Category: MDL

Fentanyl Crisis Is the Driving Force Behind Opioid Epidemic

By Emily Cox
fentanyl crisis

Accounting for 60 percent of U.S opioid deaths this past year, the Fentanyl crisis is now the primary hallmark of the opioid epidemic that continues to scorch the nation.

Bloomberg reports that America’s opioid crisis has experienced a definitive shift. As the White House and Congress continue to twiddle their thumbs, the opioid death toll is unceasing in its ruthless ascent, reaching nearly 50,000 in 2017. This represents an increase of nearly 7,000 over the previous year, which is a record-breaker in and of itself. However, death’s primary harbinger is no longer regular prescription painkillers. It’s fentanyl, which is often illicitly mixed with street drugs like heroin.

Consequently, Bloomberg is calling for an equally drastic shift in the currently latent efforts to prevent opioid deaths. The focus on tighter prescription controls for oxycodone and hydrocodone are no longer adequate to limit the supply. The U.S. desperately needs a comprehensive and multi-targeted strategy to restrict illicit fentanyl importation, as well as a broader, better-funded push to reduce demand.

Since 2011, general prescription opioid fatal overdoses have remained relatively stable. However, overdose deaths from fentanyl have skyrocketed. According to the National Center on Health Statistics, the markedly more lethal drug played a role in 60 percent of opioid deaths in 2017, marking an 11 percent increase from five years ago.

Fentanyl Crisis Management Needs to Start with China

Fentanyl emerged on the market in 1960 as a cancer pain treatment. Due to its synthetic chemical composition, it quickly gained popularity on the black market. While “natural” opioids require producers to plant and protect acres of poppies, fentanyl can be cooked in a lab. Furthermore, its exceptional potency (mere granules of the stuff packs a deadly punch) allows distributors to mail it around the world in tiny, concealable packages. Chinese drug labs fulfill online orders from U.S. users or traffickers, as well as those in Mexico, who add the fentanyl to heroin and other drugs to amplify their effects or use it to create fake prescription opioid pills.

According to U.S. law enforcement, China is the source of almost all illicit fentanyl. Inadequately regulated and monitored chemical laboratories there sell fentanyl and its precursors to U.S. users and dealers, or Mexican drug suppliers who go on to market it in the U.S.

During the Obama administration, the U.S. had started soliciting the Chinese government’s assistance in cracking down on producers. This included persuading China to add many analogues of fentanyl to its list of controlled substances. A steady and purposeful diplomatic push, along with expert support, is necessary to fortify China’s capacity to inspect and regulate the country’s thousands of drug labs.

From China, the drug pipeline flows primarily through the mail to users and dealers. Recently, Congress provided Customs and Border Protection with more chemical detection equipment for package screening. However, the volume of mail prevents scanning everything that comes into the U.S. Currently, there is legislation pending that would require the U.S. Postal Service to obtain basic identifying information from senders, including name, address, and package content descriptions. Private parcel services already mandate this information.

Battling the Fentanyl Crisis at Home

But, even with these measures, a significant amount of the drug is likely to escape detection, necessitating strenuous efforts to crack down on the fentanyl crisis within the U.S. The Justice Department recently made progress by working with Dutch authorities to shut down two major dark web sites where users made deals in virtual currencies.

However, fentanyl is also available on the regular internet. So, FDA commissioner Scott Gottlieb is demanding that internet companies work harder to remove illegal listings. For its part, the FDA could limit supply by enforcing off-label prescribing restrictions for legal fentanyl to patients who don’t need such a powerful painkiller.

Significant measures on the demand side need to be taken as well. More than 2 million Americans have opioid or heroin disorders, and few can quit without assistance. Treatment needs to be accessible at every opportunity, especially when addicts enter prisons, hospitals, or emergency rooms. Methadone, buprenorphine, and other opioid medications, along with behavioral therapy, have proven effective in overcoming these addictions.

