Wednesday, July 24, 2019

Valsartan News

A  report published as a research letter in Circulation: Cardiovascular Quality Outcomes, mapped out patterns in valsartan-associated adverse events (AEs) reported to the FDA’s Adverse Events Reporting System (FAERS). Investigators focused on reports to FAERS from January 1, 2017, to December 31, 2018, and calculated a reporting odds ratio (ROR), which captures the proportion of all reported adverse events (AEs) that were said to be neoplasms. 

The letter notes that the number of AERS reports has increased from 1.9 in June 2019, just prior to the recall, to 15.4 in July and 18.2 in August before beginning to decline. 

Read more here:

What the report fails to note is that many doctors did not link any cancer to the recalled lots. Could the cancer be the culprit? Adverse event reports are  helpful but under used. Helps keep companies on their toes (in our opinion).

Thursday, July 18, 2019

What Are the Potential Claims and Injuries Associated with TDF Drugs?

News on TDF drugs: 
TDF drugs are used to treat HIV/AIDS. The drug clinically known as tenofovir disoproxil fumarate (or TDF) was approved as an oral HIV treatment in 2001. It is an antiretroviral, which basically disrupts the progression of the HIV virus at the cellular level. The drugmaker, Gilead Sciences, markets TDF in combination with other drugs under the popular brand name, Truvada, as well as other brand names, such as Atripla, Complera, Stribild, Symfi-Lo, Cimduo and Viread. Unfortunately, studies have shown that taking TDF drugs can cause severe kidney and bone injuries.
The drugmaker has already  been sued. The lawsuits allege that Gilead knew that TDF drugs had to be given in high doses to be effective, which meant it could damage the kidneys and bones. Yet the company failed to adequately disclose those dangers in the medicine’s label.
Gilead is alleged to have developed a much safer HIV treatment compound, tenofovir alafemanide fumarate (or TAF). However, it is alleged that Gilead purposefully delayed the introduction of the safer TAF drugs, despite Gilead’s knowledge of the injuries being caused by the TDF drugs, in order to reap extended profits from Gilead’s drug patents on the TDF drugs (at the height of usage, Gilead’s TDF drugs were earning over $10 billion in annual sales). Complaints go on to assert that, after Gilead purposefully delayed the development of its TAF drugs, Gilead did eventually market TAF in combination with other drugs, under the brand names Genyova, Odefsey, Descovy and Biktarvy. But, by that time, there had already been thousands of reports of severe kidney and bone injuries from TDF drug therapy.
We are investigating these claims. Reach us anytime. 

Monday, May 13, 2019

Valsartan Recall:Tainted drugs: Ex-FDA inspector warns of dangers in U.S. meds made in China, India

This news in from NBC:

Since last summer, drug companies have announced a total of 45 recalls of generic lifesaving blood pressure medications. They include certain versions of valsartan and two other blood pressure drugs, losartan and irbesartan, as well as other blood pressure medications that contain the recalled drugs in their formulations. The raw ingredients were all traced to overseas manufacturing sites where drugs can be processed at a lower cost than at U.S. facilities.

If you were taking Valsartan and have learned of the recall, talk with your doctors. If you are worried that a cancer diagnosis may be related to your use of the medication contact us. 

Thursday, May 02, 2019

Pedestrian vs. Vehicle Accidents

It is not uncommon to hear about people being hit, injured, or even killed by a vehicle. Because of that high figure, it begs the question as to whether or not pedestrian crashes are happening more often.

The 2017 Crash Facts & Statistics Report noted the five-year trends for pedestrian accidents. Pedestrian accidents aren’t necessarily becoming more common, but they are just as dangerous. Drivers and pedestrians alike need to be aware of the possibility of an accident and what steps to take decrease the risk.

