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Day 24: Linda Gross v. Ethicon J&J Case Goes to Jury in First Vaginal Mesh Trial

Linda Gross

Linda Gross

February 19, 2013 ~  In this first lawsuit to go to trial over whether the Ethicon unit of Johnson & Johnson properly designed the Prolift vaginal mesh implant, nine jurors received instructions this morning from Judge Carol Higbee in the Atlantic City, New Jersey courtroom.

Jurors are required to accept the ‘The Charge’ of Judge Carol Higbee as she called it.

Do not read statements or questions as clues as to how she thinks, she warned. Even if they did “you should disregard them because it is their role not hers to judge the case,” she said.

Judge Higbee called the lawyers “advocates” and advised jurors that nothing they say is evidence.

Linda Gross, 47 of  Watertown, South Dakota, blames the faulty design of the Prolift pelvic repair system for her 18 surgeries, nine of them removal surgeries, and her permanent disability, pain, and mental anguish. So far none of the removal surgeries have successfully removed the polypropylene mesh.

Ethicon is a division of Johnson & Johnson.

She had the Prolift mesh implanted transvaginally in July 2006 to hold up a prolapsing colon.

Testimony in the case has put her losses at $3.38 million for past and future earning and medical expenses so far and into the future.   Punitive damages may be considered if the jurors award her compensatory damages.

But in New Jersey there is a cap on punitive damages (part of the tort reform movement) which is five times compensatory damages or $350,000 whichever is higher, according to Bloomberg.

The Linda Gross case is the first of 2,127 (as of February 5) defective product cases filed against Ethicon in the same Superior Court of New Jersey.

INSTRUCTIONS TO THE JURY 

Judge Carol Higbee of the Superior Court of New Jersey told jurors they must rely on the evidence that was presented in the case which began January 9, 2013.

“You must not consider any statement or comments you overheard between counsel and the Court at any sidebar conferences,” she warned.

“From time to time during the trial I have been called up to make rulings of objections. It is the duty of the attorney to object when they believe the other side introduces evidence that is not admissible. Do not infer from any rulings or other comment she made that she has any opinions on the merits of the case favoring one side or another,” Judge Higbee said.

The Role of the Jury: “You sit here as judges of the facts. You alone have the responsibility of deciding the factual issues in this case. It is your recollection and evaluation of the evidence that controls. If the attorneys or I say anything about the facts in this case that disagrees with your recollection of the evidence; you should rely on your recollection. Your decision in this case must be based solely on the evidence presented and my instructions on the law.”

JURORS’ ROLE

Juror’s Notes have been permitted to take notes during the course of this trial. They were advised not to overemphasize the significance of a written note made by yourself or a fellow juror, it is the jurors recollection and not the note that is important.

“Your verdict must be based solely on the evidence presented in this courtroom in accordance with my instructions. During the trial, you should not have read any newspaper or internet reports, or watched or listened to any television or radio coverage about the trial, Prolift, pelvic mesh, or the parties to this lawsuit. If you have at any point come into contact with any news reports about the trial Prolift, pelvic mesh, or the parties to this lawsuit, you must completely disregard them and advise the Court now about what news reports you have seen or heard.”

Such reports are not evidence, she said.

What is evidence?  Jury instructions define it as the testimony heard from the witnesses; the exhibits that have been marked into evidence and the deposition testimony that was played and/or read into the report as well as any stipulations of fact entered into by the parties and provided to you by the Court.

Any testimony stricken from the evidence should not be used in deliberations.

During the trial jurors were allowed to submit questions but some were not answered or asked.  In some cases Judge Higbee was not allowed to answer. Don’t take that personally, she said. Both circumstantial and direct evidence was presented. Circumstantial evidence is based on logical conclusions.

It is for jurors to decide how much weight to give either type of evidence.

CREDIBILITY

According to Judge Higbee, You can take into consideration accuracy of their recollection, their reasonableness, demeanor, and any inconsistent statements, among other things.  If they didn’t make sense jurors can reject that testimony and opposite the fact that they appear via videotapes should not hurt that testimony.

