More than 10 years ago during animal trials of the diabetes drug Actos, its manufacturer (Takeda International) learned that rats exposed to Actos developed more bladder tumors than rats exposed to a placebo. Takeda did not research the cause of increased rate of tumor formation, nor did it conduct further studies with human volunteers. Instead, Takeda minimized the risks, pushed through production and sought FDA approval. Takeda claimed “the evidence did not point to a risk in humans.”

Despite the results of the rat study and though Takeda never tested on human volunteers, the FDA approved Actos for sale in the U.S.

As a condition of its approval, the FDA required Takeda to conduct a 10-year observational safety study. In effect, the FDA gave its endorsement to use the entire global population of Actos users as “human lab rats”. When interim data was available in 2010 , it revealed that patients taking Actos for the longest period had an increased risk of developing bladder cancer — a result consistent with the rat study.

Again, Takeda decided not to warn users. But this time, the FDA disagreed and advised the public that taking Actos for more than a year may indeed carry an increased risk of bladder cancer. The European regulators went even further, banning Actos altogether from the European market.

Takeda’s failure to properly investigate Actos’ side effects and the FDA’s lackadaisical approach raises questions: What purpose do investigative studies serve? Why conduct animal studies if the correlation to humans is ultimately ignored? Can a drug manufacture use patients as “lab rats” and get away with it? If Actos had been properly tested before it hit the global market, how many victims might have been spared bladder cancer?

Actos victims are hopeful that their attorneys will find answers through the newly created multi-district litigation, In Re: Actos (Pioglitazone) Products Liability Litigation.

 

Takeda International is a global pharmaceutical company headquartered in Japan.  It’s top selling product, Actos,  improves the body’s insulin use; while it also reduces blood sugar levels.  In 1998 Takeda entered into a marketing partnership with Eli Lilly and Co. to push Actos in the United States and obtain FDA approval.  Remarkably, one year later Actos was approved for release in the U.S. market and Takeda set up shop in Deerfield, Illinois, its U.S. corporate headquarters.  Actos has been a huge success for Takeda, as Both Takeda  and Eli Lilly marketed the drug in Japan, the United States, France and Germany.  In 2010, Takeda’s global sales revenue from Actos was an estimated $4.8 billion with an estimated 2.3 million prescriptions filled in the United States.  Recently Takeda has been on the defensive.  In 2011 researchers determined that users of Actos are at an increased risk of bladder cancer.  And , the top-selling drug is now the center of hundreds of lawsuits with Takeda as their target.  

Can one person be held responsible for the wrongdoing of another? Usually no, but it depends. Some situations justify holding a person responsible for the act of another. For example, an employer will be held responsible for the wrongdoing of an employee that occurs while in the course and scope of employment. And, a landowner can sometimes be held responsible for the acts of a third person which injure someone coming on his property. 

Holding one person responsible for the wrongdoing of another is referred to as vicarious liability.

Vicarious liability can sometimes be imposed on:

  • parents for injuries caused by the intentional acts of their child;
  • a car owner for injuries caused by one driving a car with the owner’s permission;
  • an insurance company for negligence of an insured driver;
  • a person who entrusts a dangerous instrumentality to an improper person who causes harm.

But vicarious liability will generally not be imposed on:

  • parents for acts of their child that are merely negligent, except by statute in special situationst;
  • one spouse for the wrongdoings of the other;
  • a landlord for the wrongdoings of a tenant.

PG&E made a show of finally “admitting liability” for the explosion.  What brought that about?  A sudden pang of conscience?

Not quite. 

PG&E’s latest move is classic litigation strategy.  It’s designed to help PG&E escape full responsibility for what it did rather than own up to its responsibility.  The move paves the way for PG&E to ask the judge to keep out of trial any evidence concerning what caused the explosion. Expect PG&E to argue that, since it admits liability, there’s no reason to allow the victims’ lawyers to uncover what really happened. Or to explain it to the jury.  Instead, PG&E will argue that all that evidence should be swept under the rug.

This strategy isn’t really new.  It’s common when a defendant’s conduct is really, really bad.  For example, a driver who was momentarily inattentive and injures someone in a crosswalk might dispute responsibility for an accident all the way through trial.  But if that same driver was drunk, he will quickly admit liability. Then the driver will argue to the judge that that since he admits liability, the fact that he was drunk is irrelevant and should not be told to the jury.

