ThePopTort

Oops! Medtronic Did it (Yet) Again!

Several weeks ago, we told you about a Walter Reed surgeon named Timothy Kuklo who was on Medtronic’s payroll when he published a “study” that made false claims and grossly inflated the benefits of the company’s bone-growth product, “Infuse,” in treating wounded soldiers in Iraq.  Medical device companies like Medtronic, you will recall, recently received a unprecented gift from the U.S. Supreme Court - immunity from liability for its most dangerous implants - which the U.S. Congress is now trying to fix.

Since our earlier story about Dr. Kuklo, at the urging of Senator Chuck Grassley (R-IA), Medtronic has disclosed that it paid upwards of $800,000 for Dr. Kuklo’s unique “services.”  And today, the New York Times is reporting that the Justice Department has subpoenaed Medtronic to procure even more info about its ties with the dissembling doc.

The Times also reported that  “the new subpoena comes as the Justice Department and Senator Grassley continue to investigate whether Medtronic violated any federal rules by promoting unapproved uses of Infuse.” Stay tuned!

We’re Keeping Our Ears to the Ground About Sotomayor’s Views on Business

The Sonia Sotomayor speculation games have definitely begun!  Ever since her nomination to the U.S. Supreme Court on Tuesday, policy nerds, pundits, and blearly-eyed bloggers have been in a “wonkadelic” frenzy over who Judge Sotomayor is and how she’s likely to rule on various issues.

Of course, we’re particularly interested in where Sotomayor stands when it comes to battles with the business community—and on that issue, for the most part, the jury appears to be out.  Still, we’ve been keeping our ears to the ground—so we thought we’d share a little about what we're hearing.

What the Media is Saying
•    CNNMoney.com reported that Sotomayor is a “moderate” when it comes to business issues.   BusinessWeek said the same thing.
•    The New York Times characterized Sotomayor’s business opinions as “unpredictable.”
•    The Wall Street Journal  reported that “in business cases, a portrait of Sotomayor” was beginning to emerge—but it didn’t do much to clarify what that “portrait” was. 

The Business Community Is Deeply Divided
•    A very alarmed Michael Greve, writing for the National Review Online, said Sotomayor was “among the most aggressively pro-plaintiff, anti-business appellate judges in the country.” 
•    An old friend of ours over at Dick Cheney’s “favorite thinktank” seemed amused by such dire imaginings, saying Sotomayor “will not be as liberal as many Republicans are saying—but no one could be that liberal even if they tried.”
•    Reps from the big corporate law firm Mayer Brown, (perhaps best known in recent times for representing Stoneridge and Philip Morris) say Sotomayor is a “moderate” when it comes to business issues, and that there’s no reason for the business community “to be alarmed or concerned.”
•    Robin Conrad, head of the U.S. Chamber of Commerce’s litigation arm expressed “guarded optimism” about the president’s pick.

Sotomayor on Preemption
•    Evan Tager from Mayer Brown told BusinessWeek that Sotomayor has been “evenhanded in cases raising federal preemption as a defense, finding preemption about half the time and rejecting preemption about half the time.”  Keeping with the Mayer Brown talking points, his colleague, Lauren Goldman, said the same thing.
•    Roger Parloff, writing for CNNMoney.com, mused that Sotomayor “might actually offer a more receptive ear to business than Justice Souter did,” given Souter’s prior experience as a New Hampshire State AG and judge.

Sotomayor on Punitive Damages
•    Evan Tager said that “Sotomayor has ‘expressed unease’ about large punitive awards, yet has upheld large awards ‘when the ratio of punitive to compensatory damages is modest.’”  Regardless, given Souter’s Exxon Valdez decision in which he suggested in a footnote that punitive damages should perhaps be capped at a 1:1 ratio with compensatory ones, whatever Sotomayor’s position, it’s hard to believe it could be any worse.

Oops! Medtronic Did It Again!

Honestly, civil justice fans, tracking medical device maker Medtronic in the news is beginning to feel a little like watching the tabs during the Britney Spears “spiraling” period (here, here, here).  

Last week, there was a front page New York Times story about a Walter Reed surgeon who was bankrolled by Medtronic when he published a “study” that made false claims and grossly inflated the benefits of the company’s bone-growth product, “Infuse,” in treating wounded soldiers in Iraq. 

Now, Senator Chuck Grassley (R-IA), who really does seem to hate this sort of influence peddling/behind-the-scenes hokum (here, here, here) has launched another one of his letter writing campaigns to get to the bottom of it.