Who is Most at Risk?
Consequences of a Pedestrian Accident
Steps Drivers can take to Prevent Pedestrian Crashes

There are two groups of individuals who are more at risk of being struck by a vehicle. The first group is older adults over the age of 65. Senior citizens generally take longer to cross the road than someone younger. A short crossing signal could put them in danger. Roadway design can also create hazardous conditions. Not all streets and thoroughfares take pedestrians into account. Safety measures like islands, raised medians, or sufficient lighting could be missing. An elderly person is also more likely to be affected by injuries than someone who is younger.
The second group of people who are more at risk for pedestrian collisions is children. Nationally, one in every five pedestrians killed in 2015 was under the age of 15. In general, children do not have the impulse control adults have. As a result, they could run into the street to get a toy and get hit by a car. Drivers are also less likely to see children because of their short stature, which is why many children are injured in backover accidents.
The consequences related to a pedestrian accident can be staggering. When someone is hit by a car, the physical injuries can take a serious toll. The human body is not meant to withstand a collision with a multi-ton vehicle at any speed, which is why broken bones and serious head injuries are common. Victims’ lives can be permanently changed if they have to cope with a disability. Many pedestrians pass away from these accidents, which can make it hard for their families in a number of ways, as well.
The financial consequences are also likely to be difficult to manage. Victims may be tasked with paying for expensive medical bills and treatments in an attempt to get their lives back in order. Time away from work can create a monetary deficient and destroy a family’s savings. Fortunately, seeking compensation with a lawyer can aid with the financial burdens.
While the physical and financial consequences are thought of most often, pedestrians who are hit by a car will also have to deal with the psychological ramifications. It can be difficult to cope with such a traumatic event and victims may suffer from sleep disturbances, anxiety, depression, flashbacks, and mood swings. Psychological treatment is likely to be expensive and the road to recovery can be long.
While the accident rates for pedestrians vs. vehicles have been consistent over the years, learning how to prevent crashes can ensure rates do not climb. In fact, accidents rates could decline over time when drivers are aware of the importance of watching for pedestrians. There are a number of things drivers can do to avoid striking someone on foot.
First off, it’s crucial for drivers to slow down in pedestrian areas. People can be unpredictable, so driving at a decreased speed can give drivers extra time to notice and respond to nearby walkers. It’s also a good idea to look for eye contact. Pedestrians are likely to attempt to make eye contact with drivers to assure them it’s safe to cross. This confirmation can aid both parties.
In regard to the parties who are more at risk for getting into an accident, it’s important for drivers to be patient with seniors and be on the lookout for children. Drivers should give older people the time they need to cross the street without getting frustrated. They should also remember to always check the back and sides of their vehicles before pulling out of a spot or backing up, to avoid hitting a child who is near their car. Also, school bus rules and school crossing signs should always be abided by.

What You Need to Know About a Trucker’s Blind Spots

All types of vehicles share the road on a daily basis. Drivers get used to passing large trucks fairly quickly; however, they may not be doing it as safely as they think. Blind spot accidents are fairly common and typically occur while traveling at high speeds on an interstate or freeway. It’s crucial for drivers to understand the location of a commercial vehicle’s blind spots, how they can be dangerous, how they can be avoided, and what happens in the event of a blind spot accident.

It can be difficult to determine when you are driving in a trucker’s blind spot. They key is to always make sure you can see the driver’s face. If you can see their face in the side mirror, generally, they can see you. This means that you are not in a blind spot. If, however, you cannot see their face in the side mirror, they might not realize you’re driving behind them or next to them. As a result, a serious truck accident resulting in injuries could occur.

