Category: Alerts

Syngenta Slammed with $218M Verdict in First GMO Trial

By Emily Cox
Syngenta GMO Corn Verdict Is Only the Beginning
Photo by Alice Popkorn

A federal jury ordered Syngenta AG to pay $217.7 million to Kansas corn producers Friday over carelessly commercializing a genetically modified corn seed variety before China approved importing it.

More than 7,000 Kansas farmers alleged that Syngenta rushed its GMO seed to market before getting approval from China to export the resulting crops there.

Syngenta said it invested 15 years and $100 million developing its Viptera seed strain. The strain has a trait called MIR162 that protects against pests like corn borers, cutworms, earworms, and armyworms. When Monsanto Co received Chinese approval for a comparable seed strain, Syngenta allegedly thrust its strain into the stream of commerce even though it knew Chinese approval was going to be a problem.

Court papers indicate that Syngenta initially assured stakeholders that China would approve the grain in time for the 2011 crop. However, a company document showed that Syngenta’s then-CEO, Mike Mack, knew that China would object to his company’s seed strain. The company continued to aggressively market the seed strain regardless, intending to “pressurize” China into accepting it.

“Syngenta rushed this product to market to serve its own commercial interests,” a lawyer for the plaintiffs said.  “No consideration was given to the farmers. For Syngenta, there was no risk. It was all on the backs of the farmers.”

Chinese approval remained elusive for Syngenta. But, some exporters sent shipments of the genetically engineered corn to China anyway. In 2013, China stopped shipments, claiming the GMO seed had contaminated them. Most of the farmers in the class action didn’t grow Viptera. However, elevators and shippers typically mix grain from large numbers of suppliers. This made it difficult to source Viptera corn, causing China to also reject grain that would have normally been allowed in the country.

Syngenta’s Mad Dash to Market Leaves Corn Futures in the Dust

China barred an estimated total of 1.4 million metric tons of U.S. corn from entering the country, cutting the U.S. off from the world’s fastest-growing market. As demand for American corn plummeted, it took corn futures with it. While China approved Syngenta’s GMO seeds a year later, the embargo had already caused lasting damage. Corn from Ukraine and other countries had already gained a firm foothold in the market and continue to supplant U.S. crops today.

Since the 2013 Chinese ban, the average U.S. cash corn price has tumbled 20 percent. Chicago Board of Trade futures also fell 15 percent. Syngenta denies that the Chinese rejection is to blame for lower prices. However, cash prices peaked the year prior to the embargo in August 2012 at $8.26 a bushel. Prices are only now starting to creep back up. On June 22, the price was $3.30, up from $2.73 a bushel in September. All corn producers have been hurt by this price drop.

Only the Beginning of Syngenta Lawsuits

This was the first case over Syngenta’s GMO corn seeds to go to trial. Thousands of other corn producers and traders are also seeking damages over Syngenta plowing through the U.S. corn market to fill its coffers. Court papers indicate that damages for farmers nationally totaled $5.77 billion.

“This is only the beginning,” the Kansas farmers’ attorney said.  “We look forward to pursuing justice for thousands more corn farmers in the months ahead.”

A Minnesota trial, involving about 60,000 cases, goes to trial next month. It and the Kansas trial are serving as bellwether trials to provide guidance on resolving the complex litigation that is interwoven throughout the nation’s state and federal courts. Lawyers will gauge jury reactions to evidence that is likely to appear throughout the litigation.

District Judge John Lungstrum oversaw the Kansas City trial and will continue to preside over much of the litigation. He has certified eight statewide classes and said he will schedule another trial for January or February. Farmers in 14 additional states are waiting for class certification by Judge Lungstrum.

Ironically, the Kansas trial comes as state-owned conglomerate ChemChina, also known as China National Chemical Corp, is completing its $43 billion acquisition of Syngenta.

Justice Sotomayor Adds a Bright Spark to the Reserved Supreme Court Bench

By Emily Cox
Supreme Court Justice Sonia Sotomayor
Photo by CKnight70

Law360 continues its engaging Supreme Court Justice interview series with the exuberant and fearless Justice Sonia Sotomayor.

