See the Slides for An Update on Xarelto Mass Tort Litigation

gabe zambranoThe National Trial Lawyers presented An Update on Xarelto Mass Tort Litigation on June 23, 2015.

Presenter: Gabe Zambrano of Farmer, Jaffe, Weissing, Edwards, Fistos & Lehrman, P.L. in Ft. Lauderdale, FL. He is spearheading the investigation of side effects associated with Xarelto.
Mr. Zambrano served as co-counsel in an Engle Tobacco trial in 2011 that resulted in one of the largest reported verdicts that year. Today, he advocates for victims of personal injuries, and develops mass tort projects where patients suffer injuries from drugs or pharmaceutical devices, including Yasmin, Mirena IUD, Pradaxa, and Nuvaring Vaginal Ring. He continues to speak at national conferences and organizational meetings making him available to aid victims across the United States through co-counsel relationships in multiple jurisdictions.

Xarelto

Worldwide more than 7 million people have been prescribed Xarelto.

What is Xarelto?

Xarelto is a prescription medication used to treat patients with atrial fibrillation, or AFib, not caused by a heart valve problem. Atrial Fibrillation is a heart condition that causes blood to pool in the upper chambers of the heart and increases the chance of a stroke or blood clot.

In the United States, Xarelto has also been approved to treat blood clots in the legs (deep vein thrombosis) and in the lungs (pulmonary embolism).

Hundreds of deaths

In September 2013, reports emerged in Germany that Xarelto had been linked to 968 side effect reports, which included 58 deaths, with German drug regulators.

According to US lawsuits, hundreds of patients died because of bleeding caused by the drug. In 2012, the FDA reported that three times more people died from adverse events while on Xarelto compared to Warfarin.

In addition, while it is supposed to prevent blood clots, the Food and Drug Administration (FDA) has already received reports of dangerous blood clots in people taking the drug.

The number of potential deaths in the US are not known because the adverse event reporting system is a volunteer system. However, it is known that in combination,  Xarelto, Pradaxa and Warfarin or Coumadin have been linked to 789 deaths in 2013.

XARELTO as a novel anti-coagulant

As anticipated, the growing number of lawsuits has drawn the attention of victims from across the country. Realizing that they are not alone, or that they suffered side effects that others also endured, they have come forward and sought legal counsel. Most recently, this culminated on December 12, 2014, in a ruling by the United States Judicial Panel on Multi District Litigation (“JPML”).

register now NTL webinarIt entered a transfer order consolidating all pending Xarelto lawsuits. This order announced the formation of a Federal Multi District Litigation (MDL): In re Xarelto (Rivaroxaban) Products Liability Litigation, MDL No. 2592, before the Honorable Edlon E. Fallon in the Eastern District of Louisiana.

 

Office Depot Reaches $3.4 Million Settlement for Defective Office Chairs

Office Depot Quantam chair

Office Depot Quantam chair

Office Depot has agreed to pay a $3.4 million penalty to settle a claim made by the United States Consumer Product Safety Commission, charging the company knowingly failed to report defects in two models of office chairs. The chair seat backs detached from their bases.

According to the settlement agreement, Office Depot stated both models passed multiple safety tests.

Office Depot Inc., located in Boca Raton, FL received numerous complaints about its Gibson and Quantam model office chairs.

The chairs were priced at about $350 for the Quantam, and about $40 for the Gibson. The seatbacks of the chairs would loosen and detach causing injury to the users, including back injuries.

Chair Calamity

The company received initial complaints about the Quantam chair in 2008. In response to the customer complaints, Office Depot produced a second model of the chair and added additional instructions. Despite their efforts, the company received 33 additional reports of the seatback detaching and 13 reports of injury.

The Gibson chair raised concerns in 2005. This chair’s defect resulted from a broken mounting plate, which caused the seat to detach from the base of the chair. The company received 153 incident reports from consumers complaining of this issue.

At no point did the company reach out to the CPSA to report the defects. The Commission was not notified about the Gibson chair defects until December of 2012, after the Commission’s staff sent a letter requested a full report about the Gibson chair.

In addition to the monetary settlement, Office Depot has agreed to implement and monitor their internal controls and procedures  to ensure the safety of its products. As a check point, the company will be responsible for submitting written documents as proof the improvements are effective.

The settlement agreement has been provisionally accepted by the CPSC.

 

 

 

 

 

New and Noteworthy Jury Verdicts and Settlements

Recent Personal Injury Jury Awards and SettlementsLinkedIn Reaches $13M Email Harvesting Class Action Settlement
06/16/2015
LinkedIn Corp. informed a California federal court on June 11 that the company had agreed to a $13 million email harvesting class action settlement, which claims the online networking website violated users’ privacy by accessing their email accounts to send out LinkedIn invitations to potential Read More

$14 Million Verdict Affirmed in Defective Camry death case
06/16/2015
CORPUS CHRISTI, Texas, June 15, 2015 – Judge Montgomery of the District Court of Minnesota affirmed the jury’s award in a case involving a defective Toyota Camry that has been pending for the past five years which resulted in the death of three individuals and a man spending nearly three years in Read More

Jury returns $14.8M damages verdict in Brooklyn workplace injury
06/16/2015
In this courtroom sketch, Hon. Loren Baily-Schiffman listens as attorney Jeff Korek (standing), of the law firm Gersowitz Libo & Korek PC, conducts a direct examination of a witness in the labor law trial Canfield vs. Forman Jay LLC. A jury in Brooklyn, NY, returned a damages verdict of $14.8 Read More

Plaintiffs Awarded $4.5M In First Wright Hip Implant Product Liability Trial
06/15/2015
Plaintiffs’ attorney Steve Vartazarian shows jurors microsopic images of a metal hip implant that he said was defectively manufactured by Wright Medical Technlogy. Los Angeles — The first product liability lawsuit to go to trial out of nearly 1,200 pending cases involving Wright Medical Technology Read More