The Justice Department has also been investigating—specifically to see whether Medtronic “illegally promoted uses of Infuse that were not approved by the Food and Drug Administration—by paying doctors, among other alleged measures.”

Cass Sunstein’s Indelicate Balance

The following entry, by Joanne Doroshow and Andy Hoffman, has been cross-posted on InjuryBoard.com.

As the National Transportation Safety Board (NTSB) concludes its three-day public hearing on the crash of Colgan Air Flight 3407 in Buffalo, New York, and it becomes increasingly apparent that shoddy training  was largely to blame, the defense being mounted by Colgan has so far been: don’t blame us, our training was “FAA approved.” 

For those of us familiar with the so-called “preemption defense,” (i.e., I should be immune from lawsuits so long as my reckless behavior adhered to minimal regulatory standards) this argument represents a very tired old saw—one many of us were enjoying a welcome break from after the Supreme Court’s landmark decision in Wyeth v. Levine.   Nevertheless, it does say something about the continued resonance of such arguments (at least, in certain circles), and underscores the importance of not only maintaining consumers’ access to the civil justice system, but also having a federal regulatory system with genuine bite. 

Enter Cass Sunstein, Harvard law professor and Obama friend/colleague from his University of Chicago days, who is perhaps best known for his “cost-benefit” approach to public protection (as well as attacking punitive damages, we might add).  As the Colgan flight 3407 hearings wore on, Sunstein was busy “cruising” through a hearing of his own—with the U.S. Senate, no less—cementing his status as the new White House “regulatory czar.”

Since Reagan came to office, most significant regulations have required the approval of this czar—which can lead to the serious diluting of public protection regulations.  President Bush’s czar, John D. Graham, proved to be a lightening rod of controversy for relying heavily on a cost-benefit approach, endangering the public.  So, when President Obama was elected, health and safety advocates were hungry for the kind of change Obama had been promising.  But unfortunately, it seems all they got was more of the same.   

In their report, “Reinvigorating Protection of Health, Safety, and the Environment: The Choices Facing Cass Sunstein,” the Center for Progressive Reform wrote:

    * Sunstein is a stout supporter of cost-benefit analysis as a primary tool for assessing regulations, despite its imprecision and the ease with which it is manipulated to achieve preferred policy outcomes;
    * He supports such cost-benefit approaches as the widely condemned “senior discount” method for undervaluing the lives of seniors in cost-benefit analyses, an approach even the Bush Administration was forced to disown;
    * He rejects the “precautionary principle” as a basis for regulating, thus ensuring that dangerous pollutants and products will be given the “benefit of the doubt,” rather than well-grounded concerns about health and safety;
    * He supports the centralization of authority over regulatory decisions in the White House – [Office of Management and Budget’s Office of Information and Regulatory Affairs] (OIRA) in particular, even though Congress delegated the exercise of expert judgment to the regulatory agencies, not to OIRA’s staff economists in the White House; and
    * He has written that the Occupational Safety and Health Administration might be unconstitutional.

Sustein has written, for example, that he doesn’t think the toxic contamination of Love Canal, which one article on the EPA website called “one of the most appalling environmental tragedies in American history,” “ever posed significant risks to anyone” and that “people fear things like toxic chemicals or pesticides because of ‘mass delusions’ … availability heuristics (fears fanned by the media), informational and reputational ‘cascades,’ and interest-group campaigns.”

We’re going to hope for the best with Cass Sunstein.  He did testify that he’d be "inclusive and humanized" and more moral in his approach to regulation.   We hope that means better days at the FAA and all the other agencies that turned into corporate shills under Bush 43.  Rena Steinzor, president of the Center for Progressive Reform, called Sunstein’s remarks "very heartening"—but, as she also said,  "the proof will be in the pudding."

One thing seems certain, though.  Regulatory balancing of the public health and safety will continue under this Administration.  Corporations will still be able to block regulatory oversight and weaken safety regulations.  All the more reason why liability must continue to be our the last line of defense against corporate malfeasance.

Love You Back, Manhattan Institute!

It’s always a special treat to be given free publicity by our friends at Dick Cheney’s favorite “think tank,” 
the Manhattan Institute—so hugs to the Institute’s blog, PointofLaw for its extra-special shout out today on our recent story, “Just Say No to Medical Device Hooey.”

Like prior POL hat tips, this one didn’t include much (any) analysis—but it did quote us—which let’s face it, wasn’t quite as cool as being quoted in the sonorous voice of James Earl Jones or something, but it still left us with a warmish feeling.