A large commercial vehicle has four blind spots. The front blind spot can be especially dangerous if you are passing a truck and trying to merge back to the right. You want to make sure you can fully see the driver and the top of the cab to confirm you’re not riding in the front blind spot.
There are also blind spots on both sides of a tractor-trailer. If you find yourself passing a truck on the right, which you should avoid doing, or a truck is passing you on the left, it’s likely the trucker will not be able to see to their right for nearly two lanes. The blind spot is angled to a degree, so they might be able to see drivers who are near the back right of their vehicle. On the left, the blind spot extends for a single lane and is primarily located next to the trucker’s cab. Sideswipe accidents are incredibly common when drivers in small vehicles are in a semi’s side blind spots.
The final blind spot, which is behind the truck, exists because truck drivers do not have rear-view mirrors. The blind spot tends to extend for up to 200 feet from the back of the truck. If a driver is tailgating a truck and the larger vehicle needs to slow down or stop unexpectedly, the driver could crash into the rear end.
In addition to knowing where the blind spots are, there are a number of other ways drivers can safely operate their vehicles around trucks.
Passing safely is crucial. Drivers need to make sure they can see the trucker in their side mirror, use their indicator to clearly signal their intent to switch lanes, and accelerate at a reasonable speed so as not to linger next to the truck for too long. It’s also important to merge back to the right at the proper distance. Cutting it too close can be dangerous. If a truck is accelerating while a driver is merging back, the truck could ride over the smaller vehicle.
Drivers also need to be aware that truckers need extra turning room. Because of their size, big rigs swing wide or may start a turn from a middle lane. This is especially important to make note of if you drive in urban areas. In places like Philadelphia, congested traffic often leads to cars being right up behind each other. When a truck is trying to turn in an environment like that, it can be difficult to do so if other cars are too close.
Finally, drivers need to remember to be patient. Sometimes, trucks need more time to accelerate up a steep incline. Some even have technology that moderates how fast they can go. Getting frustrating and driving aggressively will only increase your risk for an accident.
It can be difficult to determine who was at fault for a blind spot accident. In some cases, the person traveling in the blind spot is held accountable. If, however, the trucker was driving erratically, merged improperly, or was distracted when they hit the other vehicle, a strong case can be built on the injured party’s behalf.

Are eScooters dangerous?

Similar to bike share and car share programs, electric scooter companies tout them as an innovative and environmentally friendly form of transportation which gets commuters out of their cars. Scooter companies proclaim them a solution to the “first mile, last mile” problem, i.e., a way to get commuters to and from mass transit stations and work places. 

Why are scooters dangerous? 
  • Riders are less visible to car drivers:  Scooters are easily hidden from view by objects on or off the roadway.
  • No barrier between scooter rider and road: Like bicyclists and motorcyclists, scooter riders do not have any protection, like the metal body of a vehicle around them. They do not have seat belts or airbags to protect them. 
  • Road hazards: Scooter riders may crash as the result of hitting or swerving to avoid potholes, gravel, roadway debris, or uneven surfaces.
  • Scooter instability: The scooters can be unstable because the scooters have small wheels and a short wheelbase, and the riders have a high center of gravity. Going over even a minor bump in the roadway, which a bicycle could handle with no problem, can cause a scooter rider to lose balance and crash. Even the slight curb that a rider must go over when transitioning from the street to the apron of a driveway can cause a rider to crash.
  • Inexperienced riders: A large percentage of Bird, Lime, Jump, and Lyft riders have never ridden one before. No special licensing or training is required. Download the app, enter your credit card number, and you are permitted to ride the scooter without proving your ability to safely do so.
  • Panic stop: If a rider brakes hard, the front wheel can lock up, throwing the rider off the scooter.
  • High-risk behavior: Scooter riders are often young and push the boundaries with high-risk behavior, like not wearing helmets. They may also ride on sidewalks, with more than one rider at a time, against traffic, or while intoxicated or impaired.
  • Vandalized scooters: Some people who are not fans of electric scooters are vandalizing them. They are cutting the brake cable. If an unknowing rider hops on one of these scooters, disaster can result. 
The common sense tips are the easiest to follow:
1. Buy a bargain bike helmet at the very least. 
2. Don't use your phone.
3. Buy a cheap flashlight.

Safety advocates slow Florida's rush for driverless cars

A good read on  how a lawyer group is playing a role in slowing the rush in Florida to driverless cars:

Last month a Reuters/Ipsos opinion found that half the country believes automated vehicles are more dangerous than traditional one driven by people. The poll found that almost two-thirds said they would not buy a fully autonomous vehicle.
Dan Sperling, director of the Institute of Transportation Studies at the University of California-Davis, told The Washington Times that “most people have never even seen a driverless vehicle, let along driven in one” and as a result, the “public is skeptical of change.”
For those in CA, in Silicon Valley, or in tech corridors like DC and NYC, driverless cars won't be on street corners in places like Lake City, or Immokalee, or Anniston anytime soon. 
Each year, the number of states considering legislation related to autonomous vehicles has gradually increased.
  • In 2018, 15 states enacted 18 AV related bills.
  • In 2017, 33 states have introduced legislation. In 2016, 20 states introduced legislation.
  • Sixteen states introduced legislation in 2015, up from 12 states in 2014, nine states and D.C. in 2013, and six states in 2012.
Stay tuned for more news. 