The trick is an old one.  Do everything possible to keep the public from finding out what really happened.

We’ll see how this plays out.

The popularity of ATVs has grown tremendously over the years, reaching 9.5 million vehicles in 2007. Accordingly, the rate of traumatic brain and spinal injuries resulting from ATV accidents has also risen, especially in children. Between 1982 and 2007, nearly 9000 riders died in ATV accidents and approximately 40% of them were children under age 16. Currently, ATV federal standards are lax, requiring manufacturers to limit speed capabilities for all youth-sized models. Recently, researchers recommended ATVs designed for children should have both size and weight limitations for riders. Confirming what may appear obvious, a recent study conducted by ER physicians and mechanical engineers, concluded that children, due to their size and weight, are at considerable risk of injury when operating an ATV. The researchers state: “mechanical differences and proportional safety risks that are present on adult-sized ATVs used by youth. Current child-sized ATV stratifications determined using regulated engine speed may not be enough to mitigate risks associated with the size and weight of these vehicles.”

According to auto safety experts at Safety Research & Standards Institute, the importation and sales of three-wheeled ATVs was banned in 2009 and the U.S. Consumer Product Safety Commission has required manufacturers to file and implement voluntary action plans. These plans include commitments to provide safety information and guidelines regarding the appropriate age for child and adult-sized machines. The manufacturers also consented to instruct dealers not to market adult machines to child riders and to monitor dealers under-cover to ensure that dealers are complying.

California’s ATV laws are also lax. The laws require riders to wear helmets and minors to be supervised by their parent/guardian or an authorized adult. The laws also restricts children from riding on public land unless the child rider is taking a safety training course; or riding while supervised by an adult who has a safety certificate. No California laws currently restrict the speed or size of the ATV a child may ride. Given the findings of the most current research, manufacturers should increase efforts to educate riders about the safety risks present when children ride adult-sized ATVs.
 

The California Supreme Court dealt the injured a serious blow in August when it handed down Howell v. Hamilton Meats and Provisions, Inc.  It is certainly one of the most pro-insurance company cases ever. 

Gary Simms and I collaborated on a couple of articles explaining how Howell will change the legal landscape in the years to come.  Gary Simms brings a unique perspective to the discussion.  Not only did he argue the case before the Supreme Court, but he spent nine years of his career as a senior judicial attorney writing the Court’s opinions. 

Our latest article is Supreme Court Put Plaintiffs Through the Hamilton Meat Grinder.

Here are our views on some key issues.  See the article for how we get there:

Does Howell apply only when there is a contract between the plaintiff’s medical providers and her insurer?

A: It seems so but the court’s opinion is unclear.  Plaintiff has asked the court to clarify.

How does the defendant prove that there is a contract between the insurer and the provider?

A: Unclear but plaintiff should be able to argue that oral evidence doesn’t suffice.

Who has the burden of proving what was paid or owing and what is reasonable?

A: Plaintiff will bear the initial burden of submitting evidence of the amounts paid or owing.  Evidence of reasonable value will not be sufficient.

Are billed charges relevant to noneconomic damages?

A: Generally not.

Are billed charges relevant to future medical expenses?

A: Defendants will certainly argue that they are not.  But that argument will be difficult to carry.

Is evidence of the amount paid by the insurer admissible?

A: Yes.

How is the amount paid or owing to be determined?

A: Unclear.

Do HMO patients recover no medical expenses?

A: The opinion isn’t clear.

Do malpractice victims recover nothing?

A: The opinion isn’t clear.

Is evidence of medical insurance now admissible?

A: As a practical matter, yes.

Can Howell be dealt with by post-trial motion?

A: Unlikely that a defendant would so agree.

 

Howell v. Hamilton Meats & Provisions, Inc.
 

