Category: Pharmaceutical

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Pharmaceutical Medicine: Pfizer Vaccine Granted FDA Approval

on September 15, 2021

On Monday, August 23, 2021, the Pfizer-BioNTech COVID-19 vaccine was granted approval by the Food and Drug Administration (FDA) for individuals 16 and older. Due to its newly approved status, what was known as the Pfizer-BioNTech COVID-19 vaccine will now be advertised as Comirnaty (koe-mir’-na-ty). According to the BBC, “The approval ultimately came less than four months after the Pfizer-BioNTech filed for licensing in early May – the fastest vaccine approval in the FDA’s more than 100 year history.” The abrupt onset of the Coronavirus last year served as the impetus for a necessary response by medical professionals to reduce spread, infections, and deaths. Even though the vaccine has been distributed since December 11th, 2020, Acting FDA Commissioner, Janet Woodcock, M.D., hopes the FDA approval will cement certainty for concerned individuals to get vaccinated. With insight from FDA Expert Witness, Mr. Alan Schwartz of mdi Consultants, Inc., this blog post will examine the approval process for vaccines before and during COVID-19 as well as enlighten readers about reasons behind Comirnaty’s FDA approval.

Alan Schwartz is a seasoned expert in FDA protocols. He has over 50 years of experience in the field . When asked about the FDA’s general approval process, he states, “The process is NORMALLY very extensive. It could take years from the start of development through laboratory bench testing, animal safety studies, then human safety, and finally efficacy studies.” Mr. Schwartz also noted the avergage costs companies pay for these trials can reach up to $100 million, which these companies were able to actualize due to the Emergency Use Authorization (EUA). “The FDA under the EUA gave the companies a BULLET TRAIN path to get these through the emergency use approval,” he stated. In an ideal situation, the FDA would contact the clinical study participants throughout the duration of a year after receiving a vaccine. However, because of COVID-19, the vaccine has been officially approved after it has been administered to approxiamtely 100 million people. This was most likely due to political pressure and, more importantly, ensuring the well-being of citizens around the globe. In this situation, the long-term follow up was missing in the approval process. Nevertheless, the fact that roughly 100 million people received the Pfizer-BioNTech vaccine before its approval provided the necessary data on its efficacy and safety in real time. “So, did the FDA expedite the approval or did they have more data to use in their decision making process… we hope that they used good science to get this through the approval process since it was already being used for a year,” Mr. Schwartz mentioned.

Some concerns from those expressing doubt include whether the Pfizer vaccine was changed or modified for the purpose of an expedited approval process. Schwartz reassured there was an absence of changes regarding the production and formula of both the EUA and approved vaccinations. “This was all new to the FDA and in the industry… Normally when a vaccine or a drug is under FDA review there are many questions and back and forth that take a lot of time. I don’t think this was necessary under these conditions.” However, since Pfizer is currently manufacturing and advertising Comirnaty, the pharmaceutical company is allowed to continue using the EUA vaccine. The EUA is considered an experimental drug, but as soon as Comirnaty is ready for vaccine administration, Pfizer will be held liable if any problems arise.

A New York Times article stated, “Regulators are still reviewing Moderna’s application for full approval of its vaccine.” Since both Pfizer-BioNTech and Moderna vaccines are based on similar mRNA technology and both had emergency use authorization, there are questions regarding when the public can expect or not expect Moderna’s approval by the FDA. “I would be very surprised if we did not see Moderna approved,” Mr. Schwartz commented. Moderna has submitted their application for full FDA approval which is currently pending review. Announcements about its approval should occur in the near future (NPR).

The FDA has stated that the immunization will continue to be available for children aged 12-15 under Emergency Use Authorization (EUA). It remains uncertain when Comirnaty will be FDA approved for younger people, as the CDC recently announced its vaccine recommendation for said demographic back in May. Although there is not an official timeline, Mr. Schwartz predicts, “It may take until next year to obtain all required safety and efficacy data for pediatric indication.” The lack of data amid clinical trials is the primary reason as to why Comirnaty has not received approval for young people. However, this is not an obstacle for the Los Angeles Board of Education, the second-largest school district, who recently voted on September 9th to require students 12 and older to get vaccinated.