$5.7 Million Verdict Reinstated For Doctor in Vicious Retaliation by Hospital CEO
06/15/2015
A California appeals court has upheld $5.7 million jury verdict for a physician’s emotional distress claim against a hospital CEO. The CEO retaliated against the doctor by having him arrested for a loaded gun planted in his car. The CEO also had the physician’s daughter’s tires slashed, causing a Read More

Jury awards $1.2M in damages to motorcyclist hurt in PA crash
06/14/2015
A Dauphin County, Pennsylvania, jury has issued a $1.26 million damage award for a Susquehanna Township motorcyclist who was injured in a June 2011 crash on Derry Street in Harrisburg. The verdict in favor of cyclist Tracey Thompson resulted from a three-day trial in Judge Andrew H. Dowling’s Read More

Jury finds ex-New York cop assaulted couple and awards $1.05 million
06/14/2015
Attorney Francis X. Young and his client Mario Gomez talk about winning a $1.05 million federal verdict against a detective who roughed up him and his ex-wife in Sleepy Hollow, New York, seven years ago. A federal jury has awarded $1.05 million to Mario Gomez, a retired corrections officer, and Read More

Take-Home Mesothelioma Trial in Washington Ends With $3.5 Million Jury Award
06/12/2015
A child’s memory of their mother washing their father’s dirty work clothes each night is one that is shared by countless Americans, as well as by people all around the world. But for Ramona Brandes, a public defender in Washington state, that memory will forever be linked to her mother’s death, as Read More

Milwaukee must pay wrongfully convicted man $1 million, jury rules
06/12/2015
A man who spent six years in prison after being wrongfully convicted of a murder actually committed by serial killer Walter Ellis won a $1 million jury verdict Thursday in his federal civil suit against the city and two Milwaukee police detectives. The two detectives, Gilbert Hernandez and Daniel Read More

Jury awards Oklahoma man $6 million in asbestos lawsuit
06/12/2015
A Moore, Oklahoma, man who sued more than a dozen companies for what he described as decades of negligent workplace exposure to asbestos prevailed against two of them for a judgment of $6 million in a jury trial in Oklahoma County District Court. Michael D. Galier, 51, filed the product liability Read More

$2.6 Million Affirmed Against Developer of Faulty NuVasive Medical Device
06/12/2015
The California District Court of Appeals affirmed the $2.6 million judgment against a medical device developer, for false claims and advertising after one of its devices failed during spinal surgery. Due to the device’s failure, a screw was implanted near a nerve in a woman’s spine causing even Read More

Georgia jury awards woman $1.57 million for erroneous medical diagnosis
06/12/2015
A Richmond County, Georgia, jury awarded more than $1.57 million Thursday to the plaintiff in a medical malpractice case. The Superior Court jury decided Melissa Gravitt should receive $474,477 in damages to cover her medical expenses and an additional $1.1 million for pain and suffering, said her Read More

Defective guardrail maker hit with $663M verdict over secret design changes
06/10/2015
RICHMOND, VA – There have been recent incidents of guardrails maiming, impaling, and even killing drivers across the country. And the company that made them? On Tuesday, a Texas judge made his final judgment, tripling a jury’s verdict to $663 million in damages and penalties. Trinity ET PLUS Read More

Lying blogger ordered to pay $3.5 million in defamation lawsuit
06/09/2015
A Shelby County, Alabama, blogger, who spent five months in jail before agreeing to remove stories from his website about the son of a former governor, has now been ordered to pay $3.5 million in a defamation lawsuit filed by a former campaign manager for the state Attorney General. The blogger had Read More

D.C. schools food vendor pays $19 million to settle whistleblower lawsuit
06/09/2015
Jeffrey Mills, then-Director of Food and Nutrition for D.C. Public Schools, talks with students about what foods they like in 2010. The largest food vendor for Washington DC’s public school system has agreed to pay $19 million to settle a lawsuit alleging that the company overcharged the city and Read More

Jury awards California man $2 million murder plot by brother & sister
06/08/2015
SAN BERNARDINO, Calif. – A California man has been awarded $2 million in punitive damages following a plot by a brother and sister to kill him. A San Bernardino jury decided Friday Leonard Epps should receive $1 million each from Erik Barajas and Stacy Nunez-Barajas. The siblings were sentenced Read More

Georgia jury awards family $4.75 million after semi truck wreck
06/08/2015
A Mitchell County jury has awarded a Camilla, Georgia, couple $4.75 million for pain and suffering after a wreck involving two semi trucks in February 2011. Ralph Murphy was awarded $4 million dollars, while Debbie Murphy was awarded $750,000 dollars. Two semi-trucks collided and burst into flames Read More

Jury awards mentally disabled woman $9 million after sexual assault
06/05/2015
ST. JOSEPH, Mo. – A jury awarded a $9 million judgment to a disabled northwest Missouri woman who was sexually assaulted by the husband of her social services caseworker, leading to the birth of a child. A Buchanan County jury recommended the award Thursday in a civil case filed by relatives of the Read More

Jury in Illinois says School District must pay $2.5 million for student’s classroom asthma death
06/05/2015
A Kendall County, Illinois, jury has ordered Community Unit School District 308 to pay $2.5 million to the family of Jeffery Stewart, an Oswego High School student who died in 2008 after he suffered an apparent asthma attack and collapsed in English class. Jeffery Stewart died on Feb. 13, 2008. His Read More

J&J Settles Risperdal Case for $7.8 Million
06/05/2015
New York, NY, June 3, 2015 – Johnson & Johnson and its Janssen Pharmaceuticals unit have agreed to pay $7.8 million to resolve a Risperdal lawsuit (http://www.risperdallawsuit2014.com/) filed by the state of Arkansas over tactics the company allegedly used to market the antipsychotic drug. The Read More

Jury Orders Beverly Hills to Pay $1 Million in Workplace Retaliation Case
06/05/2015
A Los Angeles Superior Court jury today ordered the city of Beverly Hills to pay $1 million to a parking control officer after finding that she experienced retaliation for complaining about workplace conditions, but the panel rejected her racial discrimination and harassment claims. The case was Read More

