Corboy & Demetrio Secures $1 Million in Death of Infant at Illinois Home Day Care

Francis Patrick Murphy, Corboy & Demetrio

Attorney Francis Patrick Murphy of Corboy & Demetrio.

Corboy & Demetrio of Chicago has secured a settlement of $1 million for Katlyn McDaniel, Special Administrator of the Estate of Tessa McDaniel, her 3 ½-month-old daughter who died on November 15, 2016 at Tender Hart’s Family Home Care Learning Inc., 20 South Lodge, Lombard, Illinois.

DuPage Co. Circuit Court Judge Brian McKillip approved the settlement of the insurance policy limits of $1 million for Corboy & Demetrio’s client on June 5, 2017.

According to the lawsuit, Defendant Jason Hart, husband of Tender Hart’s owner and an employee, was alone caring for 20 children of mixed ages to 5 years old including several infants. He took Tessa from a Pack ‘n Play and placed her on her stomach on a blanket. He left her to warm a bottle. 15 to 30 minutes later, she was dead. He never returned before she was blue. The DuPage Coroner ruled the death was undetermined.

Alone with 20 children

Jason Hart’s wife, Kimberly, president of the corporation has been indicted on multiple licensing violations. Facts showed that Kimberly Hart left to run errands after another employee left on her lunch break.

This left Jason Hart alone with 20 children, which was in violation of Illinois State licensing requirements pertaining to the ratio of employees to children. “This senseless death is what happens when people do not follow the law for child care and supervision,” said Corboy & Demetrio Partner Francis Patrick Murphy. “Trying to care and supervise 20 children alone was insane.”

Tessa McDaniel is survived by her mother, Katlyn; her father, Sean; and her 3 1/2-year-old sister, Nora.

“This was not an isolated incident,” said Rene Torrado, Jr., a partner at Corboy & Demetrio. “We discovered evidence these child care and supervision violations were occurring for years.”

The settlement amount was the extent of the corporation’s insurance coverage. The home day care corporation has been closed by DCFS. The house is for sale.
The McDaniel family was also represented by Corboy & Demetrio Co-founder Thomas Demetrio.

Case information: Case#2017L120, Katlyn McDaniel v. Tender Hart’s Family Home Care and Learning, Inc. and Jason Hart, DuPage Co. Illinois Circuit Court.

Supreme Court Declines Review of $25M Tobacco Case Likened to Criminal Manslaughter

Philip morris oregonThe United States Supreme Court upheld a $25 million punitive damages award against tobacco giant Philip Morris USA Inc. for the family of a Oregon woman who died from lung cancer that had metastasized to a brain tumor.

The high court declined to hear Philip Morris’ appeal of an Oregon Appeals Court ruling that upheld the $25M punitive damages award reduced from a $150M jury verdict after the Oregon Supreme Court ordered a new trial solely on the issue of punitive damages.

Low-tar cigarettes marketed as safe alternative

Michelle Schwarz survivors brought the lawsuit against Philip Morris after her death in 1999.  Schwarz smoked since the age of 18 and switched to Philip Morris’s Merit Brand cigarettes which were fraudulently marketed as low tar cigarettes as a safe alternative.

The jury found Philip Morris liable for negligence, product liability, and fraud and apportioned Schwarz 49 percent of the fault, awarding $168,000 in compensatory damages and $150 million in punitive damages.

Philip Morris appealed the verdict to the Oregon Supreme Court asserting that the trial court had not properly instructed the jury regarding punitive damages.  The court ordered a new trial and limited the question on what the correct amount of punitive damages should be.

Using the binding verdicts from the first jury trial, the jury determined a punitive damages amount considering the courts emphasis that the evidence demonstrated that the tobacco giant acted with “reckless and outrageous indifference to a highly unreasonable risk of harm and …with a conscious indifference to the health, safety, and welfare of others.”

Considering what the court noted as concerns about the “degree of reprehensibility of Philip Morris’s conduct,” and the evidence regarding the tobacco company’s worth of $50 billion, the retrial jury awarded punitive damages of $25 million.

‘Extraordinarily reprehensible’ conduct compared to manslaughter

Philip Morris appealed the verdict again, arguing the award was grossly excessive in violation of the Due Process Clause.  The state’s Supreme Court rejected the argument, concluding that Philip Morris’s conduct, which it described as a “concerted decades-long effort to deceive smokers and the public about the dangers of smoking” its low-tar cigarettes, was “extraordinarily reprehensible.”

In affirming the verdict, the court referenced the state appeals court ruling that compared Philip Morris’s conduct to criminal homicide, writing that the fraudulent conduct the company engaged in resulting in Schwarz’s death could constitute first-degree manslaughter.

Supreme Court declines review

In its petition to review to the United States Supreme Court, Philip Morris asserted that Oregon’s partial-retrial of only the punitive damage issue conflicted with the high court’s rulings that partial-retrials are only allowed in unusual circumstances because they may cause “serious due process concerns.”

Philip Morris asserted that the Oregon courts were required to order a new trial on all issues, not just that of punitive damages.

The tobacco company also argued that the Supreme Court could use the case to settle state and federal court conflicts on the permissibility of partial retrials in punitive damage cases.

The company further urged the courts review of the case, claiming its implications “transcend punitive damages” and “will provide valuable guidance to…courts across the country” in complex litigation and “mass tort litigation that has proliferated in recent decades.”