Current protocols include a mask mandate during in-person classes and frequent COVID-19 testing as a precaution against the virus. According to U.S. News, “Under LA Unified’s plan, all students age 12 and up will be fully vaccinated by the time they return to class following winter break on Jan.11. Those who are participating in sports and other activities need to receive a first dose of vaccine by Oct. 3 and a second dose by Oct. 31, while other students need to get their first dose by Nov. 21 and a second dose no later than Dec. 19.” Board members believe the implementation of this plan is the best course of action to responsibly protect children under the age of 12, the demographic not yet eligible for vaccinations. There are some parents who agree with the Los Angeles Board of Education’s vote, as it is similar to other immunizations students are required to receive such as chickenpox, polio, and measles to name a few. Other parents not only think the vote was rushed, but also believe the choice for their child receiving COVID-19 vaccine or not should be a parental decision.

So, we continue on this journey of uncertainty with COVID-19, the vaccines, and their aftereffects. It is only a matter of time before future vaccine mandates are implemented in school districts and businesses across the country. A special thanks to Mr. Alan Schwartz for his insight on the FDA approval process of the Pfizer-BioNTech produced Comirnaty vaccine.

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Landmark Oklahoma Opioid Ruling Due Monday – Expert Witness Recap

on August 22, 2019

The last two years have been a whirlwind for those of us following the litigation response to the opioid crisis. Thousands of lawsuits have been filed throughout the country. Most notably, the National Prescription Opiate Litigation (a multi-district litigation).

So what is happening on next week? Well, one of the first major opioid trials took place in Oklahoma earlier this summer. When I say “opioid trial,” I mean the legal trial, not “clinical trial.” Forgive me, I had to make the joke. The trial took place and the judge is expected to deliver his ruling on Monday. Berkeley Lovelace, Jr., of CNBC, provides an in-depth analysis of the trial here.

The case was brought by the State of Oklahoma against Johnson & Johnson, et al. The Oklahoma attorney general is seeking damages in excess of $17 billion dollars. The state sued Johnson & Johnson claiming their sales and marketing practices fueled the opioid epidemic and created a public nuisance, resulting in approximately 6,000 overdose deaths. Any damages awarded, assuming there is not a settlement before the ruling, would be used for addiction treatment and preventative measures for the next few decades.

We, at Experts.com, have been following pharmaceutical litigation for a long time. In the last two years, we’ve been laser-focused on opioid litigation. We started to pay strict attention to the matter when we realized it was similar in magnitude as the civil lawsuits involving tobacco, in the 1990s. It meant we were going to see significant litigation for years to come.

With a database of expert witnesses, we set out to write multiple articles on the matter, in the form of question-and-answer-style blog posts. In addition, I’ve written a couple of guest blogs on the topic for other legal companies. This blog post is to recap these resources we’ve published over the last two years.

Two Years of Opioid Crisis Publications:

  1. Opioid Crisis – An increase in addiction medicine and pain management expert witnesses – November 6, 2017
  2. Kentucky AG files lawsuit against opioid distributor McKesson – January 22, 2018
  3. Pain and Addiction Expert Witness Comments on 72,000 Opioid Deaths in 2017 – August 22, 2018
  4. Judicial Analytics in California Opioid Litigation – January 23, 2019
  5. Legal and Expert Witness Staffing for Opioid Litigation – June 18, 2019

We Expect More Stories in the Future:

Unfortunately for our country, we expect to be writing about these lawsuits for years to come. What happens next week, may pave the way for more lawsuits and major settlements? We don’t know how it might end, but we’re pretty sure the pharmaceutical companies will end up paying a lot of money. If not in Oklahoma, in other lawsuits still to come.

UPDATE: 08/26/2019

Today, Cleveland County District Court Judge Thad Balkman ruled against Purdue Pharma LLP, Johnson & Johnson and others. He ruled the defendant’s in the first civil opioid trial are responsible for causing a public nuisance, and held them liable for abatement of the nuisance, in the amount of $572+ million.

You can read the verdict here.

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Kentucky AG files lawsuit against opioid distributor McKesson

on January 22, 2018

As I mentioned in our blog post on November 6, 2017, we would be covering the US “opioid crisis” as the lawsuits against manufacturers and distributors heated up. Today, we found out Kentucky Attorney General, Andy Beshear, filed a complaint against McKesson Corp. According to this story by Reuters, Mr. Beshear “accused drug distributor McKesson Corp of helping fuel the opioid epidemic by failing to halt shipments of suspiciously large or frequent orders by pharmacies of prescription painkillers.”

Mr. Beshear’s office filed suit in Kentucky state court. The complaint further alleges McKesson filled suspicious orders and shipped tremendous quantities of prescription opioid pharmaceuticals to Kentucky pharmacies, without reporting them to authorities or preventing the shipments. According to the AG’s own press release, “Federal and state law requires pharmaceutical distributors to monitor and report to law enforcement when it ships large or suspicious supplies of opioids to a state or region.”