Thus far, the Trump administration has largely ignored the need for medication-assisted therapy. While Congress is considering bills that would expand its employment somewhat, like getting Medicaid and Medicare to provide more generous funding, lawmakers continue to refuse to prioritize these measures. Currently, only five percent of U.S. doctors have completed the required training to prescribe buprenorphine. Far more doctors, nurse practitioners, and healthcare providers need to have this authority.

Fentanyl along with other opioids are killing more than 130 people each day. The fentanyl crisis especially requires a thorough and well-coordinated national response. However, the White House and Congress continue to fall short, and more Americans pay the price every day.

Opioid Doctor Sentenced 20 Years for “Hospice-Level” Scripts

By Emily Cox
opioid doctor

A Florida opioid doctor will serve nearly 20 years in prison after a jury found him guilty of selling prescriptions for the painkiller oxycodone at “hospice-level” doses without ever verifying if patients actually needed it.

In June, a federal jury found John M. Gayden Jr., 64, guilty of seven counts of “distributing oxycodone outside the course of professional practice and for no legitimate medical reason.” On Monday, District Judge Carlos E. Mendoza sentenced Gayden to 19 years and seven months in prison.

Opioid Doctor Federal Charges

Prosecutors indicate that Gayden ran a pain management clinic between 2009 to 2011 and gave out medically dubious prescriptions for cash. Patients paid him $200 to $400 for an appointment. After little to no evaluation, these patients would walk out with prescriptions for what one expert dubbed “hospice-level oxycodone doses” for trivial health issues.

According to the Department of Justice (DOJ), patients would even come from other countries to line up at his clinic for their prescriptions. Many of these patients would go on to abuse or sell the pills. Furthermore, Gayden would work with patients for years without ever verifying any long-term medication necessities or consulting with them regarding their health.

The prosecutors’ sentencing memorandum requested the maximum guidelines penalty, citing the “egregious nature and scope of the defendant’s conduct, as well as his abuse of public trust.”

“The defendant was the center of a high-volume and prolific pill mill operation that was responsible for the dispensing of large volumes of opioids into the Brevard County community during the crest of the opioid crisis in Florida,” the DOJ wrote. “The defendant’s conduct had a widespread impact on his local community, as well as the lives of his patients, several of whom died of drug overdoses while under the defendant’s care or thereafter.”

The court sealed Gayden’s own sentencing memorandum.

Tentative AbbVie Testosterone Deal Reached in MDL

By Emily Cox
testosterone deal
AbbVie tentatively reaches agreement to settle claims it created Low-T to boost sales (flickr/Beth Bryda)

AbbVie, the only company still facing claims of deliberately hiding the dangers of its hormone replacement therapy products, struck a tentative testosterone deal Monday to exit the sprawling multidistrict litigation (MDL).

Illinois District Judge Matthew Kennelly entered an order Monday, staying all cases currently pending against AbbVie and its subsidiaries Abbott Laboratories, Unimed Pharmaceuticals, and Solvay Pharmaceuticals after the companies agreed to confidential terms of a global settlement to resolve hundreds of plaintiffs’ claims over their dangerous products and malicious marketing practices.

Judge Kennelly’s order also requires the companies to provide the court with regular updates on their progress in drafting a final settlement agreement, relieving them of any MDL dates and deadlines to focus “their efforts” on finalizing the testosterone deal.

The tentative testosterone deal effectively ends the litigation in the MDL that the Judicial Panel on Multidistrict Litigation (JPML) centralized in the Northern District of Illinois in 2014. Since July 2017, the court has conducted several bellwether trials and still had nearly 6,000 pending cases as of August.

Lead plaintiffs’ counsel also filed a request Monday for the judge to increase their fee awards from the 10 percent attorneys’ fees and court costs the judge set for the litigation in 2014 to 19.5 percent in fees and costs According to the filing, while counsel projected the scope of their work to an extent at the start of the litigation, they did not expect the work to encompass four and a half years of litigation, six “full blown” bellwether trials, and preparation for an three additional rounds of bellwether trials.