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When a friend or family member suffers a catastrophic medical event, he is often at a loss for the best way to show concern and to offer support. An article in The Pheonix Society focuses on the needs and issues of burn victims. Here are some specifics dos and don’ts for hospital visits and the post-hospital recovery period:

  • Don’t send or bring flowers. Although a well-intentioned first instinct ,if someone is hospitalized or recuperating at home, flowers present a potential risk. The bacteria carried by real flowers may threatened the patients weakened immune system.
  • Do send a humorous book or a blank journal.
  • Don’t stare or avoid eye contact. Burn patients usually have a greatly heightened awareness of their appearance.
  • Do try to look at them squarely and naturally. Be aware of your body language and the messages your non-verbal cues may be sending.
  •  Don’t lie. The patient knows they have physical changes and a serious condition. It is unlikely you “know how they feel”. So don’t say it.
  • Do listen and acknowledge their feelings. An appropriate response: “I can see that this is a really difficult time. I’ll be here for you.
  • Don’t make vague offers to help.Do help. Be proactive with suggestions such as “I will set up child care for the week or walk your dog every morning”. Assume the offer will be accepted and ask for specific instructions.
  • Don’t pressure the victim to make a decision about filing a lawsuit.
  • Do research names of attorneys who specialize in the issues that gave rise to the victim’s injuries. Experienced attorneys can consult with the family and help preserve important evidence or gather witness statements.

A strong support system of family and friends is invaluable to a burn patient. Most burn patients say the things people DO are more important than the things people SAY.

 

Four out of five ads in medical journals targeting doctors fail to follow FDA guidelines.  Over half fail to quantify the risks. Dr. Deborah Korenstein, lead author of  a recent study and Associate Professor of Medicine at Mount Sinai School of Medicine states:

Marketing research has consistently shown that journal advertising is the most profitable form of drug marketing, with an estimated return on investment of five dollars for every dollar spent. . . the current system is not in the best interest of the health of the public.

Drug companies know that the FDA does not have the resources to enforce its advertising "guidelines." In fact, the FDA has asked doctors for help, launching a "Bad Ads" campaign that urges doctors to take it upon themselves to report the drug companies’ bad ads to the FDA.  As if, doctors have more time and resources than the FDA? And absent independent research, how will the doctors know the ad is bad?  

Without enforcement, the drug companies will continue to violate the rules; doctors will not have the relevant information needed for safe prescribing practices and the public will be suffer avoidable harms. Doctors, as well as the public, need to be reminded not to be swayed by flashy ads and to conduct independent investigation about a drugs safety and efficacy. 

On July 2, 2012, trial will begin in 16 San Bruno Explosion cases. The Court ordered that the cases to be tried first will be representative of the following eight categories of lawsuits that have been filed:

  1. Wrongful death
  2. Serious bodily injury which required hospitalization.
  3. Minor bodily injury which required some medical treatment and total property loss.
  4. Minor bodily injury which required some medical treatment and lesser or no property loss.
  5. Bodily injury, present at the time of the explosion and total property loss.
  6. Bodily injury, present at the time of the explosion and lesser or no property loss.
  7. Homeowner not present at the time of the explosion and total property loss.
  8. Homeowner not present at the time of the explosion and lesser or no property loss.

"Bodily injury" includes emotional distress cases. Victims select eight cases and PG&E selects the other eight. Often a case includes members of the same household who have suffered varying degrees of injuries. If so, then the case will be defined by the most severe category of claim.

PG&E continues its double speak. Repeatedly, PG&E attorneys told the Court that it doesn’t blame the explosion victims for their injuries. But when pressed, PG&E would not withdraw its legal arguments that the victims may bear some responsibility for their injuries. The touchy-feely public relations voice cannot be trusted until PG&E changes its legal position. Because of the double speak, the selection of representative cases will be tricky. PG&E may have evidence of turpentine in the garage or failure to timely evacuate – right now victims can only speculate how PG&E intends to cast blame at trial.

Objectively measuring physical pain has been impossible. Doctors have relied on a patient’s self-report. And when asked to compensate accident victims for pain and suffering, so have juries.

But all that may soon change. Recently Stanford University researchers have used brain images and computer technology to assess pain.  In this study, a computer was “trained” to read brain images and assess pain levels. The researchers began by taking brain images of participants who were presented with painful and non-painful stimuli. The patterns of brain activity provided an objective physiologic assessment of whether someone is experiencing pain. The computer was 81% accurate at distinguishing painful v. non-painful stimuli.

Clinically, this tool will be most helpful to detect pain in infants, seniors with dementia, and sedated patients. But practically, it may lead to advances in pain management while establishing the credibility of victims who report they are living with ongoing pain.