Schwarz response brief pointed out that the cases cited by Philip Morris did not apply to decisions to remand for full or partial retrial.  The response further argued that issues for retrial are recognized as a matter for the court’s discretion and does not conflict with the due process clause.

The Supreme Court apparently did not find the case to be of transcending importance and declined to review, upholding the $25 million punitive damage award.

 

The case is Philip Morris USA Inc. v. Paul Scott Schwarz, case no. 15-1013, in the United States Supreme Court.

Connecticut Court Allows Lawsuit Against Gun Makers for Sandy Hook Massacre

Twenty children and six adults tragically gunned down by an AR-15 automatic rifle on December 14, 2012.

Twenty children and six adults tragically gunned down by an AR-15 automatic rifle on December 14, 2012.

A Connecticut Superior Court has allowed a lawsuit filed by family members and a survivor of the Sandy Hook Elementary School mass shooting victims against several gun manufacturers and sellers to proceed despite the Protection of Lawful Commerce in Arms Act (PLCAA).

The Act, passed with heavy NRA backing in 2005, has been used as a legal shield to protect gun manufacturers from liability lawsuits for deaths, injuries, and public nuisances created by its weapons.

Nine families of the twenty-six people and children killed and one person injured by a Bushmaster AR-15 assault rifle used by Adam Lanza during the Sandy Hook shooting, filed a 33-count wrongful death complaint against several gun manufacturers and sellers.

Wrongful death

The complaint alleges that the gun makers know that civilians are unfit to operate AR-15, disregarding the risks created by civilian use of a weapon designed for “specialized, highly regulated institutions like the armed forces and law enforcement.”

The complaint claims that gun makers continued to sell the weapons for profit, even with the knowledge that civilian use creates an unreasonable and egregious risk such as the mass casualty event of the Sandy Hook Elementary massacre.

The families also alleged that gun manufacturers “unethically, oppressively, immorally, and unscrupulously marketed and promoted the assaultive qualities” to purchasers with the expectation and intent that purchasers would share or transfer the weapon to others, including family members

A survivor of the shooting in the lawsuit made a claim for her pain and suffering arising from the terror she experienced and injuries obtained during the shooting.  The victims also allege the gun makers knowingly violated the Connecticut Unfair Trade Practices (CUPTA)

Gun Makers claim immunity

Gun manufacturers filed a motion to dismiss for lack of subject matter jurisdiction on the grounds of their immunity by virtue of the Protection of Lawful Commerce in Arms Act (PLCAA), arguing that the wrongful death claims do not fall within the negligent entrustment exception under the Act and because the plaintiffs lacked standing to pursue CUPTA violation claims.

The victims asserted that the gun maker’s motion to dismiss concerned the legal sufficiency of the victim’s claims instead of the court’s jurisdiction, and should have been construed as a motion to strike.

The court agreed with the plaintiffs, writing that it would have been more appropriate to treat the motion to dismiss as a motion to strike because the gun makers focused solely on the legal sufficiency of the complaint in arguing.  The court, however, found it was neither practical nor desirable to consider the defendant’s motion as anything other than a motion to dismiss.

The court wrote that it would “confine its analysis to” whether the court has jurisdiction over the plaintiff’s claims, as appropriately within the scope of the gun maker’s motion to dismiss.

The court discussed that other federal courts have considered the PLCAA as a defense within a motion to dismiss that challenges the legal sufficiency of the pleading, not the court’s jurisdiction, but that in Connecticut, a motion to strike is the equivalent of a federal motion to dismiss.

The court wrote that a plaintiff’s failure to allege an essential fact under a statute goes to the legal sufficiency of the complaint, not the subject matter jurisdiction of the court.  The gun makers arguments concerning the availability of the PLCAA exception application to the plaintiff claims is an issue of legal sufficiency, and any immunity that could be provided to the gun makers under the PLCAA did not implicate the court’s jurisdiction.

The court denied the gun maker’s motion to dismiss because a claim that the court lacked jurisdiction could not be granted based on a claim of immunity under the PLCAA

Victim standing under CUPTA

The court also denied the gun makers motion to dismiss citing the victims did not have standing under CUPTA.  The gun makers argued that the victims lacked standing because they interpreted case law to require that a plaintiff’s interests under CUPTA be that of a consumer, competitor, or other businessperson.

The court again wrote that the issue of who has a protected interest under CUPTA is another legal interest and sufficiency issue, and does not affect the subject matter jurisdiction of the court.  The court wrote that it could not grant the motion to dismiss on the grounds of a challenge to the legal interest of the victims.

The ruling is a big win for gun control advocates as many gun manufacturers have been able to evade liability for the deaths firearms cause since the passage of the PLCAA.

“These companies assume no responsibility for marketing and selling a product to the general population who are not trained to use it nor even understand the power of it,” said William Sherlach to the Washington Post, whose wife Mary Joy was killed by Adam Lanza in the shooting.

Before the passage of the PLCAA, gun maker Bushmaster, a defendant in this class, was sued by two survivors and the families of six victims from the Washington sniper shootings in 2002.  They settled the case for $2.5 million.

The case is Donna L. Soto, et. al., v. Bushmaster Firearms International, LLC, et. al., case number FBT-CV-15-6048103-S in the Superior Court Judicial District of Fairfield at Bridgeport.