Testosterone Deal MDL

All the MDL lawsuits allege that some of the nation’s most prolific drug companies actively hid harmful and life-threatening health risks associated with their testosterone replacement products, such as AbbVie’s AndroGel.

In the first bellwether trial against AbbVie, the jury cleared the big pharma giant of product liability claims. In fact, the jury did not even award any compensatory damages. However, they did levy a $150 million punitive damages verdict for AbbVie’s destructive advertising practices. AbbVie’s second time before a jury didn’t bode much better for the healthcare behemoth. The jury awarded compensatory damages of $140,000 for the plaintiff’s heart attack. But, then they hit AbbVie with $140 million in punitive damages. Punitive damages are designed to punish companies for immoral behavior. These verdicts speak volumes about the immorality at work behind the “Low-T” movement that these lawsuits claim that the testosterone manufacturers created to vastly expand market share and putting an entire population of men at substantial risk to satiate their collective greed.

Judge Kennelly ordered retrials in both of these instances, ruling that the juries’ punitive damages were inconsistent with their findings. In March, jurors slammed AbbVie with a $3 million verdict following the retrial of the original MDL trial.

Several companies were also facing MDL testosterone claims, including Eli Lilly & Co., Endo Pharmaceuticals Inc., and GlaxoSmithKline LLC. All these companies reached testosterone deals as AbbVie continued to proceed through the litigation. Auxillium was the only other company to face an MDL bellwether trial. The jury sided with the company over claims against its Testim product. However, Auxillium sill reached lawsuit settlements in February to exit the MDL.

Abilify MDL Requests Gambling Loss Claim Information

By Emily Cox
Abilify MDL
flickr/Lisa Brewster

As the four months that the court provided for parties to finalize the gambling loss multidistrict litigation (MDL) global settlement has drawn to a close, the District Judge presiding over the Abilify MDL is requiring plaintiffs to submit additional claim information.

Currently, there are more than 1,700 cases pending in the Abilify MDL against Bristol-Myers Squibb and Otsuka Pharmaceuticals over allegations that the drug’s inherently defective nature caused users to develop devastating gambling addictions or engage in other destructive compulsive behaviors shortly after starting treatment with the drug or changing doses.

Parties reached Abilify settlements for a small group of bellwether cases just before trials were to begin earlier this year. In May, District Judge M. Casey Rodgers issued an order, giving the parties until September 1 to finalize the global resolution framework of gambling loss claims. The parties notified the court that negotiations are progressing. However, they have not reported or finalized the details of the settlement program.

Abilify MDL Settlement Order

Judge Rodgers issued a new order August 31, indicating that additional information is necessary for all individual plaintiffs to facilitate an inventory evaluation of remaining cases currently pending in the Abilify MDL.

The court has given plaintiffs until October 31 to provide a Supplemental Plaintiff Profile Form. The form will provide answers to detailed questions about their Abilify use, gambling addiction diagnosis, other drug use, and further details about their case.

“The Supplemental PPF must be signed by each plaintiff under penalty of perjury,” Judge Rodgers wrote. “Failure to timely submit a completed Supplemental PPF will result in sanctions, up to and including dismissal of a case.”

The parties will meet with Judge Rodgers for the next Abilify MDL case management conference on September 13.

As settlement finalizations continue attempting to resolve Abilify gambling lawsuits over the medication causing users to suffer sudden compulsions to engage in destructive behaviors, the Abilify MDL is pressing forward with plans to select a second group of cases for early bellwether trials to help the parties evaluate the relative strengths and weaknesses of their positions and possibly help guide future settlements.


Invokana Heart Attack Risks Highlighted in New Lawsuit

By Emily Cox
Invokana heart attack risks
flickr/Ian McKellar

A new lawsuit indicates that Johnson & Johnson and its Janssen Pharmaceuticals unit concealed significant Invokana heart attack risks.

