Smith & Nephew Sold Hip System in Direct Violation of FDA

by Emily Cox
Smith & Nephew
Photo by Ezra Pucci

A new lawsuit alleges that Smith & Nephew failed to comply with numerous requirements of its Birmingham Hip Resurfacing (BHR) FDA Pre-Market Approval, concealing the hip system’s inherent flaws from the FDA and exposing countless patients to its dangerous defects.

Gary Lunsford filed the claim against Smith & Nephew on June 14th in the Eastern District of California. He alleges that he underwent left hip resurfacing with the BHR system in September 2010. By October 2016, the hip had already failed, requiring revision surgery. The surgeon noted metallic debris and a pseudotumor from the premature failure of the device.

According to the lawsuit, Smith & Nephew knew or should have known that Lunsford’s injuries were a probable outcome from its BHR system. However, the company continued to promote BHR as a safe alternative to other metal-on-metal devices. In fact, Smith & Nephew did not withdraw the device from US markets until 2015. Furthermore, due to PMA non-compliance, the company should not have been selling the device at all.

Smith & Nephew FDA Violations Voids Legal Protection and Approval Status

On May 9, 2006, the FDA granted conditional approval to Smith & Nephew to market the BHR. The agency set strict guidelines that mandated ongoing clinical studies, monitoring, reporting of adverse events, and post-marketing surveillance among other measures. Failure to follow these requirements is a violation of the Federal Food, Drug, and Cosmetic Act and voids any legal protection afforded by PMA status. Also, failure to comply with requirements is grounds for withdrawal of PMA. Furthermore, according to the FDA’s PMA-approval letter, this also disallows continued commercial distribution.

Smith & Nephew Hid Metal Poisoning Risk from FDA, Pointing the Finger

In the first several years after BHR entered the market, Smith & Nephew did not report the risk of metal poisoning, or metallosis, in its adverse events to the FDA. However, the company allegedly knew of dozens and possibly hundreds of such cases. Instead, Smith & Nephew went to great lengths to blame device failure on other sources, such as allergies, generalized pain, and implanting surgeons.

In fact, in August 2011, BHR inventor Dr. Derek McMinn published an article titled “Metal Ions Questions & Answers.” The article placed the blame for the hip system’s failures on surgeons improperly placing the device and even on the patients, themselves, particularly women, who experienced substantially higher failure rates.

Dr. McMinn claimed that women were “pre-sensitized” to metal due to wearing costume jewelry. Consequently, he wrote that their tissues may “over-react” to low levels of metal released from artificial devices. However, Dr. McMinn offered no scientific evidence for his theory about the connection between costume jewelry and BHR failure rates.

While Smith & Nephew tried to hide the true cause of the BHR’s failure rate, clinical data continued to pile up, showing a real risk for patients. For example, the National Join Registry of England and Wales shows the BHR 42mm femoral head component has a seven-year revision rate of 11.76 percent. This is well about the normal acceptable failure rate for this type of device.

Smith & Nephew Failed to Properly Train Surgeons

Smith & Nephew agreed to implement a training program as part of the PMA requirements. The company began a BHR training program as promised. However, it failed to achieve training milestones. In fact, the company didn’t begin widespread training until more than three years after releasing the BHR system. At this time, Smith & Nephew admitted to the FDA that surgeons were implanting the device despite receiving no training at all from Smith & Nephew on how to properly perform the procedure. While it was Smith & Nephew’s responsibility to train physicians, the company did not hesitate to lay the blame on these same inadequately trained surgeons for the device’s failings.

Smith & Nephew Did Not Comply with Clinical Study Requirements

In the first five years, tens of thousands of patients received BHR devices. However, Smith & Nephew only enrolled a small fraction of the required number of patients in its clinical study. Seven years after PMA approval, the company still had only enrolled 269 of the 350 patients in the study.

Men, who have a lower failure rate for resurfacing procedures, made up approximately seventy-five percent of study participants. This prompted the FDA to warn the company about bias in its study results. The agency issued a deficiency notice to this effect. The notice also addressed the company’s failure to reach the 80 percent target follow-up rate with study participants. Smith & Nephew didn’t even bother to respond to the FDA within the required time period.