Florida Supreme Court Rules Smoker with Lung Cancer Entitled to Punitive Damage Claims

engle punitive damages pic 2

The decision is a victory for “Engle progeny” plaintiffs, who were allowed to file individual lawsuits against the tobacco companies.

The Florida Supreme Court has allowed a widow of a man who died from lung cancer to seek punitive damages on strict liability and negligence claims in her Engle progeny wrongful death lawsuit against R.J. Reynolds Tobacco Co.

The decision resolved an appellate court split on the issue, now allowing individual members of the Engle class action to seek punitive damages on all claims properly raised.

The decision is a victory for “Engle progeny” plaintiffs, who were allowed to file individual lawsuits against the tobacco companies when the Florida Supreme Court decertified the original Engle class and overturned the $145 billion verdict.

The court permitted individual members to use the jury findings from the class action ruling, maintaining a res judicata effect for individual member’s cases.

Progeny plaintiff damage claims

Lucille Soffer brought her individual wrongful death action against R.J. Reynolds asserting the four causes of action pled in the Engle class action of negligence, strict liability, fraud by concealment, and conspiracy to commit fraud.  Soffer amended her complaint to add a demand for punitive damages.

During the jury charge conference, RJ Reynolds asserted, and the trial court agreed, that the jury should be instructed that only the fraudulent concealment and conspiracy counts could be considered for punitive damages based on the procedural posture of the Engle case.

In the Engle class action, plaintiffs initially sought punitive damages on the fraud charges, and later asked for leave to amend the complaint to include punitive damages for negligence and strict liability.  The court denied the motion as untimely.

The trial jury did not award punitive damages based on its jury instructions, but a judgment of $2 million was entered for Soffer.  She appealed, asserting the court erred in prohibiting punitive damages on the negligence and strict liability counts.

The First District Appeals Court upheld the trial court decision, finding that Engle progeny plaintiffs “wear the same shoes” as the Engle plaintiffs and could not bring other claims and remedies that had not been timely asserted as part of the Engle class action.

The Second District heard a similar Engle progeny case, but it determined that while Engle progeny plaintiffs benefit by the res judicata effect of the Engle class action findings, they are not precluded from seeking a remedy barred as untimely for “mere procedural deficiencies.”

Florida Supreme Court resolves District Court split

Soffer appealed the First District Court’s ruling, and the Florida Supreme Court found in her favor.  The Court ruled that Soffer, and all Engle progeny plaintiffs may seek punitive damages on all properly pled counts in individual actions.

The court stated that the trial court’s denial of the motion to amend in the Engle class action was not based on the merits of the request, but was based on the procedural posture at the time since the request was untimely.

Further, the procedural posture changed once the court vacated the entire punitive damages award of $145 billion, the related findings on punitive damages were vacated along with it, entitling each progeny plaintiff to punitive damages in his individual lawsuit.

The court also stated that a demand for punitive damages is not a “separate and distinct cause of action,” rather it is dependent on the existence of an underlying claim.

Progeny entitled to punitive damage claim

Finally, the court reasoned that since the burden to establish entitlement to punitive damages is on the plaintiff to prove by clear and convincing evidence that the defendant’s conduct causing the damage was either intentional or grossly negligent, claiming punitive damages does not vary depending on the underlying legal theory of the claims.

The ourt ruled that its decision on the res judicata effect of findings addressed in Engle have no application to claims for punitive damages sought by Engle progeny plaintiffs, and that there was “simply no basis to conclude that the procedural posture of Engle would bar an Engle progeny plaintiff.

The case is Lucille Ruth Soffer v. R.J. Reynolds Tobacco Company, case no. SC13-139, in the Supreme Court of Florida.

Zofran Multidistrict Litigation Allowed to Proceed Despite Motion to Dismiss

belly of pregnant woman and vitamin pills in the hand

Amid increased warnings that the anti-nausea drug Zofran may be linked to serious birth defects when used during pregnancy, a federal panel last year created a special multidistrict litigation docket for victims to use as an avenue for compensation from the drug’s maker, GlaxoSmithKline (GSK).

With hundreds of lawsuits already filed, GSK filed a request last month to have the lawsuits against it thrown out of court before families even had a chance to prove their case. The federal judge overseeing the Zofran birth defect lawsuits denied GSK’s attempts to keep the cases out of court as premature at best.

Loath to Dismiss

GSK had argued the families’ state law claims were preempted by federal law under the U.S. Supreme Court decision in Wyeth v. Levine, which held that federal regulatory clearance of a medication does not shield the manufacturer from liability under state law. U.S. District Judge F. Dennis Saylor IV said that he was “loath to dismiss” the claims without giving the families the chance to develop the facts of their respective cases through discovery.

Zofran, manufactured by GlaxoSmithKline and first approved by the FDA in 1991, is intended for extreme cases of nausea, such as with cancer medications or following surgery. It was not FDA-approved for use during pregnancy. However, it has increasingly been prescribed to expectant mothers for morning sickness since its initial approval. GSK was fined a record $3 billion in 2012 by the federal government for illegally promoting Zofran for such unapproved purposes. GSK earned more than $1.5 billion per year in sales, and it is evident the $3 billion fine had little overall impact on the pharmaceutical giant.

The families affected by Zofran usage argued on January 6 that because the FDA hasn’t approved Zofran to treat morning sickness, only GSK has control over the relevant evidence of the foreseeable risks of using Zofran while pregnant.