California Jury awards $17M to driver hurt in 2012 crash
06/05/2015
An Escondido fireman hoses a flatbed truck that rear ended one car, front left, causing a chain reaction with other vehicles southbound I-15 near Via Rancho Parkway in Escondido VISTA, California — A Vista Superior Court jury awarded more than $17.3 million this week to a man who suffered facial Read More

Jury Awards $45.6 Million in Pediatric Paralysis Case
06/05/2015
Did a renowned pediatric surgeon miss the mark with 4 screws while performing a spinal operation at a prestigious New York hospital, causing a 14-year-old boy to become paralyzed from the waist down? Yes, said the jury that heard the case. It awarded the boy’s parents $45.6 million in a malpractice Read More

Judge Denies Motion for New Trial on $1.2M Broken Arm Verdict
06/05/2015
A $1.2 million verdict for a broken arm suffered in a truck crash appears bound for appeal. Judge Jeannette Little of Troup County State Court last week denied a defense motion for a new trial arguing that she issued insufficient jury instructions and wrongly prevented testimony from a Georgia Read More

Five Top Pit Bull Verdicts
06/04/2015
Each day about 1,000 U.S. citizens require emergency care treatment for dog bite injury, according to Dogsbite.org. For pit bull injuries or dangerous breeds, one in every six bites require medical attention. In the last 10 years, pit bulls killed 203 Americans and accounted for 62 percent of total Read More

Root Canal Gone Wrong Leads to $4.5 Million Med-Mal Verdict
06/04/2015
Supriya Sarin went to her dentist, Darryl Simms, of Farmington Family Dentistry for a root canal operatrion. But rather than relieve her pain, the procedure somehow went horribly wrong. Sarin, 42, has had debilitating pain ever since the March 15, 2011, operation. It hurts when she eats, when she Read More

California athlete awarded $1M after bungled gall bladder surgery
06/03/2015
Led by coxswain Dionne Licudine, center, the team celebrates a victory at the San Diego Crew Classic. A jury awarded more than $1 million Tuesday to a former University of Southern California women’s rowing team coxswain who suffered a near-life-threatening injury during gall bladder surgery. Read More

Colgate-Palmolive Pays $2M To Settle Antibacterial Soap Lawsuit
06/02/2015
Colgate-Palmolive Co. has agreed to pay $2 million to resolve multidistrict litigation claiming the company misled consumers into thinking its Softsoap Antibacterial liquid hand soap killed most common germs, according to documents filed in New Hampshire federal court Friday. According to the Read More

Pfizer Wins 2d Trial in Zoloft Birth Defect Case

zoloft birth defectFrom Reuters

A jury in Philadelphia ruled that Pfizer Inc. properly warned about the risks that its Zoloft antidepressant could cause birth defects and isn’t responsible for a girl’s heart abnormalities. It is the drugmaker’s second win in cases over the medication.

The Philadelphia jury rejected Mia Robinson’s claims that Pfizer officials hid Zoloft’s birth-defect risks and should pay at least $2.4 million to compensate the eight-year-old girl for her heart abnormalities.

Read the full story from Reuters

The company persuaded a St. Louis jury in April to reject a family’s arguments that the drug caused a boy’s cardiac abnormalities in the first of more than 1,000 lawsuits over the medication to go to trial.

Zoloft is best-selling antidepressant on the market.

The case is Robinson v. Wolters Kluwer Health Inc., July Term, 2011, No. 778, Control No. 14123047, Pennsylvania Court of Common Pleas of Philadelphia County (Philadelphia).

$2.6 Million Affirmed Against Developer of Faulty NuVasive Medical Device

nuvasiveThe California District Court of Appeals affirmed the $2.6 million judgment against a medical device developer, for false claims and advertising after one of its devices failed during spinal surgery. Due to the device’s failure, a screw was implanted near a nerve in a woman’s spine causing even more more pain.

Brenda Kitrosser, the plaintiff, underwent spine surgery in 2008 performed by Dr. William R. Taylor at the University of California in San Diego. The doctor used the device known as NueroVision to perform the surgery.

After the surgery, Kitrosser experienced more pain and struggled to perform daily activities. She sued NuVasive, the doctor, and UCSD.

False representations to patients

The plaintiff claimed NuVasive and Taylor had conspired to make “false representations to patients, including Kitrosser, about the NueroVision device that convinced Kitrosser to undergo a procedure using the instrument.

Kitrosser settled her claim with Taylor and his employer for $1.75 million.

The trial proceeded against NuVasive only, and the jury awarded Kitrosser $3.1 million in damages, which was later reduced to $2.6 million.

On appeal, NuVasive argued the trial court erred by denying its motion for judgment notwithstanding the verdict because Kitrosser’s claim lacked facts to support the intentional theory of conspiracy.

The NueroVision

The device was designed to detect the presence of nerve tissue during spinal surgery. This detection included sensitive areas of the spine, when the surgeon performed procedures accessing the spine from the patient’s side, rather than from the back.

The marketing material prepared by a third party, stated the device would “ensure a safe approach to the spine.” However, the company had identified 28 ways the device would not raise an alarm when it should have, which could cause permanent injury. Additionally, NuVasive received one report where a false negative was returned and resulted in injury.

Kitrosser’s Surgery

 Kitrosser had undergone a discectomy for the first time in 1993. She suffered a second back injury several years later. For 10 years, she endured various levels of pain. Kitrosser combed through multiple back surgeons in hopes to avoid “open back surgery.” Finally, she was referred to Dr. Taylor after experiencing pain so severe she could not function.

During one visit to Taylor’s office, the plaintiff was told the surgery would be a “minimally invasive procedure” and “[Taylor] guaranteed the safety of [her] nerves.”

Still unsure about the procedure Kitrosser requested more information and she was sent two Nuvasive pamphlets. The pamphlets corroborated Taylor’s consultation and the plaintiff decided to proceed with the surgery.

Kitrosser experienced more pain than before the surgery after which she discovered one of the screws placed in her spine was impinging on a nerve root. The Neurovision failed to raise an alarm during and after placing the screws in her spine. 

