But now a group of federal lawmakers are stepping up to take on medical device manufacturers and the Food and Drug Administration, the gatekeeper for deciding if such devices go on the market.

A report from Safety Research & Strategies Inc. details how four members of Congress are attempting to tighten the rules that were eased during the Bush Administration to allow medical devices on the market with far less strict review. Some types of devices can now make it to market with no clinical testing or proof of efficacy.

The legislation is being pushed by by Reps. Edward J. Markey (D-Mass.), Henry A. Waxman (D-Calif.) and Jan Schakowsky (D-Ill.), who all sit on the House Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations.. A fourth sponsor, Rep. Rosa DeLauro (D-Conn.), is a member the appropriations committee’s Subcommittee on Agriculture, Rural Development, the FDA and related agencies.

Meanwhile, Consumers Union has stepped up its efforts to prod Washington to boost oversight. This week, Consumers Union’s Safe Patient Project is bringing eight patient safety activists from around the country to the Capitol to meet with lawmakers in a bid for improvements to the Medical Device User Fee Act (MDUFA).  That act has been the subject of intense scrutiny as problems with various medical devices have continued to make headlines.

“Most Americans would be surprised to learn of the lax oversight of medical implants,” Lisa McGiffert, director of Consumers Union’s Safe Patient Project, said in a press release announcing the effort.  “Too many of these devices are allowed on the market without testing to determine whether they are safe and effective. Innovation is important but patient safety should be our first priority. A medical device isn’t innovative if it doesn’t work and hurts people.”

Astonishingly, 90 percent of medical devices do not require proof that they have been clinically tested and found to be safe and effective prior to being cleared by the FDA for distribution or sale, according to Consumers Union. The group is also pushing for a better system to monitor and track devices on the market so problems can be quickly identified and patients alerted.

Among the most notable problems have been among patients who received metal-on-metal replacement hips or hip resurfacing treatments. The group  US Drug Watchdog this week launched a campaign designed to  identify every US citizen, who is the recipient of any type of metal on metal  hip implant device since 2004.

A fact sheet on problems with medical device problems on Consumer Union’s web site also calls on changes so the FDA can to use its recall authority more effectively and for lawmakers to provide the agency with authority to require device makers to do long term post market studies, regardless of which process is used in the pre-market phase.

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Toyota Fends Off Punitive Claims

By Gabe Friedman

Daily Journal Staff Writer

Marie Edwards was driving on a wooded road in Shasta County one afternoon in September 2009 when her Lexus sped out of control, barreled at least 150 feet through a grove of trees and into boulders. Edwards died at the scene.

Her family is one of a dozen plaintiffs suing Toyota Motor Corp., alleging a vehicle defect caused her to accelerate unintentionally. But developments in her case may foreshadow a costly battle looming in other litigation: Can Toyota be forced to pay punitive damages for the pain and suffering she endured in the furious few seconds between when the car sped out of control and came to a fatal stop?

As Toyota seeks to fend off lawsuits over alleged unintended acceleration while also voicing concern for safety, the degree of horror or bodily injury a driver faced in the seconds before a crash is likely the last issue the company wants to debate. But John P. Kristensen of O’Reilly Collins, a lawyer for the Edwards family, is pursuing a strategy that could force Toyota to do just that, or face additional liability from punitive damages that could stretch into the millions of dollars.

According to a recent letter between the parties, obtained by the Daily Journal, his strategy is bringing the issue to the forefront.

What plaintiffs like the Edwards family will have to show is that her death was not instantaneous and, therefore, punitive damages for pain and suffering are appropriate.

That’s because of a fissure in California law: A plaintiff can obtain punitive damages under personal injury claims but not wrongful death claims.

“Plaintiffs’ lawyers wouldn’t put it this crassly, but they love personal injury cases even more than wrongful death cases if the injury is severe enough,” said James Gash, an associate dean at Pepperdine School of Law, who specializes in punitive damages.

Gash said some jurisdictions allow punitive damages to attach to wrongful death claims while others do not.