Going before the extroverted justice can be intimidating, as she is “very inquisitive” at oral arguments. She acknowledges that this can come off as intense. Attorney interviews published in the annual Almanac Federal Judiciary resoundingly agree with her. “Frighteningly smart.” “Well-prepared.” “You need to be on top of it with her on your panel.”

As the interviews are anonymous, not every attorney was as kind in their assessment. “Harsh.” “Terror on the bench.” “She asks questions to see you squirm.”

The trajectory that elevated her from a Puerto Rican child in the Bronx public housing projects to the pinnacle of the American justice system is the stuff of legends. Her father passed away from alcoholism when she was nine, leaving her to manage her own diabetes. However, through it all, she maintained her fierce sense of self that is practically tangible when she takes the bench. Her sharp intellect, discipline, and self-reliance fueled her rise from the projects to the nation’s highest court. Along the way, she earned a Princeton degree with highest honors, a Yale law degree, served as a New York City assistant district attorney, and presided on a federal district court bench.

Justice Sotomayor Finds Power in Defeat

Justice Sotomayor’s steadfast belief in the power of dissents is a tribute to her indomitable character. When she fails to turn the tide in cases she believes in, she doesn’t just call it a day and move on to the next case. She sits down and writes “a very step-by-step-by-step destruction of whatever the majority is saying.” And, while she values respect among the bench, it won’t stop her from calling out her colleagues occasionally.

“If you seriously think the court has gone off route, you want the dissent calling the clarion and reminding people of what they’ve done and why they have gone off stride,” the justice said.

Sotomayor Dissents Turn a Public Eye to Serious Problems

While Justice Sotomayor might not be the most prolific dissenter, she maintains a steady output of passionate and forceful dissents that reflect a profound sense of civil morality. Even when Justice Sotomayor does not win in the courtroom, she manages to turn a public eye to serious problems with her dissents. According to the justice, she is often writing so that those in positions of power can address these issues outside of the courtroom. The justice has found that these people are listening. After the Supreme Court passed over an Alabama death row inmate’s plea, she voiced her concerns about Alabama’s capital punishment sentencing scheme in a 17-page dissent. In particular, she noted that Alabama’s elected judges levied more death sentences despite jury recommendations during election years. This suggests voting-booth pressures. The justice went on to say that it “casts a cloud of illegitimacy over the criminal justice system.”

These concerns made headlines and ended up winning the day. First, Delaware and Florida took heed and struck down similar laws. Alabama followed suit this past April when Gov. Kay Ivey signed a bill to invalidate judicial overrides in the state.

However, people in power are not her only audience. At times, she writes for the losing side of the case, “because sometimes, people need to hear that their views have some sense of legitimacy.”

Justice Sotomayor Champions Race Relations

As a Latina, Justice Sotomayor takes a special interest when she believes the majority has impeded civil rights or damaged efforts to bridge the nation’s racial divide. Utah v. Strieff is among her most poignant and famous such dissents. The case questioned if courts should suppress evidence the police seize during an unlawful stop even if they later discover that there was a warrant in place. The five-judge majority decided that this particular stop was an isolated incident. Justice Sotomayor, partly joined by Justice Ginsburg, cautioned that this precedent gives police the power to stop anyone and demand identification to check for warrants even if they are doing nothing wrong.

She recounted the numerous indignities of a police stop, detailing invasive searches, being handcuffed, and left with an arrest record. She went on to say it’s common knowledge that people of color will bear the brunt of this ruling. She admonished that the court “must not pretend that the countless people who are routinely targeted by police are ‘isolated.'”

“They are the canaries in the coal mine whose deaths, civil and literal, warn us that no one can breathe in this atmosphere,” she wrote, echoing the dying words of Eric Garner, “I can’t breathe,” after police put him in a chokehold.

“They are the ones who recognize that unlawful police stops corrode all our civil liberties and threaten all our lives. Until their voices matter too, our justice system will continue to be anything but.”

Justice Sotomayor Attacks “Out of Touch” Views of Majority

2014’s Schuette v. Coalition to Defend Affirmative Action is one of Justice Sotomayor’s most high-profile dissents. In this case, six justices upheld a voter-approved Michigan law that eliminated affirmative-action policies at state universities. Justice Ginsburg joined her on the 58-page dissent.

“My colleagues are of the view that we should leave race out of the picture entirely and let the voters sort it out,” she wrote. “It is a sentiment out of touch with reality.”