Dr. Taylor and NuVasive’s Relationship

Dr. Taylor consulted and engaged in business arrangements with NuVasive to develop and test new products. In many ways, Dr. Taylor became the face of NuVasive, he educated surgeons on the device, spoke at conferences, presented to the companies board of directors, and appeared as the co-inventor on a patent application.

Taylor received multiple payments, fees, stock options, and other forms of compensation for his work with the developer. He received more than $220,000 per year in compensation from NuVasive in addition to his income with UCSD.

USCD required doctors participating in clinical trials not to accept any compensation from the company for the duration of the trial. Initially, Taylor disclosed his compensation and was restricted by the UCSD review board. The second time and several times after, Taylor made false representations by simultaneously receiving compensation and working on the clinical trials.

NuVasive was also required to submit conflict of interest forms to the FDA. NuVasive was aware Taylor submitted false information and continued with the regular course of business.

The Court’s Decision 

To successfully prove civil conspiracy a plaintiff must provide substantial evidence that:

  • The formation and operation of the conspiracy;
  • Wrongful conduct in furtherance of the conspiracy; and
  • Damages arising from the wrongful conduct.

 

Generally, evidence of a conspiracy is inferred from the nature of the acts, the relation of the parties and the interest of the alleged conspirators. Wyatt v. Union Mortgage Co. 24 Cal.3d 773, 785 (1979).

The defendant contended there was no basis for liability arising from NuVasive’s direct conduct. The company stated further, the record lacked sufficient evidence of a conspiracy theory between Taylor and NuVasive to misrepresent the product. The company wanted the courts to treat the relationship of the company and Taylor as purely business.

The court disagreed, stating the focus of conspiracy is whether evidence of the conspiracy existed, not whether evidence of a different type of relationship existed.   Additionally, the court stated “ we have little difficulty concluding that inferences from the direct evidence support the finding that NuVasive and Taylor conspired to misrepresent the ability of the NueroVision device to ensure Kitrosser’s nerve safety during the [procedure].

The appellate court disagreed with the defendant’s remaining arguments about the admission of evidence and the special verdict. The court believed the trial court did not err in admitting evidence of the disclosure forms. Nor did the trial court err in concluding there was sufficient evidence to establish a conspiracy to intentionally defraud with respect to the special verdict.

This case is Kitrosser v. NuVasive, Inc., Case No. D064946 in the Court of Appeal, Fourth Appellate District, Division One, State of California

Death and Injury Suits Pending against Essure Birth Control Device

essure_birth_control_system_injuriesA Florida woman who was the first to file a lawsuit against Bayer for negligence and breach of express warranties concerning the Essure birth control device, has led the way for litigation by others who were severely injured by the implanted device.

The lawsuit, filed in Philadelphia County court, is not a products liability case, but an action for negligence because Bayer did not provide training to the physician on how to insert the device safely.

A motion for judgment on the pleadings has been filed in the case.  Depending on the outcome of this case, if the court rules that the conditional approval for Essure is no longer valid, the many other women injured by its use may also be able to bring a cause of action against Bayer.

Doctor with no training

Heather Walsh obtained the Essure implant from a physician who did not receive any training from Bayer on how to insert the device.  The device – a coil made of stainless steel, titanium and plastic — is inserted into the fallopian tubes.  The coils expand and scar tissue forms around them blocking the fallopian tubes and resulting in sterilization, according to the complaint

Walsh was hospitalized for severe pain and fainting spells two years after getting the implant.  A CT scan revealed the device had migrated in her body and lodged behind her colon.  Walsh underwent a complete hysterectomy and other surgeries to remove the device from her colon.

Walsh is not alone, as more than 4,000 reports of serious complications from use of the Essure device have been reported to the FDA, including the report of woman who died during surgery to remove the implant in January 2015.

Angie Firmalino received the implant in 2009 and after two years, had it removed because the coils broke and migrated to her uterus.  Firmalino required several operations including a hysterectomy.  She started a Facebook page to warn other women about the dangers of the device, which now has more than 17,000 followers.

Claims not preempted by Medical Device Act

Although Essure has been in use since the FDA issued a Conditional Premarket Approval (CPMA) in 2002, Walsh brought the first Essure lawsuit against Bayer in 2014. The Medical Device Act (MDA) contains a preemption provision that prevents lawsuits for injuries caused by medical device manufacturers for devices that received pre-market approval from the FDA.

In the complaint Walsh filed, she claims that her negligence and breach of express warranties claims are not preempted by the MDA because the “cause of action has nothing to do with the product itself, but rather [Bayer’s] negligence in” allowing an untrained physician use specific equipment provided by Bayer, that the physician was not qualified to use when he erroneously implanted the device, according to the court documents.

In addition, the complaint asserts that the CPMA issued by the FDA was invalid because Bayer did not comply with the express conditions set by the FDA.

Bayer violated FDA conditions

According to the complaint, the FDA and the Department of Health cited Bayer and invalidated the CPMA for its failure to report results from Essure trial studies, including failure rates.  It also “actively conceal[ed] [eight] perforations” resulting from Essure implantations.

Bayer was also required to notify the FDA when it took ownership of Essure from its previous manufacturer, Conceptus.  Because of Bayer failing to meet the conditions of the CPMA order, the complaint states that the FDA found that Essure is an “adulterated” product that violates the FDA order if it is marketed or sold.

Product pushed on physicians without training

The complaint also alleges that Bayer was neglectful in its “unreasonably dangerous distribution plan” because it failed to provide training to physicians on the insertion method of the device.

In addition, Bayer provided the untrained physicians with specialized equipment, not approved by the FDA order, required to insert the device, even though the physicians were unqualified to use the specialized equipment.  In return for the equipment, the physicians were required to purchase at least two Essure kits per month, according to the complaint.

The case is WALSH v. BAYER CORP., et al case number 2:15 – cv-00384 in the First Judicial Court of Pennsylvania Court of Common Pleas.