Mitchell Greenbaum filed the complaint August 28 in the Northern District of Ohio. He indicates that he suffered a heart attack six months after starting treatment with Invokana for diabetes.

According to his complaint, Greenbaum began taking Invokana in early 2016. In August 2016, he was stopped at a traffic light and suffered a myocardial infarction, or heart attack. Consequently, Greenbaum suffered hypoxia, necessitating resuscitation and causing permanent injuries that have led to a loss of consortium with his wife, Maria Greenbaum, among other serious consequences.

Greenbaum alleges that the drug manufacturers actively withheld Invokana heart attack risks from the public and medical community to protect its bottom line and profited immensely from this intentional concealment at the peril of diabetes patients. The complaint notes that when Invokana first received FDA approval in 2013, federal regulators ordered a study that showed that there were significant heart attack risks. However, J&J and Janssen never added new warnings to the drug’s label.

“Janssen Defendants had a duty to the public and the Plaintiff to manufacture, formulate, design and create a drug which would not adversely increase the risk of cardiac arrest in users, especially given the fact that some users foreseeably may have a prior history of hypertension,” the lawsuit states. “Janssen Defendants failed to recognize the risk of increased clotting and cardiac arrest, or intentionally chose not to recognize said risk, which constitutes both negligence and intentional misconduct.”

Health Concerns Beyond Invokana Heart Attack Risks

Invokana (canagliflozin) is a new-generation type 2 diabetes drug. It hit the market in March 2013 as the first member of a new class of diabetes medications called sodium-glucose cotransporter 2 (SGLT2) inhibitors. These drugs work in a unique way to eliminate excess glucose through urination by altering normal kidney functions. However, thousands of patients have come forward due to a number of life-threatening side effects from the drugs.

In December 2015, the FDA required J&J to add new diabetic ketoacidosis warnings to Invokana, indicating the medication increases the risk of this serious condition that usually requires emergency treatment to avoid life-threatening injuries. Before this update, the Invokana warnings didn’t alert patients about the importance of getting immediate medical attention if they experience abdominal pain, fatigue, nausea, respiratory problems, or vomiting.

In May 2017, the FDA mandated Invokana warning labels regarding the risk of leg and foot amputation. Manufacturers of other similar diabetes drugs maintain that this risk is unique to Invokana alone.

This past month, the FDA released a statement that SGLT2 drugs carried elevated risks for Fournier’s gangrene, a rare flesh-eating genital infection. The condition has resulted in at least one death so far among those taking these medications.


Taxotere MCL Conference Set for October 4

By Emily Cox
taxotere mcl
flickr/Haukeland universitetssjukehus

The newly established Taxotere multicounty litigation (MCL) in New Jersey is hitting the ground running, setting its initial Taxotere MCL conference to get the litigation underway.

Middlesex County Superior Court issued the order August 24, scheduling the litigation’s first Case Management Conference (CMC) for October 4 at 10am.

The Court is mandating that parties submit a brief statement seven days before the conference, outlining the following information:

  • All company and financial affiliations with the parties and counsel associates participating in the litigation, so the court can easily identify any recusal or disqualification issues early.
  • All relevant actions pending in federal and state courts, as well as their current status.
  • Discovery status
  • Settlement negotiations status, including settlement demands, mediation, and settlement prospects.

New Jersey Superior Court consolidated all the lawsuits pending in the state’s court systems August 15, transferring 353 cases to Middlesex County for pretrial proceedings. The plaintiffs in the Taxotere MCL allege that the cancer drug’s manufacturer actively concealed considerable risks, including permanent hair loss, while grossly overstating the potent drug’s efficacy. Similar New Jersey cases in the future will be filed directly into the Taxotere MCL to maximize judicial efficiency.