Presenting a point of view that’s rarely heard in the almost 230-year-old institution, she went on to explain why.

“Race matters,” Justice Sotomayor wrote. “Race matters to a young man’s view of society when he spends his teenage years watching others tense up as he passes, no matter the neighborhood where he grows up.”

“Race matters because of the slights, the snickers, the silent judgments that reinforce that most crippling of thoughts: ‘I do not belong here.’”

Affirmative action opened doors for the justice in her journey from the Bronx to Ivy League and beyond. Consequently, she wished for her dissent to counterbalance some of the views of the majority. She continued that they “could be perceived as insulting” to people like her who’ve benefited from these policies.

“That’s why sometimes, someone like me has to say what they perceive as a different truth,” she said.  “So those who are thinking about these issues are not presented with a one-sided picture.”

Justice Sotomayor Lashes Out Against Mass Tort Restrictions in BMS Dissent

While Justice Sotomayor tends to champion affirmative action and civil rights’ causes, she also has taken on commercial interest opinions.

She was the sole dissenter this Monday in Bristol-Myers Squibb v. Superior Court of California. The ruling significantly strengthened mandates regarding tort jurisdiction. The majority held that similar injuries were not sufficient to tie nonresident plaintiffs to residents’ claims. Justice Sotomayor admonished the 8-1 majority ruling. She warned it will curtail or may even make it impossible to hold corporations accountable for nationwide conduct. She accused the majority of handing corporate defendants one more tool to prevent aggregation of individual claims. Furthermore, the ruling forces “injured plaintiffs to bear the burden of bringing suit in what will often be far flung jurisdictions.”

 

 

 

 

Supreme Court Plavix Ruling Tightens Reins on Mass Torts

By Emily Cox and Uzma Rahman
Plavix Ruling
Photo by Keith Williamson

A Supreme Court Plavix ruling Monday could have big implications on product liability cases by limiting the jurisdictional reach of state courts.

Almost unanimously, the Supreme Court decreed that a group of nonresident plaintiffs cannot sue Plavix manufacturer Bristol-Myers Squibb (BMS) in California state court, striking down a lower court’s earlier Plavix ruling. The California Supreme Court ruling assumed jurisdiction based on BMS’ national marketing campaign and its nearly $1 billion in California Plavix sales. Furthermore, nonresidents’ injuries were similar to those suffered by Californians. This has long been accepted as adequate to establish jurisdiction in these types of mass tort cases.

Plavix Ruling Slams Door on Mass Tort Era

However, in an 8-1 opinion, the Supreme Court sided with BMS and the federal government. The high court ruled that California had not identified an “adequate link between the state and nonresidents’ claims.”

This is a big blow to so-called “plaintiff-friendly states” that are frequently “venue-shopped” by product liability plaintiffs, seeking more favorable outcomes. The Plavix ruling could scatter and shrink mass torts, slamming the door on an era when plaintiffs could pick their battlefield. These corporations have unimaginable resources at their disposal. Plaintiffs need every advantage possible for a fair fight, and the Supreme Court has ceded an important one.

The shock waves hit Missouri first, resulting in an immediate talcum powder mistrial Monday in a case against Johnson & Johnson involving three women who died from ovarian cancer after using the company’s talc-based products extensively for feminine hygiene. Two of the deceased were out-of-state residents. The ink used to pen the opinion had scarcely dried before Johnson & Johnson was applying the new jurisdiction precedent.

“Far Flung” Implications of Plavix Ruling

The Plavix ruling could make it harder for plaintiffs to sue corporations for product liability in any state.

“The effects of today’s opinion will be to curtail – and in some cases eliminate – plaintiffs’ ability to hold corporations fully accountable for their nationwide conduct,” Justice Sonia Sotomayor, the one holdout against the ruling wrote in her dissenting opinion.

She went on the write the ruling “hands one more tool to corporate defendants determined to prevent the aggregation of individual claims and forces injured plaintiffs to bear the burden of bringing suit in what will often be far flung jurisdictions.”

It also prevents plaintiffs from uniting to pool resources for singular actions against corporations that already have the resources for these legal battles in spades. Instead, individuals will have to go into battle in much smaller numbers in their home state or go deep into enemy territory to sue corporations on their home turf.