Monday, April 15, 2019

Voluntary Nationwide Recall of all Liquid Products Manufactured by Pharmatech LLC and Distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories Due to Possible Product Contamination

From the FDA:

As a precautionary measure, the distribution firms Leader Brand, Major Pharmaceuticals, and Rugby Laboratories are jointly issuing a nationwide voluntary recall of all lots within expiry of all liquid products manufactured by PharmaTech LLC at its FDA registered facility in Davie, Fla. due to possible product contamination.
The distribution firms are committed to patient safety and are partnering with the Food and Drug Administration to notify customers who may be in possession of liquid products manufactured by PharmaTech LLC. Please see the below list of affected products.
The products subject to this recall were distributed nationwide to wholesale and retail facilities, including hospitals and pharmacies. Through recent communication with FDA, the distribution firm Rugby Laboratories learned of a potential issue with a product manufactured by PharmaTech LLC. The FDA informed Rugby Laboratories that it received several adverse event reports of B. cepaciainfections in patients, which may be linked to PharmaTech LLC manufactured Diocto Syrup or Diocto Liquid (docusate sodium solutions). In response, Rugby Laboratories issued a voluntary recall on August 3, 2017, of the PharmaTech LLC manufactured Diocto Syrup and Diocto Liquid. As a precautionary measure based on additional information received from the FDA, the three distribution firms are recalling all lots within expiry of all liquid products manufactured by PharmaTech LLC.
The distribution firms are notifying their distributors and customers by recall letter and are arranging for return of all recalled products. Consumers, pharmacies, and healthcare facilities that have product being recalled should stop using and dispensing the product immediately.
Consumers with questions regarding this recall should contact Rugby Laboratories/Major Pharmaceuticals Customer Support at 1-800-645-2158, available Monday through Friday 8 a.m. – 8 p.m. EST or Leader Customer Support at 1-800-200-6313 option #1 Monday through Thursday 8 a.m. – 7p.m. and Friday 8 a.m. – 5 p.m EST. Consumers can contact their physician or healthcare provider if they have additional questions about this product.

Friday, April 12, 2019

Herbal drug kratom linked to almost 100 overdose deaths, CDC says

From USAT:

An over-the-counter herbal drug has been linked to more deaths in recent years, federal health officials say.
Kratom – a plant grown naturally in Southeast Asia and often sold in powder capsules – was a cause of death in 91 overdoses in the United States from July 2016 to December 2017, according to a report released Thursday by the U.S. Centers for Disease Control and Prevention.
In seven of the overdoses, kratom was the only substance to test positive in a toxicology report, though the CDC says other substances couldn't be ruled out.
Health officials looked at numbers from state overdose reporting databases and found that of the 27,338 overdose deaths in that time period, 152 of the deceased people tested positive for kratom, even if it was not a cause of death.

Our Firm: Filed Valsartan Lawsuits, April, 2019

Our law firm has filed two state court cases involving very nice folks who allege that each now has cancer, and that the a Valsartan containing medication may be the cause of that serious illness. This may be a difficult case to prove a link (if any) but from what we have discovered so far in our investigation, we are concerned enough to try to get consumers justice.

Our office number is 866.373.1800.

From CBS News, this report on Valsartan:

The Food and Drug Administration is warning that your blood pressure medication might be contaminated.
A number of medications have now been recalled because some may contain a suspected carcinogen. That’s creating a shortage of some essential drugs, CBS2’s Dr. Max Gomez reported Tuesday. It began last July when the FDA announced that it was recalling some generic blood pressure drugs, including Valsartan and Losartan, due to contamination with a potential cancer-causing compound called nitrosamine. Since then the agency has expanded the recall to additional generics and lots of medications of the same drug type, leading to patient concern and confusion.