Taxotere MCL Background

Taxotere (docetaxel) initially received FDA approval in 1996 to treat aggressive, metastatic breast cancer when other treatment options have failed. However, despite its limited indications, Taxotere is the most commonly prescribed breast cancer drug in the US, often as a first-line treatment even though it is considerably more toxic than equally effective and safer treatments, such as Taxol. An ongoing Qui Tam lawsuit alleges that Sanofi provided exorbitant illegal kickbacks to encourage doctors to prescribe the medication as a first-line treatment, skyrocketing Taxotere to the forefront of the cancer treatment market, while Sanofi raked in the profits – much of which was obtained by defrauding the Medicare and Medicaid.

With about 300,000 breast cancer cases diagnosed each year, Taxotere is the most prescribed drug in its class despite the fact that studies show that less-toxic Taxol is more effective. In 2009, Sanofi made more than $3 billion from Taxotere before losing patent protection.

Taxotere and Permanent Hair Loss

Not only is Taxol more effective and less toxic than Taxotere. It also doesn’t have the same permanent side effects as Taxotere. Studies have linked Taxotere with about a 10 percent occurrence of permanent hair loss. Sanofi knew about this side effect and hid it from its most profitable market – American women.

Sanofi knew about Taxotere’s alopecia risk since at least 2005. This is when the company updated Canadian warning labels to specifically include this risk. Sanofi would go on to update European warning labels in 2012. Somehow, the U.S. must just have gotten lost in the shuffle, because warning labels would not include this warning until the end of 2015. This was more than a decade after Sanofi became aware of a GEICAM study showing that 10 percent of Taxotere patients suffered permanent hair loss. Even the company’s own studies indicated more than a nine percent rate for permanent alopecia occurrence.

Outside of the Taxotere MCL, Sanofi is facing thousands of additional Taxotere lawsuits throughout the county, including nearly 10,000 federal cases that are currently pending in a multidistrict litigation (MDL) that is underway in the Eastern District of Louisiana.


Baby Powder Wrongful Death Lawsuit Says J&J Products at Fault

By Emily Cox
baby powder wrongful death lawsuit

A new baby powder wrongful death lawsuit indicates that a woman developed fatal ovarian cancer after years of using Johnson & Johnson’s Baby Powder and Shower to Shower products and alleges that J&J consciously concealed life-threatening risk factors associated with its seemingly benign talc-based products.

Her husband, Mark Vetrini, filed the Baby Powder wrongful death complaint August 24 in Delaware Superior Court. He is presenting claims on behalf of himself and the estate of his late wife, Vanessa Vetrini, against J&J, Imerys Talc, Rio Tinto Minerals, Inc., and Valeant Pharmaceuticals.

According to the lawsuit, Vanessa Vetrini used Baby Powder and Shower to Shower around her genital area for feminine hygiene purposes for decades. She received an ovarian cancer diagnosis in January 2012 and died from the disease on June 5, 2016. She was only 42 years old. However, the Baby Powder wrongful death lawsuit asserts that the manufacturers knew about the connection between talcum powder and ovarian cancer for decades but deliberately withheld this information to protect brand image at the expense of human lives. The companies even encouraged women to use the product unsafely to increase use and sales.

“All of the Defendants have been or should have been aware for nearly forty (40) years of independent scientific studies linking the use of their products to the increased risk of ovarian cancer in women when used in the perineal area,” the lawsuit states. “Despite this overwhelming body of evidence all of the Defendants have failed to inform their consumers of this known hazard.

Baby Powder Wrongful Death and Litigation

Mark Vetrini’s pursuit for justice joins thousands of other Baby Powder and Shower to Shower lawsuits pending against J&J in the nation’s courts.