Traditionally, these courts tend to favor companies over the plaintiffs, as most large corporations tend to choose sympathetic states for incorporation. In fact, nearly half of the nation’s publicly traded companies are incorporated in notoriously corporate-friendly Delaware. These companies include BMS, Apple, Coca-Cola, Google, and Wal-Mart among their ranks.

All in all, Monday was a very good day for those on the right side of the V.

Behind the Plavix Ruling

For this case, BMS is incorporated in Delaware and headquartered in New York. Although it engages in business activities in California and sells Plavix there, there were no manufacturing practices in the state. None of the 575 nonresident plaintiffs ever alleged they obtained Plavix from a California source. They also did not claim their Plavix injuries occurred in California. Finally, they never indicated they received treatment for their injuries in California. However, BMS conducted the blood thinner’s marketing nationwide. The same advertising and distribution arrangements that reached the out-of-state plaintiffs also reached residents.

Thus, the lower court validated general jurisdiction based on BMS’ extensive activities in the state. The California Court of Appeal rejected the notion of general jurisdiction and established grounds of specific jurisdiction. The California Supreme Court affirmed this jurisdiction. According to a precedent case, specific jurisdiction is established when an affiliation “between the forum and the underlying controversy, principally, [an] activity or an occurrence that takes place in the forum State.” Both the California Court of Appeals and Supreme Court found specific jurisdiction exists because BMS’ “wide ranging” contacts with the state. Nonresidents’ claims were also similar in many ways to the California residents’ claims. Furthermore, BMS engaged in other activities in the state.

Plavix Ruling Overturns Lower Court

The US Supreme Court ruled that California courts lack specific jurisdiction to entertain nonresident claims in this case. Justices cited an insufficient connection between the forum and the specific claims at issue.

Justice Alito’s opinion explains that the approach of the California court is tricky to match with existing precedents. He wrote that the current facts resemble more of a weak form of general jurisdiction. Furthermore, the California court failed to properly identify a link between the state and the nonresidents’ claims. BMS’ nationwide presence coupled with similar injuries from Plavix does not create specific jurisdiction over nonresidents’ claims.

 

Generic Invega Recall Issued Due to Dissolution Problems

By Emily Cox
Generic Invega Recall
Photo by Open Grid Scheduler / Grid Engine

The drug manufacturer has issued a generic Invega recall as testing indicates that its extended-release tablets may not enter patients’ systems at the correct rate.

Teva Pharmaceuticals and the FDA announced the generic Invega recall this past Thursday after some pills failed a dissolution test. This suggests that less of the medication may be absorbed and consequently, may not work correctly.

Paliperidone Extended Release Tablets, 3mg treat schizophrenia and shizoaffective disorders. Teva Pharmaceuticals distributes the medication nationwide in the US to wholesalers. The FDA and manufacturer warn that consecutive doses of the defective product could wreak havoc on a patient’s mental well-being. It could even pose a threat to those around the affected individual.

“Taking a product for the treatment of schizophrenia and schizoaffective disorders that has failed dissolution could result in less drug being absorbed,” the FDA cautioned. “If two or more consecutive dosing regimens are with affected product, a failure to maintain therapeutic levels could occur, which could reduce effectiveness in treating a patient’s mental and/or mood symptoms, including suicidal thoughts and behavior, self-injurious behavior, mental hospitalizations, assaults, aggressive behavior, as well as vocal and motor tics.”

Teva has determined that there is low probability of consuming two or more consecutive doses of the affected product. Furthermore, the FDA has not received any post marketing adverse event reports for lack of effectiveness of the recalled lot. However, Teva issued the generic Invega recall voluntarily to prevent the possibility of either scenario.

Generic Invega Recall Instructions

The generic Invega recall affects 360 90-count bottles of Paliperidone Extended-Release Tablets, 3mg. The Actavis Pharma Inc. label distributed them between December 12, 2016 and March 16, 2017. The recalled bottles have a 6/2018 expiration date. Their lot number is 1160682A, and NDC number is 0591-3693-19.