 

Arizona Court Revives Product Liability Case, Abolishes Learned Intermediary Doctrine

Arizona Court Revives Product Liability Case, Abolishes Learned Intermediary Doctrine

Prescription drugs are “often advertised and sold in a manner similar to other consumer goods, implicating the need for the protection.”

The Arizona Court of Appeals has taken an important defense away from drug manufacturing companies in a pro-consumer decision, finding pharmaceutical drugs are merely ordinary merchandise covered by state consumer fraud laws. After reviving a products liability case, Watts v. Medicis Pharmaceutical Corp., the Court abolished the “learned intermediary” doctrine.

This recent decision removes barriers to lawsuits against pharmaceutical manufacturers, recognizing that state consumer fraud statutes can be applied against the defendant, Medicis, and similar drug manufacturing companies. The trial court originally granted Medicis’ motion to dismiss the case entirely, but a sea change took place on the appellate level, where the Court of Appeals reversed.

“Protecting a prescription drug manufacturer from possible liability for its own actions, simply because another participant in the chain of distribution, is inconsistent with UCATA.”

When plaintiff Amanda Watts sued Medicis, the pharmaceutical manufacturer of Solodyn, a prescription acne medication, she alleged that the drug caused Lupus. Under a strict liability failure to warn theory, Watts additionally claimed Medicis knowingly provided false and misleading warning information under Arizona’s Consumer Fraud Act (CFA).

The appeals court, in a three-judge panel, rejected Medicis’s argument that pharmaceuticals should not be deemed merchandise products under the CFA, finding that prescription drugs are “often advertised and sold to consumers in a manner similar to other consumer goods, implicating the need for the protection of the CFA.”

The court found Watts had effectively stated a claim by alleging Solodyn’s labeling and promotional materials had “affirmatively and falsely” misrepresented the drug’s safety, and that she relied on those statements.

Learned intermediary doctrine

The appeals court then turned to the “learned intermediary doctrine,” which shields a manufacturer from liability for failure to warn when it provides a proper warning to the specialized class of people, such as doctors, who are authorized to sell, install, or provide the product.

After considering the doctrine in the context of the Uniform Contribution Among Tortfeasors Act (UCATA), the court concluded “that protecting a prescription drug manufacturer from possible liability for its own actions in distributing a product, simply because another participant in the chain of distribution is also expected to act, is inconsistent with UCATA.” The UCATA abolishes joint and several liability, which prevents “a partially responsible defendant from being held liable for the damages by his co-defendant.”

Importantly, the learned intermediary doctrine has been entirely quashed in the state of Arizona, not just with respect to pharmaceutical manufacturers. The consequences of this decision are as of yet unknown, as it will be up to juries to determine where liability should be placed. As DRI Today noted, “Juries may well re-affirm what the learned intermediary doctrine always assumed – that doctors and other learned intermediaries alone must be responsible for failing to communicate the warnings that they receive – or they could open a new avenue of liability for manufacturers who can no longer rely on doctors’ and other intermediaries’ duties to warn consumers.”

The case is Watts v. Medicis Pharmaceutical Corporation, Case No. 1 CA-CV 13-0358, filed on January 29, 2015. Judge John C. Gemmill delivered the opinion of the Court, in which Presiding Judge Lawrence F. Winthrop and Chief Judge Diane M. Johnsen joined.

Man Burned by Chemical Vapor Explosion Awarded $10M

Crystal Clear VOC concrete sealerA Cook County, Illinois, jury awarded a man $10,875,622 for second and third degree burns he suffered from an explosion in his home caused by the vapors of a concrete sealer he used in his basement.

The plaintiff Andrzej Plizga and his wife Katarzyna were represented by National Trial Lawyer Top 100 attorney Matthew Passen of the Passen Law Group in their lawsuit against the Euclid Chemical Company, manufacturers of the Crystal Clear VOC concrete sealer

Andrzej Plizga was using Crystal Clear VOC concrete sealer to seal the basement floor of his home.  The vapors from the sealer spread to a utility room in the home and were ignited by a water heater pilot light, causing the explosion that burned 65% of Plizga’s body.  The burns, mostly on his arms, legs and torso, required several skin graft surgeries and $1 million in medical expenses.  Also due to his injuries, Plizga is not able to return to his previous work as a brick layer.

Misleading labeling

In the product liability action against Euclid Chemical Company, Plizga concedes that the label on the containers of the sealer label it as “combustible” and contained a substantial amount of cautionary language such as “WARNING! FLAMMABLE” but warnings failed to comply with the Federal Hazardous Substances Act label requirements and state law requirements.

Plizga also asserted that the company’s use of acetone in the sealer formula was wrongful and based on profit gains even though safer alternatives solvents can be used, and are actually used in other products.  Plizga also proved that the warning label did not meet industry standards and did not properly warn consumers that their home’s water heater can possibly ignite liquid vapors, even though chemical manufacturers have substantial knowledge of this hazard.

The manufacturer argued that Plizga’s claim should have been rejected because he assumed the risk of using the product which was labeled “For Professional Use Only.”  It also argued that Plizga ignored warnings to read the Material Safety Data Sheet and product label before use, but Plizga said that he was never given a manual or instructions when he purchased the sealer, according to the Cook County Record.com.

Plizga was awarded $2.7 million for his medical bills and lost wages.  More than $8 million was awarded pain and suffering, loss of normal life, loss of society and disfigurement.

The case is Andrzej Plizga and Katarzyna Plizga  v. The Euclid Chemical Company,  Case No. 10 L 14488 in the Circuit Court of Cook County, Illinois.

$63 Million Verdict Affirmed in Children’s Motrin Case

childrensmotrinsjsThe Massachusetts Supreme Judicial Court affirmed a $63 million verdict against McNeil PPC and Johnson & Johnson for the companies’ failure to provide adequate warnings for life-threatening symptoms caused by ibuprofen, an active ingredient in Children’s Motrin.

Lisa and Richard Reckis, the child’s parents, filed suit against the companies after their daughter Samantha developed toxic epidermal necrolysis (TEN) after taking Children’s Motrin.