Over the past few years, numerous of these claims have gone to trial in state courts with many of them ending in multimillion dollar damage awards for J&J’s conscious negligence regarding the health of its consumers and valuing the all-mighty dollar over human life. Despite the massive verdicts, J&J is refusing to be cowed by the overwhelmingly negative response to its defensive measures. The healthcare giant is pursuing appeals in each of these cases and has continued to maintain that it will not offer talcum powder settlements for women who developed ovarian cancer after using its dangerous products.

Vetrini’s lawsuit is pending in Delaware state court. However, thousands of other individuals are also pursuing claims in Missouri state court, as well as the federal court system. The Judicial Panel on Multidistrict Litigation (JPML) has centralized the federal litigation before District Judge Freda Wolfson in the District of New Jersey for coordinated pretrial proceedings to expedite the dissemination of justice for those harmed by J&J’s callous disregard for the health of its consumers. The multidistrict litigation (MDL) works to reduce duplicative discovery and avoid conflicting pretrial rulings that tend to hold up these large legal actions.

If J&J still fails to resolve the litigation after discovery and the bellwether trial process, the company could face thousands of individual trials in courts nationwide. Given jury response in previous trials, this could result in crushing liability for America’s Family Company.

Invokana Linked to Flesh-Eating Genital Infections

By Emily Cox
genital infections
flickr/Steve Depolo

The FDA has issued yet another warning regarding horrific side effects from Invokana, Jardiance, Farxiga, and other similar diabetes drugs. This time, the agency indicates the drugs are linked to serious genital infections.

Federal regulators released the latest Invokana drug safety communication Wednesday in a long series of similarly significant warnings regarding sodium-glucose cotransporter-2 (SGLT2) inhibitors. This time around, the FDA says that the drugs have now been linked to cases of rare but serious flesh-eating genital infections.

SGLT2 Genital Infections

Necrotizing fasciitis of the perineum, also known as Fournier’s gangrene, is commonly classified as a “flesh-eating” infection. Federal regulators indicate that the rare infection can be life threatening. Diabetes alone can increase the risk of these infections. It is still rare among diabetes patients but cases involving SGLT2 inhibitors are currently on the rise. The FDA anticipates that the number of genital infections linked to the medications will likely increase significantly as awareness regarding the connection continues to spread.

“In the five years from March 2013 to May 2018, we identified 12 cases of Fournier’s gangrene in patients taking an SGLT2 inhibitor,” the warning notes. “This number includes only reports submitted to FDA and found in the medical literature, so there may be additional cases about which we are unaware.”

Most drug experts agree that the FDA only receives notice of approximately 10 percent or less of drug adverse event incidents.

Even within this limited scope, federal regulators note that their findings indicate that there are twice as many cases of genital infections with SGLT2 inhibitors as those linked to all other diabetes drugs combined over the past three decades. The SGLT2 genital infections also only occurred in a mere five-year span. Furthermore, five of the SGLT2 inhibitor cases involved women. All previous cases associated with other diabetes drugs only involved men.

Consequently, the FDA is mandating new warning labels for all drugs in the class. This includes Invokana, Invokamet, Invokamet XR, Farxiga, Xigduo XR, Qtern, Jardiance, Glyxambi, Synjardy, Synjardy XR, Steglatro, Segluromet, and Steglujan. Steglatro is the only drug that appears to be free of flesh-eating genital infection associations. However, the agency is requiring it to carry the label regardless.

Regulators indicate that the infections developed within several months of starting treatment with one of these drugs. All 12 patients underwent hospitalization and surgery. According to their findings, at least one patient died. Others have suffered numerous disfiguring surgeries and other irreparable complications.

SGLT2 Health Concerns Beyond Genital Infections

Flesh-eating genital infections are just the latest in a string of significant health risks from SGLT2 inhibitors like Invokana that the FDA has uncovered since manufacturers first introduced them to the market. Previous warnings include kidney failure, diabetic ketoacidosis, and amputations. However, manufacturers continue to maintain that amputation risks are unique to Invokana specifically. The drugs’ warning labels failed to address any of these substantial risks when they first received FDA approval.