Most importantly, though, in its own special way, it drew much needed attention to the dangers posed by the most dangerous medical devices, and the total lack of recourse that currently exists for those injured by them in the wake of the Supreme Court’s horrible decision in Riegel v. Medtronic—and that’s a VERY big deal to us (here, here, here).  Come to think of it, even though the Manhattan Institute may not care, we suspect it’s a big deal to Dick Cheney as well, given his well documented reliance on a pacemaker.   And the timing couldn’t have been better as Congress contemplates passing the Medical Device Act. 

Anyway, thanks again for the honorable mention, POL—and next time you see Dick Cheney, tell him that unlike, perhaps, Wanda Sykes, we’re doing everything we can to make sure friends of the Manhattan Institute have access to safe medical devices, and recourse if they’re harmed.  You are welcome!

Weighing Legislation to Overturn Medical Device Immunity

Great hearing today in front of the House Energy and Commerce Committee’s Subcommittee on Health on the need to pass Medical Device Safety Act.

There was a great deal of convincing testimony including Gregory Curfman, M.D., Editor of the New England Journal of Medicine who said, (for his full testimony click here)

Since the Supreme Court ruling in Riegel, thousands of lawsuits against medical-device manufacturers have been tossed out of court by judges following the Court’s lead in deeming such lawsuits to be preempted. We believe that preemption not only strips patients of their rights but also results in medical devices that are less safe for the American people.

There was also compelling testimony from Bridget Robb, the victim of a faulty Medtronic Medical defibrillator lead.  Her story is as follows (for her full testimony click here)

My name is Bridget Robb, and I am a thirty-five year old mother and resident of Gwynedd, Pennsylvania. On December 31, 2007, I suffered greatly and thought I was going to die because of a defective heart device implanted in my body. I am thankful to be here today and am pleased that Chairman Pallone has reintroduced the Medical Device Safety Act, which would restore the rights of patients like me to hold device manufacturers accountable when their products cause injury and sometimes, even death.

Robb had a Medtronic cardiac defibrillator implanted in her chest, which failed, sending shocks to her heart which (31 shocks in total), she said, “felt as if a cannon was being repeatedly shot at my chest at close range.”  Her terrified six-year old daughter told their pet cat that “Mommy’s dying” while Robb called 911.  “Each time I was shocked, I saw my life flash before my eyes. It was excruciating pain. At one point, I began to pass out and thought that I would never see Emma again. Ever since that day, I have been unable to sleep in my own bed due to the trauma I experienced.”  She continued,

I would like to have the opportunity to hold Medtronic accountable for the injuries that I suffered that day and the physical and emotional after-effects that I continue to experience on a daily basis. I find it discouraging and demoralizing that I have no recourse for my injuries, and that a company that manufactured a defective product that has harmed me and thousands of other individuals has no accountability. 
…
It is extremely important that injured patients have a remedy for their injuries and that the costs of their medical expenses and other needs are not borne by Medicare, private insurance, employers and the patients themselves. The medical device industry should be accountable for its products just like drug companies or any other industry.

Meanwhile, yesterday the FDA announced it would review its approval of Menaflex, a knee-surgery device made by ReGen Biologics.  According to the Wall Street Journal, this affair raised “legitimate concerns about whether the agency's review process and decision...were compromised.” 

The bigger problem is that unless Congress fixes the law, anyone harmed or killed by the device has no legal recourse.

In the News

After receiving some 160 complaints from Indiana residents about obnoxious “Your Warranty Will Expire” robocalls (not to mention receiving a few himself, as have many of you!),  Indiana AG Greg Zoeller announced a lawsuit against two companies and an individual for violating several of the state’s telephone privacy laws.

The Committee on Homeland Security and Governmental Affairs will hold a hearing tomorrow on Cass Sunstein’s nomination to head the Office of Information and Regulatory Affairs for OMB.  Sunstein, unfortunately, is no friend of civil justice (see for example). 

Also taking place on the Hill tomorrow…the House Subcommittee on Health will hold a hearing on H.R. 1346, the Medical Device Safety Act of 2009.

The NY Times offered some advice to the U.S. Senate with respect to its much-anticipated anti-predatory lending mortgage bill:  “The way to discourage irresponsible lending is to hold liable both the mortgage originators and the companies to which they sell their sometimes illegal loans. The risk of being hauled into court would make secondary investors more careful and build accountability into the securitization system.”  We couldn’t have said it better ourselves.

