.

Baby Powder Wrongful Death and Litigation

Mark Vetrini’s pursuit for justice joins thousands of other Baby Powder and Shower to Shower lawsuits pending against J&J in the nation’s courts.

Over the past few years, numerous of these claims have gone to trial in state courts with many of them ending in multimillion dollar damage awards for J&J’s conscious negligence regarding the health of its consumers and valuing the all-mighty dollar over human life. Despite the massive verdicts, J&J is refusing to be cowed by the overwhelmingly negative response to its defensive measures. The healthcare giant is pursuing appeals in each of these cases and has continued to maintain that it will not offer talcum powder settlements for women who developed ovarian cancer after using its dangerous products.

Vetrini’s lawsuit is pending in Delaware state court. However, thousands of other individuals are also pursuing claims in Missouri state court, as well as the federal court system. The Judicial Panel on Multidistrict Litigation (JPML) has centralized the federal litigation before District Judge Freda Wolfson in the District of New Jersey for coordinated pretrial proceedings to expedite the dissemination of justice for those harmed by J&J’s callous disregard for the health of its consumers. The multidistrict litigation (MDL) works to reduce duplicative discovery and avoid conflicting pretrial rulings that tend to hold up these large legal actions.

If J&J still fails to resolve the litigation after discovery and the bellwether trial process, the company could face thousands of individual trials in courts nationwide. Given jury response in previous trials, this could result in crushing liability for America’s Family Company.

Jury Hits Ford with $4.8M Explorer Defect Verdict

By Emily Cox
Ford Explorer Defect
flickr/Mike Mozart

A Texas federal jury returned with a $4.8 million Ford Explorer defect verdict Wednesday after six days of testimony involving a man whose left arm was severed when his 1999 Ford Explorer rolled over, finding that the type of window glass in the vehicle caused his injuries.

Following four hours of deliberations, the 12-juror panel in Chief Justice Judge Ricardo H. Hinojosa’s courtroom determined Wednesday afternoon that Ford Motor Co. was 90 percent liable for substantial injuries that have left welder Jose Leos-Ortiz unable to work. The jury also found Leos-Ortiz carried 10 percent of responsibility for the incident. The jurors awarded Leos-Ortiz $3.3 million for past damages and $1.5 million for future damages.

Ford Explorer Defect Accident

Court documents indicate that Leos-Ortiz was involved in a one-vehicle accident in June 2009, while he was driving the vehicle on a highway from Brownsville, Texas, to Mission, Texas. Leos-Ortiz’s attorney told jurors that if Ford had installed laminated glass, which is glass between plastic layers to keep broken pieces intact, rather than cheaper tempered class, then the Explorer’s window wouldn’t have shattered on impact. Consequently, Leos-Ortiz would not have lost his arm.

Leos-Ortiz originally filed his petition in the case in June 2011. However, his lawyer indicates the case was slow getting to trial through no fault of the court or Ford. Rather, the delay was the result of a backlogged docket that reset the trial for the case 11 times.

At the time of the accident, Leos-Ortiz was twice the legal limit of intoxication, but his lawyer argued this was irrelevant.

“I got their experts to admit that drunk or sober … this truck still turns over,” he said. “There’s no moral meter on this vehicle.”

As for the 10 percent liability that jurors ascribed to Leos-Ortiz, his lawyer said he argued to the panel that they should assign his client some blame, not because he was intoxicated, but since he hadn’t kept up with maintenance on the SUV that had more than 306,000 miles and still had its original suspension system.

Ford argued in filings that Leos-Ortiz couldn’t bring the lawsuit, because the law barred his claims “”in whole or in part, due to the contributory and/or comparative negligence of plaintiff, in that he failed to exercise ordinary care, caution and prudence to avoid the incident and injuries at issue.”

 

Cosmetics Company Sues Insurer for Coverage in Cancer Claim

By Emily Cox
cosmetics
flickr/Brian

A Georgia cosmetics company is suing a subsidiary of CAN Financial Corp. in Georgia federal court, alleging the insurer breached their insurance agreement in dodging providing coverage for the producer in a lawsuit that claims its talc-based cosmetics contained asbestos and caused cancer.

Broadview Investments LLC, along with its PTI Royston LLC and PTI Union LLC subsidiaries, filed the complaint Wednesday. The companies claim that Continental Casualty Co. initially said it would cover PTI Union in Schacke v. 3M Co. et al. However, the insurer ultimately changed its position, denying Broadview’s claim.