Invokana (canagliflozin) was the first SGLT2 inhibitor to hit the market. The FDA approved the drug in March 2013. Thanks to Johnson & Johnson’s typically aggressive marketing approach, the medication soon became a blockbuster treatment and has remained at the front of the pack ever since. SGLT2 inhibitors work in a unique way by eliminating excess glucose from the body through urination by impacting some normal kidney functions.

In December 2015, the FDA required all SGLT2 inhibitors to carry warnings about diabetic ketoacidosis, indicating that the medications significantly increase the risk for this serious condition that generally requires emergency treatment to avoid life-threatening injuries. Prior to the FDA’s intervention, warnings failed to alert patients of the importance of seeking immediate medical help if they experienced abdominal pain, nausea, fatigue, vomiting, or respiratory problems.

In June 2016, the FDA mandated additional warning labels about the connection between kidney risks and SGLT2 inhibitors, telling patients that the medications can increase the risk of acute kidney injury, kidney failure, and other severe health issues.

In May 2017, the FDA intervened once again to require amputation risks for Invokana, indicating the drug carries an increased incidence of leg, foot, and toe amputations. Regulators are only requiring Invokana to carry these warning labels for now.

Currently, Johnson & Johnson and its Janssen Pharmaceutical subsidiary are facing several thousand Invokana lawsuits, alleging that the healthcare behemoths deliberately withheld significant risk factors when they introduced the drug to maximize its marketability. Manufacturers of other diabetes drugs in the same class, including Xigduo and Farxiga, are also facing similar lawsuits. But, most of the lawsuits pending in the nation’s court systems are against J&J and Janssen thanks to the companies’ reckless, but supremely effective, marketing tactics.

The FDA indicates that prescribers wrote 1.7 million prescriptions for SGLT2 inhibitors in 2017. The agency is urging anyone who has suffered side effects after taking one of these medications to file a report with the FDA MedWatch adverse event reporting system.






Judge Awards $245M in Hip Implant Judgements

Hip implant judgements Hip research DePuy Pinnacle Metal Hip BellwetherBy Emily Cox

A Texas federal judge granted more than $245 million in final hip implant judgements Wednesday for a group of New York plaintiffs who triumphed over Johnson & Johnson and its DePuy Orthopaedics unit when a jury found the companies knowingly sold dangerous and defective hip implants.

District Judge Ed Kinkeade granted Karen Kirschner approximately $48.6 million, Hazel Miura $43.7 million, Uriel Barzel $39.2 million, Ramon Alicea $38.9 million, Michael Stevens $37.8 million, and Eugene Stevens $36.8 million for damages, including past and future medical expenses; pain and suffering; loss of consortium; and punitive damages.

The plaintiffs’ attorney indicated that he was pleased with the hip implant judgements. He also said he is gearing up for another fight against the healthcare heavy-hitters as J&J has indicated it will appeal the decision.

“We are pleased and eager to seek upholding this on appeal,” he said in an email Wednesday.

In November, a Texas federal jury slapped J&J and DePuy with a combined $247 million verdict in hip implant judgements, following the bellwether trial over DePuy’s Pinnacle metal-on-metal hip replacement systems. This is the third consecutive nine-figure verdict in the multidistrict litigation (MDL) over substantial harm from the defective line of hip implants.

Hip Implant Judgements

The unanimous jury found J&J and DePuy liable for fraud and deceptive business practices, as well as a series of design and manufacturing defects. It further found that the companies had acted with wanton, reckless, or malicious disregard for patient health. Consequently, the jury awarded $90 million and $78 million in punitive damages against J&J and DePuy, respectively, to punish the companies for their egregious conduct.

The jury awarded more than $77 million in past and future medical expenses, as well as pain and suffering, to the six plaintiffs. This included the parties’ stipulation as to their actual past medical expenses. The jury also awarded loss of consortium damages totaling $1.7 million to four of the patients’ spouses.