  • Even though parties have not yet initiated discovery, the families said they have reason to believe GSK has evidence about the link between Zofran and alleged birth defects.
  • This includes several animal studies conducted by the pharmaceutical company in Japan after the company launched sales of the drug in the U.S. One of those studies, the families said, revealed the same cardiac birth defect alleged by many of the complaints.

Proceeding With Discovery

In its January motion to dismiss, GSK argued that the FDA’s negative response to a citizen petition requesting that the agency reclassify the pregnancy risk for Zofran demonstrates the FDA had already made a decision about the validity of the Zofran warnings. Judge Saylor disagreed, stating,

“In effect, GSK argues that the court need not consider evidence of how the FDA might have answered a change request, because the petition response itself contains the actual answer. GSK’s position, however, is problematic . . .”

In short, the standard of “clear evidence” involves a fact-based evaluation, so Judge Saylor felt the court should not rule on a motion to dismiss “without giving the plaintiffs some opportunity to develop the facts, whatever those facts may be.”

“If — as plaintiffs allege — GSK was in exclusive possession of information not previously submitted to the FDA indicating the need for a new or strengthened warning, that information would presumably be included in a [change being effected] request,” Judge Saylor said. “That information could not, however, have been submitted by a citizen petition, as no citizen (according to plaintiffs) had access to it.”

Hundreds of families have joined the multidistrict litigation against GSK, and now they all will have the opportunity to proceed with their claims.

The case is In Re: Zofran (Ondansetron) Products Liability Litigation, Case Number 1:15-md-02657, in the U.S. District Court for the District of Massachusetts.

Award to Scientology Reversed for Improper Procedure and Lack of Jurisdiction

ScientologyFlorida’s Second District court of appeals ruled the trial court was void of jurisdiction in deciding a defendant’s motion and awarding damages on a voluntarily dismissed claim.

The Church of Scientology and Kennan G. Dandar had reached a settlement agreement in 2004 in a wrongful death suit against the organization.

Several hundred lawsuits have been brought against the Church of Scientology by former members and media outlets for criminal and civil issues.

In the agreement, Dandar agreed not to be involved in any adversarial proceedings against Scientology at any time or under any circumstances.

The parties subsequently agreed to dismiss the case without prejudice. The parties did not file any orders retaining jurisdiction over any dispute.

Lack of Subject Matter Jurisdiction

In 2009 Dandar filed a complaint against Scientology in a similar action. Scientology filed a motion stating Dandar violated the agreement and requested damages. Rather than following normal procedures and filing the motion with the clerk, Scientology handed the motion over to a judge.

The appeals court concluded that although there was a clause attempting to reserve jurisdiction, the voluntary dismissal trumped the parties’ agreement.

According to state civil procedure rule 1.420(a) and further explained by case law, is once a case is voluntarily dismissed, the proceeding is an act of finality that deprives the court of jurisdiction.

An exception occurs if the trial court dismissed the case based on the parties’ agreement. If so, the parties are allowed to file a motion to reopen the case, and to seek enforcement of the agreement.

In this case, no order was entered before or after the dismissal was filed. The result would have been different if Scientology and Dandar presented the agreement to the court for approval before filing a dismissal.

The court concluded that the trial court lacked jurisdiction to enforce the agreement and require Dandar to pay $1,068,156.50 in damages to Scientology.

Law of the Case Doctrine

Scientology argued the second district court was not allowed to review the trial court’s jurisdiction under the law of the case doctrine.

This law of case doctrine is limited to questions or law actually presented and considered on a former appeal. The court explained that its power extended to procedural questions and its decision was not on the merits.

Further the court stated Scientology would need to file an action for a new civil trial and give Dandar the opportunity to a trial by jury. With the previous proceeding Dandar was not given that right which made the previous proceeding improper.

The court reversed and remanded the case for an order of dismissal.

This case is Kenan G. Dandar and Dandar & Dandar PA v. Church of Scientology Flag Service Organization, Inc, Case No 2D14-1511, Second District Court of Appeal Of Florida.

1% of Physicians Account for One-third of Paid Medical Malpractice Claims

Medical Malpractice

Claim-prone physicians account for a substantial number of paid malpractice claims.

The New England Journal of Medicine has analyzed some appalling data that 1% of physicians account for approximately 32% of paid medical malpractice claims. The data – which was pulled from the National Practitioner Data Bank – shows that over a recent 10-year period, a small number of physicians with distinctive characteristics accounted for a disproportionately large number of paid malpractice claims.

Claim-prone physicians

Studying almost 70,000 malpractice claims against approximately 55,000 doctors from 2005 through 2014, the Journal analyzed data with the hope of understanding the distribution of malpractice claims among physicians. As the Journal stated, “If claim-prone physicians account for a substantial share of all claims, the ability to reliably identify them at an early stage could guide efforts to improve care.”

The breakdown of the study’s numbers is a shocking revelation for medical malpractice lawyers: claim-prone physicians do seem to be accounting for a substantial number of paid malpractice claims.

  • Among all of the physicians with paid claims, 84% incurred only one malpractice claim during the study period, which accounted for 68% of all paid claims.
  • Of the remaining physicians, 16% had at least two paid claims during the relevant time frame, accounting for 32% of the claims.
  • The last 4% of doctors had at least three paid claims (if not more), accounting for 12% of the claims.

The Journal was able to determine by adjusted analyses that the risk of recurrence increased with the number of previous paid claims.