In the case of an expert witness, you may consider their reasons to testify and their qualifications and their believability. The weight of an expert’s opinion depends on the facts on which the expert bases his or her opinion.  Jurors are not bound by the testimony of the witness, they can accept or reject the opinion.

The jurors must resolve any conflicts in the testimony of the experts. There is nothing unreasonable for an expert to be paid to attend court.

The Burden of Proof is on the plaintiff and has to be proven by the preponderance of the evidence. If you picture a scale plaintiff has to tip the scale ever so slightly to prevail.  Weighing the evidence is based on quality not quantity, the judge said.

The Plaintiffs have asserted various claims against Ethicon for the injuries Linda Gross claims she sustained from the Prolift system. Plaintiffs’ claims are based on three different legal theories:

Design Defect

Failure to Warn

Deceit

Prolift package

Prolift package

STRICT LIABILITY 

Strict Product Liability is defined as finding the Defendant  strictly liable because the the Prolift system was designed defectively and because they failed to give adequate warnings about the risks of the Prolift system.

Plaintiffs claim the Prolift was designed defectively. It had a defective design and the defective condition of the Prolift system was the proximate cause of the injuries. Linda and Jeff Gross did not need to prove that Defendant knew or should have known of the defective condition of the Prolift system, only that it was, in fact, defective.

Some products cannot be made completely safe. Jurors need to decide if the risks outweigh its benefits.  It is not unreasonably dangerous just because it is possible to be injured.  The analysis must be based on an objective standard of risk/benefit analysis.

Linda Gross can demonstrate it was defectively designed if it could have been designed to prevent a foreseeable harm without significantly hindering its function as of July 2006.

Plaintiffs can satisfy either of those tests.

Its regulatory status in July 2006 is not evidence it is defective she said referring to the fact that Prolift never received a FDA approval of any sort.

Patient brochure

Patient brochure

FAILURE TO WARN

“Defendants, as the manufacturers of a product, have the duty to provide adequate warnings of risks of the Prolift system to implanting surgeons. In this case, Linda Gross claims that Defendants failed to adequately warnings about the risks of the Prolift System.  Linda Gross claims that the Prolift system is a cause of her injuries and the warnings given to implanting surgeons were inadequate.”

Defendants contend they gave timely and adequate warnings about dangers they knew or should have known.  An adequate warning must be given to the surgeon whose role it is to decide whether or not to use a particular medical device.

A warning can be words, symbols or pictures – anything that effectively conveys the information.

The law requires the Defendant to “take reasonable steps to find out about the risks of their product. In determining what Defendants should have known, jurors must understand that the law requires manufacturer to keep reasonably familiar with and to know reliable information generally available or reasonable obtaining in the scientific community.”

Defendants are deemed to be experts in their field. The IFU (instructions for use), patient brochure,  the surgical guide or any other warnings given to surgeons can be considered.  Defendants have the responsibility to update warning based on additional information obtained a after the product was placed on the market.

FRAUDULENT MISREPRESENTATION

If the Defendants made a statement that was not true and the misrepresentation and the statement was actually relied upon and Plaintiff suffered damage as a result.  Defendant made the misrepresentation with the intent to deceive and inducting someone to rely on it and that resulted in damages.

PROXIMATE CAUSE 

Linda Gross has to prove by a preponderance of the evidence that Prolift system was a substantial factor in causing an injury to her.  That means that a reasonable person would have considered to have contributed to the harm.  It does not have to be the only cause of the harm. Gross must also prove the alleged defective design was proximate cause of that injury. It does not need to be the only cause of a result, it may act with other causes to produce a result.

Plaintiffs also must prove an adequate warning would have caused Dr. Benson not to prescribe or Linda Gross not to use the Prolift system.

COMPARATIVE NEGLIGENCE 

“You have heard evidence about Linda Gross’s medical treatment after she received the Prolift implant, including additional surgeries. In this case, you will not assign any fault to Linda Gross for her decisions to pursue certain medical treatments. Evidence about those treatments, including subsequent surgeries, however, may be considered by you in deciding whether the Prolift system caused Linda Gross’s claimed injuries.”