Also read: $48M Award in Case over Stevens-Johnson Syndrome caused by Motrin – Read More

TEN is a severe disorder that attacks the skin, resulting in a rash, blisters and significant damage to the mouth, eyes, and other parts of the body. TEN occurs when the rash and blisters affect more than 30 percent of the body.

Defective warning

In their 2007 complaint, the parents alleged the warning label on the commonly prescribed medication rendered the drug defective because it failed to warn against the serious risk of developing a life-threatening disease.

The 2012 amended complaint alleged negligence, breach of warranty, failure to warn of potentially legal side effects, loss of consortium and negligent infliction of emotional distress.

The defendants appealed the lower courts decision on three grounds:

  • The plaintiff’s claims were preempted by the FDCA-Food, Drug, and Cosmetics Act;
  • The plaintiff failed to prove causation due to an unqualified expert witness and failed to offer additional evidence; and
  • The damage award was grossly excessive.

The first three doses

In November 2003, Samantha’s parents gave her Children’s Motrin for fever and sinus congestion. Samantha was seven years old at this time.

The following morning, prior to a third dose, Samantha woke with the same fever and congestion, along with a red rash on her chest and neck and a sore throat.

The next day, Samantha was taken to her pediatrician — she had a fever, nasal congestion, crusty eyes, cracked lips, and a rash. The doctor advised the child had measles and to treat with Motrin three times a day.

By day three of taking the Children’s Motrin, Samantha was covered in blisters, could not open her eyes or mouth. After being transferred from the local emergency to a children’s hospital, the parents learned of Samantha’s rare condition and were left with little hope for her survival.

Samantha was in a medical induced coma for one month and hospitalized for six months. During this time, she suffered from a list of injuries including heart and liver failure, diminished lung capacity, and 95 percent loss of the top layer of her skin.

Defense argues Conflict Preemption

The defendants argued “conflict preemption,” and stated the type of warning the plaintiffs believe would have made a difference is a warning that was prohibited by the FDA. Thus, it caused an impossible conflict between what the federal guidelines allowed and state tort law.

The court relied on Wyeth v. Levine, which stated unless there is clear evidence the FDA would not approve a label change, then it is not impossible to comply with both federal and state requirements. 555 U.S. 555, 571 (2009).

Additionally, Wyeth explained that under a CBE regulation (changes being effected), a drug manufacturer changing a label to strengthen its warnings need not wait for FDA approval of the supplemental application before making the changes. Id. at 568-569.

The Massachusetts court agreed there was clear evidence the FDA rejected mentioning the rare disorder by name, based on the FDA response to a citizen petitioner’s request in 2005. However, mentioning the symptoms of the life-threatening disease does not mean the FDA would have rejected the changes had the defendants proposed them.

Expert Witness Was Qualified

In her opinion, Associate Justice Margot Botsford stated the trial judge did not err in its decision to qualify the witness or by allowing his testimony. Specifically, the testimony was deemed appropriate because it was in line with Samantha’s treating physicians testimony and based on the witness’s review of Samatha’s medical records.

An expert witness is qualified to give an expert opinion if the person has superior education, training, experience, and familiarity with the subject matter of the case. This special testimony is required to establish medical causation. Whether to qualify an expert witness is at the judge’s wide discretion.

The expert witness was a professor of pharmacology and toxicology at a large university’s college of pharmacy. He had received training on TEN and read scientific literature on the causes of SJS and TEN, and the effects of a drug on the body.

The defendants sole argument was the expert was unqualified because he was not a medical doctor and never diagnosed or treated a patient with TEN. Additionally, the defendants made a “third dose” argument, stating the argument was a substantial factor in the plaintiffs causation claim.

The expert testified had Samantha only received the first two doses of Motrin after the rash appeared, she would not have developed TEN. The witness further explained that if a medication causes toxic affects, prompt withdrawal would cause a better prognosis for the patient.

Samantha’s father testified he would not have given Samantha the third dose of Children’s Motrin had the label warned of the risk.

The third dose argument was essential to causation however, it was not essential for the plaintiffs to establish the third dose or any subsequent doses caused their child to develop TEN.

Damages were proportionate

The damage award was determined to be proportionate to the injuries and cost of care Samantha will need for the rest of her life. Samantha is legally blind, suffers from short-term memory damage and still has impaired lung capacity.

Despite her ailments the parents testified about her “remarkable ability to endure these injuries while maintaining a positive outlook and prospects for the future.” Also stating Samantha herself testified to her belief that she will lead a “great life.”

The jury awarded Samantha’s parents $6.5 million each for loss of consortium. The parents testified their lives were significantly restricted as a result of their daughter’s illness.

The court ruled that, based on all the evidence before it, a jury could reasonably conclude Samantha will suffer pain and need extensive care for the remainder of her life. Additionally, the parents award was justified because their lives were changed in a great way after the illness occurred.

This case is Lisa Reckis & another vs. Johns & Johnson & another Case No. SJC-11677 Supreme Court of Massachusetts.

 

 

Prescription For Oversight: Growing Liability for Pharmacists

Prescription For Oversight: The Evolution of Pharmaceutical Liability

By Jill F. Bechtold and Alison A. Hofheimer.

Nationwide, pharmacists are witnessing an epidemic: courts are beginning to hold pharmacists liable in negligence and wrongful death actions involving overdoses or adverse reactions to lawful prescriptions filled as written by the prescribing physicians.

The Florida Fifth District Court of Appeals’s recent decision in Oleckna v. Daytona Discount Pharmacy highlighted a changing area of Florida law, which has been seen nationwide. For the last decade, Florida courts have appeared to expand the traditional liability for a pharmacist, seemingly bringing the common law into closer step with the duties outlined by the statutory and administrative laws.

The trend nationwide holds pharmacists liable for the failure to consult with prescribing physicians or to warn patients of potential risks or side effects.