The Schackne lawsuit alleges that Michael Schackne developed mesothelioma due to asbestos exposure from talc-based PTI Union cosmetics.

Upon receiving notice that PTI Union was a defendant in the case, Broadview notified Continental in February. An April coverage letter from Continental indicated the companies’ coverage applied to all lawsuits over “asbestos-related cancers, including mesothelioma.” Additionally, Broadview says the letter directly referenced the Schackne lawsuit specifically. The letter specified coverage exclusions in the companies’ policy that might limit their coverage. However, according to Broadview, an asbestos exclusion was not among them.

Cosmetics Company Coverage Denied

In a July letter, Continental flatly denied any duty to defend or indemnify PTI Union in the Schackne lawsuit. Furthermore, it said it would only pay the case’s defense costs through September.

Broadview says the insurer “arbitrarily” took out “asbestos-related cancers, including mesothelioma” from its definition of claims that it had included in the April letter. The July letter defined these “related claims” as those listed in the April letter that directly includes references to Schackne.

Broadview indicates that another letter in August further altered the related claims criteria. This time the insurer removed the entire category of “asbestos-related claims” but failed to define those.

“What is clear, however, is that Continental unjustifiably transformed its coverage position established in its April 11, 2018, formal coverage letter by improperly disavowing any duty to defend or indemnify Schackne,” Broadview wrote.

Broadview is requesting damages, costs and expenses, as well as a declaratory judgement that Continental has an obligation to defend the Schackne claim and any future lawsuits against the cosmetics company relating to asbestos exposure.

Judge Awards $245M in Hip Implant Judgements

Hip implant judgements Hip research DePuy Pinnacle Metal Hip BellwetherBy Emily Cox

A Texas federal judge granted more than $245 million in final hip implant judgements Wednesday for a group of New York plaintiffs who triumphed over Johnson & Johnson and its DePuy Orthopaedics unit when a jury found the companies knowingly sold dangerous and defective hip implants.

District Judge Ed Kinkeade granted Karen Kirschner approximately $48.6 million, Hazel Miura $43.7 million, Uriel Barzel $39.2 million, Ramon Alicea $38.9 million, Michael Stevens $37.8 million, and Eugene Stevens $36.8 million for damages, including past and future medical expenses; pain and suffering; loss of consortium; and punitive damages.

The plaintiffs’ attorney indicated that he was pleased with the hip implant judgements. He also said he is gearing up for another fight against the healthcare heavy-hitters as J&J has indicated it will appeal the decision.

“We are pleased and eager to seek upholding this on appeal,” he said in an email Wednesday.

In November, a Texas federal jury slapped J&J and DePuy with a combined $247 million verdict in hip implant judgements, following the bellwether trial over DePuy’s Pinnacle metal-on-metal hip replacement systems. This is the third consecutive nine-figure verdict in the multidistrict litigation (MDL) over substantial harm from the defective line of hip implants.

Hip Implant Judgements

The unanimous jury found J&J and DePuy liable for fraud and deceptive business practices, as well as a series of design and manufacturing defects. It further found that the companies had acted with wanton, reckless, or malicious disregard for patient health. Consequently, the jury awarded $90 million and $78 million in punitive damages against J&J and DePuy, respectively, to punish the companies for their egregious conduct.

The jury awarded more than $77 million in past and future medical expenses, as well as pain and suffering, to the six plaintiffs. This included the parties’ stipulation as to their actual past medical expenses. The jury also awarded loss of consortium damages totaling $1.7 million to four of the patients’ spouses.

In August, the plaintiffs actually sought a $1.2 million reduction in the jury’s $247 million verdict to compensate for private medical insurance that offset the damage awards. For some plaintiffs, this offset eliminated past medical expenses entirely. However, some still requested damages for their paid premiums. The future medical expenses were reduced for the years the plaintiffs would retain private health insurance before Medicare eligibility.

During the trial, the jury heard that J&J used unsafe and cheap materials to shore up its bottom line and rushed the hip implants to market without testing them on humans to ensure their safety. Consequently, the plaintiffs suffered severe tissue damage, resulting in permanent muscle loss and intense pain, as well as irreparable loss of mobility and hip movement.

This was the fourth bellwether in the MDL which currently has nearly 10,000 cases pending over the implants’ destructive design defects. In 2016, Texas juries found in favor of two groups of plaintiffs. The juries awarded the Texas and California groups $502 million and more than $1 billion, respectively. However, these verdicts were later reduced $150 million and $543 million. In the first Pinnacle Ultamet trial, the jury sided with J&J against a sole plaintiff from Montana.

 

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