Teva issued an Urgent Drug Recall Letter to its buyers, asking them to return existing inventory and notify affected customer of the generic Invega recall. Consumers with questions should contact Teva by calling 888-836-2872, selecting option 3, and then option 4. They can also email druginfo@tevapharm.com. The FDA urges consumers to contact their healthcare provider and/or pharmacist if they experience any product-related problems.

Problems Beyond the Generic Invega Recall

Invega and a similar drug, Risperdal, have come under scrutiny in recent years. Scientific studies have linked the side effects of both antipsychotic drugs to an increased risk of breast growth in boys and young men. This rare medical condition is called gynecomastia. The resulting breasts often require surgical removal. Furthermore, hundreds of Invega and Risperdal lawsuits claim that the damage extends beyond physical injury. They assert that the psychological effects of young male breast growth can have a devastating impact, greatly diminishing overall quality of life.

 

Inside the Mind of the Legendary Justice Ginsberg

 

By Uzma Rahman
Inside the Mind of Justice Ginsberg
Photo www.modup.net

Law360’s Supreme Court justices’ interview series continues with Part II of the popularly named “Notorious RBG,” Justice Ginsberg.

Part II goes beyond Justice Ginsberg’s career, fame and biography, delving into her mind. The interview sheds light on her decision-making processes and her frame-of-mind when approaching a case.

For example, most people believe Supreme Court justices make up their minds during oral arguments. Justice Ginsberg does not. She has an extensive pre-hearing case-review process. Prior to lawyers even entering the courtroom, she’s already read the numerous briefs, reviewed applicable law, and come to some sort of analytical decision. Therefore, it’s highly unlikely that oral arguments would do much to sway her deeply-contemplated thinking. In fact, Justice Ginsburg told Law360 that after an extensive review of the briefs, her mind is “not closed, but certainly not totally open.”

This is an eye-opening revelation for some attorneys who assign brief writing to their associates, because they want to focus on preparing oral arguments. It stands that school of thought on its head!

But, can an oral argument hope to sway the indomitable Justice?

“It’s rare,” Justice Ginsburg said. “It has happened — not even once a term.”

Justice Ginsberg’s Been in the Trenches

Justice Ginsberg has served as a Supreme Court Justice for nearly 25 years now, but her oral arguments’ experience began long before that. In fact, she has argued six women’s rights cases before the Supreme Court, including Frontiero v. Richardson, Weinberger v. Wiesenfeld and Califano v. Goldfar. Of the six, she won five. Based on these collective cases, the Supreme Court began to strike down statutes that differentiated based on gender.

In each of those six cases, Justice Ginsberg stood her ground against the bench’s nine men. In Frontiero v. Richardson, a case she argued on behalf of the American Civil Liberties Union, she presented her entire prepared argument, running at almost 11 minutes long, without a single justice asking a question. This would be unheard of today.

Justice Ginsburg Offers Advice on What Not To Do

The changing times have brought changes to the style of oral arguments, Justice Ginsberg points out. Before, it would make sense for attorneys to memorize and prepare their parts with the expectation of minimal interruption. However, this term, the longest any lawyer spoke uninterrupted was 5 minutes and 30 seconds. But, this is an anomaly. The average was around a minute. For today’s advocates, Justice Ginsberg advises, “Don’t come with a prepared spiel, because you won’t be able to give it. Have a very well worked-out and memorized first sentence. And after that, appreciate that an argument is a conversation between the lawyer and the bench.”

As for the question on everyone’s mind—what should a lawyer refrain from doing? “There are a few people who are imperious,” she said with a grin. “It should be, as I said, a conversation.”

This conversation begins before a single word is spoken though. It begins with briefs. Shelves upon shelves of color-coded briefs testify to the fact that “The briefs are ever so much more important,” Justice Ginsburg said. “Oral argument is fleeting.”

Stay tuned for the next in the series… coming soon!

 

 

 

 

 

 

Opioid Drug Company Probe Launched

By Emily Cox
Opioid
Photo by Ralph Arvesen

In response to the opioid addiction epidemic sweeping the nation, a group of state attorneys general announced Thursday that they are starting an investigation into the marketing and sale of the drugs that are ending more lives than traffic fatalities and murders combined.

