Considerations for Plaintiff Attorneys when Starting a Successful Mass Tort Practice

John Ray
John Ray

Mass Tort Litigation has emerged as the only effective check on pharmaceutical and medical device companies that make dangerous products injuring thousands of Americans. Mass tort attorneys have filed 140,000 lawsuits in 250 federal multidistrict litigation dockets as of September 2016.

Many attorneys are expanding their personal injury practices to include mass torts because the US Judicial Panel on Multidistrict Litigation has organized the litigation so effectively against the multi-billion-dollar drug and medical device industry.

“The FDA is not a check or a balance on the pharmaceutical industry,” said Mass Tort Nexus Consultant John Ray, recently teaching a four-day course about mass torts in Fort Lauderdale, FL. “Plaintiff attorneys are the only check on the pharmaceutical industry.”

In recent years mass tort lawyers have recovered $10 billion in settlements for injured Americans: $4.8 billion for Vioxx, $1.8 billion for Yaz, $1.3 billion for the Stryker hip and $2.5 billion for the DePuy hip.

“The drug companies bake these cases into their business model,” Ray said. “Defendants call it a win when they don’t put a warning on their labels, don’t get sued and don’t have to pay a judgment at all. This means they got away with it. That happens a lot.”

When a federal MDL is created, the supervising judge will approve a standard short-form or long-form complaint, plus a plaintiffs’ fact sheet which replaces interrogatories. The consolidation of cases means that a mass tort lawyer can file a notice of appearance and file cases regardless of the jurisdiction of the plaintiff, defendant company or the location of the plaintiff’s attorney.

Criteria for a viable case

Cases that are attracting many mass tort attorneys now involve Xarelto, IVC filters and Pradaxa. Among the many factors determining the viability of a mass tort are:

  • Preemption. Congress has expressly preempted certain claims. Further, courts have ruled that generic manufacturers cannot be sued.
  • Statute of limitations: State laws govern when the statute of limitations starts to run, but in most federal litigation, the date that the FDA issues a “black box warning” for a drug marks the date when the time limit begins to run.
  • Legal viability. In many cases, research will show a connection between a drug and injuries among patients, but specific causation must be proved in a trial. Experts must be found who will survive a Daubert motion to disqualify.
  • Financial viability of the defendant. While Johnson & Johnson had $46.8 billion in annual income in 2015, some small makers of IVC filters went out of business before they could sell one.
  • Average case value. The average Pradaxa case settled for $160,000 in 2014, with some settlements valued up to $500,000, according to a grid created by US District Judge David R. Herndon.
  • Plaintiff numerosity. Cases in the Syngenta Corn Market Crash Litigation involve every corn producer in America, and IVC Filters have been implanted in millions of patients over the last 40 years.
  • Cost per client acquired. Costs can add up with Facebook advertising, website marketing, and lead generation companies. For example, The Sentinal Group will advertise for clients for a fee of $100,000 to obtain 250 calls for Xarelto plaintiffs, with 1 out of 5 calls leading to a signed client.
  • Case duration. Mass torts are litigation for the long haul, with the average case lasting 5 years and 4 months before settlement, according to Ray, with 7 years being a good benchmark for the duration of a case.
  • Case value. An example of a good outcome is with Pradaxa. The average settlement is $162,000. Calculating 40% in gross contingent fees would equal $64,800. Another 7% is deducted ($4,536) for the common benefit to pay the steering committee. Of the remaining fee of $60,204, a 40% referral fee of $24,015 is deducted for the co-counsel that handled the litigation. This leaves a net fee of $36,189 for the attorney who originated the case.
  • Financial resources. Costs to fund a case can be in the tens of thousands of dollars, with costs reaching hundreds of thousands for members of the plaintiffs steering committee.
  • Personnel resources. A law firm will have to train a small army of intake specialists to answer incoming calls when advertising is running. Additional personnel will be needed to obtain and review medical records.

Perfect timing

There are three phases of mass tort litigation, and perfect timing will be needed to enter a particular case.

Emerging Phase Cases. In this early phase, the cost to acquire a client is the least expensive, but there many issues of case viability. For example, the courts are still considering motions to consolidate cases involving Abilify and Roundup. With Abilify the FDA has issued a safety warning but not a black box warning. With Roundup the EPA has not classified the herbicide as a carcinogen, but foreign governments have.

Litigation Phase Cases. It is considered an ideal time to enter into a mass tort when the JPML has created a multi-litigation docket (MDL). Some 250 MDLs include mature litigation involving Benicar, Lipitor, Viagra, Xarelto and Zofran, and many legal issues have been settled. The supervising judge will schedule bellwether or test cases for trial.