There’s a wide array of state and local governments pursuing lawsuits against pharmaceutical companies, including McKesson, for deceptive marketing and failures to report suspicious activity which are resulting in opioid addiction and deaths within their cities and towns.

Let’s take a look at causes of action and potential experts:

Based on the complaint, we see that the Kentucky AG is attacking McKesson on some interesting causes of action, including: Consumer Protection Act Violation; Public Nuisance; Negligence per se; Negligence; Unjust Enrichment; Fraud by Omission; and Medicaid Fraud. Mr. Beshear is seeking punitive damages for the State of Kentucky. The complaint further provides the Kentucky Consumer Protection Act protects citizens from “predatory or inappropriate acts by sellers of goods.” The Act states “unfair, false, misleading, or deceptive acts or practices in the conduct of any trade or commerce are hereby declared unlawful.”

With this information it appears deceptive marketing practices will be an issue in this lawsuit. Both Kentucky and McKesson are likely to employ marketing expert witnesses to address which practices may or may not be false and misleading.

Within this cause of action, Mr. Beshear further alleges violations of the Kentucky Controlled Substances Act. This Act creates a “broad duty on the part of wholesalers to monitor, detect, investigate, refuse to fill, and report suspicious orders of prescription opioids.”

One can only imagine there will be an argument over what constitutes a “suspicious order of prescription opioids.” As such, we expect both parties will be retaining pharmaceutical and pharmacy industry experts. The parties are likely to argue about the existence of indicators used to alert a distributor when a suspect order is placed. I anticipate the parties will be looking to pharmaceutical supply chain or logistics expert witnesses to provide background about notification and indicator systems for identifying suspicious orders.

What relief is the Kentucky AG seeking?

By reviewing the complaint and articles mentioned above, Kentucky is arguing McKesson’s activity has resulted in overdoses which put a drain on emergency services and hospitals. I’m certain Mr. Beshear will argue the costs of medical services have increased significantly as the state has had to deal with opioid overdose.

I further envision an argument will be made about the increase in law enforcement and first responder costs associated with fighting the illegal sales of heroin and other opiates stemming from addiction.

The complaint makes it pretty clear Mr. Beshear is seeking punitive damages on behalf of Kentucky. That being said, both parties are going to employ damages experts. This may involve the use of economists and forensic accountants to determine the amount of financial damage inflicted on Kentucky by McKesson’s actions.

Final Thoughts:

As I’m sitting here in California, I do not understand the true ramifications of the opioid crisis on the State of Kentucky. I am interested to see what individual civil litigation options may be available to the citizens of Kentucky. As such, I invite my friend Daryl Dixon of Daryl T. Dixon Law, in Paducah, Kentucky, to provide us with his thoughts on this subject on his own blog! Ball is in your court, Daryl. Let’s see what the Wildcats have for me…

UPDATED 02/07/2018:

Here is the response from Daryl T. Dixon – Examining the Opioid Crisis: What are my options?

 

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Opioid Crisis – An increase in addiction medicine and pain management expert witnesses.

on November 6, 2017

In the nearly 8 years that I’ve been with Experts.com, I have noticed a massive increase in the number of addiction medicine and pain management expert witnesses marketing their services with our company. Between 2010, when I joined Experts.com, and today, the increase has been nearly five-fold.

Is this increase a surprise? Based on what we’re seeing in the news, the answer is no. The United States is experiencing an opioid epidemic. According to CNN’s Opioid Crisis Fast Facts, “more than two million of Americans have become dependent on or abused prescription pain pills and street drugs.” CNN further explains, “during 2015, there were 52,404 overdose deaths in the United States, including 33,091 (63.1%) that involved an opioid. That’s an average of 91 opioid overdose deaths each day.”

Just last week, I spoke to one expert witness who experienced an opioid-related death in his family.  The same day, hours apart, another expert began promoting his pain management and addiction medicine services on our site. This epidemic is impacting millions of families throughout our country. As a result of this epidemic, and much of the overdoses stemming from prescription medication, we are beginning to see significant litigation in the area of opioid-based pharmaceuticals.