Wednesday, January 09, 2019

More blood pressure medication recalled over carcinogen concerns: Losartan

Another drug company has recalled a version of losartan blood pressure medication over concerns the drug contains tiny amounts of a carcinogen. Torrent Pharmaceuticals last week recalled eight more lots of losartan potassium tablets, on top of the two it recalled last month.
In a notice shared by the Food and Drug Administration, the India-based pharmaceutical company said the medication used to treat high blood pressure and diabetic kidney disease contained unacceptable levels of the human carcinogen N-nitrosodiethylamine.
The drugs contained an active ingredient made by Hetero Labs in India, one of two overseas factories linked to more than a dozen recalls of commonly prescribed blood pressure drugs since July.
From the FDA:

Torrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.
To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.
Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. Patients who are on Losartan should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.
The products subject to recall are listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products. <
NDCManufacturerProduct DescriptionLot/BatchExpiration Date
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP 100mg,30count bottlesBO31C01604/2019
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP 100mg,90count bottlesBO31C01604/2019
Pharmaceuticals LTD
100mg,1000-count bottles
Losartan potassium tablets, USP were distributed nationwide to Torrent’s wholesale distributor, repackager and retail customers. Torrent Pharmaceuticals Limited is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Torrent is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.
Consumers with medical questions regarding this recall or to report an adverse event can contact Torrent Pharmaceuticals Limited at:
  • 1-800-912-9561 (live calls received 8:00 am – 5:00 pm Eastern Time, voicemail available 24 hours/day, 7 days/week).
Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Any general questions regarding the return of this product should be directed to Qualanex at 1-888-280-2040 (live calls received 8 am - 9:00 pm Eastern Time).
Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.  

Friday, July 20, 2018

Why the MGM lawsuit is wrong on multiple levels

By now many people have read with varying degrees of dismay that MGM (and a number of related companies) has decided to file a lawsuit seeking to limit any liability it may have as a result of the deadly massacre carried out by a lunatic during the Route 91 concert.  Stephen Paddock, the gunman, stayed at Mandalay Bay Resort and Casino and shot at concert-goers from a 32nd-floor window of the resort on Oct 1. 2017, killing 58 people and injuring hundreds more. In November 2017, 100's sued MGM and Live Nation, claiming negligence.

What is the lawsuit about?  The 57 page complaint lays it out. After identifying the Plaintiffs, the lawyers for them allege:

Named as defendants in this case are Claimants who have brought lawsuits (which they subsequently voluntarily dismissed) against the MGM Parties, alleging claims arising from Paddock’s attack, and persons who, through counsel, have threatened to bring such claims against the MGM Parties.

There is no pending litigation between Plaintiffs and Defendants relating to the attack. (Para 273). 

The Plaintiffs have attempted to utilize the SAFETY Act. According to the Complaint:

[Citing 6 U.S.C. §442(a)] the SAFETY Act expressly provides for original and exclusive federal jurisdiction over actions arising from or relating to acts of mass violence where technologies or services certified by the Secretary of Homeland Security were deployed. At the time of Paddock’s mass attack at the Route 91 concert, security services were provided by Contemporary Services Corporation as the Security Vendor for the Route 91 Harvest Festival. CSC’s security services were certified by the Secretary of Homeland Security under the SAFETY Act. (Para. 268). 

The SAFETY Act created liability limitations for claims resulting from an act of terrorism where Qualified AntiTerrorismTechnologies (QATTs) have been deployed.

Lawyers not linked with the case have claimed that law was intended to shield manufacturers of security equipment—such as airplane doors and metal detectors—under the cloak of U.S. sovereign immunity and by potentially capping damages. 


Was it terrorism?  No. "When asked if authorities believed the massacre to be an act of terrorism, Clark County Sheriff Joe Lombardo said, “No, not at this point ..."(2017)

In January of this year, the LVMPD issued a preliminary report.   The initial conclusion? This was not an act of terrorism. From the report:

Paddock acted alone. Thousands of hours of digital media were reviewed and after all the interviews conducted, no evidence exists to indicate Paddock conspired with or acted in collusion with anybody else. This includes video surveillance, recovered DNA19and analysis of cellular phones and computers belonging to Paddock. 

* No suicide note or manifesto was found. Of all the evidence collected from rooms 32-135 and 32-134, there was no note or manifesto stating Paddock’s intentions. The only handwritten documentation found in either room was the small note indicating measurements and distances related to the use of rifles. 

There was no evidence of radicalization or ideology to support any theory that Paddock supported or followed any hate groups or any domestic or foreign terrorist organizations. Despite numerous interviews with Paddock’s family, acquaintances and gambling contacts, investigators could not link Paddock to any specific ideology. 