Settlement Phase Cases. This is the very safest time to enter litigation because all an attorney must do is find qualified plaintiffs. Example cases involve transvaginal mesh, Levaquin and Pradaxa. However at this late phase the cost to acquire a client is at its highest.

“Whatever you do, maintain your single-event plaintiff’s practice,” Ray advised. “You will have to keep paying the costs of a mass tort case until it settles, and you will need a huge cash supply or credit line.”

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700 New Pradaxa Cases Filed in Connecticut State Court

 

 

 

 

 

 

 

 

So far there are 700 cases and climbing in the litigation consolidated in Connecticut, according to mass tort expert John Ray of  Mass Tort Nexus in Fort Lauderdale, and plantiffs can file there regardless of the state or original jurisdiction.

Before the first case was tried in the federal MDL, German drug maker Boehringer Ingelheim settled 4,590 cases involving Pradaxa (Dabigatran) for a total of $650 million in May 2014. Patients and their families claimed that Boehringer failed to properly warn them that the drug, which is used to prevent blood clots, caused serious and sometimes fatal bleeding that could not easily be reversed.

The average case settled for $160,000 in 2014, with some settlements valued up to $500,000, according to a grid created by US District Judge David R. Herndon.

Shortly after its release to market in 2011, Pradaxa was surrounded by more than 3,500 reports of serious adverse events. More than 750 of these reports involved the death of a Pradaxa patient. The federal MDL was created in August 2012 and the settlement came only 18 months later. The litigation produced 80 million pages of documents and the deposition of 48 defense corporate witnesses.

Qualifications to file

According to Ray, who spoke in a National Trial Lawyers webinar, following are the criteria to file in the state court:

  • The action cannot be filed previously in the federal MDL.
  • The client was not represented (signed) prior to 05/28/2014.
  • Applicable law for a Pradaxa injury without a death:  Connecticut (with a 3-year statute of limitations).
  • Applicable law for a wrongful death case: state of original jurisdiction.
  • Filing deadline: 07/27/2017 for non-death cases. This date is set by the statute of limitations, and no case filed after this date will be viable in the Connecticut litigation.

Click to read more facts about the Connecticut Judicial Branch Complex Litigation Docket

 

 

 

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Slides & Recording for Webinar: Mass Torts Update for Plaintiff Attorneys

5 Mass Torts for Plaintiff Attorneys Today

Broadcast August 31, 2016

Visit http://goo.gl/rOG9qt to see the slides and recording of this program.

John Ray
John Ray

What you will discover

For lawyers starting a Mass Torts practice, picking the right cases and having an effective law firm marketing campaign are essential. Our presenter John Ray will update plaintiff attorneys about 5 key Mass Torts:

  • New Pradaxa docket in Connecticut
  • IVC Filter
  • Xarelto
  • Fluoroquinolone antibiotics
  • Emerging: Roundup litigation

A Mass Tort is ordinarily a product liability case where hundreds of plaintiffs file suit against a pharmaceutical company. These cases are typically collected into one of 300 federal multi-district litigation dockets (MDLs).

Mass Torts is a multi-billion dollar immature market, with economies of scale and only a single barrier to entry. You have already overcome the barrier if you are admitted to practice law.

About our presenter

John Ray has been a leading consultant to the Mass Tort attorneys for more than a decade. His unique skill sets make him well suited to both teaching and consulting in the Mass Tort arena.

He graduated Magna Cum Laude from Brenau University in Atlanta and started a pharmaceutical and medical device company right out of school, selling it in an eight-figure deal when he was 35.
John’s tenure in the pharmaceutical and medical device field allowed him to gain an in-depth understanding of FDA regulatory matters, as well as, a thorough understanding of the science and epidemiology related to gaining FDA approval to market pharmaceuticals and medical devices. John’s inside knowledge of how “Big Pharma” operates gives him a unique perspective and skill sets that are very useful to Mass Tort plaintiff firms.

When John brought his “insider knowledge” and business acumen to the Plaintiff Mass Tort space, one of the first things he recognized was a lack of common terminology and well-defined metrics. John realized that firms were expressing the same concepts, but were not using the same terminology. As a result, John set out to define common terms and create methods for formulating important metrics for use by Mass Tort firms when evaluating litigations. The terminology and metrics John Ray developed are now commonly used by major Mass Tort Law firms.