By calculating concentrations of claims among physicians, the Journal was able to use “multivariable recurrent-event survival analysis to identify characteristics of physicians at high risk for recurrent claims and to quantify risk levels over time.”

Dangerous doctors

Frighteningly enough, physicians who had three paid medical malpractice claims have three times the risk of incurring another paid medical malpractice claim in the future. One size does not fit all when it comes to recurrence according to practitioner specialty: the risk of malpractice among neurosurgeons, for example, was four times as great as the risk among psychiatrists.

The Journal’s conclusion boils down to this startling fact: “A small number of physicians with distinctive characteristics accounted for a disproportionately large number of paid [medical] malpractice claims.”

According to the National Practitioner Data Bank, medical malpractice claims have only continued to increase in actual dollars in recent years. As NTL reported, 2013 saw $168 million more medical malpractice payouts than 2012 (a 4.7% increase). Most of the payouts are a result of settlements (96%) instead of judgments. For a detailed infographic snapshot of medical malpractice claim statistics, see: Infographic: Medical Malpractice Payouts Increase for First Time in a Decade.

Settlements and Verdicts

Lubin and Meyer’s list of recent medical malpractice verdicts and settlements in the last year demonstrates that medical practice claims have only continued to increase . . . both in number of claims and in the millions of dollars physicians have paid out:

  • $6.25M Settlement for Baby’s Brain Injuries at Birth
  • $35.4M Verdict: Mother’s Stroke Following Childbirth
  • Ovarian Cancer Malpractice Verdict: $11.325M
  • $16.7 Million Award in Lung Cancer Lawsuit
  • Widow Awarded $13M in Tonsillectomy Post-op Death
  • Cervical Cancer Diagnosis Delay: $1M Settlement

These are just a sampling of the lawsuits, verdicts, and settlements relating to medical malpractice claims since 2014.

Just this month, a Hampden Superior Court jury returned a $29.8 million verdict against a doctor in favor of a minor plaintiff who suffered a devastating brain injury at birth. The infant plaintiff’s mother arrived at Baystate Medical Center 28 weeks pregnant with complaints of decreased fetal movement. The residents on duty recognized the problems and placed calls to the on-call attending physician, Dr. David Seubert, who continued to provide advice to “monitor the baby closely” over the phone throughout the evening.

Dr. Seubert never came to the hospital nor did he contact any attending physicians in the hospital to have them evaluate the mother. He merely continued to encourage close monitoring. This type of concerning practice continued for the next 3 ½ hours.

Finally, after several more serious drops in the baby’s heart rate, a call was made by the residents of the hospital for emergency delivery. The baby was barely alive at birth and had to be aggressively resuscitated. An MRI scan showed her injuries were due to lack of oxygen and blood flow to her brain – something “close monitoring” without any further action could never have ameliorated.

At the time of trial, the plaintiff was 11 years-old. She is unable to walk, unable to talk, is legally blind, has a tracheostomy tube and is fed via g-tube. She is dependent on others for all of her activities.

As the New England Journal of Medicine’s troubling trends in medical malpractice claims demonstrates, repeat offenders are more likely than not. With the likelihood that physicians who have paid medical malpractice claims will continue to incur future claims due to similar behavior, medical malpractice attorneys should continue to be aware of this potential increase in verdicts and settlements.

SCOTUS Refuses to Hear Johnson & Johnson Appeal of $140M Children’s Motrin Verdict

Samantha Reckis and her parents a total of $109 million, including interest, a Plymouth Superior Court jury decided on Wednesday. Samantha was 7 when she was given Motrin brand ibuprofen, family attorney Brad Henry said. She suffered a rare side effect known as toxic epidermal necrolysis and lost 90 percent of her skin and was blinded.

Samantha Reckis was 7 when she was given Motrin brand ibuprofen. She suffered a rare side effect known as toxic epidermal necrolysis and lost 90 percent of her skin and was blinded.

The U.S. Supreme Court said on Jan 19 that it will not hear Johnson & Johnson’s appeal of a $140 million judgment in a lawsuit alleging it failed to warn that Children’s Motrin pain and fever medication could cause a devastating skin condition.

The decision leaves intact one of the largest verdicts ever awarded by a Massachusetts jury.

Johnson & Johnson had urged the US Supreme Court to weigh in on its challenge to a $140 million verdict that the pharmaceutical company must pay because of its Children’s Motrin product.

The kids’ anti-inflammatory drug has allegedly caused a potentially deadly skin condition, and Johnson & Johnson is arguing courts should look to a third party for liability: the U.S. Food and Drug Administration, for rejecting the warning labels proposed by the pharma giant.

Deadly Skin Condition

Plaintiffs Samantha Reckis and her parents brought suit against Johnson & Johnson after the Children’s Motrin product caused Samantha to develop toxic epidermal necrolysis, a terrible skin condition that damages the body’s mucous membranes. Reckis lost 80% lung capacity and 90% of her skin. She is also now blind. Reckis experienced these unbelievable side effects in 2003 at the young age of seven.

Reckis’s parents argued the medication should have come with warnings that specifically mentioned toxic epidermal necrolysis, the related skin condition Stevens Johnson Syndrome, and a general warning that rashes or blisters that develop after taking the drug could lead to a “life-threatening” condition. However, the FDA had rejected warnings similar to those urged by Reckis’s parents.