The law enforcement agency assigned to this tragedy cannot come to the conclusion that the violence was terrorism. This report was issued nearly six months prior to the MGM filing.

What has the Department of Homeland Security said? Well, they haven't said it's terrorism: 

DHS Statement on Las Vegas Shooting
Release Date: 

October 2, 2017

For Immediate Release
Office of the Press Secretary
Contact: 202-282-8010
WASHINGTON – Acting Homeland Security Secretary Elaine Duke has been briefed on the horrific shooting in Las Vegas, Nevada last night. The Department is closely monitoring the situation and working with our federal, state and local partners in responding to and investigating this tragedy.
At this time, we have no information to indicate a specific credible threat involving other public venues in the country. However, increased security in and around public places and events may be experienced as officials take additional precautions.
Our thoughts and prayers are with all those affected by this incident as we work to support the Las Vegas community.
The FBI also chimed in
The FBI said the deadly mass shooting in Las Vegas had no connection with an international terrorist group. "We have determined, to this point, no connection with an international terrorist group," an FBI special agent stated. 

The day before the lawsuit was filed, zero law enforcement on the local, state, or national levels had declared this heinous act one that was considered terrorism. 

The day before this lawsuit was filed, what is known about the SAFETY Act is what any person - lawyer or not- could find on the web: 

The purpose of the Act is to ensure that the threat of liability does not deter potential manufacturers or sellers of effective anti-terrorism technologies from developing and commercializing technologies that could save lives. Key to this act is  an “act of terrorism” is an act, determined by the Secretary of DHS. At the very least, in the absence of such a determination, reason and logic would suggest that some law enforcement agency would make that determination - not  a Judge.

Legal scholars have noted the limits of the SAFETY Act: If an incident is deemed by DHS to be an act of terrorism, an entity that has achieved this level an utilize the government contractor defense to all claims that may arise. The NFL received the distinction in December 2008, and its renewal runs through November 2018.Those benefits do not flow down to the teams or stadium owners.

Here, the legal reasoning is wrong. Was there some authentic effort to proceed in some other way? Was the only resort the filing of a lawsuit against victims, even if only seeking a declaration/limitation of rights? In the cases found on Pacer, such as Sheppard et al v. Mandalay Bay, LLC et al the Removal papers describe the SAFETY act as the basis for being before the USDCT. Would consolidation, and a stay have been the better course? Some won't ever know now. There are reports that some of the survivors are now dealing with another round of PTSD thanks to this.

Now, on to what is worse.

This is a huge business blunder in my humble opinion. By it's own admission, MGM states that there are no lawsuits pending, only a 'threat' of several. So what does it do? The Plaintiffs send out a summon to nearly 1,000 people. In some instances, there are estates established (undoubtedly). What will those people do? Ignore the lawsuit? Do they have enough money to retain counsel in Nevada? What happens if they do not answer? Is there a default? In theory, a victim who needed and received medical care incurred costs. That same victim may have lost time from work, or worse. Is this a second act that also victimizes a person who is truly innocent?

From a business perspective, MGM is getting skewered on Social Media:

Meanwhile, on Twitter:

In the quest to limit liability, common sense and reason should rule the day. In my opinion, both went out the window with that filing when it came to the victims. MGM is (in my view) clearly hoping for the entry of defaults by the hundreds. So, in a way that is best called perverse, victims will "lose" as defendants. I predict a Motion for SJ will be filed where the first few lines will state: "More than 300 Defendants have failed or refused to Answer the Complaint served."

Will the DHS Secretary be deposed? Will a retired "law enforcement expert" be hired to complete an affidavit that says yes, this was terrorism? I'll bet one person a nickel that happens. This cannot be what the SAFEY act authors envisioned. 

What do other say?

From the USA Today:

How any corporation could find the gall and lack of humanity to take such an action is beyond comprehension.The federal law was meant to protect companies, for example, that come up with new technologies to thwart terrorist attacks, but might be reluctant to market them for fear of liability if a terrorist attack occurred.