Smith & Nephew also reported 35 deviations from the study protocol, resulting in poor patient follow-up. This was, in part, due to Smith & Nephew failing to adequately staff study locations with enough research coordinators. These and other problems prompted the FDA to write the medical device company, informing it that the agency was unable to review the adequacy of BHR studies and reports due to “inadequate” information from Smith & Nephew. On several other occasions, the FDA reported that the status of the BHR study was “progress inadequate.” The agency also noted that Smith & Nephew did not meet patient enrollment milestones and failed to submit mandatory reports on time.

The company abruptly closed the study’s US patient database in 2012 before the planned completion date.

Lunsford joins a growing number of individuals filing similar product liability lawsuits against Smith & Nephew, alleging serious harm from its BHR hip system. Experts expect that hundreds, if not thousands, of these lawsuits will eventually pass through the court system.

 

 

 

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
Supreme Court Squeezing the Life Out of Mass Torts
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, the blood thinner’s marketing was conducted 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.

 

Supreme Court Ruling Fallout Causes Talc Mistrial

By Emily Cox
Supreme Court Ruling Results in Talc Mistrial
Photo by angela n.

A St. Louis judge declared a talc mistrial in the latest lawsuit alleging that Johnson & Johnson’s talcum powder products caused ovarian cancer after the Supreme Court levied a jurisdiction decision Monday morning.

The high court’s ruling could potentially obliterate St. Louis’ claims by women who reside outside the state. In August 2016, the California Supreme Court ruled that the state could preside over 86 residents and 575 non-Californians who brought Plavix claims. They allege that the blood-thinner actually increased their risk of heart attack, stroke, and internal bleeding.  The California high court assumed jurisdiction based on Bristol-Myers’ national marketing campaign. It also claimed the company’s nearly $1 billion sales of the drug in the state strengthened this authority. However, in an 8-1 opinion, the Supreme Court struck down this ruling, siding with Bristol-Myers and the federal government.

Judge Rex Burlison declared the talc mistrial at the onset of the second week of the sixth Missouri trials over the connection between Johnson & Johnson’s talcum powder products and ovarian cancer with toxicology expert testimony slated for early this week. The case was brought by the families of three women who died of ovarian cancer after using the company’s talc products for years. While Johnson & Johnson affirmed that the state held jurisdiction over the one state resident’s claims, it held that the Virginia and Texas residents should not be allowed to bring claims in Missouri under the Bristol-Myer ruling.

Possible Talc Mistrial Loophole

Justice Samuel Alito wrote for the Supreme Court majority.  He wrote that California could not hear the case “without identifying any adequate link between the state and nonresidents’ claims.” However, this doesn’t appear to be exactly the case with the St. Louis talcum powder trials.  Johnson & Johnson and co-defendant Imerys Talc use Pharma Tech Industries to package and label talc products. This company has a plant in Union, MO.

Individuals can typically bring suit against companies in a state where they have headquarters or incorporations. This also extends to states where companies have important ties. Packaging and labeling may be grasping at straws but is still essential to the distribution process. Despite the talc mistrial, lawyers still believe they will be able to pursue claims. There are currently approximately 1,100 pending in St. Louis.

“We think we’re still alive in Missouri,” a lawyer, representing the plaintiffs, said.

He continued that Burlison’s ruling merely added Pharma Tech as a potential defendant to future claims.

Ethicon Designed Hernia Mesh for Profit Not Patients

By Emily Cox
Mesh Only Profits Manufacturers
Photo by Pictures of Money

A new lawsuit alleges that Ethicon developed and designed Physiomesh to produce a substantially higher profit margin than other hernia mesh products even though the company was aware of the probability that this design would harm patients.

John Guerra filed the claim against Johnson & Johnson and its Ethicon unit this past Wednesday. He alleges that Physiomesh caused a severe adverse reaction. Furthermore, the mesh failed, causing additional severe injuries. Surgeons had to remove portions of the defective mesh. They also had to repair the hernia that the product was initially implanted to treat. After surgery, Guerra developed chronic seroma. Physicians excised the seroma cavity numerous times. However, while they accomplished reducing the seroma, doctors were unable to completely remove it. Guerra alleges the manufacturers knew outcomes like his own were likely. However, they continued to sell the product anyway due to its hefty profit margin.