Our Opioid Litigation Experiences:

Experts.com has processed more than a handful of expert witness referrals related to opioids. The cases have ranged from prescription abuse in family law settings to overdose issues resulting in wrongful death actions. Probably the most interesting opioid-related matter was as follows: general counsel for a mining company in a small town discovered the townspeople were using methadone at a rate approximately 5 times higher than the national average. Many citizens of the town were also employees of the mining company. They grew concerned about the potential liabilities of employees operating heavy equipment while ingesting powerful pain killers. The company decided to do some testing which triggered some privacy concerns and potential litigation. We have delivered toxicologists, addiction medicine specialists, and pain management professionals in dozens of different opioid-related cases.

Recent Litigation:

In the last few years, we have seen stories of both civil and criminal litigation related to the opioid epidemic, even before it was claimed to be a crisis. Here are a few of the cases you may want to follow:

Civil Litigation:

There have been many lawsuits against Purdue Pharma (maker of OxyContin) since the early 2000’s. As one article explains, more and more state and local governments are launching lawsuits against the manufacturers and distributors of heavy-duty pain medications. The frequency of these lawsuits is almost weekly.  In addition to Purdue Pharma, Cardinal Health, Teva Pharmaceuticals, Janssen, and others are targeted.

In July of this year, one of the lawyers, Michael Moore, who targeted tobacco companies in the 1990’s, began urging state lawsuits against the drug makers. By August, an Oregon County sued pharmaceutical companies for $250 million for allegedly persuading physicians to over prescribe opioids. As of September, Attorneys General in 37 states were urging insurance companies to do more to curb the opioid epidemic.

What can we deduce from the high-profile coverage of civil suits against the makers of pain killers? In my assessment, the worst is yet to come for the drug makers. This does not mean the drug makers are defenseless against the lawsuits. After all, there are others in the supply chain to be blamed: doctors, pharmacies, and the patients themselves. Over the long-term, the pain medication lawsuits are likely to be very costly for manufacturers and distributors.

Criminal Litigation:

For the sake of brevity, I’m going to ask you to assume that there is significant drug related crime and we’re going to skip the standard (possession and distribution) opioid cases. Where I have noticed a substantial increase, both in the news and in requests for expert witnesses, is in criminal prosecutions of prescribing physicians and pharmacists.

As CNN described, “doctors are increasingly being held accountable — some even facing murder charges — when their patients overdose on opioid painkillers they prescribed.” The article further explains that the DEA took action against 88 doctors in 2011 and 479 doctors in 2016. One of the doctors described has been convicted of murder. I see at least one new story a week where a doctor, or pharmacist, is being held responsible for the excessive amounts of pain killers prescribed.

The numbers described in the article above, combined with a more aware public, lead me to believe we’ll see even larger numbers of DEA actions against doctors when the 2017 statistics are available.

Other Legal Issues:

As you can tell, I focused on the two areas that I’ve noticed the largest increase in visible litigation. We have processed many other expert witness referrals associated with opioid issues. Many overdose cases are resulting in medical malpractice actions as well as actions brought by medical boards for ethical violations by doctors.  We often see the requests for expert witnesses relating to emergency medicine physicians, toxicologists, pharmacy and pharmacology experts, and more.

Opioid litigation may very well be the “tobacco” litigation of our time.  As such, we are confident that we’ll have more to write about and discuss in the future.

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PHARMACEUTICAL PRODUCT LIABILITY

on March 8, 2011

With the onslaught of legal drugs on the market, pharmaceutical product liability cases have become mainstream in the court system.  It boggles the mind how many possible harmful side effects there are for one medication alone.  Just listen to any commercial for depression medicine – and you’d better listen carefully.  They have to speak quickly to get them all in.

If a pharmaceutical company lists all possible harmful effects, does that relieve them from liability?  Do a certain number of people have to die or have a stroke in order for the drug to be pulled from the market?  Conversely, did the patient do something to exacerbate the problem?  Take too much of the medicine?  Not enough?  Is the pharmacy liable for miscalculating the dosage?

This is when Pharmaceutical, Pharmacology and Toxicology Experts and Consultants come into play.  The variables are so complex and many that a case cannot be thoroughly adjudicated without the scientific and practical experience that these particular Experts hold.  They use their skills to review medical and pharmacy records, evaluate drug delivery standards of care, toxicity, adverse drug events and even FDA regulations.  These Experts and Consultants are retained to determine the period of time a drug was used and a patient’s average compliance or adherence to taking a drug, among so many other things.

The bottom line is that Pharmaceutical, Pharmacology and Toxicology Experts and Consultants are essential to resolving complex medical issues involving pharmaceuticals and drugs.  That they play a major role in helping to regulate the industry, compensate the injured and defend the innocent cannot be denied.