From CBS:

Nine months after the Las Vegas shooting, shooting survivor Lisa Fine's physical injuries have healed. Her emotional and psychological wounds have not. Fine is the co-founder of Route 91 Strong, a group for survivors of the concert shooting. Fine says MGM's latest legal maneuver makes her feel sick to her stomach. "It feels like bullets flying at my head right now," Fine said.
An attorney for several victims has been quoted: "I've never seen a more outrageous thing, where they sue the victims in an effort to find a judge they like,” he said. "It's just really sad that they would stoop to this level."

Agree? Disagree?


Friday, May 04, 2018

FDA working with manufacturers to withdraw Zinbryta from the market in the United States

Another recall, this one on Zinbryta:

On March 2, Biogen and Abbvie announced a voluntary withdrawal of Zinbryta (daclizumab), a multiple sclerosis (MS) drug, from the global market, noting concern about the drug’s evolving benefit/risk profile. As a result, FDA is working closely with the manufacturers to help ensure a well-organized withdrawal from the market in the United States, and to ensure that health care professionals have the information they need to carefully transition their patients using Zinbryta to another treatment.  No new patients will start taking Zinbryta or participate in clinical studies. The company has begun notifying health care professionals and patients, and the drug will be available for patients as needed until April 30, 2018.
Patients using Zinbryta should not stop their medication without talking with their doctor and should contact their doctor immediately if they have any new and unexplained symptoms. Any questions or concerns about the withdrawal can be directed to the manufacturers’ service center at 1-800-456-2255 or the manufacturer’s website at www.zinbryta.comdisclaimer icon. We understand that this may be a difficult situation for some patients and will continue to work closely with the manufacturers throughout the withdrawal process.
The complex safety profile of Zinbryta has been recognized since the time of FDA approval. The drug’s safety profile led to an indication of use generally limited to patients who have had an inadequate response to two or more multiple sclerosis drugs, to a boxed warning about the risk of liver injury and of other immune-mediated disorders, and to a Risk Evaluation and Mitigation Strategy making the drug only available through a restricted distribution program. FDA has continuously monitored adverse events associated with use of Zinbryta and has updated product labeling as new information became available.

Primus Announces a Voluntary Nationwide Recall of All Lots Within Expiry of Prescription Medical Food Limbrel

Limbrel (flavocoxid 250 mg), 60 capsules

News of a recall of the product known as Limbrel. From the FDA:

Primus Pharmaceuticals, Inc. of Scottsdale, Arizona is voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level at FDA's request. FDA has requested a recall of Limbrel due to rare but serious and reversible side effects associated with Limbrel.
Between January 1, 2007, and November 9, 2017, FDA received 30 adverse event reports of elevated liver function tests or acute hypersensitivity pneumonitis associated with the use of Limbrel products. These conditions present in rare cases with varying degrees of severity in patients taking Limbrel for the first time in the initial weeks of exposure, and may go unnoticed by the patient until they consult with their physician or until symptoms develop that require hospitalization. There have been no deaths reported with the use of Limbrel, and in all reported cases adverse effects resolved without residual effects after discontinuing use of the product.
Primus retained independent medical and former senior FDA safety experts to conduct a further investigation of these cases and the ingredients in Limbrel.  It is the opinion of these experts based on a thorough review of the medical literature, adverse event reports to FDA, and FDA's health hazard evaluation that there is no basis on which to conclude that Limbrel potentially causes life-threatening adverse effects, and that none of the reported adverse events show liver failure or respiratory failure. Nonetheless, in an effort to cooperate with FDA, Primus voluntarily ceased its promotion and distribution of Limbrel on December 21, 2017, and is now recalling Limbrel as FDA has requested.
All lots within expiry of the following products are included in this recall:
  • Limbrel (flavocoxid) 250 mg capsules, Product Identity Number 68040-601-16
  • Limbrel250 (250 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules, Product Identity Number 68040-605-16
  • Limbrel (flavocoxid) 500 mg capsules, Product Identity Number 68040-602-16
  • Limbrel500 (500 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules, Product Identity Number 68040-606-16
Limbrel has been marketed since 2004 as a medical food available only by prescription for patients under active and ongoing supervision of a physician for the dietary management of osteoarthritis (OA), a degenerative disease of the joints and the most common form of arthritis. Prior to marketing, Primus conducted clinical studies that support the efficacy and safety of Limbrel and compiled an extensive dossier providing an analysis of published data to support the medical food status of Limbrel and to establish how the product meets the distinctive nutritional requirements of OA.  Primus stands by the legal status of Limbrel as a medical food. Limbrel products have been distributed nationwide in the USA to wholesalers, pharmacies, and physicians as medical foods without challenge from FDA for over 13 years, with approximately 2 million prescriptions and physician samples dispensed to an estimated 450,000 patients.