In the absence of definitive guidance from the Florida Supreme Court as to the scope of their duties, Florida pharmacists have been prescribed a tough pill to swallow: either provide an independent oversight when filling prescriptions or possibly risk legal challenges in the future. While the lasting impact remains unknown, the changing nature of pharmaceutical liability has had reverberations around the country.

Historically, courts protected pharmacists

The role of pharmacists has expanded, and with that so has their contact and advisory role with their patients. In addition, plaintiffs continue to fight removal of drug and device manufacturer cases to federal court by naming local pharmacists as parties to an action.

Historically, many courts protected pharmacists from being exposed to liability for the duty to warn, holding:

  1. Pharmacists were not expected to understand or have access to patients’ medical history.
  2. Pharmacists had no duty to monitor and intervene with patients’ continuing course of treatment.
  3. Requiring pharmacists to warn patients would undermine the doctor-patient relationship. See McKee v. American Home Prods. Corp., 113 Wn.2d 701, 782 P.2d 1045 (1989); see also, Adkins v. Mong, 168 Mich. App. 726, 425 N.W.2d 151 (1988)

 

Currently, there is a trend nationwide towards holding pharmacists liable for the failure to consult with prescribing physicians or to warn patients of potential risks or side effects of prescriptions readily detectable by reasonable physicians.

A recent movement in Florida law provides a good case study in the evolution of pharmacist liability, exhibiting what is gradually becoming a growing movement among the courts.

Eroding Protection

Traditionally, Florida pharmacists have enjoyed broad protection from potential liability claims of pharmacy customers. Florida courts have historically held that pharmacists owe no independent duty to customers, beyond exercising “due and proper care in filling prescription[s].” McLeod v. W.S. Merrell Co., Division of Richardson- Merrell, Inc., 174 So.2d 736 (Fla. 1965).

However, in the last decade, the Florida courts have increasingly abandoned this historically protective view of pharmaceutical liability and have adopted a standard of care based on reasonableness. In so doing, the courts have interjected uncertainty into a previously well-settled area of law, leaving lower courts and pharmacists alike grappling to understand the duty owed by pharmacists.

A pharmacist is no longer immune from liability merely because he or she filled a lawful prescription as written.

Although this trend was nearly a decade in the making, the Florida Fifth District Court of Appeal crystalized this doctrinal shift in its recent holding in Oleckna v. Daytona Discount Pharmacy, stating

“[W]e refuse to interpret a pharmacist’s duty to use ‘due and proper care in filling the prescription’ as being satisfied by ‘robotic compliance’ with the instructions of the prescribing physician.”  See Oleckna, —-So.3d —-(Fla. 5th DCA 2015).

Consistent with earlier decisions of the First and Fourth District Courts of Appeal, the Fifth DCA held that a pharmacist is no longer immune from liability merely because he or she filled a lawful prescription as written. Now, pharmacists arguably must act as a “check” on the prescribing physicians and must independently evaluate the “reasonableness” of prescriptions, including the quantity, frequency, dosage, or combination with other prescriptions.

Oleckna was far from groundbreaking in that it mirrored the prior decisions of the First and Fourth District Courts of Appeal ([1] See Dee v. Wal-Mart Stores, Inc., 878 So.2d 26 (Fla. 1st 2004); see also Powers v. Thobani, 90 So.2d 275, 279 (Fla. 4th DCA 2005), discussed later.)

Yet, this holding has been hailed by commentators as a seminal case marking a dramatic expansion of the duty owed by pharmacists. At a minimum, Oleckna should be credited with making the changing role of Florida pharmacists a salient issue at the forefront of pharmaceutical law. This article analyzes the evolution of Florida pharmaceutical liability jurisprudence in light of these changes.

Traditional View—Limited Duty

Florida courts have traditionally held that pharmacists merely have a duty to exercise “due and proper care in filling [a] prescription.” In McLeod v. W.S. Merrell Co., Division of Richardson- Merrell, Inc., 174 So.2d 736 (Fla. 1965), the Florida Supreme Court declined to hold a pharmacist strictly liable for breach of implied warranty based on his failure to warn a customer of the possible dangers of using a prescription drug filled pursuant to the prescribing physician’s orders. The court reasoned that a “druggist who sells a prescription warrants that

  • He will compound the drug prescribed.
  • He has used due and proper care in filling the prescription (failure of which might rise to an action in negligence).
  • The proper methods were used in the compounding process.
  • The drug has not been infected with some adulterating foreign substance.” Id. at 739.

 

Thus, while the Florida Supreme Court refused to recognize a cause of action for breach of implied warranty against a retail druggist selling drugs that were pre-packaged in the manufacturer’s sealed packets, it specifically noted that the failure to exercise due and proper care in filling a prescription could give rise to a cause of action for negligence.

For the ensuing decades, Florida courts refused to expand the a duty of pharmacists to warn a patient of the addicting qualities of a drug,

For the ensuing decades, Florida courts refused to expand McLeod to impose a duty on pharmacists to warn a patient of the addicting qualities of a drug or to notify a treating physician of the fact that a patient was addicted to a drug. See Pysz v. Henry’s Drug Store, 457 So.2d 561 (Fla. 4th DCA 1984). See also, Johnson v. Walgreen Co., 675 So.2d 1036 (Fla. 1st DCA 1996) (finding that a pharmacist had no duty to warn a customer or physician of potentially adverse drug interactions when he accurately filled two prescriptions which could be harmful when used in conjunction because the legislature did not intend to create a private cause of action when it enacted a statute requiring pharmacists to check for harmful reactions and interactions and to counsel customers).

See also Estate of Sharp v. Omnicare, Inc., 879 So.2d 34, 36 (Fla. 5th DCA 2000) (explaining that “[i]n McLeod, the Florida Supreme Court sharply limited the duties that a pharmacist owes to his or her customers. The high court chose not to make a pharmacist liable for duties that are ordinarily owed by a physician or caretaker to the patient.”)

Modern View—Heightened Duty:

In the 21st century, the Florida courts have increasingly deviated from this traditionally protective view of pharmaceutical liability and have demonstrated a willingness to hold pharmacists liable beyond just negligently filling prescriptions, and have imposed an objective reasonableness standard of care in pharmaceutical liability cases.