In August, the plaintiffs actually sought a $1.2 million reduction in the jury’s $247 million verdict to compensate for private medical insurance that offset the damage awards. For some plaintiffs, this offset eliminated past medical expenses entirely. However, some still requested damages for their paid premiums. The future medical expenses were reduced for the years the plaintiffs would retain private health insurance before Medicare eligibility.

During the trial, the jury heard that J&J used unsafe and cheap materials to shore up its bottom line and rushed the hip implants to market without testing them on humans to ensure their safety. Consequently, the plaintiffs suffered severe tissue damage, resulting in permanent muscle loss and intense pain, as well as irreparable loss of mobility and hip movement.

This was the fourth bellwether in the MDL which currently has nearly 10,000 cases pending over the implants’ destructive design defects. In 2016, Texas juries found in favor of two groups of plaintiffs. The juries awarded the Texas and California groups $502 million and more than $1 billion, respectively. However, these verdicts were later reduced $150 million and $543 million. In the first Pinnacle Ultamet trial, the jury sided with J&J against a sole plaintiff from Montana.


Mesh Sling Suit Beats Time Limit Motion

By Emily Cox
Vaginal mesh sling
flickr/Bill Smith

The Eleventh Circuit revived a woman’s claims Tuesday that a defective pelvic mesh sling caused egregious injuries, ruling that her injury report did not toll the statute of limitations as she was not aware of the mesh’s significant design defects.

In its opinion, the panel determined that Patricia Perryman’s claims could go before a jury despite filing her lawsuit more than seven years after her Mentor Worldwide LLC ObTape transobturator vaginal mesh sling removal. The panel determined that it was questionable when she noticed her injuries as the symptoms that precipitated the removal were in-line with the side effects that could happen if the product worked as intended.

“Plaintiff never suspected that ObTape was defective or that a specific defect in her ObTape implant had caused her injuries until she saw a commercial in 2013 that reported the existence of vaginal sling defects,” wrote Circuit Court Judge Julie Carnes for the panel.

Perryman’s lawsuit is part of a Mentor MDL over the defective vaginal mesh sling implant. The plaintiffs allege that Mentor did not properly test the device before introducing it into the stream of commerce in 2003. Patients claim the defective device caused erosion of internal bodily tissues, causing complications that included serious infections and pain that necessitated further invasive procedures.

Pelvic Mesh Sling Allegations

The opinion indicates that Florida resident Perryman first received the ObTape mesh sling in May 2005. According to her allegations, her physician warned her that the surgery carried risks of pain, infection, and tenderness, and that her body could outright reject the implant.

Following the surgery, she reported pain, infection, and mesh protrusion. Consequently, she underwent surgery to remove the mesh sling in February 2006. She filed her claim in September 2013, saying she realized her injuries were not merely a side effect of the mesh or the procedure after seeing a television commercial regarding ObTape’s harmful defects.

Mento moved for summary judgement, saying Florida’s four-year statute of limitations had tolled when she had the implant removed in 2006. The district court agreed with the medical device company.

However, the Eleventh Circuit disagreed, ruling that it was a question for the jury to decide when she first reasonably became aware of the mesh implant’s defects.

The panel cited a 2017 Eleventh Circuit opinion on one of the many defective vaginal mesh lawsuits against Boston Scientific Corp., saying that, under Florida case law, the time limit is not tolled until the plaintiff has notice of “an injury distinct in some way from conditions naturally to be expected from the plaintiff’s condition.”

In this case, Perryman’s symptoms were not out-of-line from what her physicians told her could happen after surgery. And, by her account, she blamed the symptoms on an infection or allergic reaction to the implant at the time.

“In other words, such symptoms could arise from a nondefective mesh that had been implanted through surgery that was properly performed,” Judge Carnes said.

Send Us a Text Message!

Contact Us

Free Consultation

Fields marked with an * are required