Stevens-Johnson syndrome, a form of toxic epidermal necrolysis, is a life-threatening skin condition in which cell death causes the epidermis to separate from the dermis. The syndrome is thought to be a hypersensitivity complex that affects the skin and the mucous membranes. The most well-known causes are certain medications, but it can also be due to infections, or more rarely, cancers. Toxic epidermal necrolysis and Stevens-Johnson syndrome essentially cause one’s skin to melt off the body.

Petitioning for Certiorari

Johnson & Johnson had sought in a brief filed December 30, 2015 for the U.S. high court to review the Massachusetts Supreme Judicial Court’s decision affirming the multi-million dollar February 2013 verdict. Johnson and Johnson said in its filing,

“It is beyond dispute that the specific warning language the [Massachusetts Supreme Judicial Court] said Massachusetts law required was proposed to the FDA, rejected by the FDA, and then proposed again at trial by respondents . . . The FDA acts intentionally and purposely when it includes particular language in one label (for patients under a physician’s care) but rejects its inclusion on another label (for over-the-counter consumers) – especially given that this same language was proposed for both products.”

The warnings rejected by the FDA were proposed by a citizens’ petition and not Johnson & Johnson. The Massachusetts high court used these facts to reason that the FDA may not necessarily have rejected such warnings if Johnson & Johnson itself had proposed them.

Johnson & Johnson believes this holding to be based on speculation and has also argued that the FDA specifically requires similar warnings for prescription ibuprofen products, not over-the-counter products (including Children’s Motrin). Johnson & Johnson believes this shows the FDA’s intent not to apply such warning labels to over-the-counter medication, regardless of the entity proposing the warnings.

The case is Johnson & Johnson et al. v. Lisa Reckis et al., case number 15-449, in the Supreme Court of the United States.

Their Duty Alone

Meanwhile, a Philadelphia jury returned a $10 million verdict against Johnson & Johnson in 2010, after siding with a family who said their 3-year-old daughter was struck with Stevens-Johnson syndrome after taking Children’s Motrin in 2000. The Pennsylvania Supreme Court declined to hear an appeal of the case in March after the state’s Superior Court upheld the verdict in July 2014.

Another ongoing case against the pharmaceutical company is Brown et al. v. Johnson & Johnson et al., case number 2:12-cv-04929, in U.S. District Court for the Eastern District of Pennsylvania. Riley Brown (age 3 at the time) was hospitalized for nearly a month after taking Children’s Motrin and saw more than 30 percent of her body affected by the painful skin condition. She was left blind in one eye and now has a severe sensitivity to light in the other. Brown has undergone multiple eye surgeries since she was stricken with SJS/TEN, including a failed cornea transplant.

Brown’s attorney told the eight-member Pennsylvania jury in September, “The law is that the drug manufacturer, the one who is making the profit by selling the drug, has a duty. Our country, our government, has decided that the duty is going to fall on the drug manufacturer to make their product safe. It is not a delegable duty. They can’t push it off on the FDA. They can’t push it off on a doctor. They can’t push it off on mom. It is their duty and their duty alone.”

Concussion Litigation Sparks Advocacy, Increases Nationwide Awareness

TBI Football

NFL players rely on government programs to provide healthcare instead of the National Football League covering their traumatic brain injury healthcare.

Professional and amateur sports leagues have finally begun making key changes to protect football and other close-contact sports players against traumatic brain injuries.

These protections are largely a result of the increased awareness surrounding traumatic brain injuries nationwide. Due to recent high-profile litigation, including suits against the National Football League, more understanding of the long-term impacts of concussions now exists.

The National Trial Lawyers recently discussed a new report by the American Association for Justice (AAJ) with several traumatic brain injury advocates currently revolutionizing the health care approach to both student and professional athletes.

Recent Widespread Awareness

According to the David Ratcliffe, a researcher with the AAJ, it is only recently that a widespread change in attitude surrounding concussions and traumatic brain injuries has occurred. Ratcliffe, the of the new AAJ concussion report said, “More players, parents, coaches, and schools are aware today more than ever before of the risks associated with head trauma. This dramatic change in culture is largely due to high-profile litigation against colleges and the NFL that has continued to push for accelerated changes, as opposed to the incremental change the AAJ has seen over years past.”

As maConcussions and the Courthouseny as 3.8 million sports-related injuries occur each year and concussion management overall is still inadequate. The AAJ issued a report to raise further awareness titled Concussions and the Courthouse, which can be found here. The AAJ will continue to advocate for better risk-management and better concussion care.

Jason Luckasevic, a Pittsburgh attorney, brought concussions in sports to international attention when he filed the first two lawsuits against the NFL in 2011 on behalf of more than 200 NFL players. Luckasevic’s neuropathologist friend, Dr. Bennett Omalu, discovered a specific form of brain disease common in NFL players.

Luckasevic hopes to protect all athletes – including millions of children – to avoid repeated head trauma. “There is a need to make sure athletes are not at risk of chronic brain damage due to chronic carelessness of leagues,” Luckasevic told NTL.

“Today, we continue this conversation to not only protect those former NFL players, but also all athletes – including millions of children – involved in contact sports, so that they can avoid this public health concern involving repeated head trauma,” said Luckasevic.

Leonard Marshall, a former NFL player for teams including the New York Giants, believes it’s his “duty, honor, and privilege to eradicate TBIs (traumatic brain injuries).” Marshall played in the NFL for twelve years and was a two-time Super Bowl champion.