Much of the inconsistency stems from the fact personal injury law and wrongful death law evolved differently: Whereas personal injury law grew out of British common law, wrongful death law grew out of statutes passed by the Legislature.

Georgene Vairo, a Loyola Law School professor who specializes in civil procedure, said the result can create bizarre inconsistencies. For instance, “If you killed somebody, you could actually walk away better than if you mangled somebody,” Vairo said.

As a result, plaintiffs’ lawyers are always searching for “ways of getting back to mangled,” Vairo added.

Kristensen alleges his client’s pain and suffering is real. He filed a survival cause of action, alleging Edwards suffered serious bodily injury in the period leading up to her death.

“My argument is my client obviously had pain and suffering before she died,” he said. “Her vehicle is taking off and going 90 miles per hour into the trees. The terror in and of itself is a form of pain and suffering.”

Vince Galvin, of Bowman and Brooke, represents Toyota. He declined to comment on correspondence with plaintiffs in the case.

But according to a Sept. 27 letter, which an associate at Bowman and Brooke wrote to Kristensen about the matter, the automaker plans to try to knock out the survival claim before it can grow into a full-scale public debate.

“It does not appear that the decedent ‘survived’ the crash,” Curtis Jimerson wrote. “You responded that the decedent was scared in the seconds before the crash, which satisfies the requirement for a survival cause of action. I advised that despite your theory, Toyota may respectfully be compelled to file a responsive pleading to cure the apparent deficiencies in the complaint.”

Legal experts said the letter suggests Toyota will likely file a demurrer, or a motion to strike, that addresses the matter as a procedural error, rather than file a summary judgment motion where the evidence can be weighed.

“To the extent that a party thinks a pleading does not satisfy the requirements of the law, this is the appropriate time to address it,” Galvin said.

Kristensen argued he is on solid ground. His office specializes in aviation law, and he analogized the situation to a plane crash: The families of deceased passengers are often able to obtain punitive damages for the pain and suffering they endure before the crash, he said.

Though the issue has not been heavily litigated in vehicle accidents, he said he found case law to back up his position.

If the survival claim survives, and the case proceeds to trial, Kristensen would likely need to present testimony from the coroner or a doctor as to Edwards’ pain and suffering, experts said. “This becomes part of the settlement negotiations,” said Vairo, the Loyola Law School professor. “What this claim is worth for those 3 seconds – it basically just gives the plaintiffs leverage at the negotiations table.”

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Under the federal Amtrak Reform and Accountability Act of 1997, the most Metrolink and Connex Railroad, which had been contracted to operate Metrolink’s trains, can be liable for in damages from that incident is $200 million — which, in fact, the two entities told a judge Wednesday they are willing to pay to settle the outstanding claims.

That comes out to an average of $1.3 million per victim, before legal fees. A paltry sum given the apparent gross negligence of the engineer, and the medical bills and other damages incurred by those who lost family members, or who were injured themselves.

The proposed settlement in the Metrolink crash could lead to a court challenge over the liability cap, which would be good, Better, though, would be for lawmakers to follow up on their previous criticisms and remove the limit. As we’re seeing in the Gulf oil disaster, such limits only benefit the guilty.

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The short version is Stossel thinks trial lawyers are “parasites.” His word. Why? Well, that’s not really clear, but it seems to come down to lawyers getting a slice of the settlements when juries agree with allegations that doctors, corporations and other defendants erred and damaged the plaintiffs in the process. (And I doubt Stossel works for free, either).

I won’t waste much space on this, since Stossel’s credibility as an independent voice is getting sliced to the core elsewhere. And it is curious that the two lawyers he mentions — John Edwards and Geoffrey Feiger — are Democrats. Republican plaintiffs’ attorney are okay?

It’s hard to argue with conservative voices who insist on people taking responsibility for their actions. Couldn’t agree more. Which is what makes it all the more bizarre when conservative voices argue against doctors, corporations and other entities being held responsible for their mistakes. Lawyers are the last line of defense for the wronged, and even with the inherent problems in the legal system they force accountability from those who pollute, and those who injure or kill people through malpractice, or by putting greed ahead of safety.