Mesh Only Profits Manufacturers

According to the lawsuit, Ethicon designed its hernia mesh with the bottom line in mind rather than helping hernia patients.

“Defendants developed, designed and sold Physiomesh, and continue to do so, because the Physiomesh has a significantly higher profit margin than other hernia repair products,” the lawsuit states.  “Defendants were aware of the probable consequences of implantation of the dangerous and defective Physiomesh, including the risk of failure and serious injury.”

Physiomesh’s design is different than any other mesh product on the market. It has five distinct layers. Two layers of Monocryl film cover two underlying layers of polydioxanone, which in turn coat a polypropylene mesh. While this multilayer coating turns a substantially higher profit than other hernia mesh products, it prevents incorporation of the mesh in the body. This leads to a whole host of problems, not the least of which is additional invasive surgery. It also provides a breeding ground for bacteria that the body’s immune response cannot eliminate. When the multilayer coating degrades, the plastic mesh is exposed to nearby tissue and organs. It can become adhered to these organs and cause significant damage.

Despite escalating adverse reaction and injury reports, manufacturers continued to rake in the big bucks from this prized cash cow until May 2016 when they quietly removed the product from the market rather than issuing a recall.

Guerra joins the growing number of individuals filing lawsuits around the country, alleging similar or worse harm from the Physiomesh device. Experts expect that hundreds, if not thousands, of these lawsuits to go through the nation’s court system.

 

 

 

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.

 

Breast Lymphoma from Implants May be Under-diagnosed

By Emily Cox
Breast Lymphoma
Photo by maf04

As more cases are confirmed worldwide, researchers are warning that breast lymphoma from textured breast implants is likely under-diagnosed and warrants further studies to determine the best treatment plans.

Following the first confirmed diagnosis in Finland, researchers took a closer look at the rare type of breast lymphoma known as breast implant analplastic large cell lymphoma (BI-ALCL). They reported their finding in a report published last week in the European Journal of Surgical Oncology. Researchers looked at the disease from diagnosis to treatment and found that it may be deadlier than previously thought.

Breast Lymphoma Prognosis

Compared with other forms of ALCL, which carry about a 40 percent survival rate, the prognosis for most BI-ALCL patients is favorable. Most cases of the breast lymphoma can be treated with surgical removal of the breast. However, researchers suggest that some of these patients develop serious conditions, making the cancer life-threatening.

“Most patients have an excellent prognosis when complete removal of the capsule and prosthesis with negative margins is achieved surgically,” they wrote. “Some patients, however, develop infiltrative disease with a potentially life-threatening clinical course. Treatment planning regarding the extent of surgery and role of adjuvant therapy, especially in advanced cases, requires further investigation.”

Breast Lymphoma From Implants Diagnosis

Doctors and health officials first detected the disease in 1977, but diagnosis has been on the rise in recent years with increasing frequency. The FDA issued a report earlier this year, indicating the agency was aware of 359 reports of the breast lymphoma and at least nine deaths. However, many still feel that it may be under-diagnosed.

When Australia’s Therapeutic Goods Administration (TGA) encouraged additional monitoring for BI-ALCL cases, the number of identified country more than doubled in Australia. However, the authors warn that determining the number of actual cases is problematic. They pointed out that not all laboratories have the equipment to perform necessary tests. Furthermore, not all cases are reported.

BI-ALCL Breast Lymphoma Awareness

Consequently, health officials have attempted to raise awareness among plastic surgeons. They are urging them to warn patients of this potential risk and to look for symptoms following surgery.

BI-ALCL symptoms include lumps, fluid buildup, and swelling around the implant site, as well as pain. These symptoms generally present after the surgical incision has fully healed. Most cases are diagnosed 8 to 10 years after the original implantation.

The underlying cause of this breast lymphoma remains elusive. However, researchers have noted that the risk seems higher with breast implants with textured surfaces. They suspect this could cause chronic inflammation and immune system reactions, leading to the development of the cancer.

 

 

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