J&J Tramples on Basic Civil Rights to Jury Trial Verdict

J&J Faces High-Stakes Appeal to Toss Pinnacle Hips Judgment

By Jef Feeley

December 7, 2017, 10:16 AM CST  Bloomberg  FiDA highlight

• Challenge to $151 million judgment affects 10,000 other cases 
• Former Solicitor General Clement squares off against Ken Starr 

The stakes are high as Johnson & Johnson seeks an appeals-court ruling tossing out a $151 million judgment over its Pinnacle artificial hips in a case could foreshadow the outcome for thousands of lawsuits over the devices.

J&J and its DePuy unit, which makes the artificial hips, will have former Solicitor General Paul Clement arguing Thursday that the verdict should be reversed because there was insufficient evidence that the hips were defectively designed and deceptively marketed. The companies will also attack “highly inflammatory comments” at the trial by prominent plaintiffs’ lawyer Mark Lanier.

Kenneth Starr, the Clinton-era independent counsel, will defend the verdict in favor of five hip patients who won a $502 million verdict last year, only to see it slashed to $151 million by the trial judge. Starr will argue that there was enough evidence to support the verdict, including proof that J&J knew the metal-on-metal hips were flawed and would prematurely fail but concealed its knowledge to preserve billions in sales.

J&J, winner of only one of the four Pinnacle cases that have gone to trial since 2014, faces more than 10,000 patient suits blaming the company for selling faulty hips. The argument is scheduled for Thursday afternoon in the U.S. Circuit Court in New Orleans.

Juries in federal court in Dallas have ordered the company to pay a total of more than $1.7 billion in damages over the hips, but several of the awards were later cut by U.S. District Judge Ed Kinkeade, who is overseeing a consolidation of suits over the devices. One verdict was for more than $1 billion.

J&J Ordered to Pay $502 Million Over Pinnacle Hip Failures

J&J welcomes the court’s “review of the multiple legal issues presented by our appeal, many of which have implications for’’ the remaining Pinnacle cases, said John Beisner, a Washington-based lawyer for the company.

A central issue on appeal is whether Pinnacle’s hips were defectively designed and doomed to fail, forcing costly and painful follow-up surgeries. J&J argues that plaintiffs failed to meet a legal standard that the product was unreasonably dangerous, a safer alternative design existed, and the defect caused the injuries.

J&J also vigorously protests Kinkeade’s decision to let Lanier tell jurors at the trial about a litany of J&J’s bad acts that the company contends had nothing to do with the hips.

The judge allowed Lanier to “inflame the jury’s passions’’ by referring to almost $80 million in settlements J&J agreed to in 2011, amid claims that overseas officials bribed European doctors to implant the company’s hips and knees, the company says. Lanier should have also been barred from telling jurors that J&J paid kickbacks to “henchmen’’ of former Iraqi dictator Saddam Hussein under a United Nations program, the company argues.

The Dallas jury hit J&J with $360 million in punitive damages, which the judge reduced to $9.6 million under a Texas law limiting such awards.

Chamber Brief

The U.S. Chamber of Commerce filed a brief supporting J&J, which also argues on appeal that the plaintiffs failed to prove the company hid the risks from patients and that the trial court lacked jurisdiction.

The hip recipients say they proved a safer alternative design existed and the company’s warnings to patients were inadequate. They note that Lanier mentioned the J&J bribery scandal at the trial only after DePuy’s lawyers “opened the door’’ by hyping the company’s good works.

The plaintiffs are challenging Kinkeade’s decision to apply the punitive-damages cap, saying the measure unconstitutionally tramples on their equal-protection rights. The award was supported by the evidence, they say.

The case is Christopher v. DePuy Orthopedics, No. 16-11051, U.S. Fifth Circuit Court of Appeals (New Orleans).

— With assistance by Christie Smythe

https://www.bloomberg.com/news/articles/2017-12-07/j-j-faces-high-stakes-appeal-to-toss-pinnacle-hips-judgment

Cardiologists Arrested: Human Experimentation

http://www.forbes.com/sites/larryhusten/2012/11/11/nine-italian-cardiologists-arrested-in-broad-investigation-of-research-fraud-and-misconduct/

Larry Husten, Contributor

A medical journalist covering cardiology news.

PHARMA & HEALTHCARE | 11/11/2012 @ 7:59PM  (FiDA highlight)

NineItalian CardiologistsArrested In BroadInvestigation Of Research Fraud And Misconduct

Nine Italian cardiologists have been arrested as part of a broad investigation into serious medical misconduct at Modena Hospital, according to multiple reports in the Italian media. The investigation encompasses at least 67 other individuals and a dozen medical equipment companies, including 6 foreign companies. The charges include conspiracy, fraud, embezzlement, bribery, forgery and performing unauthorized clinicaltrials. Several news reports mentioned that stents and angioplasty balloons were involved.
According to one Italian website, the investigation started in 2011 in response to allegations by a group, Amici del Cuore (Friends of the Heart), that patients at the Modena Hospital (Policlinico di Modena) received treatments and procedures as part of unauthorized experiments. In some cases the procedures may have resulted in fatal outcomes. The accused physicians ”performed experimental tests without making it known to patients for the sole purpose of writing about these trials in specialized magazines collecting money through bogus non-profit organization,” the website reported. [All translations in this story taken from Google Translate.]

“We wanted to ask questions about certain procedures that went far beyond the standard ones, and that seemed unusual to us,” the president of Friends of the Heart, Professor Giovanni Spinella, told Il Salvagente. “We were aware that invasive procedures were performed, often on peripheral organs, and sometimes had little to do [with] the heart. And unfortunately had caused discomfort and damage to several patients.”

Another Italian site quoted a police official who called it “a major operation” and said the accused “committed human clinical trials without authorization and installed medical devices and equipment defective in patients unaware of being subjected to an experimental treatment.” The accused physicians then “created false medical records to cover medical errors.” The Italian media said the investigation included recordings of telephone conversations between the suspects. The Italian police named the operation camici sporchi (“dirty gowns”).

The most prominent person arrested was Maria Grazia Modena, the chief of cardiology at Modena Hospital and a former president of the Italian Society of Cardiology. (Grazia Modena was the subject of a profile in Circulation European Perspectives (PDF) in 2007.) Modena, 60 years old, was trained partly at New York University and the Mayo Clinic. The second main focus of the investigation appears to be the head of the catheterization laboratory at the hospital, Giuseppe Sangiorgi. According to news reports, he is the only arrested physician who is still in jail.

Here are the names of the nine physicians:

•               Maria Grazia Modena, chief of cardiology

•               Giuseppe Sangiorgi, head of the catheterization laboratory

•               Luigi Vincenzo Politi

•               April Alexander

•               Simona Lambertini

•               Giuseppe Biondi Zoccai

•               Fabrizio Clement

•               Alessandro Mauriello

Andrea Amato, 36