John is highly sought after and writes sought-after white papers about both current and emerging torts. The accuracy of his analysis of emerging and ongoing litigations is unmatched.

The fact that John not an attorney has proven to be an asset. John thinks like a business person, employing creative problem solving and possesses an extensive set of business skills and industry-specific knowledge. He assists Mass Tort firms in making sound business decisions before and during any litigation they are involved in or are considering becoming involved in.

John is an expert at evaluating cases and looks at each tort as an individual “investment,” which can be quantified resulting in risk mitigation for you and your firm.

Contrary to popular belief, adding Mass Torts to your practice is not gambling, nor is there a secret society of Mass Tort attorneys. The only information you lack to be successful in the practice of Mass Torts is a business plan. As John says, this type of law is 80% business and 20% law. If you understand the business principles of Mass Tort law, you will be successful.

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New Study to Investigate Long-Term Xarelto and Pradaxa Use

xarelto bleedingA patient-centered research institute is conducting two studies that will compare the effectiveness of Pradaxa, Xarelto and other oral blood thinners to determine what the long-term effects are.

The Patient-Centered Outcomes Research Institute (PCORI) announced the $6.5 million studies to scrutinize anticoagulants including:

  • Warfarin
  • Dabigatran (Pradaxa, made by Boehringer Ingelheim)
  • Rivaroxaban (Xarelto, made by Janssen)
  • Apixaban (Eliquis, made by Bristol-Myers Squibb)
  • Edoxaban (Savaysa, made by Daiichi Sankyo)

The drugs are used to to treat clots and are often used for longer than the standard 3-month treatment period to prevent formation of additional clots, but the comparative safety and effectiveness of extended use is unclear, according PCORI.

Federal Xarelto Litigation is consolidated before US District Judge Eldon Fallon in MDL 2592 and the state litigation is consolidated in the Philadelphia Court of Common Pleas before Judge Arnold New. In the state MDL  Judge New has elected to allow “Efficacy Claims” to be filed in that MDL in addition to claims related to uncontrolled bleeding. Judge Fallon has yet to follow suit and may not.

Uncertainty about medications

Venous thromboembolism (VTE) causes more than half 500,000 hospitalizations and more than 100,000 deaths each year in the United States. VTE is typically treated with at least three months of an anticoagulant, or “blood-thinning,” medication. Afterward, patients are often given the option to extend anticoagulant treatment for a longer period to prevent VTE recurrence. Remaining on anticoagulants, however, can lead to serious bleeding complications and can be expensive and inconvenient for patients.

At present, there is much uncertainty about which medication is the best choice for extended VTE treatment, according to PCORI. Choosing the best anticoagulant strategy is particularly difficult when treating people of older age, people who have kidney disease, or people who have high bleeding risk, due to the scant evidence available on the relative benefits and harms in these populations.

The long-term goal of the project is to compare the benefits and harms of different anticoagulant options for the extended treatment of VTE, information that will be critical in helping clinicians and patients personalize their treatment decisions. The study focuses on people who have completed at least three months of anticoagulant treatment for VTE and compares the outcomes of 1) people who stay on anticoagulants with those who stop anticoagulants, and 2) those who are treated with extended warfarin compared with NOAC treatment. PCORI will also examine whether the benefits and harms of treatment differ by age, kidney function, or bleeding risk.

The study will be based in Kaiser Permanente Northern California and Kaiser Permanente Southern California, two large, integrated healthcare delivery systems that provide comprehensive medical care for more than 7.7 million patients in California. PCORI will identify in these health systems all adults treated for VTE from years 2010 to 2015 and collect information from electronic health records on their health history, anticoagulant treatment choices, and clinical outcomes. Next, PCORI will survey patients with VTE treated in more recent years (2014–2016) and measure their self-reported health, well-being, and satisfaction with treatment.

The main outcome of the study is the net benefit of one treatment strategy compared with another, measured in terms of the number of VTE events prevented and the number of bleeding complications induced. Because the study is an observational study of actual clinical care, PCORI will then apply advanced statistical techniques to maximize the validity of the results.

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Talcum Powder Plaintiff Seeks Centralization of Federal Ovarian Cancer Claims Against J&J

talcum powder cancer
By Sandy A. Liebhard, Bernstein Liebhard LLP, New York.

A talcum powder lawsuit plaintiff has filed a motion with the U.S. Judicial Panel on Multidistrict Litigation to centralize all federal ovarian cancer claims in a single court for the purposes of coordinated pretrial proceedings.