Once a former All-Pro defensive lineman for the Giants, Marshall was diagnosed with signs of Chronic Traumatic Encephalopathy (CTE) and became a sports safety spokesman to raise head trauma awareness. For more than eight years, he has been committed to trying to make a difference with the goal of making it safer for kids to play tackle football.

Marshall formulated a platform to reach America’s youth and parents called the Brain Unity Trust, a non-profit organization combined of medical experts, attorneys and player. Brain Unity Trust is the “first of its kind” and advocates awareness for all sports and athletes, including cheerleaders, who Marshall says “may also suffer from TBIs while participating in sports.” Find out more info at Brain Unity Trust and PracticeLikePros.com.

Marshall told the NTL, “There’s all this education out there about the risk of drinking, drugs, and sexual contact . . . these are all things that should be understood. However, TBIs should be understood, studied and talked about with the same compassion.”

Zachary Lystedt Law

Victor Lystedt experienced every football parent’s worst nightmare when his son Zachary suffered a concussion during a football game one Friday night. Zachary Lystedt went down hard during a game and was directed to sit out for two plays before being thrown back into the game. Several minutes later, Zachary became unconscious while playing and was airlifted to the nearest hospital. Lystedt’s son began rigorous physical therapy, and the Lystedt family was devastated when Zachary could not even talk for the first nine months.

“People must understand youth athlete’s brains are totally different than adult brains, and heal totally different . . . they need time. Understanding concussion management is key to keeping your kid safe,” Lystedt told the NTL. “Once we were able to use all the lawyers and the experts to identify why our son was hurt, I now feel it’s my duty to call upon parents to understand this nationwide. This is an important education piece in regards to football and all sports.”

The NTL also spoke with Richard Adler, the attorney for the Lystedt family and the drafter of the “Zachary Lystedt Law,” the first of its kind. Adler, who is based in Washington, told NTL,

“Education is the primary focus to start. An education campaign in the state of Washington still resulted in many soccer, lacrosse, and football injuries statewide. We realized education was only going so far and didn’t have the stickiness we were hoping would stay with the school administrators and parents.”

When in Doubt Sit Them Out

That’s when Adler drafted Washington’s When in Doubt Sit Them Out law. Adler’s legislation campaign garnered a lot of support from doctors and Seahawks players and fans. The law passed on May 14, 2009 and since then, all states have adopted similar principles.

Adler told NTL,

“When a player is suspected – not diagnosed – they must be removed and cannot return to play until a release by a medical professional is given. Then, there must be a graduated return to full play. We are still finding that many youth athletes across the country have died. Ages of eighteen and under are when athletes see issues of Second Effects Syndrome. A TBIs are truly traumatic. The CDC in 2002 called them a ‘silent killer’ before Congress.”

Adler also said, “Mandatory parent-meetings is an idea I’m still working with. We need to change the culture of sports. Coaches need to know parents are involved and parents need to attend school meetings and hear presentations.”

According to Adler, “Another next step is a call for national legislation. All states have concussion laws. Bicycle helmets, motorcycle helmets, and seatbelt laws are not even in all 50 states!”

Adler believes sanctions to hold coaches accountable are also invaluable tools for raising concussion awareness and protecting our country’s athletes. “Coaches all too often look the other way because of the culture of the sport,” Adler pointed out.

“The discussion is not just about returning to practice and getting to compete, but also returning to the classroom,” Adler told NTL. “We need to make education and accommodations there the focus because education should be first . . . returning to the field or arena should be second.”

Strengthen parental notification

AAJ’s David Ratcliffe stated,

“We want to strengthen parental notification, which is already in place in six states and is a very simple thing to do. Parents nationwide should push states to add this to state laws where it is not already in place. These laws generally only cover high school, but a lot of these head trauma problems expand to middle school and even elementary school. We need a push for state laws instead of a nationwide practice of avoiding them.”

Leonard Marshall

Leonard Marshall

Leonard Marshall has a message for those who believe concussion and TBI advocates are merely trying to kill football:

“Grow up. This is a contact sport and you’re in the air often with the potential to fall on your head and then contract a traumatic brain injury. I’ve come across a number of different people in my field – Hall of Famers and accountable football players – who have legitimately experienced this stuff and have seen the lack of responsibility and accountability firsthand. This stuff is going to happen. In fact, it’s going to happen to more kids between ages 8-18 because of the fact that the brain is not fully developed. When you smash into each other at a high rate of speed with improper equipment or improper coaching, the risks get greater. It’s only inevitable that over time, if we don’t make changes now, it’s only going to get worse.”

Marshall pointed out the example of Buddy Teevens, head football coach for Dartmouth University. Marshall believes Teevans has a genuine understanding of head injuries and a great approach to protecting his players. “The least amount of time spent practicing on the field actually leads to the most results and better games. It’s all about playing the game in a manner that you don’t go out on the field with the goal to maim or personally injure someone else. Athletes need to play with physicality but also with safety concerns. I’m very proud of Teevens’ football program,” Marshall told NTL.

We just had a boy die…

As a parent who has experienced firsthand the heartbreak of a traumatic brain injury suffered by his child, Lystedt often receives the question, “Would you ever let your son play football again?” His answer is a resounding, “Yes. Why wouldn’t I? It’s the safest the game has ever been. It’s more talked about now, and it’s looked at with an objective eye so much more than it ever has been.”