Americans are the largest consumers of opioids on Earth, including 99 percent of the plant’s supply of hydrocodone. In 2016, doctors wrote approximately 300 million opioid pain pill prescriptions. To put it into perspective, the population of the U.S. is 330 million. In West Virginia, drug wholesales shipped enough hydrocodone and oxycodone for every resident in the state to receive 433 pills each between 2007 and 2012.

Last year, prescription pain drugs killed 20,101 people. That’s more than the total U.S. casualties from 9/11 and the Iraq and Afghanistan wars combined. And, it happens every year. Meanwhile, there’s big bucks on all sides of the addiction cycle. Pharmaceutical companies rake in more than $24 billion annually from pain medication. Drug treatment centers make more than $35 billion each year. Our prison systems are a $74 billion industry. The motivation to curb the opioid frenzy that has swept America is decidedly underwhelming. However, this group of attorneys general have decided to at least acknowledge and investigate the problem. Hopefully, the buck stops here.

State Attorneys General Impending Opioid Company Investigation

It is unclear how states are involved in the probe. However, leaders indicated that a majority of attorneys general are part of the coalition. The group intends to see how culpable opioid companies were in creating the current epidemic.

“We are looking into what role, if any, marketing and related practices might have played in the increasing prescription and use of these powerful and addictive drugs,” District of Columbia Attorney General Karl Racine said in a statement.

The coalition announced the investigation on the heels of Ohio Attorney General Mike DeWine filing suit against drug manufacturers for misrepresenting opioids’ risks. When DeWine announced the lawsuit May 31, he denounced the drug companies for helping unleash the addiction crisis by pouring millions of dollars into marketing and promoting drugs such as Purdue’s OxyContin.

The lawsuit claims the drug companies made misleading statements about the risks and benefits of opioids. This marketing persuaded doctors and patients that the drugs should be used for chronic pain rather than short-term.

Local governments are also bringing Big Pharma to task, filing similar lawsuits. Among their ranks are two California counties, Chicago, Illinois, Dayton, three Tennessee district attorneys, and nine New York counties.

Separate lawsuits by state attorneys general in Ohio and Mississippi target Johnson & Johnson, Purdue Pharma LP, Endo International, Allergan Plc, and Teva Pharmaceutical Industries Ltd.

FDA Regulations Still in Full Force

By Emily Cox
FDA Regulations
Photo by Aaron Cannon

Trump wants FDA regulations to roll back but for now the agency has its hands full from a salmon powder that was actually gelatin powder, wrong drug listing information, and pest problems in a food warehouse to a contact lens company only using a customer survey to handle complaints.

Check Out FDA Regulations in Action:

“Gelatinous” Salmon Collagen Powder

Despite its label, the FDA has found that a nutritional supplement company’s salmon collagen powder product was actually just gelatin.

According to a May 31st FDA regulations letter, the agency inspected a Summit Nutritionals International facility that repackages the company’s bulk ingredients in June 2016 and February 2017. The FDA observed hydrolyzed gelatin being repackaged as Salmon Collagen Powder 90% Protein. Furthermore, the hydrolyzed gelatin’s original packaging stated that it is “Made in China.” However, the salmon powder’s label claims that it is “Proudly Made in the USA,” somehow magically transforming the Chinese gelatin to American salmon by the virtue of its label.

Previous inspections indicate that there may be similar misbranding of the company’s labels. The FDA recommended that the company review all of its product labels, as if this had been some sort of oversight.

In response to the FDA’s letter, Summit Nutritionals immediately disassociated itself with the salmon powder and eradicated the collagen drum from its warehouse. Out of sight. Out of mind.

FDA Yanks Inaccurate Drug Listings to Protect Public

According to a June 5th FDA regulations letter, a pharmaceutical wholesaler’s longstanding failure to correct drug listing information forced the agency’s hand to pull all its drug listing files from public view.

The Federal Food Drug and Cosmetic Act requires companies that manufacture or import drugs into the US to list all their drugs made for commercial distribution and update this information twice a year.

In May 2016, the FDA reviewed a sample of A-S Medication Solutions LLC’s drug listing files. The agency found numerous drug listing submissions that didn’t comply with federal requirements. The FDA showed the company’s CEO and attorney examples of the inaccurate information. Company representatives said they would review all its drug listings and fix the mistakes.