If you find a failure to warn, a defective design or a deceit and if you find the Prolift system was a substantial contributing factor in causing injury to Linda Gross, then by law jurors must consider Defendants responsible for any additional harm caused by negligence, mistake or lack of skill of any of her treating physicians. Defendants are liable for the ultimate result.

Witnesses testified about injuries that results from all pelvic floor repairs. They may not speculate what damages would have been if she had undergone an alternative surgery such as native tissue repair.

DAMAGES  

Disability and impairment means a worsening or loss of faculties, health or ability to participate in activities.  Jurors are to decide fair and reasonable money damages, no more and no less.  How it damaged her as a whole person and deprived her of customary activities and loss of enjoyment of life. Damages include pain physical and mental suffering as a consequence of injury for the present, past and into the future.

“You may consider her age, usual activities, family responsibilities and similar relevant facts.”  There is no table or formula which can measure a loss.Scales of Justice wikiCommons

“You are to exercise sound judgment as to what is fair, just and reasonable under all the circumstances. After considering the evidence, you shall award a lump sum of money that will fairly and reasonable compensate plaintiff for any pain, suffering, disability, impairment, and loss of enjoyment of life caused by the Prolift system.”

Future pain and suffering may be considered with Ms. Gross life expectancy estimated at another 33 years.

Any award is not subject to taxes so don’t add or subtract any taxes advised Judge Higbee.  She would be eligible for any loss of earnings take home pay only.  If she proves she was disabled by her injuries they need to decide on the amount of lost earnings, past, and future.  Were there any other jobs available to earn income.

“She must have tried to minimize the earnings lost, but extraordinary or impractical efforts are not necessary.”

Ms. Gross also would be eligible for past costs doctor services medical supplies and any other charges.  She is seeking a sum of $544,877 for her past medical expenses.  She is also entitled to receive future medical expenses in the future. The Plaintiff must prove the future need of future medical care.  They are not allowed to consider whether they will be paid by insurance.

See Day 12 of MDND coverage of the trial for the expert economist testimony.

Additionally, Jeff Gross is entitled to the services of his spouse including household duties, companionship consortium and a husband may be entitled to a worsening of their quality of life.

VERDICT

Jurors are supposed to decide without bias and sympathy.d9 ethicon a j & j company  200

“The fact that Defendants are corporation should have no bearing on your verdict in this case.”

In this civil case, seven of nine jurors is a legal verdict. It is not necessary the same seven jurors agree on each question.  When at least seven of nine agree on any answer they may move onto consider the remaining questions.

A juror outvoted on any question should continue to deliberate with the other jurors on the remaining questions.

QUESTIONNAIRE:

Question 1- Was the Prolift System Defectively Designed (yes or no) If seven don’t agree they haven’t reached a verdict.

2- If yes then go to Question 2.  Was the defective design the proximate cause of injury to Linda Gross.

3- Was there a failure to provide adequate warning to provide adequate warning to Linda Grosse’s implanting physician Dr. Benson (yes or no)

4- Was the failure to provide an adequate warning the proximate cause of injury to Linda Gross.

5- Have Plaintiffs proven the Defendants made a fraudulent misrepresentation to Plaintiff’s implanting physician Dr. Benson, if yes go to 6

6- Was fraudulent misrepresentation made to implanting surgeon the proximate cause of injury to Linda Gross?

7- Did Plaintiff proven Defendant made a fraudulent misrepresentation to Plaintiff Linda Gross?

8- Was fraudulent misrepresentation made to Linda Gross the proximate cause of her injuries?

If you answer yes to any of the eight questions you go onto the damage questions, otherwise stop deliberating.

DAMAGES

Damage question nine is what amount of money would adequately compensate Linda Gross for her past pain suffering, mental anguish, disability impairment and loss of enjoyment of life.

What amount of money would fully compensate Linda Gross for lost wages, for future lost wages, for the reasonable value to post medical treatment and what amount of money will compensate future cost of any future medical treatment and household services.

What amount of money would reasonably compensate Jeff Gross for companionship of spouse which he’s been deprived of as a result of Linda Gross’s injuries as a result of the Prolift System.

The seven have to agree the amount is reasonable and fair in deciding the damages questions 9 to 14.

“Now is the time we do want you to talk to each other,” said Judge Higbee.

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