The NY Times’ story about a terrible device that mutilates women, which we told you about, has led the paper to join the ever-growing chorus in expressing doubt about whether the FDA regulates medical devices with “sufficient rigor.”

And here are a couple of stories from last week we should tell you about.

The Washington Post took a subtle dig at the U.S. Chamber’s upcoming movie trailer/propaganda campaign—no offense, but we think ours is WAY funnier.  

Casey’s General Stores in Cedar Rapids, IA has agreed to pay more than $12 million to settle two class-action suits brought by employees who were denied overtime pay.

Just Say No—to Medical Device Hooey

As loyal readers of ThePopTort know well, one of our favorite things to do is debunk abject hooey—so today, we’re bringing you this little gem of a “study,” drawn up by MIT professors who were bought and paid for by the Advanced Medical Technology Association (AdvaMed), the leading trade organization for the medical device industry.  (Note the disclaimer at the bottom of the page—it’s the only part of the document worth reading.)  This is an industry, you may recall, that is completely immune from liability for injuring people and they want to keep it that way. 

But it’s not just MIT professors who are being paid off by this industry. Doctors are too.  Just ask New Jersey AG Anne Milgram, who recently settled with a device-maker that provided company stock to doctors who tested and recommended the devices to patients.

“It is outrageous that doctors who are testing, and in many cases, recommending the use of certain high-risk medical devices are being compensated with stock in the very companies that make these devices,” said Milgram.

Sorry Charlie! U.S. Supreme Court Says No Immunity for Chicken of the Sea

Okay, so Charlie the talking tuna was the “pitchfish” for Star-Kist, not Chicken of the Sea—but it made for a snappy headline, so we decided to go with it.  (Besides, we couldn’t think of a logical way to bring Jessica Simpson’s infamous “Chicken of the Sea” moment into it—even though we SO wanted to!)

Anywho…good news for fans of corporate accountability, Wyeth v. Levine, and the like.  The U.S. Supreme Court has quietly decided to allow a state products liability suit to go forward against the canners of Chicken of the Sea (Tri-Union Seafoods LLC) over charges that it failed to warn consumers that ingesting the product could lead to mercury poisoning.

In other words, Wyeth v. Levine really is having the impact we had hoped – i.e., just because a product is regulated by the troubled Food and Drug Administration, that is no assurance the product is safe.  Manufacturers still have the responsibility to make sure people aren’t killed or injured.  Congrat’s to Public Citizen’s Litigation Group on this win!

FDA’s Medical Device Director Calls an “All-Hands Meeting” to Discuss Approval Process

Remember when the U.S. Supreme Court decided to immunize medical device manufacturers from all liability?  Ever wonder if they knew then what they know now, they would have ruled the same way?

Just to give you a quick recap of recent events since the Court ruled…There was the letter-writing campaign led by FDA scientists (here, here), expressing concerns about “serious misconduct” surrounding the agency’s approval of dangerous medical devices.  This was followed by FDA Deputy Commissioner Frank Torti’s “shut up, or else” memo to his staff (here, here), forbidding any whistleblowing-like activities at the risk of “disciplinary sanctions and/or individual criminal liability.”  Senator Chuck Grassley (R-IA) then issued a sharp written rebuke of Torti’s actions—and Torti (perhaps coincidentally), left the agency soon after.

Now, today’s New York Times is reporting that Dr. Donna-Bea Tillman, director of the agency’s office of device evaluation, has called for an “all-hands meeting” to discuss the “strategic direction” of the device center.  According to the Times, it has been at least two years since any similar meeting has taken place.

The meeting comes on the heels of “numerous email messages” from agency scientists to principal deputy commissioner Dr. Joshua Sharfstein, as well as a memo to Sharfstein from the group, charging that the “’regulatory review process for medical devices has been severely distorted’ and that those who raised concerns about unsafe devices had been retaliated against by agency managers.”

Meanwhile, a Congressional investigation of the scientists’ concerns is underway, and the Government Accountability Office recently released a less-than-flattering report about the agency’s device center.  Congress is also considering legislation this week that would ask the Institute of Medicine to investigate the troubled division.

Of course, trouble with the FDA’s device approval process doesn’t exactly come as news to us and we’re happy to see that constructive steps seem to be underway to right the course of an agency that has been adrift for far too long.  Still, all of this underscores the important role that lawsuits play (and always have played) in supplementing the regulatory efforts of federal agencies—and more specifically, how critical it is that the Medical Device Act gets passed—soon!