Lystedt continued,

“We’re not all the way done, though. We just had a boy die here in Washington State which is a very sad thing. I know we need to do a whole lot more when it comes to the educational aspect. My son battled for his life . . . battled really hard, for a long time. I think the reason he survived is the warrior attitude that sports gave him. He’s been doing sports all his life, and now his sport is to recover and get better. He’s motivated internally to get better every day. I think with the proper coaching and management of any sport, we can keep it a lot safer. I don’t think there’s any piece of equipment that can stop a concussion if it’s going to happen. I think what we can do is manage it thereafter and give our child the full time needed to recover and monitor this recovery by the proper people in the medical field, while educating parents, coaches and teachers. The opportunity to play a sport is a very great thing to give a kid and I wouldn’t want to take that away from any one of them.”

To view a copy of the AAJ’s full report, visit Concussion.Justice.org.

Invokana’s Deadly Side Effects Create the Opportunity for Major Recovery

Invokana

Invokana, made by Johnson & Johnson subsidiary Janssen Pharmaceuticals, is a “blockbuster” drug that has been prescribed to millions of Americans with type 2 diabetes in the two short years it’s been on the market. Johnson & Johnson promoted Invokana as a “much-needed” breakthrough in diabetes research.

Invokana was designed to help control blood sugar by forcing the kidneys to purge glucose from the bloodstream through urination, but when Janssen began promoting it off-label for weight loss, deadly side effects occurred, according to a letter from Public Citizen to the FDA (see page 6 of the letter).

Blockbuster Drug With Deadly Side Effects

The host of alarming side-effects Invokana has been linked to include:

  • hypotension
  • urinary tract infections
  • yeast infections
  • ketoacidosis (a potentially-fatal rise in blood acidity)
  • decreased bone strength
  • increased risk of broken bones
  • heart attack
  • stroke
  • kidney failure

“Blockbuster drugs” like Invokana are extremely popular drugs that generate annual sales of at least $1 billion for the company that creates it. Examples of blockbuster drugs include Vioxx, Lipitor and Zoloft. Janssen heavily promoted Invokana for both the on-label and off-label use.

The FDA described Invokana as creating “an imbalance in early cardiovascular events” observed in the CANVAS trial. This trial involved a 4,300-subject study assessing the cardiovascular effects of Invokana. In the first 30 days of use, Invokana had a cardiovascular events “Hazard Ratio” of 6.9, which means that patients who were taking Invokana at the time had a 690% higher likelihood of suffering a cardiovascular event than the patients who were taking a placebo.

Janssen has opened itself up to failure-to-warn suits because the Invokana label does not warn of dangerous side effects, including: heart attack, stroke, kidney failure, and diabetic ketoacidosis.

While most personal injury attorneys are not currently pursuing bone fracture side effects Invokana cases because cases with hospitalization and prolonged injuries are generally preferred. Generally, Invokana clients must have taken an SGLT2-inhibitor, such as Invokana, Jardiance, or Farxiga (or one of the combination products Invokamet, Glyxambi or Xigduo). Additionally, the most commonly pursued injuries include:

  • Heart attack (must be within 15 days of last use).
  • Stroke (must be within 15 days of last use).
  • DKA (must be within 15 day of last use).
  • Kidney Failure (must be within 45 days of last use).

Current Invokana Lawsuits and Potential MDL

Rosalba Joudry, a resident of Ontario, Canada, filed an Invokana class action on September 10, 2015—the first Invokana lawsuit ever filed. Joudry and her lawyers filed her case with the Ontario Superior Court. The lawsuit contains accusations that the manufacturer:

  • Failed to perform “proper design, development and testing of its drug” before proceeding to advertise and sell it on the Canadian market.
  • Failed or refused to ensure that doctors and patients had access to a “clear, complete, and current” list of side effect warnings.
  • Ignored, either on purpose or through neglect, vital information on the risks of Invokana, which it should have been aware of “based on Invokana’s [kidney-facilitated] mechanism of action, the class of drugs Invokana belongs to, and numerous studies, trials, and medical journal articles”.
  • Persists in portraying Invokana as a safe product while “downplaying the seriousness of [its] potential side effects”.
  • Chose to value profits over consumer health and safety, exercising “unfair business practices” by concealing any information that might hinder sales.

Joudry requested more than $1 billion in damages from Janssen, Inc. for herself and for other claimants who may later join the suit.

Due to its widely-prescribed status, the number of lawsuits that could arise due to Invokana’s side effects may reach staggering numbers. Similar plaintiffs may elect to consolidate their cases with group litigation methods such as Joudry’s class action or multi-district litigation (MDL), which expedites the legal process. Because of differences between U.S. and Canadian law,individual lawsuits consolidated in multi-district litigation will likely offer more compensation and flexibility for similarly situated Invokana plaintiffs.

To compare the potential compensation that could arise from Invokana MDL, consider Takeda Pharmaceuticals, the manufacturer of the diabetes drug Actos. Takeda recently agreed to pay $2.37 billion in settlements to plaintiffs alleging the drug causes bladder cancer (much like the kidney failure caused by Invokana). This settlement agreement was drawn up to resolve an estimated 9,000 individual lawsuits that demanded compensation for significant damages to health, quality of life, and financial well-being. Mass torts attorneys should contemplate the benefits of marketing geared toward those injured by Invokana.