However, a recent analysis of the company’s current listing files showed that the old violations hadn’t been fully resolved. Furthermore, new drug listings also did not meet FDA regulation requirements. Some of these errors included the wrong strength for the active ingredient of a drug, inaccurate proprietary name, and an inaccurate carton label.

“Drug listing information is accessible not only to FDA but other interested parties, including consumers and health care professionals,” the FDA said. “The high error rate identified during our review of a subset of your listing files, and your continued failure to ensure that new listings comply with your regulatory obligations, lead us to conclude that the noncompliant listing files are not isolated only to those we have positively identified.”

Consequently, the FDA removed access to the company’s drug listing files to protect the public from the erroneous information.

FDA Smells a Rat at an Unsavory Food Warehouse

FDA inspectors found dead cockroaches, rodent feces, and “what appears to be insect parts” at a Puerto Rican food warehouse. Inspectors also noted spilled food and accumulated filth on the floor and around dirty repackaging equipment.

Sucerores De Esmoris & Co. Inc acknowledged the presence of mice at the facility. However, the company never indicated what it was going to do about the problem. Furthermore, it confirmed that it had not taken any measures to prevent future pest entry by installing screens.

FDA Turns Its Sight to a Contact Lens Company

In February, the FDA took a closer look at a soft contact lens company’s complaint handling and record keeping protocol. The agency found that it did not have a formal method to keep track of executive meetings. There was also no protocol for following up with customer complaints.

In 2016, the FDA inspected The See Clear Co., which makes daily wear colored contact lenses and noted numerous violations. However, the company failed to provide any evidence or documentation that it was attempting to correct violations.

These violations include:

  • The company doesn’t have a formal method for handling customer complaints. It only has a customer survey that merely asks customers to rate the company and its lenses.
  • Its contract with a lens manufacturer didn’t include quality requirements.
  • Executives couldn’t provide dates, agendas, and attendance for management meetings.
  • There was no record of personnel training.

 

Justice Ginsburg is Pushing Full Steam Ahead

By Uzma Rahman
Supreme Court Justice Ginsburg
Photo by Frank Balsinger

Supreme Justice Ruth Bader Ginsburg is nearing the end of her 24th year on the High Court, and it’s been a whirlwind journey to her current seat.

There are many words to describe Justice Ginsburg. Supreme Court Justice. Feminist. Advocate. Academic. Icon. Legend. Standing tall at a mere 5’1”, who would have thought this slight Brooklynite daughter of immigrant parents would become one of the most iconic judges in United States history?

Law360’s Supreme Court justices interview series gets off to a running start with arguably the most famous of them all. Which other justices have been featured by Rolling Stones magazine? None.

Justice Ginsberg jokes that had gender equality existed when she graduated top of her class from Columbia Law School, she would likely be a wealthy, retired law firm partner. Instead of letting the broken status quo limit her, Justice Ginsberg pushed for progress. While a tenured professor at Rutgers School of Law, she co-founded the Women’s Rights Law Reporter, the first law journal exclusively focused on women’s rights. She also became the first tenured female professor at Columbia Law School.

Judge Ginsburg Takes It to the Next Level

She didn’t stop in academia. She became general counsel of the American Civil Liberties Union, where she wrote the brief for the landmark Reed v. Reed Supreme Court case. This ruling extended the protections of the Equal Protection Clause to include women. She’s championed for women so much that the late conservative jurist, Justice Antonin Scalia, once said, “she became the leading and very successful litigator on behalf of women’s rights—the Thurgood Marshall of that cause, so to speak.” Their obvious friendship and respect for each other speaks to her broader life philosophy that you can be working towards achieving principles that really matter, while making an effort to meet people halfway.

When you take in her momentous life accomplishments, any one of which would equal a life worth living for many, it’s startling to hear her soft-spoken and thoughtful words on the record. The Law360 article quips on how this deliberateness is interwoven into her core.

“She has done that for the 54 years I have known her. She still does it at dinner,” her late husband once told her biographers in an interview recounted in “My Own Words.” “Ruth is somebody who is simply not afraid of dead air time.”

A sharp mind, an introspective tongue, a charming demeanor, and a steadfast attitude. She’s going strong and plans continuing “full steam” ahead. In fact, at 84, she still does 20 pushups and a 30-second abdominal plank daily—how many can you do?

