United States Judicial Panel on Multidistrict Litigation: November Meeting Overview

The next hearing session of the United States Judicial Panel on Multidistrict Litigation is scheduled for November 30, 2017 in St. Louis, Missouri. Eight matters are set for oral argument to consider motions to transfer each to one centralized district for coordinated pretrial proceedings. The matters include trending issues such as Equifax’s massive 2017 data breach and the national opioid litigation against Big Pharma manufacturers and distributors. Ten matters will be considered for centralization without the parties making oral arguments.

What is the United States Judicial Panel on Multidistrict Litigation?

Multidistrict litigation is a mechanism for increasing efficiency in the federal court system. Created through an Act of Congress in 1968, 28 U.S.C. 1407, the law allows for the transfer of civil actions involving common questions of fact to one federal district court for coordinated or consolidated pretrial proceedings. To transfer a case, the Judicial Panel on Multidistrict Litigation must determine that the transfer will (1) be for the convenience of parties and witnesses; and (2) promote the just and efficient conduct of the related lawsuits. The efficiency in transferring cases to on federal court, or “centralization,” is accomplished through avoidance of discovery duplication, prevention of inconsistent pretrial rulings, and conserving resources of the parties, their attorneys, and the judiciary. If the Judicial Panel determines a case should be centralized, they will also determine at the hearing which Judge will handle the centralized proceedings.

The Judicial Panel on Multidistrict Litigation consists of seven sitting federal judges appointed to serve on the panel by the Chief Justice of the United States Supreme Court. Appointment is reflective of a judge being held in high esteem on the bench. The current Chair of the panel is Judge Sarah S. Vance from the Eastern District of Louisiana.

Currently, there are Multidistrict Litigation matters pending in disaster cases involving the September 11 terrorist attacks, the Deepwater Horizon oil spill; intellectual property; employment cases; securities litigation; and several others. Multidistrict Litigation is most frequent in cases involving products liability, antitrust, or marketing and sales practices. To date in 2017, Multidistrict Litigation has been formed in 9 products liability matters; 4 marketing and sales practice matters; and 2 antitrust matters.

multidistrict litigationMatters Set for Oral Argument

The following matters are scheduled for oral argument during the hearing session:

  • MDL No. 2777 – In re: Michael Stapleton Associates, Ltd., Fair Labor Standards Act (FLSA) and Wage Hour Litigation
  • MDL No. 2800 – In re: Equifax, Inc., Customer Data Security Breach Litigation
  • MDL No. 2801 – In re: Capacitors Antitrust Litigation (No. III)
  • MDL No. 2802 – In re: Epipen (Epinephrine Injection, USP) Employee Retirement Income Security Act (ERISA) Litigation
  • MDL No. 2804 – In re: National Prescription Opiate Litigation
  • MDL No. 2806 – In re: McGregor-Mayweather Boxing Match Pay-Per-View Litigation
  • MDL No. 2807 – In re: Sonic Corp. Customer Data Security Breach Litigation
  • MDL No. 2808 – In re: Anthony Spencer Green, Sr. Litigation

Notable Motions to Transfer

MDL No. 2800 – In re: Equifax, Inc., Customer Data Security Breach Litigation. This matter involves over 300 cases filed against the consumer credit agency, alleging violations of state and federal laws for the company’s purported failure to use adequate safeguards to protect consumers. The alleged failures resulted in unauthorized individuals gaining access to Equifax, Inc.’s data network storing the private information of 143 million consumers. The Plaintiffs suing Equifax, Inc. moved for consolidation when only 22 cases were pending and noted numbers were likely to rise quickly given the amount of victims; by the morning of the hearing, over 300 cases had been filed. Equifax, Inc. acknowledged the data breach in September 2017; records accessed included names, Social Security numbers, birth dates and, in some cases, driver’s license numbers.

MDL No. 2804 – In re: National Prescription Opiate Litigation. Counsel representing several Plaintiffs filed for consolidation of the actions of state, county, and municipal governments and other agencies against opiate manufacturers Purdue Pharma, Teva/Cephalon, Janssen, Endo, Actavis, and Mallinckrodt and distributors McKesson Corporation, AmerisourceBergen Corporation, and Cardinal Health, Inc. The lawsuits allege negligence as well as violations of public nuisance laws, state consumer protection statutes, and the Federal Racketeer Influenced and Corrupt Practices Act, 18 U.S.C. §§1961, et seq. Plaintiffs allege opioid manufacturers and distributors misrepresented the risk of addiction associated with opioid use to regulators, doctors, and patients and failed to report suspiciously large orders of their drugs, actions which allegedly contributed to the current nationwide opioid epidemic.

Anaphylaxis Possible Risk of Recalled EpiPen Auto-Injector, Epi-Pen Jr Auto-Injector

A company beneath the umbrella of pharmaceutical giant Pfizer has initiated a clawback of its recalled EpiPen Auto-Injector and EpiPen Jr Auto-Injector for failing to activate in time of need.