According to a Motion for Transfer filed with the Panel on July 15, the plaintiff has suggested the U.S. District Court, Southern District of Illinois, as the most appropriate venue for the proposed multidistrict litigation. (Case Pending No. 70).

This court is the location of MDL 2385-Pradaxa (Dabigatran Etexilate) Products Liability Litigation in East St Louis, IL.

Read our hard-hitting report:

Behind the $55 Million Verdict: Johnson & Johnson Knew About Talcum Powder Cancer Risks Since the 1970s

Court records show that at least 11 product liability claims involving talcum powder and ovarian cancer have already been filed in 10 federal jurisdictions. Among other things, the motion points out that the current plaintiffs reside in several different states, and it asserts that the Southern District of Illinois “would permit convenient travel for the parties and counsel as compared to travel to the East or West Coast.”

More than 1,200 talcum powder lawsuits have been filed against Johnson & Johnson nationwide, with litigation already underway in St. Louis, Missouri and New Jersey Superior Court. The federal docket also has the potential to be large, and would likely benefit from centralization, as coordinated pretrial proceedings would eliminate duplicative discovery and inconsistent court rulings.

Talcum Powder Ovarian Cancer Litigation

All the talcum powder lawsuits currently pending in federal courts similarly allege that regular, repeated application of Johnson & Johnson’s Baby Powder and Shower-to-Shower products to the genitals can increase a woman’s risk for ovarian cancer.

The complaints charge that talc particles can make their way into the vagina and migrate to the ovaries when used in this way. Over time, the accumulating talc can result in the type of inflammation that promotes the growth of cancer cells. While a number of studies published since the 1970s have suggested such a link, plaintiffs claim that Johnson & Johnson has failed to take any steps to warn women of this possible risk.

In April, a St. Louis jury awarded $55 million in compensatory and punitive damages to an ovarian cancer victim who used Johnson & Johnson’s talc-based powders for nearly 40 years as part of her feminine hygiene routine. In February, another Missouri trial ended with an award of $72 million for the family of a woman who died from the disease after using the company’s talc products for more than 30 years. (Case No. 1422-CC09012-01)

Follow our continuing coverage:

Plaintiffs 3-for-4 in Philadelphia Risperdal trials, confident punitive damages will be reintroduced

Kentucky AG Settles Risperdal and OxyContin False Marketing Cases for $39.5 Million

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Alere Recalls Inaccurate INRatio Blood Monitor for Patients Taking Pradaxa or Xarelto

Alere INRatio2 PT/INR Monitor System
Alere INRatio2 PT/INR Monitor System

Diagnostics company Alere Inc. announced  a voluntary withdrawal of the Alere INRatio and INRatio2 PT/INR blood Monitoring Systems.

Patients taking blood thinners like Coumadin, Jantoven, Warfilone (warfarin), Pradaxa (dabigatran), Xarelto (rivaoxaban), or Lovenox (enoxaparin), can to monitor their blood levels at home instead of at a lab, by using the Alere INRatio, INRatio2 PT/INR Monitor System, or INRatio Test Strips (collectively the Alere INRatio Monitoring System) to monitor their international normalized ratio (INR) while undergoing anticoagulation therapy.


For more, read our story Xarelto MDL 2592 Important Developments.


The monitor is supposed to perform a simple blood test, letting a patient and doctor doctor know if the medication is working properly or if a dose adjustment is needed.

Over the course of the past two years, Alere invested in the research and development of software enhancements to address the potential, in certain cases, of the system to deliver a result that differs from that of another measurement method.

FDA: Not effective

The FDA notified the company that it believes the company’s studies do not adequately demonstrate the effectiveness of the software modification and advised Alere to submit a proposed plan to voluntarily remove the INRatio device from the market.

Alere seeks an orderly transition for patients requiring anti-coagulation monitoring and will provide a timeline to discontinue the product line. Alere will provide further information on patient transition to patients and healthcare providers. The FDA suggest that patients speak with their healthcare providers prior to making any changes to their current PT/INR monitoring practices.

In other news, Alere Inc. was hit with a securities fraud lawsuit on April 22, accusing it of artificially inflating its share prices ahead of the Feb. 1 announcement of its proposed $5.8 billion acquisition by Abbott Laboratories Inc.

The shareholder lawsuit, filed in federal court in Boston, accused Alere of misleading investors by stating that its financial reporting followed generally accepted accounting principles. The plaintiffs, a group of individual investors, cited a federal probe into the company’s accounting for overseas sales in arguing that Alere had not adhered to those principles.

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