Stossel makes it sound as though doctors prescribing an extra test is a bad thing. I’ve never gone under the knife or had a serious illness, but I can tell you I would much prefer a doctor who works in fear of making a mistake than one who feels he or she can gamble with a life with impunity.

And the same goes for businesses that weigh legal exposure as part of a cost-benefit analysis for projects. Only the naive believe corporations operate with the public good in mind. And it’s lawyers with access to the courts that keep them (somewhat) honest.

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Mary Bernstein and Robert Conway died in a fiery crash in 2006 after the driver of a PG&E truck blacked out at the wheel.

In July 2006, John Mayfield blacked out while driving a PG&E truck.  He said the blackout was the result of a faulty insulin injector causing his blood sugar level to fall.  Mayfield’s truck slammed into a group of cars stopped on an Interstate 280 off-ramp in San Jose, killing college students Mary Bernstein and Robert Conway.

Mayfield pleaded guilty to vehicular manslaughter and was sentenced to three years in prison.  Conway’s family settled with PG&E, but Bernstein’s mother, Lisa Bernstein, filed a wrongful death suit against the utility, saying she wanted it to be held accountable.  San Jose Mercury News reporter Tracey Kaplan wrote Bernstein wanted PG&E “to agree to more closely monitor workers’ health and driving records so this never happens to another family.  She contends PG&E should have known Mayfield was hospitalized twice for failing to manage his diabetes and was involved in two other car accidents off the job.”

Bernstein has now agreed to a $5 million settlement. “I was unwilling to let Mary’s death go unnoticed,” Bernstein told the Mercury News.  “I think Mary would approve because she really loved people and this agreement will make the roads safer for people.”

Kaplan added there was more to the settlement than a payout:

Under the terms of the agreement, PG&E agreed to record the resolution as a judgment, rather than a confidential settlement as is often the case.  That means future accident victims will be able to look up the case, which could make it easier for them to negotiate a settlement.  The $5 million payment also raises the value of a single college student’s life, Bernstein said, which typically is rated at under $2 million.

Jose Vega died under similar circumstances last September after a head-on crash with a Verizon Communications pickup driven by Mark Selander on Highway 101 in Santa Barbara.  Selander drove the wrong way on the divided highway for at least five minutes before smashing into Vega’s minivan.

Selander and Verizon argued the crash resulted from a medical emergency similar to a heart attack or a stroke — in this case, the sudden onset of a hypoglycemic attack that caused Selander to go into a “twilight state.”  But attorneys for Vega’s family pointed out Verizon knew Selander had frequent hypoglycemic attacks, as spelled out in a news release from Panish Shea & Boyle:

The evidence reflected that Selander had a long history of hundreds, if not thousands, of hypoglycemic attacks due to his uncontrolled type 1 diabetes.  Selander testified in deposition that he informed his Verizon supervisors personally and by way of personnel file documentation of his type 1 diabetes and his problems with hypoglycemia.  Plaintiffs’ evidence further demonstrated that despite Verizon being informed of these facts clearly reflecting that Selander was not fit to work with any dangerous machinery, Verizon still assigned Selander to job duties which included driving a large pickup truck on public highways.

In addition, Selander was assigned to work the graveyard shift and he worked alone…On September 23, 2009, Selander failed to control his insulin and carbohydrate levels causing a hypoglycemic event. Being familiar with the symptoms of hypoglycemia, Selander knew what all diabetics know–to consume food or juice immediately–and not endanger the public by getting into a vehicle and driving. Selander tried to make a run for the nearby 7-11 and slipped into a twilight state along the way.

Last week, a Santa Barbara County Superior Court judge agreed with the plaintiffs, ordering Verizion to pay $7 million to members of Vega’s family.

Lisa Bernstein wants to help prevent similar tragedies.  Tracey Kaplan wrote Bernstein will push for a law “requiring every company in the state with a fleet of 25 cars or more to be automatically notified when an employee is ticketed or in an accident, as happens now with truckers and other commercial drivers.”  PG&E agreed not to oppose such legislation as part of the settlement of Bernstein’s wrongful death suit.

–J.G. Preston

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