Thursday, May 03, 2018

Tasigna in the News

News across the web about Tasigna:

Tasigna (nilotinib) was approved by the U.S. Food & Drug Administration in 2007 to treat patients suffering from Philadelphia chromosome-positive Chronic Myeloid Leukemia (Ph+ CML). The medication belongs to a class of drugs called tyrosine kinase inhibitors (TKIs), which block a protein called Bcr-ABl to stop the growth of cancer cells. Since its approval, several studies have suggested that patients treated with Tasigna may be more likely to develop arteriosclerosis-related condition. For example, a 2016 study published in the American Journal of Hematology linked Tasigna to an increased risk for peripheral artery disease and sudden death.
In 2013, researchers writing in Leukemia reported that patients treated with Tasigna had higher rates of arterial disease compared to those prescribed imatinib. The Canadian label for Tasigna was updated in 2013 to note a potential risk of arteriosclerosis, after a review revealed that 277 reports of the condition had been logged with the Novartis global safety database between January 1st, 2005 and January 31, 2013. Canadian doctors were advised to closely monitor their Tasigna patients for signs of the life-threatening artery disease.
Here is the link for the Canada label changes made in 2013:

Subject: Updated information regarding the possible risk of developing atherosclerosis-related conditions with the use of TASIGNA* (nilotinib)
Novartis Pharmaceuticals Canada, Inc. (Novartis), in collaboration with Health Canada, would like to inform you about important safety information regarding reports of atherosclerosis-related conditions in patients treated with TASIGNA* (nilotinib).
TASIGNA* is a prescription medicine used to treat adult patients at different stages of a type of leukemia called Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML).
  • Cases of atherosclerosis-related conditions have been reported during clinical trials and post marketing experience with the use of TASIGNA*.
  • Patients should tell their healthcare professional if they have or have had any conditions that could cause atherosclerosis-related conditions such as a heart problem, high blood pressure, high cholesterol, or high glucose before starting TASIGNA* treatment.
  • During treatment with TASIGNA*, healthcare professionals will check for signs of atherosclerosis. Healthcare professional will also check cholesterol and blood sugar levels before starting treatment and periodically thereafter.
  • Patients should not stop treatment with TASIGNA* or change the dosage without discussing their condition with their healthcare professional.
Atherosclerosis is a disease that occurs in arterial blood vessels (arteries) and occurs more frequently in older adults. In atherosclerosis the walls of the arteries become thickened and hardened by plaque buildup. Plaque is made from fatty deposits and cells that can build up in the walls of your arteries over many years. As plaque builds up, the arteries narrow and become less flexible and the blood flow through the arteries can be reduced. Possible complications of atherosclerosis include heart attacks and strokes.

Thursday, April 26, 2018

Nuplazid in the News

The Food and Drug Administration (FDA) is re-examining the safety of a new drug after reports that it has potentially caused serious side effects and numerous deaths. 
The agency confirmed to The Hill it is “conducting an evaluation of available information” about Nuplazid, a drug approved in 2016 to treat delusions and hallucinations associated with Parkinson’s disease psychosis.
During a House hearing about FDA’s budget last week, Rep. Rosa DeLauro(D-Conn.) pressed FDA Commissioner Scott Gottlieb to answer why the drug was still on the market, even though there were 600 reported deaths associated with the drug in 2017.

Wednesday, March 21, 2018

FDA recalls BBQ sauces with South Carolina roots

Two barbecue sauces with South Carolina roots are being recalled because of a possible allergic reaction to some ingredients.
Piggie Park Enterprises Inc. of West Columbia is recalling Maurice’s Southern Gold Honey Sauce and Gourmet Carolina Gold Honey Sauce, according to the U.S. Food & Drug Administration.
Read more here.