It is well established that pharmacies and pharmacists are not “health care providers” within the meaning of F.S. Chapter 766 (the Florida Medical Malpractice Act). See Sova Drugs v. Barnes, 661 So.2d 393 (Fla. 5th DCA 1995). Thus, because pharmacists are not afforded the statutory protections of Chapter 766, compliance with the pre-suit requirements of Chapter 766 is unnecessary in negligence actions against pharmacists.

Pharmacists should warn the customer of potential dangers or confer with the physician to determine whether the prescription should be filled.

In Sanderson v. Eckerd Corp., 780 So.2d 930 (5th DCA 2001), the court held that a pharmacy that advertised a computer system that would detect and warn customers of adverse drug interactions voluntarily assumed a duty to warn customers, as measured by what is recognized as acceptable and appropriate among reasonably prudent pharmacists.

In Dee v. Wal-Mart Stores, Inc., 878 So.2d 26 (Fla. 1st 2004), the court held that based on McLeod, when a pharmacist encounters a lawfully written prescription which is “unreasonable on its face” he should warn the customer of potential dangers or confer with the physician to determine whether the prescription should be filled. In that case, the court held that a four-month old prescription for a 50 microgram Duragesic patch without any time limit or usage was unreasonable on its face. Yet, the court did not define “unreasonable” or promulgate any discernible guidelines to determine whether or not a prescription is “unreasonable.” Id.

The following year the Fourth DCA held that:

“Florida pharmacists are already specifically charged with general knowledge of prescription medication and the risks presented by taking particular prescription drugs, such that they should be able to evaluate and explain the operative risks of taking a medication or series of medications. Thus a strong policy basis already exists supporting a pharmacist’s duty to warn customers of the risks inherent in filling repeated and unreasonable prescriptions with potentially fatal consequences.”

See Powers v. Thobani, 90 So.2d 275, 279 (Fla. 4th DCA 2005) (finding that a pharmacist could be held liable for filling numerous prescriptions for narcotics written by the decedent’s neurologist too closely in time).

See also Arrington v. Walgreen Co., 919 F. Supp. 2d 1282 (M.D. Orlando Division 2009) (holding that the complaint adequately pled a claim for negligence because “the defendant knew that [the plaintiff] was allergic to sulfa-based drugs and filled her prescription for such a drug without warning her or double-checking with her physician”).

Liable for too many pills

In the most recent Florida pharmaceutical liability case, the Fifth DCA held that a pharmacy could be held liable for filling “without question, numerous prescriptions that were so close together that Pharmacy should have been put on notice that [the decedent] was getting too many pills within too short a period.”   See Oleckna v. Daytona Discount Pharmacy, —-So.3d —-(Fla. 5th DCA 2015).

The pharmacist shall, prior to the actual physical transfer, interpret and assess the prescription order for potential adverse reactions.

The court explained that “the prescriptions at issue here are alleged to be unreasonable at their face because they were written in a quantity, frequency, dosage, or combination that a reasonable pharmacist would either have checked with the prescribing doctor or warned the patient.”  Id. at *5.

The court explained that while the “Florida pharmaceutical regulatory statutes and administrative codes do not create a private cause of action against pharmacists,” they “do describe the duties of Florida pharmacists.”  See id. at n. 4. Accordingly, the standard of care promulgated in Oleckna is based on F.S. 465.003(6) and Fla. Admin. Code R. 64B16–27.300, 64B16–27.820.

Section 465.003(6), Florida Statutes (2011), provides that, “[a]s an element of dispensing, the pharmacist shall, prior to the actual physical transfer, interpret and assess the prescription order for potential adverse reactions, interactions, and dosage regimen she or he deems appropriate in the exercise of her or his professional judgment, and the pharmacist shall certify that the medicinal drug called for by the prescription is ready for transfer. The pharmacist shall also provide counseling on proper drug usage, either orally or in writing, if in the exercise of her or his professional judgment counseling is necessary.”

Oversight duty

Thus, Oleckna stands for the proposition that pharmacists must assume an oversight function over prescriptions, questioning whether they are “unreasonable on their face.”  This holding effectively incorporated the language used in provisions of the administrative code and statutes regulating pharmacies into the common law, seemingly setting forth a new common law cause of action in negligence against pharmacists.

In addition to impacting pharmaceutical liability cases, it remains unclear whether Oleckna will make any significant impact on removal jurisdiction in drug and medical device manufacturer cases. Plaintiffs routinely name local pharmacists, pharmacies, or retail stores as parties in cases involving drug and medical device manufacturers to defend against federal removal of the action.

Oleckna may now provide a sufficient argument for plaintiffs attacking removal jurisdiction by providing a viable claim against local pharmacists. Whether this argument will bear fruit for the plaintiffs remains to be seen; however, the argument is likely to be raised in these types of cases and the result may be an increase in the number of local pharmacists named as parties in drug and medical device cases in the future.


Bechtold HofheimerJill F. Bechtold (left), is Of Counsel with Marks Gray in Jacksonville, FL. She has a civil litigation practice focusing primarily in the areas of medical and professional liability defense, product liability defense, business litigation, trucking litigation and insurance defense.

Her clients include physicians, hospitals, business owners, trucking carriers and insurers. She also has experience in defending professional licensure actions, including defending medical physicians in Department of Health investigations and licensed companies in Department of Business and Professional Regulation actions.

Alison A. Hofheimer (right) is an associate at Marks Gray. She was the General Counsel of the Florida State University Supreme Court, served as the Business Relations Editor and a Senior Member of the Law Review. Her article titled, “Saved by the Bell? Is Online, Off-Campus Student Speech Protected by the First Amendment?” was published in the Fall 2013 Florida State University Law Review.

Prior to joining Marks Gray, Ms. Hofheimer was a law clerk with the Law Firm of Pajcic & Pajcic and the Law Office of Matt Liebenhaut in Tallahassee, Florida.