Congress Urged to Kill Tort Reform Bill That Targets Lower Socioeconomic Classes

By Emily Cox
Tort Reform Bill Goes to House
Photo by Ron Cogswell

The American Bar Association (ABA) urged the House of Representatives on Tuesday to vote against a tort reform bill that would install a nationwide cap on noneconomic damages in medical malpractice cases for individuals with government provided or subsidized insurance.

Thursday’s House floor debate will focus entirely on the Promoting Access to Care Act (H.R. 1215). If approved, the tort reform bill would impose a $250,000 limit on pain and suffering in any medical malpractice suit. However, this limit only applies to those who receive health care subsidized by the government or pay private insurance plans receiving federal tax exemptions. This specifically targets lower socioeconomic classes. Essentially, the value of pain and suffering for these classes has been set by this bill, and it’s $250,000. However, the sky’s the limit for those who don’t need the help as much.

On Tuesday, the ABA sent a letter to Rep. Paul Ryan, R-Wis., pleading the House speaker and his colleagues to vote against the bill, as it undermines state authority in medical liability lawsuits.

“The states are the repositories of experience and expertise in these matters,” the ABA’s Governmental Affairs Director Thomas Susman wrote. “The ABA believes that Congress should not substitute its judgment, as is proposed in H.R. 1215, for the systems that have evolved in each state over time.”

Tort Reform Bill History

The House Judiciary Committee advanced the proposed legislation in February. In March, the Congressional Budget Office said that the bill could save up to $50 billion in health care costs over the next 10 years.

The tort reform bill will also impose a sliding scale on attorney contingency fees. Awards of more than $600,000 would be subject to a 15 percent fee restriction. It would also impose a nationwide statute of limitations, which is normally set by the state. The tort reform bill would require plaintiffs to file suit within three years of the injury or one year after the patient discovers or should have discovered the injury.

 

Fast Food Class Action Limits Overtime Damages to $750K

By Emily Cox
Fast Food Class Action Limits Damages
Image by Mike Licht

According to a tentative state court ruling, McDonald’s may have to dole out around $750,000 for violating California overtime laws for its overnight workers, but fines are not likely to climb much higher as the court found that the fast food chain’s violations weren’t necessarily deliberate.

McDonald’s overnight workers allege that the fast food chain’s practice of assigning daytime shifts immediately after overnight shifts caused them to work more than eight hours in a 24-period. However, they claim they received no overtime pay.

Judge Ann Jones had already ruled back in April that McDonald’s had violated state labor law. Consequently, the company had shorted thousands of workers through its handling of overnight shifts at its company-run stores. However, Judge Jones tentatively ruled Friday that the fast food workers had failed to prove the violations were intentional. McDonald’s showed it closely monitors its overtime calculations, basing its 24-hour days on a 4am start time rather than 12:01am.

“That the company intentionally set its time parameters and internal time-keeping around that cycle wasn’t enough to show that its overtime violations were also intentional,” Judge Jones wrote in the ruling. “The uncontroverted testimony established that McDonald’s believed that its payroll date overtime practice was fair and legally required,” she continued.

However, she went on to say that the timekeeping is useful in calculating the overtime owed to the workers.

Back in April, Judge Jones rejected McDonald’s argument that its computer system and 4am to 3:59am workday practice, negated the plaintiffs’ claims. At the time, she said it wasn’t relevant and was inconsistent with earlier discovery responses.

Fast Food OT Class Action Lawsuit

Maria Sanchez filed the claim in January 2013, alleging wage and hour violations. In 2014, David Cruz, Ines Mendez Merino, and Jonathon Valentin joined the lawsuit. In addition to failure to pay overtime, they alleged that managers had erased employee hours, disallowed meal breaks during busy periods, and required unpaid work off-the-clock like washing uniforms.

The lawsuit claims that McDonald’s has about 100 company-run restaurants in California. They allege that these restaurants have a policy of cutting labor costs by limiting costs to a specific percentage of gross sales. Consequently, the corporation essentially required managers to violate state labor laws.

At the time of class certification in August, the claim had swollen to about 6,600 workers. However, she limited the class to the overnight shift claim and derivative claims under California Unfair Competition Law and PAGA.

Send Us a Text Message!

Contact Us

Free Consultation

Fields marked with an * are required