The U.S. Food and Drug Administration notified the public March 31, 2017 about the recall by Meridian Medical Technologies / Mylan N.V. The agency stated in a news release that 13 lots of the epinephrine-injection products might have a defective part.

“While the number of reported failures is small, EpiPen products that potentially contain a defective part are being recalled because of the potential for life-threatening risk if a severe allergic reaction goes untreated,” according to the release.

There have been two instances of the device failing outside the United States that have put users at risk of anaphylaxis – an allergic reaction so severe that it is life-threatening. The recall was initiated domestically and will be implemented in markets in Asia, Europe and South America. Still, the FDA asks consumers who require the devices to keep them until a replacement is obtained. None of the 13 lots in question affects the generic EpiPen Auto-Injector, also manufactured by Meridian Medical Technologies.

“The authorized generic has the exact same drug formulation, has the exact same operating instructions and is therapeutically equivalent to EpiPen Auto Injector, and may be substituted for EpiPen Auto Injector,” Mylan N.V. states on its Web site.

Recommendations in the wake of the recall are for consumers to visit mylan.com/epipenrecall for information and updates and to learn how and where to return their device once a replacement is obtained. Healthcare practitioners are asked to report any adverse events involving the EpiPen Auto-Injector or EpiPen Jr Auto-Injector by downloading an FDA form. They also can call 800-332-1088.

Visit the FDA’s recall page for more information.

Doctors to Patients: “Take A Hike”

The National Park Service is celebrating its centennial – an historic occasion that will culminate Aug. 25. On that date in 1916, President Woodrow Wilson signed into law an act creating a new bureau within the Department of the Interior that would bear responsibility for protecting the then-35 parks in existence. Today, more than 400 national parks grace the country.

Another milestone occurred on April 24, when U.S. Surgeon General Vivek Murthy and a team of healthcare workers joined National Park Service Director Jonathan Jarvis for the inaugural Park Rx Day. The day promoted the importance of getting out in nature and putting one foot in front of the other.

Nature’s Natural Antidote

Abbey_and_the_mountain

Take a hike! This trail was once walked by Henry David Thoreau and overlooks the Nashua River Valley from Saint Benedict Abbey.  By Benabbey via Wikimedia Commons

“Nature is good for us – it is a great antidote to a variety of ailments, including obesity, heart disease, and depression,” Jarvis said in a press release titled “Doctors Warn that Hiking is Contagious: Park Rx Day Events in 26 States Encourage Everyone to Take a Hike.” “A growing number of public health officials now prescribe time in parks for the overall well-being of their patients. In fact, it is becoming a standard medical practice to tell patients to take a hike.”

Park Rx Day highlighted the National Park Service program Park Rx, or park prescriptions. The program is a collaborative effort involving doctors, nurses and other community partners to use the nation’s greenspaces as a tool for improving health and fighting obesity. Breathing fresh air and admiring beautiful scenery has other benefits, too.

“Psychologically, time spent exercising in nature has been reported to not only reduce stress, and improve attention, but also positively impact mental restoration and coping with attention deficits,” the Park Rx Web site states.

Exercising in nature encourages friendships, socialization and wellness, as well.

“The reason for this is because many activities conducted outdoors – such as walking with others, picnicking, and sitting in a park can be done with one or many individuals,” according to the Park Rx Web site. “As a result, activities such as these can work to strengthen and build both an individual’s and a community’s social networks and bonds.”

Park Rx Day Activities

Activities during Park Rx Day included bicycling, talks, tours, wildlife viewing and yoga, in addition to walking. Hospitals and insurance companies provided special screenings for those interested in checking their status.

Patients are encouraged to talk to their physicians about activities they can do in nearby parks, and physicians equally are encouraged to write a park prescriptions for such things as climbing a tree, following animal tracks or going for a run.

“We know that an average of 22 minutes a day of physical activity – such as brisk walking in a national park – can significantly reduce the risk of heart disease and diabetes,” Murthy said in the press release. “The key is to get started because even a small first effort can make a big difference in improving the personal health of an individual and the public health of the nation.”

Questions About FDA’s Drug Approval Process Answered

winding road

Is the road to FDA approval of a new drug as long and winding as it sometimes seems?

The road to U.S. Food and Drug Administration approval of pharmaceutical manufacturers’ medications is a long and winding one. A dynamic process tinged with favorable – and unfavorable – factors can take a drug from lab to label in 10 months or less.

Consumer clarity on how certain products make it to market and whether they are safe is lacking, so much so that some are left wondering whether the FDA is being overpowered by “Big Pharma.” The issue is the focus of a Living Safer Magazine cover story.

“Admittedly, there’s not much in the way of studies to disprove that the FDA is doing its job,” writes Stephanie Andre in an article titled “The ABCs of the FDA Approval Process.” “Yet, one still feels as though the agency could slow down the process, instead of giving way to notions that drug companies can buy their way toward faster approvals, thereby shortening up clinical trials and never fulling understanding the long-term effects of such medications.”

At first, the drug-approval process seems cut-and-dried. Companies developing new prescriptions test them on animals to determine initial efficacy, then conduct clinical trials on humans to measure outcomes relating to specific diseases. The next step involves filing a New Drug Application, or NDA, with the agency. If the drug is made from biological elements as opposed to chemicals, another form called a Biologics License Application, or BLA, is submitted. Both documents contain test results, details on product manufacturing and contents of the label.

“The label provides necessary information about the drug, including uses for which it has been shown to be effective, possible risks, and how to use it,” Andre writes. “If a review by FDA physicians and scientists shows the drug’s benefits outweigh its known risks and the drug can be manufactured in a way that ensures a quality product, the drug is approved and can be marketed in the United States.”

But what about the risks? How much is known about them? Such questions might be prompted by the fact that the FDA does not conduct any testing. The agency instead relies on results from the sponsor seeking approval and occasionally vets the data through its Center for Drug Evaluation and Research, or CDER. The advisory committee is called upon when there are varying degrees of uncertainty about the drug, said Dr. Mark Goldberger, a former CDER director.

“Some considerations would be if it’s a drug that has significant questions, if it’s the first in its class, or the first for a given indication,” Goldberger said. “Generally, the FDA takes the advice of advisory committees, but not always. Their role is just that – to advise.”

Patients have both the responsibility and the right to gauge the safety of prescriptions they take, and the FDA acknowledges that by providing a list of “Frequently Asked Questions about the FDA Drug Approval Process” on its Web site.

Metal-on-Metal Hip Implant Case End With Significant Jury Award

If the bellwether trial of a plaintiff who suffered complications from a metal-on-metal hip implant is any indication of future verdicts, Wright Medical Technology should be worried.Savoyard-Page133

A jury awarded $11 million to a woman suing for damages following surgery to replace her joint with the company’s Conserve system. The woman, Robyn Christiansen, of Utah, experienced severe pain accompanied by a grinding sound in her groin while practicing yoga. Her hip dislocated, and she had to undergo a second surgery, called a revision, to repair the problem. During the revision, the surgeon found signs of metallosis, an adverse reaction to the metal-on-metal that causes tissue damage and tumors and is extremely debilitating.

After hearing the case, an Atlanta jury awarded the plaintiff $10 million in punitive damages and another $1 million in compensatory damages in U.S. District Court for the Northern District of Georgia in Atlanta.

“Christiansen was diagnosed as having a loose and displaced acetabular cup in her right hip replacement, which required revision surgery,” according to Harris Martin Publishing, which reported the news.

Multiple victims have taken legal action against Wright Medical Technology for its defective device. Each case is different, yet each has a lot in common. Plaintiffs complain of pain and strange sounds, like Christiansen, but also of loss of movement and swelling. Almost all cases require revisions. Still, the Conserve system has not been recalled.

According to the National Joint Registry’s 2015 Annual Report, the Wright Conserve Resurfacing Cup can experience a revision rate of up to 11.58% at only 7 years. 

The defect stems from the cobalt-chromium alloy that comprises the femoral head and acetabular cup. As the patient walks, the system, mimicking the replaced joint, emits pieces of metal into the body, causing metallosis.

“There may be the potential for a local tissue reaction due to the presence of the foreign material alone,” the American Recall Center warns. “There exists a potential of debris forming over time along with elevated metal ions formed with the constant rubbing of the surfaces together.”

Patients experiencing symptoms three months or more after their surgeries are strongly advised to follow up with their surgeons.

For more information on Wright Medical Technology Conserve Hip Implant Products Liability Litigation, click here.

Searcy Denney Celebrates Stryker’s Commitment to Settlement

Today Stryker announced that enrollment in the proposed Rejuvenate and ABG II hip implant settlement program has reached 95% and the company will be following through with its commitment to resolve over 4,000 lawsuits over the recalled hip implants. Had enrollment fallen short of 95%, Stryker could have walked away from the Stryker settlement program.

Attorney Cal Warriner

Attorney Cal Warriner

Attorney Brenda Fulmer

Attorney Brenda Fulmer

This development is fulfilling for us at Searcy Denney since our commitment to Stryker victims dates prior to the recall. Searcy Denney lawyers filed the first case in the country and currently have more cases on record than any other firm in the country. Cal Warriner of our firm served on the Plaintiffs’ Steering Committee for this litigation and spearheaded the development of the scientific evidence. He also served as Co-Chair of the American Association for Justice’s (AAJ) Stryker Rejuvenate and ABG II litigation group. More importantly, he served as part of the court-appointed negotiation team that spent months hammering out this settlement.

According to Cal Warriner, “The fact that 95% of all qualified claimants chose to opt into the program speaks volumes about the quality and depth of the settlement program. It’s a great deal for most of those who unfortunately were implanted with these defective devices.”

Searcy Denney continues to represent victims who either chose to opt out of this settlement or do not qualify for the settlement. Brenda Fulmer, another Searcy Denney attorney intimately familiar with the Stryker cases said, “I anticipate we will be working on failed Rejuvenate and ABG II cases for a long time into the future.”